[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4917-4941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01838]



[[Page 4917]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-07]


Bradley H. Chesler, M.D.; Decision and Order

    On January 8, 2020, a former Assistant Administrator, Diversion 
Control Division, of the Drug Enforcement Administration (hereinafter, 
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to 
Bradley H. Chesler, M.D. (hereinafter, Respondent) of Escondido, 
California. Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, 
(OSC) at 1. The OSC proposed the revocation of Respondent's DEA 
Certificate of Registration No. BC1317165 (hereinafter, COR or 
registration) and the denial of any pending application to modify or 
renew the registration and any applications for any other DEA 
registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because 
Respondent's ``registration is inconsistent with the public interest.'' 
Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
    On January 28, 2020, counsel for the Respondent requested a 
hearing, which, following a series of continuances due to the COVID-19 
pandemic, was conducted August 25, 2020, through September 1, 2020, at 
the DEA Hearing Facility in Arlington, Virginia with parties, counsel, 
and witnesses participating by video teleconference (VTC). On November 
5, 2020, Chief Administrative Law Judge John J. Mulrooney, II 
(hereinafter, the Chief ALJ) issued his Recommended Rulings, Findings 
of Fact, Conclusions of Law and Decision of the Administrative Law 
Judge (hereinafter, Recommended Decision or RD). On December 2, 2020, 
the Respondent filed exceptions to the Recommended Decision 
(hereinafter, Resp't Exceptions) and on December 15, 2020, the 
Government filed its Response to Government's Exceptions (hereinafter 
Gov't Response). I address the Respondent's Exceptions in the 
Recommendation Section, and throughout the relevant portions of the 
record and I issue the final order in this case following the RD. The 
ALJ transmitted the record to me on February 19, 2020. Having reviewed 
the entire record, I adopt the ALJ's rulings, findings of fact, as 
modified, conclusions of law and recommended sanction with minor 
modifications, where noted herein. *\A\
---------------------------------------------------------------------------

    *\A\ I have made minor, nonsubstantive, grammatical changes to 
the RD and nonsubstantive conforming edits. Where I have made 
substantive changes, omitted language for brevity or relevance, or 
where I have added to or modified the Chief ALJ's opinion, I have 
noted the edits in brackets, and I have included specific 
descriptions of the modifications in brackets or in footnotes marked 
with an asterisk and a letter. Within those brackets and footnotes, 
the use of the personal pronoun ``I'' refers to myself--the 
Administrator.
---------------------------------------------------------------------------

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

    *\B\ After carefully considering the testimony elicited at the 
hearing, the admitted exhibits, the arguments of counsel, and the 
record as a whole, I have set forth my recommendation findings of fact 
and conclusions of law below.
---------------------------------------------------------------------------

    *\B\ I have omitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
---------------------------------------------------------------------------

The Allegations

    Although, as discussed in greater detail, infra, much of the OSC in 
this case is burdened with a drafting peculiarity, it is clear that the 
Government's intent is to seek revocation of the Respondent's COR based 
on the alleged commission of acts that would render the continuation of 
his registration status as being inconsistent with the public interest. 
See ALJ Ex. 1 at 1. At principal issue in the case is the Respondent's 
controlled substance prescribing as it relates to ten patients. Four of 
the patients (collectively, Board Patients) were the subject of 
findings by the Medical Board of California, and charts of the other 
six patients (collectively, Six Patients) were reviewed by the 
Government's medical expert.\1\ On consent of the parties, the OSC in 
this matter was amended in accordance with a post-hearing order 
granting partial summary disposition. ALJ Ex. 25.
---------------------------------------------------------------------------

    \1\ Specific patients are referred to by their initials in this 
Recommended Decision. The Board Patients include Patients A, B, D, 
and E, ALJ Ex. 1 ] 31, while Patients AA, BB, JD, DD, SM, and ET 
comprise the Six Patients, id. ]] 8-30. The Government does not 
allege that there is any overlap between these two sets of patients. 
Id. at 11 n.14.
---------------------------------------------------------------------------

The Evidence

Stipulations

    The parties entered into factual stipulations which were accepted 
prior to the commencement of the hearing. Accordingly, the following 
factual matters are deemed conclusively established in this case:
    1. The Respondent currently possesses DEA COR No. BC1317165, which 
expires by its own terms on August 31, 2020.\2\
---------------------------------------------------------------------------

    \2\ Inasmuch as the parties agree that the Respondent has 
represented that he has made timely application for a renewal of his 
COR (ALJ Exs. 39, 40), his registration remains intact pending the 
conclusion of these proceedings. See 5 U.S.C. 558(c); 21 CFR 
1301.36(i).
---------------------------------------------------------------------------

    2. The Respondent was issued California Physician and Surgeon 
License No. A43963 on August 31, 1987.
    3. Alprazolam is a Schedule IV Controlled Substance.
    4. Carisoprodol is a Schedule IV Controlled Substance.
    5. Fentanyl is a Schedule II Controlled Substance.
    6. Hydrocodone is a Schedule II Controlled Substance.
    7. Hydromorphone is a Schedule II Controlled Substance.
    8. Lorazepam is a Schedule IV Controlled Substance.
    9. Morphine is a Schedule II Controlled Substance.
    10. Oxycodone is a Schedule II Controlled Substance.
    11. Temazepam is a Schedule IV Controlled Substance.

The Government's Case

The Diversion Investigator

    The Government presented the evidence of Diversion Investigator 
(hereinafter, DI). DI testified that he has been a DI for two and a 
half years, the majority of which has been in DEA's San Diego Field 
Office. Tr. 45-46. DI was the lead investigator in the case that 
culminated in the present charges. Tr. 46-47. He testified that the 
investigation into the Respondent began when DEA received information, 
around March 2019, from the Medical Board of California that an 
accusation was filed against the Respondent for over-prescribing 
controlled substances. Tr. 47. DI's testimony was used to authenticate 
a number of Government Exhibits,\3\ consisting of documents

[[Page 4918]]

obtained during the course of the investigation. Among the exhibits 
introduced through the testimony of DI was an order (Board Order) 
issued by the Medical Board of California (MBC or the Board) regarding 
the Respondent's treatment of the four Board Patients. See Gov't Ex. 
30.
---------------------------------------------------------------------------

    \3\ Government Exhibit 1 is a print-out of the Respondent's COR. 
Gov't Ex. 1. Government Exhibit 2 contains medical records for 
Patient AA. Gov't Ex. 2. Government Exhibit 3 comprises 
prescriptions for Patient AA, taken from Government Exhibit 2. Gov't 
Ex. 3. Government Exhibit 4 contains medical records for Patient BB. 
Gov't Ex. 4. Government Exhibit 5 comprises prescriptions for 
Patient BB, taken from Government Exhibit 4. Gov't Ex. 5. Government 
Exhibit 6 contains medical records for Patient JD. Gov't Ex. 6. 
Government Exhibit 7 comprises prescriptions for Patient JD, taken 
from Government Exhibit 6. Gov't Ex. 7. Government Exhibit 8 
contains medical records for Patient DD. Gov't Ex. 8. Government 
Exhibit 9 comprises prescriptions for Patient DD, taken from 
Government Exhibit 8. Gov't Ex. 9. Government Exhibit 10 contains 
medical records for Patient SM. Gov't Ex. 10. Government Exhibit 11 
comprises prescriptions for Patient SM, taken from Government 
Exhibit 10. Gov't Ex. 11. Government Exhibit 12 contains medical 
records for Patient ET. Gov't Ex. 12. Government Exhibit 13 
comprises prescriptions for Patient ET, taken from Government 
Exhibit 12. Gov't Ex. 13. Government Exhibit 14 is a CURES report 
for Patient AA. Gov't Ex. 14. Government Exhibit 15 is a CURES 
report for Patient BB. Gov't Ex. 15. Government Exhibit 16 is a 
CURES report for Patient JD. Gov't Ex. 16. Government Exhibit 17 is 
a CURES report for Patient DD. Gov't Ex. 17. Government Exhibit 18 
is a CURES report for Patient SM. Gov't Ex. 18. Government Exhibit 
19 is a CURES report for Patient ET. Gov't Ex. 19. Government 
Exhibit 30 is a decision by the California Board concerning the 
Respondent. Gov't Ex. 30. Government Exhibit 31 is a report from the 
Medical Examiner for Patient AA. Gov't Ex. 31. Government Exhibit 37 
is a portion of a CURES report concerning the Respondent, from 
November 2019 to August 2020 and pertaining to Patient SM. Gov't Ex. 
37.
---------------------------------------------------------------------------

    DI presented as an objective regulator and investigator with no 
discernable motive to fabricate or exaggerate. In addition to being 
uncontroverted, the testimony of this witness was sufficiently 
detailed, plausible, and internally consistent to be afforded full 
credibility in this case.

Dr. Timothy Munzing, M.D.

    The Government presented the expert testimony of Dr. Timothy 
Munzing. Dr. Munzing's curriculum vitae (CV) \4\ reflects nearly four 
decades of experience practicing primary care medicine,\5\ teaching, 
and serving as a medical expert reviewer for various state and federal 
agencies in cases involving controlled substance prescribing.\6\ Tr. 
72; Gov't Ex. 20. The witness testified that he is (and for thirty-five 
years has been) a clinical professor at the University of California, 
Irvine,\7\ and among his published scholarly work is an article 
published in a peer-reviewed publication regarding controlled substance 
prescribing. Tr. 74-75, 81; Gov't Exs. 20, 35. Dr. Munzing was tendered 
\8\ and accepted as an expert witness in the prescribing of controlled 
substances in the State of California, including for the management of 
pain. Tr. 89.
---------------------------------------------------------------------------

    \4\ Gov't Ex. 20.
    \5\ Dr. Munzing testified that most pain management treatment in 
the United States is conducted by primary care physicians. Tr. 88-
89.
    \6\ Dr. Munzing testified that he has been compensated for his 
professional work as an expert, including by DEA in this case. Tr. 
83.
    \7\ Tr. 80.
    \8\ Tr. 76.
---------------------------------------------------------------------------

    Dr. Munzing agreed to confine his testimony to outlining the 
standard of care for controlled substance prescribing in California, 
and to avoid conflating the bedrock standards with any discussion of 
best practices or his view of optimum treatment options. Id. at 93-94, 
205-06. According to Dr. Munzing, under the applicable standard in 
California, the process of controlled substance prescribing must 
commence with the taking of a patient history. Id. at 94. The history 
must include queries about the length, location, and duration of any 
pain symptoms, as well as any comorbid medical or mental health 
conditions, and what (if any) treatment modalities have been deployed 
to date. Id. at 94-95. Any and all controlled and non-controlled 
medications being taken by the patient must be factored into the 
history. Id. at 96. In Dr. Munzing's view, where controlled substances 
have been utilized, strong consideration must be given to any 
indications of historical drug and/or alcohol abuse. Id. at 95.
    A physical examination that includes the taking of vital signs and 
a detailed, focused examination of the locus of any discomfort is also 
a required element that must precede controlled medication prescribing. 
Id. at 96-97. Comorbid physical conditions encountered in a physical 
exam (e.g., breathing or cardiac issues) may impact prescribing 
decisions. Id. at 97.
    The third prescribing prerequisite, according to the witness, is 
reaching a determination as to whether to order additional objective 
testing of the patient. Id. at 98. Where controlled substances are 
contemplated by the physician, he/she should query the state 
prescription monitoring program (PMP), which in California is the 
Controlled Substance Utilization Review and Evaluation System (CURES). 
Id. at 98-99.
    According to Dr. Munzing, the fourth step in the prescribing 
process is to assess the patient based on the information acquired in 
the other steps. Id. at 100. The physician must process available 
information to formulate a differential diagnosis of the etiology of 
the symptoms. Id. at 100-02. An important element of the assessment 
stage is to stratify the patient's risks of opioid or other substance 
abuse attendant upon utilizing controlled substances. Id. at 99, 102-
04. The risk stratification piece of the equation remains an ongoing 
evaluation throughout the treatment of a patient as an aspect of 
meeting the applicable standard of care. Id. at 108-10.
    Once the assessment has been conducted, the next step in the 
process is to individualize the treatment of the patient by setting 
objectives and procuring informed consent for the designated treatment 
modalities. Id. at 104-05. Informed consent includes ``[n]otifying the 
patient about the common potential side effects or adverse effects,'' 
as well the additional risks posed by taking controlled substances as 
prescribed, to include addiction or substance use disorder, overdose, 
and death. Id. at 131-N; see also id. at 205-06.
    Dr. Munzing stressed that throughout the process, ``clear[,] true, 
and . . . appropriate documentation'' is a required element of the 
standard of care for controlled substance prescribing in California. 
Id. at 105-07. The witness explained the documentation requirements 
this way:

    Document . . . the history . . . , document the exam, document 
the vital signs, document . . . how you came up with the risk 
stratification, document the assessment. If you've done laboratory 
imaging, document those, and then document an appropriate management 
plan including either in the [progress] note or separate from the 
[progress] note an informed consent, especially sharing the most 
serious potential problems of the management figure.

Id. at 106-07.
    Dr. Munzing's view is that treatment risk stratification, coupled 
with periodic informed consent, is a process that must continue 
throughout the treatment of the patient. Id. at 111. A high-risk 
patient should be re-stratified and get renewed informed consent 
annually, whereas a lower risk patient can be addressed less frequently 
in this regard. Id. at 111, 204.
    The Government's expert testified that he reviewed patient charts 
corresponding to the Six Patients \9\ from the Respondent's practice 
and determined that the Respondent's controlled substance prescribing 
did not meet the applicable standard of care in California.\10\ Tr. 
120. There were numerous observations that Dr. Munzing offered in 
support of his position. For example, the progress notes showed no 
indicia that the Respondent or his staff conducted a physical 
examination, gauged heart or lung function, performed an abdomen check, 
[on AA] or took any vital signs from the other patients [over the 
majority of time period covered by the allegations].*\C\ Gov't Exs. 2, 
4, 6, 8, 10; Tr. 165-66, 182, 191, 193, 231-32

[[Page 4919]]

(Patient AA); <SUP>11 </SUP>*<SUP>D</SUP> Tr. 407-08 (Patient BB); Tr. 
384-89 (Patient JD); Tr. 477-79 (Patient DD); Tr. 329-31, 349-52 
(Patient SM). Further, Dr. Munzing identified instances where the 
Respondent's patients were maintained on doses of medications that far 
exceeded the morphine milligram equivalent (MME) \12\ recommended by 
the Centers for Disease Control and Prevention (CDC) \13\ guidance 
without documentation that the patient was afforded an informed consent 
that explained the risks inherent in such treatment. Tr. 120; Gov't 
Exs. 2-8, 10-13; Tr. 132-37, 139, 141-43, 145, 148-49, 156-57, 164-65, 
169, 179-84, 191-92, 204-05, 224-25, 231-32, 271, 306-07 (Patient AA); 
Tr. 401-02, 406-07, 409-15, 417-22 (Patient BB); Tr. 384-89, 393-400 
(Patient JD); Tr. 477-79, 481-84, 488, 490-95 (Patient DD); Tr. 314-17, 
321-23, 328-32, 350-51, 353-56, 360-62, 365, 370-72, 377-82 (Patient 
SM); *\E\ Tr. 424-29, 431-35, 437-38, 440-47, 450 (Patient ET). 
Likewise, controlled substances were prescribed in high-risk 
combinations \14\ that significantly elevated the risk of such things 
as central nervous system (CNS)/respiratory depression, overdose, and 
death \15\ without documented informed consent. Gov't Exs. 2-8, 10-13; 
Tr. 157-58, 164-65, 167, 191-92, 224-26, 231-32, 276-78, 302-03 
(Patient AA); Tr. 409-14, 418-22 (Patient BB); Tr. 387, 393-400 
(Patient JD); Tr. 477-81, 483-84, 488, 490-94 (Patient DD); Tr. 321-23, 
329-32, 351-56, 360-62, 365, 370-72, 377-82 (Patient SM); Tr. 424-29, 
431-35, 437-38, 440-47, 450 (Patient ET). Dr. Munzing also identified 
instances in the Respondent's patient charts where clear flags of 
potential diversion were present but not resolved prior to controlled 
substance prescribing. For example, the witness pointed to places in 
the medical records where anomalous urine drug screens (UDSs) were 
recorded, yet seemingly ignored,\16\ without documented patient 
counseling or medication modification. Gov't Exs. 3, 11, 13; Tr. 149-
55, 180-82, 196, 198, 206-09, 224-26, 228-31, 271-75, 279-82, 289-302 
(Patient AA); \17\ Tr. 362-64, 371-72 (Patient SM); Tr. 438-440 
(Patient ET). Another category where the Government's expert found 
prescribing that, in his view, was below the applicable standard was in 
the area of early refill prescribing. According to Dr. Munzing, the 
charts he reviewed showed many instances where the Respondent wrote 
prescriptions refilling controlled substance prescriptions before the 
prior medications should have been expended.\18\ Gov't Exs. 2-5, 8, 10, 
11; Tr. 158-59, 169-72, 177-78, 180-81, 184-89, 224-26, 271 (Patient 
AA); Tr. 409-17 (Patient BB); Tr. 486-89 (Patient DD); Tr. 338-47, 349-
50 (Patient SM).*\F\ Dr. Munzing testified that regarding Patients 
AA,\19\ BB,\20\ JD,\21\ DD,\22\ SM,\23\ and ET,\24\ over 150 controlled 
substance prescriptions were issued below the applicable standard in 
California, and were thus not issued in the usual course of 
professional practice by the Respondent.
---------------------------------------------------------------------------

    \9\ Patients AA, BB, JD, DD, SM, and ET.
    \10\ Some of the prescriptions reviewed by the Government's 
expert included those issued by physician assistants (PAs) who 
worked within the Respondent's practice. Dr. Munzing's testimony 
that the Respondent was responsible for the prescriptions issued by 
these PAs, see Tr. 174, is in accord with California Business and 
Professions Code Sec.  3502.1(d).
    *\C\ I have amended this sentence based on Respondent's 
Exceptions, which noted that Dr. Munzing's testimony regarding the 
lack of physical examination and lack of heart and lung function and 
abdomen check were limited to Patient AA--the patient who died of an 
overdose, and which noted that Respondent began taking vital signs 
from his patients in 2018. Resp't Exceptions at 12.
    \11\ Although the chart maintained by the Respondent's practice 
on Patient AA reflected a diagnosis of hypereosinophilic syndrome 
(HES), it is Dr. Munzing's judgment that references in the record 
that conflate this treatment with cancer are not accurate. Tr. 194. 
Further, Dr. Munzing testified that the Respondent's progress notes 
indicate that the pain medication prescribed for this patient by the 
Respondent were to treat a lower back ailment, not HES. Id. at 194-
95. As discussed, supra, the San Diego Medical Examiner reached a 
similar conclusion. Gov't Ex. 31 at 5.
    *\D\ Dr. Munzing testified that there must be some exam even for 
an established patient, because ``this patient is at much higher 
risk. We don't know whether anyone is checking the patient's heart, 
lung exam, vital signs, despite these levels. Because of that, 
you're monitoring the patient to try to keep them as safe as 
possible.'' Tr. 166. When asked if he could point to a source for 
this statement, Dr. Munzing credibly stated, ``Do I know anywhere 
where it says you must do exactly this? No, but I do know that one 
needs to monitor and try to keep the patient as safe as possible. 
That's part of trying to keep the patient as safe as possible.'' Id. 
at 168. I credit Dr. Munzing's testimony.
    \12\ Dr. Munzing testified that the MME is a protocol by which 
medications can be compared by using an equivalent dosage of 
morphine as a common denominator. Tr. 121-22. In California (and in 
the present record), the term morphine equivalent dosage (MED) is 
used interchangeably with MME. Id. at 22, 121-23. The record 
contains MME conversion tables published by the Center for Medicare 
and Medicaid Services (CMMS) and the Centers for Disease Control and 
Prevention (CDC). Gov't Exs. 26, 27; Tr. 124-31.
    \13\ The witness testified that the CDC set 90 MME as a high 
dose. Tr. 131-L; see also Gov't Ex. 23 at 24-25. [However, Dr. 
Munzing stated that there is no maximum MME because ``some patients 
need a higher amount, and so there's--there's no written absolute 
amount, but there's certainly--one certainly needs to look at the 
risk to the patients, the potential benefits, and attempt to 
mitigate the risks.'' Tr. 131-B.]
    *\E\ For example, Dr. Munzing testified that on October 31, 
2016, Respondent prescribed SM, Soma, diazepam, fentanyl patch, 
oxycodone, and Norco, and the combined MME of the three opioids is 
960 and included the trinity cocktail (see n.14). Tr. 353-55l; see 
also, e.g., Tr. 389 (1,234 MME to JD); Tr. 407 (1,920 MME to BB).
    \14\ Dr. Munzing testified that a particularly high-risk 
combination includes an opioid, benzodiazepine, and muscle relaxer. 
Tr. 324-26. This combination, colloquially known as ``the trinity,'' 
creates increased euphoria, which increases the risk of substance 
use disorder, and elevates the risk for respiratory depression. Id. 
at 323-26. [Respondent prescribed the trinity to Patient S.M. Tr. 
323, e.g. GX 11 at 11 and 281. Dr. Munzing further opined that the 
trinity prescription was a ``red flag'' of abuse or diversion. Tr. 
324. He testified that it was not always outside the standard of 
care to prescribe the trinity in 2016, but ``you are adding to the 
risk for the patient, both the risk of addiction, the risk of 
overdose, and the risk of death. And when you are increasing the 
risk, one needs to really identify it, notify the patient, and 
divulge to the patient that they are at increased risk.'' Tr. 395-
96.]
    \15\ Tr. 167.
    \16\ In some instances, in the face of obviously anomalous UDS 
results, the chart incorrectly reflected that the results were 
consistent with the patient's treating program. Tr. 198-200, 209, 
216; Gov't Ex. 2 at 75 (Patient AA); [see also e.g., Tr. 364 (Gov't 
Ex. 10 at 517 (UDS negative for opioids SM was prescribed and the 
note says UDS is ``consistent with the medication program.'')]
    \17\ According to Dr. Munzing, chart notes that indicate that 
some of the medication was prescribed to be taken ``PRN'' (as 
needed) do not resolve the conflict because the dosage level was 
sufficiently high that declining to take the medication for the 
three days or so it would take to produce a clean urine catch would 
result in profound withdrawal symptoms. Tr. 151-53, 281-87. 
Additionally, if the patient was taking the medication sporadically, 
the refills would not have been as consistent as the records 
indicate they were. Id. at 151-55, 209, 281-89.
    \18\ Dr. Munzing acknowledged that on a very occasional basis, 
to accommodate life contingencies such as weekends and vacations, 
the standard of care can absorb one or two days of flexibility 
regarding refill timing. Tr. 158. However, where the early 
prescribing forms a pattern resulting in a significant potential 
reservoir of extra medication, as is the case with the Respondent's 
patients, the controlled substance prescribing falls below the 
standard of care. Id. at 158-63. The standard of care requires that 
early prescription fills have an annotated ``do not fill before'' 
note on the prescription. Id. at 162-63. Dr. Munzing's view is that 
irrespective of the date the medication is ultimately dispensed to 
the patient (a date which can be procured by a query to the CURES 
system), it is the early prescribing of the drug that renders a 
prescribing event below the applicable standard of care. Id. at 175-
76. [``When you repeatedly write it early then it's providing 
opportunity for the patient to get more than what you're 
prescribing.'' Tr. 176). Additionally, the] Government's expert 
testified that the early refill phenomenon was confirmed by 
consultation with CURES [demonstrating that the individuals had in 
fact filled the prescriptions early on the dates that they were 
prescribed]. Tr. 217-21; Gov't Ex. 2 at 14-15.
    *\F\ Dr. Munzing testified that, for example, for Patient SM, 
prescriptions were issued two days early for a year. Tr. 347 (e.g. 
Gov't 11 at 45-46 (prescriptions for Valium, fentanyl patches, 
oxycodone and Norco)). He stated that for SM there are ``over a 
dozen times in a row where every time you're approximately two days 
early or average two days early. Over time, you've ended up getting 
a lot of extra medication. And either that medication is going and 
used by the patient in addition to what was felt necessary by the 
doctor. Or they may end up diverted in some other way.'' Tr. 348. He 
concluded that although this might happen a few times and not cause 
concern, ``after three or four times it arose, then it becomes a 
pattern and becomes a problem that you are falling below the 
standard of care.'' Id. at 348. Another example of early fills 
occurred to Patient DD, who was prescribed high dosages of opioids 
between 1-6 days early over sequential months. Tr. 486-491; Gov't 
Ex. 9 at 189-198.
    \19\ Tr. 164, 192-93, 195, 203-04, 210-12, 225, 232, 271-73, 
275-76, 278-79, 292, 295, 300-01, 303-06.
    \20\ Tr. 407-08, 415-16, 418, 421-22.
    \21\ Tr. 388-89, 393-97, 400-01.
    \22\ Tr. 486, 487-96.
    \23\ Tr. 332, 352, 365, 369, 371.
    \24\ Tr. 429-32, 435, 437-38, 442, 446, 450.
---------------------------------------------------------------------------

    One of the Six Patients merits additional discussion. On November 
11, 2017, Patient AA died in his apartment

[[Page 4920]]

due to a drug overdose. Gov't Ex. 31 at 5. The San Diego Chief Deputy 
Medical Examiner (ME) ruled the cause of death as ``fentanyl, 
clonazepam, alprazolam, ketamine, hydrocodone, and morphine toxicity,'' 
and determined that the overdose was accidental. Id. Interestingly, 
although the Medical Examiner's report (ME Report), like much of the 
Respondent's progress notes, noted that Patient AA's ``medical history 
was significant for `terminal blood and bone marrow cancer,' '' the 
examination revealed that ``[n]o terminal malignancy was identified.'' 
Id. Thus, the Medical Examiner's conclusions in this regard are 
consistent with Dr. Munzing's view that the HES that Patient AA was 
afflicted with was not cancerous,*\G\ and that the Respondent's pain 
protocols were directed at the patient's lower back ailments. Tr. 194-
95. Dr. Munzing testified that among the drugs listed in the ME Report 
as toxicity causes of death, the Respondent's practice was prescribing 
hydrocodone and morphine, and that the charts demonstrated awareness 
that Patient AA was also taking a benzodiazepine.\25\ Tr. 310. [Dr. 
Munzing testified that these two prescriptions, ``were felt to be 
contributors to the death, the hydrocodone and the morphine,'' and that 
it was not just one of the controlled substances that caused death, but 
a ``multitude, it's toxicity, a multitude of drugs including a couple 
[Respondent] prescribed.'' Id.]
---------------------------------------------------------------------------

    *\G\ I note that Respondent took Exception to the fact that the 
Chief ALJ ``seems to insinuate that because no malignancy was found 
during post mortem examination, that AA's HES was not cancerous.'' 
Resp't Exceptions at 17 (citing RD at 9). It is not relevant to this 
case whether AA's malignancy ultimately was cancerous. It would only 
be relevant if I were to credit Dr. Polston's testimony that there 
is a different standard of care for cancer patients. I agree with 
the Chief ALJ and do not credit that testimony. See infra n.87.
    \25\ According to Dr. Munzing, alprazolam, a specific causal 
medication cited in the ME Report, was one of the three 
benzodiazepines that the Respondent was prescribing. Tr. 310-11. Dr. 
Munzing also noted that the ME Report found evidence of oxycodone in 
Patient AA's system (Gov't Ex. 31 at 11), but apparently did not 
find the drug in a sufficient quantity that it was included among 
the toxicity causes of death. Tr. 311-12.
---------------------------------------------------------------------------

    Overall, Dr. Munzing's testimony was authoritative, reasonable, and 
supported by the admitted evidence of record. The witness presented as 
a qualified, knowledgeable, and dispassionate expert evaluator of the 
Respondent's controlled substance prescribing practices. Although, 
unlike the Respondent and Dr. Polston, Dr. Munzing does not practice 
pain medicine exclusively and does not hold a Board subspecialty in 
pain management, his testimony was supportive, objective, and 
convincing. Dr. Munzing's testimony was unburdened by the keen interest 
that the Respondent has in the outcome of the case. Indeed, as 
discussed elsewhere in this Recommended Decision, Dr. Munzing's 
presentation was sufficiently persuasive that on several occasions the 
Respondent accepted Dr. Munzing's conclusions and changed his practices 
*\H\ as a result of what he heard at the hearing. As discussed, infra, 
when confronted by the Respondent's agreement with Dr. Munzing's 
testimony, Dr. Polston actually altered his view to conform with the 
Respondent's version. This willingness to support the Respondent's 
opinions based merely on being advised of them undermined the weight 
that could be attached to Dr. Polston's presentation. Accordingly, in 
this Recommended Decision, Dr. Munzing's opinions will be afforded 
controlling weight.
---------------------------------------------------------------------------

    *\H\ Respondent argued in his Exceptions that he only changed 
one practice as a result of the hearing. Resp't Exceptions at 18. 
However, Respondent does argue that he changed other of his 
practices before the hearing. Id. I take note of this discrepancy, 
and to the extent Respondent finds it important, agree that the 
record only demonstrates that he only changed one of his practices 
as a result of the hearing. Respondent continues to adhere to his 
position that the new practice regarding refills that he instituted 
as a result of the hearing is not mandated by the standard of care, 
in spite of his own actions and the Chief ALJ's finding herein that 
the substantial evidence in the record demonstrates that it is. Id. 
(``Physicians in the San Diego area prescribe in this fashion, and 
Dr. Polston testified it is not below the standard of care to refill 
medications two days early. [] Notwithstanding this, Respondent took 
notice of what Dr. Munzing stated and immediately changed his 
practice to remedy this issue.'') The Government points out that in 
spite of similar arguments from Respondent in the MBC case, the MBC 
found that it was a violation for Respondent to prescribe greater 
than a 30 day supply, and yet, Respondent did not change this 
practice until August of 2020. Gov't Response at 30 (citing Gov't 
Ex. 30 at 134). Although Respondent changed this practice at the 
hearing, I cannot be sure that he will continue to implement this 
change in the future given his delay in recognizing the failure and 
his continued arguments that the practice is not required.
---------------------------------------------------------------------------

The Respondent's Case

The Respondent

    The Respondent presented his own testimony at the hearing. He 
testified that since his graduation from the University of Minnesota in 
1985, and the completion of his residency at the University of 
California, Irvine, he has been practicing medicine for over thirty-one 
years, all in Escondido, California. Tr. 895-97. The Respondent's CV 
\26\ reflects that he is Board Certified in Physical Medicine and 
Rehabilitation and holds subspecialty certifications in Pain Medicine 
and Neuromuscular and Electrodiagnostic Medicine. Resp't Ex. G; see 
also Tr. 899. The Respondent reckons that he has treated over 20,000 
patients in the course of his professional life, and that his current 
patient base consists of adults between the ages of 18 and 97, each of 
whom has ``a pain condition that causes some sort of functional 
deficit.'' Tr. 900-01. According to the Respondent, the patients carry 
``diagnoses from orthopedic, to neurology, to stroke, to debilitating 
rheumatologic diseases.'' Id. The Respondent testified that as a pain 
specialist, he routinely handles patients with high-impact pain 
conditions,\27\ that 100% of his patient base is referrals, and that at 
the outset of patient establishment he vets the patients for doctor 
shopping, early refills, indicators of abuse and/or diversion, and on 
some occasions has referred prospective patients to addictionologists. 
Tr. 949-50. By his own account, he has never been sued for malpractice, 
never settled any malpractice litigation, and other than his recent 
entanglements with the California Board, his state medical license has 
never been subjected to sanction or limitation. Id. at 901.
---------------------------------------------------------------------------

    \26\ The Respondent's CV was received into the record. Resp't 
Ex. G; Tr. 898.
    \27\ The Respondent testified that he employs the Stanford 
definition of high-impact pain conditions, which he explained as 
``somebody that's had pain greater than six months, with significant 
functional deficits.'' Tr. 951. The Respondent further explained 
that high-impact pain patients are a subset of chronic pain 
patients, with the latter comprising 20% of all national pain 
patients and the former representing 8%, with some ``affect [on] 
function in some form, [that is,] standing, walking, sitting, 
driving, sleeping, [and] self-care.'' Id. at 952.
---------------------------------------------------------------------------

    During his testimony, the Respondent narrated those of the 
Government's allegations which he accepts, elaborated on some areas 
where he took issue, and in other areas he assumed a hybrid, more 
nuanced stance.
    Regarding the Government's allegation that ten \28\ aberrant UDS 
results related to Patient AA were not adequately addressed and 
documented by patient queries and resolution,\29\ the Respondent simply 
confessed error without particular equivocation. Tr. 934. Regarding his 
custom of simply marking aberrant UDS results with the letters PRN 
(i.e., that the medication was written to be taken as needed), the 
Respondent agreed that he ``needed to do more questioning of the 
patient, more documentation of that questioning, and then more reaction 
in terms of the patient reactions.'' Id.; see also id. at 1071.
---------------------------------------------------------------------------

    \28\ This allegation was modified from 12 to 10 instances on the 
unopposed motion from the Government. ALJ Ex. 25.
    \29\ ALJ Ex. 1 ] 14.d.

---------------------------------------------------------------------------

[[Page 4921]]

    Similarly, the Respondent confessed error regarding the manner in 
which he timed his prescriptions which, as the Government alleged,\30\ 
resulted in the potential for significant reservoirs of excess medicine 
for Patient AA. Tr. 935-39. While commending himself for his practice 
of seeing Patient AA every twenty-eight days, the Respondent testified 
that he has now implemented corrections to his prescribing practice 
which circumscribes future controlled substance prescriptions to 
twenty-eight days.\31\ Tr. 936-39, 1071.
---------------------------------------------------------------------------

    \30\ ALJ Ex. 1 ] 14.e.
    \31\ The Respondent later explained that he realized the 
validity of this aspect of his prescribing while listening to Dr. 
Munzing's testimony, and started to implement corrective actions 
during the course of this hearing. Tr. 1311-12.
---------------------------------------------------------------------------

    The Respondent also conceded that to the extent the Government 
alleges \32\ that he failed to adequately document the basis for the 
extremely high opioid dosage he prescribed to Patient AA, that is true. 
Tr. 928-29. The Respondent refined his position in this way:
---------------------------------------------------------------------------

    \32\ ALJ Ex. 1 ] 14.a.

    I see in retrospect the documentation could be better, and I 
respect [the Government expert's] criticism when he was saying that 
the documents should show the next doctor what's going on. And I did 
---------------------------------------------------------------------------
not feel that I was able to do that.

Id. at 929. While conceding the inadequacy of the documentation, the 
Respondent did provide some explanatory details about the course of his 
treatment of Patient AA's pain symptoms with controlled substances. The 
Respondent explained that upon assuming his pain management care, 
Patient AA ``had been a lobster fisherman in Boston, had gotten in car 
wrecks, had a finger rotting, and also had had [sic] the onset of [HES, 
and h]e was in quite a bit of hurt.'' Id. at 930. According to the 
Respondent, he held his level of pain medication steady, 
notwithstanding the patient's requests to the contrary, and 
reemphasized his contention that he was treating this patient during 
the evolution of professional pain management guidance. Id. at 930, 
1068.
    The Respondent took issue with the Government's contention that 
chart entries regarding Patient AA ``indicate that [he] never discussed 
the risks of opioids with'' the patient.\33\ Tr. 931. He testified 
that, in his view, these risks were discussed with Patient AA, and 
while agreeing that he has beefed up the quality of his documentation 
based on the Government expert's testimony, his opinion is that the 
level of the discussion that occurred in the pain contract executed 
with the patient did meet the required standard, and the Government's 
allegation to the contrary is not supported. Id. at 931-32. As an 
example, the Respondent pushed back on the opinion of the Government's 
expert that the failure to mention the risk of death is problematic. 
Id. According to the Respondent, while true that the pain contract did 
not precisely detail the risk of death, ``it did discuss respiratory 
depression, which is usually the antecedence of that.'' Id. at 932. 
Still, while not conceding fault in this regard, the Respondent 
testified that [``it should be better'' and] he has developed an opioid 
informed consent document that ``plug[s] that hole.'' Id. The 
Respondent ultimately allowed that specific mention of death is 
``important to mention to the patient, and . . . is something [that he] 
want[s] to do better and need[s] to do.'' Id.
---------------------------------------------------------------------------

    \33\ ALJ Ex. 1 ] 14.b.
---------------------------------------------------------------------------

    The Government specifically alleges that the Respondent's 
concurrent prescribing of opioids and benzodiazepines to Patient AA was 
a ``red flag of abuse or diversion'' and ``represented a dangerous 
combination, and constituted an extreme departure from the standard of 
care for the practice of medicine.'' ALJ Ex. 1 ] 14.c. In his 
testimony, the Respondent sidestepped the principal issues of this 
allegation somewhat, by countering that, notwithstanding the absence of 
documentation in this regard, the risks of benzodiazepines were 
discussed with the patient and his standards for documenting such 
discussions has been enhanced. Tr. 933. No mention was made about the 
opinion of the Government's expert regarding whether the prescribing 
combination fell below the standard, only that the issue of 
benzodiazepine risks were discussed, if not pristinely documented. Id.
    The Respondent was unequivocal in his view that, contrary to the 
Government's allegation,\34\ the Government's expert,\35\ and the ME 
Report,\36\ his prescribing was not a contributing factor in Patient 
AA's untimely demise. Tr. 943. The way the Respondent sees it, Patient 
AA would not have died had he not taken fentanyl and drank alcohol, 
both of which the Respondent feels were covered in the patient advisals 
set forth in the pain agreement and executed by the patient. Id. at 
943-45. When pressed on the issue, the Respondent provided the 
following elucidation on his own self-exoneration:
---------------------------------------------------------------------------

    \34\ ALJ Ex. 1 ] 14.f.
    \35\ Tr. 310-12.
    \36\ Gov't Ex. 31 at 5. The ME Report, in pertinent part, 
renders the following ultimate conclusion: ``Based on the [report's 
integral] findings and the history and circumstances of [Patient 
AA's] death as currently known, the cause of death is best listed as 
`fentanyl, clonazepam, alprazolam, ketamine, hydrocodone, and 
morphine toxicity' and the manner of death as `accident.''' Id.

    [Patient AA] had been on a combination of medications for a long 
time with no issues, and I feel badly that this event happened, but 
I honestly saw no issue where what we were providing was a 
significant component to someone who had so much additional 
---------------------------------------------------------------------------
medication in his system.

Id. at 943. The Respondent testified that he had no sense, indication, 
or warning that addiction or other substances were issues with Patient 
AA, based upon the following observations: ``I never had him come early 
for his appointments, [he] never asked for additional medication, no 
exhibited behaviors, never was there alcohol.'' Id. at 944-45. Absent 
from his consideration in this regard was the ever-growing reservoir of 
extra medications the patient was receiving from refills that preceded 
the anticipated medication exhaustion dates \37\ or the aberrant UDS 
results that were never addressed and documented.\38\
---------------------------------------------------------------------------

    \37\ Tr. 158-59, 169-72, 177-78, 180-81, 184-89, 224-26, 271.
    \38\ Tr. 149-55, 180-82, 196, 198, 206-09, 224-26, 228-31, 271-
75, 279-82, 289-302. [Further, the Government highlighted that 
Respondent did not test for Ketamine or fentanyl in the UDS on 
September 19, 2017. Tr. 1098 (citing Gov't Ex. 2 at 535).]
---------------------------------------------------------------------------

    The Respondent detailed his experience with the balance of the Six 
Patients, much of it following the same pattern, notwithstanding a 
nuance or two. He agreed that the Government was right with respect to 
the potential reservoir of medication created by his temporally-
truncated prescribing practices.\39\ Tr. 960-62. By the Respondent's 
account, the patients established with his office with painful medical 
issues and high-dosage MMEs, and he either maintained the patients at 
the pain medication levels they arrived at, notwithstanding their 
protestations to the contrary, or in some cases, according to the 
Respondent, he was able to effect some reductions.
---------------------------------------------------------------------------

    \39\ ALJ Ex. 1 ] 18.d.
---------------------------------------------------------------------------

    The Respondent testified that such was the case with Patient BB. 
Id. at 946-49, 953-55, 957-58. The Respondent testified that Patient BB 
resisted his attempts to taper her pain medication,\40\ and ultimately 
left his practice as a

[[Page 4922]]

response to her frustrations.\41\ Tr. 947, 969-70. He took issue with 
the Government's allegation that the MME level he prescribed for this 
patient was ``extraordinarily high,'' \42\ opining that it was an 
appropriate dose under the circumstances, and conceding only that he 
``was not happy with [his] documentation at that point in time and 
[that he] fixed it.'' Tr. 956; see also id. at 1068. In describing what 
he thought could be improved with his level of documentation, the 
Respondent allowed, in retrospect, that his documentation was ``basic'' 
and ``wasn't descriptive enough.'' Id. at 956. The Respondent also 
resisted the Government's allegation that his medical records were 
deficient in that they contained no discussion of the risks and 
benefits of opioid therapy.\43\ The Respondent adhered to the view that 
the pain contract that he executed with this patient was sufficient to 
satisfy the requirement that the risks were discussed and true informed 
consent was obtained. Tr. 957-58.*\I\ The Respondent likewise declined 
to budge from his position that although his standard pain contract at 
the time made no mention of death, language which included the risk of 
respiratory depression was sufficient, contrary to the Government's 
allegation and the position of its expert. Id. at 958-59.
---------------------------------------------------------------------------

    \40\ The Respondent testified that the patient resisted his 
attempts to set her up with a behavioral health evaluation and 
detoxification process, and that he made numerous (ultimately 
fruitless) attempts to sort things out with her insurance provider 
and her (concurrently prescribing) primary care physician. Tr. 969-
75.
    \41\ The Respondent testified that other than the late Patient 
AA and Patient BB, the other four of the Six Patients are still 
under his care. Tr. 962.
    \42\ ALJ Ex. 1 ] 18.a.
    \43\ ALJ Ex. 1 ] 18.b.
    *\I\ Respondent seemingly contradicted his previous testimony 
that he always had the conversations with his patients on cross-
examination, when he stated: ``The--the informed consent document is 
better than it was before. It's actually an informed consent 
document. But, as you know, informed consent is more than just a 
document. It's the discussions surrounding it, and I think that's 
what we're doing much better with.'' Tr. 1070. This statement 
undermines his previous testimony that true informed consent was 
obtained, but just not documented. He also appeared to change his 
position regarding whether his previous pain agreements met the 
minimum standard of care with respect to informed consent--answering 
that they did not. Id. Regardless, as explained herein, it is 
unnecessary to conclude whether or to what extent he had these 
discussions, because the documentary evidence does not demonstrate 
that he did. Further, even if he had, he waivered on acknowledging 
whether discussing the risk of death associated with the 
medications, even if they are taken as prescribed, was essential to 
the standard of care. So even if he did have conversations about the 
risks, it is still unclear whether the content of those 
conversations met the standard of care as Dr. Munzing described it. 
Finally, I credit Dr. Munzing's testimony that the issue of 
discussing risk is universal in medicine, because a lay person is 
not expected to know what the consequence of respiratory depression 
is. See also infra n.*S for further discussion of Respondent's 
testimony regarding informed consent in the context of his purported 
acceptance of responsibility.
---------------------------------------------------------------------------

    Consistent with much of his presentation, the Respondent was 
unwilling to agree with the Government's allegation that prescribing 
the combination of opioids and benzodiazepines constituted an extreme 
departure from the standard of care,\44\ but [] acknowledged that he 
was unhappy with Patient BB's chart because it was ``not as acceptable 
as [he would] like it to be with specific benzodiazepine 
interactions.'' Tr. 960. The Respondent asserted that his standard 
paperwork has now been improved to include such interactions. He also 
testified that he has changed his practice to conform with certain 
views expressed by the Government's expert witness. Id. at 957.
---------------------------------------------------------------------------

    \44\ ALJ Ex. 1 ] 18.c.
---------------------------------------------------------------------------

    The same testimonial pattern was present regarding Patient JD. The 
patient came to the Respondent's practice on a referral with a dramatic 
and acute set of pain etiologies \45\ and on a high dosage of 
medication.\46\ In the Respondent's estimation, continuation of this 
patient's high controlled substance dosing was not ``an extreme 
departure from the standard of care for the practice of medicine,'' 
\47\ based on what he perceived as the best professional guidance 
available at the time and the existing medication level the patient was 
at when referred to his practice. Tr. 982-83, 1068. The Respondent 
explained that in his view, the available guidance regarding the pain 
management of patients has been the subject of considerable evolution 
over the past fourteen years. Id. at 901-02; see also id. at 930. The 
Respondent's handling of the issue contained a high level of nuance.
---------------------------------------------------------------------------

    \45\ According to the Respondent, Patient JD was status post a 
catastrophic vehicular/pedestrian strike, and had avascular necrosis 
involving one shoulder and both hips, cervical radiculopathy with 
osteophytes, ankylosing spondylitis affecting the lower spine, Lyme 
disease, multiple lower extremity fractures, and complex regional 
pain syndrome (RSD). Tr. 977-81.
    \46\ Tr. 976, 986-87.
    \47\ ALJ Ex. 1 ] 21.a.

    At that time, we're just coming off of the decade of maybe 2000, 
2010. Pain is a fifth vital sign. There's no limits to dosing. You 
dose to function, you don't dose to milligram quantity. And that, I 
believe that's how he got up to that level before he came to me. So 
---------------------------------------------------------------------------
at that point, it was not an unheard-of dosage.

Id. at 982 (emphasis supplied). Unpacking this analysis is somewhat 
instructive. Even accepting the Respondent's view that pain medication 
guidance was evolving, it is difficult to assess the significance that 
should be placed on his estimation of ``just coming off of the decade 
of maybe 2000, 2010'' \48\ of a divergent approach. To the extent that 
the decade the Respondent was referring to took place [ ] ended (as he 
says) in 2000, Patient JD established with the Respondent's practice 
ten years later, in 2010. There is no indication in the record or any 
available source that expert guidance inexorably changed by the decade 
or how long it would take to ``come off'' such a decade, even if there 
were some logic to this statement. Likewise, the notation that any 
decade had ``no limits to dosing'' \49\ dangerous controlled substances 
strikes as inconsistent with the limits of human endurance and common 
sense; and to justify the level at which he was medicating this patient 
by saying ``it was not an unheard-of dosage'' \50\ is far from a 
persuasive endorsement of his controlled substance prescribing 
practices. Even taking the Respondent's testimony in the most indulgent 
light possible, ``not unheard-of'' cannot be a meter that his actions 
are measured by to gauge whether he complied with the applicable 
controlled substance prescribing standard in California. When asked for 
clarification as to whether he agreed with the Government's allegation 
regarding his dosing, the Respondent supplied the following non 
sequitur:
---------------------------------------------------------------------------

    \48\ Tr. 982.
    \49\ Tr. 982.
    \50\ Id.

    I don't. As I stated, I received him at the higher dose. That's 
why it's coming to me, and I'm supposed to be the one who will 
contain it, control it, and reduce it over time while trying to 
---------------------------------------------------------------------------
increase function.

Tr. 983. The only self-criticism the Respondent offered was that his 
``documentation should have been better at that point in time . . . and 
[that he] wish[es he] had done a better job of documenting.'' Id.
    Again, the Respondent clung to his view that the Government's 
allegation that his records fail to indicate sufficient opioid risks 
discussions with the patient \51\ is unfounded because his standard 
pain contract language at the time (although improved since) was 
sufficient to do the job. Tr. 984-85. While again confessing error \52\ 
regarding the 28-day visit vs. the 30-day early prescription 
issuance,\53\ with respect to the Government's allegation that 
prescribing a combination of opioids and benzodiazepines to Patient JD 
fell below the standard of care,\54\ the

[[Page 4923]]

Respondent offered only that he engaged the patient with an ultimately 
successful protocol to eventually wean him off the benzodiazepine. Tr. 
985-86. In fact, the Respondent testified that during the course of his 
treatment of Patient JD, he successfully weaned him off multiple 
benzodiazepines and significantly reduced the overall MME of the 
medications he was taking. Id. at 988-89.
---------------------------------------------------------------------------

    \51\ ALJ Ex. 1 ] 21.b.
    \52\ The Respondent testified, ``That was a very easy one to fix 
with literally no fuss at all.'' Tr. 986; see also id. at 1071.
    \53\ ALJ Ex. 1 ] 21.d.
    \54\ ALJ Ex. 1 ] 21.c.
---------------------------------------------------------------------------

    The pattern repeated itself with respect to Patient DD. The 
Respondent owned up to the early refill allegation.\55\ Tr. 998-99, 
1071. The Respondent testified that upon intake this patient had 
complicated orthopedic problems \56\ that had been treated by another 
pain doctor prior to the referral. Tr. 990. Consistent with his 
description of the other Six Patients, the Respondent testified that 
Patient DD arrived on a high MME level of controlled medications, which 
was ultimately reduced through the Respondent's efforts. Id. at 991-95, 
1001. The Respondent disputed the Government's allegation that the MME 
levels of the medications he prescribed to Patient DD ``constituted an 
extreme departure from the standard of care for the practice of 
medicine,'' \57\ claiming that the medication levels were appropriate 
because (in his view, at that time) level of function (not the dosage) 
was the touchstone, and also because a review of prior medical records 
gave the Respondent no indication of the patient requesting early 
refills.\58\ Tr. 995, 1068. The only culpability the Respondent would 
assume in this regard came from the quality of the templates in his 
electronic medical record software. Id. at 995-96. Once again, as he 
did in addressing the other Six Patients, the Respondent eschewed any 
responsibility for documenting deficiencies related to explaining the 
risks and benefits of opioid use by pointing to the language employed 
by the standard pain contract he was using at the time. Id. at 996.
---------------------------------------------------------------------------

    \55\ ALJ Ex. 1 ] 23.c (as amended, see ALJ Ex. 25 at 2, ] 7).
    \56\ According to the Respondent, Patient DD had a catastrophic 
lumbar spinal collapse, had endured multiple surgeries and an 
infected pain pump, as well as an unsuccessful go at a dorsal cord 
stimulator, and was presenting with surgically-placed titanium 
spinal rods that had snapped. Tr. 991.
    \57\ ALJ Ex. 1 ] 23.a.
    \58\ [Omitted.]
---------------------------------------------------------------------------

    The analysis presented in the Respondent's testimony about Patient 
SM did not differ substantially from the manner in which he described 
his treatment of the other members of the Six Patients group. According 
to the Respondent, at the time of her referral to his practice, Patient 
SM presented with pain from complex and serious etiologies,\59\ and was 
being maintained on high-MME levels of pain medication combined with 
benzodiazepines. Tr. 1003-05. The Respondent testified that he worked 
to reduce the MME levels \60\ and eliminate the benzodiazepines \61\ 
from the treatment equation. Tr. 1005. The Respondent accepted error 
regarding his early refill practices,\62\ but again defended his dosing 
levels against the Government's allegation that the levels were 
sufficiently high that they constituted ``an extreme departure from the 
standard of care for the practice of medicine.'' \63\ Tr. 1005-06, 
1068. His answer was once again that the only conceivable hiccup in the 
prescribing \64\ was his level of documentation. Tr. 1006. The 
Respondent explained it this way: ``Looking at it now, with the lens 
that I have, I can see that the documentation should have been 
better.'' Id. However, the documentation deficits the Respondent owned 
up to regarding this patient, like the others, did not extend to the 
Government's allegation regarding the failure to adequately document 
risk warnings associated with opioid use,\65\ as he again explained 
that, in his opinion, his standard pain contract covered this area 
sufficiently.\66\ Tr. 1006-07. Similarly, the Respondent was resistant 
to the concept that dual prescribing benzodiazepines with opioids fell 
below the applicable standard as charged by the Government,\67\ but 
offered instead that he ``should have done a better job of documenting 
the risks of benzodiazepines.'' Tr. 1007-08.
---------------------------------------------------------------------------

    \59\ According to the Respondent, Patient SM suffered from 
cervical and lumbar issues, underwent multiple surgeries and other 
procedures, and ultimately lost the ability to swallow. Tr. 1003-04.
    \60\ Tr. 1010-12.
    \61\ The Respondent testified that he ultimately discontinued 
the trinity combination of medications for this patient. Tr. 1008.
    \62\ Tr. 1008 (``I see that as a processing error, as we talked 
about before. It's a very simple thing to correct, and it's already 
been implemented.''); see also id. at 1071.
    \63\ ALJ Ex. 1 ] 26.a.
    \64\ According to the Respondent, ``The dosing was appropriate, 
considering her medical condition, the fact that that's what she was 
on previously. And, again, that's where we start, and then we move 
down from there.'' Tr. 1006.
    \65\ ALJ Ex. 1 ] 26.b.
    \66\ Regarding this patient, and throughout the proceedings, the 
Respondent suggests that his forms had room for some improvement, 
but does not agree that utilization of this form to satisfy informed 
consent regarding the risks of opioid therapy falls below the 
standard. Tr. 1007 (``I am always in a state of continuous quality 
improvement, and I recognize that as an issue. We have corrected 
it.'').
    \67\ ALJ Ex. 1 ] 26.c.
---------------------------------------------------------------------------

    The Respondent adhered to a like pattern in his testimony regarding 
Patient ET. This referred patient arrived at his practice with high MME 
levels and sobering etiologies \68\ behind his symptoms. Tr. 1012-13. 
The Respondent again confessed error on his unintended early refills 
issue,\69\ and allowed that his documentation was inadequate,\70\ but 
testified that, based on the science at the time and the medications 
she was on when she came into his care, he stood behind his dosing 
decisions,\71\ and that he reduced this patient's MME dosing. Tr. 1015-
22. The Respondent referenced a report \72\ (PMC Report) prepared 
regarding Patient ET at the Respondent's request by the University of 
California San Diego Pain Management Clinic (PMC). Tr. 1015.*\J\ The 
Respondent's testimonial assessment of the PMC Report's conclusion is 
that:
---------------------------------------------------------------------------

    \68\ The Respondent testified that Patient ET carried diagnoses 
of hemiplegic migraine, was status post cervical surgery, and had 
cervical radiculopathy. Tr. 1012-13.
    \69\ Tr. 1027-28.
    \70\ Tr. 1024.
    \71\ Tr. 1022-24, 1068.
    \72\ Gov't Ex. 12 at 987.
    *\J\ Respondent admitted that for this patient there was ``a 
component of opiate use disorder'' and that she was weaned off all 
of the pain medication and now, years later, being prescribed 
Suboxone, which ``does have some pain implications and can reduce 
the craving for patients who need to cut back with their 
medication.'' Tr. 1020, 1021.

    [PMC] said there was nothing more to offer from their 
perspective, in terms of intervention. And they recommended we 
---------------------------------------------------------------------------
continue the path, and that we continue to wean the patient.

Id. The PMC Report does indeed recommend continuation of physical 
therapy and does state that it declines to recommend interventions, but 
it also recommends the addition of conservative therapies such as 
osteopathic manipulative medicine (OMM), acupuncture, and alternative 
medicine modalities, and states: ``Continue medications per [the 
Respondent], recommend weaning if possible.'' \73\ Gov't Ex. 12 at 992.
---------------------------------------------------------------------------

    \73\ An undated, handwritten note in the margin of the PMC 
Report reads: ``Noted wean attempt in progress.'' Gov't Ex. 12 at 
992; Tr. 1016.
---------------------------------------------------------------------------

    The Respondent, consistent with the view he espoused in his 
Corrective Action Plan (CAP),\74\ initially maintained his uniform 
position that the standard pain management contract he was employing at 
the time satisfied the applicable standard of care regarding his 
obligation to inform Patient ET about the risks associated with 
prescribing opioids,\75\ but then, in

[[Page 4924]]

something of a departure from his prior assessments, testified that 
``[o]n the issue of informed consent, the documents were not 
adequate.'' Tr. 1026. The Respondent explained his unexpected change in 
perspective this way:
---------------------------------------------------------------------------

    \74\ Resp't Ex. M at 5, ] 4.
    \75\ Tr. 1024-26.

    I needed to talk more about the actual conversations I had with 
the patient, the potential risks, including death, which was not 
mentioned specifically. And I see that as a deficit in my reading, 
---------------------------------------------------------------------------
documentation and my discussion with the patient.

Id.; see also id. at 1070. Oddly, this change of heart only apparently 
applied to his treatment of Patient ET, but the Respondent also 
testified that he has since introduced a specific opioid consent 
contract. Id. at 1039-40. While the Respondent maintained that his pain 
agreement was sufficient in all cases (other than Patient ET), he 
testified that the opioid consent document ``was created specifically 
to plug some of the gaps that the pain agreement was not fully 
compliant [sic].'' Id. at 1040. The Respondent further testified that 
he ``felt like [he] needed to expand [his] offerings in terms of 
informed consent, to be fully compliant.'' Id. at 1041. Thus, the 
Respondent testified (consistent with the position he took in his CAP) 
\76\ that the pain contracts did meet the standard, then in the case of 
Patient ET that they did not meet the standard, then he testified to 
his creation of a separate opioid consent document ``to plug some of 
the gaps'' in the aforementioned pain agreements that were ``not fully 
compliant.'' \77\ See Tr. 1040-41. It would not be hyperbolic to 
suggest that the Respondent's view on this issue in his testimony was 
all over the place and did not enhance his credibility.
---------------------------------------------------------------------------

    \76\ Resp't Ex. M at 5, ] 4.
    \77\ In his CAP, the Respondent highlighted language he added to 
his standard pain medication agreement, implicitly arguing that the 
agreement, as modified, satisfies the standard without a separate 
opioid consent agreement. Resp't Ex. M at 33, ] 15; Tr. 1061.
---------------------------------------------------------------------------

    The Respondent resisted the Government's allegation that he failed 
to appropriately respond to one of Patient ET's UDS results based on 
his view that the result was not aberrant. Id. at 1028. Specifically, 
the Respondent testified that although Patient ET supplied a urine 
sample that tested positive for temazepam (a medication she was not 
prescribed), temazepam, according to the Respondent, is a metabolizer 
of diazepam (a medication that the Respondent had prescribed). Id. The 
Respondent followed up by offering that he has enhanced his internal 
office mechanisms for responding to UDS results that appear 
inconsistent. Id. at 1028-29.
    The Respondent described numerous improvements he has effected in 
his electronic medical records software \78\ so that an increased level 
of detail and analysis would be reflected in the future.\79\ Tr. 1029-
34, 1038-39, 1044, 1047-52; Resp't Ex. M at 4-7. When pressed as to why 
a multitude of prior notes showed that no one in his office had been 
taking weight measurements or other vital signs, the Respondent 
conceded that he ``should have been doing it.'' Tr. 1034. The 
Respondent explained some improvements he incorporated into his 
practice, and explained that he now sees one less patient per hour 
under his new protocol. Id. at 1041-43, 1053. He also testified that 
his staff now takes blood pressure readings from his patients. Id. at 
1039. The Respondent explained that all his office notes correspond to 
his new, more detailed protocols, and offered that:
---------------------------------------------------------------------------

    \78\ The Respondent testified that his medical records have been 
electronically maintained since 2005. Tr. 924.
    \79\ The Respondent testified that these enhancements were not 
the result of the DEA investigation, but rather, his experience with 
the Administrative Law Judge handling the state licensing 
proceedings. Tr. 1052.

    I'm much happier. The patients are better informed. And I feel 
as though each of these notes, when I finish, we have all the facts, 
whoever goes to the primary physician and anybody else in the circle 
of care. And I just feel like I'm doing a much better job of inter-
---------------------------------------------------------------------------
operability and cooperation with the other physicians.

Id. at 1052. He also added that he ``always want[s] to improve'' \80\ 
and that he has ``never stepped down from a challenge.'' Id. at 1062.
---------------------------------------------------------------------------

    \80\ The Respondent testified to completing two continuing 
medical education (CME) courses in 2017 through the UCSD School of 
Medicine. Tr. at 1057-59. The Respondent personally attended a two-
day course on physician prescribing and a two-day course on medical 
record keeping. Id.; see Resp't M at 47, 49.
---------------------------------------------------------------------------

    The Respondent made clear in his testimony that he only accepted 
responsibility for the deficiencies he was willing to acknowledge at 
the hearing. Id. In addition to his electronic recordkeeping 
enhancements, the Respondent testified that he no longer prescribes the 
trinity combination of medications,\81\ and has eliminated carisoprodol 
from the medicines he prescribes. Tr. 1065. Throughout the hearing, the 
Respondent adhered to his position that his prescribing did not fall 
below the applicable standard of care, due to the available knowledge 
at the time, the high MME levels the patients carried upon his first 
encounter with them, and his eventual efforts to wean them down.\82\ 
Tr. 1068-69, 1073. By his reckoning, his only potential prescribing 
missteps in this regard were the unintentional early refills and the 
quality of his documentation, both of which he argues have since been 
remedied.
---------------------------------------------------------------------------

    \81\ The Respondent did not admit that his combination 
prescribing fell below the standard of care, and pointed out that 
the CDC qualified its admonition against combining opioids and 
benzodiazepines as to be avoided ``whenever possible.'' Tr. 1072. 
The Respondent maintains that the relative merits of prescribing the 
trinity combination in the past ``was not clear.'' Id. at 1073.
    \82\ The Government assisted the witness in highlighting the 
fact that, notwithstanding progress notes expressing an intention to 
wean, not all of his opioid medication titrations have pointed 
downward. Tr. 1074-96. [For just one example, Respondent's notes for 
SM stated that attempts at reducing the medication were met with 
decreased function, but there were no substantial attempts to reduce 
in the actual prescribing as demonstrated in the records from March 
2014 until April 2018. Tr. 1080, 1084; Gov't Ex. 10 at 149.] The 
Respondent offered that he encouraged some of his patients to reduce 
their medications below the amounts he was prescribing, but 
unpersuasively conceded that such a recommendation would not be 
documented in his charting. Id. at 1103-04.
---------------------------------------------------------------------------

    Surprisingly, although, as discussed, supra, the findings of the 
California Board set forth in the Board Order are entitled to 
preclusive effect in these proceedings,\83\ the Respondent devoted no 
portion of his testimony to any of those issues. Thus, although the 
Board Order established much of the Government's overall case, the 
Respondent's testimony offered neither an acceptance of responsibility 
nor a plan of remedial action concerning those issues.
---------------------------------------------------------------------------

    \83\ See Robert L. Dougherty, M.D., 76 FR 16823, 16834 (2011).
---------------------------------------------------------------------------

    As is always the case in these proceedings, among the witnesses who 
testified at this hearing, the Respondent unarguably possesses the 
greatest interest in the outcome, and hence, the greatest motivation to 
enhance, modify, or even fabricate his testimony. However, even apart 
from the risk of implicit bias, the Respondent's testimony presented a 
robust array of other reasons to eschew accepting his version of events 
without a significant level of skepticism. The Respondent initially 
testified, as he argued in his CAP, that his standard pain medication 
contracts satisfied the applicable standard of care relative to the 
required appraisal of the risks of opioid use and combined prescribing 
to his patients. However, when the identical issue arose regarding one 
of his patients, Patient ET, the Respondent suddenly changed course and 
claimed that his standard pain medication contracts did not meet the 
standard, and even cited this as a reason that he changed his practice 
and

[[Page 4925]]

introduced specific opioid consent documents and implemented changes to 
his standard pain medication contracts. Additionally, although the 
Respondent consistently defended his high-MME prescribing based on his 
practice of titrating the medications down, a review of his progress 
notes reflects that although this was a consistently-documented 
intention that would presumably be understood by anyone reviewing his 
charting, the reality was that in many instances weaning was not 
effected, and later notes, instead of reflecting the failure to taper, 
just continued to express the purported aspiration. The potential 
inescapable inference here is that inexorably repeated comments 
supposedly seeking to taper and failing to document no progress in that 
regard was intentional window dressing to create a variety of plausible 
deniability. Another aspect of the Respondent's presentation that was 
unhelpful to his credibility was the manner in which he addressed his 
perception that medical literature on the issue of opioid prescribing 
presented an evolving landscape. As discussed, supra, the Respondent 
depicted his prescribing decision point as ``just coming off of the 
decade of maybe 2000, 2010[, where p]ain is a fifth vital sign[ and 
t]here's no limits to dosing.'' Tr. 982. To be sure, scientific 
guidance is rarely fixed in any field, much less medicine, and 
controlled substance prescribing in the medical field has seen its fair 
share of fluctuation. But even assuming the accuracy of this broad 
reality, defending the prescribing of dangerous and powerful controlled 
substances to his patients based on something as vague as what 
``decade'' *\K\ he was ``coming off'' does not reflect a serious 
analysis of the issue or any level of reflective circumspection. 
Medical science does not adjust itself based on the inexorable flipping 
of the calendar decades, and it would be impossible to even define when 
a prescriber was ``coming off'' one decade and jumping into another, 
even if this were a realistic concept--which it is not. Is a month 
after a decade ``coming off''? Is three or five years? Suffice it to 
say that this sort of glib dismissal of the proper standard to be 
applied to controlled substance prescribing at the moment he was 
writing prescription after prescription did not enhance the level of 
credibility and reliability that can be reasonably assigned to the 
Respondent's testimony.
---------------------------------------------------------------------------

    *\K\ Respondent took exception to the Chief ALJ's comment that 
Respondent was vague as to the exact decade. Resp't Exceptions at 23 
n.6 (``[Respondent] states clearly the time is 2010. This means the 
decade of pain occurred approximately between 2000-2010.''). Even if 
the Respondent was clear in this statement, what remains unclear is 
the issue that the Chief ALJ highlighted--how long after the decade 
can Respondent still claim ignorance as to the dangers of 
prescribing high levels of opioids? The prescribing activity in the 
OSC allegations falls between 2014 and 2019, so if Respondent is 
claiming that this ``decade of pain'' ended around 2010, it is not 
credible that the decade would still be affecting the standard of 
care four to nine years (almost an another entire decade) after it 
ended. Respondent notably stretches the decade to around 2012 in his 
Exceptions using Dr. Polston's declaration, but even taking this 
expanded timeframe into account, he cannot cover the activity in 
question. Resp't Exceptions at 24 (citing Ex. L). In fact, the 
Government points out that the evidence demonstrates that 
Respondent's prescribing behavior did not begin to change until 
around the same time that the California Medical Board was preparing 
to file an action against Respondent, which was ``ultimately filed 
on October 5, 2017.'' Gov't Response at 33 (citing Gov't Ex. 30 at 
4).
---------------------------------------------------------------------------

    That is not to say that the Respondent is entirely incredible or 
that his professional opinions are to be easily dispatched. The 
Respondent is an experienced, knowledgeable, well-credentialed 
physician with a considerable level of subject-matter expertise. There 
were aspects of his biographical information, the progress of his 
career, and even some aspects of his testimony regarding treatment that 
were reliable and believable and should be relied upon and believed, 
but where the Respondent's testimony conflicts with the testimony of 
other witnesses and evidence of record (which is substantial), it must 
be viewed with a heightened level of scrutiny.

Dr. Gregory Polston, M.D.

    The Respondent presented the expert testimony of Dr. Gregory 
Polston.\84\ Dr. Polston's CV reflects that he has been Board Certified 
in Anesthesiology for over twenty years, has held a subspecialty 
certification in Pain Medicine for nearly twenty years,\85\ and 
completed a pain fellowship at the University of California, San Diego 
(UCSD). Tr. 1140, 1142-43, 1146-47; Resp't Ex. K. The witness testified 
that he is currently the Assistant Director of the Center for Pain 
Management at UCSD, the Sector Chief for the Pain Service at the 
Veteran's Affairs Medical Center in San Diego, and his current medical 
practice is exclusively devoted to patients with acute or chronic pain. 
Tr. 1141-42, 1148; Resp't Ex. K. Dr. Polston was tendered \86\ and 
accepted \87\ as an expert witness in controlled substance prescribing 
in California, including controlled substance prescribing for 
intractable pain. Tr. 1153-54.
---------------------------------------------------------------------------

    \84\ Dr. Polston testified that he has been compensated by the 
Respondent for his professional work as an expert in this case. Tr. 
1285.
    \85\ Dr. Polston testified that there is no pain management 
board certification available, and that the added pain management 
qualification awarded by the American Board of Anesthesiologists is 
the closest that a physician can get to a board certification in 
pain management. Tr. 1146-47.
    \86\ Tr. 1148-49.
    \87\ During voir dire, Dr. Polston stated that his expert 
opinion was influenced by statements the Respondent made during 
preparation sessions with the Respondent's counsel. Tr. 1151-52. The 
tribunal recognized Dr. Polston as an expert but directed the 
witness to inform the tribunal at any point during his testimony if 
his opinion was influenced by an explanation or elaboration that the 
Respondent gave during a preparation session. Id. at 1153-54.
---------------------------------------------------------------------------

    The Respondent's expert testified that he reviewed patient files 
for the Six Patients from the Respondent's practice and (at least 
initially) testified that the Respondent's controlled substance 
prescribing did meet the standard of care in California. Id. at 1193, 
1224-26, 1229-30, 1284. Specifically, the witness opined that the 
amount of medication the Respondent prescribed for each of the Six 
Patients was within the standard the care. Id. at 1167, 1192-93, 1199, 
1204, 1211, 1217-18, 1224-26. To support his reasoning, Dr. Polston 
identified patient records that stated the patients had a diagnosis 
that could be painful and/or the patients' history contained evidence 
of multiple pain, indicating the patients were candidates for opiate 
therapy.\88\ Gov't Exs. 2-4, 6, 8, 10, 12; Tr. 1155-56, 1166-67 
(Patient AA); Tr. 1186-88, 1190-93 (Patient BB); Tr. 1196-99, 1203 
(Patient JD); Tr. 1206-10 (Patient DD); Tr. 1214-15 (Patient SM); Tr. 
1222-24 (Patient ET). He also explained that, in determining whether to 
prescribe controlled substances, a physician should consider subjective 
input from patients and increased functionality, and then pointed to 
instances in the record where subjective input and functionality were 
identified. Tr. 1167, 1184 (Patient AA); Tr. 1191-92 (Patient BB); Tr. 
1201, 1203-04 (Patient JD); Gov't Ex. 8; Tr. 1210-11 (Patient DD); 
Gov't Ex. 10; Tr. 1215-17 (Patient SM). The Respondent's expert 
explained his view of functionality analysis this way:
---------------------------------------------------------------------------

    \88\ Dr. Polston explained that Patient AA's primary diagnosis 
was HES, which he classifies as a form of cancer. Tr. 1155-56. In 
Dr. Polston's opinion, it was important that Patient AA had a cancer 
diagnosis because ``the guidelines are much different for chronic 
benign pain versus cancer pain.'' Id. at 1156. Remarkably, the 
witness explained that, in his view, a cancer diagnosis ``really 
strips away nearly all guidelines'' for prescribing controlled 
substances. Id. at 1157. It was clear from Dr. Polston's testimony 
that his perception that the Respondent was treating this patient 
for cancer essentially dissolved other constraints that might 
otherwise be placed on his pain medication prescribing.

    Initially physicians would consider the functional report of 
pain or reduction in pain as being more important. As time evolved 
we felt that function was more important and it's a balancing act. 
There are some patients who

[[Page 4926]]

report less function as you reduce medicines because they say they 
have more pain, they reduce their activity, and have more anxiety 
and more difficulty. There are some patients that go the other way 
and find more function as the medicines go down and that is 
something that, you know, that you are always trying to use both of 
---------------------------------------------------------------------------
those markers as a way to judge whether the therapy is appropriate.

Tr. 1202-03.
    Dr. Polston also testified that the Respondent reduced the MME 
levels for Patients JD,\89\ DD,\90\ SM,\91\ and ET,\92\ and that the 
Respondent met the standard of care by virtue of the reductions he made 
in these patients' MME levels. Tr. 1200, 1213, 1221, 1228-29. However, 
according to Dr. Polston, reducing MMEs is not always necessary to meet 
the standard of care,\93\ and the Respondent met the standard of care 
when he did not reduce Patient AA's opioid dosage. Tr. 1284. After 
being directed to the autopsy report for Patient AA, Dr. Polston opined 
that the Respondent's prescriptions were not a contributing factor to 
Patient AA's overdose death. Id. at 1182; see also Gov't Ex. 31. 
According to Dr. Polston, ``[t]his patient, if he would not have taken 
the fentanyl, added in the alcohol and the ketamine, . . . would be 
still alive.'' Tr. 1182. [Dr. Polston later clarified his testimony on 
cross-examination that the fentanyl, alcohol and ketamine ``are 
contributing to his death,'' but that ``to say that those are precise 
cause of death, no, I cannot go that far.'' Tr. 1280.]
---------------------------------------------------------------------------

    \89\ Tr. 1200.
    \90\ Tr. 1211-13; see Resp't Exs. D at 1051-55, L at 8-9, ] 27.
    \91\ Tr. 1214, 1219-20; see Resp't Exs. E at 1494, L at 10, ] 
29.
    \92\ Tr. 1226-28; see Resp't Ex. L at 10-11, ] 32.
    \93\ Tr. 1273-76, 1284.
---------------------------------------------------------------------------

    Dr. Polston also testified that after reviewing all patient records 
presented to him, it was his opinion that the Respondent met the 
standard of care with respect to informed consent. Id. at 1229-30. 
However, when asked if it would change his opinion if he learned that 
the Respondent believed his care of the patients fell below the 
standard of care in regards to informed consent, Dr. Polston answered 
affirmatively; that is, learning that the Respondent's view that he 
failed to meet the standard would change Dr. Polston's mind on the 
issue. Id. at 1231-32. The witness explained his change in opinion this 
way: ``[I]f he's reviewing his records and says that he did not meet 
the standard of care then I would agree with that.'' Id. at 1232.
    The witness initially testified that there was no evidence of early 
refills in this case, and that the Respondent's practice of writing 
prescriptions of thirty day dosages every twenty-eight days was within 
the standard of care in California. Id. at 1232-33, 1236-38.*\L\ 
However, when Dr. Polston was asked if it would change his opinion if 
he learned that the Respondent believed his prescribing every twenty-
eight days fell below the standard of care, he answered affirmatively. 
Id. at 1239. The witness altered his expert opinion based on the 
Respondent's alleged testimony, explaining that ``he alone will know 
precisely what was going on at that appointment when he's writing it, 
and if he . . . feels that he was below the standard of care then I 
would say that, that would be below the standard of care.'' Id.
---------------------------------------------------------------------------

    *\L\ I also found Dr. Polston's testimony about whether early 
fills are outside the standard of care to be evasive. ``I don't 
think that's good care. I'm not sure, you know, the--your argument 
over time is concerning to me, but I can say that I know that that 
occurs. The standard of care is what reasonable physicians in the 
community would approve, and I have seen that in the community at 
multiple different levels.'' When the Chief ALJ pressed him to 
clarify, he said, ``I would say best practices is not to do that, 
but I see reasonable physicians in the community doing that.'' Tr. 
1237-38.
---------------------------------------------------------------------------

    Dr. Polston also testified regarding medical records presented by 
the Government that bore indicia of anomalous UDS results regarding 
Patient AA. Tr. 1243-44, 1250-53. Dr. Polston identified Patient AA's 
UDSs as inconsistent (not aberrant),*\M\ testifying that there was no 
indication in the records that he reviewed of aberrant behavior by 
Patient AA, and opining that the purported inconsistency could have 
resulted from the patient being a rapid metabolizer.\94\ Tr. 1244-45, 
1281-82. In his opinion, the Respondent's handling of the inconsistent 
UDS results in the charts was rendered within the standard of care by 
the act of the Respondent writing the letters PRN on some of the 
screens and by seeing the patient on a regular basis. Id. at 1263-65. 
However, when Dr. Polston was informed that the Respondent testified 
that even he believed that he fell below the standard of care when he 
dealt with the inconsistent UDSs, the witness again deserted the 
opinion he had previously offered with conviction and (with equal 
conviction) testified that it had become his (new) opinion that the 
Respondent did in fact not meet the standard of care in this category. 
Id. at 1265-66.
---------------------------------------------------------------------------

    *\M\ I did not find Dr. Polston's argument about the difference 
between aberrant and inconsistent urine screens to be credible. He 
seemed to want to justify his stance that these drug screens did not 
rise to what he deemed ``aberrant'' no matter what the circumstance. 
Respondent's counsel asked if ``there [was] any indication in any of 
the drug results or any of the records that [he] reviewed that this 
patient was having aberrant behavior and not just inconsistent?'' 
Dr. Polston answered, ``Yes. These appeared to me inconsistent and 
that those results were the same. I am concerned that there was 
multiple times. But in some ways, multiple times also means that 
there was something unusual about that.'' Tr. 1282. He first 
references a concern that could make these UDS results ``aberrant,'' 
but then decides that that very concern is, in actuality, a reason 
not to be concerned. This logic is circular and evasive. Regardless 
of which term is used, the heart of the matter here is whether or 
not there needed to be documentation of the resolution of the 
aberrant or inconsistent UDS. Dr. Polston seemingly attempted to 
evade and confuse this issue.
    \94\ Neither the Patient AA charts nor the balance of this 
record (including the Respondent's testimony) bore any indication 
that this patient was a rapid metabolizer, or that the Respondent 
believed he might be a rapid metabolizer.
---------------------------------------------------------------------------

    Overall, Dr. Polston's unabashed willingness to forsake his 
purported expert opinions at the first sign that the Respondent offered 
testimony that conflicted with those opinions obviously created 
internal inconsistencies that undermined the weight that can be 
attached to his presentation. While there is no question that the 
witness's credentials were impressive, Dr. Polston presented an overall 
impression that he was present to support the Respondent's position, 
even where the Respondent's position evolved. It was unhelpful that Dr. 
Polston initially testified that the Respondent's controlled substance 
prescribing did meet the standard of care in California, but when 
confronted by the Respondent's agreement with Dr. Munzing's testimony 
regarding informed consent, early refills, and anomalous UDSs, Dr. 
Polston unhesitatingly changed his view to conform with the 
Respondent's version. It was almost as if to say that his expert 
opinion was whatever the Respondent may have said before, now, or 
later, even if the Respondent's position toggled back and forth. To 
offer ``whatever he said'' as an expert opinion is not a feature that 
enhances the reliability that can be attached to the views expressed by 
a purported expert. Suffice it to say that Dr. Polston's amenability to 
instantly change course and support the Respondent's fluid opinions, 
based merely on being advised of them, undermines the weight that can 
be attached to his testimony. Additionally, at one point in his 
testimony, the Respondent's expert testified that ``the guidelines are 
much different for chronic benign pain versus cancer pain.'' Tr. 1156. 
According to Dr. Polston, a cancer diagnosis ``really strips away 
nearly all guidelines'' for prescribing controlled substances.\95\ Tr.

[[Page 4927]]

1157. The unique concept that a particular diagnosis would obliterate 
any controlled substance prescribing standard was offered here without 
any supporting sources and challenges common sense. Under a mild 
extrapolation of this logic, a near-lethal, or even lethal dose of 
controlled pain medication would not be excluded from Dr. Polston's 
view of acceptable prescribing.
---------------------------------------------------------------------------

    \95\ Even setting aside the relative merits of this view, [it is 
unclear from the Medical examiner's report whether AA, in fact, had 
cancer, and given that he died of an overdose, it certainly is not a 
stretch to question whether he had other motivations for seeking 
medication. Gov't Ex. 31 at 5; Tr. 194-95. However, I find that 
whether or not AA had cancer is not relevant to my overall finding 
that Respondent prescriptions to AA were issued beneath the 
applicable standard of care and outside the usual course of 
professional practice.]
---------------------------------------------------------------------------

    That is not to say that Dr. Polston is entirely unreliable. Like 
the Respondent, this is an extremely experienced and well-credentialed 
professional. There were certainly aspects of his biographical 
information, the progress of his career, and even some testimony 
regarding treatment and prescribing that presented as sensible and 
consistent with the record, and those opinions and information should 
be relied upon. However, it is where Dr. Polston's testimony conflicts 
with the testimony of other expert testimony and evidence of record 
that reliance becomes problematic. Specifically, where Dr. Polston's 
expert testimony conflicts with the testimony of Dr. Munzing, it is Dr. 
Munzing's view that must control.
    Other facts necessary for a disposition of this case are set forth 
in the balance of this Recommended Decision.

The Analysis

Public Interest Determination: The Standard

    Under 21 U.S.C. 824(a)(4), the Agency may revoke the COR of a 
registrant if the registrant ``has committed such acts as would render 
his registration . . . inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4). Congress has circumscribed the definition of public 
interest in this context by directing consideration of the following 
factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
21 U.S.C. 823(f).

    ``These factors are to be considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of 
factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Agency may properly give each factor 
whatever weight it deems appropriate in determining whether a 
registrant's COR should be revoked. Id.; see Morall v. DEA, 412 F.3d 
165, 173-74 (D.C. Cir. 2005). Moreover, the Agency is ``not required to 
make findings as to all of the factors,'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); Morall, 412 F.3d at 173, and is not required to 
discuss consideration of each factor in equal detail, or even every 
factor in any given level of detail, Trawick v. DEA, 861 F.2d 72, 76 
(4th Cir. 1988) (holding that the Administrator's obligation to explain 
the decision rationale may be satisfied even if only minimal 
consideration is given to the relevant factors, and that remand is 
required only when it is unclear whether the relevant factors were 
considered at all). The balancing of the public interest factors ``is 
not a contest in which score is kept; the Agency is not required to 
mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest . . . .'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
    In adjudicating a revocation of a DEA COR, the Government has the 
burden of proving that the requirements for the revocation it seeks are 
satisfied. 21 CFR 1301.44(e). Where the Government has met this burden 
by making a prima facie case for revocation of a registrant's COR, the 
burden of production then shifts to the registrant to show that, given 
the totality of the facts and circumstances in the record, revoking the 
registrant's COR would not be appropriate. Med. Shoppe-Jonesborough, 73 
FR 364, 387 (2008). Further, ``to rebut the Government's prima facie 
case, a[] registrant is required not only to accept responsibility for 
[the established] misconduct, but also to demonstrate what corrective 
measures [have been] undertaken to prevent the re-occurrence of similar 
acts.'' Jeri Hassman, M.D., 75 FR 8194, 8236 (2010); accord Krishna-
Iyer, 74 FR 464 n.8. In determining whether and to what extent a 
sanction is appropriate, consideration must be given to both the 
egregiousness of the offense established by the Government's evidence 
and the Agency's interest in both specific and general deterrence. 
David A. Ruben, M.D., 78 FR 38363, 38364, 38385 (2013).
    Normal hardships to the registrant, and even to the surrounding 
community, which are attendant upon lack of registration, are not a 
relevant consideration. See Linda Sue Cheek, M.D., 76 FR 66972, 66972-
73 (2011); Gregory D. Owens, D.D.S., 74 FR 36751, 36757 (2009). 
Further, the Agency's conclusion that ``past performance is the best 
predictor of future performance'' has been sustained on review in the 
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as 
has the Agency's consistent policy of strongly weighing whether a 
registrant who has committed acts inconsistent with the public interest 
has accepted responsibility and demonstrated that he or she will not 
engage in future misconduct, Hoxie, 419 F.3d at 483.\96\
---------------------------------------------------------------------------

    \96\ The Agency has repeatedly upheld this policy. See Ronald 
Lynch, M.D., 75 FR 78745, 78754 (2010) (holding that the 
respondent's attempts to minimize misconduct undermined acceptance 
of responsibility); George Mathew, M.D., 75 FR 66138, 66140, 66145, 
66148 (2010); George C. Aycock, M.D., 74 FR 17529, 17543 (2009); 
Krishna-Iyer, 74 FR 463; Steven M. Abbadessa, D.O., 74 FR 10077, 
10078 (2009); Med. Shoppe-Jonesborough, 73 FR 387.
---------------------------------------------------------------------------

    Although the burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S. 
91, 100-03 (1981), the Agency's ultimate factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence,'' Hoxie, 419 F.3d at 482. While ``the possibility of drawing 
two inconsistent conclusions from the evidence'' does not limit the 
Administrator's ability to find facts on either side of the contested 
issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092 
(8th Cir. 1989) (internal citation omitted), all ``important aspect[s] 
of the problem,'' such as a respondent's defense or explanation that 
runs counter to the Government's evidence, must be considered, 
Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); 
see Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996). The ultimate 
disposition of the case ``must be `in accordance with' the weight of 
the evidence, not simply supported by enough evidence `to justify, if 
the trial were to a jury, a refusal to direct a verdict when the 
conclusion sought to be drawn from it is one of fact for the jury.''' 
Steadman, 450 U.S. at 99 (quoting Consolo v. FMC, 303 U.S. 607, 620 
(1966)).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in

[[Page 4928]]

application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008), 
cert. denied, 555 U.S. 1139 (2009); cf. Dep't of Homeland Security v. 
Regents of Univ. of Cal., 140 S. Ct. 1891, 1913 (2020) (holding that an 
agency must carefully justify significant departures from prior policy 
where reliance interests are implicated). It is well settled that, 
because the Administrative Law Judge has had the opportunity to observe 
the demeanor and conduct of hearing witnesses, the factual findings set 
forth in this Recommended Decision are entitled to significant 
deference, see Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 
(1951), and that this Recommended Decision constitutes an important 
part of the record that must be considered in the Agency's final 
decision, see Morall, 412 F.3d at 179. However, any recommendations set 
forth herein regarding the exercise of discretion are by no means 
binding on the Administrator and do not limit the exercise of that 
discretion. See 5 U.S.C. 557(b); River Forest Pharmacy, Inc. v. DEA, 
501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the 
Administrative Procedure Act Sec.  8(a) (1947).

[Factor One

    In this case, it is undisputed that Respondent holds a valid state 
medical license in California. However, possession of a state license 
does not entitle a holder of that license to a DEA registration. Mark 
De La Lama, P.A., 76 FR 20011, 20018 (2011). It is well established 
that a ``state license is a necessary, but not a sufficient condition 
for registration.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). 
The ultimate responsibility to determine whether a DEA registration is 
consistent with the public interest resides exclusively with the DEA, 
not to entities within state government. Edmund Chien, M.D., 72 FR 
6580, 6590 (2007), aff'd Chien v. DEA, 533 F.3d 828 (D.C. Cir. 2008).
    In determining the public interest, the ``recommendation of the 
appropriate State licensing board or professional disciplinary 
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms 
of recommendations appear in Agency decisions: (1) A recommendation to 
DEA directly from a state licensing board or professional disciplinary 
authority (hereinafter, appropriate state entity), which explicitly 
addresses the granting or retention of a DEA COR; and (2) the 
appropriate state entity's action regarding the licensure under its 
jurisdiction on the same matter that is the basis for the DEA OSC. John 
O. Dimowo, M.D., 85 FR 15800, 15810 (2020); see also Vincent J. 
Scolaro, D.O., 67 FR 42060, 42065 (2002).
    In this case, neither the MBC nor any other state entity has made a 
direct recommendation to DEA regarding whether the Respondent's 
controlled substances registration should be suspended or revoked. 
There is evidence on the record that on October 29, 2019, the MBC found 
that the Respondent violated state law by prescribing dangerous 
controlled substances to the Board Patients. Gov't Ex. 30 at 147, 157-
61, 196-199. The MBC found in favor of revocation, but stayed the 
revocation pending completion of probation. Id. at 168.
    The evidence before me is different than the evidence that was 
before the MBC. It demonstrates that Respondent engaged in additional 
violations of state and federal law with respect to his prescribing 
practices. The fact that the MBC chose to stay the revocation of 
Respondent's state medical license carries minimal weight under Factor 
One, because there is no evidence that the MBC would have made the same 
decision in the face of the additional misconduct found herein 
involving different patients.*\N\ Further, it is noted that, in spite 
of the decision's stay, the Board actually found in favor of 
revocation, which does not indicate a substantial amount of trust in 
Respondent. For all of these reasons, the terms of the MBC Order have 
been considered, but I find that they have little impact on the public 
interest inquiry in this case. See Jeanne E. Germeil, 85 FR 73786, 
73799 (2020); see also John O. Dimowo, M.D., 85 FR 15810. It ultimately 
is the Administrator who makes a determination of whether maintaining a 
COR is in the public interest as defined by the CSA, and the 
Administrator's purview is focused on entrusting Respondent with a 
controlled substances registration, which is a much more narrow inquiry 
than a medical license generally. Ajay S. Ahuja, M.D., 84 FR 5479, 5490 
(2019).
---------------------------------------------------------------------------

    *\N\ In Dimowo, the Acting Administrator found that ``[a]lthough 
statutory analysis [of the CSA] may not definitively settle . . . 
[the breadth of the cognizable state `recommendation' referenced in 
Factor One], the most impartial and reasonable course of action is 
to continue to take into consideration all actions indicating a 
recommendation from an appropriate state;'' however, Dimowo also 
limited the ``recommendations'' DEA would consider to the ``actions 
of an appropriate state entity on the same matters, particularly 
where it rendered an opinion regarding the practitioner's medical 
practice in the state due to the same facts alleged in the DEA 
OSC.'' John O. Dimowo, 85 FR 15810. Although the same ``matters'' 
may include similar types of violations, in this case, I have no 
indication that the MBC would have made a similar decision in the 
face of these additional violations and misconduct.
---------------------------------------------------------------------------

    In sum, while the terms of the MBC are not dispositive of the 
public interest inquiry in this case and are minimized due to the 
differences in the evidence in the MBC Order, the record evidence 
before me and the severity of the sanctions ordered by the MBC, I 
consider the stay of the MBC's revocation of Respondent's California 
medical license and give it minimal weight in Respondent's favor, 
because the charges could have immediately resulted in the revocation 
of his medical license, instead of a stayed revocation. See Jennifer 
St. Croix, 86 FR 19010, 19022 (2021). Even with this minimal weight in 
his favor, I do not find Respondent's continued registration to be 
within the public interest as explained below.]

Factors Two and Four: The Respondent's Experience Dispensing Controlled 
Substances and Compliance With Federal, State, and Local Law

    The Government has founded its theory for sanction exclusively on 
Public Interest Factors Two (the Respondent's experience conducting 
regulated activity) and Four (the Respondent's compliance with state 
and federal laws related to controlled substances), and it is under 
those two factors that the lion's share of the evidence of record 
relates.\97\ In this case, the gravamen of the allegations in the OSC 
as well as the factual concentration of much of the evidence presented, 
share as a principal focus the manner in which the Respondent has 
managed that

[[Page 4929]]

part of his practice relative to prescribing controlled substances and 
acts allegedly committed in connection with that practice. Thus, it is 
analytically logical to consider Public Interest Factors Two and Four 
together. That being said, Factors Two and Four involve analysis of 
both common and distinct considerations.
---------------------------------------------------------------------------

    \97\ [Omitted the Chief ALJ's discussion of Factor One and added 
it into the text above]. [T]here is no record evidence of a 
conviction record relating to regulated activity (Factor Three). 
Even apart from the fact that the plain language of this factor does 
not appear to emphasize the absence of such a conviction record, 
myriad considerations are factored into a decision to initiate, 
pursue, and dispose of criminal proceedings by federal, state, and 
local prosecution authorities which lessen the logical impact of the 
absence of such a record. See Dougherty, 76 FR 16833 n.13; Dewey C. 
MacKay, M.D., 75 FR 49956, 49973 (2010) (``[W]hile a history of 
criminal convictions for offenses involving the distribution or 
dispensing of controlled substances is a highly relevant 
consideration, there are any number of reasons why a registrant may 
not have been convicted of such an offense, and thus, the absence of 
such a conviction is of considerably less consequence in the public 
interest inquiry.''), aff'd, MacKay v. DEA, 664 F.3d 808 (10th Cir. 
2011); Ladapo O. Shyngle, M.D., 74 FR 6056, 6057 n.2 (2009). 
Therefore, the absence of criminal convictions militates neither for 
nor against the revocation sought by the Government. Since the 
Government's allegations and evidence fit squarely within the 
parameters of Factors Two and Four and do not raise ``other conduct 
which may threaten the public health and safety,'' 21 U.S.C. 
823(f)(5), Factor Five considerations are inapplicable and militate 
neither for nor against the sanction sought by the Government in 
this case.
---------------------------------------------------------------------------

    Regarding Factor Two, it is beyond argument that the Respondent is 
a well-credentialed, experienced medical practitioner who has been 
treating many patients for many years. Resp't Ex. G; Tr. 898. There is 
likewise no evidence of record that, prior to his present difficulties, 
that the Respondent has been the subject of discipline by state or 
federal authorities relative to his controlled substance prescribing. 
[Omitted for brevity.] The Respondent's experience as a registrant is 
lengthy, and there is no evidence to contradict his contention that he 
has treated many, many patients, but the Agency has long held that 
benign experience cannot overcome intentional misconduct, and that the 
misconduct established by record evidence is considered under both 
Factors Two and Four. See Roberto Zayas, M.D., 82 FR 21410, 21422 n.27 
(2017) (announcing that ``misconduct is misconduct whether it is 
relevant under Factor Two, Factor Four, or Factor Five, or multiple 
factors''). Thus, the balance of the evidence related to Factor Two, 
per the Agency's interpretation, will be considered below together with 
Factor Four.
    As discussed, supra, Factor Four compels consideration of the 
Respondent's compliance with state and federal laws related to 
controlled substances. The DEA regulations provide that to be 
effective, a prescription must be issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice. 21 CFR 1306.04(a). The Supreme Court has opined that, ``the 
prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006). 
Further, the Agency's authority to revoke a registration is not limited 
to instances where a practitioner has intentionally diverted controlled 
substances. Bienvenido Tan, 76 FR 1763, 17689 (2011); see Dewey C. 
MacKay, M.D., 75 FR 49956, 49974 n.35 (2010) (noting that revocation is 
not precluded merely because the conduct was ``unintentional, innocent, 
or devoid of improper motive'') (citation omitted).
    To effectuate the dual goals of conquering drug abuse and 
controlling both legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the [Controlled 
Substance Act (CSA)].'' Gonzales v. Raich, 545 U.S. 1, 13 (2005). 
Consistent with the maintenance of that closed regulatory system, 
subject to limited exceptions not relevant here, a controlled substance 
may only be dispensed upon a prescription issued by a practitioner, and 
such a prescription is unlawful unless it 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 21 U.S.C. 
829. Furthermore, ``[a]n order purporting to be a prescription issued 
not in the usual course of professional treatment . . . is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and the 
person knowingly . . . issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' 21 CFR 1306.04(a).
    The prescription requirement is designed to ensure that controlled 
substances are used under the supervision of a doctor, as a bulwark 
against the risk of addiction and recreational abuse. George C. Aycock, 
M.D., 74 FR 17529, 17541 (2009) (citing Gonzales, 546 U.S. at 274); see 
also United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting 
that evidence established that a physician exceeded the bounds of 
professional practice when he gave inadequate examinations or none at 
all, ignored the results of the tests he did make, and took no 
precautions against misuse and diversion). The prescription requirement 
likewise stands as a proscription against doctors ``peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales, 546 
U.S. at 274. A registered practitioner is authorized to dispense, which 
the CSA defines as ``to deliver a controlled substance to an ultimate 
user . . . by, or pursuant to the lawful order of a practitioner.'' 21 
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 
(2007). The courts have sustained criminal convictions based on the 
issuing of illegitimate prescriptions where physicians conducted no 
physical examinations or sham physical examinations. United States v. 
Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 
1113 (2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 
1986).
    ``Under the CSA, it is fundamental that a practitioner must 
establish and maintain a [bona fide] doctor-patient relationship in 
order to act in the usual course of . . . professional practice and to 
issue a prescription for a legitimate medical purpose.'' Mackay, 75 FR 
49973 (citation omitted); Patrick W. Stodola, M.D., 74 FR 20727, 20731 
(2009); Ladapo O. Shyngle, M.D., 74 FR 6056, 6057-58 (2009). The CSA 
generally looks to state law to determine whether a bona fide doctor-
patient relationship was established and maintained. Stodola, 74 FR 
20731; Kamir Garces-Mejias, M.D., 72 FR 54931, 54935 (2007); United 
Prescription Servs., Inc., 72 FR 50397, 50407 (2007).
    While true that the CSA authorizes the ``regulat[ion of] medical 
practice insofar as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and 
trafficking as conventionally understood,'' Gonzales, 546 U.S. at 909-
10, and the agency also evaluates state standards. Joseph Gaudio, M.D., 
74 FR 10083, 10090 (2009); Garces-Mejias, 72 FR 54935; United 
Prescription Servs., 72 FR 50407. In this adjudication, the evaluation 
of the Respondent's prescribing practices must be consistent with the 
CSA's recognition of state regulation of the medical profession and its 
bar on physicians from engaging in unlawful prescribing. Aycock, 74 FR 
17541.*\O\
---------------------------------------------------------------------------

    *\O\ Omitted for clarity.
---------------------------------------------------------------------------

    Here, the relevant state law provisions largely mirror the CSA 
where they do not go beyond it. Compare Cal. Health & Safety Code Sec.  
11153(a) with 21 CFR 1304.06(a). California Health and Safety Code 
Sec.  1153(a), like its CSA counterpart,\98\ provides 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.'' California law 
further provides that ``[r]epeated acts of clearly excessive 
prescribing'' constitutes unprofessional conduct for a physician. Cal. 
Bus. & Prof. Code Sec.  725(a). Additionally, gross negligence, 
incompetence, and repeated negligent acts can subject a physician to 
sanction by the state medical board. Cal. Bus. & Prof. Code Sec.  2234.
---------------------------------------------------------------------------

    \98\ 21 U.S.C. 802(21), 823(f).
---------------------------------------------------------------------------

    California has specifically classified two categories of controlled 
substance prescriptions as per se illegal:

    (1) an order purporting to be a prescription which is issued not 
in the usual course of professional treatment or in legitimate and 
authorized research; or (2) an order for an addict or habitual user 
of controlled

[[Page 4930]]

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 practitioner in California 
who knowingly issues such an illegal prescription faces criminal 
exposure. Cal. Health & Safety Code Sec.  11153(b).
    During the course of his testimony, the Government's expert, Dr. 
Munzing, outlined six elements that compose the standard of care for 
prescribing controlled substances in the usual course of professional 
treatment in California. Dr. Munzing explained that a physician must 
acquire a patient history, conduct a physical examination of the 
patient, determine whether additional data is necessary, produce an 
assessment of the patient that includes risk stratification, create an 
individualized treatment plan and obtain informed consent, and have 
proper documentation throughout each step. Tr. 94-111. These elements 
laid out by Dr. Munzing are consistent with instructions provided by 
the California Board in its publication, Guide to the Laws Governing 
the Practice of Medicine by Physicians and Surgeons (the MBC Guide). 
See Gov't Ex. 21 at 57-61. The MBC Guide also lays out six basic 
components to assist practitioners in meeting the standard of care in 
managing pain patients: History/physical examination; treatment plan, 
objectives; informed consent; periodic review; consultation; and 
records. Id. at 59-61. The California Board supplies the following 
explanation for acquiring a patient history and conducting a physical 
examination:

    A medical history and physical examination must be accomplished. 
This includes an assessment of the pain, physical and psychological 
function; a substance abuse history; history of prior pain 
treatment; an assessment of underlying or coexisting diseases or 
conditions; and documentation of the presence of a recognized 
medical indication for the use of a controlled substance.

Id. at 59. The California Board explains producing an assessment of the 
patient, or the creation of a treatment plan, as follows:

    The treatment plan should state objectives by which the 
treatment plan can be evaluated, such as pain relief and/or improved 
physical and psychosocial function, and indicate if any further 
diagnostic evaluations or other treatments are planned. The 
physician and surgeon should tailor pharmacological therapy to the 
individual medical needs of each patient. Multiple treatment 
modalities and/or a rehabilitation program may be necessary if the 
pain is complex or is associated with physical and psychosocial 
impairment.

Id. In clarifying informed consent, the California Board states that 
physicians ``should discuss the risks and benefits of the use of 
controlled substances and other treatment modalities with the patient, 
caregiver, or guardian.'' Id. at 60.
    The California Board also suggests that a physician ``should 
periodically review the course of pain treatment of the patient and any 
new information about the etiology of the pain or the patient's state 
of health.'' Id. In addressing consultation, the California Board 
advises that ``physicians should give special attention to those pain 
patients who are at risk for misusing their medications including those 
whose living arrangements pose a risk for medication misuse or 
diversion.'' Id. Dr. Munzing emphasized the importance of the 
documentation requirement to ensuring patient safety. Tr. 105-07. Dr. 
Munzing's explanation of the documentation requirements mirrored the 
California Board's guidelines.

    The physician and surgeon should keep accurate and complete 
records according to [the five other controlled substance 
prescribing components], including the medical history and physical 
examination, other evaluations and consultations, treatment plan 
objectives, informed consent, treatments, medications, rationale for 
changes in the treatment plan or medications, agreements with the 
patient, and periodic reviews of the treatment plan.

Gov't Ex. 21 at 61.
    The applicable California Code provisions are consistent with the 
standards outlined by the Government's expert, Dr. Munzing. Further, 
the Respondent (and ultimately his expert) acceded that his controlled 
substance prescribing fell below the applicable standard of care in 
California in regard to prescribing early refills, addressing 
inconsistent UDSs, and (at least with respect to Patient ET) acquiring 
adequate informed consent. Accordingly, on these issues, the testimony 
of the Government's expert stands uncontroverted on the present record. 
When an administrative tribunal elects to disregard the uncontradicted 
opinion of an expert, it runs the risk of improperly declaring itself 
as an interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554 
(6th Cir. 1966). There is no shortage of reliable expert knowledge in 
the present record, at least regarding these issues, it is 
uncontroverted, and it is not favorable to the Respondent.
    At issue in this case is the Respondent's controlled substance 
prescribing to ten patients: The four Board Patients that were the 
subject of findings by MBC, and the Six Patients that were evaluated by 
Dr. Munzing. While the evidence of record is generally discernible, the 
same cannot entirely be said of the allegations propounded by the 
Government in its OSC relating to the Six Patients. While it is likely 
that the Government's intention was to contend that the Respondent 
issued prescriptions to the Six Patients for controlled substances 
outside the usual course of professional practice, that is not entirely 
reflected in the plain language of the Government's charging document.
    As discussed, supra, the CSA authorizes the Agency to impose a 
sanction upon a finding that a registrant ``has committed such acts as 
would render his registration under [21 U.S.C. 823] inconsistent with 
the public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). Thus, for the Government to satisfy its prima facie burden, 
it must allege facts that, if sustained, would actually demonstrate 
that the registrant committed such acts as would render his 
registration inconsistent with the public interest. See id. Here, in a 
subset of allegations relating to the Six Patients (the He-Opined 
Allegations), the Government does not allege actions, conduct, or 
omissions attributable to the Respondent, but rather conclusions or 
observations made by its own medical expert. ALJ Ex. 1 ]] 14.a, c, d, 
e, f; ]] 18.a, c, d; ]] 21.a, c, d; ]] 23.a, c; ]] 26.a, c, d; ]] 30.a, 
c, d. The plain language of each of the He-Opined Allegations points 
not to conduct or omissions made by the Respondent, but merely to the 
fact that (at some unspecified point in time) the Government's expert 
concluded that certain matters were true.\99\ [Omitted for brevity.]
---------------------------------------------------------------------------

    \99\ [Omitted for relevance.]
---------------------------------------------------------------------------

    In pursuing a sanction under the Administrative Procedure Act (APA) 
the Government is obligated to provide timely notice to a respondent, 
inter alia, of ``the matters of law and fact asserted.'' 5 U.S.C. 
554(b)(3); see also 21 CFR 1301.37(c). The Agency is required to 
provide a respondent with notice of those acts which the Agency intends 
to rely upon in seeking a sanction so as to provide a full and fair 
opportunity to challenge the factual and legal basis for the Agency's 
action. CBS Wholesale Distribs., 74 FR 36746, 36749 (2009). An 
administrative charging document is not subject to the same level of 
formality as

[[Page 4931]]

required in a criminal indictment or a pleading filed in a civil case, 
Clair L. Pettinger, M.D., 78 FR 61591, 61596 (2013); Roy E. Berkowitz, 
M.D., 74 FR 36758, 36759-60 (2009), but neither is the requirement 
meaningless or illusory. The notice must be adequate, but the 
allegation as written, must also establish culpability if proved. 
[Omitted for brevity.]
    However, [ ] the Agency has embraced the concept of litigation by 
consent. Grider Drug #1 and Grider Drug #2, 77 FR 36746, 44070 n.23 
(2012). Where, as here, a respondent has been provided with adequate 
notice of an allegation, was afforded a full and fair opportunity to 
litigate the issue, and did fully litigate the issue without objection, 
the Agency has applied the well-established principle of litigation by 
consent to adjudicate that which was intentionally tried by the 
parties. However, the analysis of litigation by consent is fact 
specific and the Agency may not base its decision on an issue that was 
inadvertently tried by the parties. See Farmacia Yani, 80 FR 29053, 
29059 (2015). ``Implied consent is not established merely because one 
party introduced evidence relevant to an unpleaded issue and the 
opposing party failed to object to its introduction. It must appear 
that the parties understood the evidence to be aimed at the unpleaded 
issue.'' Id. (internal citations omitted).
    It is beyond argument that the He-Opined Allegations are unartfully 
pleaded, but it is likewise irrefutable that the parties mutually 
understood that they were litigating the issue of whether the 
controlled-substance prescribing issues set forth in a subset of those 
allegations depicted conduct that fell below the applicable standard. 
In fact, the Respondent, through his counsel, frequently tracked along 
with the OSC allegations and phrased many of his queries on whether the 
Government-expert's criticisms raised by the He-Opined Allegations were 
valid. See, e.g., Tr. 535, 643, 929, 932-33, 962, 981, 983, 1005, 1182. 
Additionally, this issue was not raised by the Respondent in his 
closing brief. See ALJ Ex. 37. This case raises no realistic notice 
issues, and the language related to the opinions of the Government's 
expert will be treated here as surplusage that does not impact the 
validity of the charges or the findings. Accordingly, based on the 
conduct of the parties at the hearing, as well as their post-hearing 
briefs, the He-Opined Allegations will be considered as if the 
underlying actions are alleged, not as if the conclusions of the 
Government's expert (at some unspecified time) are the single issue 
(that is: as they were drafted and served on the Respondent and this 
tribunal).\100\ *\P\
---------------------------------------------------------------------------

    \100\ [Footnote omitted for clarity.]
    *\P\ I agree with the Chief ALJ that the OSC's drafting was 
imprecise. I note that the OSC did include overarching acts or 
omissions in addition to the more-specific expert opinions. The OSC 
stated that Respondent ``violated federal and California law by 
issuing prescriptions for controlled substances outside the usual 
course of profession practice and not for a legitimate medical 
purpose, to more than six patients.'' See, e.g., OSC at 3; see also 
id. at 2 (``a prescription for a controlled substance is legitimate 
only if `issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice.' '' (citing 21 CFR 1306.04(a))). Therefore, although I 
agree with the Chief ALJ that the drafting could be improved, I also 
agree with him that Respondent was adequately noticed of the 
allegations against it in this case.
---------------------------------------------------------------------------

    During the course of this case, Dr. Munzing delivered his expert 
opinion that the Respondent's charts did not reflect that he adequately 
discussed the risks attendant upon the opiate course of treatment he 
was employing on the Six Patients. While the Respondent and Dr. Polston 
held differing views of this perspective, Dr. Munzing's views on this 
issue (and all the issues upon which he opined in this case) are 
afforded controlling weight. Accordingly, OSC Allegations 14.b, 18.b, 
21.b, 23.b, 26.b, and 30.b are sustained.
    Similarly, Dr. Munzing's expert opinion, supported by the findings 
of the San Diego Medical Examiner's Office in its ME Report \101\ 
(although in conflict with the views of the Respondent and Dr. 
Polston), that controlled substances prescribed by the Respondent were 
among the contributing factors to Patient AA's death,\102\ is likewise 
afforded controlling weight. Accordingly, OSC Allegations 12 and 14.f 
are sustained.
---------------------------------------------------------------------------

    \101\ Gov't Ex. 31 at 5.
    \102\ The Government did not allege, nor is it necessary for 
this Recommended Decision to find, that the Respondent's prescribing 
was the sole or even principal factor [or a ``significant 
component,'' Tr. 943] in Patient AA's overdose death.
---------------------------------------------------------------------------

    The Respondent's practice of refilling 30-day controlled substance 
prescriptions every 28 days for the Six Patients, causing a reservoir 
of extra medication, is an area where the Respondent, during the course 
of his testimony, was able to agree with the expert opinion of Dr. 
Munzing. Accordingly, as amended,\103\ OSC Allegations 14.e, 18.d, 
21.d, 23.c, 26.d, and 30.c are sustained.
---------------------------------------------------------------------------

    \103\ ALJ Ex. 25.
---------------------------------------------------------------------------

    Although the Respondent remained convinced about the validity of 
the controlled medications and dosages he prescribed to the Six 
Patients, as well as the combinations of medicines in the context of 
the time and the ailments he was treating, in general he did not resist 
the Government's view, supported by the expert opinion of Dr. Munzing, 
that the documentation generated in the Respondent's charting of the 
Six Patients was inadequate to a point where it fell below the 
applicable standard of care. Dr. Munzing's expert opinion has been 
afforded controlling weight. Accordingly, OSC Allegations 14.a, 
14.c,*\Q\ 18.a, 18.c, 21.a, 21.c, 23.a, 26.a, 26.c, and 30.a are 
sustained.
---------------------------------------------------------------------------

    *\Q\ In his Exceptions, Respondent claims that the Chief ALJ 
recommended sustaining allegations 14c and 18c that Respondent's 
concurrent prescribing of opioids and benzodiazepines was beneath 
the standard of care ``without discussing the reasons why.'' Resp't 
Exceptions at 10. Respondent claims, as he did many times in this 
case, that the CDC Guidelines ``do not prohibit this combination.'' 
Id. Dr. Munzing testified that ``the fact that you prescribe a 
benzodiazepine to [sic] an opioid, the risk of overdose goes up ten-
fold. That's a significant increase.'' Tr. 448. He stated that ``the 
FDA and the CDC both came out with--one was a black box warning by 
the FDA; the other is the CDC guidelines, but it was known before 
that time. It was in literature by 2015, potentially earlier than 
that.'' Tr. 449. Dr. Munzing further testified that because ``the 
patient is being put at significantly increased risk,'' the standard 
of care requires that ``[i]t certainly needs to be recognized, 
addressed, and if the patient has conditions that the potential 
benefit is outweighed by the potential risk, which it would be hard 
to show that in this case. Doctors need to well document that and 
show that alternatives are really not an option.'' Tr. 449. 
Therefore, Respondent's testimony that he had discussions with these 
patients regarding the risks, but simply did not document those 
discussions ``as well as [he] should have,'' Tr. 933, does not 
address the other issues that Dr. Munzing raised, such as 
documenting that alternatives are not an option. The testimony 
Respondent cites to in its Exceptions clearly only addresses 
documenting the discussion of the risks with the patient, not 
alternative treatments or the risks of the combination generally. 
Resp't Exceptions at 11. Further, even if I found, in accordance 
with Respondent and Dr. Polston, that ``in the year 2014, 
prescribing opioids and benzodiazepines was not outside the standard 
of care,'' the Government's allegations would still include several 
years of prescribing to AA and BB, during which Respondent's 
documentation did not address the concerns that the co-prescribing 
of these substances raised. Resp't Exceptions at 11 (citing Ex. L at 
10). Dr. Polston notably did not testify about this combination and 
the only reference to it is in his report as the Respondent cited, 
which is given limited weight given my inability to assess the 
credibility of these statements. Ultimately, I find that the record 
evidence clearly supports the Government allegations related to the 
concurrent prescribing, and I do not find Respondent's Exception to 
be meaningful in my overall assessment that Respondent issued 
prescriptions beneath the standard of care and outside the usual 
course of professional practice to AA and BB, particularly given the 
multitude of other reasons why these prescriptions fell beneath the 
standard.
---------------------------------------------------------------------------

    The OSC contains allegations regarding controlled substances with 
doses and amounts specific to each of the Six Patients. The record 
contains sufficient evidence to preponderantly sustain the amounts 
alleged for Patients

[[Page 4932]]

AA,\104\ BB,\105\ JD,\106\ and ET \107\ as charged. Accordingly OSC 
Allegations 8, 15, 19, and 27 are sustained. However, the amounts 
specified regarding Patients DD \108\ and SM \109\ are more 
problematic, and it is at least possible that a greater investment on 
the part of the Government in this regard could have been more 
helpful.\110\ Although subsection (1) of the Patient DD OSC dosage/
amount allegation references ``patches,'' only lozenges were raised by 
the evidence, and there is no evidence to support the subsection (4) 
reference to eight fills of temazepam. Accordingly, OSC Allegation 22 
is sustained in part to the extent that subsection (1) alleges ``a 
quantity of fentanyl citrate,'' subsections (2) and (3) are sustained 
as charged, and subsection (4) is not sustained. Similarly, the dosage/
amount allegation pertaining to Patient SM contains insufficient 
quantitative evidence to support the amounts specified in subsections 
(3), (4), and (5).\111\ Accordingly, OSC Allegation 24 is sustained in 
part to the extent that subsection (3) alleges ``a quantity of 
diazepam,'' subsection (4) alleges ``a quantity of fentanyl,'' and 
subsection (5) alleges ``a quantity of oxycodone.'' Subsections (1) and 
(2) are sustained as charged.*\R\ 
<SUP>112 113 114 115 116 117 118</SUP>
---------------------------------------------------------------------------

    \104\ ALJ Ex. 1 ] 8.
    \105\ ALJ Ex. 1 ] 15.
    \106\ ALJ Ex. 1 ] 19.
    \107\ ALJ Ex. 1 ] 27.
    \108\ ALJ Ex. 1 ] 22.
    \109\ ALJ Ex. 1 ] 24.
    \110\ See Gregg & Son Distributors, 74 FR 17517, 17517 n.1 
(2009) (clarifying that ``it is the Government's obligation as part 
of its burden of proof and not the ALJ's responsibility to sift 
through the records and highlight that information which is 
probative of the issues in the proceeding''). In addressing the 
specifically-alleged amounts of medications prescribed to the Six 
Patients, the Government's closing brief avers that the Respondent 
issued ``numerous prescriptions'' of a particular controlled 
substance to a patient and then provides a general reference to a 
contemporaneously-filed attachment. ALJ Ex. 35 at 5-9. Not to put 
too fine a point on the matter, but this methodology is less helpful 
than it could have been in this case because the attachment is 
regrettably hobbled by numerous entries that appear to be less than 
entirely accurate. For instance, the chart attachment for Patient DD 
contains no reference to patches of fentanyl citrate, modafinil, or 
temazepam (although OSC Allegation 22 alleges specific amounts of 
each), it lists only 58 prescription dates (while OSC Allegation 22 
alleges 93 separate fills of fentanyl patches and 60 separate fills 
of OxyContin), and it appears that it may even be missing a third 
page. See id. at 41-42. The chart attachment for Patient BB includes 
at least one prescription issued by the Respondent outside of the 
timeframe alleged in OSC Allegation 15. See id. at 33-35. Further, 
multiple prescriptions listed in the Patient SM chart attachment 
contain inaccurate dosages and medications. See id. at 43-46.
    \111\ See Gregg & Son Distributors, 74 FR 17517 n.1 (noting that 
``it is the Government's obligation as part of its burden of proof . 
. . to sift through the records and highlight that information which 
is probative of the issues in the proceeding'').
    *\R\ The Government allegations also included references to 
``letters of concern'' from insurance companies that identified the 
high level of MMEs that Respondent was prescribing. ALJ Ex. 1 ] 13, 
16, 35, 29, 20; See e.g., Gov't Ex. 2 at 522-23, 542-44, 596-98, 
672-74. The Chief ALJ sustained some of the allegations related to 
the letters of concern, and in doing so, noted issues with the 
Government's evidence. RD at 39. I am declining to consider these 
letters as separate violations--they appear to more support the 
overall notion that Respondent's prescribing was in violation 21 CFR 
1306.04; however, there is little explanation on the record 
supporting the direct relevance of the letters, and there is ample 
evidence on the record to support finding a violation of 21 CFR 
1306.04 without such letters. As such, I have omitted this section 
of the RD.
    \112\ Omitted. See n.*R supra.
    \113\ Omitted. See n.*R supra.
    \114\ Omitted. See n.*R supra.
    \115\ Omitted. See n.*R supra.
    \116\ Omitted. See n.*R supra.
    \117\ Omitted. See n.*R supra.
    \118\ Omitted. See n.*R supra.
---------------------------------------------------------------------------

    The Government alleges that the Respondent examined CURES reports 
eight times regarding Patient BB, but presented no evidence that this 
occurred (or why it would be relevant to the extent he had done 
so).\119\ Accordingly, OSC Allegation 17 is not sustained.
---------------------------------------------------------------------------

    \119\ Again, see Gregg & Son Distributors, 74 FR 17517 n.1 
(clarifying that ``it is the Government's obligation as part of its 
burden of proof and not the ALJ's responsibility to sift through the 
records and highlight that information which is probative of the 
issues in the proceeding'').
---------------------------------------------------------------------------

    The Government alleges that on multiple occasions where the 
Respondent encountered anomalous urine drug screen results relative to 
two of the Six Patients,\120\ his medical charting failed to reflect 
actions that would have been required to stay within the standard of 
care. Dr. Munzing's expert opinion has been afforded controlling 
weight, and although the Respondent pushed back regarding Patient 
SM,\121\ in general, he accepted that his documentation in this regard 
was lacking. Accordingly, OSC Allegations 9, 10, 14.d, 28, and 30.d are 
sustained.
---------------------------------------------------------------------------

    \120\ ALJ Ex. 1 ]] 9, 10, 14.d (Patient AA); ]] 28, 30.d 
(Patient ET).
    \121\ The Respondent testified that he did not feel that Patient 
ET's positive drug screen result for temazepam was truly aberrant 
because, in his view, that result was consistent with a medication 
(diazepam) that he had prescribed. Tr. 1028. Although the Government 
did not present evidence to refute the Respondent's proposition in 
this regard, Dr. Munzing's opinion has been afforded controlling 
weight.
---------------------------------------------------------------------------

    The Government introduced an October 29, 2019 order (Board Order) 
issued by the California Board regarding disciplinary action taken by 
MBC against the Respondent. Gov't Ex. 30. In DEA administrative 
proceedings, factual findings and legal conclusions based on state law 
reached by state administrative tribunals are given preclusive effect. 
Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011); Gilbert Eugene 
Johnson, M.D., 75 FR 65663, 65666 (2010); see also James William 
Eisenberg, M.D., 77 FR 45663, 45663-64 (2012) (holding that official 
notice taken of findings in a state medical board censure order gives 
those findings preclusive effect). State medical boards are presumed to 
be the expert agency with the authority to determine whether one of its 
practitioners has engaged in unprofessional conduct or provided 
incompetent medical care, and ``[w]here . . . a state medical board has 
determined that a practitioner's conduct violated the standard of care, 
its findings of fact and conclusions of law are not subject to 
relitigation before the Agency.'' Ruben, 78 FR 38369. The key inquiry 
is not whether a full evidentiary hearing was conducted in the prior 
proceedings, but whether the parties had a full and fair opportunity to 
litigate the issues prior to the Agency's decision. Jose G. Zavaleta, 
M.D., 78 FR 27431, 27434 (2013).
    The Board Order introduced by the Government includes the following 
findings related to MBC's decision that the Respondent violated state 
and/or federal law and engaged in unprofessional conduct by prescribing 
dangerous controlled substances to the Board Patients. Gov't Ex. 30 at 
147, 157-61. MBC's findings regarding the Board Patients are herein 
discussed in seriatim.
    With respect to Board Patient A, MBC found that the Respondent 
prescribed opioids to Patient A, between December 2011 and early 2013, 
in an amount that exceeded 300 MEDs. Id. at 129-30. While prescribed 
these large quantities of controlled substances, Patient A ``reported 
lack of analgesia and continued chronic pain, and decreased function, 
and [ ] displayed aberrant behaviors.'' Id. at 129. MBC found that the 
Respondent ``committed gross negligence in his care and treatment of 
Patient A'' by continuing to prescribe high dose opioids even though 
her chronic pain was not effectively treated with the prescribed 
medications and she displayed aberrant behaviors. Id. at 128-29, 157. 
Accordingly, inasmuch as the California Board's findings are res 
judicata in these proceedings, OSC Allegation 31.a, which pertains to 
Patient A, must be and is sustained. See

[[Page 4933]]

Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
    Regarding Board Patient B, the California Board found that the 
Respondent committed gross negligence when he failed to discuss the 
attendant risks and benefits of controlled substances and failed to 
enter into a pain management agreement with Patient B. Gov't Ex. 30 at 
130, 146, 158. The Respondent additionally prescribed greater than 30-
day supplies of controlled substances to Patient B on multiple 
occasions during 2013, which the Board found to constitute gross 
negligence. Id. at 131, 144, 158. Accordingly, inasmuch as the 
California Board's findings are res judicata in these proceedings, OSC 
Allegations 31.b and 31.c, which pertain to Patient B, must be and are 
sustained. See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
    MBC found that the Respondent's treatment of Board Patient D was 
grossly negligent in that he continued to prescribe her controlled 
substances despite aberrant behaviors, possible addiction, and 
noncompliance with her pain management agreement. Gov't Ex. 30 at 135, 
158. In finding that the Respondent failed to adequately monitor his 
treatment of Patient D, the Board identified that the Respondent could 
have employed, but did not, UDSs and random pill counts as monitoring 
methods. Id. at 136. Notably, the California Board found that, for at 
least one prescription, the Respondent's conduct with respect to 
Patient D was an ``extreme departure'' from the standard of care for 
medical professionals in California. Id. at 98, 136-37. Accordingly, 
inasmuch as the California Board's findings are res judicata in these 
proceedings, OSC Allegation 31.d, which pertains to Patient D, must be 
and is sustained. See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
    With respect to Board Patient E, the California Board found the 
Respondent's conduct to similarly be grossly negligent. Gov't Ex. 30 at 
137, 158. MBC found that the Respondent prescribed controlled 
substances to Patient E without ``taking a systematic and thorough 
history including vitals, without periodically reviewing and 
documenting efficacy of treatment, without regularly assessing for 
possible diversion, and without discussing the risks, benefits, and 
alternatives of pharmacological treatment.'' Id. at 137; see also id. 
at 158. Moreover, MBC found that the Respondent further departed from 
the standard of care in prescribing methadone to Patient E, a known 
alcoholic, when methadone and alcohol are known to be contraindicated. 
Id. at 139-40, 148, 158, 161. Inasmuch as the California Board's 
findings are res judicata in these proceedings, OSC Allegations 31.e 
and 31.f, which pertain to Patient E, must be and are sustained. See 
Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
    All subsections of OSC Allegation 31(the Board Patient Allegations) 
are sustained, and any one of these subsections, standing in isolation 
is (and all, when considered collectively are) sufficient to satisfy 
the Government's prima facie burden in this case.
    OSC Allegations 1 and 2 (COR and state licensure status) are 
sustained based on the evidence \122\ and stipulations \123\ of record.
---------------------------------------------------------------------------

    \122\ Gov't Ex. 30 at 5.
    \123\ Stips 1,2.
---------------------------------------------------------------------------

    Accordingly, even in the face of the Respondent's lengthy 
experience as a practitioner and registrant, a balancing of Factors Two 
and Four militate strongly and powerfully in favor of the imposition of 
the revocation sanction sought by the Government.

Recommendation

    The evidence of record preponderantly establishes that the 
Respondent has committed acts which render his continued registration 
inconsistent with the public interest. See 21 U.S.C. 824(a)(4). Since 
the Government has met its burden \124\ in demonstrating that the 
revocation it seeks is authorized, to avoid sanction the Respondent 
must show that, given the totality of the facts and circumstances, the 
revocation sought by the Government is not warranted. See Med. Shoppe-
Jonesborough, 73 FR 387. In order to rebut the Government's prima facie 
case, the Respondent must demonstrate not only an unequivocal 
acceptance of responsibility but also a demonstrable plan of action to 
avoid similar conduct in the future. See Hassman, 75 FR 8236. On the 
present record he has accomplished neither objective.
---------------------------------------------------------------------------

    \124\ See 21 CFR 1301.44(e).
---------------------------------------------------------------------------

    Agency precedent is clear that a respondent must unequivocally 
admit fault as opposed to a ``generalized acceptance of 
responsibility.'' The Medicine Shoppe, 79 FR 59504, 59510 (2014); see 
also Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017). To satisfy this 
burden, the respondent must show ``true remorse'' or an 
``acknowledgment of wrongdoing.'' Michael S. Moore, M.D., 76 FR 45867, 
45877 (2011). The Agency has made it clear that an unequivocal 
acceptance of responsibility is an unwaivable condition precedent for 
avoiding a sanction. Dougherty, 76 FR 16834 (citing Krishna-Iyer, 74 FR 
464). This feature of the Agency's interpretation of its statutory 
mandate on the exercise of its discretionary function under the CSA has 
been sustained on review. Jones Total Health Care Pharmacy, LLC v. DEA, 
881 F.3d 823, 830-31 (11th Cir. 2018); MacKay v. DEA, 664 F.3d 808, 822 
(10th Cir. 2011); Hoxie, 419 F.3d at 483.
    As discussed, supra, the findings of the California Board, which 
are afforded preclusive effect here,\125\ preponderantly and 
conclusively establish the Board Patient Allegations, and are 
sufficient standing alone to satisfy the Government's prima facie case 
for revocation. Yet beyond noting that MBC declined to impose greater 
sanctions than it could have,\126\ the Respondent did not address those 
charges in his testimony or accept responsibility for any of the 
misconduct established therein. In his closing brief, the Respondent 
addressed the Board Order only insofar that he argued that it did not 
impact Public Interest Factor One (recommendation from an authorized 
state licensing authority) to his detriment. ALJ Ex. 37 at 3-
4.<SUP>127 128</SUP> The Agency has consistently held that without 
record evidence of both prongs (acceptance of responsibility and 
remedial steps aimed at avoiding recurrence), neither is relevant. Ajay 
S. Ahuja, M.D., 84 FR 5498 n.33; Jones Total Health Care, LLC, 81 FR 
79188, 79202-03 (2016); Hassman, 75 FR 8236. Thus, as the record 
stands, the Government has established OSC Allegations 31.a--31.f, 
which collectively and separately make out the Government's prima facie 
case for revocation, and the Respondent has offered no acceptance of 
responsibility. Hence, on this posture, based exclusively on the Board 
Patient Allegations and irrespective of the remainder of the analysis, 
it would be impossible under the Agency's interpretation of the CSA for 
the Respondent to avoid sanction.
---------------------------------------------------------------------------

    \125\ See Dougherty, 76 FR 16830; Johnson, 75 FR 65666.
    \126\ Tr. 1064-65.
    \127\ [omitted for relevance.]
    \128\ [omitted for relevance.]
---------------------------------------------------------------------------

    The Respondent's defense fares no better regarding the balance of 
the Government's case related to the Six Patients. During his 
testimony, the Respondent accepted responsibility for a standard office 
practice that yielded each of the Six Patients a bounty of extra 
medicine, but not much else. In

[[Page 4934]]

fact, the Respondent was careful to limit his acceptance to the 
deficiencies he was willing to acknowledge at the hearing.\129\ Tr. 
1062. He agreed that most \130\ of the anomalous UDS results merited 
additional patient queries and documentation in his charts, and, in 
general, that the level of his medical record documentation could bear 
some level of improvement in the future. But the Respondent stridently 
adhered to the medical correctness of his controlled substance choices 
and dosing, based primarily on the only mostly accurate premise that he 
received the patient at a high dose, the somewhat accurate premise that 
he was engaged in a taper,\131\ and the untenable premise that the 
practice of pain management was ``just coming off of the decade'' where 
there was ``no limits to dosing.'' Tr. 982. At one point in his 
testimony, he described a high dosage to one of the Six Patients as 
``not an unheard-of dosage.'' Id. The meaning (or timing) of ``coming 
off of the decade'' \132\ was never clear, and the concept that there 
was ever a point in time where there were ``no limits to dosing'' \133\ 
is unsupported in this record and dubious at best.
---------------------------------------------------------------------------

    \129\ Even in his closing brief, the Respondent's purported 
acceptance of responsibility, which is limited to the Six Patients 
allegations, reads this way: ``By way of mitigation/remediation, 
[the Respondent] acknowledged and accepted responsibility for 
deficiencies contained in the OSC.'' ALJ Ex. 37 at 32, ] 209 (record 
citation omitted). The Respondent's carefully-worded closing-brief 
assertions that he has ``unequivocally accepted responsibility for 
his deficiencies, as stated herein,'' id. at 38 (emphasis added), 
and that he ``admitted and took responsibility for numerous 
deficiencies that happened in the past,'' id. at 39 (emphasis 
added), strike as a trifle too layered to satisfy the Agency's 
requirement of an unequivocal acceptance of responsibility. Indeed, 
the Respondent's closing brief represents that ``he unequivocally 
accepted responsibility with respect to most of the allegations 
levied against him,'' id. at 41 (emphasis supplied), and lists five 
areas where he reckons he got the acceptance job done, id. at 41-42. 
No effort is made on any level to accept any responsibility 
regarding the Board Patient Allegations.
    \130\ Regarding a UDS for Patient ET that reflected a positive 
result for temazepam, the Respondent testified that he does not feel 
that this was anomalous because the patient had been prescribed 
diazepam, which according to the Respondent, would metabolize into 
yielding a positive temazepam result. Tr. 1028-29; see also ALJ Ex. 
37 at 31.
    \131\ Although the Respondent's progress notes frequently 
referenced his intention to wean down medications, the record 
evidence demonstrated that for extended periods of time these notes 
were limited to aspirations, and the medication was not reduced. The 
Respondent's post-hearing-brief argument that he was, in essence, 
resisting the urge to ``abruptly taper'' or suddenly discontinue 
opioid therapy, ALJ Ex. 37 at 8, ]] 49-50, is unpersuasive here, as 
the Government has not ascribed fault to the failure to engage in 
recklessly fast weaning of his patients' medications. No weaning 
whatsoever took place regarding Patient AA, and no weaning for 
extended periods was evident regarding the balance of the Six 
Patients.
    \132\ Tr. 982.
    \133\ Id.
---------------------------------------------------------------------------

    Furthermore, during the hearing, the Respondent sporadically 
persisted in his position that the standard pain management contracts 
executed by each of the Six Patients constituted an adequate risks/
benefits discussion to support informed consent. Admittedly, he seemed 
to acknowledge at some points that the opioid risks discussion would 
have benefitted by adding more detail (e.g., such as the risk of death 
\134\), but it would not be at all fair to say that this record paints 
a picture that demonstrates that he understands that the standard pain 
medication contract he employed did not meet the standard. It is clear 
from the plain language of the pain management contracts that these 
instruments were designed to advise patients of the consequences 
associated with medication-related non-compliance, not to supply 
adequate informed consent. Although the Respondent agreed that the pain 
management contracts did not advise the patients, inter alia, that 
death is a risk associated with the high dosage levels he was employing 
(or continuing), the Respondent maintained that the contracts did the 
job.\135\ By the Respondent's reckoning, the fact that the pain 
management contract mentioned the potential for respiratory depression 
was sufficient, because respiratory depression ``is usually the 
antecedence of [death].'' Tr. 932. This tack was particularly puzzling 
in light of the revelation that the Respondent ultimately did generate 
an opioid informed consent document that ``plug[s] that hole.'' Id. The 
Respondent's inconsistent approach to this issue seemed dependent upon 
who was asking the questions and how the questions were framed. At one 
point during his testimony, when pressed on the issue, the Respondent 
seemed to offer a limited acknowledgement:
---------------------------------------------------------------------------

    \134\ Tr. 932, 1026.
    \135\ The Respondent took a like position in the CAP he filed 
with the Agency. Resp't Ex. M at 4-5.

    I needed to talk more about the actual conversations I had with 
the patient, the potential risks, including death, which was not 
mentioned specifically. And I see that as a deficit in my reading, 
---------------------------------------------------------------------------
documentation and my discussion with the patient.

Id. at 1026. [Omitted. The Chief ALJ noted, and I agree, that 
Respondent waivered on whether he had the level of detailed 
conversations about risk that Dr. Munzing credibly testified were 
required by the standard of care, to include the risk of death, with 
his patients.]*\S\ \136\ On the present record it is far more plausible 
that such detailed conversations with the Six Patients never occurred, 
and that glossing over the issue by saying he wished he documented it 
better is unhelpful to the credibility of his position. The Respondent 
at once seemed to express understanding, even detailing a remedial step 
to improve documentation, but simultaneously declined to accept 
responsibility for the focus of the remedial step he implemented. The 
Respondent took essentially the same approach regarding his prescribing 
of dangerous combinations of drugs; to wit, that it was only the depth 
of his documentation that was lacking. More fundamentally, the 
Government's position is that the Respondent's high level of opioid 
prescribing created a sufficient danger to his patients such that he 
was required under the applicable standard of care in California to 
provide a specific warning

[[Page 4935]]

to those patients about the risks associated with such high levels of 
pain killers. The Government's expert reliably testified to that 
standard of informed consent, and the Respondent never [clearly and 
unequivocally] accepted responsibility for the absence of such a 
[detailed] warning; whether documented in his charts or not.
---------------------------------------------------------------------------

    *\S\ Respondent argues in his Exceptions that Respondent 
``unambiguously testified his pain agreement was not an adequate 
document and it needed to be improved.'' Resp't Exceptions at 25. 
Respondent did testify at times that he had conversations with his 
patients about the risks and he did admit that his pain management 
agreement ``should be, and has been improved.'' Tr. 25. I also agree 
with the Chief ALJ that Respondent pushed back at one point about 
whether he needed to include death, RD at 11-12 (citing Tr. 932). 
Contrary to Respondent's contention, it is not clear from the record 
whether he specifically discussed the risk of death with his 
patients, which Dr. Munzing testified was necessary under the 
standard of care. Regarding having ``words such as death,'' 
Respondent stated, ``I think it's important to mention to the 
patient, and that is something I want to do better and need to do.'' 
Tr. 932. Nowhere did Respondent clearly testify that he discussed 
the risks, including the risk of death with his patients. See also 
n.136 and n.*I supra. Considering the fact that Respondent and the 
Chief ALJ and myself had to pull strands of the record to try to eke 
out an understanding of Respondent's position on whether he had 
detailed discussions with his patients, including about the risk of 
death, and whether he believed he needed to have these detailed 
discussions to meet the standard of care, there is not enough on the 
record to find that Respondent accepted responsibility 
unequivocally, which necessarily includes a clear acknowledgement of 
the wrongdoing.
    \136\ The Respondent testified that he had an opioid risk 
discussion with Patient AA, but only ``in the context of his 
original pain agreement'' and supplied a vague reference to 
``subsequent discussions.'' Tr. 931. In his closing brief, the 
Respondent avers that the evidence evinces ``multiple discussions 
with [Patient AA] regarding the pain treatment agreement and the 
patient's medication program.'' ALJ Ex. 37 at 11, ] 74. Regrettably, 
the record citations supplied by the Respondent in his closing brief 
do not support the proposition that the risks associated with a high 
opioid protocol were discussed with the patients. See, e.g., ALJ Ex. 
37 at 17, ] 109; 21, ] 132; 25, ] 156. Even the few potential 
exceptions do not address high-dosage opioids, but rather ``[t]he 
risks and benefits of the medical program.'' See, e.g., Gov't Ex. 6 
at 376, 390 (cited at ALJ Ex. 37 at 21, ] 132).
---------------------------------------------------------------------------

    The Respondent likewise declined to take any responsibility for any 
role that his prescribed medications [or any of his misconduct] played 
in the unfortunate death of Patient AA. Although this patient died from 
an overdose of multiple medications, some of which were prescribed by 
the Respondent, because Patient AA did not appear early for refills or 
ask for additional medications,\137\ the Respondent, even in his 
closing brief,\138\ adheres to the position that his prescribing played 
no role in Patient AA's overdose death, notwithstanding the contrary 
views held by the Government's expert \139\ and the San Diego Medical 
Examiner.\140\
---------------------------------------------------------------------------

    \137\ Tr. 943-45.
    \138\ ALJ Ex. 37 at 13, ] 86.
    \139\ Tr. 310-12.
    \140\ Gov't Ex. 31 at 5. The ME Report, in pertinent part, 
renders the following ultimate conclusion: ``Based on the [report's 
integral] findings and the history and circumstances of [Patient 
AA's] death as currently known, the cause of death is best listed as 
`fentanyl, clonazepam, alprazolam, ketamine, hydrocodone, and 
morphine toxicity' and the manner of death as `accident.' '' Id.
---------------------------------------------------------------------------

    [Respondent notes in his Exceptions, that he believes that the 
Chief ALJ did not adequately credit him for what he contends was 
unequivocal acceptance of responsibility for failing to take vital 
signs for his patients until 2018. Resp't Exceptions at 13 (citing Tr. 
1034 ``When I consult with my orthopedist and surgeons and so on, whom 
I was in the department with, and we'd look at their notes, they didn't 
contain that. And quite honestly, looking back on it, it was really a 
defect on my part that I wasn't collecting it, and I should have been 
doing it.*\T\). Respondent is correct to point out that this statement 
is much closer to accepting responsibility for found misconduct; 
however, he is incorrect in characterizing this statement as 
unequivocal. He begins his statement with a minimizing excuse--that no 
one else in his Department was doing it, and he uses the pronoun ``we'' 
to make clear that he was acting with consensus of others of some 
kind,*\U\ but most importantly, this statement is lacking in an 
understanding of the gravity of his misconduct. Dr. Munzing testified 
that vital signs are monitored ``to try to keep [the patients] as safe 
as possible'' due the high risk of the high dosages being prescribed to 
them. Tr. 166. I find Respondent's statement here, and elsewhere, where 
he claims to accept responsibility, to be lacking in a complete 
understanding and acknowledgment of these risks and the potential 
consequences of his misconduct. ``[T]he degree of acceptance of 
responsibility that is required does not hinge on the respondent 
uttering `magic words' of repentance, but rather on whether the 
respondent has credibly and candidly demonstrated that he will not 
repeat the same behavior and endanger the public in a manner that 
instills confidence in the Administrator.'' Stein, 84 FR 46973. 
Respondent's statement acknowledges the mistake, but it lacks remorse, 
and it lacks recognition or even acknowledgement of the impact. I agree 
with the Chief ALJ that Respondent handled these issues with the 
gravity that someone would apply to nitpicks--that he is now checking 
boxes, as opposed to really changing his viewpoint. For all of these 
reasons, although I credit Respondent for admitting some fault on the 
vital signs violation, I cannot find that Respondent has unequivocally 
accepted responsibility, even for something that was clearly found in 
this case and in the MBC case against him.]
---------------------------------------------------------------------------

    *\T\ Respondent also notes that ``in response to criticism 
elsewhere, [he] started using the Vital Signs.'' Although he did not 
specifically reference it directly, in spite of arguing that he had 
accepted responsibility for the MBC's findings, I am assuming that 
he is referring to the California Medical Board complaint that was 
alleged against him around the time when he started taking vital 
signs. Tr. 1033.
    *\U\ See Stein, 84 FR 46972 (finding that a registrant's 
attempts to minimize his misconduct weigh against a finding of 
unequivocal acceptance of responsibility); see also Ronald Lynch, 
M.D., 75 FR 78745, 78754 (2010) (Respondent did not accept 
responsibility noting that he ``repeatedly attempted to minimize his 
[egregious] misconduct''); Michael White, M.D., 79 FR 62957, 62967 
(2014) (finding that Respondent's ``acceptance of responsibility was 
tenuous at best'' and that he ``minimized the severity of his 
misconduct by suggesting that he thinks the requirements for 
prescribing Phentermine are too strict.'').
---------------------------------------------------------------------------

    Although the Respondent testified that he has improved the detail 
level of his electronic charting, [takes vital signs from his patients 
to ensure their safety,] no longer prescribes dangerous combinations of 
controlled substances, now eschews the prescribing of carisoprodol, and 
has taken various courses to address controlled substance prescribing 
and documenting, in light of his refusal to enter an unequivocal 
acceptance of responsibility, his expressed, commendable plans further 
his case not at all.
    To be sure, the transgressions alleged and proved here are serious 
and numerous, but it is at least arguable that a true, unequivocal 
acceptance of responsibility, coupled with a thoughtful plan of 
remedial action could have gone a long way to supporting a creditable 
case for at least some level of sanction lenity. Indeed, while true 
that Agency precedent holds that the lack of an unambiguous acceptance 
of responsibility and remedial action plan are a cold bar to the 
avoidance of a sanction,\141\ the wisdom of the Agency's policy is 
vindicated in this case by the reality that the Respondent still 
believes that the gravamen of his transgressions amount to little more 
than documentation deficiencies and a numerical prescribing practice 
error. He feels his dosing and medicine combinations were 
appropriate,\142\ that the Six Patients received adequate informed 
consent about the high opioid levels through their pain contracts, and 
that although Patient AA died as a result of an overdose where his 
drugs were irrefutably among the medications that precipitated the 
fatality, that it was simply not his fault. The Respondent's message is 
essentially that the Government is nitpicking a knowledgeable 
practitioner, and to make the regulators happy he will clean up his 
documentation and drop dangerous combinations of medications from his 
treatment repertoire. And regarding the Board Patient Allegations, he 
has offered no responsibility acceptance whatsoever [on the record of 
this hearing.] It is not necessary or wise to conjecture whether an 
unequivocal acceptance of responsibility would have yielded a different 
result here. The fact is that it was not a part of the record.
---------------------------------------------------------------------------

    \141\ Hassman, 75 FR 8236.
    \142\ Even in his closing brief, the Respondent highlights (with 
italics for emphasis) the concept that the CDC does not prohibit 
prescribing a combination of opioids and benzodiazepines. ALJ Ex. 37 
at 12, 18.
---------------------------------------------------------------------------

    The Agency is thus faced with a choice of imposing a registration 
sanction or imposing none and therein creating a fair likelihood that 
it will be instituting new proceedings, charging the same conduct 
against the same doctor, soon thereafter. To the extent the Respondent, 
after being present at this hearing, does not see that he was not 
acting as a reliable registrant, it is highly unlikely that he will see 
the light in a month, a week, or a day from an Agency action that 
affords him another chance.
    In determining whether and to what extent imposing a sanction is 
appropriate, consideration must also be given to the Agency's interest 
in both specific and general deterrence and the

[[Page 4936]]

egregiousness *\V\ of the offenses established by the Government's 
evidence. Ruben, 78 FR 38364, 38385. Considerations of specific and 
general deterrence in this case militate in favor of revocation. 
Specific deterrence is something of a mixed bag here. On one hand, the 
Respondent has credibly related that he has deployed a prescribing 
regimen that addresses the systemic early refill issue identified by 
the Government, he has taken CME classes that address helpful 
standards, and he credibly testified that he has cleaned up some of his 
documentation. However, as discussed, supra, the Respondent has not 
supplied any indication that, beyond picayune electronic documentation 
complaints, and understandable early refills,\143\ that he has done 
anything worthy of a sanction. The Respondent did not present as a 
practitioner who intends to change the high level of his dosing, and 
there is no real way to track whether the Respondent genuinely intends 
to indefinitely limit the combination prescribing that he continues to 
feel was warranted. On the whole, [ ]*\W\ the issue of specific 
deterrence supports a sanction. [The Chief ALJ found that specific 
deterrence supports a sanction, but that it was an ``admittedly close 
case.'' *\X\ Although I agree that Respondent has made steps to improve 
his practice, I am not convinced by his limited and equivocal 
acceptance of responsibility that he will not repeat similar behavior 
once his probation period in California has ended. Therefore, I find 
that the issue of specific deterrence weighs in favor of revocation.]
---------------------------------------------------------------------------

    *\V\ The Administrator has noted that ``there may be some 
instances in which the proven misconduct is not so egregious as to 
warrant revocation . . . and a respondent, while offering a less 
than unequivocal acceptance of responsibility[,] nonetheless offers 
sufficient evidence of adequate remedial measures to rebut the 
Government's proposed sanction.'' Roberto Zayas, M.D., 82 FR 21410, 
21429 (2017). This is not such an instance. Although I do give 
credit to Respondent's remedial measures, I do not find that I can 
ultimately trust him to continue implementing them without constant 
monitoring by this Agency, and as stated herein, he has not given me 
reason to extend him such a benefit. Furthermore, the violations 
herein are egregious and absolutely warrant revocation.
    \143\ In fact, notwithstanding his seeming acknowledgement of 
this below-standard activity, his closing brief reminds that his 
expert witness, Dr. Polston, testified that this practice ``is NOT 
below the standard of care and it is something that reasonable 
physicians in the community have done.'' ALJ Ex. 37 at 13, ] 85 
(emphasis in original).
    *\W\ The Chief ALJ found that specific deterrence supports a 
sanction and I strongly agree. Although Respondent has made steps to 
improve his practice, I am not convinced by his limited and 
equivocal acceptance of responsibility that he will not repeat 
similar behavior once his probation period in California has ended. 
It is unclear to me that he understands the gravity of the 
misconduct alleged against him and that he has reacted appropriately 
and with the amount of contrition and acceptance that would convince 
me that he will not slip back into his old prescribing habits. 
Therefore, I find that the issue of specific deterrence weighs 
strongly in favor of revocation.
    *\X\ Respondent takes this statement, which was evaluating one 
of the many aspects that I consider when deciding a sanction, out of 
context, arguing that ``it is clear that Judge Mulrooney had a 
difficult time in deciding his recommendation.'' Resp't Exceptions 
at 34 (citing RD at 48). I disagree that the Chief ALJ had a 
difficult time deciding his recommendation. He stated clearly, and I 
agree, that ``the conduct preponderantly established on this record 
is extremely troubling, and warrants a substantial sanction.'' RD at 
49.
---------------------------------------------------------------------------

    As the regulator in this field, the Agency bears the responsibility 
to deter similar misconduct on the part of others for the protection of 
the public at large. Ruben, 78 FR 38385. This record contains such a 
high volume of errant prescribing and even an overdose death for which 
the Respondent eschews responsibility. To continue the Respondent's DEA 
registration privileges on the present record would send a message to 
the regulated community that it is acceptable to keep prescribing 
powerful drugs to multiple patients, in dangerous combinations, for 
years, even contributing to the death of a patient, until you get 
caught; and even then, it is not even required to admit your mistakes. 
The interests of general deterrence militate convincingly in favor of a 
sanction on this record.
    Regarding the egregiousness of the Respondent's conduct, as 
discussed, supra, the Respondent prescribed inordinately high levels of 
medication to a host of patients, in dangerous combinations, with 
inadequate documentation and informed consent for many years, and one 
of his prescribed medications was a contributing factor in the death of 
one of those patients. These actions were not borne of an 
understandable misapprehension of his responsibilities, or an isolated 
misstep taken in the midst of a busy medical practice. The conduct 
preponderantly established on this record is extremely troubling, and 
warrants a substantial sanction.
    A balancing of the statutory public interest factors, coupled with 
consideration of the Respondent's failure to unequivocally accept 
responsibility, and the Agency's interest in deterrence, supports the 
conclusion that the Respondent should not continue to be entrusted with 
a registration.
    Accordingly, it is respectfully recommended that the Respondent's 
DEA COR should be revoked, and any pending applications for renewal 
should be denied.

    Dated: November 5, 2020.

John J. Mulrooney, II,

Chief Administrative Law Judge.

Respondent's Exceptions

    On December 1, 2020, Respondent filed its Exceptions to the RD. I 
find that Respondent's Exceptions are either without merit or 
irrelevant to my Decision as explained below. Therefore, I reject 
Respondent's Exceptions and affirm the RD's conclusion that 
Respondent's continued registration is inconsistent with the public 
interest, and that revocation is the appropriate sanction.

Exception 1

    (I) Respondent first argues that Dr. Munzing should not have been 
accepted as an expert in controlled substance prescribing for pain 
management. Resp't Exceptions at 2. Respondent's argument is based on 
his concern that his attorney raised at the hearing that ``the 
credibility and weight'' given to the testimony of Dr. Munzing should 
be limited due to the fact that he does not generally treat patients on 
high dosages of opioids.*\Y\ Tr. 85. The Chief ALJ admitted Dr. Munzing 
as an expert in ``the standard of care in prescribing controlled 
substances in the State of California including for the management of 
pain.'' Tr. 89.*\Z\ Dr. Munzing was not qualified as an expert in the 
practice of pain management, which Government counsel specifically made 
clear at the hearing. Tr. 84. For that matter, neither was Respondent's 
Expert, Dr. Polston, who was tendered and accepted as an expert witness 
in controlled substance prescribing in California, including controlled 
substance prescribing for

[[Page 4937]]

intractable pain. Tr. 1153-54. In this Exception, Respondent reframes 
the primary issue in this case to be about the practice of pain 
management, when the underlying issue is actually whether Respondent's 
prescribing of controlled substances was within the applicable standard 
of care and usual course of professional practice in California. 
Respondent also conveniently ignores the fact that the MBC found 
specifically that Respondent's prescribing was beneath the standard of 
care with respect to some of the patients at issue in this case (the 
Board Patients). For the other patients (the Six Patients), Respondent 
mischaracterizes Dr. Munzing's testimony. Dr. Munzing testified that 
identified instances where the Respondent's patients were maintained on 
doses of medications that far exceeded the morphine milligram 
equivalent (MME) recommended by the Centers for Disease Control and 
Prevention (CDC) guidance without documentation that the patient was 
afforded an informed consent that explained the risks inherent in such 
treatment. Tr. 120; Gov't Exs. 2-8, 10-13; Tr. 132-37, 139, 141-43, 
145, 148-49, 156-57, 164-65, 169, 179-84, 191-92, 204-05, 224-25, 231-
32, 271, 306-07 (Patient AA); Tr. 401-02, 406-07, 409-15, 417-22 
(Patient BB); Tr. 384-89, 393-400 (Patient JD); Tr. 477-79, 481-84, 
488, 490-95 (Patient DD); Tr. 314-17, 321-23, 328-32, 350-51, 353-56, 
360-62, 365, 370-72, 377-82 (Patient SM); Tr. 424-29, 431-35, 437-38, 
440-47, 450 (Patient ET). Respondent argues that Dr. Munzing testified 
that ``he does not know the precise amount of MMEs a patient should be 
prescribed,'' and concludes that ``[i]t is appalling that credibility 
is given to an expert who does not know the proper dose of MMEs, yet 
opines the amounts Respondent prescribed are somehow incorrect.'' 
Resp't Exceptions at 3 (citing Tr. 704-06). A closer look at Dr. 
Munzing's testimony demonstrates a much more measured and neutral 
picture. Tr. 131-B (explaining that there is no maximum amount of MME 
because ``some patients need a higher amount, and so there's--there's 
no written absolute amount, but there's certainly--one certainly needs 
to look at the risk to the patients, the potential benefits, and 
attempt to mitigate the risks''); Tr. 704-05 (responding to the 
question ``[s]o what's the exact dose that you should be receiving?'' 
with ``[w]ell, obviously, you know that one can't say--I mean, you 
could have many people with the same symptoms and the dosage required 
would be very different. Again, as I said before, you balance the 
benefit of the treatments including prescribed medications and other 
treatments with risk . . . and so you just can't say here's the number. 
But what I can say is that the risk is incredibly high. We don't know 
whether or not medications at one-half or one-third this dosage may 
give the same level of benefit. Many times that is the case. And so 
that we don't know because we haven't actually tried that as far as 
what we can see here in the notes.'').
---------------------------------------------------------------------------

    *\Y\ Given the evidence, which Respondent repeatedly 
highlighted, that he had successfully managed to reduce the MME of 
his patients and the fact that the witnesses were largely in 
agreement that reduction of the high dosages was important to the 
applicable standard of care, I find this argument to be confusing. 
See, e.g., Tr. 1204 (Dr. Polston opining that Respondent's dosing 
was within the California standard of care, because ``in total, the 
patient showed indications and the doses of opioids were being 
reduced as the care was ongoing''); see also Resp't Exceptions at 10 
(touting that ``[o]ver time, [Respondent] brought each one of them 
down drastically. Today, he does not accept any patients who are on 
daily MMEs over 90, and 93% of his current patients are at 90 MME or 
below.'' (emphasis in original)). It seems that Respondent is 
suggesting that the fact that Dr. Munzing has limited risk to his 
patients by prescribing at lower MME levels somehow makes him less 
of an expert. I cannot agree. It also seems a particularly odd 
argument given Respondent's assertions that he, himself, no longer 
prescribes at these levels to most of his patients.
    *\Z\ Furthermore, it is noted that the Chief ALJ repeatedly 
ensured that the experts stayed within the scope of their expertise. 
See, e.g., Tr. 100 (``We are only talking about the standard of care 
for controlled substance prescribing in California--the minimum 
standard of care'').
---------------------------------------------------------------------------

    Contrary to Respondent's argument, I find Dr. Munzing's opinion to 
be rational and to permit much more flexibility in prescribing than 
Respondent would like to make it seem. The problem with Respondent's 
prescribing of these high levels of MMEs is not the level itself--it is 
the risk associated with that level, which has been objectively 
established, and whether the Respondent adequately addressed that risk. 
The record demonstrates that he repeatedly did not address the risk for 
these patients over the course of many years, or at the very least did 
not meet many of the documentation requirements for addressing the 
risks.
    I agree with the Chief ALJ that Dr. Munzing was qualified as an 
expert in the standard of care in prescribing controlled substances in 
the State of California including for the management of pain, and I 
reject Respondent's Exception.
    (II) Respondent next argues that Dr. Munzing's testimony should not 
be given controlling weight over that of Dr. Polston for much of the 
same reasons that underlie his arguments that Dr. Munzing should not 
have been qualified as an expert. Respondent specifically picks apart 
the Chief ALJ's rationale for finding Dr. Munzing more credible. In 
particular, he highlights that Respondent ``only changed one thing in 
response to Dr. Munzing's testimony, not many things.'' Resp't 
Exceptions, at 4 (highlighting that Respondent only changed his early 
prescribing practices as a result of Dr. Munzing's testimony). 
Respondent also dedicates an entire Exception 6 to this issue, stating 
``[w]hile it is accurate that Respondent agreed with Dr. Munzing's 
criticisms on other issues, he did not change his practices with 
respect to those issues after Dr. Munzing's testimony. In fact, the 
bulk of the criticisms that Dr. Munzing had with Respondent's care 
stemmed from care prior to April 2019.'' Respondent then emphasizes 
that he is following the standard of care as described by Dr. Munzing 
now, and in fact, he argues that the record demonstrates that he began 
to do so after April 2019.*\AA\
---------------------------------------------------------------------------

    *\AA\ In doing so, Respondent opines that it ``is critical for 
the Administrator's analysis because the Government's own expert is 
testifying that as of April of 2019, Dr. Chesler had addressed the 
issues with which he was concerned and was practicing within the 
standard of care.'' Resp't Exceptions at 18 (citing Tr. 763-64 Dr. 
Munzing opining that one progress note for Patient BB at the end of 
the Government's allegations in April 2019 was more in line with the 
standard of care as he had described it). The part of my analysis to 
which this finding might be ``critical'' is whether Respondent has 
accepted responsibility and instigated remedial measures such that I 
can entrust him with a registration. I credit Respondent for 
implementing practices that are more in line with meeting the 
standard of care in California and I hope that he continues to 
practice within the standard of care in the future, as I am sure 
does the Medical Board of California. Even assuming all of his 
current practices and all of his practices before and after the 
allegations are completely beyond criticism, which I do, the record 
still demonstrates that he prescribed beneath the applicable 
standard of care and outside the usual course of professional 
practice in California to many patients over the course of many 
years and in violation of federal and state law. Further, the record 
demonstrates that these violations were egregious and that, 
regardless of whether Respondent contributed to the cause, a patient 
died, and another patient had opiate use disorder (Supra n.*J), and 
all of the Six Patients and Board Patients were at some amount of 
risk due to the high dosages they were prescribed.
---------------------------------------------------------------------------

    I find Respondent's argument about disqualifying Dr. Munzing's 
expert testimony on the applicable standard of care to be incongruous 
with his argument that his practices now follow the standard of care as 
described by Dr. Munzing. If he only changed one thing as a direct 
result of Dr. Munzing's testimony at the hearing, that is noted, but 
the record demonstrates, and Respondent actively argues, that he has 
changed many of his practices since the time period covered by the 
majority of the allegations in the OSC, and those practices clearly 
comport with the standard of care described by Dr. Munzing. I find that 
the standard of care as described by Dr. Munzing was supported by the 
record in this case, by California laws and guidance and even by the 
findings of the California Medical Board against the Respondent for the 
Board Patients. Further, I agree with the Chief ALJ that Dr. Polston's 
version of the standard of care was less credible in that it shifted, 
was often vague and argumentative and that his testimony did not come 
across as neutral (regardless of the noted objective issues with 
neutrality for both paid experts).*\BB\ Therefore, I reject 
Respondent's Exception.
---------------------------------------------------------------------------

    *\BB\ Again, Respondent's general medical decisionmaking is not 
the basis for the allegations in the OSC--the OSC allegations are 
focused on whether or not the identified prescriptions were issued 
in accordance with the applicable standard of care and in the usual 
course of professional practice and in accordance with state law. 
See generally, OSC. The expert testimony in this case is necessary, 
in conjunction with California law and guidelines, to understand the 
applicable standard of care. Dr. Munzing clearly demonstrated his 
expertise in how the standard of care applied to the facts in this 
case and furthermore, his testimony regarding his expertise was 
credible. In those places where Dr. Munzing's and Dr. Polston's 
testimony differed regarding the standard of care, California law 
and guidelines aligned more closely with Dr. Munzing's testimony. 
Accordingly, I affirm the ALJ's decision to qualify Dr. Munzing as 
an expert in this case and to credit his testimony over Dr. 
Polston's.

---------------------------------------------------------------------------

[[Page 4938]]

Exception 2

    Respondent next takes Exception to the individual findings on the 
allegations as sustained by the Chief ALJ. I have addressed some of 
these in footnotes in the actual findings supra.
    I note in particular here that Respondent took Exception to the 
finding that a physician ``must avoid or carefully justify MMEs beyond 
90 mg per day'' and those related to the combination of controlled 
substances. Resp't Exceptions at 8, 10, 11. In sustaining these 
allegations, the Chief ALJ stated the following:

    Although the Respondent remained convinced about the validity of 
the controlled medications and dosages he prescribed to the Six 
Patients, as well as the combinations of medicines in the context of 
the time and the ailments he was treating, in general he did not 
resist the Government's view, supported by the expert opinion of Dr. 
Munzing, that the documentation generated in the Respondent's 
charting of the Six Patients was inadequate to a point where it fell 
below the applicable standard of care.

RD at 38.

    In taking Exception to these findings, Respondent once again tries 
to reframe the question regarding whether his prescribing was beneath 
the applicable standard of care and outside the usual course of 
professional practice by attempting to make this question into a 
determination about whether his patients ``demonstrated an etiology 
consistent with a need for pain treatment.'' Resp't Exceptions at 9. He 
emphasizes that the ``medical record shows a patient was receiving a 
functional benefit and pain relief based on the medications 
prescribed.'' Id. In support of Respondent's argument, I note that the 
MBC Guide does include objectives in the treatment plan, such as ``pain 
relief and/or improved physical and psychosocial function.'' MBC Guide 
at 59. However, I credit Dr. Munzing, who testified, ``[W]ell, I mean, 
it's good to get improved function. It's good to get reduced pain. 
Nowhere is the issue that this person has extremely risky treatments. 
And so in no way do we know whether or not this patient might get the 
same benefits from having medication that's one-quarter or one-third, 
one tenth the amount. We just don't know that.'' Tr. 719. Again, the 
overarching issue with Respondent's prescriptions is whether or not 
they were issued within the standard of care and usual course of 
professional practice. The record clearly indicates that Respondent's 
prescribing at dosages with high MMEs and combination prescribing put 
his patients at risk, and his documentation clearly did not adequately 
address those risks either with adequate informed consent or adequate 
acknowledgements of the risks and formulation of a plan to reduce the 
MME levels for many of the years of the allegations. Regardless of 
whether the patients were transferred to Respondent at high levels of 
MMEs or on dangerous, highly abused combinations of controlled 
substances, and regardless of whether he eventually, after several 
years, managed to reduce their MME levels or wean them off of the 
combinations,*\CC\ the medical records do not demonstrate that he 
adequately addressed these risks when they existed. Therefore, I reject 
Respondent's Exception and sustain the Chief ALJ's finding that, 
particularly given the high levels of MME and the combination of 
controlled substances that Respondent was prescribing, ``the 
documentation generated in the Respondent's charting of the Six 
Patients was inadequate to a point where it fell below the applicable 
standard of care.'' RD at 38.
---------------------------------------------------------------------------

    *\CC\ Respondent states that ``the Administrator should find 
that Respondent's mere prescribing of these medications was not 
below the standard of care.'' Resp't Exceptions at 11. I find 
nowhere in the RD that makes such a statement. Respondent seems 
again to be trying to reframe the violations. He seems intent on 
limiting his violations to what he partially accepted responsibility 
for--that ``his documentation should have been better,'' id., but he 
does not seem to understand the serious implications of his failure 
to document--that he was putting his patients at risk without 
adequately addressing those risks in the medical records--without 
demonstrating his planning and the thinking behind his prescribing 
actions, which as found herein is required by the standard of care 
and state law.
---------------------------------------------------------------------------

Exception 3

    Respondent takes Exception to the Chief ALJ's findings that he did 
not conduct physical examinations on patients other than AA. I have 
amended the RD where Respondent has asked for clarification supra and 
have addressed Respondent's contention that he accepted responsibility 
in the Recommendations Section supra. Respondent also took Exception to 
the Chief ALJ's finding that Respondent did not take vital signs from 
the patients, noting that ``[w]hile this is true in the beginning of 
the time of review, Respondent made significant changes over time and 
began taking vital signs in 2018.'' Id. Respondent states that he took 
vital signs for all patients from that period on, id., however, 
unfortunately, AA died on November 11, 2017, so he did not receive the 
benefit of Respondent's improved practices. I have made an addition to 
clarify the RD in accordance with Respondent's Exceptions. The fact 
that Respondent only failed to take vital signs from his patients for 
approximately four out of the five years covered by the Government's 
allegations, during which he was issuing controlled substance 
prescriptions at high levels of MMEs to his patients, who were at 
increased risk for respiratory depression, does not alter my finding 
that the prescriptions for controlled substances at issue in this case 
were issued outside the standard of care.

Exception 4

    I have addressed Respondent's Exception related to informed consent 
in supra n.*I and *S.

Exception 5

    Respondent takes Exception to the finding that the prescriptions he 
issued to AA contributed to his death. Resp't Exceptions at 16. The OSC 
alleged that Respondent's ``prescriptions to Patient AA were a 
contributing factor to Patient AA's overdose death.'' OSC at 14.f. The 
ME Report, in pertinent part, renders the following ultimate 
conclusion: ``Based on the[report's integral] findings and the history 
and circumstances of [Patient AA's] death as currently known, the cause 
of death is best listed as `fentanyl, clonazepam, alprazolam, ketamine, 
hydrocodone, and morphine toxicity' and the manner of death as 
`accident.' '' Id. Dr. Munzing stated that based on this report, 
``[t]wo of the medications that were prescribed were felt to be 
contributors to the death, the hydrocodone and the morphine.'' Tr. 312. 
``It's a multitude, it's toxicity, a multitude of drugs including a 
couple he prescribed.'' Id. According to Dr. Polston, the controlled 
substances prescribed did not contribute to A.A.'s death. He stated, 
``[t]his patient, if he would not have taken the fentanyl, added in the 
alcohol and the ketamine, . . . would be still alive.'' Tr. 1182. Dr. 
Polston later clarified his testimony on cross-examination that the 
fentanyl, alcohol and ketamine ``are contributing to his death,'' but 
that ``to say that those are precise cause of death, no, I cannot go 
that far.'' *\DD\ Tr. 1280.
---------------------------------------------------------------------------

    *\DD\ Based on Dr. Polston's clarification, I cannot 
characterize Dr. Polston's testimony regarding the cause of AA's 
death as ``unequivocal,'' as Respondent would suggest. Resp't 
Exceptions at 16.

---------------------------------------------------------------------------

[[Page 4939]]

    I find that the substantial evidence on the record as described 
above supports the Chief ALJ's finding that the controlled substances 
prescribed by Respondent to AA were among the contributing factors to 
his overdose. However, the overarching issue for Patient AA, and all of 
the patients, is whether the alleged prescriptions were issued beneath 
the applicable standard of care in California and outside the usual 
course of professional practice, and the evidence clearly demonstrates 
that Respondent did not issue the alleged prescriptions to AA within 
the standard of care. I am not surprised by Respondent's adherence to 
his position that his prescriptions did not contribute to AA's death, 
considering the cascading implications that such a finding could have 
on his liability, but I also find that his testimony on this issue did 
not compel me to believe that he had more than a passing regret 
regarding any of his prescribing decisions related to AA. Regardless of 
whether the hydrocodone and the morphine actually contributed to his 
death, the evidence demonstrates that AA was abusing controlled 
substances, Respondent had been prescribing controlled substances to AA 
for a considerable period of time and did not detect this, in spite of 
several negative UDS for one of his prescriptions, and importantly, 
Respondent's medical records for AA offer little-to-no ability for the 
Agency to find out what was occurring. Furthermore, the fact is that 
one of Respondent's patients died of an overdose. In light of such a 
drastic occurrence, I would expect some sort of acknowledgement of the 
wrongdoing surrounding this incident, even without taking fault for the 
actual death. Instead, Respondent stated, ``[AA] had been on a 
combination of medications for a long time with no issues, and I feel 
badly that this event happened, but I honestly saw no issue where what 
we were providing was a significant [*\EE\] component to someone who 
had so much additional medication in his system.'' Tr. 943.*\FF\ 
Respondent's sole statement of regret related to AA's death was that he 
``feels badly.'' This casual throw away statement does nothing to 
acknowledge the magnitude of the situation and furthermore focuses the 
entire attention of his remorse on himself and the way that he feels 
about the death, which is apparently ``badly.'' See Nicholas Roussis 
M.D., 86 FR 59190, 59194 (2021) (finding that ``remorse and acceptance 
of responsibility are not the same thing and . . . Respondent's 
consistent focus on his own suffering does not suggest an unequivocal 
acceptance of responsibility, but rather, suggests regret for the 
negative consequences that he has personally faced.''). Respondent 
provided no acknowledgement that any of the wrongdoing, even the 
conduct that he admitted to, related to his care of AA could have 
played a small part in the patient's overdose. Had Respondent 
documented informed consent that he had discussed the risk of death 
with AA, had he documented that he conducted a physical examination or 
vital signs, had he more completely addressed the negative UDS in the 
records, had he addressed the high levels of MMEs he was prescribing 
and shown that he was carefully assessing all of these risks, then I 
doubt that AA's death would be an issue in this case. The questions 
that are unanswered with respect to AA's death demonstrate the true 
value of a prescribing practitioner's documented rationale.
---------------------------------------------------------------------------

    *\EE\ It is noted that Respondent used the term ``significant 
component,'' which seems to acknowledge that the controlled 
substances he prescribed were a component of the death and 
contradicts his Exception to the Chief ALJ's finding that these 
controlled substances were ``among the contributing factors'' to 
AA's death. RD at 38.
    *\FF\ Respondent also stated, ``I feel badly because I know he 
was supposed to be and I'm still not sure what had him take this 
test.'' Tr. 945. It is unclear from the record what test he is 
referring to or what AA was supposed to be doing--possibly 
exhibiting signs of addiction? But again, the testimony that 
Respondent felt ``badly'' did not amount to any sort of acceptance 
of responsibility for the prescriptions he issued to this patient 
beneath the standard of care.
---------------------------------------------------------------------------

    Additionally, I do not find that Respondent has adequately accepted 
responsibility for his misconduct related to this patient, even setting 
aside whether or not the two controlled substances he prescribed were 
among the contributing factors to his death. Furthermore, my finding 
that Respondent has not accepted responsibility for something so 
serious, has significant implications about whether I can entrust him 
with a controlled substances registration in the future.

Exception 6

    I have addressed Exception 6 related to Respondent's change in his 
practices in supra n.*H.

Exception 7

    Respondent also takes Exception ``to the conclusion he did not 
accept responsibility for misconduct in the Medical Board of California 
case.'' Resp't Exceptions at 19-20. In support of his argument, he 
cites to several findings in the MBC case where ``he admitted he 
committed repeated negligent acts.'' Id. (citing Gov't Ex. 30 at 150-
51). Instead of diving into the MBC's opinion on this issue, I will 
review the evidence to which the Respondent points that he accepted 
responsibility in that proceeding. Respondent himself states that ``the 
MBC ALJ specifically made mention of this [Respondent's acceptance of 
responsibility] with respect to Patients D and E and further ruled that 
Respondent believed the care provided to A, B and C was appropriate and 
that the fact that he did not admit to mistakes with those patients was 
not a factor in the outcome of the case.'' Id. at 20. Essentially, 
Respondent is admitting that he did not fully accept responsibility in 
the MBC case, but arguing that because the MBC did not consider his 
non-acceptance as essential to its decision, I should not either. 
However, what matters to me in carrying out my responsibility under the 
CSA is whether Respondent can be entrusted with a registration. 
``Respondent must convince the Administrator that his acceptance of 
responsibility and remorse are sufficiently credible to demonstrate 
that the misconduct will not recur.'' Stein, 84 FR 46974.
    Respondent did testify that he made changes to his medical practice 
``regarding the Medical Board situation, which you know about, was 
highlighting some of the same--these are the same cases, the same era. 
It was my reaction to that, to show them that I was making a good faith 
effort to repair this.'' Tr. 1052. It appears to me that this statement 
was very careful, stumbling almost, not to acknowledge that the MBC 
found many of the exact same type of violations of the standard of care 
as were at issue in this hearing. And in fact, even though Respondent 
brought it up in his testimony, he still did not take a moment to 
accept responsibility for the MBC findings on the record, but stated 
that his reasoning for the changes to his practice was to ``show 
them''--the MBC--that he was now complying with the standard of care. 
Id. I do credit Respondent for stating that he is ``happier'' about 
these changes. Id. However, as further discussed below and herein, 
Respondent has not unequivocally accepted responsibility for the Board 
Patients or the Six Patients.
    Furthermore, I find it relevant to whether Respondent accepted 
responsibility for the MBC findings that Respondent continued to argue 
that his prescribing practices were historically within reason, given 
what he described

[[Page 4940]]

as the end of a ``decade of pain.'' On October 29, 2019, the MBC had 
clearly stated:

[A]s commented on earlier in this decision, the evaluation of 
respondent's treatment of all of these patients needs to be looked 
at in terms of the risks to these patients and respondent's efforts 
to size up and manage these risks using the tools available to him. 
By November 2011, when the CDC declared prescription drug abuse to 
be a nationwide epidemic, respondent as a pain specialist was on 
notice that he needed to use the tools available to him, whether 
UDTs, cup screens, pill counts, and/or CURES, and he also need to 
critically assess patients and what they told him. Respondent was 
slow to respond to this change in the opioid pain management 
landscape and did not consistently use the tools available to him. 
Even when he did use these tools and was put on notice of potential 
problems, he did not take actions to protect his patients from their 
risky aberrant behaviors.

Gov't Ex. 30 at 165.

    Respondent states on the one hand that he has addressed and 
accepted responsibility the issues that the MBC found, while still re-
hashing arguments that the MBC discredited--that his prescribing 
practices were explained given the historical period that had just 
ended. The MBC found that ``Respondent was slow to respond to this 
change in the opioid pain management landscape and did not consistently 
use the tools available to him.'' Id. Had Respondent really understood 
and accepted responsibility for the MBC findings, I find it doubtful 
that he would have attempted to excuse his behavior in his DEA hearing.

Exception 8

    Respondent again argues that he has adequately responsibility. I 
have discussed some of these specific arguments in the Recommendation 
Section and throughout where relevant.
    The issue of trust is necessarily a fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the credibility of that acceptance as it relates to 
the probability of repeat violations or behavior and the nature of the 
misconduct that forms the basis for sanction, while also considering 
the Agency's interest in deterring similar acts. See Arvinder Singh, 
M.D., 81 FR 8247, 8248 (2016).
    Respondent argues that he ``accepted full responsibility for 
deficiencies for which he agreed with Dr. Munzing. There were other 
allegations for which he provided a defense, as stated herein. Dr. 
Chesler should not be made to accept responsibility for allegations for 
which he does not believe are accurate. That would be disingenuous and 
not something he should do as an honorable and credible person.'' 
Resp't Exceptions at 28. I disagree, as explained in more detail supra 
that Respondent unequivocally and credibly accepted responsibility for 
the deficiencies for which he agreed with Dr. Munzing. With respect to 
his high dosing levels and combination prescribing, which seem to be 
primarily the focus of his continued disagreement with Dr. Munzing, I 
am confounded as to why he continues to argue these points, while also 
stating that he no longer prescribes these combinations or at these 
levels.
    Additionally, although Respondent repeatedly admitted that his 
documentation ``could be better,'' see, e.g., Tr. 929, he gives little 
weight or understanding to these statements. Respondent's cavalier 
assumptions about his documentation responsibilities and the fact that 
he did not undertake this responsibility with seriousness weigh against 
my ability to entrust him with a registration. See Singh, M.D., 81 FR 
8248 (``[U]ntil . . . [a] Respondent can convincingly show he accepts 
the authority of the law and those bodies charged with enforcing it and 
regulating his activities, granting [ ] a DEA registration will gravely 
endanger the public.''). The truth is that it is not possible to tell 
whether Respondent's care was as appropriate as he claims because his 
recordkeeping did not support those claims. Nowhere is this more 
obvious than with Patient AA.
    With respect to the dosing levels, Respondent argues that I should 
now trust him because he has corrected something that he does not 
believe was a mistake. He then states that if DEA wants to ensure that 
he does not prescribe at high levels, ``a CURES monitoring program 
could easily be set up between him and the DEA to track prescriptions 
for all patients.'' Resp't Exceptions at 32. DEA is responsible for 
regulating more than just Respondent and Respondent has already 
violated my trust through the multiple, egregious proven allegations. 
Ensuring that a registrant is trustworthy to comply with all relevant 
aspects of the CSA without constant oversight is crucial to the 
Agency's ability to complete its mission of preventing diversion within 
such a large regulated population.*\GG\ Jeffrey Stein, M.D., 84 FR 
46974. I do not see how I can believe that Respondent has accepted 
responsibility for his actions and reformed, while arguing that the 
rationale underlying some of those reforms is superfluous. His 
acceptance of responsibility did not adequately convince me that he can 
be entrusted with a registration. Once his state probation ends and the 
scrutiny is off of him, I am not convinced that he will continue the 
practices that he put in place, when he does not believe that they are 
necessary in the first place or truly demonstrate a grasp of their 
gravity and importance.
---------------------------------------------------------------------------

    *\GG\ With a regulated community of nearly two million 
registrants, DEA must be able to rely on registrants to comply with 
the standard of care without constantly monitoring them. See DEA FY 
2020 Budget Request available at https://www.justice.gov/jmd/page/file/1142431/download.
---------------------------------------------------------------------------

Exception 9

    Lastly, Respondent argues that ``[d]isciplining Respondent based 
upon findings of the deficiencies in the Recommended Decision is 
inconsistent with, and has no nexus to, the DEA's stated goals of 
avoiding diversion.'' *\HH\ Resp't Exceptions at 33. The Government, 
however, is not required to prove that diversion resulted from the 
unauthorized issuance of prescriptions. Arvinder Singh, M.D., 81 FR 
8247, 8249 (2016). Rather, when a practitioner violates the CSA's 
prescription requirement, set forth in 21 CFR 1306.04(a), by issuing a 
prescription without a legitimate medical purpose and outside the 
course of professional practice, the DEA essentially considers the 
prescription to have been diverted. George Mathew, M.D., 75 FR 66146. 
Furthermore, the Agency is not, as Respondent suggests, required to 
find intentional misconduct in order to support a sanction. Resp't 
Exceptions at 33. DEA decisions have found that ``just because 
misconduct is unintentional, innocent, or devoid of improper motive, 
[it] does not preclude revocation or

[[Page 4941]]

denial. Careless or negligent handling of controlled substances creates 
the opportunity for diversion and [can] justify the revocation of an 
existing registration . . .'' Bobby D. Reynolds, N.P., Tina L. 
Killebrew, N.P., & David R. Stout, N.P., 80 FR 28643, 28662 (2015) 
(quoting Paul J. Caragine, Jr. 63 FR 51592, 51601 (1998). In fact, the 
Agency has found in favor of revocation in cases where registrants have 
failed to document their prescribing decisions--a violation which has 
been clearly established in this case. The Agency has repeatedly 
emphasized that ``[c]onscientious documentation is . . . not just a 
ministerial act, but a key treatment tool and vital indicator to 
evaluate whether the physician's prescribing practices are within the 
usual course of professional practice.'' Cynthia M. Cadet, M.D., 76 FR 
19,450, 19,464 (2011) (internal citation and quotation omitted); see 
also Kaniz F. Khan-Jaffery, M.D., 85 FR 45,667, 45,686 (2020) (``DEA's 
ability to assess whether controlled substances registrations are 
consistent with the public interest is predicated upon the ability to 
consider the evidence and rationale of the practitioner at the time 
that she prescribed a controlled substance--adequate documentation is 
critical to that assessment.'').
---------------------------------------------------------------------------

    *\HH\ It is noted that the CSA's core purposes are not, as 
Respondent suggests, limited to diversion, but also include abuse of 
controlled substances. See John O. Dimowo, M.D., 85 FR 15800, 15810 
n.K, M (2020), Further, ``it is axiomatic that another core purpose 
of the CSA is to protect patients from the drug-related deaths and 
injuries that may result from drug abuse and diversion.'' Salman 
Akbar M.D, 86 Fed Reg. 52181, n.*O (2021). In this case, there is 
evidence that Respondent's prescribing put his patients at risk and 
that he did not document informed consent surrounding that risk. 
Further, there is evidence on the record that a patient died of an 
overdose, and regardless of whether the controlled substances 
Respondent prescribed contributed to that death, the overdose itself 
indicates abuse. Additionally, there is evidence that another one of 
Respondent's patients had opiate use disorder by Respondent's 
admission. Supra n.*J. And finally, there is evidence that AA was 
possibly not taking his oxycodone and that patients were repeatedly 
receiving extra controlled substances beyond their prescriptions--
all of which have the potential to contribute to diversion. 
Therefore, even though, contrary to Respondent's assertion, I am not 
required to find evidence of abuse and diversion in order to find in 
favor of a sanction, I disagree with Respondent's bold assertion 
that ``there is no evidence of addiction or medication abuse.'' 
Resp't Exceptions at 33.
---------------------------------------------------------------------------

    The case at hand demonstrates prescribing beneath the applicable 
standard of care and outside the usual course of professional practice 
in California to multiple patients over the course of many years. I 
agree with the Chief ALJ that this conduct was egregious and I agree 
with his rationale for sanction. As stated above, for many reasons, I 
cannot find that I can entrust Respondent with a registration.
    Accordingly, I reject Respondent's Exceptions and affirm the RD's 
conclusion that Respondent's registration should be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a)(4) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate 
of Registration No. BC1317165 issued to Bradley H. Chesler, M.D. 
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 
824(a) and 21 U.S.C. 823(f), I further hereby deny any pending 
application of Bradley H. Chesler, M.D., to renew or modify this 
registration, as well as any other pending application of Bradley H. 
Chesler, M.D. for registration in California. This Order is effective 
March 2, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-01838 Filed 1-28-22; 8:45 am]
BILLING CODE 4410-09-P