[Federal Register Volume 87, Number 29 (Friday, February 11, 2022)]
[Notices]
[Pages 8039-8058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02973]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-03]


John X. Qian, M.D.; Decision and Order

    On November 18, 2019, a former Acting Administrator, Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause and Immediate Suspension of Registration 
(hereinafter, OSC/ISO) to John X. Qian, M.D. (hereinafter, Respondent). 
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (Order to Show 
Cause), at 1. The OSC proposed the revocation of Respondent's 
Certificates of Registration Nos. FQ7186174, FQ7906968, and BQ7364970, 
and denial of the pending application for a new DEA Certificate of 
Registration (hereinafter, COR or registration), Application No. 
W18124091C, pursuant to 21 U.S.C. 824(a)(4) ``because [his] continued 
registration is inconsistent with the public interest. . . .'' Id. 
(citing 21 U.S.C. 823(f)).

I. Procedural History

    The OSC alleged that ``from at least early 2017, through at least 
April 29, 2019,\1\ [Respondent] unlawfully issued or approved the 
issuance of prescriptions for controlled substances'' to three patients 
``that were not for a legitimate medical purpose, were beneath the 
standard of care for the practice of medicine in the State of 
California, and were not issued in the usual course of professional 
medical practice.'' Id. at 5. The OSC alleged violations of 21 U.S.C. 
841(a) and 842(a); 21 CFR 1306.04(a); Cal. Health & Safety Sec. Sec.  
11153(a), 11154(a); and Cal. Bus. Sec.  Prof. Sec. Sec.  725(a), 22334, 
and 2242(a). Id.
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    \1\ In the Prehearing Statement, the Government clarified the 
relevant time period to be between early 2017 and ``late 2019.'' 
ALJX 4, at 15.
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    Pursuant to 21 U.S.C. 824(d) and 21 CFR 1301.36(e), the former 
Acting Administrator immediately suspended Respondent's Certificate of 
Registration, found ``that [Respondent's] continued registration [was] 
inconsistent with the public interest'' and that ``continued 
registration while [the] proceedings are pending constitutes an 
imminent danger to the public health or safety.'' Id. at 13. Pursuant 
to 21 U.S.C. 824(f) and 21 CFR 1301.36(f), the former Acting 
Administrator authorized DEA Special Agents (hereinafter, SA) and 
Diversion Investigators (hereinafter, DI) serving the OSC on Respondent 
to place under seal or to remove for safekeeping all controlled 
substances that Respondent possessed pursuant to the suspended 
registrations and to take the registrations themselves. Id.
    The OSC notified Respondent of the right to either request a 
hearing on the allegations or submit a written statement in lieu of 
exercising the right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
13 (citing 21 CFR 1301.43).
    By letter dated November 21, 2019, Respondent timely requested a 
hearing.\2\ ALJX 2 (Request for Hearing), at 1. The matter was placed 
on the docket of the Office of Administrative Law Judges and was 
assigned to Mark M. Dowd (hereinafter, ALJ). In addition to the 
traditional procedural history, the parties filed robust Joint 
Stipulations of Facts, ALJX 10 (Joint Stipulations of Facts), and the 
Government filed several Motions in Limine, which I will briefly 
summarize here. The first, a Motion in Limine to Exclude Second Expert 
Witness, ALJX 11, sought to exclude the testimony of a second expert 
witness identified a week before the hearing in this matter was 
scheduled to begin. Id. at 1. The ALJ found good cause for the 
Respondent's delay and agreed to permit both of Respondent's experts to 
testify so long as the testimony was not cumulative or repetitive. ALJX 
12 (Order Granting in Part Government's Motion in Limine and to Exclude 
Evidence). Respondent ended up calling only the later-added expert 
witness to testify. The second was a Motion in Limine to Exclude 
Character Witnesses, ALJX 13, which alleged that the dozen character 
witnesses that Respondent proposed could only offer testimony that was 
either irrelevant or duplicative. ALJX 13. The ALJ did not grant the 
Government's motion, but he did limit the number of witnesses who could 
discuss Respondent's character and dispensing experience to three 
patients and four medical professionals and limited the scope of the 
testimony to what was relevant to the hearing. Transcript of 
Proceedings in the Matter of John X. Qian, M.D. (hereinafter, Tr.), 7-
10. In the end, Respondent did not call any witnesses for these 
purposes but instead presented documentary evidence. During the 
hearing, the Government filed a Motion in Limine to Strike Testimony 
and Evidence, ALJX 18, related to Respondent's treatment of E.N. that 
predated the medical records provided to the Government in response to 
a subpoena (which began in July 2012). ALJX 18, at 1. The ALJ

[[Page 8040]]

determined that the issue was simply a miscommunication between the 
parties and denied the Government's motion. ALJX 21 (Order Denying 
Motion to Strike).
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    \2\ I find that the Government's service of the OSC was 
adequate.
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    The hearing in this matter took place both in-person in San Diego, 
California, and virtually, and spanned eight days in February and May 
of 2020. Recommended Decision (hereinafter, RD), at 1. On July 27, 
2020, the ALJ issued his Recommended Rulings, Findings of Fact, 
Conclusions of Law and Decision. The Respondent filed Exceptions to the 
Recommended Decision on August 14, 2020.\3\ (hereinafter ``Respondent's 
Exceptions'') ALJX 30. The Government was granted leave to file a 
response to the Respondent's Exceptions, and it filed them on September 
11, 2020. See ALJX 31-33. I have reviewed and agree with the procedural 
rulings of the ALJ during the administration of the hearing.
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    \3\ This decision, as compared to the ALJ's decision with which 
Respondent took exception, has been simplified and narrowly focuses 
on the issues that are relevant to my determination as to whether or 
not the relevant prescriptions were issued within the usual course 
of professional practice and standard of care in California and in 
compliance with the relevant state laws, as it was established in 
this case. Several of Respondent's Exceptions relate to findings in 
the ALJ's decision that I have not determined to be relevant to my 
decision and, accordingly, I have not addressed those Exceptions in 
detail. Throughout this decision, I have addressed in detail 
Respondent's exceptions to findings that my decision relies upon.
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    Having considered the record in its entirety, I find that 
Respondent issued one-hundred and fifteen prescriptions beneath the 
applicable standard of care and outside of the usual course of the 
professional practice in California in violation of federal law, and I 
find that Respondent committed violations of state law. I agree with 
the ALJ that revocation is the appropriate sanction. RD, at 242. I make 
the following findings of fact.

II. Findings of Fact

A. DEA Registration

    The parties stipulated that Respondent is registered with DEA as an 
individual practitioner authorized to handle controlled substances in 
schedules II through V under DEA Certificate of Registrations 
FQ7186174, at 5360 Jackson Drive, Suite 100, La Mesa, CA 91942, 
scheduled to expire on April 30, 2020; \4\ FQ7906968, at 7024 Seville 
Ave., Suite D, Huntington Park, CA 90255, scheduled to expire on April 
30, 2021; and BQ7364970 (and XBQ7364970), at 5395 Ruffin Rd., Suite 
204, San Diego, CA 92123, scheduled to expire on April 30, 2022. ALJX 
10, at 1; GX 1a-c (Respondent's Certificates of Registration), 2a-c 
(Respondent's Certificate of Registration Histories); RD, at 159. The 
parties further stipulated that Respondent submitted an application for 
a DEA COR as an individual practitioner authorized to handle controlled 
substances in scheduled II through V under Application No. W18124091C, 
at 344 F St., Suite 203, Chula Vista, CA 90910. ALJX 10, at 1; RD, at 
160.
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    \4\ The fact that a registrant allows his registration to expire 
during the pendency of an OSC does not impact my jurisdiction or 
prerogative under the Controlled Substances Act (hereinafter, CSA) 
to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 
68,474 (2019). Accordingly, even though one of the registrations at 
issue in this case has expired, it is still included as part of my 
revocation order. Infra ``Order.''
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B. Government's Case

    The Government's documentary evidence \5\ consisted of voluminous 
patient records for three individuals to whom Respondent issued the 
controlled substances prescriptions that are at issue in this case. See 
e.g., GX 4, 5, 8, 9, 12, and 13. The Government's evidence also 
contained prescription records and California Controlled Substance 
Utilization Review and Evaluation System (hereinafter, CURES) reports 
for those three individuals, the Curriculum Vitae for its expert 
witness, some DEA records, and an Accusation filed against Respondent 
by the Medical Board of California (hereinafter, MBC). See GX 1-3, 6, 
7, 10, 11, 14-16, 23. Finally, the Government produced a number of 
guidelines and publications that it presented as evidence in support of 
establishing the standard of care in California. GX 17-22. 
Additionally, the Government called three witnesses: DI, the 
Government's expert Dr. Timothy Munzing, and a systems analyst for an 
electronic medical record program, Mr. Parag Deshpande.
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    \5\ I have reviewed and considered all of the documentary 
evidence presented by both the Government and Respondent, and hereby 
incorporate the entire record; I have not cited to every record in 
this decision.
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    DI testified regarding her professional background and education. 
Tr. 66-69. She also testified about her investigation-related actions 
since early-2019 in this matter including, but not limited to, her 
involvement in obtaining and reviewing CURES reports, pharmacy records, 
and records from Respondent pursuant to the May 7, 2019 administrative 
subpoena, including records for patients D.B., B.G., and E.N. Id. at 
71-168. DI testified that her review of the records indicated that 
various red flags were present and she retained Dr. Munzing as an 
expert to review the records at issue. Id. at 167, 169, 183-222. Having 
read and analyzed all of the record evidence, I agree with the ALJ that 
DI's testimony was ``credible and should be afforded considerable 
weight.'' RD, at 165.
    Dr. Munzing testified regarding his professional and educational 
background. Tr. 249-256; GX 16 (Curriculum Vitae of Dr. Munzing); RD, 
at 27-30. He graduated medical school from the University of 
California, Los Angeles, in 1982 and has been Board-certified in family 
medicine since 1985. Id. at 250-51. He has been employed with Kaiser 
Permanente for thirty-five years and has experience treating pain 
patients. Id. at 250-254, 971-72, 980-83. Also, he has authored several 
peer-reviewed publications on pain management and prescribing for 
chronic pain.\6\ Id. at 253-55, 952-53. Dr. Munzing has testified as an 
expert witness approximately thirty times and has been qualified as an 
expert witness in cases where the respondent was a pain specialist. Id. 
at 257-60. Dr. Munzing was accepted in this matter as ``an expert in 
the standard of care [for] prescribing controlled substances in the 
State of California, including for management of pain.'' \7\ Tr. 260, 
265.
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    \6\ Dr. Munzing describes chronic pain as ``pain that last[s] 
three months'' or more and that is ``less likely to suddenly get 
completely better.'' Tr. 276. In contrast, Dr. Munzing explains that 
acute pain is shorter term such as when you are injured and your 
body heals with or without surgery. Id.
    \7\ At the hearing, Respondent objected to Dr. Munzing's 
qualification as an expert based on his ``lack of specialty in the 
area of pain management.'' Tr. 262. Throughout the hearing stage, 
Respondent repeatedly argued that Dr. Munzing's experience in pain 
management is lacking, that his lack of experience is evident in his 
testimony, and that his opinions can be afforded no weight. ALJX 28 
(Respondent's Posthearing), at 4-7, 11-2, 21-22, 25-28; ALJX 30 
(Respondent's Exceptions), at 2-10, 14-21. Respondent also took 
exception to the ALJ's determination that Dr. Munzing was qualified 
as an expert in this matter. ALJX 30, at 2-7. I have fully 
considered these arguments. Many of the areas where Respondent 
focused on Dr. Munzing's lack of experience, such as in determining 
what morphine milligram equivalent (MME) is too high for a 
particular patient, developing a titration schedule for patients, or 
managing a patient's pain pump, did not end up being relevant to my 
decision in this case. This is because the record established 
through the testimony of both experts that the standard of care does 
not set a cap on MMEs, it does not dictate a titration schedule, and 
it does not have firm rules for managing pain pumps. Infra II.D.3.a. 
Moreover, Respondent's general medical decision making 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. Tr. 1112-16, 1199-1201, 1206-07. Moreover, as is 
demonstrated below, infra II.D., 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.

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[[Page 8041]]

    The ALJ conducted a thorough analysis of Dr. Munzing's credibility, 
see RD, at 165-169 and I agree with much of it. I agree that Dr. 
Munzing's prior experience as a government witness and his compensation 
therefore does not create an actual credibility concern. RD, at 165. I 
agree that Dr. Munzing's professional experience with regard to pain 
management, while sufficient to be qualified as an expert witness and 
to offer credible opinions, was not as robust as Dr. Polston's. RD, at 
167. Dr. Munzing was a family practitioner, he was not Board-certified 
as a pain management specialist, Tr. 251, 973, 976; however, Dr. 
Munzing explained that in the Kaiser Permanente system (where he 
worked), the family practitioner managed pain conditions and prescribed 
the necessary medication even when consulting with a pain management 
specialist. Tr. 971-72, 980-83. The nature of Dr. Munzing's practice, 
along with his peer-reviewed publications in pain management, Tr. at 
253-55, 952-53, suggest that he had more experience in prescribing 
controlled substances for pain management than a typical family 
practitioner. Dr. Polston, however, was a Board-certified pain 
management specialist and had more clinical experience treating complex 
pain in patients with chronic conditions including more experience 
titrating patients down from extraordinarily high levels of opioids and 
managing patients with pain pumps.\8\ Infra II.C.; RD, at 167.
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    \8\ Although Dr. Polston's testimony regarding the 
appropriateness of Respondent's titration with respect to the 
standard of care was at times more detailed and credible than Dr. 
Munzing's, as described in infra II.D.3.a. and RD, at 183-87, Dr. 
Munzing's testimony was more far more credible than Dr. Polston's 
regarding the requirement to document a titration treatment and plan 
appropriately. Ultimately, I find that, as demonstrated by 
Respondent's recordkeeping, Respondent failed to provide 
documentation that justified the titration schedule used and the 
gaps between downward adjustments, and that failure to document 
supported a finding that Respondent issued prescriptions outside the 
usual course of professional practice and beneath the applicable 
standard of care. Infra II.D.3.a.
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    The ALJ found that ``Dr. Munzing's testimony critiquing 
[Respondent's] actual treatment of the three subject patient[s] 
carrie[d] limited weight,'' because it did not ``address[] the patient-
specific strategies used and described by [Respondent].'' RD, at 168-
69. I disagree. I find that, overall, Dr. Munzing's testimony was more 
detailed and reflected a much more thorough review of the Respondent's 
records than Dr. Polston's. Dr. Polston opined regarding the medical 
records in their entirety, which allowed Dr. Polston to apply 
subsequent prescribing rationale retroactively to justify earlier 
prescriptions, even though there was no documented justification at the 
time that the prescription was issued. Tr. 616. However, Dr. Munzing 
approached each prescription individually while also looking at the 
records as a whole. Tr. 1196-97. His testimony focused on whether the 
medical records justified each prescription at the time the 
prescription was issued consistent with 21 CFR 1306.04. Tr. 1233; infra 
III.A.2.a.
    With regard to recordkeeping, the ALJ found that ``Dr. Munzing's 
testimony . . . was internally consistent, did not depend [on] 
specialized expertise relating to the evaluation of pain management 
specialists, was consistent with the relevant statute and Guidelines, 
and thus was wholly credible.'' RD, at 169. I agree that Dr. Munzing's 
testimony regarding recordkeeping was wholly credible.
    The ALJ found, and I agree, that ``[t]he basic tenets of the 
standard of care for prescribing opioids, as described by Dr. Munzing, 
was fully credible and not controverted by the Respondent.'' RD, at 
168. Ultimately, as addressed with more specificity in the Standard of 
Care section below, where the two experts differed regarding 
application of the standard of care, I find that Dr. Munzing's 
testimony was more detailed and more closely aligned with the law and 
guidelines governing the standard of care in California. Infra. II.D. I 
therefore find Dr. Munzing's testimony to be fully credible.
    As a rebuttal witness, the Government called Mr. Deshpande who was 
a systems analyst with BizMatics, the company who developed the 
electronic medical record (hereinafter, EMR) program used by Respondent 
and his practice. Tr. 1874-75, 1878-79. Mr. Deshpande explained the 
operation of Respondent's EMR system, Tr. 1892-1901, and explained that 
physicians have the ability to ``copy over'' specific sections of 
information from a previously completed visit report to the current 
visit for the same patient. Tr. 1901. The system can also be set up so 
that it automatically copies information from the most recent previous 
visit into the current visit record. Tr. 1902-03. Finally, Mr. 
Deshpande explained his assessment of the number of times entries and 
findings from precious encounters were automatically copied into the 
record for a current encounter related specifically to the three 
individuals for whom the controlled substance prescriptions at issue in 
this case were written. Tr. 1910-49. The ALJ found, and I agree, that 
Mr. Deshpande had ``a high level of expertise in each of the areas in 
which he offered testimony.'' RD, at 170. The ALJ also found, and I 
agree, that ``[h]is testimony was internally consistent and generally 
consistent with the testimony of [Respondent] regarding the basic 
functioning of the program.'' Id. Therefore, the ALJ ``found his 
testimony fully credible and deserving considerable weight.'' Id. I 
agree.

C. Respondent's Case

    The Respondent's documentary evidence was largely duplicative of 
the Government's documentary evidence.\9\ See RX E-J, N-P. The 
Respondent presented the Curriculum Vitae of his expert, Dr. Gregory 
Polston, along with his expert report. RX HHH, TTT. The Respondent also 
presented a number of publications including the MBC's 2007 Prescribing 
Guidelines, RX A, a clarification memorandum from the authors of the 
CDC Guidelines, RX D, an AMA article criticizing the CDC Guidelines' 
impact on pain treatment, RX DD, an MBC Update to Prescribers, RX SS, 
and an Aberrant Drug Taking Behaviors Information Sheet, RX TT.\10\ 
Respondent introduced several curricula vitae and declarations of 
support from other medical professionals. See RX T-AA, RR, HHH, PPP. 
The record also contained declarations that patients of Respondent 
offered in support of Respondent's case. RX JJ-LL. Respondent produced 
records regarding training programs he had attended, RX PP-QQ, his 
Curriculum Vitae, RX RR, his Board Certifications, RX XX-YY, and 
miscellaneous records related to his practice generally, e.g. RX LLL-
MMM, QQQ. Finally, there were some records offered in support of 
Respondent's treatment of the specific individuals at issue in this 
case. RX, JJJ-KKK, RRR-SSS, UUU-VVV. Additionally, Respondent called 
two witnesses: His expert, Dr. Gregory Polston, and himself.
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    \9\ Duplicative documentary evidence that was offered, but not 
admitted, included the CDC Guidelines; the MBC Guidelines for 
Prescribing; pain agreements, urine drug screens, CURES reports 
summaries, and patient records for the individuals at issue in this 
case. I agree with the ALJ's decision to not admit these duplicates.
    \10\ Respondent also attempted to introduce what the ALJ 
characterized as a ``newspaper article,'' which the ALJ did not 
admit because it was not ``necessarily reliable'' and was not 
``authenticate[d].'' Tr. 1847. I agree that absent evidence 
establishing the reliability therein, newspaper articles should not 
be admitted into evidence. See Jones Total Health Care Pharmacy, 
L.L.C., 71 FR 79188, 79222 n. 11 (2016).

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[[Page 8042]]

    Respondent testified regarding his medical education and 
background--he came to the United States as a visiting scholar to 
conduct research related to cancer cells in 1990. Tr. 1316-19. He then 
decided to change his focus to Physical Medicine and Rehabilitation 
(hereinafter, PMR), which complimented his specialized training in 
anesthesiology. Tr. 1319-22. Respondent became Board-certified in PMR 
in 2003, and Board-certified in pain medicine in 2005 (which he allowed 
to lapse in 2015). Tr. 1328-30. Respondent opened his own practice at 
the end of 2005, and described himself as the ``go-to-guy'' in the San 
Diego area for pain management and stated that his multiple practice 
locations see approximately 100 patients a day. Tr. 1336-43.
    Respondent offered some testimony regarding his office policies, 
his recordkeeping practices, and how his EMR system worked.\11\ See 
e.g. Tr. 1564-68. Respondent testified that he was the attending or 
supervising physician for each of the three individuals at issue in 
this case, B.G., D.B., and E.N., that he was personally responsible for 
the treatment each individual received from Respondent and Respondent's 
staff, and that he was personally responsible for the controlled 
substance prescriptions issued to each individual by Respondent and 
Respondent's staff. Tr. 1564-68; ALJX 10, at 3; see also Tr. 399. 
Respondent also offered testimony regarding his understanding of the 
standard of care in California, which I have credited where it aligns 
with the testimony of the two experts in this case. Tr. 1561-86.
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    \11\ I do not find a violation with regard to the Government's 
allegation related to a note related to alcohol use and, therefore, 
I will not address this allegation further. The Government alleged 
that Respondent's recordkeeping was deficient because the records 
repeatedly included an internally inconsistent note that stated, 
``[p]atient states that [she or he] drinks alcohol [she or he] never 
drinks alcohol.'' OSC, at 4; RD, at 205-06. Respondent explained 
that this note appeared as a result of a computer glitch; an error 
within the computer program that produced the inconsistent statement 
in printed records despite the proper selection of one option 
(drinks alcohol) or the other (never drinks alcohol) in the system's 
drop down menu. Tr. 1412-24, 1831-32. As the computer error was 
corroborated by Mr. Deshpande's testimony, Tr. 2000-04, I agree with 
the ALJ and find that the Government did not sustain their burden as 
to this allegation. RD, at 206. In his decision, the ALJ found for 
Respondent but noted there was ``some level of negligence 
attributable to him for his failure to confirm the EMR was operating 
properly.'' RD, at 206. The Respondent took exception to this note. 
ALJX 30, at 14. I do not see anything in the record that suggests 
that Respondent's failure to catch the computer glitch meant that 
the relevant prescriptions were issued outside the standard of care. 
Accordingly, the ALJ's note is not relevant to and is not being 
considered as part of my decision in this matter.
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    The ALJ found Respondent's testimony to be credible at times.\12\ 
See e.g. RD, at 199, 208, 212, and 216. But at other times, the ALJ 
found Respondent to be so not credible that it ``suggest[ed] 
[Respondent] deliberately misled [the] tribunal during the hearing.'' 
RD, at 225.
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    \12\ The ALJ evaluated Respondent's credibility, ``within the 
relevant factual findings.'' RD, at 171. Many of the specific 
factual findings where the Respondent was found credible were on 
issues that I have found were not material to the case. For example, 
the ALJ credited Respondent's testimony that Retrospective Drug 
Utilization Review letters were so routine in the practice of pain 
management that they did not represent red flags under the 
circumstances of this case. RD, at 212. However, I found that the 
government did not explain why the 2016 Drug Utilization Review 
letter at issue in this case was relevant to the 2017-2019 
prescribing so the issue is not material to my decision. See infra 
n. 55. The ALJ credited Respondent's testimony that he was aware of 
and investigating E.N.'s 2015 increase in pain, RD, at 216; but 
again, the Government did not explain how this 2015 issue was 
relevant to the relevant prescribing in 2017-2019. Infra n. 52. The 
ALJ credited Respondent's testimony that an inconsistent drug screen 
was not aberrant because medication infused through a pain pump 
would not be expected to show up in urine. Tr. 208. This issue was 
abandoned by the Government and is not material to my decision in 
this case. Infra. n. 49.
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    I find that, at times, Respondent's testimony was self-serving to 
the point it denied belief. On cross examination, Respondent was asked 
if a particular individual had ``obtained [Soma] from her daughter's 
prescription, then she's obtained Soma in an unlawful manner, 
correct?'' Tr. 1688. Respondent testified, ``[l]et's put it this way. 
If it's a Soma, if you [are] so close to each other, it could be from a 
liquid contamination to make her urine positive too.'' Id. When pressed 
by the ALJ to explain how Soma could show up in your system ``[u]nless 
you took the Soma tablet,'' Respondent said ``you could get 
contaminat[ion] with the food or drop it somewhere.'' Tr. 1689. Dr. 
Munzing's testimony completely discredited Respondent's suggestion of 
``liquid contamination.'' Tr. 2066, 2118; Infra II.E.2.
    Another area of Respondent's testimony that lacked credibility, as 
the ALJ thoroughly assessed, was Respondent's testimony regarding his 
recordkeeping, particularly how the patient records that were verbatim 
for every visit were created. RD, at 216-224 (citing Tr. 1786-1804). 
Specifically, the ALJ ``found that Respondent lacked candor in [the] 
proceeding by his fallacious explanation for the verbatim repetition of 
examination results throughout the medical records.'' RD, at 240. 
Respondent testified that the records regarding the physical 
examination remained the same for lengthy periods because Respondent 
was doing the exact same examination of the patient from the prior 
month. Tr. 1775-79, 1799-1801. Because the selections were the same, 
according to Respondent, the records produced the same narrative. Id. 
However, Respondent's version of events conflicts with Mr. Deshpande's 
evidence showing that the examination results were copied forward and 
further conflicts with Dr. Munzing's and Dr. Polston's testimony that 
you would expect some visit to visit variability in the examination 
even for patients with chronic pain. I agree with the ALJ and discredit 
Respondent's testimony in this area.
    Overall, I find credible those portions of Respondent's testimony 
that were supported by the medical records, the expert testimony, and 
the record as a whole. Where his testimony was inconsistent with the 
record, I do not credit Respondent's testimony.
    Dr. Polston testified regarding his professional and educational 
background. Tr. 509-38; RX HHH (Curriculum Vitae of Dr. Polston); RD, 
at 91-94. He graduated medical school from the University of Wisconsin 
in 1989 and has been Board-certified in anesthesiology since 1999. Tr. 
509-10, 519; RX HHH, at 2. He completed a fellowship in pain management 
in 2001 and his practice has been limited to pain management since that 
time. Tr. 513. His experience includes work as a private practice pain 
physician with the Advanced Medical Centers of Alaska, a Clinical 
Professor at the University of California San Diego, a Clinical 
Director with the Center for Pain Medicine University of California San 
Diego Medical Center, and a Clinical Director and a Clinical Professor 
with the VA San Diego Medical Center. Id. Also, he has authored journal 
articles and book chapters regarding pain management, has served on 
numerous committees, and has received awards for his work as is set 
forth in his Curriculum Vitae and in the RD. RX HHH, at 2-8; RD, 92-94. 
Dr. Polston has been retained as an expert witness on behalf of 
physicians approximately ten times, Tr. 535, and has assisted the MBC 
in evaluating pain physicians since approximately 2010, Tr. 528. Dr. 
Polston was accepted in this matter as ``an expert in the area of pain 
management.'' Tr. 538.
    The ALJ conducted a thorough analysis of Dr. Polston's credibility, 
see RD, at 170-171, much of which I agree with. I agree that Dr. 
Polston ``sometimes argued the position of his

[[Page 8043]]

sponsor in lieu of a direct response.'' \13\ RD, at 170. I agree that 
Dr. Polston's professional experience with regard to pain management 
was robust and that he appeared to have more hands-on professional 
experience in the areas of downward titration and pain pump management 
than Dr. Munzing.\14\ RD, at 167, 171. I disagree with the ALJ that Dr. 
Polston ``offered credible detailed testimony relating to the specifics 
of [Respondent's] treatment, prescribing and titration strategies.'' 
RD, at 170. Instead, I find that Dr. Polston's testimony lacked detail 
and often took the specific facts of the case, excused gaps or filled 
them with speculation, and then conclusively determined that the 
standard of care was met without adequately explaining why.\15\ See Tr. 
714-16, 756, 773. I find that Dr. Polston's testimony, while generally 
credible, was not as thorough or as specific as Dr. Munzing's.
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    \13\ For example, Dr. Polston testified that in the prior seven 
years, he, himself, had not prescribed controlled substances to a 
chronic pain patient on a regular basis above 800 MME. Tr. 703. 
Right after this acknowledgment, the ALJ asked Dr. Polston, ``other 
than palliative care, cancer patients, have you ever taken a patient 
to 2,400 MME?'' Id. at 704. Dr. Polston evasively replied, ``That's 
where I--that's where some of the caution that--that some of those 
patients who have come in--they have come into my practice. And I 
don't think that that is--at the--at those higher doses that I 
would--would say that coming from before these documents came in, 
and at the time when they came in, suddenly there was a lot of 
physicians who stopped prescribing, and that they . . . taken them 
off, and then we were faced with a lot of these kind of patients.'' 
Tr. 704. I found this testimony to be evasive and it caused me to 
question Dr. Polston's objectivity.
     Another example of evasiveness and inconsistency occurred 
during Dr. Polston's testimony regarding whether it is outside of 
the standard of care to repeatedly copy physical examination notes 
from a prior office visit into physical exam notes for a current 
office visit without performing a physical examination during the 
current visit. See Tr. 717-23. Documentation of a physical 
examination that did not occur seems to be patently false, yet Dr. 
Polston evaded acknowledging this.
    \14\ Ultimately, as explained herein, I did not find that 
Respondent's titration schedule or use of pain pumps was in itself 
outside the standard of care. Supra n. 7-8; infra n. 28, 49.
    \15\ By way of one example, when asked if there was a physical 
examination performed on patient B.G. regarding his MS during a 
specific office visit, Dr. Polston answered ``[there is] a lot of 
inference there. One that . . . there's no significant changes in 
the physical exam since the last follow-up visit. The fact that he's 
got good hygiene is telling me . . . that he's being cared for and 
getting himself dressed.'' Tr. 773. Dr. Polston seems to be stating 
that the note ``good hygiene'' was sufficient to satisfy the 
physical examination requirement of the standard of care. Not only 
is his opinion based on an ``inference,'' but Dr. Polston's 
testimony reflects an extreme departure from Dr. Munzing's credible 
testimony on what a physical examination requires. See infra. 
II.D.2, II.E.1.
    Additionally, when Dr. Polston testified about whether the 
physical examination notes are simply ``cop[ied] forward'' from past 
office visits, he stated, ``when I see a `just copy forward,' and I 
see other changes, then I would say that I would think that most 
physicians are doing . . . hopefully are doing the right things.'' 
Tr. 716. Again, Dr. Polston evaded the question and filled the gap 
with an assumption.
---------------------------------------------------------------------------

    The two experts were generally in agreement about the basic 
elements of the standard of care in California. However, Dr. Polston 
seemed to advocate for leniency in the standard of care when applied to 
pain physicians, testifying that guidelines for prescribing opioids for 
pain have been and are continuing to evolve, and that because of this, 
``pain physicians, maybe, should be judged differently . . . [because] 
across the country, [there is] a wide variance of how . . . opioids 
are'' prescribed. Tr. 566-68.\16\ Dr. Polston rarely expanded upon the 
text of the law and guidelines governing the standard of care in 
California. In one place where Dr. Polston did expand--namely regarding 
what constitutes a sufficient physical examination to satisfy the 
standard of care in California, his testimony appeared to be in 
conflict with the relevant guidelines. See infra II.D.2. and II.E.2. 
With regard to recordkeeping, the ALJ found that ``Dr. Polston's 
opinions had diminished reliability,'' because the ``testimony was 
inconsistent with the relevant Guideline, was sometimes illogical, and 
frankly, sometimes defied common sense.'' RD, at 171.
---------------------------------------------------------------------------

    \16\ The standard of care guidelines that are being relied upon 
in this case explicitly state that they are the ``standard of care 
in managing pain patients,'' and that physicians and surgeons are 
expected to follow them. GX 17, at 59. I cannot see any 
justification for carving out pain specialists who are managing pain 
patients from its requirements. Notably, the MBC Guide to the Laws 
states ``[i]n continuing care situations for chronic pain 
management, the physician and surgeon should have a more extensive 
evaluation of the history, past treatment, diagnostic tests, and 
physical exam.'' GX 17, at 59. This suggests that Dr. Polston's 
position of leniency is inconsistent with the standard of care. The 
standard of care applied here is that standard of care that was in 
place in the State of California at the time of Respondent's actions 
as determined by the exert testimony and supporting literature. Any 
differences in the standard of care that existed prior to or after 
Respondent's actions are not relevant to this matter, nor is the 
standard of care in other geographic locations.
---------------------------------------------------------------------------

    Ultimately, as addressed with more specificity in the Standard of 
Care section below, I find that Dr. Munzing's testimony regarding the 
standard of care was more detailed and more closely aligned with the 
law and guidelines governing the standard of care in California. 
Accordingly, I differ with the ALJ, and find generally overall, not 
just on recordkeeping, that Dr. Munzing's testimony is more credible 
than Dr. Polston's where the two experts offered different opinions.

D. The Standard of Care in the State of California

    The parties seem to be largely in agreement as to the general 
components of the standard of care in this case, that the standard of 
care is primarily informed by California law and guidance, and that it 
is primarily captured by a 2014 publication from the MBC entitled, 
``The Guide to the Laws Governing the Practice of Medicine by 
Physicians and Surgeons,'' (hereinafter, MBC Guide to the Laws). Tr. 
266-67, 554-55, 567, 698; RD, at 168, 172-73; GX 17 (MBC Guide to the 
Laws). Based on this publication and the entire record, I find that the 
standard of care for managing pain patients in California requires: (1) 
History and physical examination; (2) treatment plan objectives; (3) 
informed consent; (4) periodic review; (5) consultation; and (6) 
complete and accurate records. Tr. 270-87, 694-95; RD, at 31-32, 172-
73. Additionally, according to Dr. Munzing, there is a 2014 publication 
from the MBC titled, ``Guidelines for Prescribing Controlled Substances 
for Pain'' (hereinafter, MBC Guidelines for Prescribing). GX 18. 
According to Dr. Munzing, this publication is ``not intended to mandate 
the standard of care,'' but it provides examples of how the standard of 
care captured in the MBC Guide to the Laws applies to the prescribing 
of controlled substances for pain. Tr. 291-92, 567. Dr. Munzing 
testified that the MBC Guidelines for Prescribing is ``a little bit 
more expansive, but . . . in alignment with the [MBC Guide to the 
Laws].'' Tr. 292. Additionally, in 2016, the Center for Disease Control 
(hereinafter, CDC) issued ``Guidelines for Prescribing Opioids for 
Chronic Pain'' (hereinafter, CDC Guidelines) which, according to Dr. 
Polston, provide ``recommendations'' specifically for primary care 
physicians, but that pain management ``[s]pecialists will take into 
consideration all aspects in . . . the literature . . . and review 
those documents.'' Tr. 550, 552; see also Tr. 1586.
1. Requirement To Keep Records
    Dr. Munzing clearly testified that each element of the standard of 
care ``must be documented in the medical records because [the 
physician] may not be the only person managing that patient.'' Tr. 299. 
Dr. Munzing testified ``[t]his patient may be seen by the emergency 
room, may be seen by the primary care physician may be seen by other 
sub-specialists, orthopedists, psychiatric

[[Page 8044]]

doctors.'' \17\ Id. at 299-300. Dr. Munzing further testified that if a 
physician is not maintaining adequate and accurate medical records then 
the physician is acting outside the standard of care. Id. at 301. Dr. 
Polston agreed that ``[m]edical records are incredibly important for 
physicians.'' Tr. 705.
---------------------------------------------------------------------------

    \17\ According to Dr. Munzing, when prescribing high doses of 
opioids, see infra II.D.3.a., the documentation should make ``very 
clear that [the physician] understand[s] the added risks [of 
prescribing over 80 MME] and . . . how [the physician] came to that 
determination . . . knowing that [he or she is] putting the patient 
at higher risk.'' Id. at 300.
---------------------------------------------------------------------------

    Dr. Munzing's testimony is supported by the MBC Guide to the Laws, 
which requires that the physician ``keep accurate and complete records 
according to items above, 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.'' \18\ GX 17, at 
61; see also id. at 67. Additionally, the MBC Guide states that 
``[d]ocumentation of the periodic reviews should be done at least 
annually[;]'' and ``[p]ain levels, levels of function, and quality of 
life should be documented. Medical documentation should include both 
subjective complaints of patient and caregiver and objective findings 
by the physician.'' Id.
---------------------------------------------------------------------------

    \18\ Dr. Polston agreed that the MBC Guide to the Laws stated 
this. Tr. 692.
---------------------------------------------------------------------------

    Similarly, the MBC Guidelines for Prescribing explain that

for a physician treating a patient with opioids for chronic, non-
cancer pain, an adequate medical record includes, but is not limited 
to, the documentation of: the patient's medical history; results of 
the physical examination . . . ; patient consent; pain management 
agreement; . . . description of treatments provided, including all 
medications prescribed or administered (including the date, type, 
dose and quantity); instructions to the patient, including 
discussions of risks and benefits with the patient . . . ; results 
of ongoing monitoring of patient progress (or lack of progress) in 
terms of pain management and functional improvement; notes on 
evaluations by, and consultations with, specialists; any other 
information used to support the initiation, continuation, revision, 
or termination of treatment and the steps taken in response to any 
aberrant medication use behaviors . . . ; . . . and results of 
CURES/PDMP data searches.

GX 18, at 22.
    Dr. Polston's opinion regarding the standard of care with regard to 
recordkeeping was more focused on obstacles created by electronic 
recordkeeping. See Tr. 619-21. Dr. Polston testified that through 
``repopulation'' or copying and pasting, electronic records can ``make 
clinic and visits more efficient.'' Tr. 527. However, he also 
emphasized limitations in medical software because sometimes a 
physician may not ``even attempt to copy it or however it was done, and 
I see errors being repopulated.'' Tr. 615-16. He also explained that 
some recordkeeping issues occur ``because the electronic record only 
allows you to enter data in certain spots, and some of the electronic 
record [do not] have the same amount of power or freedom to document 
and change things.'' Tr. 616. Dr. Polston seemed to look at records in 
totality, and seemed to find that here, where the conditions were 
chronic, justification for a prescription on one date could justify 
that same prescription on previous dates.\19\ Tr. 616, 618-19, 631, 
716-17. Regarding recordkeeping, I find that Dr. Munzing's testimony is 
more in line with California's law and guidance.
---------------------------------------------------------------------------

    \19\ Dr. Munzing explicitly rejected the notion that something 
documented later in time can justify what occurred prior in time and 
testified; ``You have to treat a patient in real time. . . . You 
have to document it [in] real time.'' Tr. 1233.
---------------------------------------------------------------------------

    Based on the experts' testimony and California law and guidance, I 
find that the applicable standard of care requires that a physician 
collect a patient's history and perform a physical examination, create 
treatment plan objectives, obtain informed consent, conduct a periodic 
review, and consult with others when needed. The standard of care 
further requires that the actions taken by the physician and 
information obtained by the physician in completing each of the 
standard of care requirements be accurately and completely recorded. 
Tr. 287. The requirement that information be accurately and completely 
recorded appears to apply equally to handwritten or electronic records. 
Based on both Dr. Munzing and Dr. Polston's testimony and California 
law and guidance, I find that accurate and complete records are an 
important aspect of prescribing within the standard of care in 
California.
2. History and Physical Examination
    Dr. Munzing testified that obtaining a history and performing a 
physical exam ``are critically important'' to get specific information 
about the individual patient's pain, including the duration, location 
and severity of the pain.\20\ Tr. 270. According to Dr. Munzing, the 
history and exam are also necessary to determine the existence of 
chronic illnesses, mental health disorders, or alcohol and drug use and 
abuse. Id. Importantly, according to Dr. Munzing, ``[t]he physical exam 
is important to find out specifically about if you can come up with the 
most reasonable differential diagnosis or sometimes an exact 
diagnosis.'' Tr. 270-71.
---------------------------------------------------------------------------

    \20\ Dr. Polston cautioned that a patient's assessment of pain 
``is a subjective response that . . . is very difficult . . . to 
quantitate'' because patients are afraid that their medication will 
be taken away ``[i]f they answer that they have too much pain . . . 
[or] if they [do not] reflect pain.'' Tr. 817. Dr. Polston's 
testimony demonstrates why a physical examination with objective 
findings is important to complement subjective complaints of pain. 
See GX 17, at 61.
---------------------------------------------------------------------------

    Consistent with Dr. Munzing's testimony, the MBC Guide to the Laws 
states that a ``medical history and physical examination must be 
accomplished.'' GX 17, at 59; see also Tr. 271-72. ``This includes an 
assessment of the pain, physical and psychological function; a 
substance abuse history; history of prior pain treatment; as 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.'' GX 17, at 59. Notably, the MBC Guidelines for 
Prescribing state that ``[t]he complexity of the history and physical 
examination may vary based on the practice location. . . . In 
continuing care situations for chronic pain management, the physician 
and surgeon should have a more extensive evaluation of the history, 
past treatment, diagnostic tests, and physical exam.'' Id. See also, GX 
18, at 54. Further, the requirement for a physical examination is 
codified in California law. Cal. Bus & Prof. Code Sec.  2242(a) states 
that it is unprofessional conduct to prescribe controlled substances 
``without an appropriate prior examination and a medical indication.'' 
See also, Tr. 286.
    The MBC Guide to the Laws also states the physician ``should keep 
accurate and complete records . . . including the medical history and 
physical examination.'' GX 17, at 61. It goes on to state that ``[p]ain 
levels, levels of function, and quality of life should be documented. 
Medical documentation should include both subjective complaints of 
patient and caregiver, and objective findings by the physician.'' Id. 
According to Dr. Munzing, the referenced documentation requirement 
mandates that a physician keep progress notes or other ``documentation 
verif[ying] what the history showed, what the exam showed . . . so one 
can look at the documentation . . . and see how did the physician 
decided that this is . . .

[[Page 8045]]

the right diagnoses or diagnosis.'' Tr. 272.
    Dr. Polston agreed that there needs to be a physical exam to 
prescribe within the standard of care. Tr. 694. However, he opined that 
a physician can either perform a ``focused exam'' or can conduct an 
examination ``just by looking at the patient and--and interacting. . . 
.'' Tr. 618. According to Dr. Polston, ``physicians are conducting 
exams just by interviewing and talking to a patient. We're always 
looking at how [they are] walking, how [they are] . . . sitting, . . . 
the degree of pain, . . . is it congruent with what [they are] 
reporting?'' \21\ Tr. 718-19. Dr. Polston's latter definition of a 
physical examination is inconsistent with Dr. Munzing's and I find Dr. 
Munzing to be more credible. Dr. Munzing testified that the type of 
information Dr. Polston described as an acceptable physical examination 
is actually collecting information for the ``history of present 
illness.'' See e.g. Tr. 1139-40. While collecting information regarding 
the history of present illness is part of the standard of care, it is 
separate and distinct from the physical examination requirement.\22\ 
Tr. 1143. According to Dr. Munzing, ``[t]he history of present illness 
is not an exam . . . [it is] not actually examining the patient, 
physically touching the patient, maneuvering the patient.'' Tr. 1143.
---------------------------------------------------------------------------

    \21\ Elsewhere, Dr. Polston seemed to testify that how the 
patient looks and talks is not a complete physical examination, but 
only a part of the examination. See Tr. 730.
    \22\ This distinction is also supported by the MBC Guide to the 
Laws, which separates the history and presentation from the physical 
examination, stating, ``[i]f a patient's request for opioid 
medication for pain is inconsistent with the patient's history, 
presentation, or physical findings, the physician may withhold the 
medication but must document the reason for the decisions.'' GX 17, 
at 59 (emphasis added).
---------------------------------------------------------------------------

    I find that the applicable standard of care in California requires 
a practitioner treating pain in chronically ill patients, to perform 
and document an appropriate physical exam, including an assessment of 
pain and physical and psychological function.
3. Treatment Plan Objectives
    Dr. Munzing explained that the history and physical exam 
requirements help a practitioner arrive at a diagnosis and that the 
treatment plan is the ``assessment . . . based on what [a practitioner 
has] determined is the diagnosis.'' Tr. 273. In addition, Dr. Munzing 
explained that documentation is required ``[s]o one can look at the 
documentation to . . . see how the physician decide[d] that this is . . 
. the correct management plan, both initially [and on] an ongoing 
basis.'' Tr. 272.
    The MBC Guide to the Laws requires that the treatment plan ``state[ 
\23\] objectives by which the treatment plan can be evaluated'' such as 
``control of pain, increase in function, and improved quality of 
life.'' GX 17, at 59. ``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. The MBC 
Guidelines for Prescribing state that ``[p]ain relief is important, but 
it is difficult to measure objectively. Therefore, it cannot be the 
primary indicator to assess the success of the treatment. Effective 
pain relief improves function, whereas addiction decreases 
functionality.'' GX 18, at 13.
---------------------------------------------------------------------------

    \23\ I find that the reference to what the treatment plan should 
``state'' is a clear indication that the treatment plan must be 
documented as is also indicated by Dr. Munzing's testimony.
---------------------------------------------------------------------------

a. Treatment Plans With >80 MME Prescribed
    According to Dr. Munzing, morphine milligram equivalent 
(hereinafter MME) is a term reflecting the ``common platform [used] 
when looking at . . . the strength of opioid treatment.'' \24\ Tr. 294-
94. In California, according to Dr. Munzing, there is a ``yellow flag 
warning'' meaning that physicians ``should be concerned if the total 
dosage for a day is 80 milligrams or higher . . . [and] proceed 
cautiously. Referral to an appropriate specialist should be considered 
with higher doses.'' Tr. 296. Dr. Munzing explained that ``as one goes 
higher on the MED or MME[ \25\], the . . . risk of the medication 
increases.'' Tr. 296. The risk increases at higher MME levels 
``regardless of how long'' a patient has been prescribed opioids, 
although for patients on long-term opioids ``the risk probably is 
somewhat less.'' \26\ Tr. 296-97. Dr. Munzing explained that the 
``yellow flag warning'' applies equally to pain specialists, because 
``the medication is [what is] putting the patient at risk . . . it 
[does not] change based on the letters at the end of the name of the 
person prescribing.'' Tr. 298. According to the CDC Guidelines, 
``prescriptions opioid-related overdose mortality rates rose rapidly up 
to prescribed doses of 200 MME/day, after which the mortality rates 
continued to increase but grew more gradually.'' GX 19 (CDC 
Guidelines), at 15; see also Tr. 306.
---------------------------------------------------------------------------

    \24\ For additional information on how the MME is calculated, 
see Tr. 311-16; GX 21 (Publication by Centers for Medicare & 
Medicaid Services); GX 22 (Publication by Centers for Disease 
Control & Prevention).
    \25\ Dr. Munzing testified that morphine milligram equivalent or 
MME and morphine equivalent dose or MED have ``identical'' meanings 
and the two phrases are used interchangeably throughout the record. 
Tr. 295.
    \26\ Dr. Munzing explained that there are no studies that look 
at the effects of a patient who is on, for example, ``300 [MME] for 
3 months as opposed to a year,'' and they are ``not going to do that 
study because of the inherent risks to patients.'' Tr. 297.
---------------------------------------------------------------------------

    Dr. Munzing clarified that despite the ``yellow flag warning . . . 
there are times when the indications are there and you weigh the 
potential benefits with the potential risks and one decides that . . . 
the potential benefits far outweigh the risks and you can proceed at 
higher amounts.'' Tr. 298. Dr. Munzing testified that there is no cap 
on the level of MME/day that can be prescribed, but as the dose and 
``risk significantly goes up . . . one needs to justify'' the 
prescribing. Tr. 308-09. Dr. Polston likewise explained that the intent 
of the CDC Guidelines was not to set 50 or 90 MME as ``hard limits'' 
and agreed that ``when patients come to a physician already on high 
doses of opioids, it is permissible to continue on those doses if the 
doctor believes it is appropriate.'' Tr. 558, 564.\27\
---------------------------------------------------------------------------

    \27\ I conclude based on the testimony of both of the experts in 
this case that the Government has not presented substantial evidence 
of a MME ceiling above which a prescriber would be per se in 
violation of the standard of care for prescribing controlled 
substances. Accordingly, if the intent of the Government's 
allegations regarding prescribing over 90 MME was that any such 
prescribing per se violated the standard of care, such an inference 
is unsupported by the record and is not sustained. See RD, at 178-
83. However, the Government has presented substantial evidence that 
controlled substance prescriptions must be justified. Tr. 281 (Dr. 
Munzing testified ``California . . . says that the prescribing must 
be justified. It has to be in the usual course of professional 
practice.''). Accordingly, where the evidence in the case 
established that controlled substance prescribing was not justified 
by appropriate documentation in the medical records, I have found 
that the Government established a violation of the standard of care. 
Dr. Munzing testified that, particularly for B.G. and E.N., the 
documentation in the medical record did not come anywhere close to 
justifying the ``extraordinarily high'' levels of opioids Respondent 
prescribed. Tr. 389, 433-34, 912-13; infra II.E.1, II.E.3.
---------------------------------------------------------------------------

    However, the fact that a patient was already on high doses of 
controlled substances, alone, is not sufficient justification to 
continue prescribing at that level. Tr. 1217-18. According to Dr. 
Munzing, physicians who inherit patients on high levels of MME have an 
obligation to attempt to try alternatives, whether alternative forms of 
treatment or prescribing lower doses, to ``decrease the risk of the 
patient while still certainly making every attempt to decrease pain, 
improve activity.'' Tr. 1277, 1275, 2040-43.
    Dr. Munzing explained that when prescribing opioids, it is 
important to ``titrate up, so slowly adjust up or titrate down, slowly 
adjusting'' the doses. Tr.

[[Page 8046]]

307; see also Tr. 700. Dr. Munzing agreed that titration is ``an 
individual process that differs for each patient,'' and there are no 
``evidence-based guidelines . . . that say, `This is the best way now.' 
'' \28\ Tr. 2091, 2071. Even so, according to Dr. Munzing, it is 
important to ``come up with a game plan . . . In one month, [we are] 
going to go down X amount. The next month, [we are] going down X 
amount. And then you may need to alter that over the way.'' Tr. 2044. 
Dr. Polston further testified that the literature ``does not support 
abrupt tapering or sudden discontinuation of opioids,'' which can 
``cause health risk for patients.'' Tr. 558, 563; GX 19.
---------------------------------------------------------------------------

    \28\ Both experts testified that there is not a firm titration 
schedule that could be used to evaluate whether the applicable 
standard of care is met. Accordingly, to the extent that the 
Government intended to charge that the percentage of titration up or 
down for any given prescription or that the titration schedule for 
any particular individual was outside the standard of care, those 
charges are not supported by the record here. See RD, at 183-87. 
However, the Government has established that the standard of care 
requires documentation of a treatment plan, which includes a 
creation of and documentation of the titration strategy the 
physician is using--those allegations are addressed below. See e.g. 
infra II.E.1.
---------------------------------------------------------------------------

b. Prescribing Opioids and Benzodiazepines
    Dr. Munzing testified that before opiates and benzodiazepines are 
prescribed together, there should be an attempt to ``mitigate'' the 
risks to the patient and ``try alternative methods that [are] safer.'' 
Tr. 388. According to Dr. Munzing, healthcare practitioners, including 
specialists, are bound by the guidance, which states that practitioners 
``should limit prescribing opioid pain medicines with benzodiazepines 
or other CNS [(central nervous system)] depressants only to patients 
for whom alternative treatment options are inadequate. If these 
medicines are prescribed together, [practitioners should] limit the 
dosages and duration of each drug to the minimum possible while 
achieving the desired clinical effect.'' \29\ GX 20, at 1; see also Tr. 
318-19. This is because, according to Dr. Munzing and the FDA Drug 
Safety Communication located at GX 20, ``the co-prescribing of opioids 
and benzodiazepine medications'' presents a ``serious risk of death.'' 
Tr. 317. Similarly, Dr. Polston testified that there is ``increased 
risk when you use benzodiazepines . . . with opioids.'' Tr. 662.
---------------------------------------------------------------------------

    \29\ The FDA Communication also requires additional warnings be 
given for informed consent. It states that practitioners should 
``[w]arn patients and caregivers about the risks of slowed or 
difficult breathing and/or sedation, and the associated signs and 
symptoms.'' GX 20, at 1.
---------------------------------------------------------------------------

4. Informed Consent
    With regard to informed consent, Dr. Munzing testified that the 
standard of care requires a practitioner ``to go through the risks, the 
benefits, and the alternatives.'' Tr. 273. Dr. Munzing's testimony is 
supported by the MBC Guide to the Laws which states that ``[t]he 
physician and surgeon should discuss the risks and benefits of the use 
of controlled substances and other treatment modalities with the 
patient, caregiver, or guardian.'' GX 17, at 60. ``A written consent or 
pain agreement for chronic use is not required but may make it easier 
for the physician and surgeon to document patient education, the 
treatment plan, and the informed consent.'' Id.
    Dr. Polston testified that the patient medication agreements and 
consent forms found throughout the record, standing alone, are 
sufficient ``documentation of discussions [regarding what] the risks 
and benefits of the medication were'' to satisfy the standard of care 
regarding informed consent. Tr. 609-10. There was limited, if any, 
evidence presented by the Government regarding whether the patient 
agreements alone were sufficient to satisfy the informed consent aspect 
of the standard of care. Here, Respondent's records contained patient 
agreements for each individual at issue in this case. Accordingly, I 
cannot find that Respondent violated the informed consent requirements 
in the standard of care for these individuals.
5. Periodic Review
    According to Dr. Munzing, periodic review for patients with chronic 
pain conditions requires ``checking periodically to see how [they are] 
doing: Are they getting better with your management? Are they getting 
worse? Are they having side effects from your . . . management? Are 
there alternatives that may be safer, may be better? And so looking 
over time, re-examine them. Is there something new in . . . the medical 
community that might benefit this person?'' Tr. 274. Periodic reviews 
are necessary, according to Dr. Munzing, because ``pain, especially 
chronic pain, usually does not stay exactly the same. It waxes and 
wanes . . . it may be better one day, worse one day . . . [it is] 
infrequent that every single day is exactly the same.'' Tr. 274.
    Dr. Munzing's opinion is supported by the MBC Guide to the Laws, 
which states ``[t]he physician and surgeon 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. 
Continuation or modification of controlled substances for pain 
management therapy depends on the physician's evaluation of progress 
toward treatment objectives. If the patient's progress is 
unsatisfactory, the physician and surgeon should assess the 
appropriateness of continued use of the current treatment plan and 
consider the use of other therapeutic modalities.'' GX 17, at 60. 
``Patients with pain who are managed with controlled substances should 
be seen monthly, quarterly, or semiannually, as required by the 
standard of care.'' Id.
    It is clear throughout the record that the ``periodic review'' 
portion of the standard of care also includes monitoring the patient. 
Both experts referenced the ``four As'' as part of monitoring. The 4As 
are: ``analgesia, activities of daily living, adverse side effects, 
aberrant drug taking behaviors.'' Tr. 357, 608-09. While it is clear 
that there is no set formula for monitoring an individual patient, some 
of the tools physicians can use include, looking for compliance with 
the pain agreement, running CURES reports, requiring urine drug 
screens, checking respiration rate and O2 levels, and using an opioid 
risk tool. See Tr. 604, 684. ``Monitoring can take many forms, 
including regular visits, . . . updated histories, updated 
examinations[,] . . . urine drug tests, CURES reviews[,] . . . pill 
counts to ensure that [they are] taking what [they are] prescribed and 
not taking potentially things that [you are] not prescribing.'' Tr. 
299.
    Dr. Munzing described a red flag as anything that comes up while 
monitoring ``that catches your attention that says that this could be a 
problem.'' Tr. 321. It could be laboratory results, certain symptoms, 
something in the CURES database, or a wide variety of things. Id. 
According to Dr. Munzing, red flags require a practitioner to 
``investigate further,'' take appropriate action ``determined by what . 
. . you found,'' and then ``all of that needs to be well-documented in 
the chart so if someone else . . . can look at [the] records and go, 
okay. He did this. He resolved that. It doesn't appear to be a 
problem.'' Tr. 323-24.
    Dr. Polston, used the term ``red flag'' in a different way that Dr. 
Munzing. Dr. Polston differentiated, albeit imprecisely, between 
``yellow flags'' and ``red flags'' and referred generally to ``aberrant 
behavior.'' Tr. 799-800. Dr. Polston described a ``red flag'' as a 
``severe deviation from the opioid agreement'' that requires immediate 
action or even termination of care. Tr.

[[Page 8047]]

799-800, 802. Dr. Polston testified that regardless of ``whether [it 
is] a yellow flag, a red flag, or any kind of aberrant behavior, we 
would hope that [it is] recorded and [there is] some type of medical 
reasoning applied as to how [you are] interpreting that particular 
event.'' Tr. 800. He went on to testify ``that when you see something 
that is considered aberrant in the sense that [it is] not [what is] 
intended or shows signs of misuse or abuse, the . . . statute said that 
that needs to be addressed. . . . Simply recording . . . that you [do 
not] think that [the aberrancy] is significant or . . . [filing] that 
as the first offence . . . in some ways resolv[es] that. . . . ``[I]f 
other minor infractions keep occurring, that . . . [would] need[ ] to 
be recorded and . . . show justification of why [you are] continuing 
therapy for the patient.'' Tr. 801.
    It appears that what Dr. Munzing refers to as a red flag 
encompasses all of the various aberrancies identified by Dr. Polston. 
Accordingly, the terms red flag and aberrancy appear interchangeably 
throughout the record. Regardless of the terminology, both experts seem 
to agree, and I find, that the applicable standard of care requires 
that red flags or aberrancies be investigated and that the results of 
that investigation be documented in the record.
a. Periodic Review With >80 MME Prescribed
    Dr. Munzing particularly stressed the importance of monitoring for 
patients that are on opioids, and stated that a practitioner needs to 
``intensely monitor'' the patient when prescribing more than 80-90 MME 
a day. Tr. 209. Dr. Polston likewise testified that ``[there are] more 
things [to be] concerned about at higher doses'' of opioids and agreed 
that there are ``more things [you are] tracking to ensure that the 
patient's health and safety [is not] at risk.'' Tr. 768.
6. Consultation \30\
---------------------------------------------------------------------------

    \30\ Although consultation is not a primary issue in this case, 
I am including this discussion as helpful in fully understanding the 
applicable standard of care for prescribing in California. See also, 
infra II.E.
---------------------------------------------------------------------------

    According to Dr. Munzing, consultation is the requirement that 
physicians work ``much more in collaboration with each other, 
especially with chronic conditions.'' Tr. 276-77. Dr. Munzing stated 
that when ``managing a patient who is not getting better over time or 
getting worse, [a physician should] seek consultation with'' a 
specialist or a colleague for a ``second opinion.'' Id. The MBC Guide 
to the Laws similarly explains that the standard of care requires 
physicians to ``consider referring the patient as necessary for 
additional evaluation and treatment in order to achieve treatment 
objectives.'' GX 17, at 60. Additionally, the Guide notes 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. 
Notably, the MBC Guide to the Laws states that ``[c]oordination of care 
in prescribing chronic analgesics is of paramount importance.'' Id.

E. Patients

1. Patient B.G.
    By way of background, B.G. was first seen by Respondent on August 
12, 2013, for ``pain management consultation.'' GX 8 (Medical Records 
for B.G.), at 1064. During that office visit, B.G. reported that he had 
``been under care of Dr. [M] for pain management for 10 years. He is on 
high dose of Methadone 240 mg per day. He gets 720 pills per month in 
the last 7 years.'' Id. There are no records in the patient file 
reflecting Dr. M's care of B.G., but Respondent testified that he 
unsuccessfully attempted to get those records.\31\ See generally GX 8; 
Tr. 341-42, 1449-50. At that time, B.G. complained of low back and leg 
pain. GX 8, at 1064. The records reflect a note from Respondent 
stating, ``I [Respondent] told him that he needs a primary care 
physician [for] his regular medical conditions. And a neurologist for 
MS in his care. Otherwise, I would not take over his care.'' Id. at 
1067.
---------------------------------------------------------------------------

    \31\ In his fourth exception, Respondent alleges that the ALJ 
erred by including Respondent's failure to document a discussion 
with Dr. M as an example of a deficient medical record because Dr. 
M's died before Respondent took over care of B.G. ALJX 28, at 13. I 
agree with Respondent on this issue and do not consider Respondent's 
inability to discuss prior care of B.G. with Dr. M or his inability 
to obtain records from Dr. M as rendering the relevant prescriptions 
outside the standard of care.
---------------------------------------------------------------------------

    Dr. Munzing testified that between February 14, 2017, and October 
3, 2019, Respondent issued forty-three controlled substance 
prescriptions to B.G. outside the usual course of professional practice 
and beneath the standard of care in California. Tr. 421-22, 945; GX 24 
(Chart of Prescriptions Reviewed by Dr. Munzing), at 1. The 
prescriptions included prescriptions for Dilaudid 4 mg. ranging from 60 
tablets in February 2017 to 30 tablets in August 2017 when the 
prescription discontinued; Valium 10 mg. ranging from 90 tablets in 
February 2017 to 45 tablets in October 2019; and Methadone 10 mg. 
ranging from 600 tablets in February 2017 to 215 tablets in October 
2019. GX 24, at 1. During the relevant period Respondent, as the expert 
witnesses testified, reduced the prescribed controlled substances' 
overall quantity of opioids from an ``astronomically high'' 2432 MME 
per day, Tr. 387-88, to 1720 MME per day, Tr. 441 and GX 24, at 1, and 
his function improved, Tr. 1099, 1191.\32\ Dr. Munzing opined that 
Respondent failed to satisfy the standard of care with regard to 
performance of physical examinations, treatment plans, periodic review 
and monitoring, and recordkeeping.
---------------------------------------------------------------------------

    \32\ Dr. Munzing explained that this sort of MME reduction 
decreases the risk to the patient, Tr. 874, but the MME is still 
high (in fact, ``anything over 120 MME is high dosage'' Tr. 304), 
``and the prescriptions are not medically justified.'' Tr. 389; see 
also id. at 309, 1216-17.
---------------------------------------------------------------------------

    Dr. Munzing testified in great detail regarding why the February 
14, 2017 prescriptions were issued outside the standard of care. 
According to Dr. Munzing, none of the medical records between October 
24, 2013, and February 14, 2017 ``confirm that there was [a physical] 
exam performed.'' \33\ Tr. 379. Dr. Munzing testified that a standard 
physical examination of a back that a pain specialist should perform 
consists of ``observation, . . . touching the back, range of motion, 
reflexes.'' Tr. 373. The physical examination notes on February 14, 
2017, state:
---------------------------------------------------------------------------

    \33\ Dr. Polston did not definitively testify regarding whether 
during B.G.'s October 24, 2013 office visit, the records documented 
a physical examination related to B.G.'s MS, but instead testified 
``[there is] a lot of inference there'' such as ``good hygiene.'' 
Tr. 773.

    Review: No significant changes noted in the patient's physical 
examination in this follow-up visit.
    General: The patient is well developed and well-nourished. 
Patient is alert and oriented. He is in no acute distress. Patient 
has good hygiene.
    Cardiovascular: Cardiovascular examination revealed regular rate 
and rhythm. No murmurs auscultated. There is no evidence of pedal 
edema.
    Abdomen: Not an obese person. The abdomen is soft, with no 
masses palpated, no rebound, rigidity or tenderness.
    Neurology-Coordination: Diadochokinesia is found to be normal. 
Finger-to-nose testing is normal. Antalgic. The patient is unable to 
do heel walk. The patient was unable to do toe walk.
    Gait: He is on W/C.

    GX 8, at 629 (emphasis removed from original). According to Dr. 
Munzing, this medical record has ``very little there'' and ``no 
documentation of any musculoskeletal exam, arm, leg, back, which were 
the areas that were

[[Page 8048]]

complained at.'' \34\ Tr. 379-80. The records confirm Dr. Munzing's 
testimony. Dr. Polston did not testify specifically regarding the 
sufficiency of the physical examinations of B.G., but did testify 
generally that ``[a]ll records show appropriate medical histories and 
examination treatment plans.'' Tr. 684. I credit Dr. Munzing's more 
specific opinion that this record did not document an adequate physical 
examination of B.G.
---------------------------------------------------------------------------

    \34\ Dr. Munzing testified there is ``no mention of the arms . . 
. [no] mention [of] anything specific about the legs other than he 
cannot do a heel or toe walk . . . no listing of the back.'' Tr. 
384. In short, Dr. Munzing opined that the performance of the 
physical examination, assuming it was performed as documented, was 
still outside the standard of care for the patient. Id.
---------------------------------------------------------------------------

    In addition to not covering the areas where B.G. complained of 
pain, the exam notes were ``always the same.'' Tr. 379. I credit Dr. 
Munzing's testimony that in complying with the applicable standard of 
care pain management physicians should see ``some visit-to-visit 
variability.[ \35\] So you might have two visits that might be 
identical. But over three-and-a-half years, [it is] not going to be 
identical.'' Tr. 380. According to Dr. Munzing, ``when you look at the 
medical records . . . there really is no evidence that there is an 
examination that verifies that this patient is in agony and extreme 
pain, certainly from an exam standpoint.'' Tr. 388.
---------------------------------------------------------------------------

    \35\ Dr. Polson's testimony on cross-examination seemed to 
agree.
    Q Do you typically see even for chronic pain patients over time, 
some change in their medical condition?
    A Somewhat. Some--sometimes not always.
    . . .
    Q And even if you were conducting the same physical examinations 
month after month, you would occasionally see for some variance in 
the results?
    A Yes.
    Tr. 717.
---------------------------------------------------------------------------

    Dr. Munzing went on to testify that the remaining relevant 
prescriptions issued between March 14, 2017, and October 3, 2019, were 
issued outside of the standard of care for the same reasons as the 
February 14, 2017 prescriptions. Tr. 405, 407, 409, 411, 415, 433, 438, 
444. With regard to the mostly identical physical examination results, 
Dr. Munzing's testimony is supported by Mr. Deshpande, who testified 
that from February 14, 2017, to May 8, 2018, twenty-one physical tests 
\36\ of B.G. were copied forward verbatim from prior medical visits 
without any new information being added. Tr. 1920-22; GX 29b (Bizmatics 
Subpoena Response), at 4-5. Eight physical tests were added on May 8, 
2018, and then all twenty-nine of those physical tests were copied 
forward verbatim until October 3, 2019. Id. Additionally, Dr. Munzing 
clearly testified that even on the occasions where more information was 
added, the records did not contain sufficient documentation to justify 
the high dosages of controlled substances prescribed; therefore, the 
prescriptions remain outside the standard of care. Tr. 438-39. He 
stated, ``we have just a long cascade of exams that by and large have 
been copy with slight variation at times . . . we're still over 2,000 
methadone equivalent . . . combination with an opiate which still puts 
the patient at very significant risk and again, if you look at the 
medical records, the medical records certainly don't verify and support 
a prescription at that extreme.'' Tr. at 433-434.
---------------------------------------------------------------------------

    \36\ Mr. Deshpande testified that ``the number of physical tests 
copied refers to the discrete number of questions or tests or 
bullets that are part of the physical exam section that got copied 
from the previous visit to this visit.'' Tr. 1911.
---------------------------------------------------------------------------

    Dr. Munzing opined that the prescriptions were also beneath the 
standard of care with regard to the documentation of treatment plan 
objectives. He testified that for the February 14, 2017 prescriptions, 
the ``total opiate dosage [was] extremely high [at 2,432 MMEs], 
astronomically high'' given the lack of ``an examination that verified 
that this patient is in agony and extreme pain.'' Tr. 387-88. Dr. 
Munzing opined that he ``[did] not see anything in the records that 
would justify medications anywhere in this range.'' Tr. 389. Moreover, 
there is a ``combination of an opiate and benzodiazepine,'' but 
``[t]here does not appear to be anything [that is] being done to 
mitigate this and to try alternative methods that were safer.'' Tr. 
388. Dr. Munzing repeated these concerns in support of his opinion that 
the remaining relevant prescriptions between March 2017 and October 
2019 were outside the standard of care. Tr. 405, 407, 409, 411, 415, 
433, 438, 444.
    Dr. Munzing also opined that the treatment plan lacked clarity as 
to what conditions Respondent was using controlled substances to treat. 
Dr. Munzing testified regarding this confusion, ``are we treating 
lumbar pain, are we treating . . . multiple sclerosis pain, or [are] 
you treating both? And . . . muscular sclerosis pain . . . typically 
[does not] respond nearly as well to opiates as with other medications 
that are focused on neuropathic pain.'' Tr. 390. This confusion is 
further heightened by the Valium prescription, because, as he 
explained, Valium, generically diazepam, is ``a longer acting 
benzodiazep[ine] and which makes it many times more risky because it 
stays in your system longer. [It has] been used for anxiety, [it has] 
been used sometimes for muscle relaxation.'' Tr. 391. Dr. Munzing 
confirmed that it is ``dangerous to prescribe Valium with opioids.'' 
Tr. 392.
    According to Dr. Munzing, there is no real indication in B.G.'s 
early medical records that Respondent was treating B.G. for his MS and 
there is no indication of the purpose of the Valium prescription.\37\ 
Dr. Munzing testified that the initial exam lacked details regarding 
the history of the multiple sclerosis condition and lacked 
``information that one would expect if [Respondent was] going to take 
over management of that condition.'' Tr. 342-43. According to a medical 
record dated March 16, 2016, B.G. reported to another medical provider, 
Dr. P., that he was taking Valium for ``irritability and depression,'' 
not for spasticity. GX 8, at 913. It was not until July 14, 2017, that 
the medical records include a note stating, ``Valium 10 mg tid x 45 for 
spasticity,'' with spasticity being an apparent reference to one of 
B.G.'s multiple sclerosis symptoms.\38\ GX 8, 485; Tr. 416. But even 
with the July note, according to Dr. Munzing, it was not clear that 
Respondent was treating B.G.'s multiple sclerosis because the 
neurological examination was insufficient to support the 
prescription.\39\ Tr. 417. Dr. Polston was also left to speculate 
regarding the Valium's purpose in the beginning, stating ``I think [it 
is] pretty much for anxiety and depression, but [B.G.] also [has] prior 
multiple back surgeries and spasms would not be irrelevant here.'' Tr. 
782; see also 818.
---------------------------------------------------------------------------

    \37\ The ALJ found that ``the failure to timely document that 
[Respondent] was prescribing Valium to B.G. for spasticity 
represents a violation of the California standard of care relating 
to complete and accurate recordkeeping.'' Tr. 207. I agree.
    \38\ In his Exceptions, Respondent argued that the medical 
record has enough information generally to determine that the Valium 
prescription was issued for spasticity prior to the 2017 medical 
note. I find this argument to be without merit particularly because 
the lack of clarity in the medical records left both Dr. Munzing and 
Dr. Polston unsure of the exact purpose of the Valium prescription 
until July 2017. Additionally, Respondent argued that ``there is no 
nexus between the alleged failure to timely document the reason for 
. . . [the] Valium, and the stated goals of the DEA to avoid 
diversion.'' ALJX 30, at 13. I also find this argument, which is 
based on a misunderstanding of the meaning of ``diversion,'' to be 
without merit for the reasons set forth in infra, n.62.
    \39\ Put another way, even though the purpose of the Valium 
prescription is known by July 14, 2017, the subsequent Valium 
prescriptions remain outside the standard of care for Respondent's 
failure to perform a proper physical examination. Supra.
---------------------------------------------------------------------------

    Dr. Munzing explained that, while Respondent reduced B.G.'s opioid 
dosages, he did not document a

[[Page 8049]]

treatment plan for so doing. On February 14, 2017, the first set of 
prescriptions for the relevant time period, Respondent prescribed B.G. 
dilaudid 4 mg, 60 tablets; Valium 10 mg., 90 tablets; and methadone, 10 
mg. 600 tablets. GX 24, at 1. Monthly from March 2017 through and 
including August 2017, Respondent prescribed B.G. dilaudid 4 mg, 30 
tablets; Valium 10 mg., 45 tablets; and methadone, 10 mg. 300 tablets. 
Id. For the prescriptions between March 2018 and October 2018,\40\ the 
dilaudid prescription was discontinued, Valium 10 mg. stayed constant 
at 45 tablets, and methadone 10 m.g. reduced gradually from 270 
tablets, to 250, to 230, to 225, and finally to 215. Id. Dr. Munzing 
testified that early in B.G.'s treatment, Respondent had an obligation 
to ``come up with a management strategy to mitigate the risks, to 
decrease the risks, to bring [the high doses] down,'' it cannot be 
``haphazard.'' Tr. 2041, 1072. Here, Dr. Munzing testified, ``there was 
an initial drop, and then it was kept stable for an extended period of 
time.'' Tr. 2045. ``Rather than we'll drop it a little bit, and then 
continue for six months,'' Dr. Munzing testified, Respondent needed to 
``come up with a game plan . . . whether it be a three-month, a six-
month plan of action, and then it may need to be tweaked along the way 
. . . or alter[ed].'' Tr. 2044. Respondent's Exhibit SS, a California 
Department of Public Health note to providers, confirms Dr. Munzing's 
testimony about the need for a plan and states, with regard to tapering 
patients on opioids, that physicians should ``[e]nsure patients 
understand the risks and benefits of dose maintenance versus dose 
tapering and develop an individualized plan in collaboration with 
patients.'' RX SS, at 2. According to Dr. Munzing, while the record 
occasionally documents that Respondent discussed tapering, Tr. 2098, it 
does not document what specifically was discussed. And there is no 
documented individualized treatment plan of action for reducing the 
controlled substance dosage in the records for B.G. between February 
2017 and August 2017. GX 8. For example, between the February 2017 
visit and the March 2017 visit, the quantity of all controlled 
substance prescriptions was cut in half without any explanation for the 
reduction; both medical record records simply stated ``[p]atient to 
continue on current medication regimen.'' GX 8, at 625. Beginning in 
December 2017, Respondent documents a plan to ``bring down [Methadone] 
5-10 tabs per visit'' and that plan appears in the records through 
October 2019. GX 8, at 359; GX 9, at 2-6. Accordingly, I find in 
accordance with Dr. Munzing's testimony, that the failure to document a 
treatment plan for the reduction of controlled substance prescribing 
between February 2017, and August 2017, was outside the standard of 
care.
---------------------------------------------------------------------------

    \40\ The prescriptions between August 2017 and March 2018 were 
not identified as being at issue in this case. Id.
---------------------------------------------------------------------------

    Dr. Munzing also explained that where Respondent did create what 
could be considered a treatment plan for B.G., he did not always follow 
it. He testified that, at Respondent's initial visit with B.G., he 
documented that he would not treat B.G. without him having a 
neurologist to manage the MS. Tr. 1067. On February 19, 2018, the 
medical records prepared by a different provider state that B.G. ``has 
been on valium tid[ \41\] for several years for spasticity of the LE. 
Discussed today with [Respondent], who states that because this is a 
PMR practice we will continue to prescribe this with the patient's 
opioid pain medications provided that the patient bring[s] an annual 
note from neurologist or neurosurgeon who currently sees him for MS if 
the valium continues to be recommended.'' \42\ GX 8, 306. Again, the 
Valium continued to be prescribed throughout the relevant period even 
though Dr. Munzing agreed that he did not see notes from a neurosurgeon 
or neurologist appear in B.G.'s records at any time. Tr. 427, see also 
1728-35. Respondent himself testified that despite the note written by 
his nurse practitioner, which Respondent admitted ``[he] missed,'' he 
``do[es] not require neurology . . . [because] [he is] more specialized 
than regular neurology to manage spasticity.'' Tr. 1739. This testimony 
directly conflicts with Respondent's initial medical record for B.G., 
which stated that if B.G. did not see a neurologist for his MS, 
Respondent ``would not take over his care.'' GX 8, at 1067. Notably, 
Dr. Polston testified that he ``would insist'' that a pain patient with 
MS see a neurologist. Tr. 772. Even if Respondent did not make that 
note as he contests, it appeared in his treatment plan. Regardless of 
whether or not a neurological consultation was required, it is clear 
that the treatment plan is not clearly or consistently documented.
---------------------------------------------------------------------------

    \41\ Dr. Munzing testified that ``tid'' means three times a day. 
Tr. 424.
    \42\ The record goes on to state ``[d]iscussed this with patient 
who is upset he needs this note when previously neuro input was no 
required. Discussed the latest opioid guidelines and the potential 
for additive respiratory depression when benzodiazepines and opioids 
are taken together. He verbalized understanding, states he was 
previously on an additional benzodiazepine for anxiety and this was 
stopped.'' GX 8, at 306.
---------------------------------------------------------------------------

    Furthermore, Dr. Munzing opined that Respondent's records for B.G. 
were beneath the standard of care regarding the requirement to conduct 
periodic review and monitoring. Dr. Munzing repeatedly criticized that 
Respondent put ``[B.G.] at significant risk'' by prescribing ``high 
doses'' of opioids in ``combination with a benzodiazepine'' without any 
evidence of ``attempting alternative medication that would be less 
risky.'' Tr. 439, see also 434. Moreover, an office visit note for May 
31, 2016, stated ``[t]he pt say Dr. [P], psych. About a couple of weeks 
ago, report is recommending to continue Opioid Medications and taper 
off benzos.'' GX 8, 797. Tr. 427-28. Dr. Munzing testified that Dr. P's 
recommendation is a red flag and that the standard of care required 
that Respondent resolve the red flag and document the resolution, which 
was not done here. Tr. 359. Additionally, Dr. Munzing testified that 
the notation regarding Dr. P's recommendation continued to be pasted in 
the medical record until July 14, 2017, yet Respondent never documented 
a resolution of the red flag and continued prescribing the valium 
without change. Tr. 363, 368, 385, 402, 413-14. Dr. Munzing testified 
that on April 29, 2019, when B.G. stated that he ``[could not] live 
without Valium,'' it presented yet another red flag, and that 
Respondent needed to ``explore'' whether that statement meant that 
B.G.'s ``condition is such that he needs it'' or whether he is ``so 
dependent on it that if he stops it, he has some symptoms [of] 
withdrawal.'' Tr. 439; GX 8, at 12.
    I note that the record contains many examples of appropriate steps 
that Respondent took to monitor B.G. including running CURES reports, 
requiring urinary drug screens, requiring regular follow-up 
appointments, and administering the opioid risk tool questionnaire; 
\43\ Respondent also referred B.G. to a cardiologist and to a pain 
psychologist.\44\ Tr. 664, 1086, 1094, 1097-98. However, Dr. Munzing 
testified that ``[s]olely that the fact that [they are] doing urine 
drug screens and a CURES reports, those alone without the other 
components . . . [do not] provide medically a justification for 
prescribing.'' Tr. 422. There were also

[[Page 8050]]

additional inaccuracies with B.G.'s patient record. For example, on 
June 15, 2017, the medical records for B.G.'s office visit on that date 
do not include a prescription for Valium, GX 8, at 529, when Valium was 
in fact prescribed, id., at 524. Tr. 408-09. The impact of this 
inaccuracy is amplified due to the dangers presented by Respondent's 
prescribing of Valium, a benzodiazepine, concurrently with opioids. See 
supra II.D.3.b. Also, back in August 2013, during the initial 
evaluation, Respondent noted that, ``[B.G.] gets 720 pills per month in 
the last 7 years.'' GX 8, at 1064. This note was repeated verbatim 
throughout Respondent's treatment of B.G. up-to-and-including the last 
relevant record dated October 3, 2019. GX 9 (Medical Records for B.G.), 
at 18). According to Dr. Munzing, while this statement may have been 
accurate in 2013, Tr. 339, once it got carried over ``year after 
year,'' it was no longer accurate and created an internal inconsistency 
within the records. Tr. 332.
---------------------------------------------------------------------------

    \43\ Dr. Munzing and Dr. Polston both testified that these are 
appropriate tools to use for monitoring. See e.g. Tr. 605, 664, 
1023, 1097-98.
    \44\ Though, as addressed herein, Respondent did not resolve the 
red flag arising from the pain psychologist's recommendation to 
taper off benzos. Tr. 1086-89.
---------------------------------------------------------------------------

    In accordance with Dr. Munzing's testimony and the record as a 
whole, I find that, the forty-three relevant prescriptions issued to 
B.G. for methadone, dilaudid, and Valium between February 14, 2017, and 
October 3, 2019, were issued outside of the usual course of 
professional practice and beneath the applicable standard of care in 
California. Particularly, in accordance with Dr. Munzing's testimony, 
the relevant prescriptions were issued beneath the standard of care and 
outside the usual course of professional practice, because Respondent 
failed to perform and/or document a proper physical examination, 
develop and/or document treatment plan objectives, appropriately 
monitor and resolve and/or document the resolution of red flags, and 
maintain accurate and complete medical records.
2. Patient D.B.
    D.B. first saw Respondent for pain management on January 3, 2017, 
when she complained of pain in her low back and hip. Tr. 449, GX 4 
(Medical Records for D.B.), at 1. At that time, according to her 
medical records, D.B. had received ``three total hip revisions,'' the 
last of which had complications with infection. Tr. 449. On September 
8, 2018, Respondent implanted a pain pump for D.B. to address D.B.'s 
continuing hip pain. Tr. 450-51; GX 4, at 401, 404. Over the course of 
D.B.'s visits with Respondent, as the expert witnesses testified, 
Respondent reduced the prescribed controlled substances' overall MME 
(outside of the pain pump) from 191 to 90 MME per day and her function 
improved.\45\ Tr. 582-83, 625, 1028, 1034.
---------------------------------------------------------------------------

    \45\ Dr. Polston testified that the MME D.B. was receiving (for 
the oral medication prescribed, not the medication in the pain pump) 
``was cut in . . . more than a half,'' which, he acknowledged, was 
an example of a ``pain management specialist doing a[n] outstanding 
job in the reduction of the medication.'' Tr. 625. Dr. Munzing 
testified that even though ``[it is] great that [Respondent was] 
tapering down,'' Tr. 1218, prescriptions that are tapered down still 
must have ``adequate[ ] justif[ication]'' other ``than just the fact 
they were on a high dose.'' Tr. 1217.
---------------------------------------------------------------------------

    Dr. Munzing testified that between January 23, 2017, and August 2, 
2019, Respondent issued thirty-one controlled substance prescriptions 
to D.B. beneath the standard of care in California. Tr. 945; GX 24, at 
2. The prescriptions included fentanyl 25 mg./ml. in a 10 ml. vial; 
hydromorphone 50 mg./ml. in a 10 ml. vial; OxyContin 30 mg., 60 tablets 
issued roughly every other month between January 2017 and May 2017; and 
finally oxycodone 15 mg. ranging from 135 tablets in January 2017 to 90 
tablets in August 2019. GX 24, at 2. Dr. Munzing opined that Respondent 
failed to satisfy the standard of care with regard to performance of 
physical examinations, periodic review and monitoring, and 
recordkeeping.
    Dr. Munzing opined that the physical examinations in the record 
were beneath the standard of care because the Respondent appeared to 
have copied and pasted the physical examination repeatedly. Dr. Munzing 
testified that at some point there was ``a documented hip exam which 
got copied, copied, copied, copied, copied. So we [cannot] confirm that 
[an exam] was done at all those times because it was a copy forward. 
And then suddenly a month after the pump goes in, it drops off, which 
is . . . curious timing . . . [because] [i]f [you are] really treating 
hip pain, you want to try [to] find . . . some improvement in that.'' 
Tr. 1294-95. I credit Dr. Munzing's opinion and find that Respondent 
failed to adequately perform physical examinations as required by the 
standard of care for prescribing for pain in California. There are 
additionally times in the records, where, according to Dr. Munzing, 
``[d]espite some increase in hip pain, [there is] no documented exam of 
the hip.'' Tr. 464, 466.
    Dr. Munzing testified that an adequate physical examination of 
D.B.'s hip would entail things like ``look[ing] for any redness, 
swelling,'' ``palpat[ing] or touch[ing] it,'' ``somewhat of a range of 
motion . . . rotational exams . . . [there is] a variety of things you 
can do even when a patient is sitting there in the wheelchair.'' Tr. 
1290-91. Dr. Munzing testified that performing a physical examination 
was important to determine if, as a result of the pain pump, ``the 
patient may have increased range of motion'' or if ``she may not have 
pain when [you are] making some maneuvers, or the pain may change.'' 
Tr. 1296. Dr. Munzing further stressed the importance of a physical 
exam because, ``[s]he had a history of an infection . . . [i]f an 
abscess or other infection started happening, she may not recognize 
that . . . this is infectious pain instead of other pain.'' Id.
    Regarding the appropriateness of a physical examination of D.B.'s 
hip, Dr. Polston testified that D.B. ``is a patient who has a lot of 
pathology in her hip. She's had five surgeries and I would be very 
cautious about any type of movement with this patient.'' Tr. 601. Dr. 
Polston testified the physical examination would consist of ``is there 
an infection there? . . . If the patient is saying . . . the hip is . . 
. stable or that [she is] responding to some of the medicines . . . 
[that is] the exam.'' Id. However, the physical examination portion of 
the records subsequent to October 1, 2018, do not include any mention 
of the hip whatsoever including mention of whether the hip was 
evaluated for potential infection.\46\ See GX 4, at 331. Respondent 
testified that following the October 1, 2018 physical examination of 
D.B.'s hip, Tr. 1382-83, no further examination was necessary because 
the patient's condition was ``permanent and stationary,'' and because 
of her history, an examination could ``potentially cause another [hip] 
dislocation right in the office.'' Tr. 1386. Based on Respondent's own 
admission and a review of the medical records, it does not seem that 
the Respondent conducted even the limited physical examination of 
D.B.'s hip that Dr. Polston testified would satisfy the standard of 
care. Regardless, I credit Dr. Munzing's testimony that Dr. Polston's 
description of the physical examination requirement did not reflect the 
standard of care. Tr. 1294.
---------------------------------------------------------------------------

    \46\ The History of Present Illness portion of the records 
contain information like ``[t]he patient complains of pain in the 
Hip pain [sic.] . . . [o]n average the pain is 7/10 . . . [p]t 
reports increased pain in the mornings'' and arguably contains 
information regarding the stability of the hip and D.B.'s response 
to the medication, which Dr. Polston testified was also required.
---------------------------------------------------------------------------

    Dr. Munzing also opined that Respondent issued prescriptions for 
controlled substances beneath the standard of care due to his failure 
to ``attempt to get prior medical records to confirm the accuracy of 
what'' D.B. reported regarding ``her multiple surgeries and . . . an 
infection . . . in

[[Page 8051]]

her hip.'' \47\ Tr. 869-70. Dr. Munzing explained that there is ``a 
history that the patient has had multiple hip surgeries and presumably 
. . . is being followed by someone else, but we really [do not] know 
specifics. And [there is] no imaging.'' Tr. 461. Dr. Munzing opined 
that Respondent had a ``responsibility to do a thorough history'' 
initially ``to confirm what [the patient was] saying.'' Tr. 1209. 
Respondent countered this opinion with testimony that he had ``a brief 
conversation with the patient transferring place, so you have to trust 
that physician . . . Second, in pain management, . . . you have to 
trust your patients.'' Tr. 1366. Notably, Respondent later confirmed 
that his purported call with the referring physician was ``[n]ot 
documented.'' Tr. 1692. Dr. Polston conclusively opined that 
Respondent's failure to secure prior records or imaging did not mean 
Respondent acted outside the standard of care. Tr. 603. However, Dr. 
Polston later agreed that he has ``had patients who, in [his] opinion, 
[were] trying to exaggerate their medical condition,'' and that you 
must ``consider'' what patients tell you regarding their condition, but 
that you ``just [cannot] take what they tell you at face value.'' Tr. 
725. I credit Dr. Munzing's testimony \48\ and find that Respondent 
failed to confirm D.B.'s prior medical history and/or failed to 
document that confirmation--either way I find that this failure 
violated the applicable standard of care.
---------------------------------------------------------------------------

    \47\ Dr. Munzing described this as a failure from a ``foundation 
standpoint'' and explained that this failure applied to all of the 
relevant prescriptions issued to this patient. Tr. 869-70.
    \48\ I find that the MBC Guide to the Laws provides further 
support to Dr. Munzing's testimony in stating that generally, 
``[m]edical documentation should include both subjective complaints 
of patient and caregiver and objective findings by the physician.'' 
GX 17, at 61. Therefore, the MBC Guide to the Laws makes it clear 
that a physician has a duty to do more than rely on the subjective 
position of the patient.
---------------------------------------------------------------------------

    Dr. Munzing opined that Respondent's periodic review and monitoring 
of D.B. was beneath the standard of care because Respondent failed to 
resolve red flags arising from D.B.'s inconsistent urine drug screen 
collected on July 7, 2017, and released on July 17, 2017.\49\ GX 4, at 
715-16; Tr. 856-62. On July 7, 2017, D.B. was prescribed neither 
carisoprodol (Soma) nor hydrocodone/codeine, yet, metabolites of those 
two medications appeared in D.B.'s urine drug screen and were 
documented as ``inconsistent'' results. Tr. 856, 858; GX 4, at 715. Dr. 
Munzing confirmed that ``Soma, in particular, can be very dangerous 
when prescribed with an opioid.'' Tr. 1246. According to Dr. Munzing, 
it was ``incumbent upon [Respondent] to, in a very timely manner,[ 
\50\] call a patient, talk to the patient.'' Tr. 1249. Respondent 
needed to figure out ``[what is] going on, and emphasize to the patient 
that . . . if [she] . . . got some medication through someone else . . 
. this can be a . . . fatal problem.'' Id. Furthermore, he had to 
``document specifically what [he] did and [his] reasoning behind a 
decision to keep on prescribing.'' Tr. 860. Here, as Dr. Munzing 
confirmed, the medical record did not document any conversation with 
the patient, Respondent's determination as to what caused the 
inconsistent results, or what Respondent planned to do about it. Id.; 
and at 1046, 2151-52.
---------------------------------------------------------------------------

    \49\ The OSC alleges other aberrant drug screens for D.B, which 
the Government appeared to drop from its case in its posthearing 
brief. OSC, at 6; ALJX 27 (Government's Posthearing), at 9-10. Dr. 
Polston and Respondent both credibly testified that medication 
infused through a pain pump does not pass through the blood/brain 
barrier and as a result, will not necessarily show up in urine. RD, 
at 194-96. Accordingly, D.B.'s UDS that showed a negative result for 
prescribed substances were not necessarily aberrant. Id. I agree 
with the ALJ and am not sustaining these allegations from the OSC. 
See id.
    \50\ Dr. Munzing testified that this UDS showed ``potentially 
serious findings of aberrancies, and so typically one would not wait 
[until] the next visit'' to discuss them with the patient. Tr. 1042. 
Rather, ``[o]ne would pick up the phone and call and manage it over 
the phone.'' Id. And the phone call needed to be in ``[s]hort 
order,'' which could ``be hours or a couple of days'' but not to 
wait weeks to the next visit. Tr. 1043.
---------------------------------------------------------------------------

    According to Respondent, the aberrancy was addressed on August 3, 
2017, as is documented in the note stating, ``MD reviewed LC/MS [liquid 
chromatography-mass spectrometry] from the DOS of inconsistent 07/07.'' 
GX 4, at 708, 1053. Respondent testified that he did not need to 
contact D.B. sooner following the UDS because there were other, less 
sensitive drug screens run on the same day that did not show aberrant 
results; therefore, it could have been ``a possible lab error'' and 
``[that is] no reason to call a patient to say you could be in 
danger.'' Tr. 1436. Respondent's argument is contradicted by the record 
evidence that the other, ``less sensitive drug screens'' run on D.B. on 
July 7, 2017, make no mention of, and do not appear to have tested for 
Soma/carisoprodol or its metabolite meprobamate or hydrocodone and 
codeine or their metabolite norhydrocodone. GX 4, at 719-20. The 
possibility of a lab error is also less likely, given that, on cross 
examination, Respondent confirmed that his office was prescribing Soma 
to D.B.'s daughter around the time of June 7, 2017. Tr. 1687. 
Respondent agreed that it was hypothetically ``possible that [D.B.] 
obtained Soma from her daughter's prescription.'' Tr. 1688. However, 
Respondent avoided a direct answer when asked whether D.B. could have 
obtained the Soma unlawfully from her daughter. Tr. 1688. He testified, 
``Let's put it this way. If [it is] a Soma, if you [are] so close to 
each other, it could be from a liquid contamination [to] make her urine 
positive too.'' Id. When pressed by the ALJ regarding how Soma could 
show up in D.B.'s system unless D.B. took it,\51\ Respondent explained 
how the daughter's Soma could accidentally be ingested if the daughter 
dropped it in D.B.'s food. Tr. 1688-89. The scenario described by 
Respondent to any logical person strains credulity. Further, there is 
no evidence on the record that supports the notion that D.B.'s daughter 
might have dropped her medication in her mother's food. If Respondent 
had some information that this scenario explained the presence of the 
Soma after talking to the patient, then in accordance with Dr. 
Munzing's testimony, that should have been documented. There is no 
dispute that the medical record did not capture any discussion 
regarding a conversation with the patient, Respondent's determination 
as to what caused the inconsistent results, or what Respondent planned 
to do about it. Tr. 1690.
---------------------------------------------------------------------------

    \51\ Dr. Munzing testified that the only way a urine drug screen 
would test positive for a substance is if the patient ingested that 
substance. Tr. 2066, 2118; RD, at 77.
---------------------------------------------------------------------------

    I credit Dr. Munzing's opinion and find that Respondent failed to 
appropriately monitor D.B. in accordance with the standard of care when 
he failed to timely follow up on the inconsistent drug screen; however, 
even if waiting until the next appointment had been proper, Respondent 
further issued the next prescription beneath the standard of care by 
not adequately documenting resolution of the aberrant UDS in the 
records. I note that the record contains many examples of appropriate 
steps that Respondent took to monitor D.B. including running CURES 
reports, requiring urinary drug screens, requiring regular follow-up 
appointments, and administering the opioid risk tool questionnaire. Tr. 
604-05; 1021-25. However, Respondent's actions with regard to this 
aberrant UDS did not, and I have found his explanation to not be 
credible. Therefore, I considered Respondent's failure in monitoring in 
finding that the prescriptions for controlled substances

[[Page 8052]]

issued after the aberrant UDS were issued beneath the standard of care.
    In accordance with Dr. Munzing's testimony, I find numerous 
recordkeeping violations on top of those already addressed above, which 
contribute to my finding that Respondent's controlled substance 
prescribing to D.B. was beneath the standard of care and outside the 
usual course of professional practice. For example, on May 12, 2017, 
Respondent wrote in the medical records that he was prescribing 120 
tablets of oxycodone, but he, in fact, prescribed 135 tablets. Compare 
GX 4, at 761 with 757 and GX 6b (Prescription Records for D.B.), at 7-
8. Dr. Munzing opined that the prescriptions on this date were beneath 
the standard of care for the above reasons and because ``the amount 
prescribed is not consistent with what was written in the chart.'' Tr. 
497. Second, different medical records dated January 7, 2019, January 
21, 2019, and February 2, 2019, all state ``recheck today 1/3/18'' 
under ``Urine Drug Screening,'' GX 4, at 104, 128, 141, which Dr. 
Munzing opined was an errant copy forward from prior examinations. Tr. 
851-55. Ultimately, Dr. Munzing opined that the ``internal 
inconsistency even within [D.B.'s] record'' and between the medical 
record and accompanying prescriptions, demonstrated that the 
prescriptions were issued beneath the standard of care. Tr. 871.
    Dr. Polston, when asked, opined that ``[i]n totality, . . . the 
standard of care . . . was . . . met by [Respondent] with regard[ ] to 
record keeping and charting of this patient D.B.'' Tr. 618-19. 
Respondent similarly testified that ``the totality of overall my charts 
are good. Of course there [are] some mistakes. [But] I think my 
chart[s] overall [are] above average.'' Tr. 1607.
    I credit Dr. Munzing's more specific opinion, which more accurately 
relies on the record evidence, and find that Respondent acted beneath 
the standard of care when he failed to maintain complete and accurate 
records for D.B. Although some of these mistakes by themselves might 
not always amount to a particular prescription being issued beneath the 
standard of care and outside the usual course of professional practice, 
the fact that these mistakes were made on top of the other failures 
further demonstrates that Respondent was not maintaining accurate 
records or documentation. As Dr. Munzing described it, the ``supporting 
information is just not there.'' Tr. 871.
    In accordance with Dr. Munzing's testimony and the record as a 
whole, I find that, the thirty-one prescriptions for Fentanyl, 
oxycodone, hydromorphone and OxyContin issued to D.B. between January 
23, 2017, and August 2, 2019, were issued outside of the usual course 
of professional practice and beneath the applicable standard of care in 
California. Particularly, in accordance with Dr. Munzing's credible 
testimony and as supported by California law, the relevant 
prescriptions were issued outside the standard of care because 
Respondent failed to perform and/or document a proper physical 
examination, obtain and/or document an adequate history, appropriately 
monitor and resolve and/or document the resolution of red flags, and 
keep accurate and complete records.
3. Patient E.N.\52\
---------------------------------------------------------------------------

    \52\ Respondent's second Exception challenges the ALJ's finding 
that Respondent did not re-evaluate the proper course of treatment 
in the face of E.N.'s reports of increased pain in November 2015. 
ALJX 30, at 7. Of note, the ALJ found that that re-evaluation did 
occur, but that it was not documented in the treatment plan. RD, at 
216. Regardless, I do not see anything in the record that ties these 
facts from November 2015 to the legitimacy of the prescriptions from 
2017-2019 that are at issue in this case. Accordingly, I consider 
the matter to be irrelevant and I have not considered the ALJ's 
finding on this particular matter in issuing my decision.
---------------------------------------------------------------------------

    By way of background, E.N. had a history of back surgeries, severe 
back pain, and weakness in the legs necessitating use of a wheelchair; 
she became a patient of Respondent in 2006. Tr. 677, 1567. The first 
medical documentation presented in the record evidence by the 
Government was dated July 3, 2012, wherein E.N. complained of pain in 
her low back and knees, complaints, which continued throughout 
Respondent's treatment of E.N. Tr. 875; GX 12 (Medical Records for 
E.N.), at 769. Tr. 1145-46; GX 12, at 770. Tr. 877-78; GX 12, p. 766. 
Over the course of E.N.'s visits with Respondent, for which there are 
medical records available, the experts testified that Respondent 
reduced E.N.'s opioid prescriptions from 1,920 MME per day to 960 MME 
per day \53\ and that E.M.'s function improved. Tr. 879, 903, 911, 
1147, 1534, 1542.
---------------------------------------------------------------------------

    \53\ Dr. Munzing explained that this sort of MME reduction is 
commendable and reduces the risk to the patient; however, the MME 
remains ``extraordinarily high'' and is not medically justified. Tr. 
912-13; see also 681, 702, 1146, 1152-53.
---------------------------------------------------------------------------

    Dr. Munzing testified that between February 3, 2017, and April 15, 
2019, Respondent issued forty-three controlled substance prescriptions 
to E.N. beneath the applicable standard of care in California. Tr. 945; 
GX 24, at 3. The prescriptions included prescriptions for Methadone 10 
mg. ranging from 360 tablets issued in February 2017 to 120 tablets 
issued twice a month in April 2019; and a single prescription for 
Dilaudid 4 mg., 14 tablets issued in January 2019. GX 24, at 3. Dr. 
Munzing opined that, based on his review of the medical file for E.N., 
Respondent failed to satisfy the standard of care with regard to 
performance of a physical examination, periodic review and monitoring, 
and recordkeeping. Tr. 911, 927-28.
    Dr. Munzing credibly testified that the ``extraordinarily high 
amounts'' of opioids, with a MME ranging from 1440 to 960 per day 
during the relevant period, Tr. 887, 903, ``would certainly not be 
medically justified'' by the medical records he reviewed for E.N. Tr. 
912-13. Dr. Munzing testified that while the section of the patient 
records that covers the history of present illness for E.N. is 
different from visit to visit,\54\ the physical examination has 
``verbiage that is the same . . . word for word'' continuously between 
May 25, 2016, and April 15, 2019. Tr. 1173, 1177-78. According to Dr. 
Munzing, this repeated physical examination is outside the standard of 
care because ``we [do not] know on any particular date, what truly was 
the patient's condition at a certain date, and [that is] required to be 
able to justify, are we going to continue using this, is this the right 
treatment?'' Tr. 911-12. Dr. Munzing further confirmed that where the 
physical examination notes were simply repopulated, the ``records do 
not establish that a physical exam actually occurred.'' Tr. 1237.
---------------------------------------------------------------------------

    \54\ In his Exceptions, Respondent argued that where the medical 
records reflected changes to the history of present illness, vital 
signs, and other sections, it ``clearly demonstrated that 
Respondent, or other physicians or mid-level providers acting on his 
behalf, had seen and evaluated the patients on a regular basis.'' 
ALJX 30, at 17. Even assuming that the information establishes that 
the patient was seen, it does not establish that an adequate 
physical examination to justify the prescription occurred. See supra 
II.D.2. Therefore, although it is true that parts of the medical 
record might have met the standard of care, those parts do not 
impact my finding that, based on Dr. Munzing's testimony, the 
physical examination records were not adequate.
---------------------------------------------------------------------------

    Dr. Munzing testified generally that, with regard to E.N.'s 
records, ``large portions of them, and almost entirely the physical 
exam, appears to get cut-and-paste or are copied forward.'' Tr. 911. 
Respondent's counsel pointed out and Dr. Munzing acknowledged that on 
three dates (May 25, 2016, May 16, 2018, and December 27, 2018), ``new 
information was put in'' alongside the repopulation. Tr. 1263; see also 
GX 12, at 90, 216, 556. Regarding E.N., Dr. Munzing acknowledged that 
it would be ``fair to say that on dates when new examination notes 
appear, that [is] probably an indication there was a physical 
examination [performed] that

[[Page 8053]]

matches what was described within the notes.'' Tr. 1238. The Government 
notably did not allege that the prescriptions issued on May 25, 2016 
(which were before the time period of the allegations) or the 
prescriptions issued on December 27, 2018, were issued beneath the 
applicable standard of care and outside the usual course of 
professional practice, GX 24, at 3; therefore, I find that Dr. 
Munzing's acknowledgement of the documented physical examination on May 
16, 2018, only affects the prescription issued on that date. The 
Government did not present any further testimony regarding the adequacy 
of the note on May 16, 2018, in documenting the alleged physical 
examination and therefore I am not finding that the prescription for 
methadone issued on that date was issued beneath the standard of care.
    With regard to the applicable standard of care's requirement to 
conduct a periodic review and monitoring, the record contains several 
examples of appropriate steps that Respondent took to monitor E.N. that 
Dr. Munzing acknowledged met the applicable standard of care. Tr. 1165-
66, 1544, 1551, 1555. However, the Government alleged that Respondent's 
prescriptions for controlled substances to E.N. fell beneath the 
standard of care when he failed to resolve a particular red flag 
related to an early refill request.\55\ OSC, at 12. On February 8, 
2019, E.N. visited Respondent for a ``methodone refill. She can not 
[sic.] get her previous RX filled due to pharmacy issues. It has tried 
two different pharmacies without help. She is here for new rx for 
refill.'' GX 12, at 58; Tr. 919. According to Dr. Munzing, this note 
constitutes a ``red flag'' because it is ``something that catches [Dr. 
Munzing's] attention that needs further exploration and 
documentation.'' Tr. 920. Dr. Munzing testified that the pharmacies 
could have refused to fill the prescriptions for ``suspicious [or] not-
suspicious reasons,'' and that it was therefore ``important . . . to 
find out from the patient why . . . are they not filling it.'' Tr. 920. 
Dr. Munzing confirmed that the medical record contains no ``notation or 
documentation resolving that red flag'' and opined that this failure 
was ``outside the standard of care.'' Tr. 927-28. Dr. Polston opined 
that Dr. Munzing's opinion was ``very na[iuml]ve and shows limited 
experience in the practice of pain medicine,'' because, at the time, 
pharmacies were ``extremely concerned about prescribing'' and 
``sometimes they [do not] have the medicines themselves.'' Tr. 683. Dr. 
Polston's testimony seems to imply that because there could have been a 
perfectly legitimate reason that E.N. required the refill, a scenario 
Dr. Munzing also acknowledged, there was no red flag present. However, 
Dr. Polston also acknowledged on cross-examination that there could 
have been suspicious reasons why the prescription was not filled, such 
as forgery or impairment (intoxication).\56\ Tr. 805, 808. Ultimately, 
Dr. Polston admitted that he does not know why the prescription was 
rejected by the pharmacies. Tr. 804, 808. I credit Dr. Munzing's 
opinion that whether or not the reason for the refill request was 
legitimate, the reason had to be documented, and I find that 
Respondent's failure to document the resolution of this red flag was 
beneath the standard of care and outside the usual course of the 
professional practice.
---------------------------------------------------------------------------

    \55\ The Government also alleged that Respondent failed to 
resolve a red flag arising from his receipt of a ``Retrospective 
Drug Utilization Review Program'' letter dated April 27, 2016, that 
states that ``[E.N.] has filled medication(s) that may be of 
concern.'' OSC, at 12. Dr. Munzing opined that to resolve this red 
flag within the standard of care, Respondent would have had to 
``document the fact that they . . . received this,'' determine that 
``the potential risks of the medications are worth it, based on the 
potential benefits to the patient,'' and document ``the 
justification behind what I'm doing moving forward.'' Tr. 924-25. 
Assuming that the Government established that Respondent failed to 
resolve this red flag in accordance with the standard of care, the 
Government has not tied Respondent's failure to resolve this 
particular red flag to the specific prescriptions at issue in this 
case, which do not begin until approximately nine months after the 
date of this letter. Absent explanation as to how this particular 
red flag ties to whether or not the relevant prescriptions were 
issued within the standard of care, I decline to consider this 
allegation.
    \56\ Dr. Polston's opinion clearly suggests that if forgery or 
impairment were the reasons why the prescription was not filled, 
then there would be documentation of that in the record. Tr. 805, 
808. The absence of this documentation seems to be what Dr. Polston 
uses to support his opinion that the reasons why the prescription 
were not filled were legitimate and his harsh criticism of Dr. 
Munzing. Id. I cannot conclude that the absence of documentation 
proves the legitimacy of the prescription, especially not in a case 
as riddled with recordkeeping problems as this one. Supra II.E.; 
infra III.A.2.
---------------------------------------------------------------------------

    In accordance with Dr. Munzing's testimony and the record as a 
whole, I find that forty-two of the forty-three prescriptions issued to 
E.N. relevant to this case were issued outside of the usual course of 
professional practice and beneath the applicable standard of care in 
California. Particularly, in accordance with Dr. Munzing's testimony, 
the relevant prescriptions were issued outside the standard of care 
because Respondent failed to perform and/or document a proper physical 
examination, appropriately monitor and resolve and/or document the 
resolution of a red flag, and keep accurate and complete records.

III. Discussion

A. Allegation That Respondent's Registration Is Inconsistent With the 
Public Interest

    Under Section 304 of the CSA, ``[a] registration . . . to . . . 
dispense a controlled substance . . . may be suspended or revoked by 
the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render his registration under section 823 
of this title inconsistent with the public interest as determined by 
such section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,'' 
defined in 21 U.S.C. 802(21) to include a ``physician,'' Congress 
directed the Attorney General to consider the following factors in 
making the public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the . . . 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 considered in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't 
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin., 
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 
477, 482 (6th Cir. 2005). Moreover, while I am required to consider 
each of the factors, I ``need not make explicit findings as to each 
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see 
also Hoxie, 419 F.3d at 482. ``In short, . . . 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; what 
matters is the seriousness

[[Page 8054]]

of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 
462 (2009). Accordingly, as the Tenth Circuit has recognized, findings 
under a single factor can support the revocation of a registration. 
MacKay, 664 F.3d at 821.
    DEA regulations state, ``[a]t any hearing for the revocation . . . 
of a registration, the . . . [Government] shall have the burden of 
proving that the requirements for such revocation . . . pursuant to . . 
. 21 U.S.C. [Sec.  ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). I 
find that the evidence satisfies the Government's prima facie burden of 
showing that Respondent's continued registration would be 
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I 
further find that Respondent failed to produce sufficient evidence to 
rebut the Government's prima facie case.
1. Factors One and Three: The Recommendation of the Appropriate State 
Licensing Board or Professional Disciplinary Authority and Respondent's 
Conviction Record Under Federal or State Laws Relating to Controlled 
Substances
    Respondent argued that a MBC decision regarding Respondent ``stands 
in favor of Respondent's continued DEA Registration.'' ALJX 28 
(Respondent's Posthearing), at 23. In this case, it is undisputed that 
Respondent holds a valid state medical license in California. Supra 
II.A. 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 
20,011, 20,018 (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 15,227, 15,230 (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 15,800, 15,810 (2020); see also Vincent J. 
Scolaro, D.O., 67 FR 42,060, 42,065 (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 effective January 31, 2020, the 
MBC found, amongst other things, that Respondent had violated state law 
by committing gross negligence in violation of Cal. Bus. & Prof. Code 
Sec.  2234 when he failed to recognize the risk to patients associated 
with concurrent use of high dose opioids, benzodiazepines, and Soma, 
and failed to perform ongoing patient assessments, GX 26 (MBC Decision 
Involving Respondent), at 161-162; repeated negligence in violation of 
Section 2234 when he failed to document certain prescriptions and 
failed to maintain adequate records documenting his treatment of a 
patient, id. at 163-64; and acted in violation of Sections 2234 and 
2266 when he failed to maintain adequate and accurate records of his 
care and treatment of the patients at issue, id. at 165. However, the 
evidence demonstrates that the matter before the MBC involved entirely 
different patients during an earlier time frame and was therefore 
different from, the conduct alleged in this case. GX 26; 21 U.S.C. 
823(f)(1). Following its evaluation, the MBC took disciplinary action 
against Respondent, suspending his license and then probating the 
suspension, which permitted the Respondent to practice medicine without 
restriction. GX 26; ALJX 28, at 3-4; RD, at 233.
    The evidence before me is different than what the MBC had at the 
time that it made its decision because it demonstrates that Respondent 
engaged in additional violations of state and federal law with respect 
to his prescribing practices. Further, the fact that the MBC did not 
choose to revoke Respondent's state medical registration carries 
minimal to no weight under Factor One, because there is no evidence 
that the MBC would have made the same decision in the face of the 
continued misconduct found herein involving different patients and 
continued recordkeeping violations.\57\ Accordingly, 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.\58\ See Jeanne E. Germeil, 
85 FR 73,786, 73,799 (2020); see also John O. Dimowo, M.D., 85 FR 
15,810. In sum, while the terms of the MBC Order are not dispositive of 
the public interest inquiry in this case and are minimized due to the 
differences between the evidence in the MBC Order and the record 
evidence before me, I consider the MBC's Order's reprimand of 
Respondent's California medical license and give it minimal weight in 
Respondent's favor, because the charges could have resulted in the 
suspension or revocation of his medical license. See Jennifer St. 
Croix, 86 FR 19,010, 19,022 (2021).
---------------------------------------------------------------------------

    \57\ 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 at 15,810. 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 continued misconduct.
    \58\ In his exceptions, Respondent argued that the ALJ, who 
found that the MBC decision weighed slightly in Respondent's favor, 
RD, at 233, should have given greater weight to the MBC's decision 
and allowed Respondent to continue prescribing. ALJX 30, at 24. For 
the reasons contained in this analysis, I disagree. I have weighed 
this factor slightly in his favor, but I find that the fact that the 
state permitted him to continue to practice of medicine is not 
dispositive as to whether Respondent's continued controlled 
substances registration is in the public interest.
---------------------------------------------------------------------------

    As to Factor Three, there is no evidence in the record that 
Respondent has a ``conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.'' 21 U.S.C. 823(f)(3). However, as Agency cases have noted, 
there are a number of reasons why a person who has engaged in criminal 
misconduct may never have been convicted of an offense under this 
factor, let alone prosecuted for one. Dewey C. MacKay, M.D., 75 FR 
49,956, 49,973 (2010). Agency cases have therefore held that ``the 
absence of such a conviction is of considerably less consequence in the 
public interest inquiry'' and is therefore not dispositive. Id.

[[Page 8055]]

2. Factors Two and Four--the Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
(a) Allegation That Respondent Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice
    According to the Controlled Substances Act's (hereinafter, CSA) 
implementing regulations, a lawful controlled substance order or 
prescription is one that is ``issued for a legitimate medical purpose 
by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a). The Supreme Court has 
stated, in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription, 
that ``the prescription requirement . . . ensures patients use 
controlled substances under the supervision of a doctor so as to 
prevent addiction and recreational abuse . . . [and] also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    I found above that the Government's expert credibly testified as 
supported by California law, the MBC Guide to the Laws and Guidelines 
for Prescribing, that the standard of care in California requires a 
physician to, amongst other things, perform and document a physical 
examination, develop and document a treatment pan, conduct periodic 
review and monitoring of the patient, and have complete and accurate 
records in order to prescribe controlled substances. See supra II.D. I 
also found above that Respondent issued one-hundred and fifteen 
controlled substance prescriptions, often extremely high doses of 
opioids, to three patients without performing or documenting adequate 
physical examinations, developing or documenting adequate treatment 
plans, resolving or documenting resolution of red flags, and/or keeping 
complete and accurate records as required by the standard of care. See 
supra II.E.
    Respondent repeatedly issued prescriptions without complying with 
the applicable standard of care and state law thus demonstrating that 
his conduct was not an isolated occurrence, but occurred with multiple 
patients.\59\ See Kaniz Khan Jaffery, 85 FR 45,667, 45,685 (2020). For 
example, Respondent's medical records for all three of the individuals 
at issue had verbatim language repeated throughout the relevant time 
frame (with very few exceptions) regarding the physical examination 
allegedly performed.\60\ Dr. Munzing opined that the verbatim records 
``do not establish that a physical exam actually occurred'' and they 
prohibited us from ascertaining truly what ``the patient's condition 
[was] at a certain date'' and whether the prescribing was 
``justif[ied].'' Tr. 911-12, 1237; supra II.E.3. The California 
standard of care clearly and indisputably requires a physical 
examination including ``an assessment of pain, physical and 
psychological function,'' and requires physicians to ``keep accurate 
and completed records . . . including the . . . physical examination.'' 
GX 17, at 59, 61. In his exceptions, Respondent acknowledged that ``the 
repopulation of his physical exam findings created inaccuracies and 
were thus deficient. . . . [And] because of the repopulation of 
physical exam findings [Respondent] cannot identify which portion or 
portions of the physical examinations he conducted during his visits 
with the patients.'' \61\ ALJX 30, at 23.
---------------------------------------------------------------------------

    \59\ And, as I discussed above, Respondent was disciplined by 
the MBC for similar conduct against different patients than those 
involved in this case during a prior timeframe. Supra III.A.1.
    \60\ I have chosen this example because it was Respondent's most 
frequently repeated and pervasive violation of the standard of care. 
However, each and every instance where I found a violation of the 
standard of care above, supra II.E.1-3, supports my decision in this 
case.
    \61\ In the same brief, Respondent took exception to the ALJ's 
finding that he had ``rampantly neglected his recordkeeping 
obligations by carrying forward verbatim entries for physical exam 
findings.'' ALJX 30, at 14-18; RD, at 224-26. I note that ``rampant 
neglect'' is not the applicable legal standard applied here--the 
question is whether the records were sufficiently accurate and 
complete to establish that the relevant prescriptions were issued 
within the standard of care. They were not. Second, all of 
Respondent's arguments regarding this exception are repetitive of 
arguments Respondent has already made and that I have already 
addressed. For example, Respondent argued the patients' physical 
examinations would not be expected to change because of their 
chronic conditions, addressed at supra II.E.1; argued Respondent 
properly monitored the patients, addressed at supra II.E.1-3; argued 
that updates to the history of present illness sections and vital 
signs demonstrated that the patients were evaluated, addressed at 
supra n. 54.
---------------------------------------------------------------------------

    Agency decisions highlight the Agency's interpretation that 
``[c]onscientious documentation is repeatedly emphasized as 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). 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 he prescribed a controlled 
substance--adequate documentation is critical to that assessment. See 
Kaniz-Khan Jaffery, 85 FR 45,686. Here, Respondent's verbatim 
recordkeeping, failure to document justification for the treatment 
plan, failure to document resolution of red flags, and other errors, 
made it impossible to evaluate Respondent's prescribing practices in 
any meaningful way. See Mark A. Wimbley, M.D., 86 FR 20,713, 20,726 
(2021). Further, as Dr. Munzing stated, complete and accurate 
``[m]edical records are incredibly important for physicians'' and 
inaccurate records could jeopardize ``patient safety'' particularly if 
the ``patient rolls into the ER.'' Tr. 705, 1197. Therefore, 
recordkeeping is not only important for compliance, but also for the 
safety of the patients.
    DEA decisions have found that ``just because misconduct is 
unintentional, innocent, or devoid of improper motive, [it] does not 
preclude revocation or 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 
28,643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51,592, 
51,601 (1998). Diversion occurs whenever controlled substances leave 
`the closed system of distribution established by the CSA . . . .' '' 
Id. (citing Roy S. Schwartz, 79 FR 34,360, 34,363 (2014)).\62\ In this 
case, I have found that Respondent issued controlled substance 
prescriptions without complying with his obligations under the CSA and 
California law. See George Mathew, M.D., 75 FR 66,138, 66,148 (2010)).
---------------------------------------------------------------------------

    \62\ In his Exceptions, Respondent argues that the Government 
has not made a prima facie case because there was ``no evidence of 
diversion nor the risk of diversion of controlled substances.'' ALJX 
30, at 20. Respondent supports this argument with Dr. Munzing's 
testimony regarding a variety of red flags that were not present in 
this case (such as patient reports of lost or stolen medication, 
requests for early refills, inappropriate physical appearance). Id. 
at 21. 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 usual course of professional 
practice, the DEA [essentially] considers the prescription to have 
been diverted. George Mathew, M.D., 75 FR 66,146. I find 
Respondent's argument to lack merit.
---------------------------------------------------------------------------

    Respondent's additional arguments likewise lack merit. In his 
Exceptions, Respondent argued that he has not

[[Page 8056]]

committed acts that render his Registration inconsistent with the 
public interest. ALJX 30, at 21-22. He argued that there were no 
``departures from the standard of care with the clinical decision-
making and prescribing; the only departures were found relating to 
documentation.'' Id. Respondent also argued that because the ALJ found 
that ``Respondent's care and treatment and prescribing to each patient 
[was] appropriate and [met] the standard of care,'' it was ``puzzling'' 
that the ALJ then found that the ``record-keeping violations 
delegitimize the controlled substance prescriptions the subject records 
sought to justify.'' ALJX 30, at 19; RD, at 229.
    The question at issue is whether the relevant prescriptions were 
issued beneath the standard of care and outside of the usual course of 
professional practice. In assessing whether the issued prescriptions 
violated 21 CFR 1306.04, it is not essential to count how many elements 
of the standard of care were violated for each prescription. The ALJ 
determined that the relevant prescriptions were issued outside of the 
standard of care due to incomplete and inaccurate record keeping, and 
that defect cannot be cured by the fact that Respondent, as the ALJ 
found, complied with other elements of the standard of care. DEA has 
previously made clear that ``a physician may not expect to vindicate 
himself through oral representations at the hearing about his 
compliance with the standard of care that were not documented in 
appropriately maintained patient records.'' Lesly Pompy, M.D., 84 FR 
57,749, 57,760 (2019). This principle was echoed in Dr. Munzing's 
testimony stating that ``you have to be treating it [in] real time[,] 
[y]ou have to document it [in] real time,'' you cannot say ``because of 
this [justification] three years from now, everything before must be 
that.'' Tr. 1233. What is essential in this case is whether at the time 
Respondent issued each prescription for a controlled substance, he met 
the standard of care in issuing that prescription--he had conducted the 
physical examination, had a treatment plan, monitored the patient, and 
documented such. California law and guidance emphasizes the importance 
of documenting crucial aspects of the rationale for prescribing to 
ensure that a practitioner is doing so in a manner that is transparent 
and recorded and adequately cares for the patient. Dr. Munzing 
testified that such practice is of particular importance where the 
prescriptions for controlled substances are in such high dosages. Tr. 
281; see also id. at 389, 348-39, 768, 912-13.
    The expert testimony demonstrates repeatedly that the accurate 
documentation of a physical examination and treatment plan that justify 
the continued prescribing of these high volume controlled substances is 
not merely a check-the-box exercise. And as explained above, it is 
impossible for the Agency or anyone to assess the legitimacy of a 
particular prescription without adequate recordkeeping. See Carol 
Hippenmeyer, M.D., 86 FR 33,748, 33,772 (finding that ``documentation 
is critical to effective enforcement of the CSA.'') With a regulated 
community of nearly two million registrants,\63\ DEA must be able to 
rely on physicians to maintain complete and accurate medical records 
justifying their prescribing decisions.
---------------------------------------------------------------------------

    \63\ See DEA FY 2020 Budget Request available at https://www.justice.gov/jmd/page/file/1142431/download.
---------------------------------------------------------------------------

    Additionally, I find that Respondent's actions as they are 
documented in the medical records, not the actions he claimed with 
limited credibility that he performed, provide the best evidence to 
determine whether or not Respondent acted within the standard of care 
in issuing these prescriptions. California's standard of care makes 
clear that complete and accurate recordkeeping is tied to each other 
element of the standard of care in California. See GX 17, at 60. 
Ultimately, it is impossible to determine whether, as Respondent 
claims, he did conduct the physical examinations, did have appropriate 
treatment plans and did adequately address red flags, because he did 
not document any of these things as he was required to do under state 
law and the standard of care. Therefore, I cannot find definitively, as 
Respondent suggests, that the prescriptions he issued were within the 
usual course of professional practice and within the standard of care. 
In fact, the record evidence demonstrates that he did not prescribe 
within the standard of care. The standard of care in California for 
prescribing controlled substances cannot be met if the justification 
for those controlled substances is not properly documented.\64\
---------------------------------------------------------------------------

    \64\ In his Exceptions, Respondent argued that ``[r]evoking 
Respondent's certificates based upon recordkeeping violations alone 
is not supported by Agency precedent,'' and he attempted to 
distinguish his case from the cases the ALJ cited for the 
proposition that ``record-keeping violations associated with 
controlled substance prescriptions may render such prescriptions 
outside the usual course of professional practice.'' ALJX 30, at 25-
26. Respondent's point was that each of the cases the ALJ cited had 
more going on than record-keeping violations. Id., at 27-28. 
Respondent's argument fails for the reasons set forth in this 
paragraph. The Government has established that Respondent's record-
keeping violations rendered the relevant prescriptions outside the 
standard of care, which is sufficient to determine a violation of 21 
CFR 1306.04. Once the Government has established a prima facie case, 
I will assess whether the Respondent has presented adequate evidence 
that he can be entrusted with a registration. See infra IV.
---------------------------------------------------------------------------

    Respondent repeatedly argued that the individuals ``were never 
harmed and because [of Respondent's] care, all achieved positive 
results.'' ALJX 30, at 26. Instead, Respondent claimed, the evidence 
shows that Respondent significantly lowered each individual's opiate 
dosage levels ``while allowing the patient[s] to maintain adequate pain 
control and functionality.'' ALJX 30, at 21. I acknowledge that the 
record evidence supports a finding that Respondent, in the big picture, 
reduced the relevant individual's opioid levels with the benefits that 
Respondent espoused. Respondent does not, however, cite legal authority 
for the proposition that I must find harm occurred before I may suspend 
or revoke a registration. And as Dr. Munzing testified, ``I would say 
not only in pain manage[ment] but in medicine in general, you [cannot] 
look back and say, based on the fact that there was no documented harm, 
whatever happened before must be okay.'' Tr. 1298. Moreover, the 
documentation is too deficient to conclusively determine that no harm 
occurred. Dr. Munzing testified that he had ``significant concern[s]'' 
with the documentation, ``[s]o there may very well be things in this 
case that we [do not] know . . . concerns that [do not just] go away 
because the patient [has not] overdosed and you [do not] document that 
[there are] adverse effects.'' Tr. 1034. Furthermore, the violations of 
the standard of care in this case are not limited to one patient nor 
are they limited to a specific timeframe. The record evidence 
demonstrates that for B.G. for example, from February 14, 2017, to May 
8, 2018, twenty-one physical tests were copied forward, verbatim from 
prior medical visits without any new information being added. Tr. 1920-
22; GX 29b (Bizmatics Subpoena Response), at 4-5. Eight physical tests 
were added on May 8, 2018, and then all twenty-nine of those physical 
tests were copied forward verbatim until October 3, 2019. Id. 
Additionally, each of the patients at issue in this case had many 
instances of required recordkeeping copied forward. These recordkeeping 
violations were not isolated: They were systematic; they spanned 
patients; they spanned years; they spanned different elements of the 
standard of care in California.

[[Page 8057]]

Additionally, the act of copying forward the examination made it more 
difficult for the Agency to determine whether Respondent had violated 
his legal obligations--the copy and forward served to hide the truth of 
whether these important aspects of care had occurred. In this case, the 
repeated and systematic violations of Respondent's obligations to 
document required elements of the standard of care when prescribing 
high dosages of opioids manifests a disturbing pattern of indifference 
that weighs heavily against a finding that Respondent's continued 
registration would be consistent with the public interest. Overall, I 
find that in issuing one-hundred and fifteen prescriptions beneath the 
applicable standard of care and outside the usual course of 
professional practice in California, Respondent violated 21 CFR 
1306.04(a) and these violations of law weigh against Respondent's 
continued registration under Public Interest Factors 2 and 4.
(b) Violation of State Law
    In addition to finding a violation of 21 CFR 1306.04(a), I also 
find that the Government has proven by substantial evidence that 
Respondent's prescribing violated state law. California law, just like 
federal law, requires that a ``prescription for a controlled substance 
shall only be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his or her professional 
practice.'' Cal. Health & Safety Code Sec.  11153(a). Therefore, for 
the same reasons I found a violation of 21 CFR 1306.04(a), I find that 
the record contains substantial evidence that Respondent violated this 
state provision with respect to the relevant prescriptions issued to 
B.G., D.B., and E.N. Supra III.A.2.a.
    Cal. Bus. & Prof. Code Sec.  2242(a) states that it is 
unprofessional conduct to ``prescribe[ ] . . . without an appropriate 
prior examination and a medical indication.'' Dr. Munzing testified 
that it means prescribers ``cannot prescribe controlled substances 
without an appropriate medical examination and without medical 
indication.'' Tr. 285. Consistent with my findings above, supra 
II.A.2.a., I find that Respondent issued the relevant controlled 
substance prescriptions without documenting an appropriate physical 
examination and/or legitimate medical indication justifying the high 
prescription doses in violation of Cal. Bus. & Prof. Code Sec.  
2242(a).
    I am not issuing a finding on the alleged violations of Cal. Health 
& Safety Sec.  11154(a); Cal. Bus. Sec.  Prof. Sec. Sec.  725(a) \65\ 
and 2234; or California Health & Safety Code Sec.  11190(a) because 
neither the Government's Expert, nor the Government fully explained 
their application to this proceeding.
---------------------------------------------------------------------------

    \65\ The ALJ evaluated Cal. Bus. Sec.  Prof. Sec. Sec.  725(a).
---------------------------------------------------------------------------

    Ultimately I find that the record contains substantial evidence 
that Respondent issued multiple prescriptions of controlled substances 
to multiple patients beneath the applicable standard of care and 
outside the usual course of the professional practice and in violation 
of state law over the course of several years. I therefore find that 
Factors Two and Four weigh in favor of revocation.

B. Summary of Factors Two and Four and Imminent Danger

    As found above, the Government's case establishes by substantial 
evidence that Respondent issued controlled substance prescriptions 
outside the usual course of the professional practice. I, therefore, 
conclude that Respondent engaged in misconduct which supports the 
revocation of his registration. See Wesley Pope, 82 FR 14,944, 14,985 
(2017).
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Respondent has ``fail[ed] . . . to maintain 
effective controls against diversion or otherwise comply with the 
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The 
substantial evidence that Respondent issued controlled substance 
prescriptions outside the usual course of the professional practice 
establishes ``a substantial likelihood of an immediate threat that 
death, serious bodily harm, or abuse of a controlled substance . . . 
[would] occur in the absence of the immediate suspension'' of 
Respondent's registration. Id. The risk of death was established in 
this case. There was ample evidence introduced to establish that 
``combined use of opioid medicines with benzodiazepines or other drugs 
that depress the central nervous system has resulted in serious side 
effects including slowed or difficult breathing and deaths.'' GX 20, at 
1; Tr. 317-19, 1278.
    Respondent argues in his Exceptions that the ``Government did not 
prove, at any point, that [Respondent's] continued registration 
constituted any danger to patients, or any threat of harm, much less 
imminent danger or harm.'' ALJX 30, at 21. Dr. Munzing's testimony was 
critical of the conclusion that these patients were not harmed. Dr. 
Munzing testified, ``[we need to be cognizant whether [it is] 
prescribing opiates, benzodiazepines, or anything else in medicine is 
we need to recognize what the potential harms are. And even if that 
patient so far [has not] experienced harm from whatever your management 
is, one still needs to be cognizant that that risk is there and not 
say, `Well, nothing's happened yet. So that means that everything must 
be okay.' That certainly is not . . . the case.'' Tr. 1267. He further 
stated that the patient could be ``stable, stable, stable, stable, 
stable until they [did not] wake up.'' Tr. 1266.
    Thus, as I have found above, at the time the Government issued the 
OSC/ISO, the Government had clear evidence of violations of law based 
on the one-hundred and fifteen controlled-substance prescriptions 
Respondent issued without complying with the California standard of 
care. See supra III.A.2.a.

IV. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration is inconsistent with 
the public interest, the burden shifts to the Respondent to show why he 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18,882, 18,910 (2018) (collecting cases). Respondent has made minimal 
effort to establish that he can be entrusted with a registration.
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 243, 
259 (2006). A clear purpose of this authority is to ``bar[ ] doctors 
from using their prescription-writing powers as a means to engage in 
illicit drug dealing and trafficking.'' Id. at 270.
    In efficiently executing the revocation and suspension authority 
delegated to me under the CSA for the aforementioned purposes, I review 
the evidence and arguments Respondent submitted to determine whether or 
not he has presented ``sufficient mitigating evidence to assure the 
Administrator that he can be trusted with the responsibility carried by 
such a registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 
(2007) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). `` 
`Moreover, because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [the Agency] has repeatedly held that

[[Page 8058]]

where a registrant has committed acts inconsistent with the public 
interest, the registrant must accept responsibility for [the 
registrant's] actions and demonstrate that [registrant] will not engage 
in future misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) 
(quoting Medicine Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72 
FR 23,853; John H. Kennedy, M.D., 71 FR 35,705, 35,709 (2006); Prince 
George Daniels, D.D.S., 60 FR 62,884, 62,887 (1995).
    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).
    Here, I agree with the ALJ's statement: ``I cannot find that the 
Respondent has unequivocally accepted responsibility for his proven 
deficiencies.'' RD, at 240. In his exceptions, Respondent claimed that 
``consistently throughout these proceedings . . . [Respondent] 
recognized that his medical recordkeeping needed improvement.'' \66\ 
However when testifying in his own words, Respondent admitted there 
were ``some mistakes'' in his recordkeeping, seeming to accept 
responsibility in one breath, but then in the next maintained that 
``overall [his] charts [were] good'' and ``above average.'' Tr. 1607. 
Respondent's Exceptions also state, ``Respondent accepts that the 
repopulation of his physical findings created inaccuracies and were 
thus deficient.'' ALJX 30, at 23. This claim is not supported by 
Respondent's own testimony that the physical findings were not 
repopulated, but rather, Respondent conducted the same examination and 
made the same selections every visit, which simply produced an 
identical narrative. See supra II.C.; Tr. 1775-79; 1799-1801. I do not 
credit the acknowledgment of responsibility made in Respondent's 
Exceptions over Respondent's actual testimony, and I find that any of 
Respondent's testimony that could be considered to be an acknowledgment 
of responsibility in this case was both equivocal and not credible.
---------------------------------------------------------------------------

    \66\ Respondent also argued that he had taken steps to mitigate 
and remediate his recordkeeping issues. ALJX 30, at 22. One example 
of these efforts included taking a course on medical recordkeeping 
in 2013. Id. This does not seem to have been an effective remedial 
effort given that the recordkeeping violations at issue in this 
matter took place years later. Id. Regardless, where, as here, the 
Respondent has not credibly accepted responsibility for his 
misconduct, I do not generally consider evidence of remedial 
measures. See Jones Total Health Care Pharmacy, L.L.C., 81 FR 
79,202-03. Even if he had adequately accepted responsibility, I 
cannot find that these remedial measures are adequate such that I 
could entrust him with a registration.
---------------------------------------------------------------------------

    In all, Respondent failed to explain why, in spite of his 
misconduct, he can be entrusted with a registration. ``The 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.'' Jeffrey Stein, M.D., 
84 FR 46,968, 49,973 (2019). Here, having considered Respondent's case 
and statements, I am still left with no confidence in Respondent's 
future compliance with the CSA.
    The Agency also looks to the egregiousness and extent of the 
misconduct, which are significant factors in determining the 
appropriate sanction. Garrett Howard Smith, M.D., 83 FR 18,910 
(collecting cases). In this case, the ALJ found, and I agree, that the 
record-keeping was so deficient that it ``delegitimize[d] the 
controlled substance prescriptions the subject records sought to 
justify.'' RD, at 229. Furthermore, the record evidence contains 
testimony from the Government's expert that explains exactly why 
recordkeeping is so important. In particular, Respondent was 
prescribing a dangerous combination of high dose controlled substances 
to a patient and his compliance with the state legal requirements 
regarding recordkeeping was so egregiously bad that it is difficult to 
determine what steps Respondent was taking to ensure this patient's 
safety, or even why a particular controlled substance was being 
prescribed. These are not solely recordkeeping requirements--these 
requirements are in place to ensure that practitioners are actively 
considering the safety of their patients and documenting that they did 
so. As Dr. Munzing stated, the patient could be ``stable, stable, 
stable, stable, stable until they [did not] wake up.'' Tr. 1266.
    Respondent argues that the sole findings of departures are related 
to documentation and therefore warrant a sanction less than revocation. 
ALJX 30, at 25. 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 was so abysmal.
    In sanction determinations, the Agency has historically considered 
its interest in deterring similar acts, both with respect to the 
respondent in a particular case and the community of registrants. See 
Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR 8248. I 
find that considerations of both specific and general deterrence weigh 
in favor of revocation in this case. There is simply no evidence that 
Respondent's behavior is not likely to recur in the future such that I 
can entrust him with a CSA registration; in other words, the factors 
weigh in favor of revocation as a sanction.
    I will therefore order that Respondent's registration be revoked as 
contained in the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a) and 823(f), I hereby revoke DEA Certificate of 
Registration Nos. FQ7186174, FQ7906968, and BQ7364970. Pursuant to 28 
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 
823(f), I hereby deny the pending application for a new DEA Certificate 
of Registration, Application No. W18124091C, for John X. Qian, M.D., 
and hereby deny any pending application of John X. Qian, M.D. to renew 
or modify these registrations, as well as any other pending application 
of John X. Qian, M.D. for registration in California. This Order is 
effective March 14, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-02973 Filed 2-10-22; 8:45 am]
BILLING CODE 4410-09-P