[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73786-73804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25528]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Jeanne E. Germeil, M.D. Decision and Order

    On March 5, 2018, a former Acting Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause and Immediate Suspension of Registration 
(hereinafter, collectively OSC) to Jeanne E. Germeil, M.D., 
(hereinafter, Respondent). Administrative Law Judge Exhibit 
(hereinafter, ALJX) 1 (Order to Show Cause), at 1. The OSC informed 
Respondent of the immediate suspension of her Certificate of 
Registration No. FG0560765 pursuant to 21 U.S.C. 824(d), because her 
continued registration constituted an imminent danger to the public 
health and safety. Id. The OSC also proposed the revocation of 
Respondent's Certificate of Registration (hereinafter, registration) 
pursuant to 21 U.S.C. 824(a)(4), ``because [her] continued registration 
is inconsistent with the public interest . . . .'' Id. (citing 21 
U.S.C. 823(f)).

I. Procedural History

    Specifically, the OSC alleged that Respondent ``prescribed 
controlled substances to [two] DEA confidential source[s], Patient Y.H. 
[and Patient L.G.], that [she] knew or should have known were not for a 
legitimate medical purpose, in violation of 21 U.S.C. 841(a) and 
842(a), 21 CFR 1306.04(a), and Fla. Admin. Code r. 64B8-9.013.'' OSC, 
at 2; see also id. at 6. The OSC alleged that Respondent ``[was] aware 
that at least a portion of the controlled substances [she was] 
prescribing to Y.H. [and to L.G.] were being sold, given to third 
parties, or otherwise diverted, because Y.H. [and L.G.] told [her] 
so.'' OSC, at 2; see also id. at 6. Additionally, the OSC alleged that 
Respondent ``had been falsifying [her] medical records.'' Id. at 9. The 
OSC alleged that Respondent's ``falsification of the[ ] records 
violated state law, see Fla. Stat. Sec.  458.331(1)(m), and further 
demonstrate[d] that [Respondent] issued prescriptions for controlled 
substances to Patients Y.H. and L.G. outside the usual course of 
professional practice and that these prescriptions were beneath the 
standard of care for the State of Florida, violating both 21 CFR 
[1306.04(a) \1\] and Fla. Admin. Code r. 64B8-9.013.'' Id.
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    \1\ The citation to 21 CFR 1604(a) throughout the OSC appears to 
be a typographical error (as no such regulation exists). It is clear 
from the surrounding text, that where the government typed 21 CFR 
1604(a), it was referring to 21 CFR 1306.04(a). The Government also 
specifically notified Respondent that was alleging violations of 21 
CFR 1306.04(a). OSC, at 2.
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    On March 5, 2018, the former Acting Administrator made a 
preliminary finding ``that [Respondent had] issued prescriptions for 
controlled substances that [she] knew were without a legitimate medical 
purpose and outside the usual course of professional practice, which is 
inconsistent with the public interest . . . .'' Id. And that ``in light 
of the rampant and deadly problem of prescription controlled substance 
abuse, that [Respondent's] continued registration . . . would 
constitute an imminent danger to the public health or safety because of 
the substantial likelihood that [she would] continue to unlawfully 
prescribe controlled substances, thereby allowing the diversion of 
controlled substances unless [her] DEA [registration was] suspended.'' 
Id. The former Acting Administrator concluded that Respondent's 
``continued registration . . . [would] constitute[ ] an imminent danger 
to the public health and safety.'' Id.

[[Page 73787]]

    Pursuant to 21 U.S.C. 824(f) and 21 CFR 1301.36(f), the former 
Acting Administrator authorized DEA Special Agents (hereinafter, SA) 
and Diversion Investigators (hereinafter, DI) serving the OSC on 
Respondent to place under seal or to remove for safekeeping all 
controlled substances that Respondent possessed pursuant to the 
suspended registration. Id. The former Acting Administrator also 
directed those employees to take possession of Respondent's 
registration No. FG0560765 and any unused prescription forms. Id.
    The OSC notified Respondent of the right to either request a 
hearing on the allegations or submit a written statement in lieu of 
exercising the right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
10 (citing 21 CFR 1301.43). According to the Government's Notice of 
Service, a member of the DEA Miami Field Division personally served the 
OSC on Respondent on March 7, 2018. ALJX 2 (Government's Notice of 
Service of OSC), at 1.
    By letter dated April 3, 2018, Respondent timely requested a 
hearing. ALJX 3 (Request for a Hearing), at 1. The matter was placed on 
the docket of the Office of Administrative Law Judges and assigned to 
Administrative Law Judge Charles Wm. Dorman (hereinafter, the ALJ). On 
April 6, 2018, the ALJ established a schedule for the filing of 
prehearing statements. ALJX 4 (Order for Prehearing Statements), at 1. 
The Government filed its prehearing statement on April 20, 2018. ALJX 6 
(Government's Prehearing Statement), at 1. After requesting and 
receiving additional time, Respondent filed her Prehearing Statement on 
May 31, 2018. See ALJX 7 (Unopposed Motion for Extension of Time to 
File Prehearing Statement), ALJX 8 (Order Granting Respondent's Motion 
for Extension of Time to File Prehearing Statement), and ALJX 9 
(Respondent's Prehearing Statement). Thereafter, the ALJ issued an 
Order denying Respondent's motion requesting discovery on the grounds 
that Respondent failed to establish that the documents she sought were 
relevant, material, and that the denial of access to the documents was 
prejudicial. ALJX 18 (Order Denying Respondent's Motion to Compel 
Discovery), at 4; see also ALJX 12 (Motion to Compel Discovery or in 
the Alternative Issuance of Subpoena), and ALJX 15 (Government's 
Response in Opposition to Respondent's Motion to Compel and 
Government's Motion to Quash Subpoena).
    On June 6, 2018, the ALJ issued a Prehearing Ruling that, among 
other things, set out 18 agreed upon stipulations and established 
schedules for the filing of additional joint stipulations and for the 
hearing. ALJX 11 (Prehearing Ruling), at 3. Joint Stipulations were 
filed on June 19, 2018, and on June 26, 2018, the Respondent proposed 
additional Stipulations to which the Government had no objection. See 
ALJX 16 (Joint Stipulations) and ALJX 19 (Additional Stipulations 
Proposed by Respondent). The hearing in this matter took place in 
Miami, Florida and spanned three days. See generally Transcript of 
Proceedings in the Matter of Jeanne E. Germeil, M.D. (hereinafter, 
Tr.). Both parties filed posthearing briefs. See ALJX 27 (Government's 
Posthearing Brief) and ALJX 28 (Respondent's Posthearing Brief). The 
ALJ's Recommended Rulings, Findings of Fact, Conclusions of Law and 
Decision (hereinafter, RD) is dated August 31, 2018. Neither party 
filed exceptions to the RD. Transmittal Letter, at 2. I have reviewed 
and agree with the procedural rulings of the ALJ during the 
administration of the hearing.
    Having considered the record in its entirety, I agree with the RD 
that the record established, by substantial evidence, that Respondent's 
``continued registration is inconsistent with the public interest 
because of her improper prescribing and falsification of medical 
records.'' RD, at 106. I further agree with the RD that Respondent's 
``failure to acknowledge any wrongdoing whatsoever'' and her 
``fabrication of documentation to cover her tracks'' shows that she 
``cannot be entrusted with the ability to continue prescribing 
controlled substances.'' Id. Moreover, I agree with the RD that 
revocation is the appropriate sanction. Id. I make the following 
findings of fact.

II. Findings of Fact

A. DEA Registration

    The parties stipulated that Respondent is registered with DEA to 
handle controlled substances in schedules II through V under DEA 
Certificate of Registration No. FG0560765, at 951 North East 167th 
Street, North Miami Beach, Florida 33162. ALJX 11, at 1; Tr. 9; and GX 
1 (Controlled Substance Registration Certificate). This registration 
expired on September 30, 2019.\2\ GX 1.
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    \2\ The fact that a registrant allows his registration to expire 
during the pendency of an OSC does not impact my jurisdiction or 
prerogative under the Controlled Substances Act (hereinafter, CSA) 
to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 
68,474 (2019).
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B. The Investigation

    DEA opened its investigation into Respondent after receiving 
information from the North Miami Beach Police Department that it had 
responded to Respondent's office several times due to ``altercations 
between the staff at the office and patients . . . [which] appeared to 
be over prescriptions for oxycodone.'' Tr. 28.
    DEA used two confidential sources (hereinafter, CS), Y.H. and L.G., 
when conducting the investigation into Respondent. Tr. 28, 150. A DEA 
SA was the DEA handler for the two confidential sources. Tr. 150. SA 
would coordinate the undercover operation, meet with the confidential 
sources, give them direction as to what DEA wanted them to say or do, 
and provide them with electronic recording devices used to record audio 
and video of the interaction between the sources and Respondent. Tr. 
151. After the undercover operation was finished, SA would obtain the 
recording devices from the confidential sources, download the 
information recorded to a DVD, and place the DVD into evidence. Tr. 
151-53. SA would also provide a copy of the DVD to a DEA contractor, 
who would transcribe the DVD. Tr. 154. Thereafter, SA would compare the 
transcript to the recording for quality control and to make sure the 
transcript was accurate. Tr. 154-56, 163.
    In November 2017, DEA executed a search warrant on Practice Fusion, 
an electronic medical record software company, to obtain Respondent's 
patient files. Tr. 29-30. DEA compared the obtained patient files for 
Y.H. and L.G. with the recordings made by Y.H. and L.G. and determined 
that there were inaccuracies in the medical records. Tr. 30. 
Thereafter, DEA retained a medical expert to review the patient files 
and recorded videos. Id.

C. Government's Case

    The Government's documentary evidence consists primarily of video 
recordings \3\ and transcripts of two confidential sources' visits with 
Respondent, and prescription records for the two confidential sources. 
See GX 1-19, 22. Additionally, the Government called five witnesses: A 
DI, confidential source Y.H., confidential source L.G., SA and an 
expert, Dr. Reuben Hoch, M.D.
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    \3\ Respondent's counsel conceded that ``there can be [no] 
question that the video evidence is always going to be good 
evidence.'' Tr. 485.
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    DI testified about his investigation-related actions, including his 
role in

[[Page 73788]]

executing a search warrant to obtain Respondent's patient files. Tr. 
26-42; RD, at 5. Having read and analyzed all of the record evidence, I 
agree with the RD that DI ``presented his testimony in a professional, 
candid, and straightforward manner.'' RD, at 5. I also agree that DI's 
testimony is ``sufficiently objective, detailed, plausible, and 
internally consistent'' to be given full credibility. Id.
    Y.H. testified about her role as a confidential source \4\ during 
DEA's investigation into Respondent, identified the recordings she made 
while meeting with Respondent, and identified the prescriptions 
Respondent issued to her. Tr. 42-95. Y.H. also testified regarding her 
non-recorded interactions with the staff at Respondent's practice. Tr. 
45-46, 52, 57. Y.H. is a felon; however, her last conviction occurred 
in 1996, and I agree with the ALJ that it is too distant to impact her 
credibility. RD, at 6; Tr. 43. Having read and analyzed all of the 
record evidence, I agree with the RD that Y.H. ``presented her 
testimony in a candid and straightforward manner.'' RD, at 6. I also 
agree that ``Y.H.'s testimony was sufficiently objective, detailed, 
plausible, and internally consistent with other evidence of record . . 
. [to] merit it as credible.'' \5\ RD, at 6.
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    \4\ Y.H. has worked for DEA as a paid confidential source since 
2002. Tr. 43.
    \5\ The Respondent requested that the ALJ treat the testimony of 
both Y.H. and L.G. as not credible and afford their testimony no 
weight. RD, at 58; Tr. 487; ALJX 28, at 13-14. In support, 
Respondent argued that Y.H. and L.G. were both convicted felons who 
were paid to serve as confidential sources and, as such, they had 
``every incentive to . . . help the government.'' Tr. 486. I agree 
with the ALJ's thorough assessment of the credibility of Y.H. and 
L.G. RD, at 94-95. In short, the relevant testimony of Y.H. and L.G. 
with regard to their encounters with Respondent is fully supported 
by the video evidence which, as Respondent notes, ``speaks for 
itself.'' ALJX 28, at 13; see also Tr. 485; RD, at 94. I also agree 
with the ALJ that the unrecorded interactions that Y.H. and L.G. had 
with Respondent's office staff and medical assistants are irrelevant 
to what Respondent herself did or did not do. See RD, at 94. As Dr. 
Hoch testified, it is the physician's responsibility to examine the 
patient, to draw his or her own conclusions, and to maintain medical 
records. Tr. 326, 354; RD, at 94. As such, it is the physician's 
recorded interactions with the patients that are relevant to this 
case. I fully agree with the ALJ's determination that Y.H. and L.G. 
are credible witnesses. RD, at 95.
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    L.G. testified about his role as a confidential source \6\ during 
DEA's investigation into Respondent, identified the recordings he made 
while meeting with Respondent, and identified the prescriptions 
Respondent issued to him. Tr. 96-145. Y.H. also testified regarding his 
non-recorded interactions with the staff at Respondent's practice. Id. 
at 98, 106-07, 113-14. On this topic (which I find is irrelevant, see 
supra n.5), the ALJ found that L.G.'s testimony was briefly evasive 
when he did not acknowledge on cross examination that hypothetical 
video evidence of his interactions with Respondent's staff would have 
been better evidence than L.G.'s live testimony. RD, at 7; Tr. 133-35. 
The RD found that this was relevant to L.G.'s credibility. RD, at 7. 
L.G. also testified that he was convicted of a felony in 2010 for 
impersonating a police officer and was released from confinement for 
that offense in 2015. Tr. 96, 119; RD, at 6. The ALJ found the felony 
conviction was relevant to L.G.'s credibility. RD, at 7. However, the 
ALJ found, and I agree, that the two items relevant to L.G.'s 
credibility, ultimately ``do not diminish L.G.'s overall credibility.'' 
RD, at 7. Having read and analyzed all of the record evidence, I agree 
with the RD that L.G. ``presented his testimony in a candid and 
straightforward manner.'' Id. I also agree that ``L.G.'s testimony was 
sufficiently objective, detailed, plausible, and internally consistent 
with other evidence of record . . . [to] merit it as credible.'' Id.
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    \6\ L.G. has worked as a confidential source for DEA for about 
two and a half years. Tr. 96.
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    SA testified about the investigative work he did regarding 
Respondent, including his work as the handler for both Y.H. and L.G. 
Tr. 150-52. SA also testified regarding the integrity and 
authentication of the video evidence and the accompanying transcripts. 
Id. at 152-63. Having read and analyzed all of the record evidence, I 
agree with the RD that SA presented his testimony ``in a professional, 
candid, and straightforward manner.'' RD, at 8. I also agree that SA's 
testimony is ``sufficiently objective, detailed, plausible, and 
internally consistent'' to be given full credibility. Id.
    Dr. Hoch, is Board-certified in anesthesiology and pain medicine. 
Tr. 193; GX 22 (Resume of Dr. Hoch); RD, at 8. He is the chief 
anesthesiologist at the Aventura Hospital, where he is involved in the 
administration of surgical anesthesia and the management of pain. Id. 
Dr. Hoch has been involved in pain management for at least 25 years, 
including managing his own pain medicine practice, working as an 
interventional pain specialist at the JFK Medical Center in Palm Beach, 
Florida, and working as the Chief of the Division of Pain Medicine at 
Brooklyn Hospital. Tr. 194-95; RD, at 8. Dr. Hoch is licensed in 
Florida and was accepted in this matter (and he has been accepted in 
other DEA matters) ``as an expert in pain management and prescribing 
controlled substances with respect to the standard of care for pain 
management in the State of Florida.'' RD, at 9; see also Tr. 198, 202. 
Having read and analyzed all of the record evidence, I agree with the 
RD that Dr. Hoch's testimony ``was sufficiently objective, detailed, 
plausible, and internally consistent . . . [to] merit it as fully 
credible.'' RD, at 10-11. Moreover, Dr. Hoch's expert testimony was 
unrebutted. Id. at 11.

D. Respondent's Case

    The Respondent's documentary evidence consists primarily of medical 
and criminal records for the two confidential sources, photos of the 
Germeil clinic, employee resumes,\7\ a list of continuing education 
courses Respondent attended,\8\ discharge letters for various patients 
\9\ (not including Y.H. or L.G.), and documents related to an 
Administrative Complaint filed by the State of Florida Department of 
Health against Respondent. See RX 1-8, 11. As for live testimony, 
Respondent called two witnesses: J.F. and J.W. The main arguments 
Respondent attempted to establish through the witness testimony were: 
(1) That Respondent's positive dispensing experience should be 
considered; (2) that the Germeil clinic's procedures were to conduct a 
physical exam at the first visit and that medical assistants conducted 
pain assessments as part of taking a patient's vitals and discussed the 
vitals (including the pain assessment) with Respondent; and (3) that 
Respondent demonstrated her acceptance of responsibility by instituting 
remedial measures. ALJX 28, at 12-15. Notably, Respondent did not 
testify in this matter.
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    \7\ Respondent's resume indicates that Respondent has been a 
licensed physician in the State of Florida since October 2007. RX 5 
(Resume of Jeanne Esther Germeil), at 1. She has had her own medical 
practice, Germeil Medical, Inc., since September 2011. Id.
    \8\ Among other things, the CLE records show that on October 7, 
2017, Respondent completed 5 credits in the educational activity 
titled ``Legal & Ethical Implications in Medicine: A physician's 
Survival Guide--Laws & Rules.'' RX 6 (List of Respondent's Completed 
Continuing Education Courses), at 7. On October 1, 2017, Respondent 
completed 8 credits in the live educational activity titled, 
``Quality Medical Record Keeping for Health Care Professionals.'' 
Id. at 9. On December 27, 2017, the Florida Medical Association 
notified Respondent that her record keeping mentor ``noted that 
[Respondent's] follow-up records showed improvement and that the 
recommendations made during Phase I, for the most part, were 
successfully implemented.'' Id. at 8 (emphasis in original). The 
Florida Medical Association mentioned that there were additional 
suggestions for further improvements, but that documentation was not 
included in the record. Id. The CLE records also show that 
Respondent took courses in prescribing for pain in 2013. Id. at 2.
    \9\ I note, that there are 47 pages of discharge letters 
including 38 unique letters and 9 duplicates. See RX 8 (Discharge 
Letters), at 14, 16, 19, 21, 24-25, 26-27, 32).

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[[Page 73789]]

    J.F. is Respondent's husband and the general manager of the Germeil 
Medical Clinic. Tr. 362, 390. J.F. testified regarding his roll 
maintaining the clinic's records and regarding the Clinic's procedures. 
Id. at 362. Concerning records, J.F. testified that, since 2011, 
medical records were contained in the Practice Fusion system and that, 
early on, the Clinic had problems with the system losing medical 
records.\10\ Id. at 368. He also testified that L.G. was ordered to 
have a urine test performed, and that Respondent would no longer see 
him as a patient when L.G. did not comply with the order. Tr. 376-78; 
RX 3 (Lab Order for L.G. dated October 4, 2017). On this issue, the ALJ 
found ``[J.F.'s] reasons why the Clinic had not issued termination 
letters to Y.H. and L.G. for failing to take urine tests to be less 
than credible.'' RD, at 12. J.F. stated that the Clinic's procedure for 
vitals included taking blood pressure, weight, height, and conducting a 
pain assessment. Tr. 372. Further, J.F. testified that he was not 
present when vitals were taken, but he made sure that the information 
was entered into Practice Fusion. Id. at 372-73. The ALJ found that 
J.F. lacked credibility when he testified that he had personal 
knowledge of what vitals were taken with Y.H. and L.G., when really, 
J.F. simply had to trust that the recorded information was accurate. 
RD, at 12-13; Tr. 392, 419-20. J.F. also testified regarding the 
general procedures Respondent used when seeing patients and regarding 
improvements that the Germeil Clinic had instituted in the year prior 
to the hearing. Tr. 385, 387-88; RD, at 12.
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    \10\ DI testified that he has investigated at least three 
clinics that used the Practice Fusion program and he has not found 
that the program deletes or omits things. Tr. 32-33.
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    Having read and analyzed all of the record evidence, I agree with 
the RD that J.F.'s testimony was not presented in a straightforward and 
candid manner. RD, at 13. Still, the RD found, and I agree, that J.F. 
was generally a credible witness. Id. The RD went on to find that much 
of J.F.'s testimony was irrelevant because he had little personal 
knowledge of how Y.H. and L.G. were treated as patients and because 
Respondent did not accept responsibility for her actions. Id. I agree.
    J.W. is the office manager of the Germeil Clinic and, in that role, 
he supervises the medical assistants. Tr. 433-34, 437; see also RX 7 
(Resume of J.W.). J.W. testified concerning the office procedures for 
taking a patient's vitals (which J.W. occasionally did himself). Tr. 
442-47. In taking vitals, a medical assistant obtains a patient's blood 
pressure, weight, height, and conducts a preliminary pain assessment. 
Id. at 443. The vitals are then provided to Respondent who occasionally 
asks questions about a patient's pain. Tr. 445, 447, 453. Diminishing 
J.W.'s credibility, the ALJ found that J.W. painted a picture of being 
able to consistently monitor (hear and observe) the medical assistants, 
while they took vitals, when he obviously had other responsibilities as 
the office manager to which he had to attend. Tr. 434, 459, 471-74. 
Moreover, while J.W. testified credibly as to the clinic's procedures 
for taking a patient's vitals, he provided no testimony that he 
observed the taking of Y.H. or L.G.'s vitals. RD, at 14. Thus, the RD 
found, and I agree, that J.W.'s testimony does not outweigh the direct 
testimony of both Y.H. and L.G. concerning how their vitals were taken 
and whether or not they were asked about their pain.\11\
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    \11\ Moreover, this testimony is irrelevant as this matter 
involves Respondent's failure to conduct physical examinations, not 
her failure to collect vitals. And as Dr. Hoch explains, 
Respondent's responsibility to conduct a physical exam cannot be 
satisfied by her medical assistants. See infra n.33; Tr. 307, 326.
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    The ALJ found the remainder of J.W.'s testimony to be generally 
credible. RD, at 14. He testified that if Respondent suspected that a 
patient was diverting drugs, she would send the patient for a urine 
drug test. Tr. 448. If the patient did not take the urine drug test, 
the patient would not be seen again until the test is taken. Id. If the 
patient refuses to take the test, the patient would be discharged. Id. 
J.W. testified that since he started in December 2016, the Germeil 
Clinic had worked to reduce patients' wait times, spend more time with 
patients, use a pain questionnaire, and give more attention to taking 
vitals. Tr. 449-50.
    Having read and analyzed all of the record evidence, I agree with 
the RD that J.W.'s testimony was presented in a straightforward and 
candid manner. RD, at 14. The RD went on to find that, like J.F.'s 
testimony and for the same reasons, much of J.W.'s testimony was 
irrelevant to the issues in this case. Id. Again, I agree.

E. The Standard of Care in the State of Florida

    According to the Controlled Substances Act (hereinafter, CSA), 
``Except as authorized by this subchapter, it shall be unlawful for any 
person knowingly or intentionally . . . to . . . distribute, . . . 
dispense, or with intent to . . . distribute[ ] or dispense, a 
controlled substance.'' 21 U.S.C. 841(a)(1). The CSA's implementing 
regulations state that a lawful controlled substance order or 
prescription is one that is ``issued for a legitimate medical purpose 
by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a).
    During the prehearing conference on June 6, 2018, the parties 
stipulated that Respondent ``is presently'' licensed in the State of 
Florida as a Medical Doctor. Dr. Hoch presented unrebutted testimony 
regarding the usual course of professional practice and the applicable 
standard of care for a Florida physician when prescribing controlled 
substances.
    Dr. Hoch explained that Florida Administrative Code, Rule 64B8-
9.013, Standards for the Use of Controlled Substances for the Treatment 
of Pain, lays out a physician's responsibilities when prescribing 
controlled substances for pain management.\12\ RD, at 9; Tr. 203-05. 
Dr. Hoch acknowledged that Florida Administrative Code Sec.  64B8-9.013 
\13\ provides guidelines rather than black-and-white rules, but he 
further acknowledged that those guidelines are authoritative regarding 
a physician's standard of care in Florida. RD, at 9; Tr. 272, 280-81. 
The Florida Code states that ``[t]he Board will not take disciplinary 
action against a physician for failing to adhere strictly to the 
provisions of these standards, if good cause is shown for such 
deviation.'' Fla. Admin. Code r. 64B8-9.013(1)(f) (West 2020).
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    \12\ Moreover, the parties stipulated that ``a Florida licensed 
physician must follow the standards and rules set forth by the 
Florida Department of Health, Standards of Practice of Medical 
Doctors. ALJX 16, at 1; Tr. 10. The parties further stipulated that 
``Florida Administrative Code, Rule 64B8-9.013, Standards for the 
Use of Controlled Substances for the Treatment of Pain, applies to a 
Florida licensed [p]hysician dispensing controlled substances.'' Id.
    \13\ The relevant portions of Florida Administrative Code Sec.  
64B8-9.013 have not been amended at any time during the relevant 
time period in this matter.
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    According to Dr. Hoch, that regulation requires that a doctor: Take 
a complete medical history and conduct a physical examination \14\ 
before issuing a prescription for a controlled substance; develop a 
written treatment plan; discuss the risks and benefits of controlled 
substances with a patient;

[[Page 73790]]

and maintain complete and accurate records with respect to a patient. 
RD, at 9; Tr. 205-06, 338. Additionally, a physician is required to 
conduct a periodic review of the course of treatment provided to a 
patient. RD, at 50; Tr. 337-38.
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    \14\ The Florida Code does not define what constitutes a 
physical exam and does not necessarily require that a physician 
conduct a physical examination of a patient each time the patient 
presents for an appointment. RD, at 50; Tr. 289. However, Dr. Hoch 
opined that the standard of care requires a physician to perform a 
physical examination in certain circumstances including before first 
prescribing a controlled substance, when the patient requests a 
higher dose of controlled substances, presents with new symptoms or 
complaints, has a new diagnosis, or has not been seen for a period 
of months. See Tr. 290, 341-42, 345-46.
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    Further, a physician's medical records must also meet the standards 
set forth in Florida Administrative Code Rule 64B8-9.003 \15\ and 
Florida Statute Sec.  458.331(1)(m).\16\ Under the Florida 
Administrative Code, ``[a] licensed physician shall maintain patient 
medical records . . . with sufficient detail to clearly demonstrate why 
the course of treatment was undertaken.'' Fla. Admin. Code r. 64B8-
9.003(2) (West 2020). The regulation also states that physician's 
``medical record shall contain sufficient information to identify the 
patient, support the diagnosis, justify the treatment and document the 
course and results of treatment accurately, by including, at a minimum, 
patient histories; examination results; test results; records of drugs 
prescribed . . . .'' Id. at 9.003(3). The Florida Statute provides that 
the ``following acts constitute grounds for denial of a license or 
disciplinary action . . .: [f]ailing to keep legible . . . medical 
records . . . that justify the course of treatment of the patient, 
including, but not limited to, patient histories; examination results; 
test results; records of drugs prescribed, dispensed, or administered; 
and reports of consultations and hospitalizations.'' Fla. Stat. Ann. 
Sec.  458.331(1)(m) (West 2020).
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    \15\ The relevant portions of Florida Administrative Code Sec.  
64B8-9.003 have not been amended at any time during the relevant 
time period in this matter.
    \16\ Florida Statute Sec.  458.331(1)(m) has not been amended at 
any time during the relevant time period in this matter.
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    The Florida Administrative Code provides the following standards 
and record keeping requirements, see Fla. Admin. Code r. 64B8-9.013 
(West 2020):

--``A complete medical history and physical examination must be 
conducted and documented in the medical record.'' Fla. Admin. Code 
r. 64B8-9.013(3)(a) (West 2020). A Florida physician ``is required 
to keep accurate and complete records to include . . . [t]he 
complete medical history and a physical examination, including 
history of drug abuse or dependence, as appropriate.'' Fla. Admin. 
Code r. 64B8-9.013(3)(f)(1) (West 2020).
--``The written treatment plan shall state objectives that will be 
used to determine treatment success, such as pain relief and 
improved physical and psychosocial function . . . .'' Fla. Admin. 
Code r. 64B8-9.013(3)(b) (West 2020). A Florida physician ``is 
required to keep accurate and complete records . . . [on t]reatment 
objectives.'' Fla. Admin. Code r. 64B8-9.013(3)(f)(4) (West 2020).
--``The physician shall discuss the risks and benefits of the use of 
controlled substances with the patient.'' Fla. Admin. Code r. 64B8-
9.013(3)(c) (West 2020). A Florida physician ``is required to keep 
accurate and complete records to include . . . [d]iscussion of risks 
and benefits.'' Fla. Admin. Code r. 64B8-9.013(3)(f)(5) (West 2020).
--``[T]he physician shall review the course of treatment and any new 
information about the etiology of the pain. Continuation or 
modification of therapy shall depend on the physician's evaluation 
of the patient's progress. If treatment goals are not being 
achieved, despite medication adjustments, the physician shall 
reevaluate the appropriateness of continued treatment.'' Fla. Admin. 
Code r. 64B8-9.013(3)(d) (West 2020). A Florida physician ``is 
required to keep accurate and complete records to include . . . 
[p]eriodic reviews. Records must remain current, maintained in an 
accessible manner, readily available for review . . . .'' Fla. 
Admin. Code r. 64B8-9.013(3)(f)(10) (West 2020).

    Dr. Hoch explained that the basic rule of thumb for medical 
documentation is a ``SOAP'' note. RD, at 51; Tr. 212. The ``S'' is a 
patient's subjective complaint; the ``O'' is the doctor's objective 
findings based on a physical examination; ``A'' is the doctor's 
assessment or impression or the diagnosis of the condition the doctor 
is treating; and the ``P'' is the plan where a doctor explains why a 
particular treatment has been selected. RD, at 51; Tr. 212. He 
testified that the plan is the most important part of the documentation 
because it allows a doctor to explain ``why [she's] doing what [she's] 
doing . . . [and] detail [her] decision-making.'' Tr. 212. Dr. Hoch 
explained that it is a doctor's responsibility to maintain patients' 
records. RD, at 50; Tr. 354.
    The Florida Administrative Code provides that ``[p]hysicians should 
be diligent in preventing the diversion of drugs for illegitimate 
purposes.'' Fla. Admin. Code r. 64B8-9.013(1)(d) (West 2020). Dr. Hoch 
explained that, in Florida, ``it is a very big responsibility for 
prescribing physicians to be concerned about diversion.'' Tr. 224. When 
a patient tells a doctor that he or she is diverting his or her 
controlled substances that statement ``is a very big red flag that has 
to be addressed at that moment.'' RD, at 51; Tr. 224-25. In fact, Dr. 
Hoch stated that if a patient tells a doctor that he or she is selling 
or giving away controlled substances, ``that's sort of a deal breaker . 
. . .'' \17\ Tr. 351. Therefore, in accordance with Dr. Hoch's 
testimony and the record as a whole, I find that the standard of care 
in Florida requires that a physician stop writing prescriptions for a 
patient following statements from the patient that are consistent with 
diversion. See Tr. 256-57.
---------------------------------------------------------------------------

    \17\ Dr. Hoch's meaning by ``deal breaker'' is clarified by the 
totality of his testimony. Tr. 351. He testified that if he had a 
patient that admitted to diversion, he would not write another 
prescription for that patient. Tr. 256-57. Similarly, the Florida 
Administrative Complaint makes clear that the Florida Department of 
Health's position is that practitioners should ``discontinue 
prescribing scheduled medications after learning that the patient 
[engaged in diversion].'' RX 11, at 19. I also note that 
Respondent's Posthearing states, ``[Respondent] knows that she 
should not have issued the prescription for Y.H. and L.G. after they 
made statements consistent with diversion . . . she had a duty to 
investigate . . . [and] should have refused to give the 
prescription[s] and sent them for drug testing immediately.'' ALJX 
28, at 15.
---------------------------------------------------------------------------

F. The Florida Department of Health Complaint

    The parties stipulated that Respondent's license to practice 
medicine has never been suspended or revoked by the State of Florida, 
Board of Medicine. ALJX 19 (Additional Joint Stipulations Proposed by 
Respondent), at 1.
    On January 20, 2017, the Florida Department of Health issued an 
Administrative Complaint (hereinafter, Complaint) against Respondent. 
Respondent's Exhibit (RX) 11 (Records from the Florida Administrative 
Complaint against Respondent), at 16-24. The Complaint alleged, among 
other things, that Respondent's medical treatment of a patient 
M.N.,\18\ between July 2013, and August 2015, ``fell below the 
prevailing professional standard of care,'' that she ``prescribed 
controlled substances inappropriately . . . , '' and that she ``failed 
to adequately create or maintain medical records that justified [the] 
amount and/or type of controlled substances she prescribed'' in 
violation of Florida Statute Section 458.331(1)(m) and Florida 
Administrative Code Rule 64B8-9.003. Id. at 20, 22-23. The facts 
alleged in support of the Complaint are that Respondent: Continued 
prescribing controlled substances to her patient upon learning that the 
patient was sharing another person's pain medication; failed to obtain 
a medical history; failed to list a chief complaint or history of 
present illness; recorded the patient's vitals only one time; and did 
not have the patient sign a pain medication contract. Id. at 17-18, 21. 
Based on the alleged violations, the Complaint sought ``permanent

[[Page 73791]]

revocation or suspension of Respondent's license, restriction of 
practice, imposition of an administrative fine, issuance of a 
reprimand'' and/or other lesser penalties against Respondent. RX 11, at 
24.
---------------------------------------------------------------------------

    \18\ There are no allegations of improper prescribing in this 
proceeding relevant to patient M.N.; however, this Complaint is 
relevant for other reasons as described herein.
---------------------------------------------------------------------------

    On February 8, 2017, Respondent signed a Settlement Agreement to 
settle the matters alleged in the Complaint. Id. at 6-15. Although 
Respondent neither admitted nor denied the allegations in the 
Complaint, she did admit that if the allegations were proven, they 
``would constitute violations of Chapter 458, Florida Statutes.'' Id. 
at 7. The Settlement Agreement (as amended by the Florida Board of 
Medicine (hereinafter, State Board) pursuant to the Final Order, dated 
April 21, 2017) required Respondent to pay a fine of $10,000, reimburse 
$2,895.21 in costs, take four classes within a year, have a risk 
manager evaluate her medical practice, and comply with the risk 
manager's recommendations for improvements. Id. at 1-2, 6-15. 
Additionally the Settlement Agreement stated that ``[i]n the future, 
Respondent shall not violate Chapter 456, 458 or 893, Florida Statutes, 
or the rules promulgated pursuant thereto, or any other state or 
federal law, rule, or regulation relating to the practice or the 
ability to practice medicine . . . .'' Id. at 12.

G. Allegation of Improper Prescribing to Y.H.

    Having read and analyzed all of the record evidence, I agree with 
the RD and find that the record contains substantial evidence that 
Respondent improperly prescribed controlled substances to Y.H. without 
a legitimate medical purpose, beneath the standard of care and outside 
the usual course of professional practice. RD, at 68, 71, and 73. Y.H. 
visited in the capacity as a confidential source for DEA a total of 
eight times between March 3, 2016, and January 25, 2017. Tr. 43-44; RX 
1.\19\ Y.H.'s first encounter with Respondent was on March 22, 2016. RX 
1, at 30. According to the patient records, Y.H.'s chief complaint 
during the first visit was, ``I just came to hav[e] some pain meds. I 
am not function [sic.] w/o pain meds. . . . I share oxycodone 30 mg. I 
had 2 MVA and a bad slip[ ] about 2 years ago. I'd like flexeril as 
well.'' RX 1, at 30. Y.H.'s last three visits with Respondent, and the 
prescriptions resulting therefrom, presented as evidence in this case--
September 8, 2016, October 12, 2016, and January 25, 2017.
---------------------------------------------------------------------------

    \19\ No videos or transcripts of Y.H.'s earlier visits with 
Respondent were introduced in this matter. However, based on Y.H.'s 
credible testimony and the opinion of Dr. Hoch, I find that 
Respondent did not document or conduct a physical examination of 
Y.H. during any of her eight visits with Y.H. Tr. 92, 338-39. 
Respondent presented no evidence to demonstrate that a physical 
examination was conducted.
---------------------------------------------------------------------------

1. Y.H.'s September 8, 2016 Visit
    On September 8, 2016, Y.H. visited Respondent in her capacity as a 
confidential source and pursuant to the instructions given to her by 
her DEA handler. Tr. 43-44. During the visit, Y.H. wore a recording 
device that provided both audio and visual recordings of the office 
visit and she activated the device when she began interactions with 
Respondent. Id. at 44. As is evident from the records, Respondent spent 
approximately ten minutes with Y.H. GX 2 (Video Recording from 
September 8, Encounter). The vast majority of that time was spent 
discussing Y.H.'s sexuality and upcoming wedding. GX 3 (Transcript of 
Recording from September 8, Encounter), at 4-14.
    During the visit, there was no discussion regarding the amount of 
Y.H.'s pain. See generally GX 3. Further, Y.H. testified that she was 
not asked to describe her pain levels by any member of Respondent's 
staff. Tr. 45, 87-88. The only discussion that occurred regarding pain 
occurred when Y.H. seemingly could not remember the location of her 
pain. GX 3, at 3

CS: I don't know. It's hurting my back.
Germeil: Uh--! \20\
---------------------------------------------------------------------------

    \20\ Throughout the transcripts of the video recorded encounters 
(GXs 3, 5, 7, 9, 11, and 13), the transcriber used ellipses to 
depict pauses in the conversation. I have removed these and replaced 
them with dashes to prevent confusion between pauses and omissions 
of word from the quotations. Where they would have appeared at the 
beginning or end of a line, I have omitted them altogether.
---------------------------------------------------------------------------

CS: Oh! I forgot. It's not my back--it's my neck.
Germeil: Uh
CS: It's my back and my neck. Yeah, `cause
[VOICES OVERLAP] \21\
---------------------------------------------------------------------------

    \21\ Bracketed text that describes the mechanics of the 
conversation between the confidential sources and Respondent, appear 
in the original transcript. Examples include, [VOICES OVERLAP], [U/
I] which stands for unintelligible (Tr. 155, 159-60), [STUDDERS], 
and [WHISPERING].
---------------------------------------------------------------------------

Germeil: So, it's not on your shoulder but [U/I]
CS: No. Not at all [U/I].

Id. After seemingly not knowing the location of her pain, Y.H. 
requested additional pills. ``Doc, remember last month you were going 
to give me one twenty (120)--for the Oxy's, but you didn't, and you 
told Josh to tell me this month you'd give me one forty (140).'' Id. at 
10. After requesting additional pills, Y.H. informed Respondent that 
she had been giving, even selling, some of her pills to her brother. 
Id. at 17, 19.

CS: Okay, [my brother] is coming and he has to get pills because 
last month
Germeil: Uh-huh.
CS: when you didn't get--uh--you did not give him enough, and again, 
he wanted to borrow from me--and I was like ``No, I'm selling them 
to you this time''
Germeil: [U/I]
CS: ``You are going to give me money''
. . . .
CS: Last month he ran out--he's drinking three (3), four (4) pills a 
day--I said, ``Bro, you are not going [to] bum anything of me, you 
are going to give me money for these pills'' and he has to pay me 
first [U/I] because I'm not going to give them to him for free. I'm 
tired of him! I'm tired of him, doc!''

Id. Respondent's only response to Y.H.'s admission to diverting her 
controlled substances was ``Okay.'' Id. at 19.
    Despite Y.H. not knowing the location of her own pain, requesting 
an increase in the number of pills prescribed, and admitting to 
diversion, Respondent wrote Y.H. prescriptions for controlled 
substances during the visit. GX 14 (Prescriptions issued to Y.H. on 
September 8), at 1. The parties stipulated that on September 8, 2016, 
Respondent prescribed Y.H. one hundred and forty \22\ dosage units of 
oxycodone HCL 30 mg.\23\ and sixty dosage units of alprazolam 2 mg.\24\ 
ALJX 11, at 2; Tr. 9.
---------------------------------------------------------------------------

    \22\ Y.H. requested an increase from one hundred and twenty to 
one hundred and forty pills a month, and this prescription shows 
that Respondent agreed to prescribe the additional pills. GX 3, at 
10; GX 14.
    \23\ The parties stipulated that oxycodone HCL is listed by DEA 
as a Schedule II controlled substance. ALJX 11, at 2.
    \24\ The parties stipulated that alprazolam is listed by DEA as 
a Schedule IV controlled substance. ALJX 11, at 2.
---------------------------------------------------------------------------

    Y.H. testified that during this visit, Respondent did not conduct a 
physical exam, did not discuss other medical conditions Y.H. might 
have, did not discuss the medications that Y.H. was taking, did not 
discuss Y.H.'s diet or exercise. Tr. 48-49. Y.H. testified that the 
person who took her vitals on September 8, 2016, did not conduct a 
physical exam, discuss Y.H.'s medical condition, or ask about 
controlled substances Y.H. was taking. Tr. 45.
    According to the patient records for that visit, Y.H.'s chief 
complaint was ``I need a little bit more of my pills, I ran out so 
fast. I really need them. I am getting married soon and I need a little 
bit more.'' RX 1, at 22. The patient records ``Plan'' stated that 
Respondent, among other things, explained the side effects of the 
medication, advised regarding adverse reactions, discussed lifestyle 
modifications to control weight and blood pressure, and that a

[[Page 73792]]

``[d]etail[ed] explanation was provided about and against `shopping' 
from physician to physicians [sic] and the harm (s) [sic] that can 
provoke.'' Id. According to the patient records, ``[a]pproximately 60 
min was spent in this encounter,'' and Y.H.'s pain level was ``9.'' Id. 
However, Y.H.'s testimony and the recordings directly contradict the 
information in the ``Plan.''
    Dr. Hoch opined that the two prescriptions issued by Respondent to 
Y.H. on September 8, 2016, (namely one hundred and forty dosage units 
of oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg.) 
were issued outside of the usual course of professional practice and 
beneath the applicable standard of care in the state of Florida. Tr. 
208-09; GX 14. In support of his opinion, Dr. Hoch noted that the plan 
does not bear any resemblance to the actual visit and discussion 
between Respondent and Y.H. Tr. 218. Compare RX 1, at 22, with GX 2 and 
GX 3. Dr. Hoch explains that Y.H. is a female and the plan refers to a 
male. Tr. 213, RX 1 (Patient File for Y.H.), at 22. Additionally, the 
plan discusses managing blood pressure when Y.H. has ``quite a good 
blood pressure'' that does not need to be controlled. Tr. 214. Also, 
Dr. Hoch explains that Respondent did not discuss side effects with 
Y.H., fall precautions, or the harms that occur by shopping from 
physician to physician, but that those non-existent conversations were 
recorded in the plan. Tr. 213-218. Additionally, Dr. Hoch pointed out 
that the plan records that the visit lasted approximately 60 minutes 
when the visit did not last an hour. Tr. 215. Finally, Dr. Hoch found 
no indication that Respondent performed a physical exam or took a 
medical history at the visit. Tr. 227. Further, Dr. Hoch opined that 
there is no indication in the patient treatment notes that Respondent 
maintained on Y.H. that Respondent conducted a periodic review of her 
treatment of Y.H.'s conditions by prescribing controlled substances to 
her. Tr. 246.
    Additionally, Dr. Hoch opined that there was nothing documented in 
the patient file to justify the oxycodone or alprazolam \25\ 
prescriptions and that ``prescription of these medications together has 
to be qualified quite extensively in the medical record.'' Tr. 259; see 
also id. at 219. Respondent prescribed Y.H. oxycodone 30 mg. which is a 
``very strong'' dosage, and prescribed her one hundred and forty pills 
which ``means approximately four to maybe five a day . . . [or] 120 
milligrams of [o]xycodone a day.'' Tr. 219. According to Dr. Hoch, the 
oxycodone prescription can cause a number of side effects that 
Respondent did not discuss with Y.H. Tr. 220-21. He further testified 
that the side effects of opioid use, in the order of ``the least to the 
most disabling,'' include pruritus or itching, urinary retention, 
nausea and vomiting, and constipation. Id. at 220.
---------------------------------------------------------------------------

    \25\ Dr. Hoch explains that ``[t]wo milligrams of [a]lprazolam 
is a very high dose of [a]lprazolam.'' Tr. 222.
---------------------------------------------------------------------------

    Dr. Hoch explained that ``the most devastating complication or side 
effect of an opioid [like oxycodone] is respiratory depression, and 
that's what kills people.'' Tr. 221-22. Dr. Hoch explained that the 
risk is particularly high where, as here, the opioid is given with a 
benzodiazepine like alprazolam. Tr. 222. In light of the medications 
prescribed, Dr. Hoch explained that Respondent was required to warn 
Y.H. about the risk of respiratory depression and instruct the patient 
to make sure there was at least a three to four hour gap between 
administering the two different medications. Id. Based on Dr. Hoch's 
credible and uncontroverted testimony and based on the video recording 
and transcript, I find that there was no discussion of the risks at 
this visit. Id.
    Dr. Hoch explained that in Florida, ``it is a very big 
responsibility for prescribing physicians to be concerned about 
diversion.'' Tr. 224. Accordingly, when Y.H. informed Respondent that 
``she[ was] either giving or selling pills that she[ was] receiving 
from the doctor,'' Respondent should have been ``[t]remendous[ly] 
concern[ed].'' Id. Dr. Hoch concludes that Y.H.'s diversion admission 
was ``a very big red flag that [had] to be addressed at that moment.'' 
Tr. 224-25. I find that Respondent did not address Y.H.'s diversion 
admission on September 8, 2016. See also RD, at 68.
    Accordingly, based on the credible and uncontroverted testimony of 
Dr. Hoch, I find that the two prescriptions issued by Respondent to 
Y.H. on September 8, 2016, (namely one hundred and forty dosage units 
of oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg.) 
were issued outside of the usual course of professional practice and 
beneath the applicable standard of care in the state of Florida. See 
RD, at 68.
2. Y.H.'s October 12, 2016 Visit
    On October 12, 2016, Y.H. visited Respondent in her capacity as a 
confidential source and pursuant to the instructions given to her by 
her DEA handler. Tr. 43-44. During the visit, Y.H. wore a recording 
device that provided both audio and visual recordings of the office 
visit and she activated the device when she began interactions with 
Respondent. RD, at 27; Tr. 52, 183. As is evident from the records, 
Respondent spent less than seven minutes with Y.H. GX 4 (Video 
Recording from October 12, Encounter); GX 5 (Transcript of Recording 
from October 12, Encounter), at 13. The majority of that time was spent 
discussing Y.H.'s cancelled wedding and a potential hurricane. GX 5, at 
2-9; RD, at 69.
    Towards the end of the visit, Y.H. informed Respondent that she had 
been selling some of her pills to her brother. GX 5, at 12-13.

CS: I tell [my brother], doc. ``Go get your own stuff.'' I'm tired 
of selling him my pills.
Germeil: You're right!
CS: But I sold him the pills, I sure did it, at twenty (20) bucks a 
pop, and he paid for them. I said, ``You don't go see the doctor?''
Germeil: You're right about that, but . . . . He has to learn.
CS: Exactly, doc.

Id. The video and transcription of the appointment show that Respondent 
did not express any concern about Y.H. selling her controlled 
substances to her brother. RD, at 69; GX 4; GX 5. Instead, Respondent 
seems to have acknowledged Y.H.'s admission of diversion and to have 
condoned the conduct. Id.; Tr. 231. Dr. Hoch explained, ``[Y.H.] is 
clearly indicating to [Respondent] that they are diverting the 
medication to someone else . . . selling their [p]ills at $20 a pop. 
The doctor notes it, addresses it and condones it.'' Tr. 231. Dr. Hoch 
explains that Respondent's actions with regard to Y.H.'s admission of 
diversion were ``a tremendous cause for concern.'' Id.
    Not only did Respondent fail to address Y.H.'s admission of 
diversion, but Respondent, as the parties stipulated, went on to 
prescribe Y.H. one hundred and forty dosage units of oxycodone HCL 30 
mg. and sixty dosage units of alprazolam 2 mg. ALJX 11, at 2; Tr. 9. 
See also GX 15 (Prescriptions Issued to Y.H. on October 12).
    Dr. Hoch opined that the two prescriptions issued by Respondent to 
Y.H. on October 12, 2016, were issued outside of the usual course of 
professional practice and beneath the applicable standard of care in 
the state of Florida. Tr. 228-29; GX 15. In support of his opinion, Dr. 
Hoch noted that the plan documented for the October 12, 2016, visit was 
identical to, and has the same problems as the plan for the September 
9, 2016 visit. Tr. 234, 236. As with the prior visit, Y.H. is a female 
and the plan refers to a male. Tr.

[[Page 73793]]

235; RX 1, at 20. Additionally, the plan discusses managing blood 
pressure when Y.H.'s does not require management. Tr. 236. Dr. Hoch 
opined that the plan was too generic and failed to identify what 
Respondent was ``doing for that particular problem.'' Tr. 235. Dr. Hoch 
also points out that in the patient record '' . . . Subjective is empty 
. . . [O]bjective is empty . . . Assessment is empty.'' Tr. 233. 
Additionally, Dr. Hoch explained that ``back pain'' is an indication of 
a complaint, but that a proper complaint, unlike this one, would 
explain ``what the patient is actually feeling, where, . . . what part 
of their back, the nature and quality of the pain.'' Tr. 234. Dr. 
Hoch's credible and uncontroverted testimony is that the patient chart 
does not justify the prescriptions that Respondent gave to Y.H. on 
October 12, 2016. Tr. 236.
    Additionally, Dr. Hoch explained that these were the same two 
prescriptions issued on October 12, 2016, as were issued on September 
9, 2016, and that the same issues about which he had already opined 
regarding the issuance of both an opioid and a benzodiazepine were 
present here. Tr. 232. Also, once again Dr. Hoch pointed out that 
Respondent failed to discuss with Y.H. the risks involved with 
prescribing opioids and benzodiazepines together. Tr. 232.
    Further, Dr. Hoch explained, that Respondent's October 12, 2016 
visit with Y.H. lacked the required ``encounter between the physician 
and the patient [and] discussion of the ongoing problem as this is a 
chronic pain problem.'' Tr. 229. Dr. Hoch explained that Respondent did 
not address the patient's pain, conduct a physical examination, take a 
complete medical history, discuss the risks of controlled substances, 
develop a treatment plan, or conduct a periodic review of the treatment 
of Y.H.'s conditions. Tr. 230, 246.
    Based on Dr. Hoch's uncontroverted and credible testimony, the ALJ 
found, and I agree, that Respondent failed to make any statements that 
addressed Y.H.'s medical concerns during the October 12, 2016 visit. 
RD, at 27 (citing GX 4 and GX 5). Respondent did not ask any questions 
to determine Y.H.'s current medical condition, assess Y.H.'s level of 
pain or determine whether the treatment regimen she had prescribed to 
Y.H. was effective. RD, at 28 (citing GX 5); Tr. 87-88, 230. Respondent 
failed to: Conduct a physical examination of Y.H.; \26\ discuss the 
side effects of the medication she was prescribing to Y.H. or the risks 
of using controlled substances; discuss the risks of doctor shopping; 
discuss Y.H.'s diet and exercise; discuss any medications Y.H. was 
taking; take a complete medical history of Y.H.; or develop an adequate 
treatment plan for Y.H. RD, at 28 (citing Tr. 54, 230, 232); GX 4; GX 
5; RX 1, at 20.
---------------------------------------------------------------------------

    \26\ In fact, during the appointment, Dr. Germeil sat on one 
side of an office desk and Y.H. sat across the desk from her. RD, at 
70 (citing GX 4).
---------------------------------------------------------------------------

    In contrast, the patient notes that Respondent created concerning 
Y.H.'s October 12, 2016 appointment indicate that: The encounter lasted 
60 minutes; and that Respondent discussed ``side effects,'' ``adverse 
reactions,'' ``safety precautions,'' and doctor shopping with Y.H. RD, 
at 28 (citing RX 1, at 20). The ``Plan'' for the October 12, 2016, 
visit was identical to the ``Plan'' for the September 8, 2016, visit 
and did not accurately capture what happened during the October 12, 
2016, visit. RD, at 29; and compare RX 1, at 20, with id. at 22. Y.H.'s 
chief complaint was recorded as ``I have a lot [of] back pain and I 
need my pain meds.'' RX 1, at 20. Y.H.'s pain level was recorded as 
``9.'' Id. But Dr. Hoch explained that a patient who presents with a 
pain level of nine would show ``a tremendous degree of discomfort.'' 
RD, at 29 (citing Tr. 331). The October 12, 2016 records lacked any 
information in the ``Subjective,'' ``Objective,'' and ``Assessment'' 
sections. RX 1, at 20.
    The ALJ found based on Dr. Hoch's testimony, and I agree, that 
Respondent should have recognized Y.H.'s admission that she was 
diverting controlled substances as a red flag and considered it a 
``deal breaker'' such that Respondent should not have issued 
prescriptions to Y.H. on October 12, 2016. RD, at 71; Tr. 351. The ALJ 
found, and I agree, that the prescriptions Respondent issued to Y.H., 
on October 12, 2016, were not issued for a legitimate medical purpose, 
and were not issued in the usual course of professional practice in the 
State of Florida. RD, at 71; Tr. 229, 236.
3. Y.H.'s January 25, 2017 Visit
    On January 25, 2017, Y.H. visited Respondent in her capacity as a 
confidential source and pursuant to the instructions given to her by 
her DEA handler. Tr. 43-44. During the visit, Y.H. wore a recording 
device that provided both audio and visual recordings of the office 
visit and she activated the device when she began interactions with 
Respondent. RD, at 30; Tr. 58, 183. As is evident from the records, 
Respondent spent approximately seven and a half minutes with Y.H. GX 6 
(Video Recording from October 25, Encounter). The majority of that time 
was spent on small talk discussing Y.H.'s family matters, including 
Y.H.'s trip to Cuba following her aunt's death, her brother's drug 
dependency, and the financial strain that resulted. GX 7 (Transcript of 
Recording from October 25, Encounter); RD, at 72.
    At several points during the visit, Y.H. informed Respondent that 
she had been selling some of her pills. GX 7, at 4, 6, 9-11. During a 
discussion regarding an aunt of Y.H.'s who died in Cuba, Y.H., stated, 
``I didn't even have money--I had to actually sell my pills 
unfortunately. I had to make some money. I had to go over there. 
Everything was on me.'' GX 7, at 4. Y.H. went on to state, ``Thank God 
I had some--the--some of the--pills that I had I was able to get rid of 
them and get some money to help me out, which I had to do now, 
because--I had to pay my rent.'' GX 7, at 6. Then the visit concluded 
with a final conversation regarding diversion.

CS: You think is right that I have to sell my own pills, my meds to, 
to pay for stuff for--[STUTTERS] that's just crazy doc.
Germeil: Listen! [STUTTERS] You are a good person . . . good things 
happen to good people. . . .
CS: . . . Right now, I'll probably go and I'll take some of these, I 
have to keep some, and then the others I probably have to sell [to 
my brother]. He probably, he'll probably take some from me `cause 
that's all he does.'' . . .
Germeil: I feel sorry for you but uh--that's your call. That's mine, 
too. . . .
CS: Yeah, [o]xycodone's--thirty milligrams--[MURMERS] Yeah, we're 
good. Quantity one-forty (140). This is great. You don't know how 
much this helps me out, doc. You just don't know.
Germeil: Relax! Do not say that to nobody.
CS: Of course, not. . . .
Germeil: I know. I don't want to . . . get into trouble.

Id. at 9-11.
    Despite Y.H.'s admission of diversion, Respondent, as the parties 
stipulated, prescribed Y.H. one hundred and forty dosage units of 
oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg. ALJX 
11, at 2; Tr. 9. See also GX 16 (Prescriptions Issued to Y.H. on 
January 25). Dr. Hoch found that the same two prescriptions were issued 
on January 25, 2017, as were issued on September 9, 2016, and October 
12, 2016, and that the same concerns about which he had already opined 
regarding the issuance of both an opioid and a benzodiazepine were 
present here. Tr. 237-38.
    Dr. Hoch's credible and uncontroverted opinion was that the two 
prescriptions issued by Respondent to Y.H. on January 25, 2017, (namely

[[Page 73794]]

one hundred and forty dosage units of oxycodone HCL 30 mg. and sixty 
dosage units of alprazolam 2 mg.) were issued outside of the usual 
course of professional practice and beneath the applicable standard of 
care in the State of Florida. Tr. 237, 244; GX 16. In support of his 
opinion, Dr. Hoch found that the plan documented for the January 25, 
2017 visit is nearly identical to, and has the same problems as the 
plan for the September 9, 2016, and October 12, 2016 visits. Tr. 241. 
As with the prior visits, Y.H. is a female and the plan refers to a 
male. Tr. 241; RX 1, at 19. Further, as with the prior visits, the plan 
stated that side effects, adverse reactions, diet and exercise, blood 
pressure, doctor shopping, and other matters were discussed during the 
encounter when the transcript and video evidence make clear that they 
were not. Tr. 241-42. Dr. Hoch opined that the plan has ``a 
disconnect'' in so far as it fails to address Respondent's approach for 
treating the diagnoses identified in the assessment section 
(specifically anxiety disorder and back ache). Tr. 240. Again, Dr. Hoch 
identified flaws in the chief complaint section of Respondent's records 
for Y.H., which contained a list of diagnosis rather than a true 
complaint. Tr. 239. Dr. Hoch's opinion was that the patient chart 
reflects an incomplete medical record and does not justify the 
prescriptions that Respondent gave to Y.H. on January 25, 2017. Tr. 
250.
    Additionally, Dr. Hoch explained that, once again, Respondent 
failed to conduct a thorough physical exam, take a complete medical 
history, or conduct a periodic review of the treatment of Y.H. Tr. 242, 
246. In fact, during the encounter, Respondent sat on one side of an 
office desk and Y.H. sat across the desk from her. GX 6; RD, at 72. Dr. 
Hoch's conclusion is further supported by Respondent's failure to 
address Y.H.'s admission of diversion. Dr. Hoch explained, that there 
was a statement from ``the patient to the physician that the pills were 
being sold[,]'' which ``is diversion[,]'' and that ``the rule states 
that diversion is not acceptable.'' Tr. 243-44.
    Based on Dr. Hoch's expert testimony, the ALJ found, and I agree, 
that Respondent failed to make any statements that addressed Y.H.'s 
medical concerns during the January 25, 2017 visit. RD, at 30 (citing 
GX 6 and GX 7). Respondent did not ask any questions to determine 
Y.H.'s current medical condition, assess Y.H.'s level of pain or 
determine whether the treatment regimen she had prescribed to Y.H. was 
effective. RD, at 32 (citing GX 7; Tr. 87-88, 246). Respondent did not 
discuss the side effects of the medication she was prescribing to Y.H.; 
discuss the risks of doctor shopping; discuss Y.H.'s diet and exercise; 
discuss any medications Y.H. was taking; take a complete medical 
history of Y.H,; or develop an adequate treatment plan for Y.H. RD, at 
32 (citing Tr. 59, 241-243; GX 6; GX 7; RX 1, at 19). Further, Y.H. 
testified that Respondent did not conduct a physical exam during the 
encounter. Tr. 59.
    In contrast, the patient notes that Respondent created concerning 
Y.H.'s January 25, 2017, appointment indicate that: the encounter 
lasted 60 minutes; and that Respondent discussed ``side effects,'' 
``adverse reactions,'' ``safety precautions,'' and doctor shopping with 
Y.H. RD, at 33 (citing RX 1, at 19). The ``Plan'' for the January 25, 
2017 visit was nearly identical to the ``Plan'' for the September 8, 
2016, and October 12, 2016 visits (the only difference is the first 
line regarding a request for a urine drug test) and did not accurately 
capture what happened during the January 25, 2017 visit. RD, at 33; 
compare RX 1, at 19, with id. at 20, 22, and with GX-6, GX-7. Y.H.'s 
pain level was recorded as ``10.'' RX 1, at 19. But Dr. Hoch explained 
that a patient who presents with a pain level of ten would be in 
``excruciating pain'' and one would question how such a patient could 
``even sit in front of you.'' RD, at 33 (citing Tr. 331). If a person 
has a pain level of ten, then that person is usually in the hospital. 
Id. As with the prior patient records, the January 25, 2017 records 
lacked any information in the ``Subjective,'' and ``Objective'' 
sections. RX 1, at 19.
    The ALJ found, and I agree, that Respondent did not advise Y.H. not 
to sell her controlled substances or otherwise engage in any meaningful 
conversation about diversion with Y.H. RD, at 72-73; GX 6; GX 7. The 
ALJ found, and I agree, that Respondent should have recognized Y.H.'s 
admission that she was diverting controlled substances as a red flag 
and considered it a ``deal breaker'' such that Respondent should not 
have issued prescriptions to Y.H. on January 25, 2017. RD, at 73; Tr. 
242-44, 351.
    The ALJ found, and I agree, that based on Dr. Hoch's testimony, the 
prescriptions Respondent issued to Y.H., on January 25, 2017, were not 
issued for a legitimate medical purpose, and were not issued in the 
usual course of professional practice in the State of Florida. RD, at 
73-74.
    In summary, I find that the six controlled substance prescriptions 
Respondent issued to Y.H., on September 8, 2016, October 12, 2016, and 
January 25, 2017, were not issued for a legitimate medical purpose and 
were issued outside of the usual course of professional practice and 
beneath the applicable standard of care in the State of Florida.

H. Allegation of Improper Prescribing to L.G.

    Having read and analyzed all of the record evidence, I agree with 
the ALJ and find that the record contains substantial evidence that 
Respondent improperly prescribed controlled substances to L.G. without 
a legitimate medical purpose, beneath the standard of care, and outside 
of the usual course of professional practice in the State of Florida. 
RD, at 77, 80, and 82; infra.
    L.G. visited Respondent in the capacity as a confidential source 
for DEA a total of five times between July 2016, and August 2017. Tr. 
96-97; RX 2 (Patient File for L.G.). L.G.'s first encounter with 
Respondent was on July 25, 2016.\27\ RX 2, at 22. According to the 
patient records, L.G.'s chief complaint during the first visit was, ``I 
have been having this strong right shoulder pain since a few years 
back. It just started again. I am tired of: [sic] ibuprofen/bengay/
tylenol.'' RX 2, at 22. L.G.'s last three visits with Respondent, and 
the prescriptions resulting therefrom, were presented as evidence in 
this case--February 3, 2017, July 18, 2017, and August 3, 2017.
---------------------------------------------------------------------------

    \27\ No videos or transcripts of L.G.'s other visits with 
Respondent were introduced in this matter. However, based on L.G.'s 
credible testimony, I find that Respondent did not document or 
conduct a physical examination of L.G. during any of his five visits 
with L.G. Tr. 137, 338-39. Respondent presented no evidence to 
demonstrate that a physical examination was conducted.
---------------------------------------------------------------------------

1. L.G.'s February 3, 2017 Visit
    On February 3, 2017, L.G. visited Respondent in his capacity as a 
confidential source and pursuant to the instructions given to him by 
his DEA handler. Tr. 96-97. During the visit, L.G. wore a recording 
device that provided both audio and visual recordings of the office 
visit and he activated the device shortly before he went into 
Respondent's office. Tr. 97, 183. As is evident from the records, 
Respondent spent approximately seven and a half minutes with L.G. GX 8 
(Video Recording from February 3rd Encounter). The vast majority of 
that time was spent discussing L.G.'s family issues and travels. GX 9 
(Transcript of Video Recording from February 3, Encounter). At this 
visit, there was no discussion between L.G. and Respondent regarding 
any medical concerns. RD, at 35; GX 8; GX 9.

[[Page 73795]]

    Although medical concerns were not discussed at the visit, L.G. 
made several statements indicating that he was diverting pills. GX 9.

CS: and--what I did last time--with one of the prescriptions--
knowing I'm not supposed to do that, I flipped it--I took some for 
me . . . took the rest to make some money
. . .
CS: I'm not trying to get in trouble or nothing like this.
Germeil: I know. Sometimes you have to help.
. . .
Germeil: But don't worry--uh. [L.G.]. You are okay.
CS: No, I mean--I'm being honest with you. That's what I've been 
doing. I--I sold a few of them . . . I--kept some for me.
. . .
Germeil: That's okay. Relax. Okay? But try to keep it for yourself. 
Try to keep your medication for yourself, okay?
. . .
CS: I mean, like I said, I took some--I took some for me and then 
the rest--just sold some of them
Germeil: Okay.
CS: Well, the majority of them.
Germeil: The majority of them?
Germeil: Okay. That--that is--Isn't, is that illegal, . . . ?
CS: I don't--I don't believe so. I know that but I'm telling you 
`cause uh
Germeil: You don't know?
CS: You're my doctor!
. . .
Germeil: Be careful, okay?

Id. at 7-8, 11-13.
    Despite L.G. admitting to diversion, Respondent wrote L.G. 
prescriptions for controlled substances during the visit. GX 17 
(Prescriptions Issued to L.G. on February 3). The parties stipulated 
that on February 3, 2017, Respondent prescribed L.G. one hundred and 
twenty dosage units of oxycodone HCL 30 mg. and sixty dosage units of 
alprazolam 2 mg. ALJX 11, at 2; Tr. 9.
    During the encounter, there was no discussion regarding the amount 
of L.G.'s pain. GX 9. L.G. testified that on February 3, 2017, 
Respondent did not conduct a physical exam--in fact, the video evidence 
shows that Respondent sat on one side of an office desk and L.G. sat 
across the desk from her. Tr. 103; GX 8. Respondent also did not 
discuss any medical conditions L.G. had, did not discuss the side 
effects of or adverse reactions to the medications she was prescribing 
to L.G., did not discuss other medications L.G. was taking (other than 
the ones Respondent was prescribing), did not discuss L.G.'s diet or 
exercise. Tr. 103. L.G. testified that the employee at the Clinic who 
took his vitals on February 3, 2017, did not conduct a physical exam, 
ask any question about his medical conditions or ask about his pain. 
Tr. 98.
    The ``Plan'' in L.G.'s records stated that Respondent, among other 
things, explained the side effects of the medication, advised regarding 
adverse reactions, discussed lifestyle modifications to control weight 
and blood pressure, and that a ``[d]etail[ed] explanation was provided 
about and against `shopping' from physician to physicians [sic] and the 
harm (s) [sic] that can provoke.'' RX 2, at 20. According to the 
patient records, ``[a]pproximately 60 min was spent in this 
encounter,'' and L.G.'s pain level was ``9.'' Id.
    Dr. Hoch opined that the two prescriptions issued by Respondent to 
L.G. on February 3, 2017 (namely one hundred and twenty dosage units of 
oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg.) were 
issued outside of the usual course of professional practice and beneath 
the applicable standard of care in the state of Florida. Tr. 248, GX 
17. In support of his opinion, Dr. Hoch explained that the plan does 
not bear any resemblance to the actual visit and discussion between 
Respondent and L.G. Tr. 254. Compare RX 2, at 20, with GX 8 and GX 9. 
Additionally, the plan discusses managing blood pressure, when L.G.'s 
blood pressure does not require monitoring. Tr. 253. Also, Dr. Hoch 
explains that Respondent did not discuss side effects with L.G., fall 
precautions, or the harms that occur from shopping from physician to 
physician, but those conversations are recorded in the plan. Tr. 251-
54. Additionally, Dr. Hoch explains the plan records that the visit 
lasted approximately 60 minutes when the visit did not last an hour. 
Tr. 252-53.
    Dr. Hoch testified that the plan Respondent recorded for L.G.'s 
February 3, 2017 visit was ``very similar to,'' the plan for Y.H.'s 
September 9, 2016 visit which, as discussed above, was riddled with 
problems. Tr. 250. Also compare, RX 1, at 22, with RX 2, at 20.
    Additionally, Dr. Hoch's credible and uncontested opinion was that 
there was nothing documented in the patient file to justify the 
oxycodone or alprazolam prescriptions. Tr. 250. As Dr. Hoch has 
mentioned, this combination of controlled substances is a particular 
concern due to the risk of respiratory depression--and Respondent did 
not discuss those risks with L.G. during this visit as was required. 
Tr. 247. Moreover, Dr. Hoch opined that it was ``a source of tremendous 
concern'' (for L.G.'s safety) that L.G. was prescribed this combination 
of a high-dose opioid and benzodiazepine after Respondent informed the 
physician that he drinks alcohol (and Respondent again did not discuss 
the risks with L.G.). Tr. 255.
    Dr. Hoch, as discussed above, explained that in Florida, ``it is a 
very big responsibility for prescribing physicians to be concerned 
about diversion.'' Tr. 224; see supra II(E). Accordingly, when L.G. 
informed Respondent that he was selling these ``potentially deadly 
medications'' that was ``a huge issue for the community at large.'' Tr. 
256. Dr. Hoch opined that Respondent failed to follow the ``state's 
recommendation of being always cautious about diversion of the 
medications . . .'' and that she should not have written another 
prescription for L.G. following his admission of diversion. Tr. 256-57. 
I find that Respondent did not engage L.G. in any meaningful discussion 
about diversion. RD, at 76; GX 8; GX 9.
    Further, Dr. Hoch testified that Respondent did not conduct a 
periodic review of her treatment of L.G.'s conditions before 
prescribing controlled substances to him and also did not document a 
periodic review in the medical record. Tr. 250.
    In conclusion, I concur with the ALJ and find that, based on Dr. 
Hoch's testimony, the two prescriptions for controlled substances 
issued by Respondent to L.G. on February 3, 2017, were not issued for a 
legitimate medical purpose and were issued outside of the usual course 
of professional practice and beneath the standard of care in the State 
of Florida. RD, at 77; Tr. 248.
2. L.G.'s July 18, 2017 Visit
    On July 18, 2017, L.G. visited Respondent in his capacity as a 
confidential source and pursuant to the instructions given to him by 
his DEA handler. Tr. 96-97. During the visit, L.G. wore a recording 
device that provided both audio and visual recordings of the office 
visit and he activated the device shortly before he went into 
Respondent's office. Tr. 97, 183. As is evident from the records, 
Respondent spent approximately seven minutes with L.G. GX 10 (Video 
Recording from July 18, Encounter). Much of that time was spent 
discussing travel to Cuba. GX 11 (Transcript of Recording from July 18, 
Encounter), at 8-12. At this visit, discussion between L.G. and 
Respondent regarding medical concerns was limited to L.G. stating that 
he had pain ``like last time.'' GX 11, at 6-7; RD, at 40. However, 
there was no further elaboration of L.G.'s pain intensity or even where 
it was located, and Respondent and L.G. did not discuss pain at the 
prior visit. Id. Respondent also pointed out that L.G. did not visit 
Respondent often, in fact, his last

[[Page 73796]]

appointment had been more than four months prior, and that he could 
have an appointment every month. GX 11, at 11. Respondent did not ask 
L.G. how he had managed his pain between appointments without a 
prescription. Id.
    Respondent and L.G. had a more elaborate conversation discussing 
diversion at the July 18, 2017 visit. GX 11. The conversation began 
with Respondent admonishing L.G. for selling his pills. GX 11.

CS: Between you and me, [WHISPERING] remember last time I told you I 
was selling my script.
Germeil: Yes, I know.
CS: I had to sell it to get to Cuba, to help somebody in the family, 
which I did. And that's why I say, ``Thank you!''
Germeil: Yeah, but you cannot sell that. That's a controlled 
medication, uh, . . . . [Y]ou have to keep that for your pain. . . .
Germeil: Don't do that or I can't give you the meditation--
medication.

GX 11, at 2-3, 6. Following the admonition, Respondent stated that she 
was going to ``send [L.G.] to have a drug test done.'' GX 11, at 7. But 
then, Respondent said that she would still give L.G. a prescription 
because she knew that L.G. was in pain and she knew that L.G. was 
joking when he said that he was selling his pills. GX 11, at 8.

Germeil: I know that you have pain so, that's the reason I'm gonna 
give them to you.
CS: Okay, thank you.
Germeil: Yeah, but I shouldn't [U/I]. Never tell a doctor that you, 
you sell your medication. I know you didn't sell them, okay?
CS: Okay.
Germeil: You just wanted to be--to be--[i]t's fashionable now, okay?
CS: Okay.
Germeil: It's fashionable that everybody sells their medications but 
uh . . . I know that you don't do that.
CS: [CHUCKLES] Okay, no
Germeil: Because you joke, right?
CS: Yeah. A joke. Big joke.

Id.
    Respondent wrote L.G. prescriptions for controlled substances 
during the visit. GX 18 (Prescriptions Issued to L.G. on July 18). The 
parties stipulated that on July 18, 2017, Respondent prescribed L.G. 
one hundred and twenty dosage units of oxycodone HCL 30 mg. and sixty 
dosage units of alprazolam 2 mg. ALJX 11, at 2; Tr. 9.
    L.G. testified that on July 18, 2017, Respondent did not conduct a 
physical exam--in fact, the video recording reveals that Respondent sat 
on one side of an office desk and L.G. sat across the desk from her. 
Tr. 108-09, GX 10. Again, L.G. testified that Respondent did not 
discuss any medical conditions L.G. had, did not discuss the side 
effects of or adverse reactions to the medications she was prescribing 
to L.G., did not discuss other medications L.G. was on, did not discuss 
L.G.'s diet or exercise. Tr. 109. L.G. testified that the clinic 
employee who took his vitals on February 3, 2017, did not conduct a 
physical exam, ask any question about his medical conditions or ask 
about his pain. Tr. 107.
    The ``Plan'' in the patient records for L.G.'s July 18, 2017, visit 
was identical to the plan for the February 3, 2017, visit. Compare RX 
2, at 18 with RX 2, at 20. The ``Plan'' again documents that 
Respondent, among other things, explained the side effects of the 
medication, advised regarding adverse reactions, discussed lifestyle 
modifications to control weight and blood pressure, and that a 
``[d]etail[ed] explanation was provided about and against `shopping' 
from physician to physicians [sic] and the harm (s) [sic] that can 
provoke.'' RX 2, at 18. According to the patient records, 
``[a]pproximately 60 min was spent in this encounter,'' and L.G.'s pain 
level was ``9.'' Id.
    Dr. Hoch opined that the two prescriptions issued by Respondent to 
L.G. on July 18, 2017 (namely one hundred and twenty dosage units of 
oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg.) were 
issued outside of the usual course of professional practice and beneath 
the applicable standard of care in the state of Florida. Tr. 259; GX 
18. In support of his opinion, Dr. Hoch noted that there was no 
indication that a physical exam was conducted or that a medical history 
was taken. Tr. 261.
    Dr. Hoch explained that the plan Respondent recorded for L.G.'s 
July 18, 2017 visit was similar to the plan for L.G.'s February 3, 
2017, visit. Tr. 262. Also compare, RX 2, at 18, with RX 2, at 20. 
Accordingly, Dr. Hoch opined that the patient's record does not bear 
any resemblance to the actual visit and discussion between Respondent 
and L.G. Tr. 264. Compare RX 2, at 18, with GX 10 and GX 11. Again, Dr. 
Hoch explained that Respondent did not discuss side effects or adverse 
reactions with L.G., fall precautions or safety measures, or the 
dangers of shopping from physician-to-physician, but those 
conversations are recorded in the plan as if they had happened. Tr. 
263-64.
    Additionally, Dr. Hoch opined that there was nothing documented in 
the patient file to justify the oxycodone or alprazolam prescriptions 
here. Tr. 258-59, 263. As found above, this combination of controlled 
substances, namely ``a very strong opioid with a very strong 
[b]enzodiazepine[,] . . . has to be qualified quite extensively in the 
medical record to justify that both of them are being given at the same 
time.'' Tr. 258-59. Dr. Hoch explained that the justification was not 
present here. Tr. 259.
    Regarding diversion, Dr. Hoch again opined that L.G. ``was 
admitting to [Respondent] that he was diverting medications that were 
given to him, and regardless of that statement, he did, in fact, get 
the prescription[s].'' Tr. 259. Accordingly, I agree with the ALJ's 
finding that Respondent did not engage L.G. in any meaningful 
discussion about diversion. RD, at 79; GX 10; GX 11.
    Further, Dr. Hoch opined that the record for L.G. did not indicate 
that Respondent conducted a periodic review of her treatment of L.G.'s 
conditions. Tr. 262. Dr. Hoch explained that Respondent's Medical 
record for L.G.'s July 18, 2020 visit was not accurate, complete, or 
otherwise sufficient to meet the Florida standard of care. Tr. 262.
    In conclusion, based on the credible and uncontroverted opinion of 
Dr. Hoch, I concur with the ALJ that the two prescriptions for 
controlled substances issued by Respondent to L.G. on February 3, 2017, 
were not issued for a legitimate medical purpose and were outside of 
the usual course of professional practice and beneath the applicable 
standard of care in the State of Florida. RD, at 80; Tr. 259.
3. L.G.'s August 30, 2017 Visit
    On August 30, 2017, L.G. visited Respondent in his capacity as a 
confidential source and pursuant to the instructions given to him by 
his DEA handler. Tr. 96-97, 113. During the visit, L.G. wore a 
recording device that provided both audio and visual recordings of the 
office visit and he activated the device shortly before he went into 
Respondent's office. Tr. 97, 183. As is evident from the records, 
Respondent spent approximately seven minutes with L.G. GX 12 (Video 
Recording from August 30, Encounter); RD, at 45. The vast majority of 
that time was spent on small talk and discussing potential appointments 
for people L.G. knew. GX 13 (Transcript of Recording from August 30, 
Encounter).
    At this visit, there was limited discussion between L.G. and 
Respondent regarding a new medical concern. RD, at 35; GX 12; GX 13.

CS: . . . Can you, really quick, check my knees right here, cause 
it's discomfort--Ouch, you saw, you heard?
Germeil: Let me see, let me see.
CS: It's still in discomfort. . . .

[[Page 73797]]

Germeil: Uh-huh. Yeah, you have arthritis, bones against bones . . . 
. Listen, you have to put [STUTTERS] a, uh, support. . . .
CS: Yeah, cause it's always been in discomfort.
Germeil: Uh-huh. Maybe you had a, a trauma in this knee before? You, 
you hit--did you hit it--somewhere? . . .
CS: I mean, I think so. . . .
Germeil: You have arthritis, the worst arthritis . . . . [Y]ou need 
to put a, a support, and then massage. Buy Bengay

GX 13, at 9-10. In response to the newly identified knee problem, L.G. 
testified that Respondent touched his knee; she ``grabbed [his] knee 
[right on his kneecap] with her two fingers and her thumb, and for like 
no more than three seconds, and she said [he] had arthritis.'' Tr. 143. 
L.G. further testified that Respondent did not conduct ``a thorough 
physical exam.'' Tr. at 115. See also RD, at 81; GX 12.
    In addition to the limited discussion of his knee concern, L.G. 
stated during this appointment that he was no longer selling his pills. 
GX 13, at 4-5. Later in the visit, Respondent seemed to advise L.G. to 
``be careful with the medications.'' GX 13, at 7. L.G. also explained 
to Respondent that the guys he was selling to would like to become 
Respondent's patients and Respondent told him to check with the front 
desk. GX 13, at 4-5.

CS: Anyways--pss--[WHISPERING] I'm not selling no more. I'm taking 
my own stuff.
Germeil: Okay. . . .
CS: . . . I was gonna mention it to you, if I can, the guys that I 
was, whatever they need to see a doctor. I don't know if you want 
new patients or you might need new patients, because they want to 
get the meds. . . . The [o]xycodone or whatever. . . .
Germeil: You can, you can, you can ask [at the front desk] if they 
have any, any, uh--any, any spot . . . [f]or new patients.
CS: Yeah, they guys, okay the guys I was selling to, but they are 
good people, they're reliable people. They won't even miss their 
appointments or nothing. They are good people. . . .

Id.
    Respondent wrote L.G. prescriptions for controlled substances 
during the visit (prior to touching L.G.'s knee). GX 19 (Prescriptions 
Issued to L.G. on August 30); GX 12. The parties stipulated that on 
August 30, 2017, Respondent prescribed L.G. one hundred and twenty 
dosage units of oxycodone HCL 30 mg. and sixty dosage units of 
alprazolam 2 mg. ALJX 11, at 2; Tr. 9.
    Prior to issuing the prescriptions on August 30, 2017, there was no 
discussion of the amount of L.G.'s pain. GX 12. After receiving the 
prescriptions, L.G. mentioned that he had ``discomfort'' in his right 
knee, which Respondent quickly looked at and claimed was the result of 
arthritis. GX 13, at 9; Tr. 115; RD, at 45. L.G. testified that 
Respondent did not conduct a thorough physical exam. Tr. 115. For most 
of the appointment, Respondent sat on one side of an office desk and 
L.G. sat across the desk from her. GX 13; RD, at 81. Respondent also 
did not discuss any medical conditions L.G. had, did not discuss the 
side effects of or adverse reactions to the medications she was 
prescribing to L.G., did not discuss other medications L.G. was on, did 
not discuss L.G.'s diet or exercise. Tr. 115-16. L.G. testified that 
the person who took his vitals on August 30, 2017, did not conduct a 
physical exam, ask any question about his medical conditions or ask 
about his pain. Tr. 113-14.
    The ``Plan'' in Respondent's records on L.G. for the August 30, 
2017, visit, was identical to the plans for L.G.'s July 18, 2017, and 
February 3, 2017, visits; and was nearly identical to the plan sections 
purporting to capture Y.H.'s three visits at issue in the case. Compare 
RX 2, at 16, with RX 2, at 18 and 20, and RX 1, at 19, 20, and 22. Once 
again, the ``Plan'' stated that Respondent, among other things, 
explained the side effects of the medication, advised regarding adverse 
reactions, discussed lifestyle modifications to control weight and 
blood pressure, and that a ``[d]etail[ed] explanation was provided 
about and against `shopping' from physician to physicians [sic] and the 
harm (s) [sic] that can provoke.'' RX 2, at 16. According to the 
patient records, ``[a]pproximately 60 min was spent in this 
encounter,'' and L.G.'s pain level was ``9.'' Id.
    Dr. Hoch opined that the two prescriptions issued by Respondent to 
L.G. on August 30, 2017, (namely one hundred and twenty dosage units of 
oxycodone HCL 30 mg. and sixty dosage units of alprazolam 2 mg.) were 
issued outside of the usual course of professional practice and beneath 
the applicable standard of care in the state of Florida. Tr. 270-71; GX 
19. In support of his opinion, Dr. Hoch explained that the plan differs 
from the actual visit and discussion between Respondent and L.G. Tr. 
267-69. Compare RX 2, at 16, with GX 12 and GX 13. Dr. Hoch explained 
that Respondent did not discuss side effects or adverse reactions with 
L.G., fall precautions, or the harms that occur by shopping from 
physician to physician, but those conversations are recorded in the 
plan. Tr. 268-69. Dr. Hoch explained that the plan Respondent recorded 
for L.G.'s August 30, 2017 visit was ``identical'' to the plan for 
L.G.'s July 18, 2017, and February 3, 2017, visits. Tr. 267-68. Compare 
RX 2, at 16, with RX 2, at 18 and 20.
    Additionally, Dr. Hoch's expert opinion was that the patient file 
was insufficient to justify the oxycodone or alprazolam prescriptions 
here. Tr. 267. He also explained that the record was not complete and 
accurate. Tr. 269. As found above, per Dr. Hoch, this combination of 
controlled substances is a particular concern due to the risk of 
respiratory depression, and Respondent did not discuss those risks with 
L.G. during this visit as was required. Tr. 247, 265-66.
    Regarding diversion, Dr. Hoch pointed out that once again at this 
visit, L.G. informed Respondent that he had been selling his 
medication. Tr. 266. Dr. Hoch noted that Respondent did inform L.G. 
that he needed to be careful with the medications, but opined that the 
statement was not sufficient to warn L.G. of the dangers of diversion. 
Tr. 270.
    Further, Dr. Hoch opined that Respondent did not conduct a periodic 
review of her treatment of L.G.'s conditions before prescribing 
controlled substances to him (let alone document it in the medical 
record). Tr. 269. He also opined that there was no indication in the 
record that Respondent gave a physical exam \28\ or took a full and 
complete medical history. Tr. 269.
---------------------------------------------------------------------------

    \28\ Dr. Hoch testified that merely touching a knee is 
insufficient for a doctor to determine that a patient has arthritis. 
Tr. 330. To adequately conduct a physical examination regarding knee 
pain, a physician would ``have to do flexion extension exercises . . 
. palpate or examine the knee, press it and try to find particular 
locations and then if you['re] very concerned . . . [t]his is where 
x-rays and perhaps MRIs do come into play.'' Tr. 329. Thus, I agree 
with the ALJ's finding that Respondent's touching of L.G.'s right 
knee on August 30, 2017, did not constitute a sufficient physical 
examination. RD, at 81.
---------------------------------------------------------------------------

    In conclusion, and based on the credible and uncontroverted 
testimony of Dr. Hoch, I concur with the ALJ that the two prescriptions 
for controlled substances prescriptions issued by Respondent to L.G. on 
August 30, 2017, were not issued for a legitimate medical purpose and 
were outside the usual course of professional practice and beneath the 
applicable standard of care in the State of Florida. RD, at 83; Tr. 
270-71. In summary, I find that the six controlled substance 
prescriptions Respondent issued to L.G., on February 3, 2017, July 18, 
2017, and August 30, 2017, were issued outside of the usual course of 
professional practice and beneath the applicable standard of care in 
the State of Florida.

[[Page 73798]]

I. Allegation of Recordkeeping Violations and Other State Law 
Violations

    The medical records at issue in this case cover the six different 
encounters \29\ discussed in detail above: Y.H.'s encounters with 
Respondent on September 8, 2016, October 12, 2016, and January 25, 
2017; and L.G.'s encounters with Respondent on February 3, 2017, July 
18, 2017, and August 30, 2017. See OSC; supra II. According to Dr. 
Hoch's credible and uncontroverted testimony, the records Respondent 
maintained for Y.H. and L.G. do not document a complete medical 
history, a physical examination, or a periodic review as required by 
state law. RD, at 50; Tr. 324, 338-39; RX 1; RX 2. Based on Dr. Hoch's 
testimony and the record as a whole, I find that the medical records 
for each of the six encounters are insufficient, inaccurate, and 
incomplete.
---------------------------------------------------------------------------

    \29\ Dr. Hoch explains that the word ``encounter refers to the 
direct encounter for the physician with the patient,'' and does not 
include time the patient spent with a medical assistant. Tr. 303.
---------------------------------------------------------------------------

    Consistent with the findings of the ALJ and based on the 
uncontroverted and credible testimony of Dr. Hoch, I find that the 
``Plan'' sections of the patient records for each of the six encounters 
at issue in this case are identical (with the exception of Y.H.'s 
January 25, 2017, plan which contains one additional line regarding the 
need for a drug test). Compare RX 1, at 19, 20, 22; and RX 2, at 16, 
18, 20; see also Tr. 234, 236, 241, 250, 262, 267-68. All six of the 
patient records document that Respondent, among other things, explained 
the side effects of the medication, advised regarding adverse 
reactions, discussed lifestyle modifications to control weight and 
blood pressure, discussed safety precautions, and that a ``[d]etail[ed] 
explanation was provided about and against `shopping' from physician to 
physicians [sic] and the harm (s) [sic] that can provoke.'' RX 1, at 
19, 20, 22; and RX 2, at 16, 18, 20. In contrast to the patient 
records, I have found that Respondent did not discuss the side effects 
of the medication, adverse reactions, lifestyle modifications to 
control weight and blood pressure, safety precautions, or shopping from 
physician to physician during any of the six encounters at issue. See 
supra and GX 3, GX 5, GX 7, GX 9, GX 11, and GX 13. My finding is 
consistent with Dr. Hoch's testimony that the plan section of the 
patient records does not bear any resemblance to the actual visits and 
discussions between Respondent and the confidential sources. See Tr. 
218, 241-42, 251-54, 263-64, 268-69. I agree with the ALJ's finding 
that ``merely by comparing the recordings made by both Y.H. and L.G. 
when they met with [Respondent] with her treatment notes, it is readily 
obvious that the records [Respondent] prepared do not accurately report 
what happened during those encounters.'' RD, at 91.
    Not only are the plans inaccurate, but even if they were accurate, 
Dr. Hoch opined that none of the plans explain what the objectives are 
that the Respondent was planning to use to determine the success of her 
treatment. Tr. 353. See also 230, 246. This is because, as Dr. Hoch 
characterized it, there was a ``generic rehashing of the same plan 
visit after visit'' and the plans fail to identify what Respondent was 
``doing for [any] particular problem.'' Tr. 235.
    I have found above that the patient records for each of the six 
encounters at issue reflect that ``[a]proximately 60 min was spent in 
[each] encounter.'' RX 1, at 19, 20, 22; and RX 2, at 16, 18, 20. In 
contrast to the patient records, I have found that the lengthiest 
encounter at issue in this matter was only approximately ten minutes, 
and that most of the encounters were around seven to seven-and-a-half 
minutes long. GX 2, GX 4, GX 6, GX 8, GX 10, and GX 12.
    I have found above, based on the record as a whole and Dr. Hoch's 
testimony, that Respondent did not conduct a physical exam during any 
of the six encounters and that none of Respondent's medical records 
reflect that a physical exam was conducted at any of the six encounters 
at issue. GX 2, GX 4, GX 6, GX 8, GX 10, and GX 12; RX 1, at 19, 20, 
22; and RX 2, at 16, 18, 20; Tr. 48-49, 54, 103, 109, 115, 230, 232, 
242, 246, 269, 324, 339. Additionally, I find, consistent with Dr. 
Hoch's testimony, that none of the medical records at issue in this 
matter reflect a complete medical history. Tr. 324. Additionally, I 
find, consistent with Dr. Hoch's testimony, that there was no periodic 
review conducted at any of the six encounters at issue here. Tr. 230, 
242, 246, 250, 262, 269. Therefore, I agree with the ALJ and find 
substantial evidence that Respondent issued a total of twelve 
prescriptions to two different CSs without maintaining sufficient, 
accurate or complete records.
    To summarize my findings above, I agree with the ALJ and find 
substantial evidence that Respondent issued these twelve prescriptions 
for controlled substances outside of the usual course of professional 
practice and beneath the standard of care in the State of Florida in 
violation of federal and state law.

III. Discussion

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

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

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

21 U.S.C. 823(f). These factors are considered in the disjunctive. 
Robert A. Leslie, M.D., 68 F R 15,227, 15,230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't 
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin., 
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 
477, 482 (6th Cir. 2005). Moreover, while I am required to consider 
each of the factors, I ``need not make explicit findings as to each 
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see 
also Hoxie, 419 F.3d at 482. ``In short, . . . the Agency is not 
required to mechanically count up the factors and determine how many 
favor the Government and how many favor the registrant. Rather, it is 
an inquiry which focuses on protecting the public interest; what 
matters is the seriousness of the registrant's misconduct.'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462

[[Page 73799]]

(2009). Accordingly, as the Tenth Circuit has recognized, findings 
under a single factor can support the revocation of a registration. 
MacKay, 664 F.3d at 821.
    Under DEA's regulation, ``[a]t any hearing for the revocation . . . 
of a registration, the . . . [Government] shall have the burden of 
proving that the requirements for such revocation . . . pursuant to . . 
. 21 U.S.C. [Sec.  ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). 
In this matter, while I have considered all of the factors, the 
relevant evidence is confined to Factors One, Two and Four. I find that 
the evidence satisfies the Government's prima facie burden of showing 
that Respondent's continued registration would be ``inconsistent with 
the public interest.'' 21 U.S.C. 824(a)(4). I further find that 
Respondent failed to produce sufficient evidence to rebut the 
Government's prima facie case.
1. Factors One and Three: The Recommendation of the Appropriate State 
Licensing Board or Professional Disciplinary Authority and Respondent's 
Conviction Record Under Federal or State Laws Relating to Controlled 
Substances
    Respondent suggests that Factor One weighs in her favor because the 
parties stipulated and the ALJ found that Respondent holds a valid 
state medical license in Florida. ALJX 28 (Respondent's Posthearing 
Brief), at 11; ALJX 11, at 1; RD, at 59.
    In determining the public interest, the ``recommendation of the 
appropriate State licensing board or professional disciplinary 
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms 
of recommendations appear in Agency decisions: (1) A recommendation to 
DEA directly from a state licensing board or professional disciplinary 
authority (hereinafter, appropriate state entity), which explicitly 
addresses the granting or retention of a DEA COR; and (2) the 
appropriate state entity's action regarding the licensure under its 
jurisdiction on the same matter that is the basis for the DEA OSC. John 
O. Dimowo, M.D., 85 FR 15,800, 15,810 (2020); see also Vincent J. 
Scolaro, D.O., 67 FR 42,060, 42,065 (2002).
    In this case, neither the State Board nor any other state entity 
has made a direct recommendation to the Agency regarding whether the 
Respondent's registration should be suspended or revoked; however, as 
previously discussed, the State Board issued an Order incorporating a 
Settlement Agreement reached following an Administrative Complaint 
filed by the State of Florida Department of Health against Respondent 
based on Respondent's treatment of one patient, M.N., between July 2013 
and August 2015. RX 11, at 19. The Florida allegations regarding 
Respondent's treatment of M.N. are similar \30\ to the facts I found 
above regarding Respondent's treatment of Y.H. and L.G between 2016 and 
2017; however, they clearly do not constitute the same matter as the 
facts alleged in the OSC (they involved an entirely different patient 
during a preceding timeframe). See supra II(F).
---------------------------------------------------------------------------

    \30\ Respondent's Posthearing Brief states: ``In January 2017, a 
complaint was filed against Dr. Germeil before the Florida Board of 
Medicine for allegations similar to the instant case.'' ALJX 28, at 
15. Additionally Respondent's counsel stated in her oral closing 
arguments, ``the allegations, as you'll see, are similar in 
prescribing medication for not a legitimate purpose and for medical 
records.'' Tr. 489-90.
---------------------------------------------------------------------------

    I have much more evidence of misconduct before me than the State 
Board had at the time that it made its decision. Further, the fact that 
the State Board did not choose to revoke Respondent's state medical 
registration carries minimal to no weight under Factor One, because 
there is no evidence that the State Board would have made the same 
decision in the face of the egregious conduct found herein involving 
two further patients, who were openly diverting their prescriptions, 
after the State Board had already disciplined Respondent for similar 
behavior.\31\ Accordingly, the terms of the State Board Order have been 
considered, but I find that they have no impact on the public interest 
inquiry in this case. See John O. Dimowo, M.D., 85 FR at 15,810.
---------------------------------------------------------------------------

    \31\ In Dimowo, the Acting Administrator found that ``[a]lthough 
statutory analysis [of the CSA] may not definitively settle . . . 
[the breadth of the cognizable state `recommendation' referenced in 
Factor One], the most impartial and reasonable course of action is 
to continue to take into consideration all actions indicating a 
recommendation from an appropriate state;'' however, Dimowo also 
limited the ``recommendations'' DEA would consider to the ``actions 
of an appropriate state entity on the same matters, particularly 
where it rendered an opinion regarding the practitioner's medical 
practice in the state due to the same facts alleged in the DEA 
OSC.'' John O. Dimowo, 85 FR at 15,810. Although the same 
``matters'' may include the same types of violations, in this case, 
I have no indication that the Board would have made a similar 
decision in the face of these additional egregious violations and 
continued misconduct. In fact, Respondent specifically agreed in the 
settlement not to commit further violations of law. RX 11, at 12.
---------------------------------------------------------------------------

    As to Factor Three, the parties stipulated that Respondent has 
never been convicted of violating any federal or state law relating to 
the manufacture, distribution, or dispensing of controlled substances. 
ALJX 19; Tr. 11. See also 21 U.S.C. 823(f)(3). However, as Agency cases 
have noted, there are a number of reasons why a person who has engaged 
in criminal misconduct may never have been convicted of an offense 
under this factor, let alone prosecuted for one. Dewey C. MacKay, M.D., 
75 FR 49,956, 49,973 (2010). Agency cases have therefore held that 
``the absence of such a conviction is of considerably less consequence 
in the public interest inquiry'' and is therefore not dispositive. Id.
2. Factors Two and Four--the Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
    Respondent asks that I consider evidence of her positive dispensing 
experience. ALJX 28, at 12. In evaluating Respondent's dispensing 
experience, I note that Respondent has significant experience as a 
licensed physician in Florida since October 2007, and running her own 
medical practice since 2011. RX 5, at 1. Respondent claimed, without 
providing any evidence to support the claim, that she has treated 
``thousands of patients for pain medicine, and there have been no 
reported overdoses or deaths during that period of time.'' \32\ Tr. 19. 
The Agency assumes that all of the prescriptions Respondent issued were 
issued lawfully, except for those prescriptions that the Government 
alleged and established were issued unlawfully. See Wesley Pope, M.D., 
82 FR 14,944, 14,982-84 (2017). Respondent also claimed, and included 
38 unique letters to patients as evidence, that she has discharged 
patients who refused urine testing. RX 8. However, Respondent's 
evidence shows that both Y.H. and L.G. were ordered to take urine drug 
tests, did not take those urine drug tests, and did not receive 
discharge letters (although they were not seen again). RX 1, at 13, 18; 
RX 3; RX 8; Tr. 405-06, 409-10, 413. Furthermore, even without the 
urine drug tests, Respondent knew that Y.H. and L.G. were not taking 
their medication as prescribed because they directly told her that they 
were diverting the controlled substances.
---------------------------------------------------------------------------

    \32\ I decline to consider that ``no reported overdoses or 
deaths'' is an indicator of positive dispensing experience and there 
is no legal authority for the proposition that I must find death or 
an overdose before I may suspend or revoke a registration. Agency 
decisions have found that ``diversion occurs whenever controlled 
substances leave `the closed system of distribution established by 
the CSA . . . .'' Roy S. Schwartz, 79 FR 34,360, 34,363 (2014)).
---------------------------------------------------------------------------

    Respondent's handling of the two confidential sources as found 
herein demonstrates that her prescribing practices fell short of the 
applicable standard of care for twelve

[[Page 73800]]

prescriptions. As I discuss further below, Respondent failed to address 
patient admissions of diversion, failed to conduct physical exams, 
failed to discuss the risks of controlled substances, and falsified 
medical records.
    Factor four is demonstrated by evidence that a registrant has not 
complied with laws related to controlled substances, including 
violations of the CSA, DEA regulations, or other state or local laws 
regulating the prescribing of controlled substances.
(a) Allegation that Respondent Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice
    According to the CSA's implementing regulations, a lawful 
prescription for controlled substances is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). The 
Supreme Court has stated, in the context of the CSA's requirement that 
schedule II controlled substances may be dispensed only by written 
prescription, that ``the prescription requirement . . . ensures 
patients use controlled substances under the supervision of a doctor so 
as to prevent addiction and recreational abuse . . . [and] also bars 
doctors from peddling to patients who crave the drugs for those 
prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    As I have found, in agreement with the RD and based on the credible 
expert testimony of Dr. Hoch, Florida regulations require that a 
doctor: Take a complete medical history and conduct a physical 
examination \33\ before issuing a prescription for a controlled 
substance; develop a written treatment plan; discuss the risks and 
benefits of controlled substances with a patient; and maintain complete 
and accurate records with respect to a patient. RD, at 9; Tr. 205-06, 
338. Additionally, a physician is required to conduct a periodic review 
of the course of treatment provided to a patient. RD, at 50; Tr. 337-
38.
---------------------------------------------------------------------------

    \33\ The Florida Code does not define what constitutes a 
physical exam and does not necessarily require that a physician 
conduct a physical examination of a patient each time the patient 
presents for an appointment. RD, at 50; Tr. 289. However, Dr. Hoch 
opined that the standard of care requires a physician to perform a 
physical examination in certain circumstances including when the 
patient requests a higher dose of controlled substances, presents 
with new symptoms or complaints, has a new diagnosis, or hasn't been 
seen for a period of months. See Tr. 290, 341-42, 345-46.
---------------------------------------------------------------------------

    Based on the credible and uncontroverted testimony of Dr. Hoch, and 
in agreement with the RD, I find that Respondent issued a total of 
twelve prescriptions outside of the usual course of professional 
practice and beneath the applicable standard of care in the State of 
Florida in violation of 21 CFR 1306.04(a). RD, at 92.
i. Failure To Address Patients' Admissions of Diversion
    The Florida Code provides that ``[p]hysicians should be diligent in 
preventing the diversion of drugs for illegitimate purposes.'' Fla. 
Admin. Code r. 64B8-9.013(1)(d) (West 2020). Dr. Hoch explained that 
when a patient tells a doctor that he or she is diverting his or her 
controlled substances that statement ``is a very big red flag that has 
to be addressed at that moment.'' Tr. 224-25; RD, at 51. In fact, Dr. 
Hoch stated that if a patient tells a doctor that he or she is selling 
or giving away controlled substances, ``that's sort of a deal breaker . 
. . .'' Tr. 351. In other words, as I found above the standard of care 
in Florida requires that a physician stop writing prescriptions for a 
patient following statements from the patient that are consistent with 
diversion. See supra, II(E).
    I have found above that each of the CIs admitted to having engaged 
in diversion at each of the six encounters at issue in this matter. 
Y.H. clearly admitted to Respondent that she had been selling at least 
some of her pills to her brother on September 8, 2016, October 12, 
2016, and January 25, 2017. GX 3, at 17, 19; GX 5, 13 12-13; GX 7, at 
4, 6, 9-11. Yet, as I have found, Respondent did not advise Y.H. not to 
sell her controlled substances or otherwise engage in any meaningful 
conversation about diversion with Y.H. See RD, at 68, 71, 73. In fact, 
on October 12, 2016, Respondent clearly acknowledged Y.H.'s admission 
of diversion and seems to have even condoned the conduct. See supra, 
II(G)(2); GX 5, at 12-13. And on January 25, 2017, Respondent replied 
to Y.H.'s admission of selling pills by reassuring Y.H. that she was a 
good person. GX 7, at 9-11. The only counseling Respondent did with 
Y.H. regarding diversion was to warn Y.H. not to tell anyone that 
Respondent was helping her out because Respondent ``d[idn't] want to . 
. . get into trouble.'' Id. at 11.
    L.G. also clearly admitted to Respondent that he had been selling 
at least some of his pills to people on February 3, 2017, July 18, 
2017, and August 30, 2017. GX 9, at 7-8, 11-13; GX 11, at 2-3, 6; GX 
13, at 4-5. Yet, as I have found above, Respondent did not engage in 
any meaningful conversation about diversion with L.G. either. See 
supra, II(H); RD, at 76, 79. Respondent did discuss diversion in 
greater detail with L.G. than she did with Y.H., and Respondent did 
provide warnings to L.G. at each of the three encounters including: 
That he needed to ``try to keep [his medication] for himself,'' GX 9, 
at 12; that ``[he] cannot sell [the scripts because] [t]hat's a 
controlled medication,'' GX 11, at 3; and that he should ``be careful 
with the medications.'' GX 13, at 7. However, Respondent issued 
prescriptions to L.G. immediately following these warnings, which 
renders her comments perfunctory. See RD, at 80.
    Dr. Hoch opined that each of the twelve prescriptions at issue in 
this case were issued without a legitimate medical purpose because 
diversion was not appropriately addressed at any of the six visits in 
this case.\34\ See Tr. 224, 231, 243-44, 256-57, 259, 270. Indeed, the 
confidential sources admitted to having engaged in diversion during 
each of the six visits and the parties have stipulated that 
prescriptions were issued during each of the six visits.
---------------------------------------------------------------------------

    \34\ The ALJ found that diversion was not properly addressed at 
only five of the encounters. We both found that the prescriptions 
issued by Respondent to L.G. were not issued for a legitimate 
medical purpose on August 30. 2017; however, the ALJ found that 
Respondent did not have any obligation during this visit to address 
L.G.'s diversion, because L.G. stated that he was no longer selling 
pills and that the people he was selling pills to wanted to become 
patients. RD, at 81-82. I agree that L.G.'s statements indicate that 
he did not plan to engage in diversion in the future, however L.G. 
did still admit that he had engaged in diversion of Respondent's 
prescriptions in the past. Dr. Hoch seemed to be fully aware that 
L.G. was admitting to past diversion (stating, ``[t]he CS or patient 
informs the doctor that he was selling the medication . . .'' Tr. 
266 (emphasis added), when he opined that Respondent's discussion of 
the dangers of diversion at the August 30, 2017, encounter were 
insufficient and that the prescriptions that followed were not 
issued in the usual course of professional practice. Tr. 270. I see 
no reason to stray from Dr. Hoch's credible and uncontroverted 
opinion. Further, the fact that the former customers of L.G. who 
previously obtained controlled substances unlawfully might visit 
Respondent to obtain controlled substances directly from Respondent 
hardly seems to address the diversion issue.
---------------------------------------------------------------------------

    For all of these reasons, I find that Respondent violated federal 
law and Florida Administrative Code Sec.  64B8-9.013(1)(d) by 
prescribing controlled substances to Y.H. and L.G. in spite of their 
admitting to engaging in diversion immediately prior to the issuance of 
the prescriptions.
ii. Failure To Conduct Physical Examinations
    As I found above based on Dr. Hoch's testimony, the State of 
Florida requires that, when prescribing controlled

[[Page 73801]]

substances for pain, a ``physical examination must be conducted and 
documented in the medical record.'' Fla. Admin. Code r. 64B8-
9.013(3)(a) (West 2020); supra, II(E). According to Dr. Hoch, the 
Florida Code does not define what constitutes an initial physical exam 
and does not necessarily require that a physician conduct a physical 
examination of a patient each time the patient presents for an 
appointment. RD, at 50; Tr. 289. However, Dr. Hoch opined that the 
standard of care requires a physician to perform a follow up physical 
examination in certain circumstances including when the patient 
requests a higher dose of controlled substances, presents with new 
symptoms or complaints, has a new diagnosis, or has not been seen for a 
period of months. See Tr. 290, 341-42, 345-46.
    I found above that Respondent did not conduct a physical exam 
during any of the confidential sources' six visits.\35\ See supra, 
II(I); Tr. 230, 232, 242, 246, 269, 324, 339. Not only did the 
confidential sources credibly testify that no physical examination was 
conducted during their respective encounters, see Tr. 48-49, 54, 59, 
104, 109, 115, but Dr. Hoch's uncontroverted testimony was that there 
was no indication in the record (including the video evidence) that 
Respondent performed a physical exam during the six visits. Tr. 227, 
230, 242, 249, 261, 269, 338-39. I find that Respondent's failure to 
perform a physical exam during any of the six visits in this matter 
violates the standard of care.
---------------------------------------------------------------------------

    \35\ In fact, the ``objective'' section of each and every one of 
the patient records Respondent introduced into evidence was empty. 
See RX 1, and RX 2. Dr. Hoch testified that the ``objective'' 
section is where a doctor should identify her objective findings 
based on a physical examination. RD, at 51; Tr. 212. Based on the 
records and Dr. Hoch's testimony, it is fair to conclude that 
Respondent never conducted a physical exam of either confidential 
source.
---------------------------------------------------------------------------

    The record in the evidence establishes that Respondent never 
performed a physical examination on Y.H.\36\ RD, at 22; Tr. 92. 
Additionally, Dr. Hoch opined that, even if an initial physical 
examination had been performed, Respondent would have been required to 
give a new physical examination to Y.H. on September 8, 2016, to 
justify the 40% increase in oxycodone HCL 30 mg. that Respondent 
prescribed. RD, at 25; Tr. 339-342.
---------------------------------------------------------------------------

    \36\ See supra n.19.
---------------------------------------------------------------------------

    Similarly, there is no indication in the record that Respondent 
ever performed a physical examination of L.G.\37\ RD, at 79; RX 2, at 
16, 18, 20-22. Additionally, Dr. Hoch opined that, even if an initial 
physical examination had been performed, Respondent would have been 
required to give a new physical examination to L.G. on February 3, 
2017, because of the new diagnosis of chronic back pain on that date. 
Tr. 345-46. Per Dr. Hoch a new physical examination would also have 
been required on both February 3, 2017, and July 18, 2017, because it 
had been over five months between Respondent's prescriptions to L.G. 
for controlled substances for pain and the delay in treatment gives 
rise to the question of whether L.G. had such severe pain that he 
needed the controlled substances to relieve his pain. RD, at 37, 43, 
76, 79; Tr. 345-48.
---------------------------------------------------------------------------

    \37\ See supra n.27.
---------------------------------------------------------------------------

    For all these reasons, I find that Respondent violated Florida 
Administrative Code Sec.  64B8-9.013 and issued prescriptions outside 
the usual course of professional practice and beneath the applicable 
standard of care by prescribing controlled substances for pain without 
conducting a physical exam.
iii. Failure To Discuss Risk of Controlled Substances With Patients
    In accordance with Dr. Hoch's opinion, I found above that the State 
of Florida requires that a doctor discuss the risks and benefits of 
controlled substances with a patient. See supra, II(E); RD, at 9; Tr. 
205-06; Fla. Admin. Code r. 64B8-9.013(3)(c) (West 2020). Here 
Respondent prescribed each confidential source both oxycodone 30 mg., 
which Dr. Hoch stated is a very strong dose, and alprazolam 2 mg., 
which Dr. Hoch stated is a very strong dose, during each of the six 
encounters at issue in this case (for a total of twelve prescriptions). 
RX 1, at 16; RX 2, at 14; Tr. 219, 222.
    Dr. Hoch explained that the oxycodone prescription alone can cause 
a number of side effects that Respondent did not discuss with Y.H. Tr. 
220-221. Some of the less disabling side effects of opioid use include 
pruritus or itching, urinary retention, nausea and vomiting, and 
constipation. Tr. 220-221. Dr. Hoch explained that ``the most 
devastating complication or side effect of an opioid [like oxycodone] 
is respiratory depression, and that's what kills people.'' Tr. 221-222. 
Dr. Hoch explained that the risk is particularly high where, as here, 
the opioid is prescribed with a drug like alprazolam. Tr. 222.
    In light of the medications prescribed, Dr. Hoch opined that 
Respondent was required to warn of the risk of side effects including 
respiratory depression and instruct the patient to make sure there was 
at least a three-to-four hour gap between administering the two 
different medications. Id. Based on Dr. Hoch's credible and 
uncontroverted opinion, I find that there was no discussion of the 
risks of using these controlled substances (much less the risk of 
respiratory depression that can occur when using them together) at any 
of the six encounters. Tr. 222, 230, 232, 237-38, 241, 247, 251, 258-
59, 263, and 268.
    Another example of Respondent's failure to discuss the risks of 
using controlled substances occurred when L.G. informed Respondent he 
drinks alcohol. Tr. 255. According to Dr. Hoch, when a physician learns 
that a patient could be drinking while being prescribed a high dose 
opioid and benzodiazepine, the patient ``should be warned very 
strongly'' that the medications and alcohol should not be taken 
together. Tr. 255. According to Dr. Hoch, ``[w]hen [patients] tell you 
that they're drinking, that's a huge issue for their safety.'' Tr. 256. 
Dr. Hoch opined that on February 3, 2017, L.G. informed Respondent that 
he drinks alcohol, Respondent was required to warn L.G. of the risks of 
taking the prescribed controlled substances with alcohol, and 
Respondent failed to issue the required warning. Tr. 255-56.
    For all these reasons, I find that Respondent violated Florida 
Administrative Code Sec.  64B8-9.013 and issued prescriptions outside 
of the usual course of professional practice and beneath the applicable 
standard of care by failing to discuss the risks of using the 
prescribed controlled substances with Y.H. and L.G.
    In light of the above, the ALJ found, and I agree, that Respondent 
issued a total of twelve prescriptions outside of the usual course of 
professional practice and beneath the applicable standard of care in 
the State of Florida. RD, at 92.
iv. Recordkeeping Violations
    Florida Administrative Code, Rule 64B8-9.013 lays out a physician's 
responsibilities when prescribing controlled substances for pain 
management.\38\ See supra, II(E); RD, at 9; Tr. 203-05. With regard to 
medical records, the Florida Administrative Code provides that a 
physician is required to ``keep accurate and complete

[[Page 73802]]

medical records'' to include, but not be limited to:
---------------------------------------------------------------------------

    \38\ Admin. Code r. 64B8-9.013 provides guidelines that are 
authoritative on physicians in Florida; however, ``[t]he Board will 
not take disciplinary action against a physician for failing to 
adhere strictly to the provisions of these standards, if good cause 
is shown for such deviation.'' Fla. Admin. Code r. 64B8-9.013(1)(f) 
(West 2020); see also RD, at 9; Tr. 272, 280-81.

--``The complete medical history and a physical examination, 
including history of drug abuse or dependence as appropriate.'' Fla. 
Admin. Code r. 64B8-9.013(3)(f)(1) (West 2020).
--``Treatment objectives.'' Fla. Admin. Code r. 64B8-9.013(3)(f)(4) 
(West 2020).
--``[D]iscussion of risks and benefits.'' Fla. Admin. Code r. 64B8-
9.013(3)(f)(5) (West 2020).
--``Periodic reviews. Records must remain current, maintained in an 
accessible manner, readily available for review, and must be in full 
compliance with Rule 64B8-9.003 . . . .'' Fla. Admin. Code r. 64B8-
9.013(3)(f)(10) (West 2020).

Fla. Admin. Code r. 64B8-9.013(3)(f) (West 2020) (emphasis added).
    Additionally, a physician's ``medical record shall contain 
sufficient information to identify the patient, support the diagnosis, 
justify the treatment and document the course and results of treatment 
accurately, by including, at a minimum, patient histories; examination 
results; test results; records of drugs prescribed . . . .'' Fla. 
Admin. Code r. 64B8-9.003(3) (West 2020) (emphasis added). Similarly, 
the Florida Statute provides that the ``following acts constitute 
grounds for denial of a license or disciplinary action . . .: Failing 
to keep legible . . . medical records . . . that justify the course of 
treatment of the patient, including, but not limited to, patient 
histories; examination results; test results; records of drugs 
prescribed, dispensed, or administered; and reports of consultations 
and hospitalizations.'' Fla. Stat. Ann. Sec.  458.331(1)(m) (West 
2020).
    Dr. Hoch testified that the ``plan'' portion of Respondent's 
records was where Respondent should have provided ``a justification as 
to why [she] was doing what [she was] doing'' with regards to her 
treatment of a patient. Tr. 212. Dr. Hoch further opined that the 
``plans'' contained in Respondent's medical records concerning L.G. and 
Y.H. are not plans in so far as they did not contain any objective 
standards by which treatment success could be measured. Tr. 335-36, 
353. In light of Dr. Hoch's testimony, I find that the Respondent's 
records were insufficient to meet the requirements set by the State of 
Florida. Dr. Hoch also testified that the plans do not bear any 
resemblance to the recorded corresponding visits they were meant to 
document. Tr. 218. In fact, the ALJ found, and I agree, that merely by 
comparing the recordings made by both Y.H. and L.G. when they met with 
Respondent with the treatment notes, it is readily obvious that the 
records that Respondent prepared do not accurately report what happened 
during these encounters. RD, at 91. I therefore find that Respondent 
did not maintain the records required by the State of Florida. In fact, 
Respondent admitted as much in her Posthearing Brief, stating ``that 
her medical records for Y.H. and L.G. were not complete and accurate.'' 
ALJX 28, at 15. Therefore, I find, consistent with the ALJ and Dr. 
Hoch's testimony, that in failing to keep sufficient and accurate 
records as required by the State of Florida, Respondent violated 
Florida Administrative Code Sec.  64B8-9.013 and 9.003.
    The Government further alleged that Respondent violated the state 
law by ``falsif[ying] numerous patient records in order to conceal 
[her] illegal prescribing.'' OSC, at 2. More specifically, the OSC 
alleged that Respondent falsified her records by documenting that 60 
minutes was spent on each encounter when none of the encounters 
exceeded 15 minutes and by documenting that she discussed side effects, 
adverse reactions, safety precautions and the risks of physician 
shopping, when ``those issues were never discussed.'' OSC, at 9; see 
also RD, at 83.
    To support the allegation that Respondent's recordkeeping was 
fraudulent, the Government points to the Administrative Complaint filed 
against Respondent by the State of Florida. ALJX 27 (Gov Posthearing 
Brief), at 29. The Government states that, regardless of the merits of 
the allegations contained in the Administrative Complaint, it clearly 
put Respondent on notice ``no later than January 2017 that the standard 
of care required her to discontinue prescribing controlled substances 
to patients engaged in diversion and required her to properly maintain 
medical records.'' ALJX 27 (Gov Posthearing), at 30. Despite this 
notice, Respondent continued to issue prescriptions for controlled 
substances to Y.H. and L.G, without maintaining proper records in 
violation of the relevant standard of care and Florida law.
    The ALJ found, and I agree, that not only do Respondent's medical 
records for Y.H. and L.G. fail to contain the minimum information 
required under Florida law, they also clearly report events that did 
not occur during the medical appointments. RD, at 91. DEA has 
recognized that the falsification of medical records creates a ``fair 
inference'' that a prescriber is issuing prescriptions ``outside the 
usual course of professional practice and lacked a legitimate medical 
purpose.'' Syed Jawed Akhtar-Zaidi, M.D., 80 FR 42,962, 42,964 (2015). 
Here, the ALJ found, and I agree, that Respondent falsified the medical 
records of Y.H. and L.G., and that these false entries allow for the 
fair inference that Respondent acted outside of the usual course of 
professional practice and beneath the standard of care in the State of 
Florida in issuing the twelve prescriptions to Y.H. and L.G. RD, at 91-
92.
    For all these reasons, I find that Respondent violated 21 CFR 
1306.04(a), Florida Statute Sec.  458.331(1)(m), and Florida 
Administrative Code Sec. Sec.  64B8-9.013 and 64B8-9.003, by falsifying 
patient records.
    In total, I find that the Government has proven by substantial 
evidence that Respondent issued twelve controlled substance 
prescriptions without a legitimate medical purpose and outside of the 
usual course of professional practice and beneath the applicable 
standard of care in the State of Florida in violation of 21 CFR 
1306.04(a), Florida Statute Sec.  458.331(1)(m), and Florida 
Administrative Code Sec. Sec.  64B8-9.013 and 64B8-9.003. Overall, I 
find that the Government has established a prima facie case that 
Respondent's continued registration is inconsistent with the public 
interest.

B. Summary of Factors Two and Four and Imminent Danger

    As found above, the Government's case establishes by substantial 
evidence that Respondent issued controlled substance prescriptions 
outside the usual course of the professional practice. I, therefore, 
conclude that Respondent engaged in misconduct which supports the 
revocation of her registration. See Wesley Pope, 82 FR 14,944, 14,985 
(2017).
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Respondent has ``fail[ed] . . . to maintain 
effective controls against diversion or otherwise comply with the 
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The 
substantial evidence that Respondent issued controlled substance 
prescriptions outside the usual course of the professional practice 
establishes ``a substantial likelihood of an immediate threat that 
death, serious bodily harm, or abuse of a controlled substance . . . 
[would] occur in the absence of the immediate suspension'' of 
Respondent's registration. Id.; see e.g., Tr. 256 (opinion of the 
Government's expert, Dr. Hoch, that Respondent was prescribing 
``potentially deadly'' medications); Tr. 221-22 (opinion of Dr. Hoch 
that using ``an opioid [can result in] respiratory

[[Page 73803]]

depression, and that's what kills people'').
    Not only was Respondent prescribing a ``potentially deadly'' 
combination of medications to confidential sources without properly 
warning them of the risks associated with taking those controlled 
substances, but, Respondent continued writing the prescriptions after 
the confidential sources admitted to diverting these ``potentially 
deadly'' controlled substances. See supra, III(A)(2)(a)(i) and (iii); 
Tr. 221. According to Dr. Hoch, when a patient diverts medication 
``that's a huge issue for the community at large.'' Tr. 256.
    Thus, as I have found above, at the time the Government issued the 
OSC/ISO, the Government had clear evidence of violations of law based 
on the two confidential sources, who had been unlawfully prescribed 
controlled substances, with no physical exam, with no explanation of 
the risks associated with the potentially deadly combination of 
controlled substances, and after the confidential sources had admitted 
to diverting the prescriptions.

IV. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration is inconsistent with 
the public interest, the burden shifts to the Respondent to show why 
she can be entrusted with a registration. Garrett Howard Smith, M.D., 
83 FR 18,882, 18,910 (2018) (collecting cases). Respondent has made 
little to no effort to establish that she can be trusted with a 
registration.
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 243, 
259 (2006). A clear purpose of this authority is to ``bar[ ] doctors 
from using their prescription-writing powers as a means to engage in 
illicit drug dealing and trafficking.'' Id. at 270.
    In efficiently executing the revocation and suspension authority 
delegated to me under the CSA for the aforementioned purposes, I review 
the evidence and argument Respondent submitted to determine whether or 
not she has presented ``sufficient mitigating evidence to assure the 
Administrator that [she] can be trusted with the responsibility carried 
by such a registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 
23,853 (2007) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 
(1988)). ```Moreover, because ``past performance is the best predictor 
of future performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir. 1995), [the Agency] has repeatedly held that where a registrant 
has committed acts inconsistent with the public interest, the 
registrant must accept responsibility for [the registrant's] actions 
and demonstrate that [registrant] will not engage in future 
misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting 
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72 FR at 
23,853; John H. Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince 
George Daniels, D.D.S., 60 FR 62,884, 62,887 (1995).
    The issue of trust is necessarily a fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the credibility of that acceptance as it relates to 
the probability of repeat violations or behavior and the nature of the 
misconduct that forms the basis for sanction, while also considering 
the Agency's interest in deterring similar acts. See Arvinder Singh, 
M.D., 81 FR 8247, 8248 (2016).
    In evaluating the degree required of a respondent's acceptance of 
responsibility to entrust him with a registration, in Mohammed Asgar, 
M.D., 83 FR 29,569, 29,572 (2018), the Agency looked for ``unequivocal 
acceptance of responsibility when a respondent has committed knowing or 
intentional misconduct.'' Id. (citing Lon F. Alexander, M.D., 82 FR 
49,704, 49,728).
    In this case, Respondent made statements to the confidential 
sources during their encounters that I believe demonstrate that she 
knew it was unlawful to prescribe controlled substances after the 
confidential sources had admitted to diversion. For example, on January 
25, 2017, Y.H. told Respondent how much the prescriptions helped her 
out (in connection with her need to sell pills to make money) and 
Respondent replied, ``Relax! Do not say that to nobody . . . . I don't 
want to . . . get into trouble.'' \39\ GX 7, at 10-11. Additionally, 
the State of Florida Administrative Complaint,\40\ clearly notified 
Respondent that the professional standard of care required that 
Respondent discontinue prescribing scheduled medications upon learning 
that a patient was sharing medications. RX 11, at 19. The ALJ found, 
and I agree, ``it is clear that when [Respondent] issued prescriptions 
to Y.H. and L.G. after they told her they were selling their 
prescriptions, her actions constituted a knowing diversion of oxycodone 
HCL and alprazolam.'' RD, at 100.
---------------------------------------------------------------------------

    \39\ Additional examples include Respondent's statement on July 
8, 2017, that if L.G. sells his medication then Respondent cannot 
give him medication. GX 11, at 3 and 6. And during the same 
appointment Respondent tried to cover herself by stating that she 
knew L.G. was just joking and really did not sell his medication. GX 
11, at 8.
    \40\ Respondent seems to have received the Administrative 
Complaint on or about January 20-23, 2017, but certainly received it 
no later than February 8, 2017, when she signed the Settlement 
Agreement. See RX 11, at 15, 24.
---------------------------------------------------------------------------

    But there is no clear acceptance of responsibility in the record. 
Here, Respondent did not testify on her own behalf, and did not attempt 
to explain why, in spite of her egregious misconduct, she can be 
entrusted with a registration.\41\ Such silence weighs against the 
Respondent's continued registration. Zvi H. Perper, M.D., 77 FR 64,131, 
at 64,142 (citing Medicine Shoppe, 73 FR at 387); see also Samuel S. 
Jackson, 72 FR at 23,853.
---------------------------------------------------------------------------

    \41\ In Zvi H. Perper, the Respondent did not testify in this 
proceeding; therefore, the Agency found, ``he neither took 
responsibility for his misconduct nor provided any assurances that 
he has implemented remedial measures to ensure such conduct is not 
repeated.'' Zvi H. Perper, M.D., 77 FR 64,131, at 64,142.
---------------------------------------------------------------------------

    Respondent argued, that even though she did not testify in this 
case, her actions showed her acceptance of responsibility. ALJX 28, at 
15. Respondent claimed that she updated the practice's procedures and 
equipment, completed continuing education courses, and discharged 
patients who refused to submit to urine drug screening.\42\ Id.; RD, at 
105. ``The degree of acceptance of responsibility that is required does 
not hinge on the respondent uttering ``magic words'' of repentance, but 
rather on whether the respondent has credibly and candidly demonstrated 
that [s]he will not repeat the same behavior and endanger the public in 
a manner that instills confidence in the Administrator.'' Jeffrey 
Stein, M.D., 84 FR 46,968, 49,973 (2019). In this case, Respondent has 
not issued any words of repentance or acceptance of responsibility, 
because she has not testified, nor has she made any admissions of 
fault. As such, I cannot trust that Respondent would not repeat her 
behavior. See MacKay, 664 F.3d at 820 (upholding the Agency's finding 
that a respondent's failure to testify warranted an adverse inference,

[[Page 73804]]

because there was ``no evidence that [respondent] recognized the extent 
of his misconduct and was prepared to remedy his prescribing 
practices''); see also T.J. McNichol, M.D., 77 FR 57,133 (2012) 
(stating that ``it is appropriate to draw an adverse inference from 
Respondent's failure to testify.'').
---------------------------------------------------------------------------

    \42\ The continuing education courses were required by 
Respondent's Settlement Agreement and the remaining actions appear 
to have been related to the Settlement Agreement's requirement to 
engage a risk manager to conduct a quality assurance consultation or 
risk management assessment. See RX 11, at 10-12; Tr. at 385-386.
---------------------------------------------------------------------------

    Indeed, the facts on the record irrefutably demonstrate that 
Respondent cannot be entrusted to amend her behavior. The State of 
Florida Administrative Complaint, dated January 20, 2017, notified 
Respondent that she should discontinue prescribing after learning that 
a patient is diverting. RX 11, at 19. Days later, on January 25, 2017, 
Respondent prescribed to Y.H. following an admission of diversion. See 
supra II(G)(3). On or about February 8, 2017, Respondent signed a 
Settlement Agreement (which became a Final Order on April 21, 2017), 
wherein Respondent agreed to not violate Chapters 456, 458 or 893 of 
the Florida Statutes or any other state or federal law relating to the 
practice of medicine. RX 11, at 15. Yet, on both July 18, 2017, and on 
August 30, 2017, Respondent violated those laws when she again issued 
prescriptions (this time to L.G.) following an admission of diversion. 
See supra II(H)(2) and (3).
    The Agency also looks to the egregiousness and extent of the 
misconduct which are significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR at 18,910 (collecting 
cases). In this case, I agree with the ALJ that Respondent's actions 
can be characterized as ``particularly egregious.'' RD, at 100. On six 
separate occasions over an eleven-month period, Respondent issued 
twelve prescriptions to confidential sources without having conducted a 
physical exam or warning of the potential risks in violation of state 
law. Supra III(A)(2)(a); RD, at 104. Furthermore, Respondent issued 
prescriptions to the confidential sources immediately after those 
confidential sources admitted to diverting the medication. Supra 
III(A)(2)(a)(i); Tr. 221. As a separate matter, the medical records 
that Respondent maintained on the confidential sources not only 
contained false information, but they did not document any physical 
examinations, medical history, or periodic reviews. See supra II(I). I 
agree with the ALJ's finding ``that [Respondent's] misconduct of 
diversion and falsifying records to cover it up, as proven in the 
Administrative Record, is egregious and supports the revocation of her 
registration.'' RD, at 104.
    In sanction determinations, the Agency has historically considered 
its interest in deterring similar acts, both with respect to the 
respondent in a particular case and the community of registrants. See 
Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR at 8248. 
I agree with the ALJ who found ``that considerations of both specific 
and general deterrence weigh in favor of revocation in this case.'' RD, 
at 105. There is simply no evidence that Respondent's egregious 
behavior is not likely to recur in the future such that I can entrust 
her with a CSA registration; in other words, the factors weigh in favor 
of revocation as a sanction.
    I will therefore order that Respondent's registration be revoked 
and that any pending applications be denied as contained in the Order 
below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FG0560765 issued to Jeanne E. Germeil, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of Jeanne E. Germeil, M.D. to renew or 
modify this registration, as well as any other pending application of 
Jeanne E. Germeil, M.D. for registration in Florida. This Order is 
effective December 21, 2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-25528 Filed 11-18-20; 8:45 am]
BILLING CODE 4410-09-P