[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54052-54059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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