Notice2024-14199
Jeffrey Pollock, P.A.; Decision and Order
Primary source
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Published
June 28, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 89 Issue 125 (Friday, June 28, 2024)</title>
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[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54052-54059]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-14199]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-29]
Jeffrey Pollock, P.A.; Decision and Order
On February 6, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Jeffrey Pollock, P.A., (Respondent) of
Midvale, Utah. OSC/ISO, at 1. The OSC/ISO informed Respondent of the
immediate suspension of his DEA Certificate of Registration, Control
No. MP2900935, pursuant to 21 U.S.C. 824(d), alleging that Respondent's
continued registration constitutes ```an imminent danger to the public
health or safety.''' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also
proposed the revocation of Respondent's registration, alleging that
Respondent's continued registration is inconsistent with the public
interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
A hearing was held before DEA Administrative Law Judge Paul E.
Soeffing (the ALJ), who, on July 28, 2023, issued his Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), which recommended revocation of
Respondent's registration. RD, at 54. Following the ALJ's Recommended
Decision, Respondent filed Exceptions. Having reviewed the entire
record, the Agency adopts and hereby incorporates by reference the
entirety of the ALJ's rulings, credibility findings,\1\ findings of
fact, conclusions of law, sanctions analysis, and recommended sanction
as found in the RD.
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\1\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 2-31. The Agency agrees with
the ALJ that the testimony from the DEA Diversion Investigator (DI),
which was primarily focused on the introduction of the Government's
documentary evidence, the subpoenas the DI issued to obtain
documents, and the DI's involvement with the case, was generally
consistent without indication of any animosity towards Respondent
and thus was fully credible and warranted substantial weight. RD, at
8. The Agency also agrees with the ALJ that the testimony from the
Government's expert witness, Dr. Phillip Engen, M.D., which was
focused on the Utah standard of care and Respondent's prescribing to
Patient J.M., presented an objective analysis that was internally
consistent and logically persuasive and thus was credible, reliable,
and warranted significant weight. Id. at 21. Finally, the Agency
agrees with the ALJ that the testimony from Respondent, which was
focused on his background and his treatment of Patient J.M., was
genuine and generally consistent. Id. at 31. However, as noted by
the ALJ, there was minimal evidence offered to corroborate
Respondent's testimony and neither the supervising physician nor the
pharmacist, both of whom Respondent claims were partners with him in
coordinating Patient J.M.'s care, were called as witnesses. Id.
Further, Respondent has a significant personal interest in the
outcome of the proceedings that was also considered when weighing
the testimony in relation to other evidence presented during the
hearing. Id. Overall, however, the ALJ found, and the Agency agrees,
that Respondent's testimony was generally credible. Id.
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I. Findings of Fact
1. Utah Standard of Care
Dr. Phillip Engen, M.D., testified for the Government as an expert
in the area of pain management and the standard of care in the
prescribing of controlled substances, specifically oxycodone. RD, at 9;
Tr. 86-87. Dr. Engen is an anesthesiologist licensed to practice
medicine in Colorado since 1993 and is Board certified in anesthesia,
pain medicine, and hospice and palliative medicine.\2\ RD, at 8; Tr.
75; Government Exhibit (GX) 14, at 2-3.\3\ Dr. Engen testified that he
has direct experience prescribing opioids for pain, including to
patients with addiction issues, and is familiar with the risks
associated with prescribing opioids. RD, at 8; Tr. 77, 79, 95.\4\
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\2\ For Dr. Engen's full qualifications, see GX 14; RD, at 8-9.
\3\ Dr. Engen testified that he has not seen patients in a
clinical setting since the onset of the coronavirus pandemic in
March 2020 and that he currently practices predominately forensic
medicine, which he described as ``[n]ot necessarily'' distinct from
clinical work; Dr. Engen explained that forensic work ``entails
looking at patient data. Patient data with patients that are alive--
their records when they [are] alive--patient[ ] data when patients
are expired, and clinically evaluating the signs and symptoms of
opioid overdose-related deaths, or adverse effects.'' RD, at 8, 9;
Tr. 71, 147-48.
\4\ Dr. Engen asserted that although he currently practices in
Colorado, he familiarized himself with Utah state law in preparation
for the current matter, including by visiting the Utah Division of
Professional Licensing (DOPL) website where he found links and
information relating to the Utah Medical Practice Act, Utah's opioid
prescribing guidelines, and other Utah state law relating to
prescribing opioids. RD, at 9; Tr.78-83. Dr. Engen also testified
that he is familiar with the CDC opioid guidelines, which the Utah
opioid prescribing guidelines reference. RD, at 9 n.13; Tr. 83.
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Regarding the Utah standard of care for a patient inherited from
another provider, Dr. Engen testified that the inheriting provider must
first evaluate the patient and determine if the patient is within the
scope of his or her practice, including by obtaining informed consent
and conducting a physical exam. RD, at 21; Tr. 139-40. If the patient
is not within the scope of the provider's practice, then the provider
must refer the patient out to a qualified specialist. RD, at 21;
Tr.139-140. A physician treating a patient for pain is then required to
complete a comprehensive evaluation of the patient. RD, at 10; Tr. 89-
90.\5\ Further, Dr. Engen testified that the physician must conduct a
physical examination of the patient ``directed specifically to the
nature of the pain history.'' RD, at 10; Tr. 90. Prior to prescribing
opioids, the physician must query the controlled substance database
(CSD) as well as attempt to retrieve records from the previous
prescriber if the patient was inherited. RD, at 10; Tr. 90. The
physician must also enter into an informed consent and opioid agreement
[[Page 54053]]
with the patient establishing the clear functional goals of the opioid
therapy and informing the patient of the risks of breaking the
agreement. RD, at 10; Tr. 90-91. Dr. Engen testified that after opioid
treatment has begun, the patient must be closely monitored, and each
follow-up visit with the patient requires the same physical, risk, and
functional improvement evaluations as during the initial visit as well
as assessment of any adverse effects and aberrant behaviors. RD, at 8
n.12, 10; Tr. 91-92. Dr. Engen testified that signs of aberrant
behavior indicative of controlled substance abuse are called ``red
flags'' and that if a red flag is noticed, the red flag must be
documented and the prescriber must follow up with, consult, or generate
a differential diagnosis for the patient, any/all of which must also be
documented. RD, at 13-14; Tr. 99-101. Further, any red flags
highlighted in an opioid treatment agreement must be addressed and
investigated. RD, at 12; Tr. 191. Dr. Engen explained that urine drug
screens are required when prescribing opioids for a prolonged period to
make sure that the patients are taking the medications as well as not
taking any other unprescribed opioids or illicit substances. RD, at 13;
Tr. 98. According to Dr. Engen, if a prescriber finds illicit
substances or unprescribed opioids in a patient's urine drug screen,
the prescriber must immediately call the patient in because ``that's a
red flag for misuse and abuse''; during the visit, the prescriber would
need to generate a differential diagnosis that either accounts for the
improper substance or highlights the suspected abuse. RD, at 13; Tr.
98-99.
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\5\ Such comprehensive evaluation includes risk assessment,
opioid risk assessment, review of history of opioid use, and
``documentation of the character of the pain, onset, location,
duration, exacerbating factors, relieving factors[,] and all of the
items that identify a specific pain complaint.'' RD, at 10 (quoting
Tr. 90); Tr. 89-90.
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Finally, Dr. Engen testified that completing all of these steps, as
well as documenting all of these steps, is necessary to protect the
patient, provider, and community from the potentially harmful effects
of opioids.\6\ RD, at 10-11; Tr. 92-93. Dr. Engen reiterated that a
provider in the context of ``chronic opioid therapy'' is required to
document the comprehensive evaluation, risk assessment, physical
examination, informed consent and opioid agreement, functional goals,
assessment of the functional goals, review of the Prescription Drug
Monitoring Program (PDMP) or CSD, and a proper diagnosis. RD, at 11;
Tr. 93. Dr. Engen testified that in the context of opioid therapy, ``if
you don't document it, it did not happen.'' RD, at 11 (quoting Tr.
187).
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\6\ Such harmful effects can include sleep disorder breathing,
hypogonadism, hypoadrenalism, and osteoporosis with long-term opioid
use and death as a potential effect of ingesting a high strength
opioid. RD, at 11 n.15; Tr. 95-96.
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2. Respondent's Prescribing to Patient J.M.
Dr. Engen reviewed CSD prescribing data, medical records, and
prescriptions relating to Respondent's prescribing of oxycodone to
Patient J.M. from April 21, 2021, through October 4, 2022. RD, at 14;
Tr. 101. Respondent is licensed as a Physician Assistant (P.A.) in the
state of Utah and has approximately twenty-five years of experience.
RD, at 2 (Stip. 4), 22; Tr. 210. Respondent is a hormone and thyroid
specialist who does not regularly prescribe opioids \7\ and has worked
under a supervising physician, Dr. K.M., since moving to Utah.\8\ RD,
at 3 (Stip. 5), 22, 23; Tr. 210, 216-17. Between April 21, 2021, and
September 6, 2022, Respondent issued at least 140 prescriptions for
oxycodone, a schedule II controlled substance, in dosages of 20 mg and
30 mg to Patient J.M. RD, at 3-6 (Stips. 6-7).
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\7\ Respondent testified that after his graduation in 1998, he
worked in occupational and sports medicine for the first seven years
of his career, during which he prescribed opioids on a near daily
basis while working under the supervision of a physician. RD, at 22;
Tr. 203-06. According to Respondent, prior to treating Patient J.M.,
the last time he prescribed opioids was between 2005 and 2006, when
he briefly practiced pain management. RD, at 22; Tr. 208-209. Dr.
Engen testified that pain management is not within Respondent's
usual course of professional practice as he prescribes mostly
testosterone, anabolic steroids, and growth hormones, and does not
have 4,000 hours of experience treating patients or working with
providers who have a chronic pain certification. RD, at 11; Tr. 188-
89; see also Tr. 336-37. Respondent testified that in his current
practice, 99% of the controlled substance prescriptions that he
writes are for testosterone; further, aside from initial
consultations, he sees most of his hormone therapy patients via
telehealth. RD, at 22; Tr. 211-12.
\8\ Respondent testified that he and Dr. K.M. entered into a
written ``delegation of services of agreement,'' which is a
physician supervision agreement that defines the scope of a P.A.'s
practice and is required for all P.A.s in Utah until they have
completed a certain number of hours of practice experience. RD, at
23; Tr. 217-20; see also Respondent Exhibit (RX) 5. According to
Respondent, supervising physicians are ``ultimately responsible''
for their P.A.'s practice and P.A.s check everything that they do
with their supervising physicians. RD, at 23; Tr. 221. Respondent
testified that he consulted Dr. K.M. in all medical decision-making
and trusted Dr. K.M.'s judgment; Respondent also testified that Dr.
K.M. is directly responsible for Respondent's patients and that
treatment decisions are Dr. K.M.'s to make ``because [they]
ultimately fall[] on him.'' RD, at 23; Tr. 221-22. On cross-
examination, Respondent agreed that the delegation of services
agreement that he entered into with Dr. K.M. states that Respondent
will mostly prescribe controlled substances related to hormones and
weight loss and that Dr. K.M. must cosign ``any medical chart record
of a prescription of a Schedule 2 or Schedule 3 controlled substance
made by [Respondent].'' RD, at 23; Tr. 341-42; RX 5, at 2. Further,
the agreement provides that ``situations or areas outside of
[Respondent's] scope of practice will be referred to the appropriate
specialist,'' to which Respondent agreed that Dr. K.M. should have
signed off on every opioid prescription that Respondent wrote for
Patient J.M. and should have referred Patient J.M. to a pain
management specialist. RD, at 23; Tr. 342-43; RX 5, at 2.
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Respondent testified that he first met with Patient J.M. in March
2021 \9\ and initially observed Patient J.M. to be in poor health;
Patient J.M. reported back pain and told Respondent that he had been
taking opioids to treat his back pain. RD, at 24; Tr. 222-25; 345-46.
According to Respondent, the first visit by Patient J.M. involved
discussion of a rehabilitative treatment plan not including opioids.
RD, at 24; Tr. 225. Respondent testified that during a later visit,
Patient J.M. told him that the provider who had been prescribing him
opioids was moving and so he was looking for someone else to prescribe
him the medication; \10\ when Patient J.M. asked if he could continue
care and discussed the opioids, Respondent ``turned [Patient J.M.]
down.'' RD, at 24; Tr. 226-27, 346. Respondent testified that after
``an emotional plea from [Patient J.M.] who was desperate and talking
about how he [felt] so tied to his pain medications,'' Respondent
consulted Dr. K.M. RD, at 24; Tr. 228-29.
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\9\ Respondent testified that Patient J.M. initially sought out
hormone therapy and to ``have somebody available to talk to'' and
``order a test if needed'' as Patient J.M. was a ``hypochondriac.''
RD, at 24; Tr. 224, 226.
\10\ Respondent testified that Patient J.M. requested help in
weaning off of opioids to ``have a better quality or life or at
least a more basic dosing.'' RD, at 25; Tr. 229.
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Respondent testified that he completed a ``full targeted exam on
[Patient J.M.]'s back,'' the pain of which was related to an ATV
rollover incident; Respondent also testified that he conducted multiple
examinations throughout the course of his treatment of Patient J.M. but
admitted they were not well-documented. RD, at 25; Tr. 231-34.
According to Respondent, he requested Patient J.M.'s records from
Patient J.M.'s previous providers, and although Patient J.M. said he
would provide these records, he never did. RD, at 25; Tr. 234-35,
247.\11\ Respondent also asserted that he would not have gotten to this
point if Dr. K.M. had not been ``on board'' with treating Patient J.M.
RD, at 25; Tr. 238. According to
[[Page 54054]]
Respondent, he conducted an examination of Patient J.M. with Dr. K.M.
and had a ``larger visit'' that involved Patient J.M., Dr. K.M., and a
pharmacist (none of whom were pain specialists). RD, at 25-26, 26 n.26;
Tr. 229-30, 239-40, 350. Respondent testified that during the meeting,
he checked the CSD database to confirm that Patient J.M. was getting
the prescriptions at the dosages and frequencies that he was reporting
and to look for red flags. RD, at 26; Tr. 240-42.\12\
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\11\ The only records from prior treatment that Patient J.M.
provided to Respondent were MRI results from 2017. RD, at 25; Tr.
235, 238; see also GX 12, at 90-96. Dr. Engen opined that these MRI
results were insufficient to substantiate a conclusion that Patient
J.M. was experiencing pain and Respondent should have conducted a
pain-directed physical examination; however, based on the
documentation present in Patient J.M.'s patient file, Dr. Engen
could not say definitively whether Respondent had conducted such an
exam. RD, at 12; Tr. 165-70, 173; GX 12, at 90-96.
\12\ Respondent also testified that the pharmacist sent
Respondent a copy of the prescription fill history for Patient J.M.
at that pharmacy, and these records gave Respondent a ``level of
comfort'' because there was no indication of opioid abuse. RD, at
26, 26 n.27; Tr. 242-44; see also GX 12, at 53-75.
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According to Dr. Engen, there was no ``proper'' diagnosis noted in
Patient J.M.'s medical records during the first four months of his
treatment by Respondent.\13\ RD, at 14; Tr. 102. Nonetheless, Patient
J.M. received weekly prescriptions for 150 tablets of oxycodone 20 mg
and 200 tablets of oxycodone 30 mg, a dosage of ``almost twice the
[morphine milligram equivalent (MMS)] of the previous prescriber.''
\14\ RD, at 14; Tr. 103; GX 12, at 53-62. Further, in Dr. Engen's
opinion, this frequency and dosage was inappropriate for the conditions
noted in Patient J.M.'s medical file. RD, at 14; Tr. 103-04. Dr. Engen
noted that the opioid treatment agreement signed by Respondent and
Patient J.M. included some of the risks associated with opioid use such
as addiction, physical dependence, and potential for withdrawal
symptoms.\15\ RD, at 11; Tr. 156-60; 174-75; GX 12, at 51. Further, Dr.
Engen noted that he observed indicators that were suggestive of
addiction in Patient J.M.'s patient file.\16\ RD, at 12; Tr. 175. More
than a year into treatment, Respondent began tapering the opioids for
Patient J.M. which Dr. Engen agreed was appropriate; however, Dr. Engen
opined that the tapering should have begun earlier than it did as
tapering had been an initial goal of the treatment. RD, at 12; Tr.
178.\17\
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\13\ Dr. Engen testified that he noticed general notes in the
``history of present illness'' section of Patient J.M.'s medical
records after four months of treatment; however, Dr. Engen did not
find any ``proper assessment[s] [or] planned diagnoses'' in the
``assessment and plan'' section nor anywhere else in Patient J.M.'s
medical file and had to assume diagnoses based on the notes that he
saw in the ``history of present illness'' section. RD, at 14; Tr.
102-03. Dr. Engen also noticed an ICD-10 code for cancer written on
the prescriptions at issue in the current matter, but found no
substantive documentation noting or supporting this diagnosis. RD,
at 14; Tr. 103; GX 11, at 2, 4, 6. Regarding the cancer diagnosis
code, Respondent testified that during his meeting with Dr. K.M. and
the pharmacist, the pharmacist told Respondent that he needed a
diagnosis code for all controlled substance prescriptions;
Respondent testified that the pharmacist provided him with the
cancer diagnosis code ``that the previous provider used.'' RD, at
30; Tr. 316; see, e.g., GX 11, at 2, 4, 6. Respondent testified that
because he thought the diagnosis codes were ``just for insurance
billing purposes'' and he knew that Patient J.M. was not using
insurance, he ``didn't look into it'' and ``just documented . . .
the ones that he gave me.'' RD, at 30; Tr. 316-17.
\14\ Dr. Engen testified that Patient J.M. had previously been
prescribed approximately 683 MMEs of opioids per day. RD, at 11; Tr.
160-62; GX 12, at 67. Dr. Engen explained that MMEs--morphine
milligram equivalents--are a uniform measurement of the strength of
opioids and are utilized to determine opioid-related overdose or
death; the higher the MMEs of an opioid dosage, the more likely it
is to be associated with an opioid overdose or related death. RD, at
13; Tr. 96. According to Dr. Engen, the CDC opioid prescribing
guidelines recommend limiting MME to 50 mg a day and having
``extensive conversations with the patient if you want to go to 90
MME.'' RD, at 13; Tr. 96-97. Dr. Engen opined that if a patient is
being prescribed over 90 MME per day, the provider should have
``specific discussions regarding the increased risk of opioid
overdose and death'' with the patient. RD, at 13; Tr. 97. Further,
Dr. Engen testified that the Utah opioid guidelines specifically
state that patients taking more than 80 mg of oxycodone a day should
be referred to a pain specialist. RD, at 13; Tr. 97.
\15\ Dr. Engen opined, however, that although withdrawal would
have been an important consideration for Respondent if Patient J.M.
had been an established patient receiving a high dose of opioids,
because Patient J.M. was inherited from another provider, Respondent
should have referred Patient J.M. to a specialist. RD, at 11-12; Tr.
163-64. Regarding the opioid treatment agreement signed by
Respondent and Patient J.M., see GX 12, at 51-52, Respondent
testified that he and Dr. K.M. had discussed its contents and Dr.
K.M. had reviewed the final draft. RD, at 28; Tr. 252-53. On cross-
examination, Respondent agreed that violation of the opioid
treatment agreement should have resulted in the safe discontinuation
of his care of Patient J.M. RD, at 29; Tr. 351.
\16\ Dr. Engen also opined that it is ``medically probable''
that the erectile dysfunction, low testosterone, and delirium
experienced by Patient J.M. as noted in his patient file were caused
by long-term opioid use at an ``egregiously large,'' ``toxic''
dosage. RD, at 12; Tr. 175-78. Respondent testified that erectile
dysfunction had been a longstanding issue for Patient J.M. and was
only included in the notes because Patient J.M. expressed interest
in trying a new ``shockwave therapy'' treatment. RD, at 29; Tr. 259,
261; see also GX 12, at 40.
\17\ Dr. Engen noted that the tapering of opioids for Patient
J.M. did not begin until nearly eight months after a delirium
incident in September 2021 that resulted in Patient J.M. visiting an
emergency room. RD, at 12 n.17; Tr. 189-90; GX 12, at 41. Regarding
this incident, Respondent testified that the episode was not opioid-
related and so he decided to not ``follow through with much.'' RD,
at 29; Tr. 256-67. Even so, Respondent acknowledged and agreed with
Dr. Engen that his documentation was ``way subpar, especially for
this.'' RD, at 29; Tr. 258.
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Respondent testified that the amount of medication he prescribed to
Patient J.M. was related to a discussion with the pharmacist about
Patient J.M.'s tolerance to opioids; further, Dr. K.M. was ``on board''
with the amounts prescribed. RD, at 26; Tr. 244-45. Respondent
testified that the goal of treatment was to wean Patient J.M. off of
opioids but after the ATV accident, they ``decided to just not wean,
but to give him some pain relief . . . ''; Respondent also testified
that his attempts to wean Patient J.M. off of opioids were ``met with a
lot of resistance.'' RD, at 27; Tr. 245-46, 253.\18\ RD, at 27; Tr.
245-46. Further, Respondent testified that Dr. K.M. ``played a big
part'' in his continuing to prescribe opioids to Patient J.M. and that
he would ``just kind of do what [Dr. K.M.] ask[ed] for the most part.''
RD, at 27; Tr. 249-50.\19\
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\18\ Regarding steps he took to refer Patient J.M. to a
specialist, Respondent testified that he told Patient J.M. that he
did not feel qualified or comfortable continuing prescribing him
opioids; further, Respondent testified that he documented this
conversation and Patient J.M. agreed to look for another provider.
RD, at 27; Tr. 369-70. Respondent testified that he never issued an
official written referral, but did provide names of suggested
practitioners; these practitioners were pain management specialists,
not addiction specialists. RD, at 27; Tr. 370-71.
\19\ Respondent testified that he had in-person visits with
Patient J.M. every two weeks and was not concerned about Patient
J.M. diverting his medication because Patient J.M. was wealthy;
moreover, Respondent witnessed Patient J.M. take his medication when
his watch timer went off, as well as concluded that someone taking
so much medication would not give his or her medication away. RD, at
26-27; Tr. 233, 246-47, 250-51.
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3. Improper Documentation
Dr. Engen noted that although the opioid agreement signed by
Respondent and Patient J.M. was dated April 21, 2021, and the first
opioid prescription Respondent wrote for Patient J.M. was dated April
21, 2021, the first documented visit from Patient J.M. was nearly four
months later on August 2, 2021. RD, at 14-15; Tr. 104-05; GX 12, at 49,
51. Notably, Patient J.M. had been prescribed approximately 5,000
oxycodone tablets without proper documentation in the medical record.
RD, at 15; Tr. 105; GX 11, at 1; GX 13, at 1. Further, Dr. Engen opined
that the medical records for Patient J.M.'s August 2, 2021 visit do not
contain sufficient information to support any medical diagnoses and
were entirely inadequate for either an initial or follow-up visit. RD,
at 15; Tr. 106-08.\20\ Specifically, Dr. Engen observed that no
history, physical exam, assessment, functional evaluation, or attempts
to assess aberrant behavior or adverse effects of medications were
documented
[[Page 54055]]
from this visit. RD, at 15; Tr. 105; GX 12, at 49. The records for the
August 25, 2021 visit were similarly inadequate \21\ and insufficient
to justify the high amount of oxycodone prescribed (350 tablets a
week). RD, at 16; Tr.111.\22\
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\20\ Dr. Engen testified that if this had been a first office
visit by Patient J.M., there should have been documentation of a
comprehensive evaluation, a pain-directed physical examination, a
``proper diagnosis,'' and a diagnosis and functional goals
assessment plan; if this had been a follow-up visit, there should
have been documentation of a proper diagnosis, a pain-directed
physical examination and diagnosis, and an assessment of adverse
effects, aberrant behaviors, and progress towards therapeutic goals.
RD, at 15; Tr. 107-08.
\21\ Dr. Engen testified that the only notes present for the
August 25, 2021 visit indicate that Patient J.M. was ``doing ok, no
new problems . . . [s]ome increased pain recently due to extra
effort put into opening new store''; further, Respondent wrote
Patient J.M. an early refill because he would be on vacation. RD, at
16; Tr. 110; GX 12, at 46.
\22\ Respondent repeatedly wrote Patient J.M. a prescription for
oxycodone 30 mg, four to five tablets every four hours, 200 tablets
per week, and a prescription for oxycodone 20 mg, three to four
tablets every four hours, 150 tablets per week. RD, at 16; Tr. 110;
GX 12, at 46.
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Moreover, the records for all of the following visits were
inadequate and insufficient to justify the high amount of oxycodone
prescribed: 1) Patient J.M.'s September 7, 2021 visit, in which Dr.
Engen observed no notes at all despite CSD data showing that Respondent
wrote a prescription for 150 tablets of oxycodone 20 mg for Patient
J.M. and Patient J.M. filled the prescription; 2) Patient J.M.'s March
16, 2022 visit, in which Dr. Engen observed no notes other than an
indication that Respondent again wrote prescriptions for Patient J.M.
for 200 tablets of oxycodone 30 mg and 150 tablets of oxycodone 20 mg;
and 3) Patient J.M's April 21, 2022 visit, in which Dr. Engen noted
that while Respondent included notes indicative of a physical
examination, the documentation was still insufficient to justify the
opioid prescriptions as the notes were not thorough enough, the notes
lacked a plan or assessment, and the type of pain noted (muscle pain)
was not an indication for opioid treatment. RD, at 16, 19, 20; Tr. 112,
127-28, 133; GX 12, at 20, 25, 45; GX 13, at 1.\23\ Respondent also
admitted that he had made after-hours visits to Patient J.M.'s home to
conduct medical evaluations, though Respondent neither created nor kept
medical records for these visits. RD, at 26 n.28; Tr. 361, 363-64.\24\
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\23\ Regarding blank patient notes in Patient J.M.'s medical
records, Respondent testified that there had been occasions when he
opened a note during a visit but found that ``there was really
nothing that needed to be documented . . . .'' RD, at 28-29; Tr.
254-55; see, e.g., GX 12, at 45.
\24\ Respondent testified that despite visiting Patient J.M.'s
house numerous times and sharing his personal cell phone number with
Patient J.M., he did not have a personal relationship with Patient
J.M. RD, at 26 n.28; Tr. 328, 347-48.
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4. Failure To Properly Address Red Flags of Abuse/Diversion
Dr. Engen highlighted a note from the August 2, 2021 visit that
indicated that Patient J.M. had lost prescriptions and was given
replacement prescriptions during this visit; Dr. Engen opined that the
loss and replacement of opioid prescriptions caused him concern for two
reasons. RD, at 15; Tr. 105, 108; GX 12, at 49. One reason was that
Patient J.M., who has an opioid use disorder, could have been taking
more opioids than prescribed. RD, at 15; Tr. 108. The second reason was
that the authorities were not notified of a high-dose, large quantity
oxycodone prescription that might be found and filled by someone else.
RD, at 15; Tr. 109. Dr. Engen opined that this red flag of a lost
prescription was not properly addressed because there was no documented
differential diagnosis, no documentation that local authorities were
contacted, and no documented urine drug screen ordered to determine the
medications present in Patient J.M.'s system. RD, at 15-16; Tr.
109.\25\ Similarly, with regard to the February 9, 2022 visit, Dr.
Engen said the record indicated that Patient J.M. was in the process of
moving and had misplaced prescriptions. RD, at 17; Tr. 122; GX 12, at
28. On this occasion, Respondent reissued prescriptions for oxycodone
20 mg and 30 mg, noting that he ``checked CSD and last fill was
[February] 3.'' RD, at 17-18; Tr. 122-23; GX 12, at 28.\26\
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\25\ Regarding the issue of lost prescriptions, Respondent
testified that Patient J.M. lost his prescriptions on two or three
separate occasions; Respondent testified that Patient J.M. was able
to locate the missing prescriptions and return them to Respondent
for disposal on one occasion, and on another occasion, Patient J.M.
destroyed a missing prescription over video call with Respondent.
RD, at 29-30; Tr. 260, 358, 360; see also GX 12, at 28, 49.
Respondent also testified that he monitored the CSD to ensure that
the missing prescriptions ``didn't surface'' and were not filled.
RD, at 30; Tr. 359. On cross-examination, Respondent testified that
he never conducted a pill count of Patient J.M. despite the lost
prescriptions and early refill requests by Patient J.M. RD, at 30;
Tr. 353-54.
\26\ Dr. Engen noted that during the August 2, 2021 visit,
Respondent noted in the medical file that he would no longer offer
replacement prescriptions. RD, at 18; Tr. 123; GX 12, at 49. Dr.
Engen reiterated that missing prescriptions warranted a differential
diagnosis and Respondent should have contacted local authorities to
track the prescriptions; moreover, all of these required actions
needed to be documented. RD, at 18; Tr. 123; GX 12, at 28.
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In addition to Patient J.M.'s instances of missing prescriptions,
Dr. Engen also highlighted that notes from Patient J.M.'s March 3,
2022, and April 21, 2022 visits indicated that urine drug screens of
Patient J.M. had tested positive for hydrocodone, a non-prescribed
opioid. RD, at 18, 19; Tr. 124-25, 130; GX 12, at 20, 26. Dr. Engen
explained that a non-prescribed opioid present in a urine drug screen
is a red flag that needed to be addressed; specifically, Respondent
should have created a differential diagnosis and discussed medication-
assisted addiction treatment with Patient J.M. as well as documented
this resolution. RD, at 18, 19; Tr. 125, 130-31. Instead, Respondent in
both instances prescribed Patient J.M. 200 tablets of oxycodone 30 mg
and 150 tablets of oxycodone 20 mg without documenting that any such
action had been taken. RD, at 18, 20; Tr. 125-26, 132-33; GX 12, at 20,
26.\27\
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\27\ Respondent testified that he used urine drug screens in his
treatment of Patient J.M. because Patient J.M. was receiving a high
dose of medication and he wanted to make sure that Patient J.M. was
not getting additional medication elsewhere that could elevate
risks; Respondent testified that he ordered urine drug screens for
Patient J.M. ``pretty regularly'' and Patient J.M. always complied.
RD, at 29; Tr. 258-59. Regarding the note reporting hydrocodone in
Patient J.M.'s urine drug screen, Respondent testified that the note
was a typo and that the tests he used for Patient J.M. did not test
for hydrocodone. RD, at 29; Tr. 266-67, 354-55; see also GX 12, at
20. Dr. Engen opined that Respondent's actions were insufficient and
opined that the positive result on this test should have resulted in
Respondent ordering a more precise ``confirmatory'' test. RD, at 19
n.19; Tr.131-32; see also GX 12, at 20. Even so, based on Patient
J.M.'s patient file note from the April 21, 2022 visit indicating a
positive result for ``opiates/hydrocodone,'' Dr. Engen testified
that he would assume that the test that Respondent used was
sensitive enough to detect and differentiate oxycodone (as an
opiate) and hydrocodone. RD, at 19 n.19; Tr. 131-32; see also GX 12,
at 20.
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Finally, Dr. Engen opined that an early refill given to Patient
J.M. during his August 15, 2022 visit due to travel was a red flag that
was not properly addressed or documented by Respondent. RD, at 20; Tr.
134-136; GX 12, at 5.
5. Failure To Address Signs of Adverse Effects
Dr. Engen highlighted a note from Patient J.M.'s September 27, 2021
visit that indicated Patient J.M. had been feeling ``groggy''--which
Dr. Engen explained can be indicative of delirium, an ``acute toxic
effect'' of opioids--and had visited the emergency room. RD, at 16-17;
Tr. 113; GX 12, at 41. Dr. Engen opined that this instance of delirium
was particularly concerning to him because the opioid doses prescribed
to Patient J.M. were ``clearly'' in the range that could cause death.
RD, at 17; Tr. 113. According to Dr. Engen, this incident should have
resulted in a differential diagnosis and face-to-face physical
examination to determine if it was related to the prescribed opioids.
RD, at 17; Tr. 113-14. Dr. Engen testified that following this
incident, Patient J.M. should have been referred to a pain medicine
and/or addiction medicine specialist to consider medication-assisted
treatment or a switch away from opioids, but instead, Respondent wrote
Patient J.M. two more
[[Page 54056]]
prescriptions for oxycodone. RD, at 17; Tr. 114-15; GX 12, at 41.\28\
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\28\ Dr. Engen noted the sleep disordered breathing mentioned
throughout Patient J.M.'s medical file and opined that Patient
J.M.'s oxygenation was likely affected by the opioids that he was
prescribed; Dr. Engen testified that a safety net needed to be
created to prevent unintended overdose. RD, at 17; Tr. 113. Dr.
Engen also testified that erectile dysfunction was an additional
adverse effect of opioids noted during the September 27, 2021 visit;
Dr. Engen explained that long-term opioid use can cause low
testosterone and can affect the parasympathetic nervous system,
either of which could result in erectile dysfunction, and opined
that soundwave therapy, which Respondent noted as his recommended
treatment, is not appropriate and does not address the opioid-
related causes of erectile dysfunction. RD, at 17; Tr. 115-16; GX
12, at 40.
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Regarding Patient J.M.'s March 3, 2022 visit, Dr. Engen highlighted
notes that Patient J.M. visited the ER once more for gastrointestinal
issues such as vomiting blood and inability to swallow \29\ and a lab
result indicated low testosterone. RD, at 18; Tr. 124; GX 12, at 26.
Dr. Engen explained that opioids can cause such effects and again
opined that a differential diagnosis to account for these adverse
effects should have been considered and documented. RD, at 18; Tr. 124-
25; GX 12, at 26. Finally, during Patient J.M.'s August 15, 2022 visit,
Patient J.M. reported various adverse effects such as stomach problems,
brain fog, and memory issues, but Respondent again failed to properly
address and document these adverse effects. RD, at 20; Tr. 134-36; GX
12, at 5.
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\29\ Regarding this ER visit, Respondent testified that this
occurrence did not cause him concern because Patient J.M.
``overreacts sometimes to certain things''; according to Respondent,
the cause turned out to be gastroesophageal reflux that was
``corrected by acid lowering medications.'' RD, at 29; Tr. 260-61.
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6. Weaning Off Patient J.M. From Opioids
In the medical file for Patient J.M.'s April 25, 2022 visit,
Respondent's notes indicate that he and Patient J.M. discussed the
long-term risks of opioid treatment and Patient J.M. stated that he
wished to wean off in a safe manner; the initial goal was to lower
Patient J.M.'s opioid dosage below 90 MME. RD, at 19; Tr. 128; GX 12,
at 22.\30\ Dr. Engen pointed out that Patient J.M.'s opioid therapy had
begun nearly a year before this visit and opined that this discussion
should have taken place on the first day. RD, at 19; Tr. 128-29; see GX
12, at 51; GX 13, at 1. However, Dr. Engen credited Respondent for
recognizing the importance of lowering the dose from the ``massive''
1900 MME per day that it had reached, and noted that Respondent did
taper the dose by approximately 10% about one month after the April 5,
2022 visit. RD, at 19; Tr. 129. Even with the reduction, Dr. Engen
noted that there was still insufficient documentation of a proper
diagnosis, treatment plan, assessment, or functional evaluation to
justify the dosage. RD, at 19; Tr. 129-30. Respondent continued to
lower Patient J.M.'s dose by about 10% during each of Patient J.M.'s
visits on July 6, 2022,\31\ August 15, 2022, and September 13, 2022.
RD, at 20, 28; Tr. 133-35, 270-71, 329; GX 12, at 2, 5, 11.
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\30\ According to Respondent, this discussion was inspired by
Patient J.M.'s reluctance to wean off of opioids and the fact that
Patient J.M. had ``been on pain meds for so long.'' RD, at 27-28;
Tr. 264. Respondent testified that after his discussion with Dr.
K.M. and realizing that he had been prescribing opioids to Patient
J.M. for a year, he was tired of ``excuses'' to delay Patient J.M.'s
weaning off; Respondent felt he needed to ``make it happen'' because
he ``just was kind of done with it.'' RD, at 28; Tr. 264-65.
According to Respondent, he told Dr. K.M. that he felt ``locked in''
to which Dr. K.M. told Respondent to ``make a demand'' and start
lowering the dosage to Patient J.M. by 10% per month until it
reached a ``more manageable dose.'' RD, at 28; Tr. 265. Respondent
noted that he ``learned a lot about . . . how this works'' and
agreed that Patient J.M. should have been referred to a specialist.
RD, at 28 n.30; Tr. 266.
\31\ Regarding this visit, Respondent testified that this was
the point at which he believed he was beginning to make progress
with Patient J.M. because Patient J.M. was being more compliant and
the decrease in dosage did not result in increased pain; Respondent
believed that Patient J.M. responded positively to their ``frank
discussion'' and there were no more excuses to delay decreasing the
dosage. RD, at 28; Tr. 269-70. Though recognizing progress had been
made, Dr. Engen opined that Respondent still failed to include
sufficient documentation in the patient file to support the still
``massive'' doses. RD, at 20; Tr. 134.
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7. Respondent's Prescribing to Patient J.M. Was Beneath the Standard of
Care
Dr. Engen concluded that each of the prescriptions issued by
Respondent to Patient J.M. from April 2021 to at least September 2022
was issued outside the usual course of professional practice. RD, at
21; Tr. 142. Specifically, Dr. Engen opined that the amount of opioids
prescribed to Patient J.M. was ``egregiously excessive,'' and that
there was no clinical justification for the ``nearly 1,000 MME per day
increase'' from April 21, 2021, to April 28, 2021, and from a previous
dose that was already ``extremely high.'' RD, at 21; Tr. 143. Moreover,
Dr. Engen again highlighted that there was insufficient documentation
to support a diagnosis that would justify Respondent's prescribing of
an ``egregious, massive dose'' of opioids to Patient J.M. RD, at 21;
Tr. 143, 193-94. Dr. Engen opined that Respondent needed to conduct a
comprehensive evaluation and develop a comprehensive treatment plan for
Patient J.M. that, in light of the documented instances of likely
opioid misuse, should have resulted in referral of Patient J.M. to
medication-assisted addiction treatment. RD, at 21; Tr. 141-42. Dr.
Engen ultimately emphasized that Patient J.M. was likely in a toxic
range of oxycodone and oxycodone metabolites, that Respondent's care of
Patient J.M. was ``grossly negligent'' and caused Patient J.M. harm,
and that Respondent's care was outside the scope of Respondent's
practice and fell below the Utah standard of care. RD, at 21; Tr. 143-
44.\32\
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\32\ Following an investigation by the Utah DOPL regarding
Respondent's care of Patient J.M., Respondent entered into a
stipulation with the DOPL that puts Respondent on probation for a
period of five years, requires Respondent to have a supervising
physician that is in good standing with the DOPL, and prohibits
Respondent from prescribing opioids. RD, at 28; Tr. 318-320, 322-
324; RX 7. In the stipulation, Respondent admits to making
insufficient notations or diagnoses in the medical record to justify
his prescribing of oxycodone to Patient J.M. and admits that his
treatment of Patient J.M. constituted ``unprofessional'' conduct
under Utah law. RD, at 28; Tr. 356-357; RX 7. Ultimately, Respondent
wishes to relinquish his ability to prescribe opioids in the future;
Respondent stated that he only needs to be able to handle and
prescribe testosterone to be able to keep his practice open. RD, at
31; Tr. 335, 371-372.
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Ultimately, the ALJ found, and the Agency agrees, that Respondent's
prescribing was outside the usual course of professional practice and
in violation of the Utah standard of care. RD, at 43. As described
above, Respondent repeatedly failed to conduct and document proper
physical examinations of Patient J.M.; repeatedly failed to document
diagnoses justifying his continued prescribing of controlled substances
to Patient J.M.; repeatedly failed to adequately address and document
the risks of Patient J.M.'s continued use of controlled substances; and
repeatedly failed to establish and document a proper treatment plan
while continually writing Patient J.M. prescriptions for controlled
substances at dangerously high dosages. Id.
II. Discussion
A. The Five Public Interest Factors
Under the Controlled Substances Act (CSA), ``[a] registration . . .
to . . . dispense a controlled substance . . . may be suspended or
revoked by the Attorney General upon a finding that the registrant . .
. has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section.'' 21 U.S.C. 824(a). In making the public
interest determination, the CSA requires consideration of the following
factors:
[[Page 54057]]
(A) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. While the Agency has considered all of the public interest
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of
its prima facie case for revocation of Respondent's registration is
confined to Factors B and D.\33\ RD, at 34; see also id. at 34 n.34
(finding that for Factor A, while there was an indirect recommendation
from the Division of Professional Licensing of the Department of
Commerce of the State of Utah, in the form of a stipulation and order
related to Respondent's state license to practice as a physician
assistant and to administer and prescribe controlled substances, such a
recommendation has not historically been a case-dispositive issue under
the Agency's precedent, and that Factors C and E do not weigh for or
against revocation).
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\33\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Pub. L. 117-215, 136 Stat. 2257
(2022) (Marijuana Research Amendments or MRA), amended the CSA and
other statutes. Relevant to this matter, the MRA redesignated 21
U.S.C. 823(f) as 21 U.S.C. 823(g)(1). When discussing the public
interest factors, the RD refers to their former numerical
designations (i.e., 1-5) under 21 U.S.C. 823(f).
---------------------------------------------------------------------------
Having reviewed the record and the RD, the Agency agrees with the
ALJ, adopts the ALJ's analysis, and finds that the Government's
evidence satisfies its prima facie burden of showing that Respondent's
continued registration would be ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4); RD, at 31-48.
B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Respondent violated numerous federal and state laws
regulating controlled substances. OSC/ISO, at 1-3. Specifically,
federal law requires that ``[a] prescription for a controlled substance
to be effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' 21 CFR 1306.04(a). As for state law, Utah regulations
prohibit issuing a prescription for a controlled substance ``without
first obtaining information in the usual course of professional
practice, that is sufficient to establish a diagnosis, to identify
conditions, and to identify contraindications to the proposed
treatment.'' Utah Code Ann. section 58-1-501(2)(m)(i); \34\ see also
id. section 58-37-6(7)(i) (a practitioner may not prescribe controlled
substances in excess of medically recognized quantities necessary to
treat the ailment, malady, or condition). Further, Utah regulations
require that prior to issuing a prescription for opiates, a
practitioner must discuss with the patient: ``(a) the risks of
addiction and overdose associated with opiate drugs; (b) the dangers of
taking opiates with alcohol, benzodiazepines, and other central nervous
system depressants; (c) the reasons why the prescription is necessary;
(d) alternative treatments that may be available; and (e) other risks
associated with the use of drugs being prescribed.'' Id. section 58-37-
19(2)(a)-(e). Finally, Utah regulations require that prescribing
practitioners keep accurate records for each patient reflecting
examination, evaluation, and treatment. Utah Admin. Code r. 156-37-
602(b). Patient medical records shall: ``(i) accurately reflect the
prescription or administration of controlled substances in the
treatment of the patient; (ii) the purpose for which the controlled
substance is utilized; and (iii) information upon which the diagnosis
is based.'' Utah Admin. Code r. 156-37-602(c).\35\
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\34\ Since the issuance of the OSC/ISO, this statute has been
redesignated (with the language unchanged) as Utah Code Ann. section
58-1-501(2)(xiii)(A). See RD, at 36 n.35.
\35\ Utah regulations also require that a ``physician assistant
who wishes to change specialties to another specialty . . . shall
engage in collaboration for a minimum of 4,000 hours with a
physician who is trained and experienced in the specialty to which
the physician assistant is changing.'' Utah Code Ann. section 58-
70a-307(4).
---------------------------------------------------------------------------
In the current matter, the Agency agrees with the ALJ's analysis
that Respondent repeatedly issued controlled substance prescriptions to
Patient J.M. in violation of the Utah standard of care--and thus
outside of the usual course of professional practice--because, as
detailed above, Respondent repeatedly failed to conduct and document
proper physical examinations of Patient J.M., repeatedly failed to
document a diagnosis justifying the prescribing of controlled
substances to Patient J.M., repeatedly failed to adequately address and
document the risks of prolonged use of controlled substances with
Patient J.M., and repeatedly prescribed dangerously high dosages of
opioids to Patient J.M. without establishing and documenting a proper
treatment plan; further, Respondent lacked the requisite training and
experience to issue the prescriptions that he issued to Patient J.M.
RD, at 43-48.\36\
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\36\ The Agency also agrees with the ALJ's conclusion that none
of Respondent's arguments to the contrary, as detailed above, refute
this analysis. Id.
---------------------------------------------------------------------------
As Respondent's conduct displays clear violations of the federal
and state regulations described above, see supra I.7, the Agency agrees
with the ALJ and hereby finds that Respondent repeatedly violated
federal and state law relating to controlled substances. Id. at 48.
Accordingly, the Agency agrees with the ALJ and finds that Factors B
and D weigh in favor of revocation of Respondent's registration and
thus finds Respondent's continued registration to be inconsistent with
the public interest in balancing the factors of 21 U.S.C. 823(g)(1).
Id.
III. Sanction
Where, as here, the Government has established sufficient grounds
to revoke Respondent's registration, the burden shifts to the
registrant to show why he can be entrusted with the responsibility
carried by a registration. Garret Howard Smith, M.D., 83 FR 18882,
18910 (2018). When a registrant has committed acts inconsistent with
the public interest, he must both accept responsibility and demonstrate
that he has undertaken corrective measures. Holiday CVS, L.L.C., dba
CVS Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012). Trust is
necessarily a fact-dependent determination based on individual
circumstances; therefore, the Agency looks at factors such as the
acceptance
[[Page 54058]]
of responsibility, the credibility of that acceptance as it relates to
the probability of repeat violations or behavior, the nature of the
misconduct that forms the basis for sanction, and the Agency's interest
in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D., 86
FR 33738, 33746 (2021).
Here, and as noted by the ALJ, Respondent did admit some fault and
accept some responsibility for his misconduct such as admitting and
accepting his documentation failures. RD, at 50; Tr. 258. However, as
noted by the ALJ, Respondent repeatedly shifted the blame for his
misconduct to others. RD, at 51. In particular, Respondent blamed his
supervising physician, Dr. K.M., who Respondent testified was
``ultimately responsible'' for the P.A.'s practice; Respondent also
emphasized that he would ``just kind of do what [Dr. K.M.] ask[ed] for
the most part.'' RD, at 50-51; Tr. 221-22, 238, 224-50, 334-35.
Therefore, the ALJ concluded, and the Agency agrees, that Respondent
has not demonstrated unequivocal acceptance of responsibility for his
actions.\37\ RD, at 51 (citing Jones Total Health Care Pharmacy, L.L.C.
& SND Health Care, L.L.C., 81 FR 79188, 79201-02 (2016)).\38\
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\37\ In his Exceptions, Respondent argues that other statements
he made demonstrate that he ``clearly accepted responsibility for
his actions.'' Exceptions, at 2-4. For example, Respondent stated:
``I wrote the prescriptions, and I'm totally responsible for that.
It's not [Dr. K.M.]'s fault. It's not [Patient J.M.]'s fault. It's
mine;'' and ``[t]here's a lot of regrets there. I realize the
mistakes I made.'' Exceptions, at 2-3; Tr. 334, 362-63. In the case
cited by Respondent in his Exceptions, the practitioner explained
his misconduct, but ultimately took full responsibility and did not
shift any of the blame or responsibility to others for his own
actions and decisions. Exceptions, at 5 (citing Wesley G. Harline,
M.D., Continuation of Registration With Restrictions, 65 5665, 5669
(2000)). In contrast, in the current matter, Respondent has made
various statements essentially arguing that he was just doing what
he was told to do by his supervising physician, as described above,
and in contradiction to his other statements expressing a total
acceptance of responsibility. RD, at 50-51; Tr. 221-22, 238, 224-50,
334-35. Therefore, the Agency does not find Respondent's acceptance
of responsibility to be fully sincere and unequivocal; Respondent
continually shifted between taking total responsibility himself and
assigning blame to others.
\38\ In his Exceptions, Respondent argues that he will change
his behavior and that ``his stipulation with the Utah [DOPL]
provides a structure for him to avoid making similar mistakes in the
future.'' Exceptions, at 2, 5-7. When a registrant fails to make the
threshold showing of acceptance of responsibility, the Agency need
not address the registrant's remedial measures. Ajay S. Ahuja, M.D.,
84 FR 5479, 5498 n.33 (2019) (citing Jones Total Health Care
Pharmacy, 81 FR 79202-03); Daniel A. Glick, D.D.S., 80 74800, 74801,
74810 (2015). Even so, in the current matter, the ALJ noted, and the
Agency has considered, that Respondent testified that he will not
``prescribe an opioid again or anything of a real addictive nature
of any sort,'' as well as that he is less ``willing to go along with
what people want'' and has ``tightened up everything'' going
forward, though Respondent did not offer any further explanation of
the latter statement. RD, at 51 n.44; Tr. 373-74. Notably, the
stipulation order that Respondent entered into with the Utah DOPL
puts Respondent on probation for five years, requires Respondent to
have a supervising physician that is in good standing with the Utah
DOPL, and prohibits Respondent from prescribing opioids. RD, at 51;
Tr. 318-20; 322-24; RX 7. In light of Respondent's failure to
unequivocally accept responsibility and due to the egregiousness of
his actions and need for deterrence, the Agency does not find that
the offered remedial measures are sufficient for it to trust the
Respondent with his registration.
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In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74810. In this case, the
Agency agrees with the ALJ that given that Respondent was the sole
prescriber that issued all of the prescriptions at issue in the current
matter, the interests of specific deterrence weigh in favor of
revocation of Respondent's registration. RD, at 53; Tr. 227-238; GX 11-
13. Further, the Agency agrees with the ALJ that the interests of
general deterrence also support revocation, as a lack of sanction in
the current matter would send a message to the registrant community
that failure ``to complete and document even the most basic treatment-
related evaluations and examinations, or document any information
related to treatment decisions'' can be overlooked or excused. RD, at
53.
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. Id. at 51-53. As stated by the ALJ, ``Respondent issued
many controlled substance[ ] prescriptions over a one-year period
without any regard for his obligations to conduct and document adequate
examination and evaluation to justify treatment.'' RD, at 51-52.\39\
The ALJ also highlighted that ``Respondent's heavy reliance on, and
deferral to, Dr. K.M., the pharmacist, and even Patient J.M.
himself,\40\ appears to have resulted in an almost complete abdication
of Respondent's own role and responsibilities for the proper medical
treatment of Patient J.M.'' RD, at 52.\41\
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\39\ In his Exceptions, Respondent argues that his prescribing
did not cause Patient J.M. harm. Exceptions, at 12. Agency precedent
is clear that proof of actual, subsequent harm is not required when
a registrant has acted inconsistently with the public interest.
Melanie Baker, N.P., 86 FR 23998, 24009 (2021); Larry C. Daniels,
M.D., 86 FR 61630, 61660-61 (2021); Jeanne E. Germeil, M.D., 85 FR
73786, 73799 n.32 (2020). Even so, the Agency gives substantial
weight to the opinion of the Government's expert witness that
Respondent's prescribing did cause harm to Patient J.M., with the
amount of opioids prescribed to Patient J.M. being ``egregiously
excessive'' and lacking documented clinical justification. Tr. 142-
44; see also RD, at 52.
\40\ The ALJ was particularly concerned ``by the instances of
notes in Respondent's patient file that were entirely self-reported
by Patient J.M., as well as the instances of Patient J.M.
essentially treating himself with the capitulation of Respondent.''
RD, at 52.
\41\ In his Exceptions, Respondent argues for a limited
revocation of his registration, asserting that there is no
``rational connection'' between his wrongful conduct and a full
revocation of his registration because he primarily practices
hormone therapy, for which he is fully qualified, and he has never
had any issues with respect to prescribing testosterone. Exceptions,
at 7-8 (emphasis omitted) (quoting Hoxie v. Drug Enf't Admin., 419
F.3d 477, 482 (6th Cir. 2005)) (citing 21 U.S.C. 824(b); 21 CFR
1301.36(c); Tr. 210-13, 215). Respondent also emphasized that he has
treated thousands of patients and has never previously been the
subject of any other complaints regarding controlled substances.
Exceptions, at 8-9 (citing Krishna-Iyer v. Drug Enf't Admin., 249
Fed. Appx. 159, 160 (11th Cir. 2007)); Tr. 211, 215. However, in
Jayam Krishna-Iyer, M.D., 74 FR 459 (2009), the Agency stated that
``even where the Government proves only a few instances of illegal
prescribing in the `entire corpus' of a practitioner's experience,
the Government has nonetheless made out a prima facie case and thus
shifted the burden to the registrant to show why he should be
entrusted with a [new or continued] registration.'' Jayam Krishna-
Iyer, 74 FR 464. In the current matter, given the particular
egregiousness of Respondent's misconduct as well as Respondent's
lack of unequivocal acceptance of responsibility, the Agency finds
that considerations of the rest of Respondent's positive experience
as a practitioner do not sway the Agency's findings that the
Government has made a prima facie case for revocation of
Respondent's registration and Respondent has failed to unequivocally
accept responsibility for his actions. As for Respondent's argument
of a lack of rational connection between his actions and his primary
practice of prescribing testosterone such that full revocation of
his registration is unwarranted, the Agency finds that Respondent's
misconduct--such as his continuous documentation failures and his
continuing to treat a patient while lacking the requisite
qualifications and experience--does not speak only to his
prescribing of opioids but to his prescribing practices as a whole.
Accordingly, the Agency finds that there is undoubtedly a rational
connection such that full revocation of his registration is
warranted.
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In sum, Respondent has not offered any credible evidence on the
record to rebut the Government's case for revocation of his
registration and Respondent has not demonstrated that he can be
entrusted with the responsibility of registration. RD, at 54.
Accordingly, the Agency will order that Respondent's registration be
revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
MP2900935 issued to Jeffrey Pollock, P.A. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Jeffrey Pollock, P.A., to renew
or modify this registration, as well as any other pending application
of Jeffrey Pollock, P.A., for additional registration in Utah. This
Order is effective July 29, 2024.
[[Page 54059]]
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 21, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-14199 Filed 6-27-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on June 28, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.