[Federal Register Volume 86, Number 85 (Wednesday, May 5, 2021)]
[Notices]
[Pages 23998-24012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09463]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-32]
Melanie Baker, N.P.; Decision and Order
On June 21, 2019, a former Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause and Immediate Suspension of
Registration (hereinafter collectively, OSC) to Melanie Baker, N.P.
(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. MV3148257 (hereinafter, registration) 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 registration and denial of any
pending applications for renewal or modification 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
The OSC alleged that ``[f]rom at least February 2017 to May 2019,
[Respondent] issued numerous prescriptions for Schedule IIN through
Schedule IV controlled substances to five patients in violation of
federal and state law.'' OSC, at 3. The OSC alleged violations of 21
CFR 1306.04(a), Louisiana Statute Annotated Sec. 40:978, and Louisiana
Administrative Code tit. 46, Pt. LIII, Sec. 2745(B)(1), and Pt. XLVII,
[[Page 23999]]
Sec. 4513(D). Id. at 2. The OSC stated that the prescriptions
Respondent issued to the five patients in this case ``were issued
outside the usual course of professional practice and not for a
legitimate medical purpose.'' Id. at 3. The OSC included the expert's
opinion that Respondent ``regularly prescribed highly addictive and
intoxicating combinations of controlled substances to [her] patients.''
Id. The OSC also alleged that Respondent ``consistently failed to: (1)
Perform adequate psychiatric and cognitive evaluations; (2) make
appropriate diagnoses based on sufficient clinical evidence, and
document [those] diagnoses in [her] medical records; (3) document a
legitimate medical purpose for the controlled substances that
[Respondent] prescribed; (4) monitor [her] patients' medication
compliance; and (5) respond to red flags of drug abuse and diversion.''
Id. The OSC then went on to outline specific allegations of
deficiencies for each of the five patients at issue in this case. Id.
at 3-10.
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
11 (citing 21 CFR 1301.43).
By letter dated July 22, 2019, Respondent timely requested a
hearing and proceeded pro se.\1\ ALJX 2 (Request for Hearing), at 1;
Tr. 11. The matter was placed on the docket of the Office of
Administrative Law Judges and was assigned to Administrative Law Judge
Mark M. Dowd (hereinafter, ALJ). On July 23, 2019, the ALJ established
a schedule for the filing of prehearing statements. ALJX 3 (Order for
Prehearing Statements), at 1-2. The Government filed its prehearing
statement on July 30, 2019. ALJX 4 (Government's Prehearing Statement),
at 1. Respondent filed her Prehearing Statement on August 6, 2019. See
ALJX 5 (Respondent's Prehearing Statement), at 1. On August 8, 2019,
the ALJ issued a Prehearing Ruling that, among other things, set out
twenty-five agreed upon stipulations and established schedules for the
filing of additional prehearing documents and for the hearing. ALJX 6
(Prehearing Ruling). Respondent filed a supplemental prehearing
statement on August 13, 2019. ALJX 7 (Respondent's Supplemental
Prehearing).
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\1\ I find that the Government's service of the OSC was
adequate.
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The hearing in this matter took place in New Orleans, Louisiana,
and spanned two days. See generally Transcript of Proceedings in the
Matter of Melanie Baker, N.P. (hereinafter, Tr.). Both parties filed
posthearing briefs. See Government's Proposed Findings of Fact and
Conclusions of Law (hereinafter, Govt Posthearing), and Respondent's
Posthearing Brief (hereinafter, Resp Posthearing). On November 8, 2019,
the ALJ issued his Recommended Rulings, Findings of Fact, Conclusions
of Law and Decision (hereinafter, RD). According to the ALJ, neither
party filed exceptions to the RD and the deadline for doing so has
passed. See Transmittal Letter from the ALJ, dated December 4, 2019. I
have reviewed and agree with the procedural rulings of the ALJ during
the administration of the hearing.\2\
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\2\ My agreement includes the ALJ's decision to proceed with the
scheduled hearing when Respondent's identified witnesses were
unavailable. RD, at 14-15. Respondent identified additional
witnesses in her Prehearing Statement, but they were not present to
testify at the hearing. RD, at 14; Tr. 11-14. Respondent said she
was ``prepared to proceed'' to the hearing without the witnesses
because one of the witnesses could not ``speak to the reasons
[Respondent] made clinical decisions,'' and Respondent was ``unable
to reach'' the other witnesses. Tr. 13. I agree with the ALJ's
decision to proceed with the hearing. See RD, at 14; Tr. 13-15.
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Having considered the record in its entirety, I find that
Respondent issued controlled substance prescriptions to five
individuals beneath the applicable standard of care and outside of the
usual course of the professional practice in Louisiana in violation of
federal law, and I find that Respondent committed violations of state
law. I agree with the ALJ that revocation is the appropriate sanction.
RD, at 120. I make the following findings of fact.
II. Findings of Fact
A. DEA Registration
The parties stipulated that Respondent is registered with DEA as a
practitioner able to handle controlled substances in schedules IIN
through V under DEA Certificate of Registration No. MV3148257, at 4480
General DeGaulle Drive, Suite 107, Executive Square, New Orleans,
Louisiana 70131. RD, at 44; ALJX 6, Appendix A, at 1; and ALJX 4,
Attachment A (Controlled Substance Registration Certificate). This
registration expired on July 31, 2020.\3\ See ALJX 4, Attachment A.
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\3\ The fact that a respondent allows her 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. Government's Case
The Government's documentary evidence consisted primarily of
patient files and prescription records for five individuals prescribed
controlled substances by Respondent between February 2017 and May 2019.
See Government Exhibits (hereinafter, GX) 1-10. The Government's
evidence also contained a copy of the Louisiana Prescription Drug
Monitoring Results for Respondent from May 23, 2017, to May 23, 2019.
See GX 11 (Louisiana Prescription Drug Monitoring Results). Finally,
the Government included the Curriculum Vitae for its expert witness Dr.
Chambers. See GX 12 (Curriculum Vitae of Dr. Chambers). The Government
called two witnesses to testify at the hearing: A DEA Diversion
Investigator (hereinafter, DI) and the Government's expert Dr.
Chambers.
DI testified regarding her professional background and training,
Tr. 27-28, and about her investigation-related actions in this
matter.\4\ Tr. 28-48; RD, at 17-18. She testified that in June 2018,
DEA discovered questionable prescriptions issued by Respondent while
investigating two pharmacies located in New Orleans. Tr. 28. DEA
identified several ``red flags'' in the prescriptions issued by
Respondent, including ``patients that were living at the same address,
patients that were coming from long distances, patients that were being
prescribed high strengths of amphetamines and other dangerous
combinations.'' Id. In July 2018, DI queried the Louisiana Prescription
Monitoring Program for Respondent's prescriptions and discovered the
same red flags. Id. at 29. DI also testified that she received
statistics from the Louisiana Board of Pharmacy indicating that
Respondent was the number one prescriber of controlled substance dosage
units among mid-level practitioners in the state.\5\ Id. at 29-30.
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\4\ DI's testimony explained that that Respondent used to go by
the name Melanie Varnado. Tr. 37. I find that Melanie Baker and
Melanie Varnado are used interchangeably in the record to describe
the same person.
\5\ DI defined a ``mid-level practitioner'' as ``nurse
practitioners, physician assistants, [prescribers] that are not
actual medical doctors.'' Id.
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DI further testified that DEA visited pharmacies where
prescriptions issued by Respondent were filled to obtain copies of the
prescriptions. Id. at 32. DEA also served an administrative subpoena
for thirty of Respondent's patient files, which were received in August
2018. Id. at 30-31. Finally, DI testified that DEA sent eleven of the
patient files to an expert witness, Dr. Andrew Chambers, to review. Id.
at 31, 73-74. Having read and analyzed all of the record evidence, I
agree with the ALJ that DI's testimony was ``credible and should be
afforded considerable weight.'' RD, at 77.
[[Page 24000]]
Dr. Chambers testified regarding his professional and educational
background. Tr. 49-60; RD, at 56-57, 79-80. Dr. Chambers testified that
he was a licensed physician and he was a board-certified addiction
psychiatrist. GX 12, at 8; Tr. 49-50; RD, at 56. He testified that he
maintained a clinical practice, which he had operated since the year
2000, and that approximately 50% of his work was clinical. Tr. 52; RD,
at 56, 80. He further testified that he was a teacher, and from his
resume it appears that he teaches at various institutions including as
a tenured Associate Professor of Psychiatry and director of the
addiction psychiatry specialty at the Indiana University School of
Medicine. Tr. 53-54; GX 12, at 1; RD, at 56. Dr. Chambers testified
that he has had the opportunity to teach nurses and to supervise nurse
practitioners including providing oversight of their prescribing
decisions. Tr. 53-54; RD, at 56. I agree with the ALJ's finding that
``Dr. Chambers possesse[d] an impressive amount of study, experience,
and expertise in th[e] relatively narrow field of addiction
psychiatry.'' RD, at 82.
Although Dr. Chambers is licensed in Indiana, he testified that he
was familiar with the standard of care for prescribing controlled
substances in Louisiana and had reviewed relevant sections of the
Louisiana code. Tr. 60; RD, at 80. I agree with the ALJ that Dr.
Chambers ``demonstrated a formidable knowledge relating to the
Louisiana standard of care involving the prescribing of controlled
substances, and the requisite professional practices.'' RD, at 82.
Ultimately, Dr. Chambers ``was offered and qualified as an expert in
the field of addiction psychiatry and on the standard of care for
prescribing controlled substances for psychiatric care in Louisiana.''
Id. at 79-80. I find that Dr. Chambers was properly qualified as an
expert witness.\6\
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\6\ Dr. Chambers has previously been qualified as an expert in
DEA proceedings and his testimony was found credible. See, e.g.,
Bernard Wilberforce Shelton, M.D., 83 FR 14,028, 14,036 (2018); Lon
F. Alexander, 82 FR 49,704 (2017).
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The ALJ conducted a thorough assessment of Dr. Chambers'
credibility, with which I agree. Id. at 79-82. I further agree with the
ALJ's finding that ``Dr. Chambers provided consistent, reliable and
fully developed testimony in this matter.'' Id. at 82. I additionally
note that Respondent presented no expert testimony that conflicted with
Dr. Chamber's opinions. Id.; see also, infra n.7.
C. Respondent's Case
The Respondent's documentary evidence consisted of Respondent's
Curriculum Vitae, Initial Psychiatric Evaluation and Medication
Management forms implemented in Respondent's practice, starting in
October 2018, following a quality review from an insurance company, and
the practice's discharge policy. Respondent's Exhibits (hereinafter,
RX), 1-4; Tr. 325-29. Respondent also provided eight scholarly articles
in defense of her treatment practices.\7\ RX 5; RD, at 81. Respondent's
testimony on her own behalf was limited to offering and authenticating
her five exhibits.\8\ Tr. 324-30. The ALJ found, and I agree, that
Respondent's limited testimony was ``internally consistent and
consistent with the remaining record.'' RD, at 77. Respondent's
testimony on this limited scope was also uncontested. Id.
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\7\ The ALJ found, and I agree, that ``Dr. Chambers thoroughly
and credibly discounted the articles' prominence, repute, and
application to the issues before us.'' RD, at 81; see also Tr. 280-
307. Ultimately the ALJ concluded, and I agree, that ``the articles
provided no defense to the Respondent's charged practices'' and that
``Dr. Chambers' live testimony and opinions greatly outweigh the
journal articles submitted by the Respondent.'' RD, at 81 and n.21.
\8\ See supra n.2.
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Despite being instructed during the hearing that she could not
present her case for the first time in closing, Respondent attempted to
introduce a number of evidentiary ``facts'' in her posthearing brief
\9\ that she presumably believed to be mitigating or to explain the
rationale behind her prescribing. RD, at 77; Tr. 341; Resp Posthearing.
Some of these ``facts'' had little-to-no relevance to this case,\10\
and other ``facts'' were blanket statements that Respondent's actions
were correct and/or were supported by scientific evidence. Resp
Posthearing, at 5-8. None of these supposed ``facts'' were given under
oath and none were subject to cross-examination; therefore, I agree
with the ALJ that they were ``not part of the evidentiary record.'' RD,
at 77. Even if Respondent's ``facts'' had been appropriately submitted
through testimonial evidence, they would likely not have outweighed the
credible testimony of the Government's expert.\11\ Moreover, many of
these ``facts'' could not be given significant weight because they were
not documented in the patient files, as the Government's expert
credibly testified was required to satisfy the standard of care. See
infra II.E.
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\9\ Many of these same ``facts'' were also referenced in
Respondent's opening statement, prehearing brief, and/or cross-
examination questions. See RD, at 77; ALJX 5; ALJX 7; Tr. 20-24,
243-79.
\10\ For example, Respondent included statements that all of the
prescription medications at issue were approved by insurance
providers. See, e.g., Tr. 24.
\11\ Respondent attempted to challenge Dr. Chamber's expertise
by providing examples of what she believes reflects Dr. Chambers'
unfamiliarity with the manner in which prescriptions must be written
in Louisiana. Resp Posthearing, at 3 (arguing that Dr. Chambers
``was unfamiliar with the state board of pharmacy requirement to
write certain prescriptions a certain way''). The standard of care
violations alleged in this case are related to Respondent's issuance
of prescriptions without a legitimate medical purpose; the manner in
which the prescriptions were written is not at issue in this case.
Infra II.E.
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D. Respondent's Practice
As there was no substantive testimony from Respondent or anyone
affiliated with Respondent's practice, R.V. Psychiatric Services,
L.L.C., it was difficult to determine the structure of the practice
from the evidence at hand. It is clear, however, that all of the
medical records prior to the year 2013 appear to be created by R.V.\12\
Beginning in 2013 for K.W., 2014 for M.G., 2015 for F.P., and 2016 for
M.H.,\13\ both R.V. and Respondent appear to be seeing and/or
prescribing for the individuals identified in this case. See GX 3; GX
5; GX 7; GX 9; Tr. 116. At all times relevant to this case, namely
February 2017 to May 2019, Respondent appears to be the only provider
from R.V. Psychiatric Services, L.L.C., prescribing controlled
substances to the five individuals identified in this case.\14\
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\12\ In making this decision, I am not attributing to Respondent
any actions or inactions of R.V. Respondent was judged herein solely
on her actions or inactions during the period of time at issue in
this case. Where I have discussed actions or inactions by R.V. or by
Respondent outside of the period of time at issue in this case, it
is only to provide context to understand the allegations against
Respondent. See also RD, at 92 n. 24.
\13\ F.A. does not appear to have been seen by R.V. since she
began treatment at the practice in 2017. GX 1.
\14\ There are some notations in the medical records during the
time period at issue in this case that do not appear to be written
by either Respondent or R.V.; however, the Respondent ultimately
signs and therefor adopts those notations as her own. See supra
II.E.; Tr. 225-27.
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E. The Standard of Care in the State of Louisiana
In accordance with Dr. Chambers' credible and uncontroverted
testimony and the record as a whole, I find that the standard of care
for prescribing controlled substances in Louisiana requires the
following: (1) An appropriate assessment and evaluation to make a
diagnosis; (2) sound rationale for prescribing controlled substances
related to that diagnosis; (3) ongoing monitoring to ensure that the
desired outcome is achieved and undesirable side effects are not
experienced; and (4) appropriate documentation. Tr. 69-70,
[[Page 24001]]
72; RD, at 57-58. Throughout his testimony, Dr. Chambers expanded on
the standard of care, explaining in detail what a prescriber must do to
satisfy each of these four requirements.
First, Dr. Chambers explained what a prescriber must do to satisfy
the standard of care's requirement that there be an appropriate
assessment and evaluation to make a diagnosis. To satisfy this
requirement, a prescriber should conduct ``a clinical interview that
would cover psychiatric history, addiction history, social history, and
demographics, in order to develop a hypothesis as to the correct
diagnosis.'' Tr. 71. To make a psychiatric diagnosis, ``the standard of
care is that the physician would evaluate for signs and symptoms that
are consistent with that diagnosis and actually write them in the
chart.'' Id. at 213. Further, ``[i]t is actually not sufficient to
simply state the diagnosis and not have evidence to support that
diagnosis.'' Id. Dr. Chambers explained that a prescriber should also
do objective measures testing because ``the nature of addictive disease
is such that the self-report is often not as reliable as you might find
in other areas of health care. . . .'' Id. at 71. Dr. Chambers
testified that urine drug screening and evaluation of the prescription
drug monitoring program database are two ways to conduct an objective
assessment. Id. at 71-72
Dr. Chambers also explained that a provider must conduct an
appropriate assessment or evaluation to inform the diagnosis even when
that provider is sharing in care or taking over care of a patient from
a prior prescriber. Id. at 116-17. ``There is a responsibility of the
second practitioner to look at the information from the prior
prescriber, but to also come to their own conclusion and build a
treatment plan that would incorporate [the prior] information but also
incorporate their own examination, . . . you owe it to the patient to
double-check the prior prescriber.'' Id. at 117. If a new provider
``[does not] make any changes'' and'' continues to do exactly what [the
previous provider] did,'' then the new provider ``own[s] that person's
decision.'' Id. at 224-25.
Dr. Chambers' opinion that the standard of care in Louisiana
requires an appropriate assessment and evaluation to make a diagnosis
is reflected in Louisiana law. La. Admin. Code tit. 46, Pt. XLVII,
Sec. 4513(D)(2)(b)(xi) (2019) \15\ states that ``no APRN[\16\] shall
prescribe any controlled substance or other drug having addiction-
forming or addiction sustaining liability without a good faith prior
examination. . . .''
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\15\ This citation is to La. Admin. Code tit. 46, Pt. XLVII,
Sec. 4513 effective February 20, 2018, through September 19, 2019.
There is no substantive changes to the portions of Sec. 4513 that
are relevant to this case between the prior version of this law,
effective April 2016 to February 19, 2018, and the cited version of
the law.
\16\ APRN stands for Advance Practice Registered Nurse which
means, amongst other things, that the nurse has ``acquired advanced
clinical knowledge and skills [to prepare her] to provide direct
care to patients'' including the ``assessment, diagnosis, and
management of patient problems, which includes the use and
prescription of pharmacologic and non-pharmacologic interventions.''
La. Admin. Code tit. 46, Pt. XLVII, Sec. 4505 (2018) (amended on
February 20, 2018, with no substantive changes to the cited text).
Respondent is an APRN. RX 1 (Respondent's Curriculum Vitae), at 1.
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Second, Dr. Chambers explained what constitutes sound rationale for
prescribing controlled substances related to a specific diagnosis.
Throughout his testimony, he described sound rationale as having a
``clear, strong basis.'' Tr. 194. He explained that the standard of
care required that new controlled substance prescriptions be justified
in the medical records. Id. at 193. He also explained that ``clinical
decision-making about controlled substances especially is a multi-
variable decision'' that has to be made within the ``whole context'' of
an individual patient. Id. at 111.
Dr. Chambers' opinion that the standard of care in Louisiana
requires sound rationale for prescribing controlled substances is
further supported by Louisiana law. La. Admin. Code tit. 46, Pt. XLVII,
Sec. 4513(D)(2)(b)(xi) states that ``no APRN shall prescribe any
controlled substance or other drug having addiction-forming or
addiction sustaining liability without a good faith . . . medical
indication.''
Third, Dr. Chambers explained what ongoing monitoring the standard
of care required to ensure that the desired outcome of treatment is
achieved and that negative side effects are avoided. With regard to
monitoring, Dr. Chambers explained that an initial evaluation is
comprehensive, and that at each subsequent visit a physician should
``continuously [gather] new data to, A, confirm [you are] not running
into trouble with your [prescribed medications], but B, are they
working, or can you get rid of them, because maybe [the patient got]
better.'' Tr. 118. One ``side effect'' Dr. Chambers opined that
practitioners should look for is diversion. Id. at 246, 272-73. Dr.
Chambers testified that he considers ``the potential for diversion'' to
be an ``unfortunate side effect,'' and that diversion is ``more common
if [a practitioner is] not also monitoring [the patient] or dosing them
correctly.'' \17\ Id. at 246. By ``monitoring,'' Dr. Chambers ``mean[s]
urine drug screens, [and/or] prescription drug monitoring program
database inquir[ies].'' Id. at 317. Dr. Chambers also explained that
addiction is a negative side effect that a prescriber should monitor
for signs of.\18\ Id. at 70, 115, 137. Dr. Chambers opined that ``[a]ny
time you make a diagnosis, or if you have sufficient evidence that a
person has addiction, it [is] absolutely a standard of care to drug-
test them . . . [r]andomly and frequently.'' Id. at 137. According to
Dr. Chambers, a prescriber ``cannot rely on a patient with mental
illness and addiction [to] self-report . . . [i]t needs confirmation
with drug-testing.'' Id. at 149. Appropriate monitoring also requires
investigation and documentation of issues that arise, such as reasons
for a missed appointment, potential withdrawal if the patient was
without medication, and reports of hospitalization. Id. at 275, 279.
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\17\ Dr. Chambers further testified that with regard to
diversion of controlled substances, a practitioner has ``to really
make sure [the dosage is] not too high.'' Tr. 317.
\18\ Dr. Chambers explained that monitoring is especially
important in a psychiatric practice because people with several
varieties of mental illness present in this case have a higher rate
of becoming addicted including addiction to prescribed controlled
substances. Tr. 70, 77-78. Dr. Chambers explained ``that the
circuits in the brain that are impacted by the mental illness cause
the individual to have a much more rapid acceleration into the
disease process of drug addiction, because the circuits in the brain
where mental illness happens and addiction happens are
interlinked.'' Id. at 78.
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Fourth, Dr. Chambers explained what appropriate documentation was
required to be in compliance with the standard of care. He explained
that the record must document a comprehensive evaluation including a
mental status or psychiatric exam, and the history including the
psychiatric history, substance abuse history, and social history. Id.
at 72. Appropriate documentation requires the practitioner to ``[build]
a narrative that describes real people and events,'' including what the
patient is doing that causes concern, in order to establish ``that
there really is a cognitive problem.'' Id. at 257. The record must also
document objective measures testing, such as urine drug screening or
inquiries of the prescription drug monitor database. Id. at 72, 257.
Moreover, for documentation to be appropriate, anyone who sees a
patient must sign their notes in the medical record. Id. at 201-02,
225. A practitioner signing a note written by another practitioner
``owns it'' despite the ambiguity over ``who actually made [the]
decision[s].'' Id. at 227.
[[Page 24002]]
Dr. Chambers also explained that the standard of care requires that
a prescriber act on data obtained from urine drug screening or the
prescription drug monitoring program: ``you [cannot] just gather that
and put it in the chart.'' Id. at 73.
Dr. Chambers' opinion that the standard of care in Louisiana
requires appropriate documentation is additionally supported by
Louisiana law. La. Admin. Code tit. 46, Pt. XLVII, Sec. 4513(D)(4)
(2019) states that ``[a]n APRN who prescribed a controlled substance
shall maintain a complete record of the examination, evaluation and
treatment of the patient which must include documentation of the
diagnosis and reason for prescribing controlled substances.'' \19\
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\19\ The law further clarifies, ``[t]he name, dose, strength,
quantity of the controlled substance and the date that the
controlled substance was prescribed must also be documented in the
record.'' Id.
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F. Patients
1. Facts Relevant to All Patients
During his testimony, Dr. Chambers outlined some of the dangers of
prescribing various classes of controlled substances \20\ both
singularly and collectively. With regard to stimulants or uppers, Dr.
Chambers explained that they are addictive, are susceptible to
diversion, and one form of stimulants, amphetamine, can be readily
converted to methamphetamines in a home lab. Id. at 78-80.
Additionally, Dr. Chambers noted that recently in the United States
there was an increase in prescribing amphetamines to adults and an
increase in overdoses caused by stimulants. Id. at 81. Prescribing
amphetamines to adults to treat ADD, as Dr. Chambers explained, is
``controversial and problematic.'' Id. at 81. According to Dr.
Chambers, ``[m]ost cases of legitimate ADD and ADHD are diagnosed
between [the] age of six and 13, kind of school-aged children. When you
get outside of that age zone, you have to worry about a . . .
differential diagnosis, where there could be a whole lot of other
things going on, and actually [they are] not ADD.'' Id. at 88-89.
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\20\ I find the following facts related to the controlled
substances at issue in this case. (1) The parties stipulated that
amphetamine is a Schedule II controlled substance, and that Adderall
is a brand name drug containing amphetamine salts. ALJX 7, at 13.
According to Dr. Chambers, amphetamines are stimulants, and
stimulants are sometimes referred to as uppers. Tr. 81, 132, 264.
(2) The parties stipulated that lisdexamfetamine is a Schedule II
controlled substance, and that Vyvanse is a brand name drug
containing lisdexamfetamine. ALJX 7, at 13. According to Dr.
Chambers, lisdexamfetamine is a stimulant that is ``very similar''
to and ``essentially has the same effects'' as Adderall. Tr. 186.
(3) The parties stipulated that codeine is a Schedule III controlled
substance. According to Dr. Chambers, codeine is an opiate and can
be found in acetaminophen with codeine. Id. at 205. (4) The parties
stipulated that alprazolam is a Schedule IV controlled substance.
ALJX 7, at 13. According to Dr. Chambers, alprazolam is a short-
acting benzodiazepine and it is marketed under the brand name Xanax.
Tr. 151; see also GX 8, at 7-8. According to Dr. Chambers,
benzodiazepines, or ``benzos'' for short, are sedatives and are
sometimes referred to as downers. Tr. 206, 264. (5) The parties
stipulated that clonazepam is a Schedule IV controlled substance.
ALJX 7, at 13. According to Dr. Chambers, clonazepam is a
benzodiazepine. Tr. 205. Klonopin is a brand name drug containing
clonazepam. Compare GX 9, at 23-24 with GX 9, at 5; GX 10, at 3. (6)
The parties stipulated that lorazepam is a Schedule IV controlled
substance. ALJX 7, at 13. Lorazepam is marketed under the brand name
Ativan. See GX 6, at 1-2. According to Dr. Chambers, Ativan is a
benzodiazepine, and is ``even more potent and powerful than the
Ambien.'' Tr. 128-29. (7) The parties stipulated that zolpidem is a
Schedule IV controlled substance. ALJX 7, at 13. Zolpidem is
marketed under the brand name Ambien. See GX 10, at 10. According to
Dr. Chambers, Ambien is another benzodiazepine. Tr. 207.
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Regarding sedatives, benzodiazepines or downers, Dr. Chambers
described the biggest danger as addiction. Id. at 82. When prescribed
chronically, patients ``can rapidly develop tolerance and dependence on
a benzodiazepine'' and ``when that tolerance occurs, . . . the brain .
. . acquire[s] a form of psychopathology that mimics the problem that
the drug was originally intended to treat.'' Id. at 82. Additionally,
Dr. Chambers testified that ``benzodiazepines are central nervous
system depressants, so they suppress cognitive and motor function over
time.'' Id. at 83. Dr. Chambers explained, that in patients with
certain mental illnesses these drugs can cause disinhibited behavior,
which tends to increase impulsiveness in patients, and they shorten the
patients' lifespan. Id. at 84. Additionally, when benzodiazepines are
combined with additional downers or other drugs, they become quite
dangerous, which can cause an overdose death. Id. at 79, 84-85, 213.
Dr. Chambers further testified that the prescribing of benzodiazepines
and addictive medications to preteens and teenagers is especially
problematic, because in those years, ``the brain is especially
vulnerable to addiction.'' Id. at 195; see also id. at 120.
Dr. Chambers testified extensively about the dangers of prescribing
both an upper and a downer to the same individual, and stated that
``[there is] no legitimate medical indication for that'' combination.
Id. at 132; see also id. at 146, 198, 215, 231. Instead, according to
Dr. Chambers, the combination of ``uppers and downers, has long been
understood to be a pattern of illicit substance use.'' Id. at 146. And
the combination ``can create a bipolar pattern of symptoms in someone
who [does not] even have bipolar, but if they do have bipolar it could
make it worse.'' Id.
Dr. Chambers also provided generally applicable testimony about
controlled substance prescribing pitfalls for common mental health
diagnoses. Regarding ADD diagnoses, Dr. Chambers explained that
``virtually all [of] the major mental illnesses--schizophrenia, bipolar
disorder, major depression, PTSD, some of the personality disorders--
they all generate cognitive symptoms that look like ADD.'' Tr. 131. He
further explained that in a psychiatric practice, ``someone who really
[does not] know how to diagnose mental illness could readily diagnose
every person that walks in the door with ADD, and if they just follow
the FDA guideline, [you are] now delivering amphetamines to everybody
who walks in your door with any mental illness.'' Id. Similarly,
``insomnia [is] built into [a] depression'' diagnosis. Id. at 209.
2. Prescribing for F.A.
Between February 2018 and February 2019, Respondent issued twenty-
three controlled substance prescriptions to F.A. for mixed amphetamine
salts. GX 2 (Prescriptions Issued to F.A.); RD, at 88. Dr. Chambers
testified that each of these twenty-three prescriptions was issued
outside the usual course of professional practice and without a
legitimate medical purpose. Tr. 102-03; RD, at 88.
In support of his opinion, Dr. Chambers testified that Respondent
did not perform an appropriate assessment to diagnose the three-year-
old patient with ADD. Tr. 88-92, 97; RD, at 89. Dr. Chambers explained
that ``normal children [that young] have behaviors that can look like
ADD.'' Tr. 89. Accordingly, Dr. Chambers explained, to diagnose a
three-year-old with ADD, a practitioner must gather ``more than one
independent source of information.'' Id. at 90; see also RD, at 89. Put
another way, Dr. Chambers explained that the standard of care for this
particular patient required ``a collection of lines of evidence.'' Tr.
93; see also RD, at 89. Per Dr. Chambers, the evidence can come from
parents, teachers, or even through objective testing in the form of
``cognitive batteries.'' Tr. 91; see also RD, at 89. Dr. Chambers
criticized the information Respondent collected to support the
diagnosis, which consisted of a report from a day care center and
reports from the parents. GX 1 (Patient File for F.A.), at 12; Tr. 90-
95. With regard to the day care report, Dr. Chambers criticized that it
documented behavior occurring more than a year prior to the diagnosis.
Tr. 91. He further explained that preschool
[[Page 24003]]
teachers are not likely to require enough ``cognitive demand that would
elicit a concern [about ADD] in a three-year-old.'' Id. at 90. With
regard to the parents' reports, Dr. Chambers questioned their
credibility, because there were other indications in the patient files
that the parents themselves could be addicted to or diverting
controlled substances.\21\ Id. at 94-95. In forming this opinion, Dr.
Chamber's noted that F.A.'s parents were also being treated by
Respondent and were prescribed a dangerous and addictive combination of
controlled substances.\22\ Id. at 87, 94-95; RD, at 88.
---------------------------------------------------------------------------
\21\ Respondent, likely in an attempt to challenge Dr. Chambers'
credibility, argued that Dr. Chambers ``offered statements in each
of the five patient cases that there was subversive abuse and
diversion,'' and ``demonstrated clear suspicion of everyone,
including these patients whom he has never met.'' Resp Posthearing,
at 2. I believe Respondent missed Dr. Chambers' point. Dr. Chambers'
testimony was not that every patient was abusing or diverting
controlled substances, but that every patient should have been
monitored to ensure that potential abuse or diversion was not
occurring. Tr. 246 (Dr. Chambers testified, ``I don't think every
patient diverts. I think [there is] a high rate of it, and I think
that you have to anticipate it could happen with any patient.'');
see also id. at 70, 115, 137, 149, 272-73; supra II.E.
\22\ F.A.'s parents were each prescribed two benzodiazepines and
amphetamines by Respondent. Tr. 90, 95; RD, at 88.
---------------------------------------------------------------------------
Dr. Chamber's opinion was further supported by Respondent's failure
to provide sound rationale for her prescriptions to F.A. in the patient
records. Tr. 91-92; RD, at 89-90. Specifically, Dr. Chambers opined
that, ``[i]t [was] not at all clear . . . that this child, based on
this document, has ADD.'' Tr. 92. This is because F.A.'s ``symptoms
describe problems that don't really fit the diagnosis of ADD . . .
[they are] either inconsistent or outside the diagnosis of ADD.'' Id.
at 91; see also RD, at 89. In fact, Dr. Chambers testified that based
on the documentation, his opinion was that the ADD \23\ diagnosis was
outside the standard of care. Tr. 97; RD, at 89. Even if ADD had been a
proper diagnosis, according to Dr. Chambers, Respondent did not issue
the controlled substance prescriptions within the standard of care. Tr.
97-100; RD, at 89-90. This is because, Dr. Chambers opined, there were
two other treatment options, namely behavioral therapy and
methylphenidate, that should have been tried before issuing a
controlled substance prescription for Adderall.\24\ Tr. 97-100; RD, at
89-90. Moreover, the 10-30 milligram dosages of Adderall prescribed by
Respondent exceeded the 2.5 to 10 milligram dosing range that is
recommend for a young child. Tr. 99, 112; RD, at 90. Dr. Chambers
ultimately opined that the Adderall prescriptions that Respondent
issued to F.A. were ``beyond the dose range . . . for a child of this
age and size. . . . [and] [i]n the context of this case, it [was]
outside the standard of care.'' Tr. 103.
---------------------------------------------------------------------------
\23\ Dr. Chambers often referred to the diagnosis as ADD, but
there are other references in the record to F.A. being diagnosed
with ADHD. See, e.g., Tr. 96-97; GX 1, at 15. It is clear from the
testimony and the record as a whole that the acronyms ADD and ADHD
are used interchangeably throughout this case.
\24\ Respondent argued, both with regard specifically to F.A.
and generally, that while Dr. Chambers described situations where a
non-controlled substance could have been used in lieu of a
controlled substance, the Government failed to establish that the
non-controlled substance had to be used. Resp Posthearing, at 4. The
Government does not have to establish that Respondent should have
prescribed a different medication or that the controlled-substances
Respondent prescribed were wrong. The standard of care requires that
Respondent have a sound rationale for prescribing a controlled
substance, whether or not a non-controlled substance alternative is
available, and that she document her justification or rationale for
prescribing any controlled-substance. Tr. 97-100, 193; supra, II.E.;
La. Admin. Code tit. 46, Pt. XLVII, Sec. 4513(D)(4) (stating that
medical records ``must include documentation of the . . . reason for
prescribing controlled substances''). Here however, Dr. Chambers
opined that Respondent did not have sound rationale for prescribing
the controlled substances at issue nor did she document any
rationale.
---------------------------------------------------------------------------
Dr. Chambers also noted that Respondent did not appropriately
monitor F.A.'s use of the controlled substances she was prescribed. Dr.
Chambers explained that you cannot rely on a three-year-old child to
accurately report on her compliance with a controlled substance
treatment regimen. Tr. 105. Although Dr. Chambers noted that basic
vital signs, weight, and height were recorded appropriately, id. at
105, Dr. Chambers' opinion appears to be that, under the circumstances,
the standard of care required Respondent to do some form of compliance
monitoring and Respondent did none. Tr. 106; RD, at 91. When asked what
monitoring was required to satisfy the standard of care, Dr. Chambers
testified that ``the context of this case is so out of the standard of
care for 10 different reasons that, for goodness sakes, do something .
. . at the very least, get a urine drug screen.'' Tr. 106-07. Dr.
Chambers testified, ``if the parents are using benzos and amphetamines
from some source, and there's extreme poverty, and they live really far
away,[\25\] and now the patient's been out of [the Adderall for a
month], and [it is] possible they could be selling [the controlled
substances], you might get a urine drug screen on the child, or do pill
counts, or something to understand what's going on.'' \26\ Id. at 106;
see also id. at 103.
---------------------------------------------------------------------------
\25\ Dr. Chambers testified that F.A. and her family ``live very
far away, hundreds of miles away, and so . . . that creates
monitoring problems.'' Tr. 96; see also id. at 252-53.
\26\ Dr. Chambers identified several red flags of diversion,
which he testified needed to be monitored under the standard of
care. Specifically, Dr. Chambers identified the following red flags:
Traveling a long distance to see a practitioner, Tr. 253, 309;
getting multiple controlled substance prescriptions from one
practitioner, id. at 308-09; and getting controlled substance
prescriptions from multiple practitioners, id. at 169. Respondent
has conclusively asserted both with regard to F.A. and other
patients, that there were no red flags of diversion. Resp
Prehearing, at 10-12, 15; Resp Posthearing, at 6, 8. However, there
is no evidence in the record to support Respondent's indications
that she conducted the necessary inquiries to resolve the red flags
that Dr. Chambers identified. See supra II.C. And even if Respondent
had investigated any red flags, the results of those hypothetical
investigations were not appropriately documented in the medical
records. See supra II.E.
---------------------------------------------------------------------------
As final support for his opinion that the alleged prescriptions
were issued outside of the standard of care, Dr. Chambers opined that
Respondent failed to appropriately document F.A.'s file. Tr. 91-92; RD,
at 89. Dr. Chambers testified that the documentation had ``distortions
and insufficient data streams to inform a diagnosis of ADD.'' Tr. 91.
The documentation included shorthand references suggesting that
Respondent analyzed what Dr. Chambers called the DSM-IV criteria, but
stated there is ``not substantial narrative evidence that any of those
criteria were actually well supported.'' Id. at 92; see also GX 1, at
12; RD, at 89. Dr. Chambers' ultimately opined that there was not a
legitimate medical purpose for the prescriptions to F.A. because
``[b]ased on what's documented . . . the diagnosis of ADD is not
supported at a sufficient level to make the diagnosis.'' Tr. 103.
I find that, the twenty-three controlled substance prescriptions
Respondent issued to F.A. between February 2018 and February 2019, were
issued outside of the usual course of professional practice and beneath
the applicable standard of care in Louisiana. This is because, based on
Dr. Chambers' credible and uncontroverted expert testimony and the
record as a whole, Respondent did not obtain sufficient information to
diagnose, did not have sound rationale for the controlled substance
prescriptions that were issued, did not monitor compliance with the
prescription instructions, and failed to appropriately document any of
the above in the patient file. See also RD, at 91.
[[Page 24004]]
3. Prescribing to K.W.
Between July 2017 and April 2019, Respondent issued twenty-three
\27\ controlled substance prescriptions to K.W. for mixed amphetamine
salts and alprazolam. GX 8 (Prescriptions Issued to K.W.); Tr. 113-14;
RD, at 92. Dr. Chambers testified that each of these twenty-three
controlled substance prescriptions was issued outside the usual course
of professional practice and without a legitimate medical purpose. Tr.
140-41, 150-52, 155-56; RD, at 95.
---------------------------------------------------------------------------
\27\ The OSC alleged that there were ``at least 24
prescriptions'' issued to K.W. outside the usual course of
professional practice. OSC, at 7. However, the Government only
presented evidence on twenty-three prescriptions. See GX 8.
---------------------------------------------------------------------------
In support of his opinion, Dr. Chambers testified that Respondent
failed to provide sound rationale for the controlled substance
prescriptions issued to K.W. to treat her diagnosed ADD, bipolar
disorder, and insomnia. Tr. 115, 119-20, 122-23, 128, 132-33, 142, 144,
146, 150-53, 159; RD, at 89-90. First, Dr. Chambers opined that the
amphetamine salt prescriptions were contraindicated because K.W. was
diagnosed as being bipolar, an ``[illness] that greatly increase[s] the
risk of adverse effects of controlled substances and addiction.'' Tr.
114; RD, at 92. Dr. Chambers explained that K.W.'s symptoms, ``cutting,
depression, quasi-psychotic hearing voices,'' were coming from her
mental illness, but ``all of it could also be contributed to by the
drugs. . . . if you put people on high-dose amphetamines you can
actually cause them to get psychotic as if they have schizophrenia.''
Tr. 159; RD, at 95. Moreover, Dr. Chambers testified that, ``the
patient [had] been using various drugs, street drugs, that are closely
akin to the drugs that [Respondent] [was] prescribing.'' Tr. 114. Dr.
Chambers explained that K.W.'s use of illegal street drugs; \28\
including ecstasy at age fourteen, GX 7, at 272, 274; crack cocaine, GX
7, at 53, Tr. 138-39; and methamphetamines, GX 7, at 38, Tr. 38; was
evidence that K.W. had a stimulant addiction and that the amphetamines
should no longer have been prescribed. Tr. 115; RD, at 92.
---------------------------------------------------------------------------
\28\ Additionally, there is a Psychosocial Assessment in K.W.'s
medical record that was performed on December 17, 2013, by an
outside professional unaffiliated with R.V. Psychiatric Services,
L.L.C. GX 7, at 223. In that assessment, K.W. reported that she
``was 12 [years] old when she first drank alcohol,'' . . . ``has
abused [A]mbien before, [and] was 12 [years] old when [she] first
smoked marijuana.'' Id. at 224.
---------------------------------------------------------------------------
Second, Dr. Chambers opined that the benzodiazepine prescriptions
were contraindicated. According to Dr. Chambers, ``benzodiazepines can
unleash out-of-control behavior, especially in people with . . .
bipolar disorder who are already prone to that.'' Tr. 128. K.W.
exhibited those side effects while on benzodiazepines. Id. at 119-20,
127. While taking prescription benzodiazepine (Ambien) at the age of
fourteen, K.W. experienced hallucinations and was hearing voices, so
the benzodiazepine prescription was discontinued.\29\ GX 7 at 293, 295;
Tr. 119-20. While on a benzodiazepine (Ativan) at the age of seventeen,
she suffered from blackouts that lead to her being arrested and charged
with resisting arrest, domestic violence, and violence against a police
officer.\30\ Tr. 127-29; GX 7, at 133. While on a different
benzodiazepine (Restoril) at the age of twenty-one,\31\ K.W. reported
to Respondent that she ``used a `rock,' became agitated, took sleeping
[medication] (Restoril), blacked out, hit mom, police came, was
arrested . . . 5 days in jail.'' \32\ GX 7, at 53; see also Tr. 129.
Following that incident, K.W. requested, and was prescribed by
Respondent, a different benzodiazepine (Valium) \33\ to be taken as
needed. GX 7, at 53; Tr. 129, 144-46. By November 2017, which was in
the timeframe of the prescriptions underlying the allegations in this
case, Respondent was prescribing K.W. another benzodiazepine (Xanax)
for insomnia. Tr. 151-52; GX 7, at 41. According to Dr. Chambers, a
practitioner should ``not prescribe Xanax for insomnia because it is a
very short-acting benzoid and there are other ones . . . that are
milder, less risky.'' Tr. 151-52. As explained by Dr. Chambers, those
risks played out in July 2018, when K.W. attempted suicide again and
was placed in emergency detention and hospitalized. GX 7, at 29; Tr.
160-61; RD, at 94. ``Grandmother stated it all started over zanie[\34\]
bars. Patient takes zanie bars and goes in a rage. Patient went crazy
because she woke up and [could not] find the zanie bars.'' Tr. 154; see
also GX 7, at 29; RD, at 94-95.
---------------------------------------------------------------------------
\29\ K.W. was first prescribed a benzodiazepine in 2009 by R.V.,
not Respondent. GX 7, at 295; Tr. 119-20. In 2009, K.W.'s
benzodiazepine prescription was stopped in light of the side effects
she experienced. GX 7, at 293.
\30\ By the year 2014, while being treated by both Respondent
and R.V., K.W. was prescribed Ativan which is ``even more potent and
powerful than the Ambien.'' Tr. 129, see also id. at 127-28; GX 7,
at 133. According to Dr. Chambers, Respondent misattributed the side
effects K.W. experienced, while taking Ambien to another medication
K.W. was prescribed (which, according to Dr. Chambers, does not
include blackouts as a side effect), and continued K.W. on the
benzodiazepine. Tr. 128-29. Dr. Chambers opined that by this time in
2014, ``the evidence [was] overwhelming that the diagnostic
indication [was not] right, the diagnosis [was not] correct, the
treatment [was] worsening the diagnosis . . . contributing to
worsening of the mental illness,'' but Respondent continued to
prescribe benzodiazepines. Tr. 129; RD, at 93.
\31\ By March 2017, Respondent appears to be K.W.'s only
treating practitioner. See, e.g., GX 7, at 53.
\32\ The quoted medical notes contained arrows between each
phrase; I have replaced those arrows with commas for clarity.
\33\ Dr. Chambers testified that ``Valium and Restoril are both
benzoids, so there is not really much gained by stopping the
Restoril which she just blacked out on and merely replacing that
with another benzoid.'' Tr. 139; RD, at 94.
\34\ Dr. Chambers testified that ``zanie bars is normal street
usage for Xanax.'' Tr. 154.
---------------------------------------------------------------------------
In addition to testifying that K.W. should have been prescribed
neither the amphetamines nor the benzodiazepines by themselves, he
explained the compounding impact of prescribing both at the same time.
Tr. 151. Dr. Chambers testified, ``[w]e have an upper, which is the
amphetamine, and a downer [the benzodiazepine] being delivered to a
patient with a mental illness [that is] defined by out-of-control ups
and downs, bipolar disorder.'' Id. at 132. Ultimately, Dr. Chambers
opined that for K.W. ``[there was] no legitimate medical indication''
for prescribing ``a cocktail of an upper and downer.'' Id.; see also
id. at 114; RD, at 92.
In addition to not having sound rationale for prescribing, Dr.
Chambers noted that Respondent did not appropriately monitor K.W.'s use
of the controlled substances she was prescribed. As I found above based
on Dr. Chamber's expert testimony, the standard of care requires
monitoring of side effects and monitoring to ensure an appropriate
outcome is reached. Supra II.E.; Tr. 118. Regarding K.W., Dr. Chambers
opined that the ``most important and deadly outcome of [the prescribed
drugs] . . . is addiction, and death, and legal outcomes, and worsening
mental illness.'' Tr. 115. Many of those side effects occurred. Supra.
Dr. Chambers further opined that ``despite the incoming evidence [of an
amphetamine addiction], [there was] no attempt to actually treat or do
further monitoring to investigate an addiction.'' Id.; see also id. at
160; RD, at 92. Dr. Chambers further stated that he ``never saw
evidence that [a urine drug screen] test was ordered or acted on by
[Respondent] or the whole practice'' as required by the standard of
care. Tr. 136; see also RD, at 94.
As final support for his opinion that the alleged prescriptions
were issued outside of the standard of care, Dr. Chambers opined that
Respondent failed to appropriately document K.W.'s file. Tr. 124, 161;
RD, at 93. Dr. Chambers testified that the documentation Respondent
kept for K.W. was ``a problem'' because ``[there was] no kind of
detail.'' Tr. 124. As an
[[Page 24005]]
example, Dr. Chambers explained that following K.W.'s July 2018
emergency detention at a hospital, Respondent's outpatient note did not
express any acknowledgment or investigation of the incident. Id. at
161. ``[There was] a check-mark for billing[;] . . . [t]here [were]
some check-marks in the evaluation[;] but there is no conversation here
about what just happened. How did you get this way? What happened with
your meds? How was it in the hospital? . . . [it is] like it never
happened.'' Id. Dr. Chambers also stated that ``any time an outside
professional submitted a work-up or evaluation,[\35\] it provid[ed] a
whole higher level of clarity and detail that is non-existent'' in the
medical records prepared by Respondent. Id. at 124.
---------------------------------------------------------------------------
\35\ The patient file for K.W. included copies of hospital
records and of assessments performed by other practitioners. See GX
8, at 4-28, 188-190, 208-226.
---------------------------------------------------------------------------
I find that, the twenty-three controlled substance prescriptions
Respondent issued to K.W. between July 2017 and April 2019, were issued
outside of the usual course of professional practice and beneath the
applicable standard of care in Louisiana. This is because, based on Dr.
Chambers' credible and uncontroverted expert testimony and the record
as a whole, Respondent did not have sound rationale for the controlled
substance prescriptions that were issued, did not monitor compliance
with the prescription instructions, and failed to appropriately
document any of the above in the patient file. See also RD, at 95-96.
4. Prescribing to M.G.
Between February 2017 and May 2019, Respondent issued forty-two
\36\ controlled substance prescriptions to M.G. for mixed amphetamine
salts, and clonazepam. GX 4 (Prescriptions Issued to M.G.); RD, at 96.
Dr. Chambers testified that each of the forty-two controlled substance
prescriptions was issued outside the usual course of professional
practice and without a legitimate medical purpose. Tr. 172, 175, 180,
181; RD, at 98-99.
---------------------------------------------------------------------------
\36\ The OSC alleged that there were ``at least 57
prescriptions'' issued to K.W. outside the usual course of
professional practice. OSC, at 5. However, the Government only
presented evidence on forty-two of those prescriptions at the
hearing in this matter. See GX 4.
---------------------------------------------------------------------------
In support of his opinion, Dr. Chambers found Respondent's
diagnosis of M.G. with ADD to be problematic in-light-of the existing
bipolar disorder diagnosis. Tr. 165-66; RD, at 96; supra II.F.1. Dr.
Chambers opined that the benzodiazepine prescription Respondent issued
to M.G. can ``cause ADD symptoms because any benzo[diazepine] causes
cognitive problems and memory disturbances that look like ADD.'' Tr.
166.
In further support of his opinion, Dr. Chambers testified that
Respondent failed to provide sound rationale for the controlled
substance prescriptions issued to M.G. to treat his diagnosed ADD and
bipolar disorder. Id. at 165, 166, 169, 172, 180. Dr. Chambers
explained that Respondent should have treated M.G. ``with mood-
stabilizers[,] not an addictive drug that bipolar people are vulnerable
to getting addicted to and [that] could inflame the bipolar.'' Tr. 165;
supra II.F.1; RD, at 96. In addition to the controlled substances
Respondent prescribed, on May 22, 2017, M.G. informed Respondent that
he was taking ``Norco for back from [primary care physician]'' due to
``4 herniated disks [from a] motorcycle accident.'' GX 3, at 176. Dr.
Chambers opined that the stimulant and benzodiazepine prescriptions
Respondent issued to M.G. were already outside the standard of care,
but they became ``super-dangerous both with respect to addiction and
worsening of mental illness,'' when M.G. started receiving narcotics
from his primary care physician.\37\ Tr. 170; GX 3, at 176; RD, at 97.
Dr. Chambers opined that ``outside of an intensive care unit setting, .
. . there is just no indication of any disease that would justify that
kind of dangerous regimen.'' Tr. 170; RD, at 97. Dr. Chambers testified
that it was ``outside the appropriate standard of care'' for Respondent
to issue the clonazepam and amphetamine salt prescriptions to M.G.
knowing that he was on Norco. Tr. 172; RD, at 97.
---------------------------------------------------------------------------
\37\ According to Dr. Chambers, Respondent should have inquired
about narcotic use during the February 20, 2017, visit when M.G.
reported he had missed appointments because of back pain. Tr. 169;
GX 3, at 179. It is also clear that Respondent was again notified
that M.G. was taking narcotics on October 23, 2017 and August 1,
2018. GX 3, at 161, 171.
---------------------------------------------------------------------------
In addition to not having sound rationale for prescribing, Dr.
Chambers noted that Respondent did not appropriately monitor M.G.'s use
of the controlled substances he was prescribed. For example, in May
2017, Dr. Chambers testified, Respondent was aware that M.G. was taking
Norco prescribed by another practitioner and yet she issued to M.G.
three months of prescriptions for Adderall and Klonopin. Tr. 173.
First, Dr. Chambers opined that ``you would expect the patient to be
back in August, but we [did not] see that . . . then there [was] a note
for October and the patient [was] a no-show.'' Id. at 173. Dr. Chambers
explained that the patient had ``been going on for five months on a
lethal combination of drugs prescribed by doctors[,] and [Respondent]
[knew] this.'' Id. at 174. Dr. Chambers explained that, at this point,
some investigation was necessary to determine what had happened in the
two months during which M.G., had he taken the controlled substances as
prescribed, would have been out of medication. Id. at 175; RD, at 97-
98. Dr. Chambers opined that there were three possible scenarios.
First, the controlled substances may not have ``actually gotten in his
body'' as he could have been ``selling every bit of it.'' \38\ Id. at
175. Alternatively, M.G. could have run out and gotten the drugs ``from
street sources.'' Id. A third possibility was that M.G. was ``fine
going with these big gaps [without controlled substances] . . . [so] he
[should not] be on [them] anyway.'' Id. Dr. Chambers' testimony made
clear that there was ``[n]othing appropriate'' going on in any of the
three scenarios and that some investigation was required to
appropriately monitor M.G. Id. at 175, 275. Dr. Chambers opined that
``[t]his [was] not health care.'' Id. at 174.
---------------------------------------------------------------------------
\38\ Dr. Chambers later explained that ``you have to assume that
anybody might divert [controlled substances]'' and that ``without
monitoring them, [you are] not applying appropriate controls to make
sure [they are] not diverting. . . .'' Tr. 272.
---------------------------------------------------------------------------
Dr. Chambers testified that, for M.G., ``[t]here [was] not a single
drug-screen in the record.'' Id. at 175; see also id. at 182. Dr.
Chambers further explained that Respondent should have monitored M.G.
with drug testing upon receiving the May 27, 2014 report from Dr. L.G.,
Ph.D. that diagnosed M.G. with ``Cannabis Use Disorder--Mild to
Moderate,'' and ``Tobacco Use Disorder--Moderate.'' GX 3, at 39; Tr.
178-79. Dr. Chambers explained that where ``there [are] substance use
issues, you have to start drug-testing. People [do not] have
compartmentalized addictions . . . [t]he part of the brain where
addiction happens does not care what the source of the drug is.'' Tr.
179; RD, at 99.\39\
---------------------------------------------------------------------------
\39\ Dr. Chambers further opined that it was outside the
standard of care for Respondent to issue any controlled substance
prescriptions to M.G. after receiving the May 27, 2014 report and
that it was outside the standard of care for Respondent to receive
the report and not act on it; however only the prescriptions issued
between February 2017 and May 2019 are at issue in this case. Tr.
178, 180.
---------------------------------------------------------------------------
As final support for his opinion that the alleged prescriptions
were issued outside of the standard of care, Dr. Chambers opined that
Respondent failed to appropriately document M.G.'s file. Tr. 164, 173,
175-76. Dr. Chambers explained that ``there [was] no documentation of
warnings'' provided
[[Page 24006]]
to M.G. when he was taking the ``lethal combination'' of a narcotic,
amphetamine salts, and a benzodiazepine. Id. at 173-74; RD, at 97. And
after M.G. went five months without a visit, as Dr. Chambers explained,
``all you see in [the] assessment is . . . ADD and bipolar diagnosis
and check-marks'' for billing purposes. Tr. 174. He generally described
the medical record for M.G. as being ``devoid of information.'' Id. at
175. Dr. Chambers contrasted Respondent's documentation with the May
27, 2014 report from Dr. L.G. which, according to Dr. Chambers,
provided an example of a ``thorough, adequate evaluation that has a lot
of information about this patient and is at the standard of care when
you are taking care of people with mental illness.'' Id. at 176; RD, at
98.
I find that, the forty-two controlled substance prescriptions
Respondent issued to M.G. between February 2017 and May 2019, were
issued outside of the usual course of professional practice and beneath
the applicable standard of care in Louisiana. This is because, based on
Dr. Chambers' credible and uncontroverted expert testimony and the
record as a whole, Respondent did not obtain sufficient information to
diagnose, did not have sound rationale for the controlled substance
prescriptions that were issued, did not monitor compliance with the
prescription instructions, and failed to appropriately document any of
the above in the patient file. See also RD, at 99.
5. Prescribing to F.P.
Between April 2017 and May 2019, Respondent issued seventy-two
controlled substance prescriptions to F.P. for mixed amphetamine salts,
Vyvanse, and lorazepam. GX 6 (Prescriptions Issued to F.P.); RD, at 99.
Dr. Chambers testified that each of the seventy-two controlled
substance prescriptions was issued outside the usual course of
professional practice and without a legitimate medical purpose. Tr.
189-90, 192-94, 196-98; RD, at 100-01.
In support of his opinion, Dr. Chambers found that Respondent's
diagnosis of F.P. with depressive disorder and post-traumatic stress
disorder (hereinafter, PTSD) lacked sufficient supporting clinical
evidence. Tr. 191-92, 200, 202; RD, at 101. On January 6, 2017, when
F.P. was eleven years old, Respondent diagnosed F.P. with depressive
disorder and the medical records reflected very little information--
just ``circles and check-marks, . . . father has leukemia.'' Tr. 192;
GX 5, at 39-40. According to Dr. Chambers, ``father having leukemia is
terrible, but that is not a diagnosis of depression'' and ``there is no
clinical data that would'' support the depression diagnosis. Tr. 192.
Respondent continued to treat F.P. for depression throughout the time
period relevant to this case (April 2017 to May 2019). GX 5, at 2-40.
Additionally, Dr. Chambers explained that on April 27, 2017, ``now
suddenly [there was] a new psychiatric diagnosis, PTSD, for which there
[was] not sufficient clinical evidence to support that diagnosis.'' Tr.
200. Dr. Chambers noted that F.P.'s files demonstrated his father had
died, ``but that is not PTSD.'' Id. With regard to Respondent's
diagnosing and treatment of F.P., Dr. Chambers testified, ``[i]t just
[does not] make any sense. It is like chaos.'' Id. at 202.
In further support of his opinion, Dr. Chambers testified that
Respondent failed to provide sound rationale for the controlled
substance prescriptions issued to F.P. both individually and as a group
of prescriptions. Id. at 192-201. By way of background, the medical
records reflect that F.P. first began visiting the practice in 2013 at
the age of seven and he was seen by R.V. GX 5, at 95-99; Tr. 184. At
that time, F.P.'s mother reported that F.P. experienced auditory and
visual hallucinations, so R.V. diagnosed him with psychosis and
prescribed Seroquel, an anti-psychotic medication. GX 5, at 75, 95-99;
Tr. 184-86. Respondent first visited with F.P. on August 12, 2014, and
at that time she discontinued his Seroquel prescription. GX 5, at 74.
Dr. Chambers opined that it was unwise to discontinue the Seroquel
because ``the history of psychosis is really clear from before.'' Tr.
187. Beginning in October of 2016, when F.P. was eleven, and continuing
throughout the relevant time period in this case, Respondent prescribed
Adderall to F.P. GX 5, at 44; GX 6. Dr. Chambers testified that
prescribing ``Adderall, given the psychosis that happened earlier and
the fact that [F.P.] is no longer on an antipsychotic, . . . [was] a
mistake'' and was outside the standard of care. Id. at 190; RD, at 100.
Dr. Chambers also opined that there was ``no adequate data or rationale
explain[ing]'' the prescriptions for two different stimulants, Vyvanse
and Adderall,\40\ which were prescribed throughout the relevant time
period in this case. Tr. 192; see also GX 5, at 1, 4, 7, 10, 13, 22,
25, 34, 40; RD, at 100. In January 2017, Respondent began prescribing
Ativan/lorazepam, a benzodiazepine, to F.P. and continued to prescribe
it throughout the relevant time period in this case. Tr. 192; GX 5, at
1, 4, 7, 10, 13, 22, 25, 34, 40. Dr. Chambers questioned the rationale
for the Ativan prescription, ``[F.P.'s] [s]leeping has always been poor
. . . so now all of the sudden there is Ativan . . . he's had insomnia
before, why the Ativan? . . . there is no adequate data or rationale
explained.'' \41\ Tr. 192. Collectively, Dr. Chambers opined that
``there is no rationale'' for prescribing a benzodiazepine to a ``child
who is also on amphetamine, and two different types.'' Id. at 194.
Moreover, the three controlled substances were prescribed alongside a
non-controlled substance, Prozac. Id. at 195. According to Dr.
Chambers, prescribing Prozac and the two stimulants to ``a kid with a
history of psychosis'' could ``provoke [psychosis].'' Id. Ultimately
Dr. Chambers explained that ``[t]here are four meds here . . . [and]
[t]hey all could worsen the side effects of the other. [It is] not
good.'' Id.
---------------------------------------------------------------------------
\40\ When asked how Vyvanse was different from Adderall, Dr.
Chambers explained that ``it is amphetamine with a slight variation
on the molecule and it essentially has the same effects.'' Tr. 186.
\41\ Dr. Chambers further testified ``there has been an insomnia
diagnosis, but it's been there without the Ativan and it is here
now, so nothing has changed in the diagnosis or the clinical data to
justify the introduction of a heavy-duty benzo in a child.'' Tr.
193.
---------------------------------------------------------------------------
As final support for his opinion that the alleged prescriptions
were issued outside of the standard of care, Dr. Chambers opined that
Respondent failed to appropriately document F.P.'s file. Tr. 202. As
with the other medical records, Dr. Chambers commented on the
insufficiency of Respondent's recordkeeping for F.P., which he
describes and ``just some circles and check-marks.'' Id. at 191; see
also id. at 192; RD, at 100. Additionally, he explained that there was
``chaos with who [was] assessing the patient.'' Tr. 201. ``[T]here is
[a] totally different set of handwriting, so it looks like there [were]
three or four people seeing the same patient and they [were] not even
signing the chart, which is also not an acceptable standard of care for
documentation.'' Id. at 201-02. When asked whether the level of
documentation in F.P.'s record was ``adequate given the controlled
substances that [were] being prescribed,'' Dr. Chambers said, ``No.''
Id. at 202.
I find that, the seventy-two controlled substance prescriptions
Respondent issued to F.P. between April 2017 and May 2019, were issued
outside of the usual course of professional practice and beneath the
applicable standard of
[[Page 24007]]
care in Louisiana. This is because, based on Dr. Chambers' credible and
uncontroverted expert testimony and the record as a whole, Respondent
did not obtain sufficient information to diagnose, did not have sound
rationale for the controlled substance prescriptions that were issued,
and failed to appropriately document any of the above in the patient
file. See also RD, at 100-01.
6. Prescribing to M.H.\42\
---------------------------------------------------------------------------
\42\ M.H. (which appears to be her unmarried name) is also
referred to as M.G. (which appears to be her married name)
throughout the patient records. See, e.g., Tr. 75, 166, 168.
---------------------------------------------------------------------------
Between May 2017 and April 2018, Respondent issued forty-three \43\
controlled substance prescriptions to M.H. for mixed amphetamine salts,
acetaminophen with codeine, clonazepam, and zolpidem tartrate. GX 10
(Prescriptions Issued to M.H.); RD, at 101. Dr. Chambers testified that
each of the forty-three prescriptions was issued outside the usual
course of professional practice and without a legitimate medical
purpose. Tr. 207-08, 218, 235-36.
---------------------------------------------------------------------------
\43\ The OSC alleged that there were ``at least 54
prescriptions'' issued to M.H. outside the usual course of
professional practice. OSC, at 9. However, the Government only
presented evidence on forty-three of those prescriptions at the
hearing in this matter. See GX 10.
---------------------------------------------------------------------------
In support of his opinion, Dr. Chambers questioned Respondent's
diagnosis of M.H. Id. at 209, 213, 216; RD, at 104. The medical records
reflect that M.H. had been a patient of R.V.'s at the practice since
2009. GX 9, at 249. On June 10, 2016, according to the medical records,
Respondent began treating Respondent and adopted R.V.'s earlier
diagnoses of depressive disorder, ADD, and insomnia. GX 9, at 44-45,
47. While Respondent maintained the ADD and insomnia diagnoses for M.H.
through the relevant time period in this case, her diagnosis of M.H.
with depressive disorder was intermittently left off of the patient
records (id. at 11, 16, 19, 22, 34, 37, 40) and on (id. at 25, 28, 30,
44) including during the relevant time period in this case. Dr.
Chambers questioned Respondent's diagnosis of M.H. with depressive
disorder, ADD, and insomnia because ``depression alone, all by itself,
could account for attention deficit and insomnia.'' Tr. 209.
Additionally, Respondent added a diagnosis of anxiety on October 16,
2016, and maintained that diagnosis throughout the relevant time period
in this case. GX 9, at 11, 16, 19, 22, 25, 28, 30, 34, 37. Dr. Chambers
opined that there was no clear ``basis for an anxiety diagnosis'' in
the record, Tr. 213, and that it is possible that any anxiety symptoms
could have been caused by the Adderall prescription or M.H.'s nicotine
use.\44\ Id. at 214-16, 227; RD, at 75. Finally, Respondent diagnosed
M.H. with tension headaches on February 1, 2017, and maintained that
diagnosis throughout the relevant time period in this case except for
omitting it from the patient record on October 26, 2017. GX 9, at 11,
16, 19, 22, 25, 28, 30. Dr. Chambers noted that Respondent just
``check-mark[ed] the tension headache diagnosis,'' without an
examination or work-up, Tr. 221, and that again, the Adderall could
have been the cause of the headaches.\45\ Id. at 222; RD, at 102.
---------------------------------------------------------------------------
\44\ Dr. Chambers testified that ``there [were] all kinds of
reasons the anxiety could be there that [had] nothing to do with a
generalized anxiety disorder,'' and where ``there [was] a constant
march in dose escalation of the benzo[s],'' and ``[M.H.] [was] still
anxious, [you have] got to think that the treatment [does not]
work.'' Tr. 227.
\45\ Dr. Chambers also explained that M.H. could have been
diverting her medication and then ``going into withdrawal from
benzos and developing headaches from that.'' Tr. 222. Though it is
clear that Dr. Chambers is speaking hypothetically when he discusses
the potential causes for the anxiety symptoms or tension headaches,
his point is that Respondent failed to perform an appropriate
assessment to make these diagnoses. See, e.g., id. at 214-16, 222. I
agree.
---------------------------------------------------------------------------
In further support of his opinion, Dr. Chambers testified that
Respondent failed to provide sound rationale for the controlled
substance prescriptions issued to M.H. See, e.g., Tr. 207, 209-16, 218,
220, 223, 227-30, 235. Dr. Chambers explained that Respondent's
prescribing to M.H. showed ``dose escalation over time without clear
justification or diagnostic rationale.'' \46\ Id. at 216; RD, at 102.
Additionally, Dr. Chambers explained, that with regard to Klonopin,
Ambien, and Butalbital,\47\ ``just those three [prescriptions] alone
could be . . . lethal.'' Tr. 207; RD, at 101. Dr. Chambers testified
that those three prescriptions combined with codeine \48\ and Adderall
\49\ created ``a very high-risk . . . an unacceptable risk'' of
``[a]cceleration [or] worsening of mental illness, acquisition or
worsening of addiction, medical injury, legal consequences and death.''
Tr. 207; see also id. at 208. The record evidence demonstrates that on
or about February 2018, M.H. reported to Respondent that she was
hospitalized for ``failure to thrive, . . . malnutrition, [being] too
weak to walk.'' Id. at 229; see also GX 9, at 12; RD, at 76. Dr.
Chambers testified that ``something [was] not right, and in this
collapse [Respondent had] a patient who [was] being prescribed every
class of addictive drug and multiple addictive drugs and dangerous
drugs within each class, a whole laundry list of controlled drugs, so
it is not a surprise.'' Tr. 229. Dr. Chambers concluded that the
prescriptions Respondent issued to M.H. were not only lacking
justification, but were likely ``contributing to [her] deterioration.''
\50\Id.
---------------------------------------------------------------------------
\46\ Dr. Chambers specifically noted the lack of rationale for
dosing increases of Ambien, Tr. 212; the addition of and then the
doubling and tripling of Klonopin, Tr. 213, 220, 223; dosing
increases of Adderall, Tr. 217-18; and the addition of butalbital,
Tr. 220, 223.
\47\ While issuing to M.H. controlled substance prescriptions
for Klonopin and Ambien, Respondent also issued prescriptions for
Fioricet, which contains butalbital. See, e.g., GX 9, at 21. The
Fioricet/butalbital prescriptions are not at issue in this case and
are only discussed herein as necessary to understand Dr. Chamber's
opinion that the controlled substances at issue in this case were
prescribed beneath the standard of care.
\48\ Regarding the prescribed codeine, Dr. Chambers explained
that the Louisiana Prescription Monitoring Program shows that M.H.
had been prescribed Suboxone by another provider, which in his
opinion, could indicate an opiate addiction. Tr. 208. According to
Dr. Chambers, ``if someone is treating opiate addiction with an
opiate that is approved for opiate addiction, [and] you . . . are
prescribing an opiate on top of that, you are directly fueling the
disease.'' Id. at 208.
\49\ Regarding the Adderall prescription, Dr. Chambers explained
that Respondent prescribed M.H. 60 and then 80 milligrams a day when
the FDA guidelines recommend a maximum daily dose of 40 milligrams.
Tr. 209-10. Though, Dr. Chambers explained, there are circumstances
when the recommended maximum dose can be exceeded, none of those
circumstances are present here. Id. at 210. One example of when the
dosage could be higher, according to Dr. Chambers, is when there are
no other controlled substances prescribed and the patient is not
responding to the medication due to something like high body weight
(M.H. weighed only 92 pounds). Id. at 210.
\50\ As examples, Dr. Chambers explained that benzos can
contribute to pneumonia because the patient would not be inhaling or
breathing as rapidly and not aerating the lungs the same way, and
opioids suppress the cough reflex which is necessary to get rid of
bacteria. Tr. 229-30.
---------------------------------------------------------------------------
In addition to not having sound rationale for prescribing, Dr.
Chambers noted that Respondent did not appropriately monitor M.H.'s use
of the controlled substances that she was prescribed. Id. at 204, 211,
214-15, 219, 227-28, 230. Respondent did not monitor to ensure an
appropriate outcome; according to Dr. Chambers, ``if someone is on . .
. that load of benzos and they are still anxious, you've got to think
that the treatment doesn't work.'' Id. at 227. Additionally, Dr.
Chambers noted several indicators that M.H. had addiction disorder and
vulnerability to multiple addictions. Id. at 215-16; RD, at 101-02.
First, Dr. Chambers testified that according to the Louisiana
Prescription Drug Monitoring Report,\51\ M.H. received suboxone, which
is usually used to treat opioid addiction, from another provider, Tr.
205, 208; second, she smoked a pack of cigarettes
[[Page 24008]]
a day which is indicative of a nicotine addiction, id. at 215; and
third, M.H. received dose escalations of addictive drugs over time,
which is indicative of drug addiction, id. at 216, 222. Yet, as Dr.
Chambers testified, there was no drug-screening of this patient.\52\
Id. at 211. Ultimately, on March 28, 2018, M.H. was ``discharged from
[Respondent's] care.'' GX 9, at 1; RD, at 104. While the discharge
letter did not state the reason for the discharge, a note in the
medical records for M.H. with a March 28, 2018, date indicated that
M.H. was ``noncompliant w[ith] medications'' and that it was her
``[second] time calling about her Fioricet [and] Tylenol.'' GX 9, at 1-
2. Even after M.H. was discharged as a patient, Respondent wrote M.H.
prescriptions for a two-month supply of Klonopin and Ambien. GX 9, at
2; RD, at 104. Dr. Chambers testified that ``it appears that after
firing the patient[,] she prescribed the patient more benzoids,'' and
they were ``prescribed without any link to a provider or any
supervision or appointments.'' Tr. 235. Moreover, when asked whether
the professional standard required a prescriber to drop a patient who
was addicted, Dr. Chambers stated, ``No.'' Id. at 273-74. He said
``dropping them would be abandoning a sick person. . . . [it is] a
failure of appropriate care for the patient.'' Id. at 274. Instead, Dr.
Chambers testified, a prescriber should expand treatment to ``include
addiction treatment,'' and ``make adjustments in [the] practice to stop
the diversion but hold on to the patient.'' Id.
---------------------------------------------------------------------------
\51\ Copies of two Louisiana Prescription Drug Monitoring
Reports were contained in Respondent's patient file for M.H. at GX
9, at 9, and 93-98.
\52\ Dr. Chambers also testified that drug-screening was
necessary to rule out diversion in light of the high doses of
Adderall given. Tr. 210-11
---------------------------------------------------------------------------
As final support for his opinion that the alleged prescriptions
were issued outside of the standard of care, Dr. Chambers opined that
Respondent failed to appropriately document M.H.'s file. Id. at 212-14,
221, 223, 225, 228, 235. As with the other medical records, Dr.
Chambers commented on the insufficiency of Respondent's recordkeeping
for M.H., which he again described as ``check-marks and circles.'' Id.
at 212; see also id. at 213, 221. Additionally, Dr. Chambers again
explained that there was insufficient documentation indicating who was
seeing the patient, because while Respondent's handwriting and
signature appeared on the records, there was also unknown handwriting
with no corresponding signature. Id. at 223, 228; RD, at 103. Dr.
Chambers testified that ``part of what is complicating the picture is
again more unknown writers and evaluators entering the chart.'' Tr.
223. Moreover, with regard to the prescriptions issued to M.H. after
Respondent discharged her from care, Dr. Chambers explained that there
was no ``charting that goes along with [those prescriptions].'' \53\
Id. at 235; see also RD, at 104.
---------------------------------------------------------------------------
\53\ Dr. Chamber's exact testimony referred to ``that
prescription'' in the singular. Tr. 235. I have edited the quote
because it is clear from the context of the testimony that when Dr.
Chambers refers to ``that prescription'' he is referencing GX 9, p.
3 which is a copy of one page of a prescription pad upon which two
prescriptions for controlled substances were written. Tr. 235; GX 9,
at 3.
---------------------------------------------------------------------------
I find that, the forty-three controlled substance prescriptions
Respondent issued to M.H. between May 2017 and April 2018, were issued
outside of the usual course of professional practice and beneath the
applicable standard of care in Louisiana. This is because, based on Dr.
Chambers' credible and uncontroverted expert testimony and the record
as a whole, Respondent did not obtain sufficient information to
diagnose, did not have sound rationale for the controlled substance
prescriptions that were issued, did not monitor compliance with the
prescription instructions, and failed to appropriately document any of
the above in the patient file. See also RD, at 104.
7. Summary of Fact Findings Relevant to All Patients
In accordance with Dr. Chambers' testimony and the record as a
whole, and in agreement with the ALJ, I find that, for each of the two-
hundred and three prescriptions at issue, Respondent did not obtain
sufficient information to diagnose, did not have sound rationale for
the prescriptions that were issued, did not monitor compliance with the
controlled substance prescriptions, and/or did not appropriately
document the file. See RD, at 105. Ultimately, I find that there is
substantial evidence on the record that Respondent issued two-hundred
and three prescriptions without a legitimate medical purpose, outside
of the usual course of professional practice and beneath the applicable
standard of care in Louisiana.
III. Discussion
A. Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
Under Section 304 of the Controlled Substances Act, ``[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 FR 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 (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.
In a likely attempt to argue that her continued registration was
consistent with the public interest, Respondent stated that her
practice occurred in a ``Health Care Shortage Area, with very few
providers accepting underserved populations,'' and that her practice
[[Page 24009]]
managed a case load of 9,500 patients during the 2017-2018 period at
issue in this case. Resp Posthearing, at 1. Even assuming the truth of
all of these alleged ``facts'' that are not in evidence, community
impact evidence is generally considered to be irrelevant to DEA
revocation proceedings. See, e.g., Frank Joseph Stirlacci, M.D., 85 FR
45,229, 45,239 (2020) (declining to consider Respondent's argument that
his revocation ``would deprive the low-income and homeless patients . .
. of his medical services''); Mark De La Lama, P.A., 76 FR 20,011,
20,020 n.20 (2011) (declining to consider a registrant's service to
underserved and underinsured persons).
Respondent also argued that ``the [G]overnment failed to produce
evidence of actual abuse or diversion [for] the 750,000 doses/year
[prescribed] . . . by way of arrest records, law enforcement testimony,
or drug rehabilitation admissions of patients.'' \54\ Resp Posthearing,
at 3. Respondent does not, however, cite legal authority for the
proposition that I must find that patients became addicted or drugs
were sold before I can find that continued registration is inconsistent
with the public interest. Agency decisions have found that ``diversion
occurs whenever controlled substances leave `the closed system of
distribution established by the CSA. . . .' '' Id. (citing Roy S.
Schwartz, 79 FR 34,360, 34,363 (2014)). See also, Jeanne E. Germeil,
M.D., 85 FR 73,786, 73,799 (rejecting Respondent's argument that ``no
reported overdoses or deaths'' was indicative of positive dispensing
experience).
---------------------------------------------------------------------------
\54\ Respondent also argued that the Government has only alleged
CSA violations related to ``0.052% of patients.'' Resp Posthearing,
at 1. Assuming the truth of these facts not in evidence, the Agency
already 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).
---------------------------------------------------------------------------
DEA regulations state, ``[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,\55\ the
relevant evidence is confined to Factors 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.
---------------------------------------------------------------------------
\55\ As to Factor One, there is no evidence in the record of any
recommendation from Respondent's state licensing board or
professional disciplinary authority. 21 U.S.C. 823(f)(1). State
authority to practice medicine is ``a necessary, but not a
sufficient condition for registration. . . .'' Robert A. Leslie,
M.D., 68 FR at 15,230. Therefore, ``[t]he fact that the record
contains no evidence of a recommendation by a state licensing board
does not weigh for or against a determination as to whether
continuation of Respondent's DEA certification is consistent with
the public interest.'' Roni Dreszer, M.D., 76 FR 19,434, 19,444
(2011).
As to Factor Three, there is no evidence in the record that
Respondent has a ``conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(f)(3). However, as Agency
cases have noted, there are a number of reasons why even 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.
---------------------------------------------------------------------------
1. Factors Two and Four--the Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
(a) Allegation That Respondent Issued Prescriptions for Controlled
Substances Outside the Usual Course of the Professional Practice in
Violation of Both Federal and State Law
According to the CSA's implementing regulations, 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).\56\
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).
---------------------------------------------------------------------------
\56\ Similarly, La. Admin. Code tit. 46, Pt. LIII, Sec.
2745(B)(1) (2021) (last amended July 2016) states that ``[a]
prescription for a controlled substance shall be issued for a
legitimate medical purpose by an individual practitioner acting in
the usual course of [her] professional practice.'' Additionally, La.
Admin. Code tit. 46, Pt. XLVII, Sec. 4513(D)(2)(b)(xi) states that
``no APRN shall prescribe any controlled substance or other drug
having addiction-forming or addiction sustaining liability without a
good faith . . . medical indication.''
---------------------------------------------------------------------------
Under the CSA, it is fundamental that a practitioner must establish
and maintain a legitimate doctor-patient relationship in order to act
``in the usual course of . . . professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' Ralph J. Chambers,
79 FR 4962 at 4970 (2014) (citing Paul H. Volkman, 73 FR 30,629, 30,642
(2008), pet. for rev. denied Volkman v. Drug Enf't Admin., 567 F.3d
215, 223-24 (6th Cir. 2009)); see also U.S. v. Moore, 423 U.S. 122,
142-43 (1975) (noting that evidence established that the physician
exceeded the bounds of professional practice, when ``he gave inadequate
physical examinations or none at all,'' ``ignored the results of the
tests he did make,'' and ``took no precautions against . . . misuse and
diversion''). The CSA, however, generally looks to state law to
determine whether a doctor and patient have established a legitimate
doctor-patient relationship. Volkman, 73 FR 30,642.
Based on the credible expert testimony on the record, I found above
that the standard of care for prescribing controlled substances in
Louisiana requires the following: (1) An appropriate assessment and
evaluation to make a diagnosis; (2) sound rationale for prescribing
controlled substances related to that diagnosis; (3) ongoing monitoring
to ensure that the desired outcome is achieved and undesirable side
effects are not experienced; and (4) appropriate documentation. See
supra II.E. Based on the credible expert testimony on the record, I
also found above that each of the two-hundred and three prescriptions
at issue in Respondent's case were issued without an appropriate
assessment to diagnose, sound rationale for prescribing, adequate
monitoring, and/or appropriate documentation. See supra II.F.7.
Accordingly, I found that Respondent dispensed controlled substances
beneath the applicable standard of care and outside of the usual course
of the professional practice in Louisiana. See supra II.F.7. I find
that in issuing two-hundred and three prescriptions beneath the
applicable standard of care and outside the usual course of
professional practice in Louisiana, Respondent violated 21 CFR
1306.04(a). Similarly, I find that Respondent violated La. Admin. Code
tit. 46, Pt. LIII, Sec. 2745(B)(1) by issuing two-hundred and three
prescriptions without a legitimate medical purpose and outside the
usual course of professional practice.
Respondent, however, appears to have argued and believed that her
actions were permissible and were supported by scientific evidence.
Resp Posthearing, at 5-8. I have already rejected these arguments
because they were based solely on facts that were not in evidence.
Supra II.C. However, even if
[[Page 24010]]
Respondent believed the controlled substance prescriptions she issued
were issued within the usual course of professional practice, DEA has
found that ``just because misconduct is unintentional, innocent, or
devoid of improper motive, [it] does not preclude revocation or denial.
Careless or negligent handling of controlled substances creates the
opportunity for diversion and [can] justify the revocation of an
existing registration. . . .'' Bobby D. Reynolds, N.P., Tina L.
Killebrew, N.P., & David R. Stout, N.P., 80 FR 28,643, 28662 (2015)
(quoting Paul J. Caragine, Jr., 63 FR 51,592, 51,601 (1998).
(b) Allegation That Respondent Violated State Law
I have found that Respondent issued prescriptions for controlled
substances without a ``legitimate medical purpose'' and outside of
``the usual course of [her] professional practice'' in violation of La.
Admin. Code tit. 46, Pt. LIII, Sec. 2745(B)(1) for the same reasons
that I found she violated 21 CFR 1306.04(a). La. Admin. Code tit. 46,
Pt. LIII, Sec. 2745(B)(1). I also find that the record contains
substantial evidence that Respondent's actions violated La. Admin. Code
tit. 46, Pt. XLVII, Sec. 4513(D), which addresses the prescriptive
authority of advanced practice registered nurses in Louisiana.
Under that section, ``no APRN shall prescribe any controlled
substance or other drug having addiction-forming or addiction-
sustaining liability without a good faith prior examination and medical
indication.'' Id. at Sec. 4513(D)(2)(b)(ix) (2019). Dr. Chambers
testified repeatedly about Respondent's failure to perform an
appropriate assessment to make a diagnosis prior to prescribing
controlled substances, and testified to instances where ``the evidence
[was] overwhelming that the diagnostic indication [was not] right.''
Tr. 129. See also id. at 88-92, 97, 166, 191-93, 200, 202, 209, 213,
216. Dr. Chambers also testified that the controlled substances
prescribed by Respondent were often contraindicated. Id. at 115, 141,
170, 221, 270. Repeatedly, Dr. Chambers testified that ``[there is] no
legitimate medical indication'' for ``prescribing . . . a cocktail of
an upper and downer.'' Id. at 132; see also id. at 133, 146, 170, 198.
For these reasons, I find that Respondent violated La. Admin. Code tit.
46, Pt. XLVII, Sec. 4513(D)(2)(b)(ix) by prescribing controlled
substances without a good faith prior examination and medical
indication.
Moreover, even if Respondent had conducted a good faith examination
and established a medical indication prior to prescribing the
controlled substances, her failure to document appropriately is an
independent violation of Louisiana law. Under Louisiana law, ``[a]n
APRN who prescribes a controlled substance shall maintain a complete
record of the examination, evaluation and treatment of the patient
which must include documentation of the diagnosis and reason for
prescribing controlled substances.'' La. Admin. Code tit. 46, Pt.
XLVII, Sec. 4513(D)(4)(a) (2019). Dr. Chambers repeatedly testified
regarding the deficiencies in Respondent's documentation and explained
that there was no documentation of Respondent's reasons for prescribing
the controlled substances at issue. Tr. 213-14, 335. Specifically, Dr.
Chambers described Respondent's documentation as ``a fa[ccedil]ade,''
id. at 92; ``check-marks'' with ``no conversation . . . about what just
happened,'' id. at 161; and ``superficial [and] not credible,'' id. at
258. See also id. at 174, 192, 212, 221. For these reasons, I find that
Respondent violated La. Admin. Code tit. 46, Pt. XLVII, Sec.
4513(D)(4)(a) by failing to ``maintain a complete record of the
examination, evaluation and treatment of the patient . . . includ[ing]
. . . [the] reason for prescribing controlled substances.
For all these reasons, I find that the record contains substantial
evidence that Respondent violated La. Admin. Code tit. 46, Pt. LIII,
Sec. 2745(B)(1), and La. Admin. Code tit. 46, Pt. XLVII, Sec.
4513(D).
In total, I find that the record contains substantial evidence that
Respondent issued two-hundred and three 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 Louisiana in violation of 21 CFR 1306.04(a), La.
Admin. Code tit. 46, Pt. LIII, Sec. 2745(B)(1), and La. Admin. Code
tit. 46, Pt. XLVII, Sec. 4513(D). As Respondent issued these
prescriptions without complying with her obligations under the CSA and
Louisiana law, I find that Factors Two and Four weigh in favor of
revocation. See George Mathew, M.D., 75 FR 66,138, 66,148 (2010)).
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, there is substantial record evidence that
Respondent issued controlled substance prescriptions outside the usual
course of the professional practice and beneath the applicable standard
of care in Louisiana and in violation of state law. I, therefore, have
concluded 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
uncontroverted, substantial evidence that Respondent repeatedly issued
prescriptions without having a sound rationale or legitimate medical
purpose for doing so 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 also Tr.
79, 115 (testimony of Dr. Chambers that Respondent was prescribing a
``whole host of high-volume addictive drugs'' which could have a
``deadly outcome''); 143, 171 (testimony of Dr. Chambers that ``the
combination of a benzo and opiate is an imminently lethal combo''),
207, 228, 272.
Not only was Respondent prescribing highly addictive drugs with a
potentially ``deadly outcome'' without a legitimate medical purpose for
so doing, but she was prescribing combinations of controlled substances
known to be ``imminently lethal.'' Id. at 115, 171; see also supra IV
(providing examples of egregious misconduct by Respondent which had a
substantial likelihood of causing serious bodily harm or leading to
abuse of a controlled substance).
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-hundred and three controlled substance prescriptions
Respondent issued without obtaining sufficient information to diagnose,
having sound rationale to prescribe, monitoring compliance with the
controlled substance prescriptions, and appropriately documenting the
file. See supra III.A.1.a.
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
[[Page 24011]]
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[Sec. ]
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 arguments Respondent submitted to determine whether or
not she has presented ``sufficient mitigating evidence to assure the
Administrator that [s]he 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).
Here, Respondent has presented no evidence on the record that I
could consider as accepting responsibility and I agree with the ALJ's
finding that ``the Respondent has failed to unequivocally accept any
responsibility in this matter.'' RD, at 118. Respondent has maintained
throughout these proceedings that she believes that her prescribing to
the five individuals in question, was proper. See RD, at 117; supra
II.C. Respondent did admit that she ``agree[d] that the documentation
[was] lacking,'' but she seemed to minimize her inadequate
documentation when she stated that ``[e]very spoken word that a patient
says in a visit, as well as every thought that crosses a clinician's
mind in making a decision, cannot possibly be written down on paper.''
\57\ Tr. 22. Respondent also stated in her opening statements, that she
``suspect[ed] that the reason that we're really here is because of a
pattern of behaviors by the previous owner of the practice . . . [who
was] also [her] ex-husband.'' Tr. 21. Specifically, she suggested that
her ex-husband had maliciously reported her actions to various places
``hoping that [she] would lose [her] license.'' Id. The limited
evidence presented by Respondent and her failure to testify
substantively demonstrate a complete unwillingness to accept
responsibility for her actions or to appreciate the seriousness of her
misconduct.
---------------------------------------------------------------------------
\57\ Obviously, capturing ``every spoken word'' and ``every
thought that crosses a clinician's mind'' is not the documentation
standard of care to which Respondent has been held in this matter.
See supra II.E; Tr. 335.
---------------------------------------------------------------------------
In all, Respondent failed to explain why, in spite of her
misconduct, she can be entrusted with a registration. ``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
46968, 49973.
Even if I were to consider her remedial measures, in spite of her
complete lack of acceptance of responsibility,\58\ Respondent's
statements that she adjusted her forms following an insurance company's
review of her records for quality compliance is nonetheless
insufficient to ensure me that her documentation deficiencies will not
be repeated in the future. Tr. 22; 332 (Dr. Chambers testified that
``at the end of the day, [it is] not the form, [it is] what goes in
it'' that matters, and that he cannot tell from Respondent's blank
forms how she would ``change [her] practice mode.'').
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\58\ See Jones Total Health Care Pharmacy, L.L.C., 81 FR 79,202-
03.
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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). Here, the ALJ found, and I agree, that the evidence suggests
that Respondent's violations ``were egregious.'' RD, at 105. Respondent
prescribed controlled substances to three year old F.A. that were
``beyond the dose range . . . for a child of [F.A.'s] age and size,''
Tr. 103, to treat ADD when ``it [was] not at all clear to [Dr.
Chambers] that [F.A.] . . . [had] ADD.'' Id. at 92; see also supra
II.F.2. Respondent prescribed addictive medications to F.P. at age
eleven when ``the brain is especially vulnerable to addiction.'' Id. at
195; see also id. at 120. Respondent prescribed benzodiazepines to K.W.
(who already had a history of blackouts, violence, and arrests while on
benzodiazepines, supra II.F.3.) that sent K.W. into ``a rage,'' caused
her to attempt suicide, and necessitated her being placed in emergency
detention and hospitalized. GX 7, at 29. Respondent prescribed ``every
class of addictive drug and multiple addictive drugs,'' to M.H., which
Dr. Chambers stated likely ``contribut[ed] to [her] deterioration'' and
hospitalization. Tr. 229; see also supra II.F.6. Respondent prescribed
both ``uppers and downers'' to K.W., M.G., F.P., and M.H., the
combination of which Dr. Chambers testified is often used for ``illicit
substance use,'' and ``can create a bipolar pattern of symptoms in
someone who [does not] even have bipolar, but if they do have bipolar
it could make it worse.'' Tr. 146.
Indeed, Respondent's found violations go to the heart of the CSA by
not complying with the closed regulatory system devised to ``prevent
the diversion of drugs from legitimate to illicit channels.'' Gonzales
v. Raich, 545 U.S. 1, 13-14, 27 (2005).
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 find that considerations of both specific and general deterrence
weigh in favor of revocation in this case. 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 as
contained in the Order below.
[[Page 24012]]
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.
MV3148257 issued to Melanie Baker, N.P., and deny any pending
applications for renewal or modification of that registration. This
Order is effective June 4, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-09463 Filed 5-4-21; 8:45 am]
BILLING CODE 4410-09-P