[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:
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\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.
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\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.
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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.
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\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.'').
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\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