[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.'').
---------------------------------------------------------------------------

    \58\ See Jones Total Health Care Pharmacy, L.L.C., 81 FR 79,202-
03.
---------------------------------------------------------------------------

    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