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Notice2022-08514

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

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Published

April 22, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

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<title>Federal Register, Volume 87 Issue 78 (Friday, April 22, 2022)</title>
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[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24228-24262]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08514]

[[Page 24227]]

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

[[Page 24228]]

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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

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