[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24228-24262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08514]



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Vol. 87

Friday,

No. 78

April 22, 2022

Part II





Department of Justice





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Drug Enforcement Administration





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Brenton D. Wynn, M.D.; Decision and Order; Notice

  Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / 
Notices  

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-10]


Brenton D. Wynn, M.D.; Decision and Order

    On February 20, 2020, a former Acting Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause and Immediate Suspension of Registration 
(hereinafter collectively, OSC) to Brenton D. Wynn, M.D. (hereinafter, 
Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1 
(OSC), at 1. The OSC immediately suspended Respondent's DEA Certificate 
of Registration Number BW7210759 (hereinafter, registration or COR) 
``because [Respondent's] continued registration constitutes an 
`imminent danger to the public health or safety.' '' Id. (citing 21 
U.S.C. 824(d)). The OSC also proposed revocation of Respondent's 
registration, the denial of any pending applications for renewal or 
modification of such registration, and the denial of any pending 
applications for any additional DEA registrations pursuant to 21 U.S.C. 
824(a)(4) and 823(f), because Respondent's ``continued registration is 
inconsistent with the public interest.'' Id.
    In response to the OSC, Respondent timely requested a hearing 
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this 
matter was conducted on November 16-20, 2020, via video teleconference 
technology. On December 30, 2020, Administrative Law Judge Mark M. Dowd 
(hereinafter, the ALJ) issued his Recommended Rulings, Findings of 
Fact, Conclusions of Law and Decision (hereinafter, Recommended 
Decision or RD) to which neither party filed Exceptions. The ALJ 
transmitted the record to me on January 25, 2021. Having reviewed the 
entire record, I adopt the ALJ's rulings, findings of fact, as 
modified, conclusions of law and recommended sanction with minor 
modifications, where noted herein. I issue my final Order in this case 
following the Recommended Decision.*\A\
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    *\A\ I have made minor, nonsubstantive, and grammatical changes 
to the RD and nonsubstantive conforming edits. Where I have added to 
the ALJ's opinion to include additional information, I have noted 
the additions in brackets or in footnotes marked with an asterisk 
and a letter. Where I have made substantive changes, omitted 
language for brevity or relevance, or where I have modified the 
ALJ's opinion, I have noted the edits in brackets and have included 
specific descriptions of the modifications in brackets or in 
footnotes marked with an asterisk and a letter. Within those 
brackets and footnotes, the use of the personal pronoun ``I'' refers 
to myself--the Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge *B 1 2 3
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    *\B\ I have ommitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
    \1\ [Omitted pursuant to n.*B.]
    \2\ [Omitted pursuant to n.*B.]
    \3\ [Omitted pursuant to n.*B.]
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    The issue to be decided by the Administrator is whether the record 
as a whole establishes by a preponderance of the evidence that the DEA 
Certificate of Registration, No. BW7210759, issued to Respondent should 
be revoked, and any pending applications for modification or renewal of 
the existing registration should be denied, and any pending 
applications for additional registrations should be denied, because his 
continued registration would be inconsistent with the public interest 
under 21 U.S.C. 823(f) and 824(a)(4).
    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
of law below.

The Allegations *C 4
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    *\C\ For brevity, I have omitted large portions of this section 
that were repetitive of the OSC and have replaced them with a 
summary of the allegations.
    \4\ [Omitted pursuant to n.*C.]
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Overview

    [The Government alleged Respondent violated federal and California 
law by issuing numerous controlled substance prescriptions outside the 
usual course of professional practice and not for a legitimate medical 
purpose to four individuals between September 2016 and September 2019. 
ALJ Ex. 1. Specifically, the Government alleged that Respondent 
violated 21 CFR 1306.04(a) and the following state laws and 
regulations:*\D\
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    *\D\ However, in its Posthearing Brief, the Government did not 
address Cal. Health & Safety Code Sec.  11154(a), at all, and seemed 
to cite to Cal. Bus. & Prof. Code Sec.  2234 to support the legal 
proposition that the Government does not have to establish that the 
misconduct was intentional. Because there is not adequate legal 
support in the Posthearing Brief for a finding regarding either of 
these state laws, I am not addressing them further herein.
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    a. Cal. Health & Safety Code Sec.  11153(a), requiring 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'';
    b. Cal. Health & Safety Code Sec.  11154(a), directing that ``no 
person shall knowingly prescribe, administer, dispense, or furnish a 
controlled substance to or for any person . . . not under his or her 
treatment for a pathology or condition . . .'';
    c. Cal. Bus. & Prof. Code Sec.  2242, prohibiting the 
``[p]rescribing, dispensing, or furnishing [of controlled substances] . 
. . without an appropriate prior examination and a medical 
indication,'' the violation of which constitutes unprofessional 
conduct;
    d. Cal. Bus. & Prof. Code Sec.  2234, defining unprofessional 
conduct to include: ``[g]ross negligence''; ``[r]epeated negligent 
acts''; ``[i]ncompetence''; or ``[t]he commission of any act involving 
dishonesty or corruption that is substantially related to the 
qualifications, functions, or duties of a physician and surgeon''; and
    e. Cal. Bus. & Prof. Code Sec.  725, further defining 
unprofessional conduct to include ``[r]epeated acts of clearly 
excessive prescribing, furnishing, dispensing, or administering of 
drugs. . . .''
    Additionally, the Government alleged that Respondent issued 
prescriptions outside of California's applicable standard of care as 
outlined in the ``Guide to the Laws Governing the Practice of Medicine 
by Physicians and Surgeons,'' Medical Board of California, 7th ed. 2013 
(the ``Guide''). See ALJ Ex. 1. The Government alleged that these 
prescriptions fell below the standard of care applicable to the 
practice of medicine in California, and that therefore, these 
prescriptions violated federal and California State law.
    The OSC provided specific examples of Respondent's alleged failures 
related to his prescribing controlled substances to the four 
individuals: D.P., J.K., D.L., and P.S. ALJ Ex. 1, at 4-10. Examples of 
the Government's allegations as to each patient included that 
Respondent: (1) Prescribed dangerous controlled substances and 
combinations of controlled substances resulting in high morphine 
milligram equivalent (MME) dosages without a medically legitimate 
basis; (2) failed to resolve red flags of diversion; (3) failed to 
discuss the risks of the prescribed controlled substances sufficiently 
to obtain informed consent; (4) failed to appropriately evaluate and 
monitor his patients; and/or (5) failed to document physical 
examinations and other information as required by the standard of care. 
The Government alleged that these failures constituted extreme 
departures from the standard of care in California. Because of these 
failures, the Government alleged that Respondent regularly put his 
patients at significant risk for harm, including overdose or death.]

[[Page 24229]]

The Hearing

Government's Opening Statement

    The Government argued that the Controlled Substances Act sets up a 
closed system for distribution of pharmaceutical controlled substances 
from DEA registrants. Tr. 12. In order for that system to stay closed, 
the professionals entrusted with DEA registrations are expected and 
required to be professional. Doctors are expected to know the bounds of 
their profession, to prescribe within those bounds and rules, to know 
the dangers of controlled substances, and prescribe them in a matter 
that reflects those dangers. Tr. 12-13. When doctors fall short of 
these expectations they are supposed to be up front about it and change 
course. Tr. 13. The evidence in this case will show a doctor who is 
prescribing controlled substances in an unsafe manner and without 
regard to the rules on prescribing pain medication. The Respondent 
prescribed opioids at extremely high and dangerous levels and the 
Respondent did not adequately address the risks of combining opioids 
with other medications, such as benzodiazepines, with his patients. The 
Respondent also prescribed substances to patients with abnormal drug 
tests, including tests that were positive for drugs that patients 
should not have had in their system, or negative for prescribed 
substances that should have been in their system. The Respondent 
prescribed controlled substances in a dangerous manner that put his 
patients' lives at risk.
    It is not the Government's burden to prove that every prescription 
the Respondent issued to every patient was outside the usual course of 
professional practice. Tr. 13-14. The Government expected that the 
Respondent would present the Tribunal with testimony from patients and 
other doctors who believed that Respondent is a good doctor and a good 
member of the community. Tr. 14. However, on balance, the character 
testimony and other testimony offered by the Respondent cannot outweigh 
the fact that the Respondent issued prescriptions that were both 
outside the course of usual and professional practice in California and 
not for a legitimate medical purpose.
    At the closing of the case, the Government urged this Tribunal to 
look at the Government's evidence showing a doctor who put his patients 
in danger by not abiding by the requirements as established by the 
Controlled Substances Act and the laws of California for issuing 
controlled substances. The Government argued that Respondent's 
professional access to controlled substances is inconsistent with the 
public interest.

Respondent's Opening Statement

    Respondent argued that this case is a reflection of a pain 
management specialist in San Diego with four patients, who represent 
less than one percent of his overall practice. Tr. 15. The patients 
with their high morphine milligram equivalent dosages were patients who 
came to him from a referral, already on these high doses. None of these 
patients passed away, of course. In all his years of practice, none of 
his patients have ever passed away due to an overdose or had to be 
transported to a hospital under a 911 service because of an overdose. 
The four patients the Government alleged represent an aberration in the 
sense of the high amount of opioid medications that they were taking.
    The Respondent had evidence from expert witnesses that disputed the 
Government's case about whether in these particular patients the high 
amounts represented a breach in the standard of practice and therefore 
was practicing outside the scope of the law. Respondent said the 
evidence would show that the Respondent had consistently followed most 
if not all of the architectural requirements for a pain management 
doctor to follow patients who are being prescribed pain medication such 
as having pain management agreements, checking CURES reports, doing 
urine screens, or other types of screening. Tr. 16. The Respondent's 
experts told the Court that the Respondent exceeded the standards of 
practice at the time with how he followed these patients with numerous 
drug screens, frequent visits, and close monitoring. There was a 
dispute between the experts about the degree to which these patients 
should have been on these medications and the Respondent's efforts to 
try to bring them off those high doses eventually.
    Respondent said that the Tribunal would see, upon review of the 
records, that the documentation from the Respondent's practice 
throughout the years with his patients had not followed best 
documentation practices. As a consequence of this, the Government's 
witnesses have made assumptions that certain things have occurred that 
did not, in fact, actually occur. The evidence included examples of 
inconsistent urine drug screen or blood sample screens where Respondent 
properly decided to continue to prescribe medications to the patients 
even though the records do not reflect the Respondent's analysis. Tr. 
16-17.
    The evidence, Respondent argued, would also show that none of the 
patients were diverting any medications or abusing them, and that the 
purposes of the Controlled Substances Act, to guard against diversion 
or abuse by patients, had not been fulfilled here because there was no 
diversion and no abuse of the medications. Tr. 17.
    In the end, ``the documentation fails in instances throughout the 
patients' care and [the Respondent] has taken steps to improve his 
documentation.'' Tr. 17. Evidence will show that the Respondent has 
taken a medical record-keeping course from the University of San Diego. 
He has also taken a prescribing course from the University of San Diego 
to enhance his future practice. In the end, the Respondent asked the 
Tribunal to allow the Respondent to retain his certificate. If 
monitoring conditions need to be attached to that, then the Respondent 
said that he would fully follow those conditions. The Respondent argued 
that he represents a very significant provider in an under-served, 
under-privileged community in San Diego that needs doctors like him. 
Tr. 17-18.

Government's Case-in-Chief

    The Government presented its case-in-chief through the testimony of 
two witnesses. First, the Government presented the testimony of a 
Diversion Investigator. Secondly, the Government presented the 
testimony of its expert, Timothy Munzing, M.D.

Diversion Investigator (DI)

    DI has been a DI for thirty-two years. Tr. 21, 47. As a DI, her 
duties include the enforcement of the Controlled Substances Act, 
specifically the CFR, which is the Code of Federal Regulations as they 
pertain to DEA registrants and controlled substances. Her duties also 
include regularly inspecting and investigating DEA registrants and 
their handling and accountability of controlled substances and 
detecting any diversion from the licit to illicit market.
    She investigates any DEA registrant, including doctors and 
pharmacists, to ensure they are following the requirements of the 
Controlled Substances Act and California regulations and that they are 
prescribing controlled substances in the usual course of professional 
practice and for legitimate medical purposes. Tr. 22, 57-58. As a DI, 
she is looking for instances or examples of overprescribing as they 
tend to suggest that the patient may not be taking prescriptions as he 
should, and oftentimes is diverting them. Tr. 48. She has found that 
some physicians are

[[Page 24230]]

prescribing a lot of opiates and that there is a severe problem with 
physicians overprescribing and patients diverting drugs.
    In order to conduct her investigations, she uses information 
technology, the computer, for analyzing records. Tr. 22. She uses Excel 
spreadsheets, computer technology in the tables that she inserts inside 
the Excel spreadsheets, and subpoenas to obtain records and conduct 
auditing. Tr. 21-22.
    DI first learned about the Respondent when a pharmacist came to the 
DEA's office in October of 2018. Tr. 22. The pharmacist wanted to 
report several physicians that she believed were excessively 
prescribing controlled substances, which included the Respondent. This 
is just one way an investigation can begin.
    After DI looked up the Respondent in the DEA's system and 
identified his DEA registration, she then accessed California's 
Prescription Drug Monitoring Program (PDMP), called CURES, and ran a 
two-year CURES report on the Respondent's prescribing, which included 
March 17, 2017, to March 19, 2019. Tr. 23. The CURES report showed that 
the Respondent had dispensed over 590,000 dosage units of schedule II 
to V controlled substances to patients, which in DI's experience is an 
extremely high number and warranted further investigation. Tr. 23-24, 
51-52. Through this further investigation, she discovered that the most 
frequent drug the Respondent was prescribing was oxycodone, of various 
strengths. Tr. 24, 51.\5\ The next highest drug was hydrocodone. Tr. 
25, 51. The DI believed that the high dosages warranted further 
investigation. Tr. 25.
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    \5\ This included 1,700 prescriptions or 190,000 dosage units, 
which was almost thirty-two percent of all the prescriptions the 
Respondent issued. Tr. 24, 50.
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    While looking through the CURES report, she relied on the morphine 
milligram equivalent (MME) that the CDC recommends for the daily dosage 
amount. Tr. 48-49. For oxycodone, it is currently ninety milligrams a 
day. Tr. 49. When she did her review, she could tell without even doing 
calculations that it was going to be extremely high, especially for one 
particular patient that was receiving almost 200 MME of four different 
strengths of immediate relief oxycodone every week. She had never seen 
anything like that. Tr. 49. There is no standard protocol to 
investigate at a certain level of total MME, rather, investigations are 
based on various factors. These factors include the fact that a 
pharmacist reported the Respondent to the DEA, as the DEA relies on 
pharmacists or others that regularly fill prescriptions. Tr. 49-50. 
Other factors include where a patient lives, the distances a patient 
travelled, criminal history, whether the patient is going to various 
physicians, how often the patient is going somewhere, and if the same 
drugs are consistently being prescribed over and over in high 
quantities. Tr. 50-51.
    After reviewing the CURES data, she reviewed a ``pivot table'' she 
had created and identified the patients who were obtaining the most 
prescriptions for controlled substances. Tr. 25. She identified eight 
patient records to review, but only selected six of those to submit for 
medical review, as six was sufficient to obtain a meaningful opinion on 
the Respondent's prescribing. Tr. 52, 53-54. Next, she obtained the 
medical records and medical charts of the identified patients to have 
them reviewed by a government expert to determine if the prescribing 
was appropriate. Tr. 25.
    She also reviewed the Respondent's DEA registration, No. BW7210759, 
which identified his name and his business address or his registered 
address and the controlled substances for which he has privileges. Tr. 
38. She discovered he became registered in April 2001, with an 
expiration date of May 31, 2022. She also obtained the history of when 
he initially got the registration, any changes to his registration as 
far as address, state license, updates, and renewal fees. Tr. 38-39; GX 
1.\6\ She looked the Respondent up on the internet and learned that he 
specialized in pain management. Tr. 51.
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    \6\ On cross-examination, the Respondent's counsel asked if DI 
was referring to notes during her testimony. Tr. 40. DI responded 
that she was referring to her notes and Dr. Munzing's report. The 
Respondent's counsel then requested that DI provide him a copy of 
her notes as well as Dr. Munzing's report. Tr. 41-42. After hearing 
from both counsel, the Tribunal ordered that the Government provide 
DI's notes to the Respondent's counsel via email, but did not order 
Dr. Munzing's be shared as DI's testimony was very general as to Dr. 
Munzing's findings and did not include anything outside the Order to 
Show Cause and Prehearing Statements. Tr. 42-47.
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    On June 26, 2019, DI issued an administrative subpoena to the 
Respondent, which requested six patients' medical records. Tr. 26-27; 
GX 16. The Respondent complied with the subpoena within a few days by 
providing the patients' records in a paper format. Tr. 27-28.
    DI issued subpoenas to pharmacies where the subject patients had 
filled their prescriptions according to the CURES report. Tr. 28. The 
pharmacies complied with the subpoenas by providing copies of 
prescriptions, which DI saved, and they became part of her 
investigatory file.
    DI asked Dr. Munzing if he had time to assist with the 
investigation by reviewing patient files. Tr. 37. She chose Dr. Munzing 
because the DEA had used Dr. Munzing in other investigations, he was 
therefore already in the system and was available. Tr. 54-56. DI 
provided to Dr. Munzing all the medical records for the six patients 
listed in the subpoena on a CD, as well as the CURES report for the 
Respondent. Within a few weeks, Dr. Munzing provided a report that 
found four of the six patient files were very problematic and that the 
controlled substances being prescribed were outside the usual course of 
legal, professional, and medical practice. Tr. 37-38, 56. Dr. Munzing 
did not believe these prescriptions were medically legitimate and were 
an extreme departure from the standard of care, putting the patients at 
risk for side effects including addiction, overdose, and/or even 
overdose death. Tr. 38.

Dr. Timothy Munzing, M.D.

    Dr. Munzing is a licensed physician in California and received his 
first medical license in approximately 1983. Tr. 61.\7\ He received a 
Bachelor of Science in Biochemistry at the California State University 
at Fullerton and received his MD from UCLA in 1982. Tr. 62. From 1982-
1985, he attended Family Medicine Residency through the Kaiser 
Permanent Foundation Hospital, which is now known as the Los Angeles 
Medical Center. Tr. 62-63. He became Board Certified in Family Medicine 
in 1985 and remains board certified. Tr. 63. He has been a family 
physician for about thirty five years and takes care of patients of all 
ages, from children to the elderly. He currently primarily takes care 
of adult patients. For the last thirty-two years he has been the 
founding residency director of a family medicine residency program, 
where he oversees twenty-four residents and a fairly sizeable faculty. 
In family medicine, he works closely with people in every specialty, 
including Internal Medicine, Pediatrics, OBGYN, anesthesia, and pain 
medicine. As a family doctor, he sees people for chronic pain as well 
as for high blood pressure, diabetes, and weight issues; he manages all 
of their conditions, sometimes seeking a sub-specialist, when needed. 
Tr. 319-20.
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    \7\ Dr. Munzing's CV was entered into evidence. Tr. 61-62; GX 2.
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    Dr. Munzing also sits on the National ACGME Family Medicine Review

[[Page 24231]]

Committee, as one of twelve individuals that accredits the 600-plus 
Family Medicine Residency Programs in America, as well as the 
fellowships under Family Medicine which includes Geriatrics, Addiction 
Medicine, and others. Tr. 63-64. He has been a Medical Expert 
Consultant for the Medical Board of California, also known as the 
Health Quality Investigation Unit for approximately sixteen-years. Tr. 
64. He currently holds a DEA COR and maintains a clinical practice. Tr. 
64. He typically spends about twenty-five to thirty percent of his time 
performing clinical work, including seeing patients in the residency 
office or at after-hours clinics or urgent care, and working as a 
preceptor. Tr. 64-65, 75-76; 315. When it is indicated and appropriate, 
Dr. Munzing prescribes controlled substances, such as opioid 
medications, benzodiazepines, sleeping medications, medications with 
codeine, and others. Tr. 65. He has treated and provided ongoing 
medical treatment to thousands of patients for acute and chronic pain 
throughout this career. Tr. 65. He treated patients in continuity for 
approximately thirty-years and only stopped this practice in 
approximately 2016 because he was asked to help develop the Kaiser 
Permanente School of Medicine, now called the Bernard J. Tyson School 
of Medicine. He no longer works at this medical school. Tr. 66; 315-16. 
He primarily works in the Orange County area at the Anaheim Hospital. 
Tr. 65-66, 76. There are no pain management specialists on cite at the 
Santa Ana office. Tr. 317-18.
    In the course of his professional career, he has been called upon 
to provide opinions about the professionalism of physicians and the 
regulation of the practice of medicine. Tr. 66. In approximately his 
third year of practice, he was elected President of the medical staff 
and was responsible for overseeing professionalism. He was also on the 
Quality Improvement Committee and as a residency director he is 
essentially the person ultimately responsible for the quality and 
professionalism of the twenty-four residents and faculty. Tr. 66-67. He 
also precepts residents in their first, second, or third year of 
residency; Dr. Munzing is ultimately responsible for those patients and 
must review and countersign those records. Tr. 76. During his career, 
he has also sat on some national organizations for Family Medicine and 
Multi-disciplinary care including other specialties, reviewing 
professionalism. Tr. 67.
    For approximately sixteen years, he has provided opinions in 
approximately 100 cases regarding professional physicians and the 
regulation of the practice of medicine regarding prescribing practices, 
as an expert for the Medical Board of California. Tr. 68, 342. For 
approximately the last six and a half years, he has provided opinions 
for a number of federal agencies including the DEA, Federal Bureau of 
Investigation (FBI), and the Department of Justice. Tr. 67, 341, 454. 
All of the cases with the federal agencies involved opiate and other 
controlled substance prescribing. Tr. 68. For Medical Board cases he 
charges $200 an hour and for the DEA, FBI, and DOJ, he charges $400 an 
hour for his expert work. Tr. 343-44.
    He has been qualified as a medical expert in legal proceedings to 
opine on the standard of care for the legitimate use of opioids to 
treat pain approximately thirty-times. He has also been qualified as a 
medical expert in legal proceedings to opine on whether prescriptions 
were issued with a legitimate medical purpose in the usual course of 
professional practice ``many times.'' Tr. 67-68. [Dr. Munzing was 
qualified in this matter as ``an expert in pain management'' and in the 
``standard of care for prescribing controlled substances in 
California.'' Tr. 77.]
    According to Dr. Munzing, the standard of care is what a 
reasonable, prudent physician would do under the same or similar 
circumstances. Tr. 328. The standard of care generally allows for 
alternative means of diagnosis, and of treatment amongst reasonably 
competent, prudent physicians. Tr. 384. Within the field of pain 
management, there are accepted alternative judgments about what would 
be reasonable and prudent, or what would be included in a careful pain 
management plan. An exercise of judgment within the scope of the 
standard of care, can vary between reasonably prudent, careful 
physicians. Tr. 385. In fact, some physicians may have not chosen to 
even try to treat these four patients in this case.
    Dr. Munzing became familiar with the standard of care for 
prescribing controlled substances in California through practicing in 
California and prescribing controlled substances and also by being a 
physician leader in California which required he be responsible for 
overseeing the quality, and standard, of care. Tr. 68-69. There are 
guides which inform the standard of care in California, including the 
Guide to the Laws Governing the Practice of Medicine by Physicians and 
Surgeons, which applies to both primary care and specialty care 
physicians. Tr. 70; GX 3.
    Dr. Munzing has reviewed the Guide to the Laws Governing the 
Practice of Medicine by Physicians and Surgeons many times. Tr. 70-73. 
He has also studied the Guidelines for Prescribing Controlled 
Substances for Pain, as a clinician, physician leader, and a medical 
expert. Tr. 73. Dr. Munzing noted both documents inform the standard of 
care in California for prescribing controlled substances for pain. 
Based on his education and professional experience, he believes he can 
determine whether controlled substances are issued in the usual course 
of professional practice in California. Tr. 74.\8\
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    \8\ Without objection from the Respondent, the Tribunal 
qualified Dr. Munzing as an expert in pain management and also for 
presenting an expert opinion related to the standard of care for 
prescribing controlled substances in California. Tr. 76-77.
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    The Medical Board guidelines and Government Exhibits 3 and 4 lay 
out many of the guidelines that contribute to the standard of care; the 
guidelines pertain to both primary care physicians as well as 
physicians managing pain, regardless of specialty. Tr. 77-78, 82-83, 
336; GX 3, 4. The standard of care is what a knowledgeable, reasonable 
physician would do if given the same set of circumstances. Tr. 82.
    For each patient, the first thing a provider should do is take a 
history and perform an examination. Tr. 79, 83; GX 3, at 59. Depending 
on the specific complaint, the provider must evaluate the patient to 
decide if any other information is needed through laboratory tests, 
imaging studies, or other studies and make either a specific assessment 
diagnoses or likely diagnoses. The provider then does a risk 
stratification of the patient and determined what other medication 
problems he might have and how the provider may manage them. The 
provider then develops a management plan specific to his evaluation. If 
the plan includes controlled substances prescribing or other 
potentially dangerous treatments needing informed consent, the provider 
tells the patient the benefits and risks. Tr. 79-80. Once a provider 
starts managing the patient, he monitors them on a periodic, regular 
basis. Tr. 80. The specifics depend on the patient. The provider 
decides if he needs additional referrals or consultation in general. 
The provider should try to minimize the risk and maximize the benefits 
of treatment. All of these things should be documented in detail so 
that the provider and any future person managing the patient or 
reviewing the care can look at the documentation and get a detailed, 
truthful understanding about how the patient was on a particular date 
and what the reasoning was behind the management of that patient. Tr. 
81.

[[Page 24232]]

    In continuing care situations for chronic pain management, a 
physician and surgeon should have a more extensive evaluation of the 
history, past treatment, diagnostic tests, and physical exams. Tr. 83, 
GX 3, at 59. When looking at chronic pain, it is not about someone who 
just twisted an ankle an hour ago with no other pain history. Tr. 83. 
Instead, a provider should know more about the patient and the 
chronicity, i.e. how did it start, how long has someone had it, what 
methods were used before, and what limitations the pain imposes. Tr. 
83-84. Therefore, getting a detailed current assessment and history to 
find out what imaging studies, treatments, or physical therapies were 
performed and what medications were used is helpful for putting the 
patient's treatment in context. Tr. 84. There is also a lot of 
crossover between chronic pain and addictive issues [so a drug and 
alcohol history is needed]. Also, a mental health history is important 
to get including anxiety, depression, bipolar disease, ADD, etc. Tr. 
85. It is also important to put the pain in context of who the patient 
is, because the provider's pain management may vary dramatically 
depending on the health or lack of health of the patient. Tr. 85.
    A physician/surgeon should discuss the risks and benefits of the 
use of controlled substances and other treatment modalities with the 
patient, caregiver, or guardian. Tr. 85, 456; GX at 60. Again, the 
patient needs to understand the potential benefits, and the potential 
risks, as well as available alternatives. Tr. 85-86, 460. [According to 
Dr. Munzing, ``this all has to be well documented in their records.'' 
Tr. 87.] He further testified that, ``MME studies show that at 100, the 
risk of overdose [for a patient] goes up about 8.9-fold and the risk of 
overdose death is increased.'' Tr. 86. When an individual is on a 
combination of an opiate and a benzodiazepine, the increased risk of 
overdose death goes up tenfold. There is also a significant risk for 
addiction in patients that are on only moderate doses of opiates and 
benzodiazepines. Tr. 86.
    Periodic review means the patient needs to be seen on a periodic 
basis. Tr. 86-87. The frequency of visits is often driven by the 
circumstances: The severity of pain, the level of medication, and the 
potential risk for side effects. So an ongoing monitoring would include 
getting vital signs, blood pressure, heart rate, respiratory rate, and 
performing an exam on the pertinent area on a regular basis or at every 
appointment. Tr. 87. The provider should also check CURES and 
periodically issue urine drug tests to ensure that the patient is 
taking what is being prescribed and not taking what is not being 
prescribed. [According to Dr. Munzing, periodic review also encompasses 
``periodically reviewing the patient and constantly trying to assess 
their risk and whenever possible, try[ing] to . . . mitigate the risk 
by either bringing the dosage of medications down, using alternative 
strategies, [so] they can still benefit the patient but try to mitigate 
the risk.'' Tr. 87-88.]
    In the event a doctor is unable to mitigate risks, and instead of 
tapering medications he decides to increase a patient's dosage of 
controlled substances, the doctor must well-document why the increase 
is necessary despite the increased risk and also note that the patient 
has been informed of the higher risk. Tr. 88. It is important to keep 
accurate and complete records when managing a patient, so a provider 
can look back and see how the patient was at a particular time. Tr. 88-
89; GX 3 at 61. Equally important is, if the patient sees another 
provider for whatever reason, that other provider sees the 
justification for the patient's prescription and knows that the patient 
is aware of the risks and accepts those risks. Tr. 89. [According to 
Dr. Munzing, documentation, ``bottom line[,] is a patient safety 
issue.'' Tr. 88.]
    To meet the standard of care in California, a provider must ensure 
that the medical history, examination, other evaluations, treatment 
plans, objectives, informed consent, treatments, medications, 
rationale, and agreement with the patient are well-documented in the 
medical records. Tr. 89-90.
    The Medical Board of California also uses the Guidelines for 
Prescribing Controlled Substances for Pain in determining the standard 
of care for prescribing controlled substances in the State of 
California for physicians and other prescribers. Tr. 70, 73, 90-91; GX 
4. These guidelines inform a provider's standard of care by laying out 
the specifics on what needs to be done. Tr. 91. The standard of care 
requires checking CURES for managing chronic pain, which the Respondent 
did with the four patients in this case. Tr. 91, 337, 360. The 
guidelines also require drug testing. The Respondent did urine drug 
screens on a frequent basis. Tr. 338. These guidelines are relevant for 
evaluating the Respondent's treatment of patients within the standard 
of care in California.
    There is an increased risk of overdose death and overdoses when 
benzodiazepines and opioids are co-prescribed. Tr. 92. In 2016, the 
Center for Disease Control and Prevention (CDC) highlighted the risk of 
co-prescribing these controlled substances and the Food and Drug 
Administration (FDA) came out with a black box warning highlighting the 
risk of combining these two medications. Whenever possible, a provider 
should titrate down the benzodiazepine and if a provider is unable to 
do that, he should taper the opioid medications; co-prescribing these 
medications is ``significantly increasingly risky.'' Tr. 93.
    The Patient Evaluation and Risk Stratification requirement 
addresses: The importance of completing a medical history and physical 
examination, performing a psychological examination for patients with 
long-term chronic opioid use for noncancerous pain, and provides 
examples of screening tools for mental health or potential addiction 
issues. Tr. 93-94; GX 4 at 12-13. Risk stratification is broken down 
into two components: (1) The risk of potential addiction or substance 
use disorder; \9\ and (2) risk stratification as far as the overall 
health and well-being of the patient. Tr. 94. If a patient has other 
underlying conditions besides chronic pain that need to be dealt with, 
those need to be listed in the medical record as a provider is managing 
a patient as a whole person. Tr. 95. It is also important as it relates 
to informed consent, because the risk to a patient may be much higher 
if the patient has other chronic medical problems. Tr. 95-96.
---------------------------------------------------------------------------

    \9\ According to Dr. Munzing, it has been shown that managing 
mental health issues appropriately is often a significant tool in 
decreasing the chronic pain one needs to manage. Tr. 94-95.
---------------------------------------------------------------------------

    ``Ongoing Patient Assessment'' or ``monitoring'' involves following 
patients whose conditions are dynamic and have varying degrees of pain 
over time. Tr. 96; GX 4 at 17. A provider should also check CURES, 
perform point-of-care testing by checking urine screen for consistency, 
and may perform pill counts or other ways of monitoring. Tr. 97-98. 
There is also a confirmatory urine test that is much more extensive 
that looks in much finer detail at medications both prescribed and 
illegal. However, these tests are not always accurate. Tr. 98. The 
frequency of these drugs screens based on the standard of care in 
California is determined on risk stratification. Tr. 99. Different 
organizations contribute to this opinion, including the American 
Academy of Pain Medicine and the Agency Medical Directors Group in 
Washington State. The CDC generally recommends doing urine screens 
approximately quarterly when the MME is over 90 or 100. Some suggest as 
often as once a month, while

[[Page 24233]]

others maintain that if there are no inconsistencies or aberrances, 
quarterly is fine. If there are any aberrances that are unexplained, 
then the provider needs to strongly document why he is considering 
continuing prescribing at the same level, and that there was a strong 
consideration of trying to bring the medication level down. Tr. 99-100. 
Requiring more urine screens would not exceed the standard of care, but 
rather just meets the standard of care for that element. Tr. 100.
    There are certain things that would drive a provider to taper to a 
lower, safer dosage, including the level of MMEs. Tr. 102; GX 4 at 20. 
A provider looks at intolerable side effects, if there is a failure to 
comply with the pain management agreement, or if there are aberrancies 
showing up that are not explained. A provider should also look at the 
overall risk of the treatment. Tr. 102-03. It is necessary to maintain 
accurate and adequate medical records from both a legal standpoint as 
well as a patient quality standpoint. Tr. 103; GX 4 at 22.
    The CDC issued a fact sheet that gives instructions regarding 
conversion factors for calculating MMEs, which Dr. Munzing used in 
informing his opinion on the standard of care and usual course of 
professional practice in California. Tr. 104-06; GX 5. There is no 
maximum MME that a provider can prescribe because every patient is 
different; a provider needs to look at whether an opiate is appropriate 
and what dosing is appropriate. Tr. 106. However, the CDC and others 
recommend that providers try not to exceed 90 MME per day. Tr. 107. 
Although there is no absolute that one can never exceed, the provider 
should try to reduce the risk; and if a provider is exceeding 90 MME, 
the provider should provide documented justification for the dosage and 
document the patient's informed consent of the risk. Tr. 107-08; GX 5.
    If a patient presents to a new doctor after having already 
prescribed at a dosage higher than 90 MME, the new doctor should 
perform a thorough history, examination evaluation, and whenever 
possible should get prior medical records to put the prescribing into 
context and confirm that the patient is really being prescribed that 
dosage. Tr. 108. The doctor should also look at urine drug tests, 
CURES, and the PDMP. If the doctor confirms that the patient is indeed 
taking that high dosage, the doctor should evaluate whether that high 
dose it is still appropriate at that time and look at the overall risk, 
including whether alternatives are available.*\E\ Tr. 108-09. A doctor 
should then decide if he is able to reduce the medication of the 
patient slowly, while also incorporating other pain management 
strategies that will hopefully decrease the risk to the patient. Simply 
keeping the patient on the high MME because he was prescribed it before 
does not meet the standard of care in California. Continuing high 
dosages of opioids and controlled substance medications puts a patient 
at risk; not having side effects in the present does not prevent a 
patient from having problems with the higher dosage in the future. Tr. 
109-10.\10\
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    *\E\ [Text relocated for clarity.] Dr. Munzing noted there is a 
condition called Opioid-Induced Hyperalgesia, where higher doses of 
opioid medications may increase pain rather than decrease pain or 
may increase a patient's sensitivity to pain. Tr. 109.
    \10\ Dr. Munzing noted that the CDC guideline was primarily for 
primary care physicians so his opinion in this proceeding did not 
completely rely on a strict adherence to the CDC guidelines. Tr. 
110-11, 334; GX 5. Furthermore, the CDC guidelines are simply 
guidelines and not absolute mandates. Tr. 111.
---------------------------------------------------------------------------

    The FDA document providing the black box warning describing the 
risks when combining opiate pain medication and benzodiazepines 
contributed to Dr. Munzing's opinion in the instant case as it relates 
to the standard of care and usual course of professional practice in 
California for prescribing controlled substances for the treatment of 
pain. Tr. 113-14; GX 6. There is a serious increase in risk and 
potential death when combining opiates and benzodiazepines, and a 
doctor should try to avoid this combination whenever possible whether 
he is a primary care physician or a pain specialist. Tr. 114-15; GX 6.
    In general, pain patients may not take their pain medications as 
prescribed, but the pain contract dictates how patients should take 
their medication. If they are not taking them as prescribed, the 
provider needs to discuss the resulting risks with them. Tr. 411.
    A fast metabolizer is a patient whose body may metabolize a certain 
medication faster than others so it may potentially not remain in the 
patient's system as long as it might in someone else's. Tr. 310.\11\ 
This would require dosages to be divided more throughout the day, using 
the same quantity of the drug, but dividing the doses more frequently 
throughout the day. The standard of care for such patients requires 
documentation specifically identifying that a fast metabolism is the 
reason for any aberrant drug screens, because there are many 
possibilities why a urine drug screen can be negative. Tr. 310-11. A 
doctor has several options when resolving aberrant drug screens 
including actually querying the patient, doing random pill counts, 
doing more randomized drug screens, and recording the last time a 
medication was taken. Tr. 312. As to all the patients, there is no 
evidence in the record that the Respondent took any of these 
approaches. Tr. 312-13. Although the Respondent may have discussed the 
risks of combining benzodiazepines and opiates, there was no informed 
consent in the record. Tr. 415-17.
---------------------------------------------------------------------------

    \11\ Dr. Munzing noted that such patients are relatively rare. 
Tr. 313-14.
---------------------------------------------------------------------------

General Patient Discussion
    According to Dr. Munzing, a legacy patient is a patient that comes 
from another provider or a patient whom a doctor has been following for 
quite some time who comes in for a certain treatment. Tr. 325-26. It 
could be within the standard of care to keep a patient on the 
medications he was prescribed by a previous provider if the current 
doctor has done an appropriate, independent evaluation and concludes 
that what was previously prescribed is reasonable, indicated, and 
medically justified. Tr. 326-28.
    Vitals should be taken during each and every visit when patients 
are on a very high dose of opioids because they are at a greater risk. 
This is true even if the visits are one day after each other because 
patients vary day-by-day. Tr. 331-32. Despite the fact that there are 
no written guidelines that require this, Tr. 338-39, Dr. Munzing based 
his opinion on discussions with providers who focus on pain management 
and other specialties, as well as on information obtained at trainings 
and lectures. There is no maximum MME because a doctor needs to make 
prescribing decisions within context of each individual patient; 
prescribing could be a little bit higher than 90 MME depending on the 
patient. Tr. 332-33.
    Dr. Munzing stated that he is ``here to help protect patients [by] 
. . . looking at the standard of care, looking at the dosage of 
medications, looking at the areas of informed consent, of aberrant 
urine drug tests, or documentation. . . .'' Tr. 341.
    According to Dr. Munzing, when a patient reports that his pain is 
staying at a five on a scale of one-to-ten, that does not necessarily 
indicate that the treatment plan is working. The provider must look at 
the complete context of that patient and look at the risk and potential 
benefits. Tr. 354. However, if the pain number has come down 
significantly and the patient's function has significantly improved, 
then a patient may have stabilized at that

[[Page 24234]]

dosage. Tr. 355. One or more of the patients' records infrequently 
mentioned that their activities of daily living and their ability to 
function on a daily level was pretty good for them, which could be seen 
as a potential benefit of the treatment. But this does not necessarily 
mean that the patient is on the right dosage and the provider still 
needs to assess the potential risk. Tr. 355-56. A doctor also needs to 
review where a patient was before prescribing and where he is now, and 
whether there is potential for continued improvement while 
simultaneously trying to mitigate the risk. Tr. 356-57.
    It is typical for pain to fluctuate in chronic pain patients who 
have good days and bad days; but patients who are reporting pain at a 
seven or eight, after having initially reported pain at an eight or a 
nine, have only minimally changed. This scenario would not be 
considered a success because this is only a slight improvement at the 
cost of a significant risk. Tr. 358-59.
    If one does not document something and there is no way to verify 
it, then you cannot infer that it has happened. Tr. 406. Although there 
may be ways to secondarily find that something was done; [for example, 
if a physician says they ordered imaging but did not document the 
imaging, imaging results in the medical record could verify that the 
imaging was ordered.] Id. However, the State of California has stated 
that a doctor not only needs to prescribe Narcan or Naloxone, but also 
needs to educate the patient, and both need to be documented. Tr. 407. 
[Accordingly, Dr. Munzing could not infer that a patient was educated 
regarding Narcan based solely on the fact that the patient received a 
Narcan prescription. Tr. 405.]
    Dr. Munzing was provided materials to review relating to the 
Respondent's prescribing of controlled substances including medical 
records and CURES information for six patients that spanned 
approximately three-and-half-years. Tr. 116-17, 385-87.\12\ He may have 
spent approximately fifty-to-sixty hours reviewing these records prior 
to providing his opinion to the DI. Tr. 342. He concluded that the 
prescribing for two of the patients he was initially presented with was 
consistent with the standard of care. Tr. 116. He did conclude, 
however, that the controlled substances prescribed to J.K., D.P., P.S., 
and D.L. were not medically justified as prescribed, and were beneath 
the standard of care in California and outside the usual course of 
professional medical practice as prescribed. Tr. 117.
---------------------------------------------------------------------------

    \12\ When questioned on cross examination, Dr. Munzing stated 
that if it appeared that he received insufficient records, he could 
ask the DEA whether there are additional records available. Tr. 325. 
He also explained that for the patients not discussed at this 
hearing, he had done a high level analysis of the CURES report data 
and did not notify the DEA that he had concerns about patient safety 
regarding the other patients based on what the DEA had asked him to 
review. Tr. 388-90.
---------------------------------------------------------------------------

    Overall, Dr. Munzing generally reached this conclusion based on 
several factors, including the high morphine milligram equivalent, with 
one patient's prescriptions being as high as 6,000 MMEs, which is the 
highest he has ever seen. Tr. 117-18. The patient histories were also 
limited with little to no mental health history and the use or aberrant 
use of drugs and alcohol was typically not listed in significant 
detail. Tr. 118. The examination was absent from the medical records; 
examinations were sometimes performed fifty-percent of the time and 
sometimes less. Two or more vital signs were not frequently obtained, 
oftentimes less than fifty-percent of the time. Tr. 118-19. Urine 
screens were typically ordered for patients on the first visit and were 
done as many as two or three times per month, using much more costly 
confirmatory tests. Tr. 119, 359-60. Furthermore, urine drug tests for 
three of the four patients had aberrant or even inconsistent values. 
Resolution of those aberrancies were not typically documented in the 
medical records, yet the Respondent continued to prescribe the 
medications. There were a whole host of things that were concerning, 
including patients continuing on very high dosages of medications and 
three of the four patients actually had their dosage increased over 
time. After reviewing the records, Dr. Munzing did believe that all 
four patients were likely in pain and were not ``tricking or faking 
their pain.'' Tr. 120, 419.
    Dr. Munzing further noted that some of the patients received Narcan 
or some other form of opioid reversal medication. Dr. Munzing noted 
that it was possible that the Respondent had a discussion with his 
patients regarding why the Narcan was being given--that a person could 
overdose from being prescribed certain medications and this opioid 
reversal medication could prevent them from dying. Tr. 364-65. However 
there is no evidence in the records that this was discussed. Tr. 366-
67. J.K., D.L., and P.S. had a number of aberrant drug screens. Tr. 
309-10. Overall, it was within the standard of care for the Respondent 
to attempt to pursue a treatment plan with these patients after 
verifying the pain in some way through studies, etc. Tr. 419-20.
    The Respondent reported he tried alternative methods to opioids, 
including prescribing gabapentin or neuropathic medication, electrical 
analgesia, and injections, which Dr. Munzing said were reasonable for 
the Respondent to pursue at the time. Tr. 351-52. With most, if not all 
of the four patients, the Respondent either ordered tests or attempted 
to order tests, and on occasion he made efforts to refer patients to 
specialists. Tr. 353. Dr. Munzing agreed that this is not a case of a 
doctor just giving patients pills to control their pain. Tr. 353-54.
Patient D.P.
    A Controlled Substance Agreement is separate from an informed 
consent. An informed consent may be added to a Controlled Substance 
Agreement. Tr. 120-21.; GX 8 at 239. The Controlled Substance 
Prescription Agreement for Patient D.P., dated April 5, 2017, is 
adequate as a controlled substances prescription agreement, but is not 
adequate as an informed consent because it does not lay out for the 
patient that he/she is at a much higher risk of addiction, overdose, 
and death. Tr. 121-22, 458. This missing information and lack of 
informed consent contributed to Dr. Munzing's opinion that the opioid 
prescriptions were outside the usual course of professional practice. 
Tr. 122-23.
    D.P. was a complex patient. Tr. 321. As to D.P.'s medical record 
regarding evaluation and monitoring, the medical record shows frequent, 
expensive urine tests occurring approximately three times a month; this 
was unnecessary because the patient was fairly consistent in showing 
that he was taking the prescribed medication. Tr. 123. As discussed 
previously, doing testing more often than required is not necessarily a 
good thing and does not mean that a doctor is exceeding the standard of 
care. Based on CURES, D.P. was receiving an exceedingly high MME dose 
and high number of pills (approximately 160 tablets per day) over long 
periods of time that were refilled on a weekly basis. Tr. 123-24. Dr. 
Munzing has never seen a patient get anywhere near that number of 
tablets per day. Tr. 123. Over the course of three years, the patient's 
prescriptions ``bounce[d] up and down,'' between approximately 3,500 to 
6,000 MME. Tr. 124, 428. D.P. was receiving somewhere around 1.4 
million milligram dosage units per year, sometimes higher than that, 
which was the highest Dr. Munzing has ever seen. Tr. 119-20.
    D.P. then appeared to receive treatment at Pain Management, UC San 
Diego where the amount dropped to 2,700 MME and the patient was then in 
and out of the hospital for very serious medical problems unrelated to 
the pain including a heart attack and kidney

[[Page 24235]]

failure. He began working with other pain management providers and was 
taken down to 1,000 MME and tapered down. Tr. 124. He was most recently 
in the 700 range and was continuing to taper down.* \F\
---------------------------------------------------------------------------

    *\F\ The Government seems to have offered this evidence as an 
example of what prescribing and documenting within the standard of 
care for D.P. could have looked like. However, this information is 
not material to my decision. I also note that I am not holding 
Respondent accountable for any actions other than his own.
---------------------------------------------------------------------------

    Overall, the Respondent's documentation for D.P. was ``pretty 
poor'' without additional information, it did not reflect adequate 
attempts to mitigate symptoms or risk over time and did not meet the 
standard of care. Tr. 125. Furthermore, the medical records show that 
vital signs were taken at fewer than fifteen-to-twenty percent of the 
total visits. Tr. 125, 137. Many of the visits lack documented vital 
signs and a musculoskeletal exam, which is outside the standard of care 
in California for a doctor who is managing patients at incredibly high 
dosages. Furthermore, Dr. Munzing opined, the documentation was far 
below what was necessary and did not justify the incredibly high 
dosing. Tr. 126.
    Comparing the documentation from the Respondent to UC San Diego, it 
was like ``night and day'' and D.P.'s pain score was not ``all that 
different'' despite the fact that D.P. went down from 6,000 to 1,000 
MME. Tr. 126-27. The Respondent's records do not reflect that D.P.'s 
pain scores and functional level improved when he was on the highest 
dosages of opiates, which Dr. Munzing would expect to see. Tr. 127. 
There is a ``great difference'' between the Respondent's records and 
those provided by UC San Diego and the other pain management group. The 
Respondent did not provide records of treatment prior to him 
establishing care with D.P., which is ``vitally important'' as it 
relates to the standard of care. Tr. 127-28.
    There were four prescriptions written by Respondent for D.P. on 
April 18, 2017, to be filled on April 26, 2017; all were for Oxycodone 
but in four different strengths. Tr. 129; GX 9 at 2. Between the four 
prescriptions D.P. was prescribed 160 tablets of Oxycodone per day. Tr. 
130. Dr. Munzing calculated that the MME for one of the prescriptions 
alone was 1,200 MME. For all four Oxycodone prescriptions, the total 
MME was 4,500, which is astronomical and the highest dosage Dr. Munzing 
has reviewed, including his review of approximately 150 overdose 
deaths. Tr. 132, 135. There are also medical records dated April 12, 
2017, that provide only a minimal level of investigation, with no vital 
signs or examination listed; therein Respondent prescribed additional 
medication, despite there being no justification to do so. Tr. 132-34; 
GX 8; 246-253. On April 19, 2017, Respondent wrote four prescriptions 
identical to the four written on April 18, 2017, to be filled on April 
19, 2017. GX 9, at 3. It is highly unusual that these two prescriptions 
were issued to be filled only one week apart, but the Respondent 
repeatedly prescribes medications over long periods of time on a weekly 
basis. Tr. 134-35. Dr. Munzing had the same issues with the 
prescriptions issued on April 19, 2017, and found that they were not 
issued in the usual course of professional practice or for a legitimate 
medical purpose. Tr. 135. The Respondent continuously prescribed a 
combination of 280 tablets of oxycodone 10 milligram, 180 tablets of 
oxycodone 15 milligram, 280 tablets of oxycodone 20 milligram, and 280 
tablets of oxycodone 30 milligram between March 17, 2017, and January 
3, 2018. Tr. 136. Rather than tapering, as required by the standard of 
care, D.P.'s records shows that Respondent periodically added a 
prescription for oxymorphone, so episodically the MMEs went from 4,500 
to 5,100 as the Respondent increased D.P.'s dosage. Tr. 136-37. [Dr. 
Munzing said that there was no justification in the record for the 
oxymorphone prescriptions and they were also outside the standard of 
care. Tr. 137.]
    Furthermore, vital signs were taken infrequently, which puts a 
patient at a high risk; checking blood pressure is important to ensure 
the blood pressure is not too low or too high, and checking the 
respiratory rate is important because the medications are respiratory 
depressants. Tr. 137-38. Furthermore, on July 3, 2017, the Respondent 
added Opana as an additional opioid prescription that is long-acting, 
which increases the MME and therefore the risk to the patient. Tr. 139; 
GX 8 at 372. Any added benefit of this prescription would be minimal as 
D.P. was already on an astronomically high dose and there was no 
documented reason why this was added as a prescription. Tr. 140-41. 
Furthermore, D.P.'s pain level was listed as a ``5,'' which would have 
made this a great opportunity to start reducing the pain medication. 
Tr. 141-42. Overall, the Respondent failed to provide adequate 
justification for why D.P. was prescribed such a high level of MME.\13\ 
Tr. 142
---------------------------------------------------------------------------

    \13\ [Footnote text moved to the body of the decision.]
---------------------------------------------------------------------------

    Dr. Munzing continued to review the Government's exhibits and 
explained how each prescription did not meet the standard of care for 
patient D.P. Tr. 142-177. [Dr. Munzing opined that each of the relevant 
prescriptions to D.P. were issued outside the usual course of 
professional practice and without a legitimate medical purpose. Tr. 
146-47, 149, 151-52, 154, 157, 159, 161, 177. He testified in support 
of that opinion that: Vital signs were not taken and physical 
examinations were not performed, Tr. 145, 148, 150, 153; the MME 
bounced up and down but was always ``in the [high] stratosphere'' 
without obtaining informed consent or informing the patient of the 
risks, Tr. 145, 158-59, 163, 171; and there was no plan for tapering 
medications or assessing withdrawal when the dosages decreased, and 
there was insufficient justification in the record when the dosages 
increased. Tr. 146, 148, 150, 152, 156, 172. Dr. Munzing also noted 
that there is a gap in the medical records between June 25, 2019, and 
September 30, 2019, but that prescribing continued during that time. He 
testified, ``these are astronomically high levels [of controlled 
substances] and it's certainly not based on sufficient justification, 
not usual professional practice, and now there's a big gap, but the 
prescribing continued. So I have very significant concerns about that . 
. . [and the patient] ended up being admitted to the hospital on 
multiple occasions and multiple ER visits, starting in late 2019 and 
going through the early parts of 2020.'' Tr. 162-63.]
    It appears that D.P. went to a detox facility in September 2019, 
and his MME was decreased to 60 or 65; there was some discussion in a 
note from the Respondent that he would not prescribe above 90 MME per 
day going forward. Tr. 164, 433-34. Dr. Munzing clarified that the 
detox process (which was not performed by Respondent) was not 
particularly relevant to his case or his opinions regarding Respondent. 
Tr. 164.
    [Summarizing his opinion of Respondent's prescribing to D.P., Dr. 
Munzing testified that each of the prescriptions captured in the 
stipulations were issued without a legitimate medical purpose and were 
outside the usual course of professional practice. Tr. 177. Dr. Munzing 
further testified that the prescribing ``was incredibly dangerous. The 
patient is lucky to be alive. It certainly was not [within the] 
standard of care. The way he prescribed the dosages, the MMEs, were 
certainly not medically justified and not usual professional 
practice.'' Tr. 176.]

[[Page 24236]]

Patient P.S.
    In reviewing P.S.'s file, Dr. Munzing did not find any documented 
discussion regarding the specific risks of opioids, including 
addiction, overdose, or death, and opined that the lack of 
documentation violated the standard of care. Tr. 178; but see, Tr. 390-
91 (a note relating to a visit from January 25, 2018, stating generally 
that the Respondent discussed the risks with P.S. regarding the use of 
opiates and benzodiazepines and mentions respiratory distress).
    On almost every occasion during the relevant period, P.S. was 
prescribed an opioid and a benzodiazepine, a combination that falls 
under the FDA warning. Tr. 177-78. Dr. Munzing explained that, 
curiously, a progress note dated January 9, 2017, mentions that on May 
31, 2019, R.R-G. ``discussed that benzodiazepines should not be taken 
concomitantly with pain medications due to an increased risk of 
respiratory depression.'' Tr. 179. The patient was reportedly advised 
``not to take both prescriptions at the same time,'' and there was a 
plan to taper down alprazolam or Xanax.'' Id. Tr. 179; GX 10 at 4. This 
warning was repeated word for word on several occasions going into the 
future, but the patient was not really tapered down. Tr. 181. Patient 
P.S. was switched from 1 milligram of lorazepam to half a milligram of 
alprazolam; this is not considered a dramatic tapering, and there is no 
documentation stating why this medication change was made. Tr. 179-81, 
193. Furthermore, comparing the two prescriptions is like comparing 
apples and oranges as there is no definitive data that supports or 
refutes whether one is more or less risky than the other. Tr. 371-72. 
Although the patient notes demonstrate that ``R.R-G.'' \14\ had a 
discussion with the patient regarding respiratory depression, Dr. 
Munzing opined that the records did not adequately document informed 
consent because there is no indication that anyone discussed the 
specific risks of addiction, overdose, and death. Tr. 182; GX 10. The 
questionable date of the entry, and the lack of documentation regarding 
informed consent contributes to Dr. Munzing's opinion that those 
prescriptions to P.S. were issued outside the usual course of 
professional practice.*\G\ Tr. 183, 374.
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    \14\ The Tribunal later learned that this is the Respondent's 
nurse practitioner. The Respondent is responsible for his mid-level 
and lower-level employees. Tr. 220-21, 272. On cross examination, 
Dr. Munzing elaborated that in California, nurse practitioners are 
able to see patients, but the Respondent would still be responsible 
for the overall management of the patient as he continued with the 
patient's care. Tr. 350-51.
    *\G\ Text omitted for clarity.
---------------------------------------------------------------------------

    According to Dr. Munzing, the Respondent only took vital signs 
approximately fifty-percent of the time and failed to perform proper 
musculoskeletal exams. Tr. 183. The records also fail to provide an 
adequate history of the patient's anxiety or evidence that alternative 
methods of treatment such as non-controlled substances were considered. 
Tr. 183-84. There were also no prior medical records in the file and no 
documented attempt to get them. These failures contribute to Dr. 
Munzing's opinion that the prescriptions to P.S. at issue did not meet 
the standard of care. Tr. 184. [Dr. Munzing testified that the ``MMEs 
are fairly consistent [throughout,] in the mid-300 range,'' but the 
patient did not seem to be getting sufficient pain relief to justify 
the risk of ``the high MME and the combination with benzodiazepines.'' 
Tr. 185.]
    Dr. Munzing testified that Respondent attempted alternative 
treatments for P.S. At one point, the Respondent prescribed 
testosterone to P.S. to help treat the side-effects of opioids, and the 
patient reported feeling better after receiving the testosterone. Tr. 
360-61. Dr. Munzing recalled one of the patients was prescribed a 
Medrol dose pack, but could not recall if this was for Patient P.S. Tr. 
361. At some point in time, Patient P.S. was given injections in the 
facet joint to help control the pain. Tr. 362-63. The Respondent also 
attempted to have P.S. see a psychiatrist or psychologist \15\ to help 
with his chronic anxiety problem, which is a reasonable thing for a 
doctor to do if he is not qualified or competent to deal with that. Tr. 
396.
---------------------------------------------------------------------------

    \15\ Dr. Munzing acknowledged that the Respondent had some 
challenges getting a psychiatrist or psychology to actually see the 
patient. Tr. 366-97; GX 10 at 1238-44.
---------------------------------------------------------------------------

    Patient P.S. was prescribed five medications, four of which were 
controlled substances: Morphine sulfate extended release 30 milligrams 
three pills a day, morphine sulfate extended release 60 milligrams 
three pills per day, Dilaudid (hydromorphone), and lorazepam (a 
benzodiazepine) which is a total MME of 366 (not including the 
benzodiazepine). Tr. 185-187; GX 11. Dr. Munzing testified that the MME 
was very high. Tr. 187. Furthermore, Dr. Munzing testified, [``we also 
have the opioid and the benzodiazepine that both the CDC and the FDA 
warn against'' prescribing together. Tr. 187.] Dr. Munzing testified 
that these prescriptions were not issued in the usual course of 
professional practice or for a legitimate medical purpose. Tr. 189. Dr. 
Munzing opined that the note for February 17, 2017, was deficient 
because there is a pop-up warning ``from the future, from May 31, 
2019,'' \16\ it did not note alcohol use, and it did not provide a 
record of an exam being performed despite the patient being prescribed 
a high dosage of medication and receiving a benzodiazepine, without a 
diagnosis to justify it. Tr. 187-88. This patient also has significant 
medical problems, including history of an acute embolism and thrombosis 
or deep vein thrombosis (DVT), which puts him at an increased risk. Tr. 
188-89. Dr. Munzing opined that the opioid prescriptions were not 
written in the usual course of professional practice or for a 
legitimate medical purpose because the dosages are high, there are 
dangerous combinations, there is no informed consent, the exam was 
deficient, and the documentation had ``a whole multitude of parts that 
were necessary that were missing.'' Tr. 189.
---------------------------------------------------------------------------

    \16\ On cross examination Dr. Munzing said it could be possible 
that this print out may include errors. Tr. 346, 347. However, Dr. 
Munzing also stated that in his work as an expert, he does not 
recall ever seeing an issue with an EMR that resulted in a case 
printing things from the future. Tr. 348-49.
---------------------------------------------------------------------------

    Overall, Dr. Munzing's review of all of P.S.'s medical records 
indicated there was no proper justification documented for the ``very 
high'' and ``dangerous'' dosage of opioids nor the benzodiazepines that 
were prescribed to P.S., and they therefore were not issued in the 
usual course of professional practice or for a legitimate medical 
purpose. Tr. 190-97. [Dr. Munzing testified that the prescribing was 
``not appropriate, this is very high, this is dangerous.'' Tr. 191. 
Specifically, he testified ``[t]here's no informed consent. The exam is 
missing on the area [Respondent was] treating. And we don't know really 
anything about the anxiety that reportedly the Xanax is coming from. . 
. . [This] patient still is put at significant risk and still the 
documentation is poor.'' Id. Dr. Munzing also testified that there was 
never justification in the medical record for the benzodiazepine 
prescriptions. Tr. 193.]
    Patient P.S. had urine drug screens dated March 17, 2017,\17\ April 
14, 2017, June 19, 2017, August 7, 2017, September 12, 2017, October 
10, 2017, November 3, 2017, September 11, 2018, October 3, 2018, 
December 21, 2018, and March 26, 2019. Tr. 195-225; GX 10. All of these 
drug screens showed

[[Page 24237]]

that Patient P.S. was negative for either lorazepam or alprazolam,\18\ 
an aberrancy, and the later drug screens showed that P.S. was negative 
for morphine, another aberrancy. Tr. 195-97; GX 10 at 76. Some of the 
drugs screens also showed alcohol use, [which Dr. Munzing testified 
``increases the risk to the patient of certainly overdose and overdose 
death.'' Tr. 217.] According to the standard of care, the Respondent 
should have contacted the patient within a couple of days of receiving 
these aberrant drug screens to have the patient explain why he was not 
taking his prescribed medication or why he consumed alcohol. Tr. 198-
99. There is no indication that the Respondent documented that he 
questioned the patient nor that the Respondent resolved these aberrant 
drug screens. Tr. 199-202.\*H\
---------------------------------------------------------------------------

    \17\ The Respondent documented that there was no aberrant drug 
screen on this day. Tr. 198.
    \18\ [Omitted for clarity.]
    \*H\ Omitted repetitive text for brevity.
---------------------------------------------------------------------------

    Despite all of these aberrant results (including P.S.'s evident 
alcohol use), there were no attempts for the Respondent to either 
address or resolve these issues with documentation in the medical 
record, which contributed to Dr. Munzing's opinion that the 
prescriptions were written outside the usual course of professional 
practice and were not for a legitimate medical purpose. [According to 
Dr. Munzing, following the aberrant drug screens, Respondent needed to 
explore the reason for the inconsistent result and resolve that reason 
``before continu[ing] to prescribe.'' Tr. 213.] There are several 
potential dangers posed by these aberrant drug screens, including that 
the patient is not taking medication some days and taking extra other 
days, is hoarding the medication, or is illegally diverting the 
medication. Tr. 199, 211. [Dr. Munzing testified that the inconsistent 
drug screens and failure to document a resolution contributed to his 
opinion that the prescriptions issued to P.S. were outside the usual 
course of professional practice and not for a legitimate medical 
purpose. Tr. 201-04, 211.]
    Ultimately, Dr. Munzing found that the prescriptions prescribed to 
P.S., which were stipulated to by the parties and listed in the 
Government's Prehearing Statement, were far outside the standard of 
care, were not medically justified, and were outside the usual course 
of professional medical practice. Tr. 225; GX 4.19 *I
---------------------------------------------------------------------------

    \19\ On cross examination, the Respondent's counsel referred Dr. 
Munzing to a note regarding P.S. seeking an early refill due to 
leaving his paper prescription in a Lyft and Dr. Munzing confirmed 
that the Respondent's note on this date indicated that he was 
``doing something to explore'' the claim. Tr. 391-95.
    \*I\ Dr. Munzing testified that ``all four of the patients 
certainly have the likelihood of known pain generators.'' Tr. 226. 
But he made clear in his testimony that having a source of pain 
alone, without complying with the steps required by the standard of 
care, was insufficient to justify prescribing controlled substances. 
Tr. 226-27.
---------------------------------------------------------------------------

Patient J.K.
    Dr. Munzing testified that the standard of care for patients with 
chronic migraine headaches, or chronic headaches in general, [such as 
those for which Respondent was treating J.K.], requires that a provider 
take an appropriate history and examination, including a neurological 
examination, in order to narrow down what type of a headache the 
patient has and rule out certain causes such as a tumor or infection. 
Tr. 229. If the headaches become more severe, the provider typically 
does an imaging scan such a CT scan or an MRI to ensure there is no 
tumor. Tr. 229-30. The medical records for J.K. do not meet the 
standard of care because there is no detailed history, no detailed 
exam, and no evidence of imaging studies, yet the Respondent prescribed 
opioids, which is not generally a successful treatment for chronic 
headaches, especially migraine headaches. Tr. 230-31; GX 12.
    [Dr. Munzing opined that Respondent did not meet the standard of 
care for evaluating and monitoring J.K. Tr. 232.] The Respondent's 
documentation of J.K.'s medical records did not establish that 
Respondent met the standard of care because there was no comprehensive 
history regarding mental health issues or prior alcohol or drug use: 
there were no prior medical records; there were multiple unresolved 
aberrant drugs screens; and vital signs were not taken at every visit. 
Tr. 232-33. There was also limited, vague documentation regarding the 
patient's cancer diagnosis with no information regarding oncology 
doctors, chemotherapy, or treatment for cancer pain. Tr. 233-34. 
Overall, the medical history done for J.K. did not justify the high 
dosage of medications that the Respondent prescribed to her. Tr. 234. 
The standard of care would require a detailed medical history and past 
medication history, specifically discussing the patient's breast 
cancer, and a history regarding the patient's headaches in general, 
including any treatments that had been attempted as well as 
consultations with other doctors. Tr. 234-35. [According to Dr. 
Munzing, each of these elements was missing. Id.] The Respondent also 
failed to adequately document the risks and attempts to moderate the 
risks, and there is no evidence of informed consent in the file. Tr. 
235, 446, 448, 458.
    The Respondent issued controlled substance prescriptions to J.K. on 
November 28, 2016, which included: (1) Fentanyl patch,\20\ 75 
micrograms ever hour to change every four hours; (2) Percocet 10 
milligrams, 180 for 30 days, 6 per day; (3) Soma, a muscle relaxant; 
and (4) Nuvigil, which is a stimulant. Tr. 235-236; GX 13. The 
combination of the Percocet and fentanyl patch equals 360 MME. Tr. 237. 
[Dr. Munzing testified that Soma ``is a respiratory depressant . . . 
[and it is] fairly habit forming or addicting. . . . [I]t is part of a 
dangerous triad; an opioid, Soma and a benzodiazepine is referred to . 
. . as the trinity or the holy trinity.''] Tr. 238. In fact, many 
organizations stopped prescribing Soma ten years ago. Tr. 238-39. The 
patient's pain level of four out of ten would not justify a higher 
level of opioids and in fact, the standard of care would dictate trying 
other modalities prior to prescribing opioids. Tr. 239-40; GX 13.
---------------------------------------------------------------------------

    \20\ A fentanyl patch is like a large band aid that works by 
absorbing through the skin over a period of time, and is really 
meant to be prescribed on a 3-day basis because when it is used 
every two days, the MME calculation is higher, but it is a long-
acting opioid. Tr. 236-37. Sometimes a patient can have difficulty 
using the fentanyl patch and in this instance there are several ways 
to help keep it stuck in the skin, and if they are not successful, 
the doctor should stop prescribing the patch and instead prescribe 
oral medication. Tr. 237-38, 452-53.
---------------------------------------------------------------------------

    [The combination of fentanyl and Percocet was prescribed a number 
of occasions, but] there was no justification as to why J.K. was 
prescribed this combination or the very high doses, and therefore these 
prescriptions were not issued in the usual course of professional 
practice or for a legitimate medical purpose. Tr. 240-41. [Dr. Munzing 
opined that every time Respondent prescribed a combination of fentanyl 
and Percocet to J.K., it was outside the usual course of professional 
practice. Tr. 241.] On January 29, 2017, the Respondent prescribed 
medications to J.K. that equaled 405 MME, without justification 
provided in the medical records, and outside the usual course of 
medical practice and without a legitimate medical purpose. Tr. 242-44; 
GX 13. On August 18, 2017, the Respondent changed J.K.'s prescription 
by switching the fentanyl patch and added OxyContin and oxymorphone ER, 
which would be 450 MME. Tr. 244. J.K.'s opioid prescriptions were 
therefore being increased without any justification for doing so 
documented in the medical records [and without trying

[[Page 24238]]

other treatment options,] which violates the standard of care. Tr. 245. 
The prescriptions were therefore not issued in the usual course of 
professional practice or for a legitimate medical purpose. Tr. 244-47.
    On November 10, 2017, J.K. had an office visit; the record stated 
that her pain level was 4 and that the Respondent would continue 
prescribing her current medications, making these prescriptions outside 
the usual course of professional practice and not for a legitimate 
medical purpose. Tr. 247-48. Patient J.K. had another visit on January 
8, 2018, but there were no documented vital signs and there was nothing 
written under the objective assessment plan, which violates the 
standard of care; therefore, the prescriptions issued at this time were 
not issued in the usual course of professional practice or for 
legitimate medical purpose. Tr. 248-49. On February 9, 2018, the 
Respondent replaced OxyContin with oxycodone without any justification 
for doing so documented in the patient record,\21\ which does not meet 
the standard of care. The prescriptions were not issued in the usual 
course of professional practice or for a legitimate medical purpose. 
Tr. 249-55. GX 13. On October 16, 2018, the prescriptions totaled 330 
MME and there was no justification for providing these prescriptions 
documented in the record. Tr. 255-56; GX 13. Furthermore, there was a 
note in the record that J.K. was taking leftover pain medication, which 
means that she was not following the directions of the Respondent and 
may be receiving a higher dosage than she needed. Such prescribing is 
contrary to the standard of care. Tr. 256-57.
---------------------------------------------------------------------------

    \21\ The Respondent's counsel objected to this questioning and 
noted that it was a nurse practitioner who met with J.K. regarding 
the prescriptions for February 9, 2018, and not the Respondent. Tr. 
252. The Government clarified with Dr. Munzing that the Respondent 
should have been aware of these prescriptions that went out under 
Respondent's name. Tr. 252-53.
---------------------------------------------------------------------------

    There is also a note in the file from an incident that occurred on 
October 12, 2018, when J.K. called the office and stated that she was 
unsure if she would be alive tomorrow and ``she [is] going to drive off 
the road due to not getting [her] prescription.'' Tr. 258. Dr. Munzing 
noted that this was a very alarming note and that to a reasonable 
person, this would indicate that J.K. was suicidal. Tr. 258. The 
standard of care for a doctor with a patient who is on high opioids and 
has suicidal ideations is to get that patient immediate care, look into 
the patient's mental health history, work with other providers such as 
a psychiatrist, and come up with a plan. Tr. 259. Typically, a doctor 
would not continue the medications being prescribed and would work to 
develop a possible management plan for the patient. The standard of 
care would also require that the doctor have a discussion with the 
patient on a subsequent visit, [but Respondent did not.] Tr. 259-60. 
The October 16, 2018, prescription was therefore written outside the 
usual course of professional practice and was not for a legitimate 
medical purpose. [Dr. Munzing explained that it was ``dangerous'' to 
continue to prescribe opioids in this manner for a patient with 
suicidal ideation. Tr. 260. ``You may give a three-day dosage or 
something, recognizing that if this person is suicidal you may be 
providing them the wherewithal and the means to do it.'' Id.]
    J.K. also had inconsistent urine drug screens on April 27, 2017, 
February 9, 2018, March 19, 2018, June 4, 2018, and July 31, 2018, 
which showed the presence of THC, or marijuana, and amphetamine. Tr. 
261, 263, 270. This is problematic because it was not a prescribed 
medication, and taking marijuana, even if it were legally prescribed, 
while on a high dosage of opioids adds a risk to the patient. Tr. 262-
63. J.K. also tested positive for amphetamine, which is a stimulant and 
can be addictive and dangerous. Tr. 263-64. There is no indication that 
this was part of J.K.'s management plan with the Respondent, and even 
if the amphetamine was prescribed by another doctor, it should be very 
clearly documented in the medical records along with informed consent. 
Neither controlled substance was in J.K.'s medical records. Tr. 264-
66.\22\ J.K. tested positive for amphetamines again on May 12, 2017, 
and September 15, 2017. Tr. Tr. 267; 269; 270; GX 13. There is no 
indication in the record that the Respondent discussed any of these 
aberrant drug screens with J.K. at subsequent office visits. [Dr. 
Munzing opined that there was no evidence that Respondent addressed 
J.K.'s inconsistent drug screen results at all. Tr. 267.] There was 
some indication that Respondent's nurse practitioner had discussions 
with J.K. regarding risks on March 7, 2018,\23\ and March 21, 2018,\24\ 
[but Dr. Munzing testified that those discussions, as documented, were 
insufficient to satisfy the requirement for obtaining informed 
consent.] Tr. 266-67; 268-69; 270; 279. This contributes to Dr. 
Munzing's opinion that the prescriptions written for J.K. were outside 
the usual course of professional practice and were not for a legitimate 
medical purpose. Tr. 266-67; 268-69; 270; 279.\25\
---------------------------------------------------------------------------

    \22\ On cross examination, Dr. Munzing stated that although he 
believed that J.K. was seeing a psychiatrist, who was prescribing 
Adderall and a benzodiazepine, these medications were not listed on 
the medication list and therefore the medications showing up in the 
urine screen were not consistent with what the medical records were 
documenting. Tr. 440-41. However, upon further pressing from counsel 
he agreed that the test would not be inconsistent if the patient was 
taking everything in its entirety, but that it would need to be 
documented. Tr. 442.
    \23\ On cross examination, the Respondent questioned Dr. Munzing 
about a note from the March 7, 2018 visit with Nurse Practitioner 
Pasco that mentioned a ``discussion'' and later stated ``patient 
understandable'' and Dr. Munzing stated that it could have referred 
to describing the risks of combining benzodiazepine and opioid 
together and in fact was more likely there was a discussion that 
there is a risk of those medication categories. Tr. 362-64, 67-68.
    \24\ On cross examination, the Respondent questioned Dr. Munzing 
about a note from the nurse practitioner from March 21, 2018, 
stating ``discussed risk of respiratory depression with concurrent 
opioid and benzodiazepine use . . . patient verbalized 
understanding'', which Dr. Munzing stated appears to seem that the 
nurse practitioner talked about the risk of respiratory depression 
from P.S.'s combined medications. Tr. 372-73. [But, Dr. Munzing made 
clear that there were other risks that did not have a documented 
discussion and that, overall, the discussion of risks was 
insufficient to meet the standard of care for informed consent. Tr. 
374-75.]
    \25\ On cross examination, the Respondent questioned Dr. Munzing 
about a visit with the Respondent and the note mentioned ``discussed 
to patient current CDC guideline and the need to decrease his opiate 
dose, his current morphine equivalent is 366 milligrams per day,'' 
which likely means there was a general discussion that the 
Respondent mentioned the CDC guidelines say 90 MME, and the patient 
is currently at 366 MME. Tr. 375-76; GX 10 at 544, 550. Dr. Munzing 
had no objection to the statement in the note itself, [text omitted 
for clarity] but noted that whether it meets the requirement for 
informed consent is a different question. Tr. 377.
---------------------------------------------------------------------------

    Dr. Munzing reviewed the medical records that pertained to the 
treatment of J.K.'s breast cancer, including records from her 
oncologist. Tr. 279. Reviewing these records informed Dr. Munzing's 
opinion that J.K. had been cancer-free for at least four years, so the 
Respondent was not prescribing opioids to J.K. for end stage 
cancer.\*J\ Tr. 279-81. Overall, Dr. Munzing opined that each of the 
relevant prescriptions to J.K. were issued outside the standard of care 
in a ``multitude of standard of care elements that should have been 
done and weren't done,'' were not medically justified as prescribed, 
and were not within the usual course of professional practice, and they 
put the patient at a higher risk. Tr. 281.
---------------------------------------------------------------------------

    \*J\ Dr. Munzing testified that the standard of care when 
prescribing for end stage cancer is different. Tr. 281.
---------------------------------------------------------------------------

Patient D.L.
    D.L. is a patient who is in her late 60's/early 70's. Tr. 287. 
Overall, Dr.

[[Page 24239]]

Munzing's review of D.L.'s medical records indicated that the 
evaluation and monitoring the Respondent did for D.L. did not meet the 
standard of care, and the opioid prescriptions issued to D.L. were not 
medically justified nor issued in the usual customary medical practice 
in the State of California. Tr. 282-83. [The medical history was 
``cursory . . . and lack[ed] detail.'' Tr. 282.] Furthermore, the 
Respondent did not [attempt to obtain] prior medical records, which was 
mandated by the standard of care. Tr. 283.
    The Respondent prescribed D.L. lorazepam, Percocet, morphine 
sulfate, and oxymorphone, with an initial MME of 455.\26\ Tr. 283-86; 
288; GX 14; 15. D.L. was also prescribed Lunesta, a sleeping agent and 
respiratory depressant that has the potential risk of habit-forming 
addiction as well as the increase the risk of overdose when prescribed 
in combination with opioids. Tr. 286. Furthermore, adding a sleeping 
medication increases the risk, especially when taking into account 
D.L.'s age. Tr. 286-87. [Dr. Munzing testified that over the three-year 
period of treatment, the ``extremely high dose medications'' did not 
``show that there was significant improvement'' in the pain level. Tr. 
289.] There was no justification for prescribing a benzodiazepine 
(lorazepam) and a sleeping agent, and there was no informed consent. 
Furthermore, at a visit on May 31, 2018, the Respondent wrote a note 
indicating that Percocet would be decreased; but in reality, the 
Respondent increased the Percocet prescription. 295-96; GX 15 at 445. 
The record also indicated that D.L. had been consulted regarding her 
MME of 410, which was above the recommended 90 MME dosage by the CDC 
guidelines, and that the patient would be seen once a week until 
decreased. Tr. 297. Although the MME was mildly decreased over time, 
there was no evidence that the MME was significantly decreased and it 
remained at a dosage well above 90 MME. This note/discussion does not 
meet the standard of care in California and does not serve as an 
informed consent [because there was no documentation showing that the 
``exceedingly high risk of the opioids,'' including ``addiction, 
overdoses, [and] death,'' were discussed with the patient whose age 
``adds to the patient's risk.''] Tr. 297-98. Furthermore, the 
Respondent did not start tapering the patient down slowly and carefully 
in order to mitigate the risk, nor did he look at alternative 
strategies to manage the patient's pain. Tr. 300.
---------------------------------------------------------------------------

    \26\ The Respondent also increased D.L.'s dosage of morphine 
sulfate on February 23, 2018. Tr. 288-89. There was no justification 
in the records for this increase to a higher MME.
---------------------------------------------------------------------------

    Dr. Munzing found that the relevant prescriptions violated the 
standard of care and were not issued in the usual course of medical 
practice or for a legitimate medical purpose. Tr. 287, 290, 292, 294, 
299, 301, 308, 309.
    D.L. had drug screens on March 23, 2018, (which was negative for 
oxycodone and lorazepam), April 20, 2018,\27\ (which was negative for 
oxycodone and lorazepam), and January 31, 2019, (which was negative for 
Percocet and Lunesta). Tr. 302-05. Nothing in the record showed that 
there was any discussion regarding the aberrant drug screens. Tr. 308. 
[And as Dr. Munzing opined, a physician ``needs to address [the reason 
for the inconsistency] and document the resolution if one is going to 
continue prescribing.'' Tr. 307.]
---------------------------------------------------------------------------

    \27\ The visit subsequent to this drug screen, on May 4, 2018, 
is silent as it pertains to resolving the aberrant drug screen and 
instead mentions that the patient had no aberrant behavior and none 
was reported. Tr. 304-05.
---------------------------------------------------------------------------

    As to the documented discussion the Respondent had with D.L. 
regarding using a pain pump, Dr. Munzing testified there was 
insufficient information to determine whether that was a reasonable 
alternative because there was not even two full lines of information in 
the medical record. Specifically, Dr. Munzing testified he could not 
``even come close to making that determination.'' Tr. 407-08. On June 
2, 2017, it appeared that the Respondent reviewed an X-ray of the hip 
and left knee and had a discussion regarding hip injections, but there 
is nothing documenting what the Respondent discovered from the X-rays. 
Tr. 408-09.

Respondent's Case-in-Chief

    The Respondent presented his case-in-chief through the testimony of 
five witnesses: (1) The Respondent, (2) D.P., (3) Dr. Wiederhold, (4) 
Dr. Joseph Shurman, and (5) D.L.
Patient D.P.\28\
---------------------------------------------------------------------------

    \28\ The Tribunal ruled that this patient witness could only 
testify relating to his discussions with the Respondent, his 
discussions with medical staff at the Respondent's office, treatment 
received, the regularity of treatment, but nothing relating to the 
patient's own evaluation of treatment, or efficacy of treatment 
because such discussion would require medical expertise. Tr. 504.
---------------------------------------------------------------------------

    Patient D.P. met the Respondent after a fall that resulted in five 
compression fractures and five fractured vertebrae in his back. Tr. 
507. He was in extreme pain and had several procedures that did not 
help him. At one point, he was bedbound and had some pretty dark times 
lying in bed, sweating through the pain. He saw lots of different 
doctors, but nothing really happened. At one point his mother 
recommended her doctor, [not Respondent,] who did not have a ``normal 
medical office;'' that physician told D.P. that there was no upper 
limit on pain medicine, and that as long as D.P. was ``breathing [he 
would] just increase it until [he is] comfortable.'' Tr. 507-08. At 
every visit he would pay that doctor in cash and that doctor would just 
``kind of double the dosage. . . [of] OxyContin.'' Tr. 508. After 
months of this prescribing, the other doctor ``closed up shop'' and 
``went back to Russia.'' Id. D.P. was then referred to the Respondent 
from the ER at Paradise Valley Hospital. In the meantime, D.P.'s 
primary care physician continued to prescribe the same level of opioids 
for many months until ``we kind of got things squared away'' and D.P. 
was able to see the Respondent. Tr. 508-09.
    According to D.P., Respondent seemed surprised to learn that D.P. 
was on such a high dosage and explained to D.P. that opioids can 
depress breathing, other sensory functions, digestion, libido, and 
affect pain reception. Tr. 511-13. The Respondent explained that D.P. 
needed to be brought down [from his high doses] and to be aware of 
symptoms, such as being tired, indicative of not breathing. Respondent 
told D.P. that even though D.P. was taking these prescriptions 
regularly, he could still potentially overdose. Tr. 513, 517. The 
Respondent gave D.P. a Narcan pack that could be used to reverse the 
effects of opioids on the body. Tr. 513-15.\29\ The Respondent also 
suggested that D.P. try some other treatments including injections and 
physical therapy, and said that they would ``work through this.'' Tr. 
517-18. Being on the opioids allowed D.P. to work and even volunteer 
and ``function[ ] like a normal person would.'' Tr. 519. D.P. was 
reluctant to lower his dosage because he was functioning pretty well 
and his pain range was between 2 and 4. Tr. 520.
---------------------------------------------------------------------------

    \29\ The Tribunal gave the Government a running objection on 
leading questions. Tr. 516.
---------------------------------------------------------------------------

    The Respondent had D.P. try injections and SANEXAS therapy,\30\ and 
physical therapy with his home health. Tr. 521, 522. The SANEXAS 
therapy, which is a unit that sends electrical stimulation to the body 
through a computer, helped his back relax a little, but did not help 
with his bone pain. Tr. 521-22.
---------------------------------------------------------------------------

    \30\ The SANEXAS therapy and injections were done in the 
Respondent's office. Tr. 526.

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

[[Page 24240]]

    D.P. was going to the Respondent's office once every week and 
usually saw the Respondent, but for some visits he saw a nurse 
practitioner who would always check to make sure he was breathing well. 
Tr. 522-24. Usually before seeing the Respondent, a nurse would take 
his blood pressure and weight, and he would usually do a drug screen. 
Tr. 525. The Respondent would listen to his heart, listen to him 
breathe, and feel for where the pain was by ``like push[ing] on [his] 
back.'' Tr. 525-26. At some point the Respondent explained to D.P. that 
he would not be able to prescribe to him at the level he was taking, so 
D.P. tried to go to a detox facility; he was ultimately admitted into 
Sharp Memorial Hospital and went through detox there. Tr. 528-29. The 
doctor at that hospital prescribed opioids upon his release. Tr. 529-
30. D.P. is currently being treated for pain. Tr. 531.
Patient D.L.
    D.L. has been the Respondent's patient for four or five years, 
maybe longer. Tr. 794. Her primary care physician referred her to the 
Respondent for her uncontrolled pain. Tr. 795. At that time, she was 
prescribed Narco or Percocet and lorazepam. The Respondent went into 
detail with her about the safety of those medications and how the 
combination could cause respiratory depression, and that she could die 
or they could lead to addiction. Tr. 797-99, 805. The Respondent also 
gave her Narcan spray at some point, with prescription refills. Tr. 
799-800. The Respondent discussed the importance of taking her 
medications as prescribed and her son dispenses her prescriptions to 
her. Tr. 801. She and the Respondent are working to bring her pain 
medications down and are looking into having an experimental implant in 
her back to help with the pain. Tr. 802, 806. The Respondent currently 
prescribes her Percocet, oxycodone, gabapentin, and another medication 
she could not recall. Tr. 803-04. The nurse practitioners in the office 
have also discussed the risks and safety issues with her. Tr. 804-05.
Mark Wiederhold, M.D.\31\
---------------------------------------------------------------------------

    \31\ [The Government objected to the qualification of Dr. 
Wiederhold as a witness primarily because he was not identified as 
an expert witness in Respondent's Prehearing Statement. Tr. 596, 
604.] The tribunal ultimately found that Dr. Wiederhold's summary in 
the Respondent's Prehearing Statement dated October 16, 2020, and 
the summaries filed as exhibits sufficiently described his testimony 
as an expert. Tr. 596-603. Tr. 603-04, 608.
---------------------------------------------------------------------------

    Dr. Wiederhold received his Ph.D. in Pathology at the University of 
Illinois and did a year fellowship in the Special Life Center for 
Multiple Sclerosis at the University of Chicago. Tr. 578. He started 
medical school at Rush Medical College and started his internship and 
residency at the Scripps Clinic in La Jolla; he finished in internal 
medicine and critical care. Tr. 578. He then took part in clinical 
trials and research programs, and he spent some years at the Science 
Applications International Corporation where he worked on national 
security issues including work with the DEA. Tr. 578-79, 604-05. He is 
not board certified because he failed the board exam and did not want 
to take it again. Tr. 579. He also periodically performs locums work, 
meaning he fills a temporary position within a medical group. Tr. 595, 
594.
    He has been seeing patients for thirty years. Tr. 577, 605. He has 
been in private practice for twenty one years at Virtual Reality 
Medical Center focusing on managing pain with non-narcotic methods \32\ 
for veterans with post-traumatic stress disorder. Tr. 576. He also 
treats patients with COVID. Tr. 576.
---------------------------------------------------------------------------

    \32\ He is currently working with a company that is developing a 
subcutaneous Naltrexone implant which can be very important for 
medication assisted therapy. Tr. 581. He is also working with 
another company that is looking for a way to objectify levels of 
pain, which involves looking at electroencephalogram (EEG) and other 
type of physiological signals to try to match those to identifiable 
levels of pain.
---------------------------------------------------------------------------

    He was on the staff at Scripps for fifteen years doing 
administrative work on review committees that reviewed charts of other 
physicians. Tr. 577. At Scripps Clinic, he reviewed patient charts for 
accuracy and completion, and to ensure that the doctors were meeting 
protocols. Tr. 579-80. This review included reviewing patients who were 
treated for chronic pain conditions. Tr. 580, 83.
    He was also an expert witness for the State of California in 
worker's compensation cases, many of which involved chronic pain 
management. Tr. 577. He said he has testified as an expert witness, but 
could not recall the name of the court/tribunal. Tr. 583-84. He was an 
internal medicine physician and ran the intensive care unit for many 
years; he has treated patients in the emergency room and in the 
emergent care section, so he has a lot of experience evaluating 
patients for pain management. Tr. 577-78. [Dr. Wiederhold was qualified 
in this matter as ``an expert in pain management.'' Tr. 608.]
    At the request of the Respondent's counsel's office, Dr. Wiederhold 
became involved in the instant case and was asked to review medical 
records and evaluate the quality of care provided to four patients.\33\ 
Tr. 584, 606. He evaluated these patients on three levels: (1) He 
generally made sure that he understood the types of patients that were 
being seen and the complexity of the patients; (2) he prepared a number 
of metrics to make some type of objective record; and (3) he made sure 
he understood the complexities and difficulties of dealing with the 
Government-supported healthcare system. Tr. 607.
---------------------------------------------------------------------------

    \33\ The Respondent's counsel showed Dr. Wiederhold Respondent 
Exhibits S, T, U, V and he confirmed that he prepared these exhibits 
in the course and scope of reviewing the patient records for D.P., 
D.L., J.K., and P.S. respectively. Tr. 586-88. The tribunal later 
allowed Dr. Shurman to be recalled to testify that the page numbers 
listed in the exhibits may not actually correspond to the date in 
the medical records. Tr. 807-816. The Respondent also offered 
Exhibit F into evidence and the Tribunal admitted the document into 
evidence over objection. Tr. 817-18.
---------------------------------------------------------------------------

    He confirmed that he drafted reports with Dr. Shurman, and he has 
worked with him for five or six years in developing new pain programs. 
Tr. 589. The two of them discussed their findings from reviewing the 
record and their opinions and thoughts about the management of these 
patients. He does not currently practice pain management or see pain 
patients. Tr. 590. Although he previously prescribed controlled 
substances, he does not currently prescribe controlled substance at the 
Virtual Reality Medical Center. Tr. 593-94. He agreed that the standard 
of care requires sufficient documentation in medical records to justify 
controlled substance prescriptions to patients, which is for the 
patient's well-being and also protects the doctors. Tr. 595-96. Doctors 
are also responsible for reviewing their patient's medical records to 
ensure they are accurate and complete. Tr. 596.
Dr. Shurman \34\
---------------------------------------------------------------------------

    \34\ The Respondent's counsel posed hypothetical questions to 
Dr. Shurman throughout this testimony. The Government's counsel 
noted this on cross-examination and Dr. Shurman admitted that the 
questions were posed as hypotheticals because the discussions were 
not documented in the medical records. Tr. 728-29.
---------------------------------------------------------------------------

    Dr. Shurman attended Temple University for his undergraduate 
education and then attended Temple Medical. Tr. 612. He then went to 
Mass General, Harvard's residency in anesthesia and intensive care. Tr. 
612, 613. He then worked at the University of Washington for four or 
five years, where the first model pain center for the country started, 
and then he came to Scripps as a clinical instructor. Tr. 612-13, 615, 
616. He believes that he was one of the first full-time pain 
specialists in the country. Tr. 616, 639. When he

[[Page 24241]]

moved to San Diego, he joined the Anesthesia Service Medical Group, 
where he was the Chairman of Pain Management and head of Medical 
Research. Tr. 617. He has been the Chairman of Pain Management at 
Scripps Memorial Hospital for many years; he consults for multiple 
companies primarily in alternative forms of care, he serves as the co-
chair for Palliative Care at Scripps, and he is involved in six or 
seven research projects to try to address the opioid epidemic, 
addiction, and the use of alternative forms of therapy. Tr. 610-12, 
617. He has been the treating physician for approximately twenty to 
thirty patients in the last three years prescribed with high dose 
opioids, including patients who have also been prescribed either 
benzodiazepines, muscle relaxant medications, or other medications. Tr. 
632-33, 635, 638-39. He would slowly taper patients off high doses of 
opioids, and testified that it should be a long-term goal to attempt to 
gradually taper patients off high-dose opioid use. Tr. 636, 726. In 
fact, he opined, it can take as long as three years to gradually and 
safely taper a patient. Tr. 727. In the last ten years, he has 
prescribed patients over 1,000 MME. Tr. 637.
    He has worked with the California Medical Board as a reviewer and 
expert and has testified in cases involving pain management as an 
expert witness. Tr. 628-29. The standard of care is what a reasonable 
pain management specialist would do when treating patients in the San 
Diego community. Tr. 629, 733-35. He has met with other pain management 
specialists at conferences and gatherings. Tr. 643. [Dr. Shurman was 
qualified in this matter as ``an expert in pain management and 
treatment.'' Tr. 640.]
    In 2016, there were no upper MME limits if a doctor had a difficult 
patient that had multiple surgeries. Tr. 630. The guidelines were more 
for risk stratification and in 2016, the CDC implemented its guidance 
regarding 90 MME, which was primarily for family practice doctors. If a 
patient was prescribed above 90 MME, then the recommendation was for 
the doctor to refer the patient to a pain specialist. Tr. 630-31.
    The standard of care requires that a doctor have complete and 
accurate documentation of patient treatment in the medical records and 
sufficient documentation to justify controlled substance prescriptions, 
which protects the doctors as well as the patients. Tr. 720-21. It is 
also the doctor's responsibility to review patient medical records and 
ensure they are complete and accurate. Tr. 720. [Dr. Shurman agreed 
that ``patients on high-dose opioids are put at a higher risk for other 
problems.'' Tr. 721.]
    It was within the standard of care at the time of an initial visit 
to keep a patient on his existing medication level, even if he was on 
high-dose pain control medications or a combination of anti-anxiety 
drugs, benzodiazepines, or muscle relaxants, if the patient was already 
on these drugs for some time. This is because, according to Dr. 
Shurman, it is important to get to know the patient and make a plan to 
slowly taper. Tr. 630-32, 640-41. The standard of care from 2016-2019 
did not require that a physician take a patient's vital signs at every 
visit when the patient was prescribed above 90 MME. Tr. 642-43. The 
Respondent's frequency in taking vitals was within and even above the 
standard of care for the four patients because the Respondent was using 
pulse oximetry to measure the oxygen saturation levels of his patients 
and monitor for respiratory depression. Tr. 644-46.
    Dr. Shurman opined that the standard of care does not require that 
a doctor examine the same area on the body every week or every two 
weeks; a limited exam every month or two is sufficient [``unless the 
patient has a complaint . . . or an exacerbation.''] Tr. 648. Pain 
management agreements are important for the doctor to have a discussion 
with his patients about the risks of psychological dependency, 
addiction, physical dependence, and side effects. Tr. 649. Executing a 
pain management agreement with a patient as a way of having an informed 
consent discussion was the standard of care. Tr. 650-52. Dr. Shurman 
reviewed the pain management agreements available in this case, [but he 
did not clearly testify that the pain agreements here, absent a 
documented discussion, were sufficient to meet the standard of care for 
informed consent.] Tr. 652-54.
    During the period from 2016 to 2019, the standard of care was to 
review CURES Reports for patients on high doses of opioids every four 
months and the Respondent met this standard of care for all four 
patients. Tr. 665-66. According to Dr. Shurman, addiction is when a 
patient is ``crushing . . . injecting . . . diverting . . . selling and 
all that.'' Tr. 680-82. The standard of care in California allows 
physicians to have different opinions about the alternative methods of 
treatment of patients. Tr. 701.

Overview

    For this case, Dr. Shurman spent approximately ten hours reviewing 
the Respondent's medical records (which included the time ``he 
dream[ed] about [the case]'') and the summary prepared by Dr. 
Wiederhold, which assisted in his opinion about this case. Tr. 718-19. 
Dr. Shurman prepared, signed, and reviewed the reports, which were 
identified as Respondent's Exhibits S, T, U, and V. Tr. 618-20.
    Dr. Shurman opined that the Respondent met the standard of care in 
terms of informed consent for all four patients based on the Respondent 
offering Narcan and performing the oximetry [which, according to Dr. 
Shurman, reflected that Respondent ``was concerned.''] Tr. 655-56. The 
existence of pain management agreements is very important. Tr. 656. The 
Respondent's actual documentation should have been better than it was 
in some areas for all patients. Tr. 669-71.
    Legacy patients are long-term patients who have been brought in on 
high-dose opioids. Tr. 687-88. [Dr. Shurman clarified that all of the 
patients at issue in this case are legacy patients and suggested that 
the standard of care for them was different than for patients who are 
new to pain management.*K Id. (``When you look at the 2016 
guidelines, the focus is really on new patients.'')] The CDC guidelines 
suggest to slowly taper such patients if possible. Tr. 729.
---------------------------------------------------------------------------

    \*K\ The CDC Guidelines do address prescribing for patients who 
are new to opioids; however, they also clearly address patients who 
use opioids long-term and even patients who are new to the clinician 
but on long-term opioid therapy. See GX 5. Accordingly, I disagree 
with Dr. Shurman's suggestion that the CDC Guidelines do not apply 
to legacy patients.
---------------------------------------------------------------------------

    All of the Respondent's patients had some organic source for their 
chronic pain conditions and the Respondent explored alternative means 
of trying to help these patients with their chronic pain problems. Tr. 
695-96. Dr. Shurman opined that it was excellent that the Respondent 
tried various other avenues besides medications, including electric 
stimulation, injections, and medications other than opioids. Tr. 696. 
The Respondent also conducted pharmacogenetic testing, which identified 
that some patients were rapid metabolizers, which would need to be 
taken into consideration when reviewing urine screens; such a diagnosis 
would be important to document in the patient's medical record. Tr. 
696-99, 731. The Respondent closely monitored all his patients. Tr. 
707. When treating these four patients who were on high-dose MMEs and 
combinations of medications such as benzodiazepines, muscle relaxants, 
or sleep medication, it is a balancing of risks versus benefits in

[[Page 24242]]

deciding how to manage the patient and it depends on the patient. Tr. 
711. None of the risks manifested in these four patients while the 
Respondent was treating them, and Dr. Shurman opined that the 
Respondent had really good judgment. Tr. 712.

Patient D.P.

    Regarding D.P., Dr. Shurman testified that the standard of care 
would require that, at the initial visit, the doctor have a discussion 
with the patient and try to taper down his dosage slowly as he had been 
prescribed approximately 3,000 MME by a previous physician, which is an 
unusual situation. Tr. 653-54, 657, 660-61, 685. The standard of care 
would also require that the Respondent talk about the risk of addiction 
and the risk of overdose. Tr. 654. The records did reflect that D.P. 
was provided Narcan, which is used to reverse the effects if someone 
has a severe respiratory depression. Tr. 654. The notes in the medical 
records also showed that the Respondent had discussions about trying to 
taper D.P. Dr. Shurman testified there was a risk in quickly decreasing 
D.P.'s MME as there was a study that forced tapers led to forty-three 
percent of the patients being hospitalized. Tr. 657-58, 726.\35\
---------------------------------------------------------------------------

    \35\ [Footnote modified for clarity. On cross-examination, Dr. 
Shurman stated that he ``[did not] find specific documentation of a 
discussion'' between Respondent and D.P. regarding the ``various 
risks associated with him taking opioids at such a high dose.'' Tr. 
722-23. However, he inferred these discussions occurred because the 
pain management agreement said ``he will discuss other side effects 
with the patient.'' Tr. 723. And without such a conversation, ``why 
did he use an oximeter, why did he give the patient Naloxone, . . . 
there's obviously a reason for it.'' Tr. 723. However, Dr. Shurman 
ultimately agreed that he ``never saw anything in the medical 
records that documented a discussion about the high risks due to 
high-dose opioids.'' Tr. 723-24.]
---------------------------------------------------------------------------

    It was evident that the D.P. remained relatively safe under the 
Respondent's care because D.P. was clear and alert; his urine 
screens,\36\ oximetries, and CURES were appropriate; and he had a 
quality of life. Tr. 658. D.P. had a painful condition called chronic 
cellulitis. Tr. 660. He went to a detox center and ultimately ended up 
with severe withdrawal and pain. Tr. 667-68. When he was at UCSD, the 
doctors there continued to prescribe him the same medications. Tr. 659. 
Dr. Shurman disagreed with Sharp's detox treatment in 2019. Tr. 726-27.
---------------------------------------------------------------------------

    \36\ Urine screens are used for multiple purposes including to 
make sure that a patient is taking his prescriptions and to monitor 
illicit drugs. Tr. 661. In D.P.'s case, the Respondent went above 
the standard of care regarding urine screens because it is an 
undeserved population and such screens only need to be done about 
every three months. Tr. 662-63, 725. The urine screens for the other 
three patients were also excellent and above the standard of care, 
as they were the more costly, confirmatory urine screens. Tr. 663-
64.
---------------------------------------------------------------------------

    The standard of care requires that a doctor make an attempt to 
obtain patient records, but in this instance, the Respondent had D.P. 
as a patient in the past. Tr. 687. It would be a good idea to get 
records, but it is in the Respondent's judgment if he knows the patient 
well.*L Tr. 686. It is also better to document any 
discussion with patients, but Dr. Shurman made inferences that such 
discussions were had based on the different things Respondent did 
during exams. Tr. 724-25. Looking at the prescriptions for D.P., [Dr. 
Shurman opined that] these prescriptions were within the standard of 
care. Tr. 687.
---------------------------------------------------------------------------

    \*L\ Sentence moved for clarity.
---------------------------------------------------------------------------

Patient J.K.

    Assuming the Respondent had discussions with J.K. about the urine 
drug screen reflecting the presence of amphetamine and about her 
prescriptions for medical marijuana, and assuming he checked CURES to 
verify the amphetamine prescription,*M Dr. Shurman opined 
that it was appropriate for the Respondent to continue J.K.'s 
prescriptions despite the fact that she was taking marijuana. Tr. 672-
74. However, such discussions should be in the medical 
records.*N Tr. 727-28. Dr. Shurman has encountered 
circumstances where fentanyl patches did not properly adhere to 
patients, which is a common problem. Tr. 675. J.K. was also on hormone 
therapy which could cause excessive perspiration. Tr. 709. Assuming the 
Respondent had discussions with J.K. regarding why the fentanyl 
derivative was not in her system, it was within the standard of care 
for him to continue to treat her with medication. Tr. 676. Patients 
will not always take medications as prescribed and the doctor should 
look at the average of what their patients are taking.*O Tr. 
677-78.
---------------------------------------------------------------------------

    \*M\ Sentence modified for clarity.
    \*N\ Dr. Shurman testified that, ``one of the things [Respondent 
is] going to improve on [is] to take an abnormal screen, document in 
his records and in certain cases discuss it with the patients. But 
[there is] no lapse in his clinical judgment.'' Tr. 728.
    \*O\ Specifically, Dr. Shurman testified, ``[t]here are side 
effects sometimes, nausea, constipation. And sometimes they're 
having a good day, they may not take it. Or sometimes they're having 
a bad day and they may take more. And to kind of look at the average 
of what these patients take, . . . sometimes it may not show up.'' 
Tr. 678. He went on to testify that the standard of care did not 
require that a physician immediately taper medications or refer a 
patient to an addictionologist following an aberrant drug screen. 
Tr. 679. Instead, ``you talk to them about [the aberrancy]'' and if 
the patient says they are ``taking more than they usually take . . . 
to stabilize their pain . . . [then you] don't consider it aberrant 
behavior.'' Tr. 682.
---------------------------------------------------------------------------

    The Respondent attempted to treat J.K.'s migraine headaches with 
Botox while she was seeing an oncologist for her breast cancer. Tr. 
699-700. It is considered a controversial position, but some doctors, 
including Dr. Shurman believe it is appropriate to use higher doses of 
opioids to treat resistant or intractable migraines, which is within 
the California standard of care. Tr. 700-01. Overall, [Dr. Shurman 
opined that] the Respondent's prescriptions for J.K. were acceptable 
within the standard of practice under the circumstances. Tr. 702.

Patient P.S.

    P.S.'s pain scale reporting did not change much over time and it 
would have been difficult to taper his prescriptions due to his chronic 
pain problems. Tr. 689-91; RX U. Regarding the aberrant drug screens, 
Respondent followed the standard of care of P.S. as long as he had a 
discussion with him because Respondent followed him closely with CURES, 
urine screens, etc., to ensure there is not an ongoing problem. Tr. 
692-94. Based on a review of P.S.'s medical record, P.S. had an anxiety 
disorder. Tr. 695. Overall, the prescriptions the Respondent prescribed 
to P.S. were prescribed within the acceptable standards of practice 
under the circumstances, as P.S. was a very challenging patient. Tr. 
699.

Patient D.L.

    The Respondent treated D.L. with opioid medication, 
benzodiazepines, and a sleep medication, Lunesta.\37\ Tr. 702, 706. 
Although there is a black box warning about prescribing ``benzos'' and 
opioids, the doctor may still prescribe the combination after 
considering the risks/rewards and following the patient carefully. Tr. 
706. It was within the standard of care for the Respondent to continue 
D.L. on those medications at the initial visit because she had colon 
cancer, polyneuropathy, hip pain, and a failed spine surgery. Tr. 702-
03. As that was Respondent's first time meeting the patient, the 
Respondent would not want to promptly start to taper the patient and 
should ``get a feel for them'' by getting a history, urine screens, 
CURES, etc. before making a decision. Tr. 703. The Respondent did 
pursue these urine drugs screens and CURES reports in this 
instance.\38\ Dr. Shurman disagrees with

[[Page 24243]]

Dr. Munzing's opinion that every single prescription for patient D.L. 
was below the standards of practice and in fact [opined that] the 
Respondent's prescriptions for D.L. were within the standard of care. 
Tr. 707-08. D.L.'s reported pain level stayed around five or six-of-ten 
throughout treatment, which is an indication that overall the treatment 
was effective for her and is in fact a doctor's goal. Tr. 711.
---------------------------------------------------------------------------

    \37\ Dr. Shurman clarified that Lunesta, or a sleeping agent, is 
not part of ``the Holy Trinity.'' Tr. 706. [Text from preceding 
sentence omitted for clarity.]
    \38\ At this point in the testimony the Government's counsel 
noted that the document Dr. Shurman was using had highlights and 
notes. Tr. 704. The Respondent's counsel emailed the document to the 
Government's counsel at the next recess. Tr. 705.
---------------------------------------------------------------------------

Brenton D. Wynn, M.D. (the Respondent)

    The Respondent grew up in San Diego and graduated from UCLA with a 
bachelor of science in physiological sciences. Tr. 469. He attended 
Howard University College of Medicine and received his M.D. in 1998. He 
did his first year of preliminary internal medicine at Good Samaritan 
Regional Medical Center in Phoenix, Arizona, and started his physical 
medicine and rehabilitation residency program at Stanford University 
Medical Center. He then went to the Louisiana State University Health 
Science Center for a fellowship in musculoskeletal and interventional 
spine medicine.
    In 2004, he went back to San Diego and became the only pain 
physician affiliated with Paradise Valley Hospital in National City, 
where he maintained the practice for ten years. Tr. 469, 475. He is 
board certified in both physical medicine rehabilitation and pain 
medicine. Tr. 470. He then started with another group in 2014, where 
his focus was on pain management patients, but left that group in May 
2016 to begin the process of rebuilding his own private practice. Tr. 
475-76. From 2014-2016, he also worked at the Paradise Valley Hospital 
Outpatient Senior Health Center, where he did pain management or pain 
medicine. Tr. 476.
    He currently works in outpatient medicine, primarily doing 
interventional procedures four days a week. He has two nurse 
practitioners in the practice that assist him with the evaluations and 
management of the patients. Tr. 477. Eventually, Respondent was able to 
secure his practice location separate and apart from the Senior Care 
Facility. Tr. 478. He is currently leasing a space in National City. He 
is the only pain management doctor that services this area of National 
City, of approximately 62,000 patients. Tr. 479-80. About sixty percent 
of the Respondent's patients use Medicare, and the vast majority of the 
remaining patients are under some sort of IP or managed care plan that 
is a Medi-Cal or Medi-Cal-affiliated program. Tr. 480.
    When he was at the Senior Health Center, he used the hospital-based 
electronic record system and his primary entry method was through 
dictation. Tr. 481. He currently uses Practice Fusion, a free internet-
based electronic health record system, which he was using once the four 
patients came to him at the new location. Tr. 481-82. During this time 
he worked with a receptionist, an office manager, a practice manager, 
medical assistants, a biller, and nurse practitioners that were hired 
and staffed through a management company but were ``not technically'' 
his employees. Tr. 483-84. He currently uses a scribe to enter 
information into the EMR for better record entry, while his nurse 
practitioners enter the notes themselves. Tr. 484-85.
    Since Dr. Wynn received the subpoena for this case, he has tried to 
enhance his recordkeeping practices and enrolled in courses through the 
University of San Diego School of Medicine and the PACE Program that 
focused on recordkeeping and prescribing controlled substances. Tr. 
488, 490.*P He has stayed abreast on current thinking in his 
area of chronic pain management over the last five years by attending 
conferences, where there is a PME available, reaches out to fellow 
colleagues to have dialogues about treatment or new ideas, and attends 
educational events where pharmaceutical representatives present 
information. Tr. 567. In 2019, he sat and recertified for his Pain 
Boards, which required numerous hours of review. Tr. 567. He also 
attended multiple national meetings.
---------------------------------------------------------------------------

    \*P\ When Respondent was asked whether he had ``any thoughts or 
opinions about whether or not the recordkeeping for these patients 
in some areas . . . was adequate enough for purposes of good 
recordkeeping,'' he answered ``I would say that some areas are 
appropriate.'' Tr. 488. Then when asked whether ``there are any 
areas that in your opinion, looking back now at these records, that 
you feel are less than adequate for what they should be?'' 
Respondent answered ``Yes, I do.'' Id.
---------------------------------------------------------------------------

    The Respondent saw all four of the patients at issue in his current 
practice and had been treating them prior to establishing his current 
practice. Tr. 491-92. All of these patients were already prescribed 
opioids when they first met with the Respondent. Tr. 492. When patients 
enter the Respondent's office, they check in at the front with the 
receptionist, and there is a process to verify their eligibility, 
address, and insurance information. Tr. 538. Patients then fill out a 
pain diagram and sit in the waiting room. Patients then have their 
height, weight, and temperature taken and are taken to the exam room, 
where vitals, including blood pressure and maybe temperature are taken. 
Medical assistants (hereinafter, MAs) ask some of the questions that 
are done on the subjective. That information is then discussed with the 
provider who will see them at the visit. The CURES report and previous 
drug screen are reviewed if that patient is there for a refill visit 
prior to the provider entering the exam room. Tr. 538-39. The provider 
then typically discusses the patient's history and any new or ongoing 
concerns, performs a physical exam, reviews any documentation such as 
imaging studies or nerve conduction studies or information from a 
primary care doctor, and discusses the treatment plan.*Q Tr. 
539. Since COVID, the vast majority of medication refill visits are 
done through telemedicine. Tr. 539. Prior to COVID, it was his 
customary routine to do an exam and put his hands on the patient, which 
could include listening to the heart, lungs, and respiratory rate, 
observing their gait, and palpating the area of concern. When he 
prescribed a significant amount of opioids, he also provided Narcan. 
Tr. 753.
---------------------------------------------------------------------------

    \*Q\ With regard to the treatment plan's timing for titration 
down from high levels of opioids, Respondent believed ``there's a 
right time to initiate doing some changes to a patient, and I would 
prefer to do it when the patient is able to comply and buy in 
because they're a lot more stable with their current pain or pain 
and anxiety control.'' Tr. 771.
---------------------------------------------------------------------------

    In the beginning of the practice, they were still getting 
acclimated to the Electronic Health Records (``EHR''), so some things 
were missing in the medical records, but as time went on, there was 
improvement with the vitals ``actually making it into the chart and the 
documentation making it into the chart.'' Tr. 540. For instance, 
earlier in the practice, the MAs would write vital signs on a sticky 
note and the Respondent did not know if they always ``ended up in the'' 
medical record. Tr. 540-51. He currently continues to see P.S. and D.F. 
as patients. Tr. 747. None of his patients, have experienced the risks 
of overdose, addiction, or significant respiratory distress to the 
point that they needed Narcan or to call 911 while he was treating 
them. Tr. 748-49.
    As to all his patients, he believed he was within the range of the 
accepted standard of care, setting aside the issue of documentation, 
because he conducted a thorough examination at each initial visit, 
reviewed CURES, gave urine screens, reviewed any documentation provided 
by previous physicians, discussed the treatment plan, went through a 
controlled substance agreement, discussed the use

[[Page 24244]]

of Narcan, discussed the risks of opioid-use, and discussed the CDC 
guidelines. Tr. 764-68. Some of the areas of the medical records were 
less than adequate. Tr. 488.
    Respondent agreed that the standard of care requires sufficient 
documentation in the medical records to justify controlled substance 
prescriptions to patients [and requires complete and accurate medical 
records], which protects the doctors as much as it helps the patients. 
Tr. 778-80. Doctors are also ultimately responsible for preparing those 
complete and accurate medical records. Tr. 780. He currently serves 600 
active patients and has approximately 7,000 patient visits annually. 
Tr. 830.

Patient D.P.

    Patient D.P. was referred to the Respondent for pain management in 
approximately 2014. Tr. 493. Patient D.P. went to another doctor at 
some point and then returned to the Respondent's care when he opened 
his new practice. Tr. 493-94. When D.P. returned, he was on a high 
level of opioids and the Respondent had never taken care of any 
patients who were at that high of a level of controlled substances 
prescriptions. Tr. 494-95. When D.P. came to the Respondent in 
approximately 2016, the Respondent had reservations about taking him on 
as a patient because of the high MME, but took him back because he was 
familiar with D.P., he knew he was a reliable historian, he had worked 
with the pharmacy where D.P. had received his prescriptions, and D.P. 
understood that they would establish a plan to safely taper his 
medication. Tr. 496-97. He and D.P. had a discussion that he was 
willing to work with him, but discussed the CDC guidelines and D.P.'s 
opioid load and said that the amount prescribed would need to be 
decreased to an amount under 1,000 MME. Tr. 496, 544-45. The Respondent 
is familiar with the concept of informed consent and ``in his mind'' he 
had a discussion with D.P. that was adequate informed consent regarding 
his wound care and the risk of habituation,\39\ overdose, or death from 
overdose due to his high MME. Tr. 499-500.
---------------------------------------------------------------------------

    \39\ According to Respondent, habituation is a form of physical 
dependence on a drug. Tr. 503. This terms tends to be interchanged 
with the term ``addiction,'' which is a behavioral syndrome. Illicit 
drugs appearing in urine screens is the initial most common thing 
that indicates a patient is abusing drugs. Tr. 747. Drug metabolites 
test positive for a longer period of time in urine than blood. Tr. 
763. He would go around patients showing drug-seeking behavior, 
asserting they could not produce a urine sample by taking a saliva 
or blood sample. Tr. 763.
---------------------------------------------------------------------------

    The Respondent initiated titration at some point, but D.P. either 
would not tolerate it or had withdrawal and there was an incident where 
D.P. was removed from a plane because he looked ill, which the 
Respondent attributes to aggressive titration. Tr. 545. After a course 
of detox, D.P. was placed on Suboxone, which did not manage his pain at 
all. Tr. 546. D.P. returned to the Respondent and his pain was 
uncontrolled; the Respondent believes he tried to continue to manage 
D.P. on the Suboxone, but ultimately had to prescribe oxycodone not 
exceeding 90 MME. Tr. 546-47, 549. The Respondent stated that there was 
room for significant improvement in his documentation of D.P.'s care. 
Tr. 549.
    The Respondent testified that he talks to patients about safety 
issues and diversion prevention and emphasizes the risks of opioid use, 
including the fact that these patients can be targets for theft, 
assault, and having their medication stolen if people learned they had 
those medications. Tr. 500. He typically explains the meaning of MME in 
a way the patients can understand. Tr. 501.
    Patient D.P. admitted to the Respondent that he had over-used some 
his medications at times. Tr. 541-42. When this happened, with D.P. as 
well as with other patients, the Respondent would review the controlled 
substance agreement with the patient and then discuss that is not how 
the medications were intended to be used; he talked about safety 
issues, and explained the potential of moving to non-medication options 
for future management if D.P. could not get back on track. Tr. 542. The 
Respondent did not discharge D.P. from the practice because they 
discussed other treatment options including nerve blocks, but 
ultimately Respondent decided to keep D.P. on his medications. Tr. 542-
43. In particular, he had wound care that would be very painful when he 
received debridement and he would take more medication before and after 
those debridements. Tr. 543-44. In such cases, however, the Respondent 
should have discussed and documented this in the medical records. Tr. 
781.
    If D.P. had problems filling his prescriptions, he would let the 
Respondent know in most cases. Tr. 782-83. On August 14, 2019, D.P.'s 
pharmacy started to severely restrict his ability to fill his Oxycodone 
prescription by only allowing a 48-72 hour fill and there is a note 
stating ``Cardinal would NOT . . . replenish the Oxycodone need for 
this patient. Therefore as an urgent matter, only do a 48 to 72-hour 
prescription for all his four oxycodones until his doctor finds a 
different solution.'' Tr. 783-85.

Patient J.K.

    Patient J.K. was referred to the Respondent and she followed him to 
the group clinic, he ``kind of lost care to her directly,'' and then 
she was re-referred to him after he reestablished his own practice. Tr. 
549-50. Aside from migraines, she had chronic knee pain and various 
joint pain that she attributed to her chemotherapy. Tr. 550, 569, 738. 
The Respondent evaluated whether or not the extent of these problems 
made it appropriate to use pain medication to treat these conditions. 
She had previously been prescribed an opioid from another provider to 
help manage her migraines and the Respondent continued that care. Tr. 
550-51. He prescribed a Botox treatment for her, but due to insurance 
issues he could not get an ongoing authorization approved to treat her 
migraines with Botox. Tr. 551, 552, 743-44. At some point, the 
Respondent was treating her while she was uninsured and when she did 
receive insurance, it was an insurance plan that he had not contracted 
with so she ended up being treated by another physician. Tr. 551-52.
    Respondent testified that J.K. had previous workups with a 
neurologist in the past and had sinus surgery so the Respondent did not 
feel as though he needed any imaging studies to treat her for migraine 
headaches. Tr. 552. She was initially on a fentanyl patch and he 
continued with that. Tr. 553. She was also prescribed Percocet, (as a 
short-acting breakthrough medication), Soma (to diffuse muscle spasms), 
and Nuvigil (to improve excessive daytime sleepiness \40\). Tr. 553-54, 
559. It was his custom and practice to discuss any risk associated with 
combining muscle relaxants with the other pain control medications. Tr. 
559. He explained to J.K. that this was not a safe medication 
combination and that it is habit-forming and addictive and he explained 
the negative effects of opioids in terms of overdose and potential 
death. Tr. 559-60, 739. After this discussion, he still continued 
prescribing the medications because he believed there was a legitimate 
medical purpose in doing so. Tr. 560. He wanted to reduce the Soma 
because he was concerned it was not the best medication for her, but it 
took a while for her to ``buy-in on reducing the medication.'' Tr. 560. 
If J.K. reported her pain as being a four or five out of a scale

[[Page 24245]]

of 10, he saw that as her being stable and her pain being controlled. 
The plan was that she would remain stable if he did a slow titration. 
Tr. 561. She also reported that the medication would allow her to 
maintain her work duties and activities of daily living at home.
---------------------------------------------------------------------------

    \40\ At one point the Respondent tried to refer J.K. to a sleep 
medicine specialist for a sleep lab. Tr. 739-40.
---------------------------------------------------------------------------

    He suspected that J.K. had some elements of undiagnosed brain 
injury based her behavioral issues, continued headaches, and her 
history of being the victim of physical abuse. Tr. 554. Regarding 
inconsistencies in J.K.'s urine drug screen, he believed the 
amphetamine was a prescription medication based on how it appeared. Tr. 
553-54, 740. After inquiring, J.K. told him that she was prescribed 
Adderall from her psychiatrist, which the Respondent also saw in the 
CURES report. Tr. 555-56. He therefore did not have any issues with 
J.K.'s drug screen testing positive for amphetamine because he knew it 
was not an illicit drug. Tr. 557.
    The Respondent also recalls times when J.K.'s urine screens lacked 
the presence of one or more of her prescribed pain medications and he 
recalls having a conversation with her at a visit. She stated that she 
was having issues with her fentanyl patches adhering due to excessive 
sweating so she would replace them before they were due to be changed, 
which left her short prior to the time of her next refill. Tr. 557. The 
Respondent considered switching J.K. to an oral medication and at some 
point he did and prescribed oxycodone and oxymorphone. Tr. 558.
    At one point, his office was treating her despite her not having 
insurance and not charging her for continuity of care. Tr. 561-62. On 
her last visit the Respondent wrote her a supply of medications that 
would help her until she could get a new provider with her new 
insurance, but she was unable to obtain the medications due to an 
authorization issue. Tr. 562. She did not understand that the 
Respondent could not fill out the authorization because he was not 
affiliated with her new insurance plan and acted out of desperation 
because she was out of medication. Tr. 563. He ultimately authorized 
some additional prescriptions for her with the understanding that she 
was actually without her medication. He did not believe she had any 
intention of following through on her suicide threats. Tr. 564.
    The Respondent acknowledged that some drug screens came back 
positive for THC and [he did not believe it was an inconsistent result] 
because she had previously been placed on Marinol during her treatment 
for stage-one breast cancer. Tr. 564-65, 781. He discussed with her 
that THC could be a sedative or a stimulant depending on what type she 
was using and if it did not come from a reputable source, it could be 
laced or tainted, which could be dangerous. Tr. 565-66. She was getting 
marijuana from a dispensary and the Respondent did not find that her 
concomitant use of marijuana was a contraindication for him to 
prescribe her medications for pain management. Tr. 566-67, 740. Other 
providers agree with this line of thinking. Tr. 567. Furthermore, the 
chemotherapy J.K. underwent could cause residual side effects, 
including prolonged pain syndromes. Tr. 738. The Respondent carefully 
monitored her to ensure that risks did not develop through frequent 
visits where her vitals were taken and discussions were had with her, 
even though these discussions may not be reflected in the record. Tr. 
745-46. He testified that his care of J.K. was within the standard of 
care despite not lowering her MME closer to 90 or 100 because they had 
a discussion about the overall plan to bring her down, but they had 
challenges with insurance *R and had various social 
stressors; he was able to ultimately completely titrate her completely 
off benzodiazepines. Tr. 744, 770-72. Furthermore, she is currently on 
close to 200 MME, which is a significant improvement [in safety] and 
his decisions for her care were made based on his personal judgment and 
how the patient's overall quality of life is affected. Tr. 772-73.
---------------------------------------------------------------------------

    \*R\ Respondent testified that ``every time you change a dosing, 
the insurance requires that you submit an authorization, . . . [s]o 
that in itself can delay the process of even initiating a titration 
when you would like to.'' Tr. 744.
---------------------------------------------------------------------------

Patient D.L.

    D.L. is still the Respondent's patient. Tr. 751. When she returned 
to the Respondent as a patient, she was already on [a dose of 100 mg 
morphine sulfate],*S and he had a discussion with her about 
what medications she was on and what risks they might pose moving 
forward, which included a discussion of the 2016 CDC Guidelines. Tr. 
751-52; 782. He also provided Narcan and explained how to use it. Tr. 
754-55; GX 14 at 37. On a November 2016 visit, a note indicated, 
``Education,'' which Respondent testified meant that he would have 
discussed the combination of medications and the high-dose opioid. 755-
57; GX 14 at 40. He also ordered pharmacogentic testing on D.L. to 
understand why she may have needed a higher dose of opioids or why 
there were discrepancies in urine screens. Tr. 759-60. He learned she 
had an altered gene expression that related to how she responded to 
morphine, but he could not change her dose due to insurance reasons. 
Tr. 760. His management of D.L. was within the range of the accepted 
standard of care, setting aside the issue of documentation, because 
they had discussions regarding her treatment goals and she was still 
having uncontrolled pain. Tr. 764-65, 769-70.
---------------------------------------------------------------------------

    \*S\ Modified for clarity.
---------------------------------------------------------------------------

Patient P.S.

    The Respondent believes that for P.S., he struck a reasonable 
balance under the standard of care between his need to have relief, 
have a quality of life, and the risks associated with his pain levels. 
Tr. 773-74. He is still the Respondent's patient, and is currently [at 
a lower MME than he had been] *T and he is open to other 
therapeutic interventions. Tr. 774. The Respondent resolved P.S.'s 
inconsistent urine screens by counseling him and reassuring him when he 
was being compliant. Tr. 776. The Respondent did not think that P.S. 
was abusing his prescriptions, but instead thought he had good days and 
bad days with taking his prescriptions.*U The Respondent 
tried to get P.S. in to see a psychiatrist. Tr. 776-77. Furthermore, 
sometimes when the Respondent changed a patient's dose, there can be 
issues with the insurance companies or authorizations with the 
pharmacies and he would have to ``play their insurance games in order 
to actually get the patients treatment the way we're intending,'' so 
sometimes it looked as if some medications were duplicated when they 
were not. Tr. 778.
---------------------------------------------------------------------------

    \*T\ Modified for clarity.
    \*U\ Respondent agreed that for a patient on high-dose opioids, 
taking a little more than prescribed, even if it is to control pain, 
can be dangerous. Tr. 781. He further agreed, that if a doctor finds 
out that a patient is taking more than prescribed, he should discuss 
that with the patient and document the discussion in the medical 
records. Id.
---------------------------------------------------------------------------

    In October of 2020, the Respondent prepared a document with the aid 
of his staff and Dr. Shurman to show ongoing actions that his practice 
is taking ``to improve the quality of documentation and care and 
compliance with the guidelines.'' Tr. 822-24; RX W.\41\ [Respondent 
testified that he is implementing the actions currently and intends to 
continue to so do. Tr. 823.]
---------------------------------------------------------------------------

    \41\ The tribunal allowed the Respondent's counsel to recall the 
Respondent to testify regarding this exhibit over the objection of 
the Government's counsel. Tr. 820-21.

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

[[Page 24246]]

Closing Statement 42
---------------------------------------------------------------------------

    \42\ The Government deferred its closing statement to the post-
hearing brief.
---------------------------------------------------------------------------

    The Respondent acknowledged there was a lack of documentation in 
this case. Tr. 870-71. However, when balancing whether it would be 
inconsistent to allow the Respondent to continue with his DEA 
certificate, Respondent argued that it was important to weigh his 
experience as a pain management physician overall. Tr. 871. None of his 
patients had an overdose and there were no particular complications or 
adverse effects the patients suffered. The record reflects that he 
monitored patients, reviewed CURES reports, had patients visit 
frequently, performed frequent urine screens, and tried to find 
alternative means of treatment, which reflects what is in the public 
interest and patient safety. Tr. 871-72. The Respondent also served an 
underserved population. Tr. 872. The evidence shows that even though 
the Respondent did not keep accurate records regarding informed consent 
discussions with his patients, these discussions likely took place. Tr. 
872-73. Patients D.L. and D.P. also stated that they had informed 
consent discussions with the Respondent. Tr. 873. In the big picture, 
there can be a debate between experts about whether the prescriptions 
were within the balance of reasonable judgment. Tr. 873.
    The Respondent has put forth evidence that he has demonstrated 
efforts to rehabilitate and did not deny anything about the records 
being lacking. Tr. 874. According to Respondent, the evidence does not 
support the Respondent having his DEA certificate revoked. Tr. 875.

Rebuttal

Dr. Munzing
    After listening to the testimony from Dr. Shurman, Dr. Wiederhold, 
D.P., D.L., and the Respondent, Dr. Munzing did not change any of the 
opinions to which he previously testified. Tr. 833-35. Dr. Munzing 
strongly disagreed with Dr. Shurman's opinion regarding the 
acceptability of prescribing benzodiazepines and opioids together. Tr. 
837. Specifically, there are strong pushes, based on warnings and 
guidelines from the CDC and FDA that doctors should avoid prescribing 
benzodiazepines and opioids together and, if it is done, such 
prescribing requires documentation. Tr. 827-38. Dr. Munzing did agree 
with Dr. Shurman that keeping a patient on a higher dose when he first 
begins care is consistent with Dr. Munzing's testimony.*V 
Tr. 839. Dr. Munzing's issue with the instant case is that the patients 
were maintained at high levels over a period of many years. Tr. 839, 
856. Dr. Munzing also agreed with Dr. Shurman's assertions that chronic 
patients should be slowly tapered. Tr. 839-40. Ultimately, Dr. 
Shurman's assertion that there was no lapse in the Respondent's 
clinical judgment was incorrect. Tr. 841. Dr. Munzing also reiterated 
that multiple aberrant drug screens are problematic and must be 
documented in the medical records. Tr. 844.
---------------------------------------------------------------------------

    \*V\ On cross-examination, Dr. Munzing testified that it was 
possible, given Respondent's prior relationship with the patients, 
that the initial prescriptions at the first visit when the patients 
returned to Respondent could have been within the standard of care 
on every element other than appropriate documentation. Tr. 860-62.
---------------------------------------------------------------------------

    Dr. Munzing also reiterated the importance of the Respondent 
failing to take vitals at each visit, even if visits are weekly, 
because such frequent visit shows that the Respondent believed his 
patients needed close monitoring. Tr. 852. [According to Dr. Munzing, 
``if you believe the patient is unstable enough or tenuous enough that 
you need to see the patient every week, then you're indicating that you 
need to more intensively see the patient.'' Tr. 852.]
Dr. Shurman
    Dr. Shurman testified that it would not be extremely dangerous for 
a patient to take medical marijuana with an opioid and a 
benzodiazepine, it should just be treated as another medication, and it 
is common for people to be prescribed to this combination. Tr. 866.

The Facts *W
---------------------------------------------------------------------------

    \*W\ The parties agreed to Joint Stipulations A-U, Y-Z, BB, CC, 
EE, FF, HH, and II. See ALJ Ex. 4, Govt Prehearing, at 2-38; ALJX 
15, Resp Supp. Prehearing, at 1. The RD included many of the 
stipulated facts between the parties, but appears to have 
inadvertently left some out. See RD at 70-110. I have omitted the 
joint stipulations from the text of this decision in the interest of 
brevity, but I incorporate fully herein by reference Joint 
Stipulations A-U, Y-Z, BB, CC, EE, FF, HH, and II.
---------------------------------------------------------------------------

Findings of Fact

    The factual findings below are based on a preponderance of the 
evidence, including the detailed, credible, and competent testimony of 
the aforementioned witnesses, the exhibits entered into evidence, and 
the record before me:
    During the hearing conducted via video teleconference from November 
16-20, 2020, the Government established the following facts through 
evidence, testimony, or stipulation.
    1. DI has been employed by the DEA as a Diversion Investigator for 
thirty-two years. Tr. 21:4-6.
    2. Respondent came to the attention of the DEA in October 2018, 
based on a report by a local pharmacist that Respondent was excessively 
prescribing controlled substances. Tr. 22:11-17.
    3. Between March 17, 2017, and March 19, 2019, Respondent dispensed 
over 590,000 dosage units of schedule 2 through schedule 5 controlled 
substances. Based on DI's experience, this was an extremely high number 
of dosage units. Tr. 23:19-25--24:1-8.
    4. Between March 17, 2017, and March 19, 2019, Respondent dispensed 
almost 190,000 dosage units of various strengths of oxycodone, equating 
to over 1,700 prescriptions. This represented 32% of all Respondent's 
prescribing over this period. Tr. 24:15-25--25:1-3.
    5. Between March 17, 2017, and March 19, 2019, Respondent dispensed 
almost 123,000 dosage units of various strengths of hydrocodone, 
equating to over 1,370 prescriptions. This represented 20% of all 
Respondent's prescribing over this period. Tr. 25:4-7.
    6. Between March 17, 2017, and March 19, 2019, Respondent dispensed 
almost 88,000 dosage units of oxycodone with acetaminophen, equating to 
over 922 prescriptions. This represented 14% of all Respondent's 
prescribing over this period. Tr. 25:7-10.
    7. Dr. Munzing's curriculum vitae was admitted into evidence as GX 
2. Tr. 61:10-25--62:1-15. He is a licensed physician in the State of 
California, who has worked in the field of family medicine for nearly 
40 years. Tr. 89:14-23.
    8. Dr. Munzing received his undergraduate degree, a Bachelor of 
Science in Biochemistry, at the California State University at 
Fullerton. He received his medical degree from the University of 
California, Los Angeles, in 1982, and did his residency at Kaiser 
Permanente Medical Center in Los Angeles. He became Board Certified in 
Family Medicine in 1985, and that certification still current and 
active. Tr. 62-63.
    9. Dr. Munzing has been a family doctor for 35 years. For the last 
32 years he has been the Founding Residency Director of a Family 
Medicine Residency program, which works in close conjunction with every 
other specialty, including Internal Medicine, Pediatrics, ObGyn, 
Anesthesia, and pain medicine. Tr. 63.
    10. Dr. Munzing has been working in the family medicine department 
of Kaiser Permanente, Orange County, for the last 35 years, twice 
serving as

[[Page 24247]]

president of the medical staff. In his role as president of the medical 
staff, he was responsible for overseeing the professionalism and 
quality of care provided by the staff. Tr. 66.
    11. Dr. Munzing has a DEA COR and an active clinical practice, 
prescribing, inter alia, opioids, benzodiazepines, and other controlled 
substances when indicated. Tr. 64-65.
    12. Dr. Munzing also sits on the National Accreditation Board for 
Family Medicine Residency, which accredits all of the family medicine 
residency programs in the United States of America. Tr. 63-64.
    13. Dr. Munzing has been a Medical Expert Consultant for the 
Medical Board of California for approximately 16 years. Tr. 64:6-13.
    14. Dr. Munzing has been called upon to provide opinions about the 
prescribing of other medical professionals, and he has been qualified 
as an expert witness in over 30 cases, including in DEA administrative 
hearings. Tr. 67-68.
    15. As a licensed California physician who has been practicing in 
California for nearly 40 years, Dr. Munzing is familiar with the 
standard of care for prescribing controlled substances in California. 
He also has reviewed publications by the Medical Board of California 
that inform his understanding of the standard of care, including the 
``Guide to the Laws Governing the Practice of Medicine by Physicians 
and Surgeons (7th Edition)'' (admitted as GX 3, Tr. 71:2-13); the 
``Guidelines for Prescribing Controlled Substances for Pain,'' 
(admitted as GX 4, Tr. 74:4-15); the CDC guidelines regarding Morphine 
Milligram Equivalents (GX 5, Tr. 104-108); and the FDA black label 
warning concerning prescribing opioids and benzodiazepines together (GX 
6, Tr. 113-115). Further, Dr. Munzing reviewed several laws and 
regulations that informed his understanding of the standard of care. 
Tr. 68-74.
    16. Dr. Munzing was qualified as an expert in Pain Management and 
as an expert in the standard of care for prescribing controlled 
substances in California. Tr. 77:4-9.
    17. Dr. Munzing testified that the standard of care in California 
first requires that, before prescribing controlled substances, a 
practitioner perform a sufficient evaluation of the patient, including, 
a medical history and appropriate physical examination. This includes 
an assessment of the patient and a determination as to whether any 
additional information is needed through, for example, laboratory 
tests, imaging studies, or other studies. Then, the doctor comes up 
with a specific assessment or diagnosis or likely diagnosis. After 
which, a doctor performs a risk stratification of the patient and 
assesses any other medical problems that may contribute to management 
of the patient. Then the doctor comes up with a management plan 
specific to the evaluation. Tr. 79.
    18. If the management plan includes prescriptions for controlled 
substances, a determination needs to be made weighing the potential 
benefits and risks of such treatment. Once the plan is put into place, 
a doctor must monitor the patient on a periodic, regular basis. At all 
times, a doctor is attempting to mitigate risks to the patient by 
maximizing the benefit of the treatment and minimizing the risk. Tr. 
79-80.
    19. All of the elements of the management plan must be documented 
in detail, so in the future, a reviewer can get a detailed and truthful 
understanding about how the patient was on a certain date and what the 
reasoning was behind why a patient was being managed in a particular 
way. Tr. 80:12-21.
    20. These rules regarding the standard of care in California apply 
equally to all practitioners, be it family practitioner or a doctor who 
specializes in pain management. Tr. 80:22-25.
    21. The ``Guide to the Laws Governing the Practice of Medicine by 
Physicians and Surgeons (7th Edition)'' applies to all physicians in 
California, regardless of specialty. Tr. 82:11-17; GX3.
    22. [The standard of care requires that] a patient should give 
informed consent regarding the risks and benefits of the use of 
controlled substances. Patients need to be fully aware of the risks 
they face and whether any alternatives exist to the proposed treatment, 
particularly when prescribing opiates. Tr. 85-86.
    23. The standard of care in California requires that for patients 
at the high dosages of opioids, like those in this case, the doctor 
should obtain vital signs, blood pressure, heart rate, respiratory rate 
and perform an examination on the pertinent area at every appointment. 
Tr. 87:1-15, Tr. 851:5-15, 852:2-10.
    24. Standard of care in California requires periodic review of the 
patient and constantly trying to assess the patient's risk and whenever 
possible, try to mitigate the risk by either bringing down medication 
dosages or using alternative treatments. Tr. 87:16-25.
    25. When a doctor increases the dosage of a medication, it 
increases the risk to the patient. As such, the standard of care 
requires the doctor to well-document why the increase is necessary and 
document that the patient has been informed of and is aware that the 
increased medication poses an increased risk. Tr. 88:1-16.
    26. The California standard of care requires that all physicians 
keep accurate and complete records for all aspects of patient care. GX 
3 at 61; GX 4 at 22; Tr. 88-89.
    27. The Medical Board of California's Guideline for Prescribing 
Controlled Substances for Pain (GX4) applies to all doctors, regardless 
of specialty. Tr. 90-91.
    28. Patients taking benzodiazepines and opioids are at an increased 
risk for respiratory depression, particularly in elderly patients. 
Physicians should consider a trial of benzodiazepine tapering in 
patients concomitantly using opioids or other respiratory depressant 
medications. If a trial of tapering is not indicated or is 
unsuccessful, opioids should be titrated more slowly and at lower 
doses. GX 4 at 12; Tr. 92-93.
    29. As treatment progresses, a physician must monitor the patient. 
A practitioner must periodically update the patient's medical history, 
conduct further physical examinations, and obtain updated information 
regarding the etiology of a patient's state of health. The practitioner 
must periodically review the course of treatment, ascertain how the 
patient is responding thereto, determine if continued treatment is 
appropriate or if the treatment plan needs to be modified, and document 
the rationale for any modifications. The practitioner must also 
periodically re-inquire into the patient's urine drug screens. Tr. 96-
97.
    30. Maintaining a high MME dose of medication for a patient, simply 
because that patient was on a high MME dose prior to treatment with a 
particular doctor, does not meet the standard of care in California. 
Tr. 109:17-21.
    31. The standard of care and usual course of professional practice 
in California for treatment of pain and prescribing of controlled 
substances does not depend on whether the prescribing physician is a 
pain care specialist. Tr. 115:9-15. Appropriate documentation is a 
well-known, fundamental requirement in the medical community. GX 3 at 
61; GX 4 at 22.
    32. The practitioner must also comply with all relevant California 
law. Tr. 460-61, 462-63.
    33. Between March 13, 2017, and October 29, 2019, Respondent issued 
Patient D.P. the controlled substance prescriptions stipulated to in 
ALJ Ex. 4.
    34. Dr. Munzing concluded that the prescribing of these controlled 
substances to Patient D.P. between March 13, 2017, and October 29, 
2019, violated the standard of care in

[[Page 24248]]

California in numerous ways and was not done in the usual course of 
professional practice. Tr. 120-77.
    35. At times, D.P. was prescribed a dosage in excess of 6,000 MME 
per day. Dr. Munzing testified he believed it to be the highest MME he 
has ever seen. Tr. 118:1-5.
    36. Between March 13, 2017, and October 29, 2019, Respondent 
prescribed D.P. approximately 1.4 million milligram dosage units of 
opioids per year, which was the highest Dr. Munzing has ever seen. Tr. 
119:19-25.
    37. The Controlled Substance Agreement executed by D.P. is not 
adequate to demonstrate informed consent by D.P. to the risks 
associated by Respondent's high-dose prescribing. GX 8 at 239; Tr. 121-
22.
    38. Over the course of his treatment, D.P received exceedingly high 
MME doses and exceedingly high numbers of pills, approximately 160 
tablets per day. Dr. Munzing testified he had never seen a patient 
receive anywhere near that number of tablets per day. Tr. 123:19-25.
    39. Between March 13, 2017, and October 29, 2019, D.P.'s MME levels 
fluctuated between 3,500 MME to over 6,000 MME, at times going down to 
4,000 MME and then back up to 6,000 MME. Tr. 124:5-11.
    40. Once D.P.'s care was taken over by Pain Management at U.C. San 
Diego in late 2019, D.P.'s MME dropped fairly quickly to 2,700 MME and 
has been slowly tapered to 1,000 MME and is now in the 700 MME range. 
Tr. 124:12-24.
    41. The medical histories taken by Respondent for D.P. are poor and 
do not meet the standard of care in California. The medical records do 
not contain sufficient information and there is no documentation of 
attempts to mitigate D.P.'s symptoms or mitigate D.P.'s risk over time. 
Tr. 125:1-11.
    42. Respondent acted outside the standard of care for D.P. by 
failing to adequately manage a patient on incredibly high doses of 
opioids and by failing to take vital signs at most of D.P.'s medical 
visits. Vital signs were taken at approximately 20% of D.P.'s visits, 
which, for a patient on such high doses of opioids, was outside the 
standard of care in California. Tr. 125:12-23.
    43. Respondent's medical histories for D.P. do not even come close 
to meeting the standard of care to justify the incredibly high doses of 
opioids he prescribed to D.P. Tr. 125-26.
    44. D.P.'s self-assessed pain score has not changed significantly 
despite being dropped from Respondent's incredibly high 6,000 MME to UC 
San Diego's 1,000 MME range. Tr. 126-27.
    45. Dr. Munzing testified that, while there is no upper limit on 
the amount of opioids a patient can be prescribed by a practitioner, it 
would be hard to justify a dosage of over 500 MME. Dr. Munzing further 
testified that he has spoken with many pain management practitioners 
and lectured to a lot of pain management practitioners, and he has 
never had any pain management practitioner say that 1,000 MME is 
medically acceptable, much less two, three, four, five, or six thousand 
MME. Tr. 128-29.
    46. On April 18, 2017, Respondent prescribed D.P. 280 tablets of 10 
mg oxycodone, 280 tablets of 15 mg oxycodone, 280 tablets of 20 mg 
oxycodone, and 280 tablets of 30 mg oxycodone for 4,500 MME per day and 
160 tablets per day (do not fill until April 26, 2017). Tr. 129-31; ALJ 
Ex. 4 at Stip. Y, 5-8; GX 9 at 2. Dr. Munzing testified this level of 
MME is astronomical. He testified he had never seen a dosage that high, 
including in his review of over 150 overdose deaths. Dr. Munzing also 
testified that Respondent's medical records were nowhere close to 
justifying this level of opioid prescribing. Lastly he testified that 
these prescriptions were written outside the usual course of 
professional practice and were not for a legitimate medical purpose. 
Tr. 132-34; GX 8 at 246-53.
    47. D.P. received a second set of prescriptions on April 18, 2107, 
for 280 tablets of 10 mg oxycodone, 280 tablets of 15 mg oxycodone, 280 
tablets of 20 mg oxycodone, and 280 tablets of 30 mg oxycodone that 
could be filled on April 18, 2017. These are the same dosages as the 
prescriptions to be filled on April 26, 2017, another 4,500 MME per day 
and 160 tablets per day. ALJ Ex. 4 at Stip. Y, 9-12; GX 9 at 3. Dr. 
Munzing testified that Respondent's medical records lacked sufficient 
information to justify this level of opioid prescribing, including no 
record of vital signs or an examination. Dr. Munzing testified that 
these prescriptions were written outside the usual course of 
professional practice and were not for a legitimate medical purpose. 
Tr. 134-36; GX 8 at 261-69.
    48. Between March 17, 2017, and January 3, 2018, Respondent 
repeatedly prescribed D.P. a combination of 280 tablets of 10 mg 
oxycodone, 280 tablets of 15 mg oxycodone, 280 tablets of 20 mg 
oxycodone, and 280 tablets of 30 mg oxycodone. ALJ Ex. 4 at Stip. Y, 1-
105. Each time the MME was 4,500. Dr. Munzing testified these 
prescriptions were outside the standard of care as there was no attempt 
to taper D.P.'s opioid dose, and in fact, Respondent increased the 
opioid dosage by adding oxymorphone, 40 mg, 150 tablets, and oxycodone 
prescriptions on numerous occasions, including on May 30, 2017, July 3, 
2017, and July 11, 2017. Between March 17, 2019, and January 3, 2018, 
Respondent acted outside the standard of care by failing to justify 
either the high doses of opioids or the spikes in MME by adding 
oxymorphone to D.P.'s prescriptions. Over this time period Respondent 
acted outside the standard of care by failing to document D.P.'s vital 
signs. Dr. Munzing testified that the prescriptions written to D.P. 
between March 17, 2019, and January 3, 2018, were written outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. Tr. 136-43, GX 8 at 261-69, 372-78, 534-38.
    49. On May 30, 2017, July 3, 2017, and July 11, 2017, Respondent 
prescribed D.P. 280 tablets of 10 mg oxycodone, 280 tablets of 15 mg 
oxycodone, 280 tablets of 20 mg oxycodone, 280 tablets of 30 mg 
oxycodone, and 150 tablets of oxymorphone 40 mg. This was a dosage of 
5,100 MME. Tr. 140:9; ALJ Ex. 4 at Stip. Y, 21-23, 25-26, 38-47.
    50. On November 13, 2018, Respondent prescribed D.P. a combination 
of 245 tablets of 10 mg oxycodone, 270 tablets of 15 mg oxycodone, 285 
tablets of 20 mg oxycodone, and 260 tablets of 30 mg oxycodone. ALJ Ex. 
4 at Stip. Y, 259-62. This represents an increase in Respondent's 
opioid dosage for D.P., which Dr. Munzing testified was 
``astronomically high.'' Tr. 149-50. Dr. Munzing testified that in 
issuing these prescriptions, Respondent acted outside the standard of 
care by failing to document a reason to continue to prescribe D.P. this 
level of opioids, failing to properly taper D.P. off such high opioid 
doses, and failing to document vital signs. Dr. Munzing testified that 
these prescriptions were written outside the usual course of 
professional practice and were not for a legitimate medical purpose. 
Tr. 149-51; GX 8 at 1352-57; ALJ Ex. 4 at Stip. Y, 259-62.
    51. On December 18, 2018, Respondent prescribed D.P. a combination 
of 280 tablets of 10 mg oxycodone, 309 tablets of 15 mg oxycodone, 325 
tablets of 20 mg oxycodone, and 297 tablets of 30 mg oxycodone. ALJ Ex. 
4 at Stip. Y, 259-62. This represents an increase in Respondent's 
opioid prescribing to D.P., which Dr. Munzing testified was 
``astronomically high.'' Tr. 149-50. Dr. Munzing testified that in 
issuing these

[[Page 24249]]

prescriptions, Respondent acted outside the standard of care by failing 
to document a reason to continue to prescribe D.P. this level of 
opioids, failing to properly taper D.P. off such high opioid doses, and 
failing to document vital signs. Dr. Munzing testified that these 
prescriptions were written outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 151-52; GX 
8 at 1447-52; ALJ Ex. 4 at Stip. Y, 259-62.
    52. On January 10, 2019, Respondent prescribed D.P. a combination 
of 245 tablets of 10 mg oxycodone, 270 tablets of 15 mg oxycodone, 285 
tablets of 20 mg oxycodone, and 260 tablets of 30 mg oxycodone. ALJ Ex. 
4 at Stip. Y, 291-94. Dr. Munzing testified that in issuing these 
prescriptions, Respondent acted outside the standard of care by failing 
to document a reason to continue to prescribe D.P. this level of 
opioids, failing to properly taper D.P. off such high opioid doses, 
failing to document informed consent, failing to document an 
appropriate medical examination, and failing to document vital signs. 
Dr. Munzing testified that these prescriptions were written outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. Tr. 152-54; GX 8 at 1480-84; ALJ Ex. 4 at Stip. Y, 
291-94.
    53. Between December 11, 2018, and April 30, 2019, Respondent 
consistently prescribed D.P. a combination of at least 245 tablets of 
10 mg oxycodone, 270 tablets of 15 mg oxycodone, 285 tablets of 20 mg 
oxycodone, and 260 tablets of 30 mg oxycodone. ALJ Ex. 4 at Stip. Y, 
275-378.
    54. On February 11, 2019, Respondent prescribed D.P. a combination 
of 245 tablets of 10 mg oxycodone, 270 tablets of 15 mg oxycodone, 285 
tablets of 20 mg oxycodone, 260 tablets of 30 mg oxycodone, 105 tablets 
of 10 mg oxycodone, 114 tablets of 15 mg oxycodone, 120 tablets of 20 
mg oxycodone, and 114 tablets of 30 mg oxycodone. ALJ Ex. 4 at Stip. Y, 
311-18. This amounts to approximately 6,144 MME. Dr. Munzing testified 
that in issuing these prescriptions, Respondent acted outside the 
standard of care by failing to document a reason to continue to 
prescribe D.P. this level of opioids, failing to document the reason 
for the eight oxycodone prescriptions, failing to properly taper D.P. 
off such high opioid doses and instead significantly escalating his MME 
level, failing to document informed consent, failing to document an 
appropriate medical examination, and failing to document vital signs. 
Dr. Munzing testified that these prescriptions were written outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. Tr. 155-57; GX 8 at 1543; ALJ Ex. 4 at Stip. Y, 327-
42, 361-68.
    55. Respondent continued this level of prescribing on March 4, 
2019, March 13, 2019, and April 15, 2019. ALJ Ex. 4 at Stip. Y, 327-42, 
361-68. This amounted to 6,000 MME per day. Tr. 158:3-6. Dr. Munzing 
testified that Respondent acted outside the standard of care by failing 
to document a reason to continue to prescribe D.P. this level of 
opioids. Dr. Munzing testified that these prescriptions were written 
outside the usual course of professional practice and were not for a 
legitimate medical purpose. Tr. 157-59; GX 8 at 1607; ALJ Ex. 4 at 
Stip. Y, 327-42, 361-68.
    56. Between April 2019 and June 2019, Respondent prescribed D.P. 
combinations of 10 mg oxycodone, 15 mg oxycodone, 20 mg oxycodone, and 
30 mg oxycodone that caused D.P.'s daily MME to bounce between 4,000 
MME and 6,000 MME. Tr. 159:4-19; ALJ Ex. 4 at Stip. Y, 351-423. Dr. 
Munzing testified that on each occasion, Respondent acted outside the 
standard of care by failing to document a reason to continue to 
prescribe D.P. this level of opioids. Dr. Munzing testified that these 
prescriptions were written outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 159; ALJ 
Ex. 4 at Stip. Y, 351-423.
    57. On July 8, 2019, Respondent prescribed D.P. a combination of at 
233 tablets of 10 mg oxycodone, 265 tablets of 15 mg oxycodone, 115 
tablets of 20 mg oxycodone, 103 tablets of 30 mg oxycodone, 100 tablets 
of 10 mg oxycodone, 111 tablets of 15 mg oxycodone, 270 tablets of 20 
mg oxycodone, 240 tablets of 30 mg oxycodone, 14 tablets of oxymorphone 
40 mg, and 6 tablets of oxymorphone 40 mg. ALJ Ex. 4 at Stip. Y, 429-
38. This is over 6,000 MME per day. Tr. 160:7-23. Dr. Munzing testified 
that in issuing these prescriptions, Respondent acted outside the 
standard of care by failing to document a reason to continue to 
prescribe D.P. this level of opioids. Dr. Munzing testified that these 
prescriptions were written outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 160-61; ALJ 
Ex. 4 at Stip. Y, 429-38.
    58. There is a gap in Respondent's medical records for D.P. from 
June 25, 2019 until September 30, 2019. Tr. 161-162; GX 8 at 1847.
    59. Respondent continued to issue prescriptions for 10 mg 
oxycodone, 15 mg oxycodone, 20 mg oxycodone, and 30 mg oxycodone in 
July and August 2019. Stip. Y, 424-76. During this time, Respondent 
acted outside the standard of care by failing to taper D.P.'s opioid 
levels, which ranged between 3,000 and 6,000 MME. Tr. 163:4-17. 
Respondent acted outside the standard of care by issuing prescriptions 
to D.P. without any medical record documentation. Tr. 162-63. Dr. 
Munzing testified that due to these failures, these prescriptions were 
written outside the usual course of professional practice and were not 
for a legitimate medical purpose. Tr. 162-63; ALJ Ex. 4 at Stip. Y, 
424-76.
    60. UC San Diego doctors described Respondent's opioid prescribing 
to D.P. as ``massive amounts,'' ``very high amounts,'' and ``exorbitant 
amounts.'' Tr. 165:2-6. Over time, UC San Diego stabilized D.P.'s 
multitude of medical conditions and was then able to put him on a 
steady tapering program which reduced his MME to 1,000 and then down to 
the 700 MME range. Tr. 165, 167.
    61. Respondent acted outside the standard of care by prescribing 
extremely high doses of opioids without referring D.P. for a mental 
health evaluation. Tr. 175:12-25.
    62. Dr. Munzing testified that the overall care provided by 
Respondent for D.P. was incredibly dangerous and certainly not within 
the standard of care. In fact, Dr. Munzing testified D.P. is lucky to 
be alive. Tr. 176:17-23.
    63. Dr. Munzing testified that, based on the extremely high MMEs, 
the failure to provide a medical justification, and the failure to 
properly document treatment including vital signs and appropriate 
physical examinations, all of the stipulated prescriptions Respondent 
issued to D.P. were issued outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 176-77.
    64. Dr. Munzing testified that Respondent acted outside the 
standard of care in prescribing to P.S. because he found no evidence in 
the medical records that Respondent had informed consent discussions 
with P.S. to make him aware of the specific risks from taking high dose 
opioids, including addiction, overdose or death. Tr. 178, 182.
    65. Respondent failed to take or document vital signs in 
approximately 50% of his visits with P.S. and performed or documented a 
musculoskeletal examination less than 20% of the time; these were 
necessary because P.S. was being treated for musculoskeletal complaints 
with opioid medications. Tr. 183:12-21. Respondent failed to obtain a 
significant medical history regarding P.S.'s anxiety before

[[Page 24250]]

prescribing him anti-anxiety medications, lorazepam and alprazolam, and 
failed to try non-controlled substances to treat P.S.'s anxiety. Tr. 
183-84.
    66. Respondent acted outside the standard of care in California by 
prescribing P.S. high dose opioids, mid-300 MME range, in combination 
with a benzodiazepine; these prescriptions did not correlate to any 
significant improvement in P.S.'s condition, but the combination put 
P.S. at significant risk. Tr. 184-85.
    67. On February 17, 2017, Respondent prescribed to P.S. 45 tablets 
of morphine sulfate ER 30 mg, 45 tablets of morphine sulfate ER 60 mg, 
and 45 tablets of Dilaudid (hydromorphone), 8 mg and 30 tablets 
lorazepam 1 mg. This was a dosage of 366 MME. GX 11 at 1; ALJ Ex. 4 at 
Stip. BB, 1-4; Tr. 185-86. Dr. Munzing testified that 366 MME is 
classified as very high; four times the CDC's recommended high of 90. 
Tr. 185:5-15; GX 5.
    68. Dr. Munzing testified that in issuing these prescriptions, 
Respondent acted outside the standard of care by failing to document a 
reason to prescribe P.S. this level of opioids, failing to document a 
reason for prescribing the dangerous combination of high dose opioids 
with a benzodiazepine, failing to document informed consent, failing to 
document an appropriate medical examination, failing to properly 
perform a psychiatric examination, and failing to assess the increased 
risk to P.S. due to his age and history of acute embolism and deep 
venous thrombosis. Dr. Munzing testified that these prescriptions were 
written outside the usual course of professional practice and were not 
for a legitimate medical purpose. Tr. 187-189; GX 10 at 46; ALJ Ex. 4 
at Stip. BB, 1-4.
    69. Between February 17, 2017, and September 16, 2019, Respondent 
prescribed to P.S. 45 tablets of morphine sulfate ER 30 mg, 45 tablets 
of morphine sulfate ER 60 mg, and 45 tablets of hydromorphone 8 mg, and 
a benzodiazepine (either lorazepam 1 mg or alprazolam 0.5 mg). ALJ Ex. 
4 at Stip. BB, 1-175.
    70. Based on a review of P.S.'s entire medical record Dr. Munzing 
testified that Respondent acted outside the standard of care by failing 
to document a reason to prescribe P.S. this level of opioids, failing 
to document a reason for prescribing a benzodiazepine, failing to 
document a reason for prescribing the dangerous combination of high 
dose opioids with a benzodiazepine, failing to document informed 
consent, failing to taper P.S. off of high dose opioids, failing to 
document an appropriate medical examination, failing to properly 
perform a psychiatric examination, and failing to use a non-
benzodiazepine to treat P.S.'s anxiety. Dr. Munzing testified that 
these prescriptions were written outside the usual course of 
professional practice and were not for a legitimate medical purpose. 
Tr. 190-95; ALJ Ex. 4 at Stip. BB, 1-175.
    71. P.S. had an aberrant urine drug screen on March 3, 2017, (GX 10 
at 67-78) when P.S. tested negative for lorazepam, which was 
inconsistent with P.S.'s February 17, 2017 lorazepam prescription. Tr. 
196-97; ALJ Ex. 4 at Stip. BB, 4. Respondent acted outside that 
standard of care by failing to address or resolve the aberrant result. 
Tr. 198-200; see also, e.g. GX 10, at 89.
    72. P.S. had aberrant urine drug screens on the following dates:
    a. April 14, 2017, (GX 10 at 106-08) when P.S. tested negative for 
lorazepam, which was inconsistent with P.S.'s March 29, 2017 lorazepam 
prescription. Tr. 200-01; ALJ Ex. 4 at Stip. BB, 8.
    b. June 19, 2017, (GX 10 at 195-97) when P.S. tested negative for 
lorazepam, which was inconsistent with P.S.'s June 5, 2017 lorazepam 
prescription. Tr. 201-02; ALJ Ex. 4 at Stip. BB, 15.
    c. August 7, 2017, (GX 10 at 275-77) when P.S. tested negative for 
lorazepam, which was inconsistent with P.S.'s July 25, 2017 lorazepam 
prescription. Tr. 202-03; ALJ Ex. 4 at Stip. BB, 32.
    d. September 12, 2017, (GX 10 at 324-26) when P.S. tested negative 
for alprazolam, which was inconsistent with P.S.'s August 16, 2017 
alprazolam prescription. Tr. 203-04; ALJ Ex. 4 at Stip. BB, 40.
    e. October 10, 2017, (GX 10 at 359-61) when P.S. tested negative 
for alprazolam, which was inconsistent with P.S.'s September 12, 2017 
alprazolam prescription. Tr. 209-10; ALJ Ex. 4 at Stip. BB, 44. P.S 
also tested negative for morphine, which was inconsistent with P.S.'s 
morphine prescriptions on September 12, 2017. Tr. 210:7-12; ALJ Ex. 4 
at Stip. BB, 41-43.
    f. November 3, 2017, (GX 10 at 389-91) when P.S. tested negative 
for alprazolam, which was inconsistent with P.S.'s October 23, 2017 
alprazolam prescription. Tr. 211-12; ALJ Ex. 4 at Stip. BB, 48. P.S 
also tested negative for morphine, which was inconsistent with P.S.'s 
morphine prescriptions on October 23, 2017. Tr. 212:18-23; ALJ Ex. 4 at 
Stip. BB, 45-47.
    g. September 11, 2018, (GX 10 at 754-56) when P.S. tested negative 
for alprazolam, which was inconsistent with P.S.'s August 28, 2018 
alprazolam prescription. Tr. 213; ALJ Ex. 4 at Stip. BB, 114. P.S also 
tested negative for morphine, which was inconsistent with P.S.'s 
morphine prescriptions on August 14, 2018. Tr. 213-14; ALJ Ex. 4 at 
Stip. BB, 111-13.
    h. October 3, 2018, (GX 10 at 793-95) when P.S. tested negative for 
alprazolam, which was inconsistent with P.S.'s September 25, 2018 
alprazolam prescription. Tr. 214-15; ALJ Ex. 4 at Stip. BB, 122. P.S 
also tested negative for morphine, which was inconsistent with P.S.'s 
morphine prescriptions on September 25, 2018. Tr. 215:6-11; ALJ Ex. 4 
at Stip. BB, 119-21. P.S. tested positive for alcohol, which is an 
aberrant result because the P.S.'s Controlled Substance Agreement 
stated a patient should not be drinking alcohol with these medications. 
There is an increased risk to a patient for overdose or death when 
combining alcohol and controlled substance medications. Tr. 217:7-25.
    i. December 21, 2018, (GX 10 at 911-13) when P.S. tested negative 
for alprazolam, which was inconsistent with P.S.'s December 10, 2018 
alprazolam prescription. Tr. 222-23; ALJ Ex. 4 at Stip. BB, 132. P.S 
also tested negative for morphine, which was inconsistent with P.S.'s 
morphine prescriptions on December 10, 2018. Tr. 212:18-23; ALJ Ex. 4 
at Stip. BB, 133-35.
    j. March 26, 2019, (GX 10 at 1105-07) when P.S. tested negative for 
alprazolam, which was inconsistent with P.S.'s March 1, 2019 alprazolam 
prescription. Tr. 224; ALJ Ex. 4 at Stip. BB, 144.
    78. Respondent acted outside that standard of care by failing to 
address, resolve, and document each of the above aberrant drug screen 
results. Tr. 198-204, 211, 213-14, 218-21, 224; see also, e.g. GX 10 at 
807-11.
    79. Dr. Munzing testified that P.S.'s numerous aberrant drug 
screens and Respondent's failure to address or resolve those aberrant 
drug screens contributed to his opinion that Respondent's prescriptions 
to P.S. were outside the usual course of professional practice and were 
not for a legitimate medical purpose. Tr. 200-04, 211, 222.
    80. Respondent acted outside the standard of care in prescribing 
controlled substances to J.K. by failing to provide appropriate 
treatment and examinations for her migraine pain. Respondent prescribed 
controlled substance but failed to do a proper neurological 
examination, including imaging scans, CT, or MRI, to ensure that other 
diagnoses are not being missed. Tr. 229-31.
    81. Responded acted outside the standard of care when prescribing 
the

[[Page 24251]]

relevant controlled substances to J.K. by failing to take a 
comprehensive medical history including an examination of mental health 
issues, failing to address and document J.K.'s use of alcohol and other 
drugs in the past, failing to perform a neurological exam or refer to a 
neurological subspecialist for J.K.'s migraine treatment, failing to 
take vital signs, and prescribing controlled substances without 
resolving numerous aberrant drug screens. Tr. 232-33.
    82. Respondent's medical records for J.K. did not document that she 
was being treated for cancer pain, as her cancer treatment ended in 
2014. Tr. 233-34.
    83. Dr. Munzing testified that Respondent acted outside the 
standard of care when prescribing opioids to J.K. by failing to 
properly document justification for the high dosages of opioids he 
prescribed to J.K. Tr. 234:2-7.
    84. Dr. Munzing testified that Respondent acted outside the 
standard of care when prescribing opioids and benzodiazepines to J.K. 
by failing to obtain and document proper informed consent for the risks 
of high dose opioids (300 to 400 MME), as well as the increased risk 
posed by Respondent prescribing a combination of opioids and 
benzodiazepines. Tr. 235:7-22.
    85. On November 28, 2016, Respondent prescribed to J.K. a fentanyl 
patch, 75 micrograms per hour (change every 4 hours), 180 tablets of 
Percocet 10/325 mg, and 30 tablets of Soma 350 mg. This is 366 MME. GX 
13 at 1; ALJ Ex. 4 at Stip. EE, 1-3; Tr. 236-37. Dr. Munzing testified 
that 366 MME is classified as very high, four times the recommended CDC 
limit of 90. Tr. 185, 237; GX 5.
    86. Dr. Munzing testified that in issuing the November 28, 2016 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to document a reason for prescribing the dangerous combination 
of high dose opioids with Soma, failing to document informed consent, 
and failing to document an appropriate medical examination. Dr. Munzing 
also testified that J.K.'s expressed pain level of 4 did not justify 
this high dose of opioids and possibly not even a low dose of opioids. 
Dr. Munzing testified that these prescriptions were written outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. Tr. 235-41; GX 13 at 1; GX 12 at 3-8; ALJ Ex. 4 at 
Stip. EE, 1-3.
    87. On January 19, 2017, Respondent prescribed J.K. a fentanyl 
patch with 12 micrograms per hour, a fentanyl patch with 50 micrograms 
per hour, a fentanyl patch with 75 micrograms per hour, 90 tablets of 
Percocet 10/325 mg (two week supply), and 15 tablets of Soma 350 mg. GX 
13 at 2; ALJ Ex. 4 at Stip. EE, 4-8. This was 440 MME. Tr. 242-43; GX 
12 at 30. Respondent failed to document a justification for the 
increase in opioid medication prescribed to J.K. GX 12 at 29-34; Tr. 
242-43. Dr. Munzing testified that Respondent failed to perform an 
appropriate examination, failed to document J.K.'s present illness, and 
put J.K. at much higher risk based on minimal information. Id. As such, 
Dr. Munzing testified that these prescriptions were written outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. Id.; ALJ Ex. 4 at Stip. EE, 4-8.
    88. Respondent prescribed J.K. a combination of fentanyl patch, 
Percocet 10/325 mg, and Soma 350 mg, on a number of occasions between 
November 28, 2016, and March 14, 2017. ALJ Ex. 4 at Stip. EE, 1-14; GX 
13 at 1-5. Dr. Munzing testified, based on a review of all of J.K.'s 
medical records, that on each occasion, Respondent failed to justify 
the very high doses of opioids prescribed to J.K. and failed to justify 
the dangerous combination of opioids with Soma. As such, Dr. Munzing 
testified that these prescriptions were written outside the usual 
course of professional practice and were not for a legitimate medical 
purpose. Id.; Tr. 240-46.
    89. On August 18, 2017, Respondent prescribed J.K. 180 tablets of 
Percocet 10/325 mg, 60 tablets of oxymorphone ER 40 mg, 60 tablets of 
OxyContin 40 mg, and 60 tablets of Soma, 350 mg. ALJ Ex. 4 at Stip. EE, 
19-22; GX 13 at 9. This is approximately 450 MME. Tr. 244:1-15.
    90. Dr. Munzing testified that in issuing the August 18, 2017 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to taper J.K. off high dose opioids and in fact increasing her 
dosage, failing to document a reason for prescribing the dangerous 
combination of high dose opioids with Soma, failing to document 
informed consent, failing to document an appropriate medical 
examination, and a failing to document a justification for switching 
J.K. from a fentanyl patch to oxymorphone and OxyContin. As such, Dr. 
Munzing testified that the August 18, 2017 prescriptions were written 
outside the usual course of professional practice and were not for a 
legitimate medical purpose. Tr. 243-47; GX 13 at 9; GX 12 at 109-16; 
ALJ Ex. 4 at Stip. EE, 19-22.
    91. On November 10, 2017, Respondent prescribed J.K. 180 tablets of 
Percocet 10/325 mg, 60 tablets of oxymorphone ER 40 mg, 60 tablets of 
OxyContin 40 mg, and 90 tablets of Soma 350 mg. ALJ Ex. 4 at Stip. EE, 
23-26; GX 13 at 10-12. This was approximately 450 MME. Tr. 244, 247.
    92. Dr. Munzing testified that in issuing the November 10, 2017 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to taper J.K. off high dose opioids, failing to document a 
reason for prescribing the dangerous combination of high dose opioids 
with Soma, and failing to document informed consent. Dr. Munzing also 
testified that J.K.'s expressed pain level of 4 did not justify this 
high dose of opioids and possibly not even a low dose of opioids. As 
such, Dr. Munzing testified that the November 10, 2017 prescriptions 
were written outside the usual course of professional practice and were 
not for a legitimate medical purpose. Tr. 247-48; GX 13 at 10-12; GX 12 
at 129-35; ALJ Ex. 4 at Stip. EE, 23-26.
    93. On January 8, 2018, Respondent prescribed J.K. 180 tablets of 
Percocet 10/325 mg, 60 tablets of oxymorphone ER 40 mg, 60 tablets of 
OxyContin 40 mg, and 90 tablets of Soma 350 mg. ALJ Ex. 4 at Stip. EE, 
29-32; GX 13 at 14-16. This was approximately 450 MME. Tr. 244, 248.
    94. Dr. Munzing testified that in issuing the January 8, 2018 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to taper J.K. off high dose opioids, failing to document a 
reason for prescribing the dangerous combination of high dose opioids 
with Soma, failing to provide an objective assessment and plan, failing 
to record vital signs, and failing to document informed consent. Dr. 
Munzing also testified that Respondent failed to record a pain level 
for J.K. As such, Dr. Munzing testified that the January 8, 2018 
prescriptions were written outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 248-49; GX 
13 at 10-12; GX 12 at 144-48; ALJ Ex. 4 at Stip. EE, 29-32.
    95. On February 9, 2018, Respondent prescribed J.K. 180 tablets of 
Percocet 10/325 mg, 60 tablets of oxymorphone ER 40 mg, 60 tablets of 
oxycodone 36 mg, and 120 tablets of Soma, 350 mg. ALJ Ex. 4 at Stip. 
EE, 33-36; GX 13 at 17-20. This is 430 MME. Tr. 250:14-18.

[[Page 24252]]

    96. Dr. Munzing testified that in issuing the February 9, 2018 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to taper J.K. off high dose opioids, failing to document a 
reason for prescribing the dangerous combination of high dose opioids 
with Soma, failing to record vital signs, failing to document an 
objective assessment, failing to provide information about alcohol use, 
failing to document the subjective/objective assessment and plan in the 
medical records, failing to document reasoning for changing J.K.'s 
opioid medications, and failing to document informed consent. As such, 
Dr. Munzing testified that the February 9, 2018 prescriptions were 
written outside the usual course of professional practice and were not 
for a legitimate medical purpose. Tr. 249-55; GX 13 at 17-20; GX 12 at 
149-56; ALJ Ex. 4 at Stip. EE, 33-36.
    97. On October 16, 2018, Respondent prescribed J.K. 10 fentanyl 
patches 75 mg, 120 tablets of morphine sulfate IR 15 mg, 120 tablets of 
Soma 350 mg, 180 tablets of Percocet 10/325 mg, and 60 tablets of 
morphine sulfate ER 60 mg. ALJ Ex. 4 at Stip. EE, 54-57; GX 13 at 36-
37. This is 330 MME. Tr. 255:9-23.
    98. Dr. Munzing testified that in issuing the October 16, 2018 
prescriptions to J.K., Respondent acted outside the standard of care by 
failing to document a reason to prescribe J.K. this level of opioids, 
failing to taper J.K. off high dose opioids despite J.K. having left-
over opioids from previous prescriptions, failing to document a reason 
for prescribing the dangerous combination of high dose opioids with 
Soma, failing to record vital signs, failing to document an appropriate 
examination, failing to address the fact that J.K. indicated she is not 
following Respondent's dosing instructions as she was taking left-over 
medications, failing to provide information about alcohol use, failing 
to provide an objective assessment or plan, failing to document 
informed consent, and for prescribing controlled substance despite J.K. 
having possible suicidal ideations. As such, Dr. Munzing testified that 
the October 16, 2018 prescriptions were written outside the usual 
course of professional practice and were not for a legitimate medical 
purpose. Tr. 255-61; GX 13 at 36-37; GX 12 at 272-75; ALJ Ex. 4 at 
Stip. EE, 54-57.
    99. [J.K. had aberrant urine drug screens on the following dates:]
    a. April 27, 2017, (GX 12 at 62-64) when J.K. tested positive for 
THC and amphetamines, neither of which were prescribed to J.K. by 
Respondent. Tr. 261-66.
    b. May 12, 2017, (GX 12 at 74-76) when J.K. tested positive for 
amphetamines, which were not prescribed to J.K. by Respondent. Tr. 267-
68.
    c. September 15, 2017, (GX 12 at 109-11) when J.K. tested positive 
for amphetamines, which were not prescribed to J.K. by Respondent. Tr. 
269:5-13.
    d. February 9, 2018, (GX 12 at 159-61) when J.K. tested positive 
for THC and amphetamines, neither of which were prescribed to J.K. by 
Respondent. Tr. 270-71.
    e. March 19, 2018, (GX 12 at 180-82) when J.K. tested positive for 
THC and amphetamines, neither of which were prescribed to J.K. by 
Respondent. Tr. 273:5-14.
    f. June 4, 2018, (GX 12 at 221-23) when J.K. tested positive for 
THC and amphetamines, neither of which were prescribed to J.K. by 
Respondent. Tr. 274, 276.
    g. July 31, 2018, (GX 12 at 241-43) when J.K. tested positive for 
THC and amphetamines, neither of which were prescribed to J.K. by 
Respondent. Tr. 277-78.
    100. Respondent acted outside that standard of care by failing to 
address or resolve the above aberrant results. Tr. 198-200, 247-50, 
266-67, 268-73, 277-79; GX 12 at 67-70, 80-83, 125-28, 165-68, 185-92, 
227-31, 247-50.
    101. Dr. Munzing testified that each of J.K.'s [unresolved] 
aberrant drug screens contributed to his opinion that Respondent's 
prescriptions to J.K. were outside the usual course of professional 
practice and not for a legitimate medical purpose. Tr. 267, 279.
    102. Based on Dr. Munzing's review of J.K.'s oncology records, he 
was able to confirm that Respondent's opioid prescriptions to J.K. were 
not related to [treatment of end stage cancer]. Tr. 279-81.
    103. Dr. Munzing testified that Respondent's prescribing to D.L. 
did not meet the standard of care in California. The controlled 
substance prescriptions issued to D.L. were not medically justified as 
prescribed and were not issued in the usual course of professional 
practice. Further, Respondent's medical histories for D.L. were not 
consistent with the standard of care due to their brevity and lack of 
detail. The histories did not include even limited information 
regarding a mental health or alcohol and drug use. The medical history 
also lacks necessary details regarding any chronic medical problems 
D.L. has and how they might interact with the controlled substances 
prescribed by Respondent. Tr. 282-83.
    104. On January 23, 2018, Respondent prescribed D.L. 60 tablets of 
lorazepam 1 mg, 240 tablets of Percocet 10/325 mg, 60 tablets of 
morphine sulfate ER 100 mg, 90 tablets of morphine sulfate IR 30 mg, 21 
tablets of oxymorphone HCl 5 mg, and 30 tablets Lunesta 3 mg. ALJ Ex. 4 
at Stip. HH, 1-6; GX 15 at 12-17. This is 455 MME. Tr. 285-86.
    105. Lunesta poses a risk of habit forming addiction. It is also a 
respiratory depressant, which, when added to an opioid prescription, 
increases the risk of overdose or overdose death. Tr. 286:13-21.
    106. Combining opioid, Lunesta and benzodiazepine prescriptions 
creates an even greater risk to a patient due to the combination of 
multiple respiratory depressants. Tr. 287:1-11.
    107. Dr. Munzing testified based on his review of D.L.'s medical 
records that the high MME, the combination of the controlled 
substances, and the risks associate with prescribing these combinations 
to an elderly patient makes the January 23, 2018 prescriptions issued 
to D.L. outside the usual course of professional practice and not for a 
legitimate medical purpose. Tr. 287; ALJ Ex. 4 at Stip. HH, 1-6; GX 15 
at 12-17.
    108. On February 23, 2018, Respondent prescribed to D.L. 60 tablets 
of lorazepam 1 mg, 240 tablets of Percocet 10/325 mg, 60 tablets of 
morphine sulfate ER 100 mg, 120 tablets of morphine sulfate IR 30 mg, 
and 30 tablets Lunesta 3 mg. ALJ Ex. 4 at Stip. HH, 7-11; GX 15 at 18-
22; Tr. 288:1-8.
    109. In issuing the February 23, 2018 prescriptions to D.L., 
Respondent acted outside the standard of care by failing to justify the 
increase in morphine sulfate 30 mg from 90 to 120 tablets, failing to 
document an appropriate examination, failing to justify the overall 
level of opioid prescribing to D.L., failing to justify the lorazepam 
prescription, and failing to document informed consent for the 
significant risk to the patient with this combination of controlled 
substances. As such, Dr. Munzing testified that the February 23, 2018 
prescriptions to D.L. by Respondent were prescribed outside the usual 
course of professional practice and were not for a legitimate medical 
purpose. ALJ Ex. 4 at Stip. HH, 7-11; GX 15 at 18-22; Tr. 289-90; GX 14 
at 355-60.
    110. On March 23, 2018, Respondent prescribed to D.L. 60 tablets of 
lorazepam 1 mg, 240 tablets of Percocet 10/325 mg, 60 tablets of 
morphine sulfate ER 100 mg, 120 tablets of morphine sulfate IR 30 mg, 
and 30

[[Page 24253]]

tablets of Lunesta 3 mg. ALJ Ex. 4 at Stip. HH, 12- 16; GX 15 at 23-27.
    111. In issuing the March 23, 2018 prescriptions to D.L., 
Respondent acted outside the standard of care by failing to justify in 
the medical records the high level of opioid prescribing to D.L., 
failing to document a justification for the combination of high dose 
opioids with the Lunesta and the benzodiazepine, failing to document a 
physical exam and the fact that D.L. described her pain level only at a 
5. As such, Dr. Munzing testified that the March 23, 2018 prescriptions 
to D.L. by Respondent were prescribed outside the usual course of 
professional practice and were not for a legitimate medical purpose. 
ALJ Ex. 4 at Stip. HH, 12-16; GX 15 at 23-27; Tr. 289-90; GX 14 at 368-
73.
    112. On May 4, 2018, Respondent prescribed to D.L. 60 tablets of 
lorazepam 1 mg, 210 tablets of Percocet 10/325 mg, 60 tablets of 
morphine sulfate ER 100 mg, 120 tablets of morphine sulfate IR 30 mg, 
and 30 tablets Lunesta 3 mg. This was approximately 420 MME. ALJ Ex. 4 
at Stip. HH, 17-21; GX 15 at 28-31; Tr. 293-294.
    113. In issuing the May 4, 2018 prescriptions to D.L., Respondent 
acted outside the standard of care by failing to justify in the medical 
records the high level of opioid prescribing to D.L., failing to 
document a justification for the combination of high dose opioids with 
the Lunesta and the benzodiazepine, failing to make any efforts to 
taper D.L.'s morphine levels, and in fact, increasing those levels 
since 2016, and failing to document a physical exam. As such, Dr. 
Munzing testified that the May 4, 2018 prescriptions issued to D.L. by 
Respondent were outside the usual course of professional practice and 
were not for a legitimate medical purpose. ALJ Ex. 4 at Stip. HH, 17-
21; GX 15 at 28-31; GX 14 at 405-09; Tr. 294.
    114. On May 31, 2018, Respondent prescribed to D.L. 240 tablets of 
Percocet 10/325 mg, 60 tablets of morphine sulfate ER 100 mg, 120 
tablets of morphine sulfate IR 30 mg. This was approximately 435 MME. 
ALJ Ex. 4 at Stip. HH, 22-24; GX 15 at 32-34; Tr. 295.
    115. In issuing the May 31, 2018 prescriptions to D.L., Respondent 
acted outside the standard of care by failing to justify in the medical 
records the increased number of Percocet tablets, failing to justify in 
the medical records the high level of opioid prescribing to D.L. 
particularly because D.L.'s pain was only at a pain level of 5 out of 
10, failing to taper D.L.'s high level of opioids, and failing to 
document a physical exam. As such, Dr. Munzing testified that the May 
31, 2018 prescriptions issued to D.L. by Respondent were outside the 
usual course of professional practice and were not for a legitimate 
medical purpose. ALJ Ex. 4 at Stip. HH, 22-24; GX 15 at 32-34; GX 14 at 
440-45; Tr. 295-98.
    116. On July 31, 2018, December 4, 2018, and January 3, 2019, 
Respondent prescribed to D.L. 60 tablets of 210 tablets of Percocet 10/
325 mg, 60 tablets of morphine sulfate ER 100 mg, 120 tablets of 
morphine sulfate IR 30 mg, and 30 tablets Lunesta 3 mg. On July 31, 
2018 (OK to fill August 9, 2018), Respondent prescribed to D.L. 60 
tablets of 210 tablets of Percocet 10/325 mg, 60 tablets of morphine 
sulfate ER 100 mg, 120 tablets of morphine sulfate IR 30 mg. ALJ Ex. 4 
at Stip. HH, 25-39.
    117. In issuing these prescriptions to D.L., Respondent acted 
outside the standard of care by failing to justify in the medical 
records the high level of opioid prescribing, failing to document a 
justification for the combination of high dose opioids with the 
Lunesta, failing to make any efforts to taper D.L.'s morphine levels, 
failing to document vital signs for each visit, and failing to document 
a physical exam. As such, Dr. Munzing testified these prescriptions to 
D.L. were issued outside the usual course of professional practice and 
were not for a legitimate medical purpose. ALJ Ex. 4 at Stip. HH, 25-
39; Tr. 298-301.
    118. D.L. had an aberrant urine drug screen on March 23, 2018, (GX 
14 at 379-81) when D.L. tested negative for oxycodone, which was 
inconsistent with D.L.'s February 23, 2018 oxycodone prescription. Tr. 
302; ALJ Ex. 4 at Stip. HH, 9. D.L. also tested negative for lorazepam, 
which was inconsistent with D.L.'s lorazepam prescription on February 
23, 2018. Tr. 302; ALJ Ex. 4 at Stip. HH, 7. Respondent acted outside 
that standard of care by failing to address or resolve the aberrant 
results. Tr. 302-03; GX 14 385-90.
    119. D.L. had an aberrant urine drug screen on April 20, 2018, (GX 
14 at 395-97) when D.L. tested negative for oxycodone, which was 
inconsistent with D.L.'s March 23, 2018 oxycodone prescription. Tr. 
303; ALJ Ex. 4 at Stip. HH, 14. D.L. also tested negative for 
lorazepam, which was inconsistent with D.L.'s lorazepam prescription on 
March 23, 2018. Tr. 303-04; ALJ Ex. 4 at Stip. HH, 12. Respondent acted 
outside that standard of care by failing to address or resolve the 
aberrant results. Tr. 304-05; GX 405-09.
    120. D.L. had an aberrant urine drug screen on January 31, 2019, 
(GX 14 at 577-79) when D.L. tested negative for oxycodone, which was 
inconsistent with D.L.'s January 3, 2019 oxycodone prescription. Tr. 
305-06; ALJ Ex. 4 at Stip. HH, 38. Respondent acted outside that 
standard of care by failing to address or resolve the aberrant results. 
Tr. 307-08; GX 588-93, 609-13.
    121. Dr. Munzing testified that D.L.'s aberrant drug screens and 
Respondent's failure to address or resolve the aberrant drug screens 
were facts that contributed to his opinion that Respondent's 
prescriptions to D.L. were outside the usual course of professional 
practice and were not for a legitimate medical purpose. Tr. 211, 303.
    122. Due to the importance of ensuring a patient has given informed 
consent regarding treatment, including prescriptions for controlled 
substances, the standard of care in California requires that 
practitioners document in the medical records specifically what was 
discussed with a patient and specifically what risks and benefits the 
patient was informed of prior to the patient's agreement to the 
treatment or receipt of controlled substances. Tr. 460-62.
    123. Respondent testified that in his medical practice, his 
documentation of certain areas of patient care did not meet the 
standard of care. Tr. 488, 490.
    124. Patient D.P. testified that, when seen by nurse practitioners 
at Respondent's practice, they did not necessarily discuss the risks or 
issues with taking high dose opioid medications. Tr. 524:12-22.
    125. Patient D.P. testified that he did not have his vital signs 
taken at every medical visit with Respondent. Tr. 525:8-11.
    126. Patient D.P. testified that Respondent did not conduct a full 
physical exam at each of D.P. visits. Tr. 525:15-20.
    127. Patient D.P. testified he was able to calculate the MME for 
his opioid prescriptions. He calculated that his MME with the doctor 
treating him prior to Respondent was between 4,500 and 4,800. Tr. 534-
35.
    128. Patient D.P. testified he did not know how high his MME level 
was with the opioid medications prescribed by Respondent. Tr. 535:9-12.
    129. Patient D.P. testified his knew his current MME level to be 
752. Tr. 535:16-17.
    130. Respondent testified he suspected J.K. to have an undiagnosed 
brain injury, and he admitted that he

[[Page 24254]]

did not assess or treat the brain injury.\*X\ Tr. 554:2-16.
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    \*X\ This fact is not material to my decision in this matter; it 
appears to assert failures in Respondent's medical treatment of J.K. 
that extend beyond Respondent's failures with regard to prescribing 
controlled substances.
---------------------------------------------------------------------------

    131. Dr. Mark Wiederhold, Dr. Joseph Shurman, and Respondent all 
confirmed that the standard of care requires a doctor to have complete 
and accurate documentation of the patient's treatment in the patient's 
medical records. Tr. 595, 719-20, 779.
    132. Dr. Mark Wiederhold, Dr. Joseph Shurman, and Respondent 
confirmed that the standard of care requires patient medical records to 
contain sufficient documentation to justify controlled substance 
prescriptions issued to that patient. Tr. 595, 720, 779-80.
    133. Dr. Mark Wiederhold, Dr. Joseph Shurman, and Respondent 
confirmed that the standard of care requiring complete and accurate 
documentation in a patient's medical record is for the protection, not 
only of the patient, but for the protection of the doctor as well. Tr. 
595, 720, 780.
    134. Dr. Mark Wiederhold, Dr. Joseph Shurman, and Respondent 
confirmed that a doctor is ultimately responsible for preparing 
complete and accurate medical records. Tr. 595-96, 720, 780.
    135. Dr. Mark Wiederhold, Dr. Joseph Shurman, and Respondent 
confirmed that doctors are responsible for reviewing their patient's 
medical records to assure that the records created by the doctor are 
accurate and complete. Tr. 596, 780.
    136. Dr. Joseph Shurman testified that it is much easier to taper 
off immediate release opioids than off the extended release opioids. 
Tr. 685:16-20.
    137. Ultimately, Dr. Shurman testified he spent approximately 10 
hours reviewing over 4,000 pages of medical records in this case. Tr. 
719:7-15; GX 8, 10, 12, 14.
    138. Dr. Joseph Shurman confirmed that doctors must justify their 
use of high dose opioids in the medical records. Tr. 721:1-4.
    139. On the basis of his review of the D.P. medical records, Dr. 
Shurman found no evidence that Respondent documented any discussions he 
had with D.P. regarding the various risks associated with taking high 
dose opioids, including the risk of death. Tr. 722-24.
    140. Dr. Shurman testified that a long term goal for a patient on 
high-dose opioids would be to attempt to gradually taper the patient 
off the high-dose opioids. Tr. 725:12-16.
    141. Dr. Shurman testified that the standard of care for a pain 
doctor in San Diego is measured by what a reasonable pain specialist 
would do in the San Diego area. Tr. 733:13-25.
    142. Dr. Munzing, Respondent's two experts, and Respondent all 
agreed that the standard of care in California requires sufficient 
documentation in the medical record to justify controlled substance 
prescriptions. Tr. 89-90, 245, 595, 720, 779-80.
    143. In May 2019, D.P. was seen by Respondent or someone in 
Respondent's office on a weekly basis. Tr. 782:19-22. D.P. went to 
Respondent's office on May 21, 2019, May 29, 2019, June 4, 2019, June 
11, 2019, June 17, 2019, and June 25, 2019. Tr. 782-83.
    144. D.P. would notify Respondent if D.P. had any problems filling 
any of his prescriptions. Tr. 783:2-5.
    145. In August 2019, D.P.'s pharmacy began to severely restrict his 
ability to fill oxycodone prescriptions at that pharmacy. Tr. 783:6-10; 
GX 9 at 397.
    146. As of August 14, 2019, the pharmaceutical distributor Cardinal 
would not replenish the Respondent's oxycodone prescriptions issued to 
D.P. GX 9 at 397; Tr. 784-85.
    147. Due to Cardinal's refusal to replenish Respondent's oxycodone 
prescriptions to D.P., the pharmacy would only fill a 48-72 hour 
prescription for all four oxycodone prescriptions issued by Respondent. 
Id.

Analysis

Findings as to Allegations

    The Government alleges that the Respondent's COR should be revoked 
and any applications should be denied, because as recently as September 
16, 2019, Respondent violated federal and California law by issuing 
prescriptions for controlled substances outside the usual course of 
professional practice and not for a legitimate medical purpose. ALJ Ex. 
1, p. 3, ] 6. The Government further alleges that the Respondent's 
conduct reflects negative experience in prescribing with respect to 
controlled substances under 21 U.S.C. 823(f)(2), and shows that 
Respondent has failed to comply with applicable federal and state laws 
relating to controlled substances under 21 U.S.C. 823(f)(4). ALJ Ex. 1, 
p. 2, ] 2.
    In the adjudication of a revocation or suspension of a DEA COR, the 
DEA bears the burden of proving that the requirements for such 
revocation or suspension are satisfied. 21 CFR 1301.44(e).*\Y\
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    *\Y\ Remaining text moved to the Sanctions section infra or 
omitted for brevity and clarity.
---------------------------------------------------------------------------

California Law
    The applicable laws in this case include: *\Z\ Cal. Health & Safety 
Code Sec.  11153(a), requiring that a ``prescription for a controlled 
substance shall only be issued for a legitimate medical purpose by an 
individual practitioner practicing in the usual course of his or her 
professional practice;'' Cal. Bus. & Prof. Code Sec.  2242(a) which 
includes in the definition of unprofessional conduct subject to 
sanction, ``[p]rescribing, dispensing, or furnishing [controlled 
substances] without an appropriate prior examination and a medical 
indication''); and Cal. Bus. & Prof. Code Sec.  725(a), which includes 
in the definition of unprofessional conduct subject to sanction, 
``[r]epeated acts of clearly excessive prescribing, furnishing, 
dispensing, or administering of drugs . . . .''
---------------------------------------------------------------------------

    *\Z\ Omitted text pursuant to supra n.*D.
---------------------------------------------------------------------------

Failure To Maintain Complete and Accurate Records
    [The ``Guide to the Laws Governing the Practice of Medicine by 
Physicians and Surgeons,'' requires that a practitioner ``keep accurate 
and complete records, including but not limited to, records of the 
patient's medical history, physical examinations of the patient, the 
treatment plan objectives and the treatments given, and the rationale 
for any changes in treatment.'' GX 3, at 59. Not surprisingly, the 
failure to maintain accurate and complete patient records itself is 
outside the usual course of professional practice and represents a 
violation of the California standard of care. Tr. 89.] The Respondent 
concedes, [though not unequivocally,] that he failed to maintain 
complete and accurate patient charts [in ``some areas,''] which he 
agreed is required by the standard of care. Tr. 488, 779. Beyond the 
lack of detail, there is evidence of missing records. He has 
acknowledged [at least some recordkeeping] failures, has taken steps to 
educate himself as to this critical aspect of the standard of care, and 
has credibly vowed to correct this failure. Tr. 822-24; RX W.
    Dr. Munzing's opinions and conclusions regarding the Respondent's 
failure to appropriately document within the charts are fully credible. 
[Dr. Munzing opined that to meet the standard of care in California, a 
provider must ensure that the medical history, examination, other 
evaluations, treatment plans, objectives, informed consent, treatments, 
medications,

[[Page 24255]]

rationale for prescribing, and agreement with the patient are well-
documented in the medical records. Tr. 89-90. He further testified that 
the standard of care required the resolution of aberrant drug screens 
to be well documented before continuing to prescribe. Tr. 99, 310-11. 
Dr. Munzing repeatedly opined that Respondent acted beneath the 
standard of care with regard to documentation in many of the categories 
where documentation was required for each of the four individuals. For 
D.P. alone, Dr. Munzing testified that the documented medical history 
was ``actually pretty poor,'' Tr. 125, that ``the documentation was far 
below what was necessary [to] justify the incredibly high dosing,'' Tr. 
126, ``there's no vital signs, there's no examination, there's [a] 
limited amount of information . . . [and] the documentation is 
inadequate . . . and we still don't have an informed consent.'' Tr. 
132, 154.]
    I find that the Government has proven the allegations as to the 
Respondent's failure to appropriately document within the patients' 
medical records as to each of the subject patients.\43\ The failure to 
document is closely related to a practitioner's responsibility to 
establish informed consent.*\AA\
---------------------------------------------------------------------------

    \43\ [Omitted for brevity and relevance.]
    *\AA\ Remaining text omitted for legal clarity.
---------------------------------------------------------------------------

    The Government expert, Dr. Munzing, appropriately based many of his 
opinions on the absence of supporting notes in the patient chart, 
applying the truism, ``if it is not documented, it did not happen.'' 
Tr. 406. [Dr. Munzing testified, that ``[i]f one doesn't document 
something and there's no other way to verify it, then you can't 
necessarily infer that it's happened.'' Tr. 405-06. This opinion is 
consistent with prior DEA decisions, stating, based on credible expert 
testimony, 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 57749, 57760 
(2019). The RD stated that, because in this case there was] credible 
testimony from patients and credible testimony from the Respondent 
regarding aspects of undocumented but otherwise appropriate treatment 
protocol, [the ALJ was] not prepared to accept the blanket conclusion 
that because Respondent failed to include treatment notes in the 
record, such treatment was not provided.\44\ [I do not agree with the 
ALJ's suggestion that because a few undocumented actions were 
corroborated by testimony, all of the undocumented actions must have 
occurred in accordance with Respondent's testimony. Here, the testimony 
from the two testifying patients was limited and corroborated only a 
few of the undocumented actions, such as obtaining informed consent. 
The vast majority of Respondent's actions remained uncorroborated by 
either documentary evidence or testimony.]
---------------------------------------------------------------------------

    \44\ [Text from the body and from the footnote omitted for legal 
clarity.]
---------------------------------------------------------------------------

    The Government argues that the failure to document alone renders 
the resultant prescriptions illegitimate under the standard of care, 
and therefore unjustified. Although the Respondent may indeed have 
performed certain treatment protocols that were not documented in the 
medical records, I accept the Government's conclusion that the failure 
to document alone violates the standard of care. The Government also 
alleges a number of clinical failings by the Respondent. These will be 
addressed as well.
Discussion as to Patient D.P.*BB 45
---------------------------------------------------------------------------

    *\BB\ The RD included an extensive write up of the OSC's 
allegations pertaining to each of the four individuals at issue 
prior to discussing each individual. The allegations are set forth 
clearly in the OSC, see ALJ Ex. 1, and are summarized above; 
therefore, for brevity, I have omitted each of the four sections 
outlining the allegations pertaining to each of the four 
individuals. The ALJ's analysis of those allegations remains.
    \45\ [Omitted pursuant to n.*BB.]
---------------------------------------------------------------------------

    The major dispute between the parties regarding D.P. was the 
Respondent's failure to titrate D.P. from the astronomical levels of 
opioids on which D.P. came to the Respondent, 3,000 MME per day. As 
D.P. was a returning patient and well-known to the Respondent, the 
Respondent decided to provide treatment even though he had never 
treated a patient who was prescribed such high levels of opioids. The 
Respondent and his expert, Dr. Shurman, both recognized the importance 
of reducing D.P.'s MME. D.P. testified that he was ``reluctan[t]'' to 
lower his dosage because he was functioning pretty well and his pain 
range was between a two-to-four out of ten. Tr. 520. The Respondent 
testified that D.P. did not tolerate titration, either suffering 
withdrawal or manifesting physical reactions when attempts were made. 
The Respondent attempted alternative treatment, and took positive 
measures, such as providing D.P. with Narcan, but ultimately decided to 
continue D.P. on the opioid medication regimen. Additionally, there was 
an admission by D.P. to the Respondent that he had taken medication not 
as prescribed. An insurance company stepped in and greatly restricted 
the pharmacy's ability to fill the subject prescriptions. Rather than 
re-evaluating his treatment strategy, the Respondent adjusted his 
prescribing schedule to work around that restriction. Ultimately, 
although Sharp Hospital's attempt at titration failed as too rapid, UC 
San Diego Pain Management successfully titrated D.P. down to 700 
MME.*\CC\
---------------------------------------------------------------------------

    *\CC\ Some text has been moved or omitted from this paragraph 
for clarity.
---------------------------------------------------------------------------

    [Dr. Shurman and Dr. Munzing both testified that the standard of 
care required Respondent to try to taper down D.P.'s dosage slowly. Tr. 
146-48, 653-54. Instead of attempting titration as required by the 
standard of care], the patient chart reveals a sporadic treatment 
strategy, with MME levels [first increasing] and then alternating 
between 3,500 and 6,000 MMEs.*\DD\ [Dr. Munzing testified that 
Respondent's prescribing was beneath the standard of care because 
``rather than tapering, [he] episodically increases the dosages,'' and 
there was no documented titration plan. Tr. 137, 145-46. Dr. Shurman 
excused the high MME levels Respondent prescribed to D.P. without 
titrating because he concluded Respondent's monitoring of D.P. was 
sufficient to ensure D.P. remained relatively safe. Tr. 658. This 
position is not convincing over Dr. Munzing's credible testimony. I 
cannot find that monitoring, assuming for the sake of argument that it 
was sufficient, can overcome Respondent's failure to document medical 
justification for prescriptions as high as 6,000 MME and failure to 
document a treatment plan for titration. Dr. Munzing testified that 
these levels were the highest MME that he had ever seen. Tr. 117. He 
further described this level of prescribing to be ``incredibly 
dangerous.'' Tr. Tr. 177.]
---------------------------------------------------------------------------

    *\DD\ Sentence relocated and additional text omitted for 
clarity.
---------------------------------------------------------------------------

    I find that the evidence supports [Dr. Munzing's opinion] that the 
Respondent's [prescribing to] D.P. was dangerous and outside the 
standard of care. Dr. Munzing's opinions relating to the Respondent's 
evaluation and monitoring of D.P. and the Respondent's overall 
[prescribing to] D.P. as being outside the standard of care are 
accepted.\46\
---------------------------------------------------------------------------

    \46\ Although disputed during the hearing, even with the use of 
oximetrics at visits, I accept Dr. Munzing's opinion that vital 
signs should have been taken at each of D.P.'s visits, due to the 
high levels of MME and his concurrent medical issues.
---------------------------------------------------------------------------

    The Government has sustained its burden as to the allegations 
relating to the Respondent's [issuance of the prescriptions at issue 
to] D.P.

[[Page 24256]]

Discussion as to Patient J.K.
    There were several disputes as to the propriety of [the 
prescriptions issued to] J.K. Again, Dr. Munzing's conclusions are 
based on his review of the medical chart. Dr. Munzing criticized 
Respondent for failing to order a neurological exam to determine if 
J.K.'s migraines could be caused by a tumor or other organic issue. 
This was confronted by the Respondent's memory, undocumented in the 
chart [and not supported by other testimony or evidence], that J.K. had 
a ``workup with a neurologist'' in the past. The Respondent had seen 
J.K. when he worked for a medical group prior to reopening his own 
practice. It seems unusual that the Respondent did not obtain J.K.'s 
medical records from the prior group, which requires the tribunal to 
assume that she had this prior workup. I will give him the benefit of 
the doubt that he properly evaluated her need for further testing.*\EE\
---------------------------------------------------------------------------

    *\EE\ I do question how Respondent could credibly testify both 
that J.K. had previous workups from a neurologist such that no other 
imaging studies were necessary, and that Respondent suspected that 
J.K. had some elements of undiagnosed brain injury based her 
behavioral issues, continued headaches, and her history of being the 
victim of physical abuse. Tr. 552, 554. Ultimately the evidence on 
this issue was not fully developed by expert testimony and is not 
material to my decision in this matter.
---------------------------------------------------------------------------

    The next controversy relates to the Respondent's use of opioids to 
treat intractable migraines, which Dr. Munzing characterized as being 
beneath the standard of care [because ``opioids are not generally a 
very successful treatment for chronic headaches.'' Tr. 231.] Dr. 
Shurman presented the opinion that some physicians, including himself, 
believe opioids are an appropriate treatment for migraines within the 
standard of care. The Respondent testified that he treated J.K. with 
Botox, but her insurance eventually failed to cover these injections. 
Without further detail or explanation from the experts, I [decline to 
decide whether or not the prescribed opioids were appropriate to treat 
J.K. migraines.] *\FF\
---------------------------------------------------------------------------

    *\FF\ Text modified for clarity.
---------------------------------------------------------------------------

    The next dispute relates to Dr. Munzing's assertion that J.K.'s 
ongoing pain could not be attributed to cancer pain as J.K. had been 
cancer free for four years. The Respondent counters that chemotherapy 
can produce residual pain syndromes, which can extend after treatment 
has ended. Dr. Munzing did not address whether the treatment for cancer 
can produce ongoing pain issues. Therefore, I credit the Respondent's 
explanation. [However, I also credit Dr. Munzing's testimony that 
regarding cancer pain, ``[t]here really wasn't anything in [J.K.'s 
medical records]. The focus of the treatment was not anything related 
to cancer per se.'' Tr. 233-34. To prescribe to J.K. within the 
standard of care for pain stemming from cancer or cancer treatment, Dr. 
Munzing testified that Respondent's ``medical history certainly should 
have included more specifics in regards to the diagnosis of breast 
cancer.'' Tr. 234.]
    The next controversy relates to J.K.'s abnormal urine drugs screens 
(UDS). J.K.'s UDS failed to reveal the fentanyl she had been prescribed 
in the form of a patch. According to the Respondent, when confronted 
with this discrepancy, J.K. explained that the patches would fall off 
prematurely due to her perspiring. She would then put on a new patch 
prematurely, and run out of her prescribed patches prior to her next 
medical visit. Dr. Shurman confirmed this scenario was not uncommon and 
noted that J.K. was on hormone replacement. I accept Dr. Shurman's 
opinion that this abnormal UDS was properly investigated and found to 
be reasonably explained. [However, I also agree with Dr. Munzing that 
the required documentation showing that Respondent addressed and 
resolved the aberrant results was missing from the medical records, 
which is itself beneath the standard of care. Tr. 266-67; 268-69; 270; 
279.]
    The next UDS controversy relates to THC appearing in J.K.'s UDS, 
which had not been prescribed by the Respondent. Dr. Munzing noted the 
danger in combining marijuana with J.K.'s prescribed medications. The 
Respondent testified that J.K. had been prescribed Marinol during her 
cancer treatment, and she apparently continued to take it after 
obtaining it from a dispensary. The Respondent testified that he 
cautioned her about potential side effects and contraindications in 
conjunction with the other medications she was taking, but the 
testimony was not supported by documentation in the medical records. 
Dr. Shurman opined that marijuana derivatives were commonly prescribed 
now and did not present a significant danger to J.K. [Even assuming 
that the aberrant result was investigated and handled appropriately, I 
find in accordance with Dr. Munzing's testimony that Respondent's 
failure to document that he investigated and resolved the aberrant 
results was beneath the standard of care. Tr. 266-67; 268-69; 270; 
279.]
    The next abnormal UDS relates to the appearance of amphetamine, 
which was not prescribed by the Respondent. The Respondent recognized 
that the UDS results indicated the dose was likely pharmaceutical. The 
Respondent remembered that J.K. was being seen by a psychiatrist, who 
prescribed Adderall. The Respondent testified that he cautioned J.K. 
regarding taking her medications as prescribed. I find that the 
Respondent investigated and properly handled this UDS. [Even assuming 
that the aberrant result was investigated and handled appropriately, I 
find in accordance with Dr. Munzing's testimony that Respondent's 
failure to document that he investigated and resolved the aberrant 
results was beneath the standard of care. Id.]
    The next issue related to J.K. taking in excess of the opioid 
dosage prescribed. Tr. 256-57. The Respondent testified that he 
counseled J.K. regarding the dangers of doing so. However, no further 
cautionary steps were taken. J.K. had a dosage of approximately 400 MME 
at this time and the MME had been increased by the Respondent. [With 
regard to patients who are not taking medications as prescribed, Dr. 
Munzing testified that ``there are significant risks of either taking 
too much [and] potentially overdosing [or] taking too little and 
potentially going through withdrawal.'' Tr. 411. Accordingly, Dr. 
Munzing testified, when ``a prescriber learn[s] about it, you need to 
counsel the patient and document that.'' Id.] Dr. Shurman suggested 
that it was normal for patients to take medications other than as 
strictly prescribed, and it was appropriate to average their compliant 
versus noncompliant behavior. That position is contrary to common 
sense, and I must reject it. At such high levels of MME, taking an 
opioid as prescribed must be more than a suggestion [in light of the 
risks identified by Dr. Munzing]. Allowing a patient to increase [or 
decrease] dosages on his own can be dangerous. I find the Respondent's 
[failure to take action and/or document the action taken with regard to 
addressing J.K.'s admission that she did not take the medication as 
prescribed] was insufficient to satisfy the standard of care.
    The next controversy relates to attempts to titrate J.K. down on 
her opioids, Soma, and benzodiazepine. In reviewing the record, the 
Respondent described his efforts to get J.K. to ``buy in'' on the idea 
of titrating her off the high level MME she was on and off her 
benzodiazepine dose.\*GG\ The Respondent also defended the medication 
regimen as it allowed J.K. to work and to complete her ADLs. However, 
according to Dr. Munzing, the standard of care requires practitioners 
to

[[Page 24257]]

reduce the MME to the level that balances the highest level of activity 
with the least MME. Dr. Munzing described the danger inherent in the 
combination of controlled substances that J.K. found herself on, ``the 
Holy Trinity,'' as prescribed by the Respondent. When J.K. returned to 
the Respondent as a patient, she was on a fentanyl patch, which the 
Respondent continued. He also prescribed a short-acting opioid for 
breakthrough pain, and Soma to diffuse muscle spasms. He later 
concluded that Soma was not the right medication for J.K. and attempted 
to have her ``buy in'' to titrate off of it. Even crediting the 
Respondent's explanation for prescribing, which is not documented in 
the record, I credit Dr. Munzing's opinion that having J.K. on that 
dangerous combination was unjustified and contrary to the standard of 
care.
---------------------------------------------------------------------------

    \*GG\ Text omitted for clarity.
---------------------------------------------------------------------------

    As to J.K.'s threat of suicide, Dr. Munzing opined that the 
Respondent's actions fell below the standard of care. Dr. Munzing 
testified that the standard of care for a doctor with a patient on 
high-dose opioids and has suicidal ideations is to get that patient 
immediate care, review the patient's mental health history, work with 
other providers such as a psychiatrist, and come up with a plan. Tr. 
259. Typically, Dr. Munzing testified, a doctor would not continue the 
medications being prescribed and would work to develop a possible 
management plan for the patient. The standard of care would also 
require that the doctor have a discussion with the patient on a 
subsequent visit. Tr. 259-60. [Dr. Shurman did not offer an opinion on 
this issue.] The Respondent testified that he believed that J.K. [had 
no intention of following through on her] threat, which he believed was 
based solely on her fear that she would be without her medication. Tr. 
564. Accordingly, the Respondent continued her prescription regime. I 
agree with Dr. Munzing's [credible opinion] that the Respondent's 
reaction, [particularly his continued prescribing without modification 
following J.K.'s suicide threat,] was outside the standard of care.
    [In addition to the above areas, Dr. Munzing testified that with 
regard to prescribing to J.K., Respondent failed to take an appropriate 
history and examination to narrow down the cause of the headaches, Tr. 
229; failed to adequately document the risks and attempts to moderate 
the risks, Tr. 235, 446, 448, 458; failed to obtain informed consent, 
id.; failed to medically justify the high levels of opioids or the 
dangerous combinations of opioids with Soma and a stimulant, Tr. 235-
40; failed to document justification for increased dosages and changes 
to prescriptions, Tr. 244-45; and failed to take or document vital 
signs at multiple visits, Tr. 248-49. Based on these failures, I find 
in accordance with Dr. Munzing's testimony that each of the relevant 
prescriptions issued to J.K. were issued outside the usual course of 
professional practice and beneath the standard of care. Tr. 281.]
Discussion as to Patient P.S.
    The following issues were controverted by the parties. The most 
significant controversy was related to P.S.'s repeated abnormal UDS. He 
tested negative for lorazapam and alprazolam several times, which were 
prescribed controlled substances. He also tested negative for morphine, 
a prescribed pain medication. Dr. Munzing faulted the Respondent for 
not immediately contacting P.S. to investigate and to monitor him more 
closely. The Respondent believed that P.S., who suffered from chronic 
pain and an anxiety disorder, had good days and bad days and would 
refrain from taking his medications some days, but was not abusing his 
medication. The Respondent also tried to refer P.S. to a psychiatrist. 
Dr. Shurman viewed P.S. as a challenging patient. He viewed the 
abnormal UDS, as long as they were not ongoing, as something which at 
least requires the practitioner's attention. Dr. Shurman believed the 
Respondent followed the standard of care with P.S. because he had a 
discussion with him and followed him closely with CURES, urine screens, 
etc., to ensure there was not an ongoing problem.\*HH\ Tr. 692-94.
---------------------------------------------------------------------------

    \*HH\ Again, this position is not convincing. I cannot find that 
monitoring, assuming for the sake of argument that it was 
sufficient, can overcome Respondent's other failures, here, the 
failure to resolve repeated aberrant drug screens.
---------------------------------------------------------------------------

    I find Dr. Munzing's testimony more credible in this instance. P.S. 
was prescribed dangerous combinations of medications with serious 
concurrent medical issues. He also suffered from mental health issues, 
but was not under psychiatric care. He demonstrated a propensity to 
refrain from taking his medication if he felt he did not need it and 
had fifteen abnormal drug screens, including several evidencing alcohol 
use. [As Dr. Munzing testified, there are significant risks for taking 
too much or too little medication. Tr. 411. And here, there is no 
indication that the Respondent documented that he investigated the 
aberrant results, counseled P.S. regarding them, or resolved the 
aberrancies; Dr. Munzing testified Respondent acted beneath the 
standard of care. Tr. 198-202.] I therefore find that the Respondent 
continuing prescribing to P.S. without modification, despite multiple 
aberrant drugs screens, fell below the standard of care.\*II\
---------------------------------------------------------------------------

    \*II\ Text omitted for legal clarity.
---------------------------------------------------------------------------

    The next matter in controversy was the justification for 
prescribing opioids and a benzodiazepine together. The Respondent 
prescribed P.S. morphine, hydromorphone, and a benzodiazepine at 366 
MME per day. P.S. had serious concurrent health issues, including an 
embolism and DVT. The Respondent did not address these issues at the 
hearing, either through his own testimony or through his expert's 
testimony, except in the most general terms that his prescriptions were 
within the standard of care. As noted by Dr. Munzing, the patient's 
medical record does not reveal Respondent's rationale for issuing these 
prescriptions. Dr. Munzing's opinion is rational, logical, consistent 
with his other opinions and with the credible facts of the case, and 
was uncontroverted. Accordingly, I accept Dr. Munzing's opinion. I 
therefore find that the Respondent's actions to prescribe opioids and 
benzodiazepine fell below the standard of care because the Respondent 
failed to justify this dangerous medication regimen for P.S.
    [In addition to the above areas, Dr. Munzing testified that with 
regard to prescribing to P.S., Respondent failed to obtain an adequate 
medical history, Tr. 183-84; failed to adequately document the full 
range of risks of using opioids and a benzodiazepine, Tr. 178; failed 
to obtain informed consent, Tr. 183, 374; failed to medically justify 
the controlled substance prescriptions, Tr. 190-97; failed to document 
justification for changes to prescriptions, Tr. 179-81, 193; failed to 
take or document vital signs at multiple visits and failed to perform 
proper musculoskeletal exams, Tr. 183. Based on these failures, I find 
in accordance with Dr. Munzing's testimony that each of the relevant 
prescriptions issued to J.K. were issued outside the usual course of 
professional practice and beneath the standard of care. Tr. 193.]
Discussion as to Patient D.L.
    The first matter in controversy relates to the Respondent's 
inability to taper D.L. down from the high doses of medication. Despite 
acknowledging the importance of reducing the MME, D.L. would eventually 
reach 455 MME under the Respondent's care. Dr. Munzing explained that 
although the patient's chart suggests her opioid dosage was going to be 
reduced, the medical records

[[Page 24258]]

reflect that the opioid dosage was actually increased over time. [Dr. 
Shurman opined that ``at the time she [first] came to Dr. Wynn'' it 
would not have been appropriate for Respondent to immediately taper 
D.L. from her dosages without ``getting a feel for [her], get[ting] a 
history, urine drug screens, CURES, etc.'' Tr. 703. Dr. Shurman went on 
to testify that D.L. continued getting the same combination of 
medications for a while, id., but then never offered further testimony 
regarding the appropriateness of tapering after the first visits.] I 
credit Dr. Munzing's opinion that the [prescriptions issued to] D.L. 
were not consistent with the standard of care. Documenting an intent to 
reduce an opioid dosage, yet increasing it, is troubling. The 
Respondent provided no justification for increasing D.L.'s MME to such 
a high level.
    The next matter in controversy relates to the indication of 
abnormal UDS. Dr. Munzing notes there is no explanation in the file for 
the aberrancies, nor any indication the Respondent investigated the 
matter or discussed any aberrant drug screens with D.L. The Respondent 
testified that he had ordered pharmacogenic testing for D.L. and 
discovered she had an altered gene expression that related to how she 
responded to morphine. He explained this condition was the reason for 
her aberrant UDSs, although nothing in the record showed that there was 
any discussion regarding the aberrant drug screens. Tr. 308. I 
therefore find that the Respondent did investigate and address the 
abnormal UDS results [but did not document resolution of the aberrant 
drug screens appropriately.]
    Dr. Munzing cited D.L.'s age as an aggravating factor relative to 
Respondent's prescribing as she was is in her late 60's/early 70's. Tr. 
287. She presented with a history of colon cancer, then experienced 
uncontrolled pain due to polyneuropathy, hip pain, and a failed spine 
surgery. The Respondent testified that he investigated hip injections 
and a pain pump as possible alternatives. Dr. Shurman noted that 
throughout treatment, D.L.'s subjective pain scale remained at a five 
or six out of ten. He considered this a success. [Dr. Shurman also 
offered his opinion that Respondent's prescribing to D.L. was 
appropriate because of ``how he handled it;'' specifically that ``he 
followed [her] closely, CURES, urine screens, kept an eye on [her] 
mentally . . . .'' Tr. 708.]\*JJ\
---------------------------------------------------------------------------

    \*JJ\ Again, this position is not convincing. Based on Dr. 
Munzing's credible expert testimony, I cannot find that monitoring, 
assuming for the sake of argument that it was sufficient, can 
overcome Respondent's other failures.
---------------------------------------------------------------------------

    [In addition to the above areas, Dr. Munzing testified that with 
regard to prescribing to P.S., Respondent: Failed to obtain an adequate 
medical history, Tr. 283; failed to adequately document the full range 
of risks of using opioids with a benzodiazepine and a sleeping agent, 
Tr. 286; failed to obtain informed consent, Tr. 297-98; failed to 
consider or document consideration of alternative strategies to manage 
D.L.'s pain, Tr. 300; failed to medically justify the controlled 
substance prescriptions, Tr. 289; and failed to take or document vital 
signs or perform proper musculoskeletal exams at multiple visits, Tr. 
294, 296, 300. Based on these failures, I find in accordance with Dr. 
Munzing's testimony that each of the relevant prescriptions issued to 
J.K. were issued outside the usual course of professional practice and 
beneath the standard of care. Tr. 287, 290, 292, 294, 299, 301, 308, 
309.]
Government's Burden of Proof and Establishment of a Prima Facie Case
    Based upon my review of each of the allegations by the Government, 
it is necessary to determine if it has met its prima facie burden of 
proving the requirements for a sanction pursuant to 21 U.S.C. 
824(a)(4). At the outset, I find that the Government has demonstrated 
and met its burden of proof in support of its allegations relating to 
Respondent's prescribing of controlled substances to patients D.P., 
J.K., D.L., and P.S.

Public Interest Determination: The Standard

    [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.'' \*KK\ 21 U.S.C. 824(a)(4).] \47\ Evaluation of the 
following factors has been mandated by Congress in determining whether 
maintaining such registration would be inconsistent with the ``the 
public interest'':
---------------------------------------------------------------------------

    \*KK\ Respondent argued that his continued registration is 
consistent with the public interest because he provides medical 
services to a community that is ``very under-served, under-
privileged and in need of doctors like him.'' Tr. 18. The CSA 
requires me to consider Respondent's controlled substance dispensing 
experience, among other things, not whether Respondent's practice of 
medicine as a whole was beneficial to the community. 21 U.S.C. 
823(f)(2); see Frank Joseph Stirlacci, M.D., 85 FR 45229, 45239 
(2020) (declining to accept community impact arguments); see also 
Richard J. Settles, D.O., 81 FR 64940, 64945 n.16 (2016).
    \47\ [This text replaces the ALJ's original text and omits his 
original footnote for clarity.]
---------------------------------------------------------------------------

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

21 U.S.C. 823(f). ``These factors are . . . considered in the 
disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
    Any one or a combination of factors may be relied upon, and when 
exercising authority as an impartial adjudicator, the Agency may 
properly give each factor whatever weight it deems appropriate in 
determining whether a registrant's registration should be revoked. Id. 
(citation omitted); David H. Gillis, M.D., 58 FR 37507, 37508 (1993); 
see also Morall at 173-74; Henry J. Schwarz, Jr., M.D., 54 FR 16422, 
16424 (1989). Moreover, the Agency is ``not required to make findings 
as to all of the factors,'' Hoxie, 419 F.3d at 482; see also Morall, 
412 F.3d at 173. [Omitted for brevity.] The balancing of the public 
interest factors ``is not a contest in which score is kept; the Agency 
is not required to mechanically count up the factors and determine how 
many favor the Government and how many favor the registrant. Rather, it 
is an inquiry which focuses on protecting the public interest . . . .'' 
Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
    The Government's case invoking the public interest factors of 21 
U.S.C. 823(f) seeks the revocation of the Respondent's COR based 
primarily on conduct most aptly considered under Public Interest 
Factors Two and Four.\48\
---------------------------------------------------------------------------

    \48\ 21 U.S.C. 823(f)(2), (4). There is nothing in the record to 
suggest that a state licensing board made any recommendation 
regarding [Respondent's prescribing practices] (Factor One). [Where 
the record contains no evidence of a recommendation by a state 
licensing board that absence does not weigh for or against 
revocation. See Roni Dreszer, M.D., 76 FR 19434, 19444 (2011) (``The 
fact that the record contains no evidence of a recommendation by a 
state licensing board does not weigh for or against a determination 
as to whether continuation of the Respondent's DEA certification is 
consistent with the public interest.'')] Likewise, the record 
contains no evidence that the 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 49956, 49973 
(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. The 
Government does not identify Factor Five as being relevant.]

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

[[Page 24259]]

[Factors Two and Four: The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances *LL
---------------------------------------------------------------------------

    \*LL\ The ALJ evaluated Factors 2 and 4 in separate sections and 
I have combined and expanded on his analysis herein.
---------------------------------------------------------------------------

    According to the Controlled Substances Act's 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).\49\
---------------------------------------------------------------------------

    \49\ [Footnote omitted along with original text for legal 
clarity.]
---------------------------------------------------------------------------

    Respondent has demonstrated substantial experience as a licensed 
California doctor since 2000; he has been board certified in Physical 
Medicine and Rehabilitation since 2004, and has maintained a 
subspecialty certification in Pain Management since 2006. RX 1, at 1. 
Respondent has practiced pain medicine in a variety of settings 
including in affiliation with hospitals, in group settings, and most 
recently rebuilding his preexisting private practice since 2016. Tr. 
469-76. At the time of the hearing, Respondent testified that he served 
600 active patients, and handled a total of approximately 7,000 medical 
appointments a year. Tr. 830. The Agency assumes that Respondent has 
prescribed legally, except where the Government has established 
violations of the law. Here, Respondent's treatment of the four 
patients as alleged in the OSC demonstrates that his prescribing 
practices fell beneath applicable standard of care.
    I find that the Government's expert credibly testified, as 
supported by California law and California's Guide to the Laws and 
Guidelines for Prescribing, that the standard of care in California for 
prescribing controlled substances requires a physician to, amongst 
other things, obtain a detailed medical history, perform and document a 
physical examination, come up with a diagnosis, perform a risk 
stratification, and develop and document a customized management plan. 
Tr. 79. Thereafter, the physician must monitor the patient on a 
periodic and regular basis, which includes obtaining vital signs 
including blood pressure, heart rate, and respiratory rate at every 
office visit for patients on high dose opioids. Tr. 79-80, 87, 851-52. 
The standard of care further requires that physicians maintain complete 
and accurate records documenting all of the above steps in detail. Tr. 
79-80. The standard of care requires that patients be notified of the 
risks and benefits of the use of controlled substances and the 
availability of any alternatives, that patients give informed consent, 
and that the notification of risks and informed consent be documented. 
Tr. 85-86.
    I also found above, in accordance with Dr. Munzing's testimony, 
that Respondent issued each of the relevant controlled substance 
prescriptions to the four patients at issue without taking a proper 
medical or mental health history; conducting a sufficient physical, 
mental, or neurological examination; recording pain levels; documenting 
an appropriate treatment plan; documenting medical justification for 
the high levels of prescribed opioids; documenting discussion of the 
risks of the prescribed controlled substances and informed consent; 
monitoring the patient including taking key vital signs; and/or 
resolving inconsistent urine drug screen results. See supra Findings of 
Fact. I further found that each of the relevant prescriptions 
Respondent issued to the four individuals were issued without a 
legitimate medical purpose, outside the usual course of professional 
practice and beneath the standard of care in California. Accordingly, I 
find that Respondent violated 21 CFR 1306.04(a).
    Indeed, 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. See Kaniz Khan Jaffery, 85 FR 45667, 
45685 (2020). For each of the four individuals, Respondent repeatedly, 
amongst other things, failed to have medical justification for issuing 
high dosages of opioids often in combination with other dangerous 
controlled substances, failed to properly obtain or document obtaining 
informed consent, and failed to properly monitor by taking or 
documenting the taking of vital signs.
    Agency decisions highlight the concept 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 19450, 19464 
(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 at 45686. Dr. Munzing testified that complete and 
accurate records are necessary because ``bottom line[,] it's a patient 
safety issue . . . . [I]f this patient ends up seeing another provider, 
whether it be the primary care provider, another sub-specialist, or the 
emergency room . . . they know . . . how the patient was, here's why 
they were taking what they're taking as far as a justification, and the 
patient is aware of the risk and accepts those risks.'' Tr. 89. The 
extreme failures in Respondent's documentation extended to each of the 
four individuals.
    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 
28643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51592, 51601 
(1998). ``Diversion occurs whenever controlled substances leave `the 
closed system of distribution established by the CSA . . . .' '' Id. 
(citing Roy S. Schwartz, 79 FR 34360, 34363 (2014)). 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 66138, 66148 (2010)).
    With regard to California law, just as I found a violation of 21 
CFR 1306.04(a), I find that Respondent repeatedly issued controlled 
substance prescriptions what were not ``for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
or her professional practice,'' in violation of

[[Page 24260]]

Cal. Health & Safety Code Sec.  11153(a). California law also prohibits 
``[p]rescribing, dispensing, or furnishing'' controlled substances 
``without an appropriate prior examination.'' Cal. Bus. & Prof. Code 
Sec.  2242(a). Crediting Dr. Munzing's testimony, I have found that the 
Respondent failed to conduct an appropriate prior physical, mental, 
and/or neurological examination with regard to his prescribing to each 
of the four individuals at issue, which I find violates Cal. Bus. & 
Prof. Code Sec.  2242(a). Crediting Dr. Munzing's testimony, I find 
that Respondent acted outside the bounds of these laws with regard to 
his prescribing to each of the four patients.
    Finally, California law prohibits ``[r]epeated acts of clearly 
excessive prescribing, furnishing, dispensing, or administering of 
drugs.'' Cal. Bus. & Prof. Code Sec.  725(a). The Government cited to 
the sheer volume of prescriptions issued by Respondent to the four 
individuals at issue as its only proof of a violation of Cal. Bus. & 
Prof. Code Sec.  725(a). While I note that the prescriptions were 
voluminous, the Government did not elicit testimony from its expert to 
establish that Respondent's prescribing to the four individuals at 
issue constituted clearly excessive prescribing in California. 
Accordingly, the Government has not met its burden of establishing a 
violation of Cal. Bus. & Prof. Code Sec.  725(a).]
    Here for the reasons discussed supra, I find the Government has 
proven by substantial evidence that Respondent violated California 
Business & Professional Code Sec.  2242(a), California Health & Safety 
Code Sec.  11153(a), and 21 CFR 1306.04(a).\*MM\
---------------------------------------------------------------------------

    \*MM\ Sentence modified to remove findings regarding California 
laws that were either dropped from the Government's case, see supra 
n.*D, or not established.
---------------------------------------------------------------------------

[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 that supports the 
revocation of his registration. See Wesley Pope, 82 FR 14944, 14985 
(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 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, comas, and deaths. GX 
6, at 1. Dr. Munzing testified that ``[w]hen an individual is on a 
combination of an opiate and a benzodiazepine, the increased risk of 
overdose death goes up approximately tenfold.'' Tr. 86.
    I credit Dr. Munzing's repeated testimony that Respondent was 
prescribing ``astronomical'' and ``incredibly high doses'' of 
individually dangerous drugs; one patient was prescribed over 6,000 MME 
which Dr. Munzing testified was ``the highest [he had] ever seen.'' Tr. 
118, 125, 132. Moreover, many of the prescriptions at issue were issued 
in dangerous combinations including the ``holy trinity'' the ``new holy 
trinity'' and other dangerous combinations as have been discussed. Tr. 
189, 238, 264. Dr. Munzing testified that for D.P. alone, the 
prescribing ``was incredibly dangerous. The patient is lucky to be 
alive.'' Tr. 177. In contrast, Respondent testified that he was not 
aware of any of his patients having suffered the consequence of an 
overdose due to medications he prescribed. Tr. 748. Even if I credit 
Respondent's testimony that none of his patients overdosed, I cannot 
rule out the real potential for addiction. Dr. Munzing testified, that 
``addictive issue[s] with benzodiazepines and opiates is a very real 
risk and potentially life-altering risk.'' Tr. 458. Even the 
individuals' exposure to the increased risks caused by the dangerous 
combinations of the controlled substances Respondent prescribed could 
be harmful.
    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 many controlled-substance prescriptions Respondent issued 
without complying with the California standard of care. See supra 
Factors Two and Four.]
[Sanction *NN
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    \*NN\ I am replacing portions of the Sanction section in the RD 
with preferred language regarding prior Agency decisions; however, 
the substance is primarily the same.
---------------------------------------------------------------------------

    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 
18882, 18910 (2018) (collecting cases). Here, Respondent has not 
established 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 23848, 23853 
(2007) (quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (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 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 at 23853; John H. Kennedy, 
M.D., 71 FR 35705, 35709 (2006); Prince George Daniels, D.D.S., 60 FR 
62884, 62887 (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

[[Page 24261]]

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, [the ALJ found that] the Respondent had accepted 
responsibility that his record-keeping was not appropriate or 
sufficient.\50\ [At the hearing, Respondent agreed with his attorney's 
question that ``looking back now at these records, [there were areas 
that he felt were] less than adequate.'' Tr. 488. But he also 
testified, ``I would say that some areas are appropriate.'' Id. The 
testimony does not contain sufficient detail for me to determine that 
Respondent fully understands the documentation requirement in the 
applicable standard of care and which ``areas'' were appropriate and 
which were not. Moreover, this limited acceptance of responsibility 
cannot be said to be unequivocal, or even complete.] Respondent has 
taken remedial steps to improve his documentation, including taking 
courses/trainings to bring himself into compliance with the critical 
documentation standard and hiring a scribe to help draft his patient 
notes, [but I find these remedial measures to be insufficient, without 
an unequivocal acceptance of responsibility, to convince me that 
Respondent's documentation failures will not recur]. Moreover, as to 
all of the allegations [unrelated to documentation failures], such as 
the dangerous prescribing of opioids in conjunction with 
benzodiazepines, failure to timely titrate, and ongoing failure to 
sufficiently monitor some of his patients, he has not accepted any 
responsibility.\51\
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    \50\ [Omitted for clarity.]
    \51\ Where a registrant has not accepted responsibility, it is 
not necessary to consider evidence of the registrant's remedial 
measures. Id. at 5498 n.33.
---------------------------------------------------------------------------

Egregiousness and Deterrence
    [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 at 18910 
(collecting cases). As Dr. Munzing testified, not all of Respondent's 
prescribing practices were beneath the standard of care.] Dr. Munzing 
conceded he believed each of the subject patients likely had genuine 
pain, and testified that the Respondent either ordered tests or 
attempted to order tests, conducted UDS, prescribed Narcan, and made 
efforts to refer patients to specialists. Tr. 353. Dr. Munzing agreed 
that this is not a case of a doctor limiting treatment to merely giving 
patients pills to control their pain. Tr. 353-54. However, I find that 
[there were still substantial deviations from the standard of care such 
that each of the relevant prescriptions were issued in violation of the 
CSA and California law.] The proven misconduct is egregious and 
deterrence considerations weigh in favor of revocation. The proven 
misconduct involved the Respondent's repeated failure to maintain 
complete and accurate patient charts. The proven misconduct also 
involved the medically unjustified increase and maintenance of 
extraordinarily high MME levels for years at a time and combinations of 
dangerous medications.\*OO\ [For example, Respondent prescribed D.P. 
opioids reaching 6,000 MME, which Dr. Munzing testified ``was 
incredibly dangerous. The patient is lucky to be alive.'' Tr. 176.]
---------------------------------------------------------------------------

    \*OO\ Sentence modified for clarity.
---------------------------------------------------------------------------

    I further find that deterrence considerations weigh in favor of 
revocation. [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 10083, 10095 (2009); Singh, 81 FR at 
8248.] Allowing the Respondent to retain his COR despite the proven 
misconduct would send the wrong message to the regulated community. 
Imposing a sanction less than revocation would create the impression 
that registrants can maintain DEA registration despite their wholesale 
failure to maintain accurate and complete records, increase MME levels 
to dangerous levels, and maintain those levels without documenting 
appropriate medical justification.\52\ Revoking the Respondent's COR 
communicates to registrants that DEA takes all failings under the CSA 
seriously and that severe violations will result in severe sanctions.
---------------------------------------------------------------------------

    \52\ [Omitted for legal clarity.]
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Lack of Candor
    The degree of candor displayed by a registrant during a hearing is 
``an important factor to be considered in determining . . . whether 
[the registrant] has accepted responsibility'' and in formulating an 
appropriate sanction. Hills Pharmacy, LLC, 81 FR 49816, 49845 (2016) 
(citing Michael S. Moore, 76 FR 45867, 45868 (2011)). The Government 
has established that the Respondent lacked candor during his testimony 
by claiming the term ``education'' within a prescribing order reflected 
that the Respondent had then admonished the patient as to the risks of 
the subject medications. [The record at issue states in relevant part: 
``2. Medication refill Norco 10/325 . . . 3. Medication refill 
OxyContin 20 mg . . . 4. Education refill morphine sulfate ER 200 mg . 
. . 5. Medication refill morphine sulfate ER 30 mg . . . .'' GX 14, at 
40.] The context of term within the sentence makes it much more likely 
that the term ``education'' was a scrivener's error for the intended 
term, ``medication.'' Tr. 756; GX 14 at p. 40.] This was a lapse in 
candor by the Respondent [which weighs against my ability to entrust 
him with a registration].

Recommendation

    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for revocation. In evaluating Factors 
[Two and] Four of 21 U.S.C. 823(f), I find that the Respondent's COR is 
inconsistent with the public interest. Furthermore, I find that the 
Respondent has failed to overcome the Government's prima facie case 
[and that the sanction of revocation is warranted].\*PP\
---------------------------------------------------------------------------

    \*PP\ Remainder text omitted consistent with my findings above.
---------------------------------------------------------------------------

    Therefore, I recommend that the Respondent's DEA COR No. BW7210759 
should be revoked, and that any pending applications for modification 
or renewal of the existing registration, and any applications for 
additional registrations, be denied.\*PP\
---------------------------------------------------------------------------

    \*PP\ The ALJ went on to state: ``I note that Dr. Shurman has 
agreed to shepherd the Respondent in his future practice, and the 
Respondent has represented he is more than amenable to a conditional 
allowance of his registration. Dr. Munzing observed that this is not 
a case of a doctor limiting treatment to merely giving patients 
pills to control their pain. The Respondent either ordered tests or 
attempted to order tests and on occasion made efforts to refer 
patients to specialists. As the violations by the Respondent do not 
appear wanton and may have been more the result of inexperience, as 
the Respondent is a relatively young physician, and with relatively 
limited experience, the Administrator may consider permitting the 
Respondent to retain his registration with the requirement of weekly 
review and certification of his prescribing practices by Dr. 
Shurman, for a one year period.'' As an initial matter, I cannot 
agree with the ALJ's characterization that Respondent is 
inexperienced where he has been board certified in a pain management 
subspecialty for approximately sixteen years and has been a licensed 
practitioner in California for approximately twenty-two years. 
Regardless, with a regulated community of more than 1.8 million 
registrants and fewer than two-thousand Diversion Control Employees 
(See DEA FY 2022 Budget Request available at https://www.justice.gov/jmd/page/file/1399016/download), DEA must be able to 
rely on physicians to maintain complete and accurate medical records 
and otherwise comply with the CSA without overseeing weekly 
monitoring. Accordingly, I agree with the ALJ that revocation is the 
appropriate sanction.

Mark M. Dowd,
U.S. Administrative Law Judge.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C.

[[Page 24262]]

824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of 
Registration No. BW7210759 issued to Brenton D. Wynn, M.D. Pursuant to 
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 
21 U.S.C. 823(f), I further hereby deny any other pending applications 
for renewal or modification of this registration, as well as any other 
pending application of Brenton D. Wynn, M.D., for registration in 
California. This Order is effective May 23, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-08514 Filed 4-21-22; 8:45 am]
BILLING CODE 4410-09-P