Melanie Baker, N.P.; Decision and Order, 23998-24012 [2021-09463]
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Supp. 2d 37, 40 (D.D.C. 2001); United
States v. Enova Corp., 107 F. Supp. 2d
10, 16 (D.D.C. 2000); InBev, 2009 U.S.
Dist. LEXIS 84787, at *3. Instead, ‘‘[t]he
balancing of competing social and
political interests affected by a proposed
antitrust consent decree must be left, in
the first instance, to the discretion of the
Attorney General.’’ W. Elec. Co., 993
F.2d at 1577 (quotation marks omitted).
‘‘The court should bear in mind the
flexibility of the public interest inquiry:
the court’s function is not to determine
whether the resulting array of rights and
liabilities is one that will best serve
society, but only to confirm that the
resulting settlement is within the
reaches of the public interest.’’
Microsoft, 56 F.3d at 1460 (quotation
marks omitted); see also United States v.
Deutsche Telekom AG, No. 19–2232
(TJK), 2020 WL 1873555, at *7 (D.D.C.
Apr. 14, 2020). More demanding
requirements would ‘‘have enormous
practical consequences for the
government’s ability to negotiate future
settlements,’’ contrary to congressional
intent. Microsoft, 56 F.3d at 1456. ‘‘The
Tunney Act was not intended to create
a disincentive to the use of the consent
decree.’’ Id.
The United States’ predictions about
the efficacy of the remedy are to be
afforded deference by the Court. See,
e.g., Microsoft, 56 F.3d at 1461
(recognizing courts should give ‘‘due
respect to the Justice Department’s . . .
view of the nature of its case’’); United
States v. Iron Mountain, Inc., 217 F.
Supp. 3d 146, 152–53 (D.D.C. 2016) (‘‘In
evaluating objections to settlement
agreements under the Tunney Act, a
court must be mindful that [t]he
government need not prove that the
settlements will perfectly remedy the
alleged antitrust harms[;] it need only
provide a factual basis for concluding
that the settlements are reasonably
adequate remedies for the alleged
harms.’’ (internal citations omitted));
United States v. Republic Servs., Inc.,
723 F. Supp. 2d 157, 160 (D.D.C. 2010)
(noting ‘‘the deferential review to which
the government’s proposed remedy is
accorded’’); United States v. ArcherDaniels-Midland Co., 272 F. Supp. 2d 1,
6 (D.D.C. 2003) (‘‘A district court must
accord due respect to the government’s
prediction as to the effect of proposed
remedies, its perception of the market
structure, and its view of the nature of
the case.’’). The ultimate question is
whether ‘‘the remedies [obtained by the
Final Judgment are] so inconsonant with
the allegations charged as to fall outside
of the ‘reaches of the public interest.’ ’’
Microsoft, 56 F.3d at 1461 (quoting W.
Elec. Co., 900 F.2d at 309).
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Moreover, the Court’s role under the
APPA is limited to reviewing the
remedy in relationship to the violations
that the United States has alleged in its
complaint, and does not authorize the
Court to ‘‘construct [its] own
hypothetical case and then evaluate the
decree against that case.’’ Microsoft, 56
F.3d at 1459; see also U.S. Airways, 38
F. Supp. 3d at 75 (noting that the court
must simply determine whether there is
a factual foundation for the
government’s decisions such that its
conclusions regarding the proposed
settlements are reasonable); InBev, 2009
U.S. Dist. LEXIS 84787, at *20 (‘‘[T]he
‘public interest’ is not to be measured by
comparing the violations alleged in the
complaint against those the court
believes could have, or even should
have, been alleged’’). Because the
‘‘court’s authority to review the decree
depends entirely on the government’s
exercising its prosecutorial discretion by
bringing a case in the first place,’’ it
follows that ‘‘the court is only
authorized to review the decree itself,’’
and not to ‘‘effectively redraft the
complaint’’ to inquire into other matters
that the United States did not pursue.
Microsoft, 56 F.3d at 1459–60.
In its 2004 amendments to the APPA,
Congress made clear its intent to
preserve the practical benefits of using
judgments proposed by the United
States in antitrust enforcement, Public
Law 108–237 § 221, and added the
unambiguous instruction that ‘‘[n]othing
in this section shall be construed to
require the court to conduct an
evidentiary hearing or to require the
court to permit anyone to intervene.’’ 15
U.S.C. 16(e)(2); see also U.S. Airways,
38 F. Supp. 3d at 76 (indicating that a
court is not required to hold an
evidentiary hearing or to permit
intervenors as part of its review under
the Tunney Act). This language
explicitly wrote into the statute what
Congress intended when it first enacted
the Tunney Act in 1974. As Senator
Tunney explained: ‘‘[t]he court is
nowhere compelled to go to trial or to
engage in extended proceedings which
might have the effect of vitiating the
benefits of prompt and less costly
settlement through the consent decree
process.’’ 119 Cong. Rec. 24,598 (1973)
(statement of Sen. Tunney). ‘‘A court
can make its public interest
determination based on the competitive
impact statement and response to public
comments alone.’’ U.S. Airways, 38 F.
Supp. 3d at 76 (citing Enova Corp., 107
F. Supp. 2d at 17).
VIII. Determinative Documents
There are no determinative materials
or documents within the meaning of the
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APPA that were considered by the
United States in formulating the
proposed Final Judgment.
Dated: April 29, 2021
Respectfully submitted,
FOR PLAINTIFF UNITED STATES OF
AMERICA:
lllllllllllllllllllll
KERRIE J. FREEBORN
(D.C. Bar #503143)
United States Department of Justice
Antitrust Division
Defense, Industrials and Aerospace Section,
450 Fifth St. NW, Suite 8700 Washington DC
20530
Telephone: (202) 476–9160
Email: kerrie.freeborn@usdoj.gov
[FR Doc. 2021–09504 Filed 5–4–21; 8:45 am]
BILLING CODE 4410–11–P
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 § 40:978,
and Louisiana Administrative Code tit.
46, Pt. LIII, § 2745(B)(1), and Pt. XLVII,
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§ 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).
The hearing in this matter took place
in New Orleans, Louisiana, and spanned
two days. See generally Transcript of
1 I find that the Government’s service of the OSC
was adequate.
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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
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.
B. Government’s Case
The Government’s documentary
evidence consisted primarily of patient
files and prescription records for five
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.
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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23999
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.
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.
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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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
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.
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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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.
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
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.
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
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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.
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
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,
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.
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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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,
§ 4513(D)(2)(b)(xi) (2019) 15 states that
15 This citation is to La. Admin. Code tit. 46, Pt.
XLVII, § 4513 effective February 20, 2018, through
September 19, 2019. There is no substantive
changes to the portions of § 4513 that are relevant
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‘‘no APRN[16] shall prescribe any
controlled substance or other drug
having addiction-forming or addiction
sustaining liability without a good faith
prior examination. . . .’’
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,
§ 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
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 nonpharmacologic interventions.’’ La. Admin. Code tit.
46, Pt. XLVII, § 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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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 drugtesting.’’ 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.
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.
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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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,
§ 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
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
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.
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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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 schoolaged 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.
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
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[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
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teachers are not likely to require enough
‘‘cognitive demand that would elicit a
concern [about ADD] in a three-yearold.’’ 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.
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
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.
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.
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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.
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],
24 Respondent argued, both with regard
specifically to F.A. and generally, that while Dr.
Chambers described situations where a noncontrolled 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 noncontrolled 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,
§ 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.
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.
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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.
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.
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.
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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.
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, quasipsychotic 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 highdose 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.
Second, Dr. Chambers opined that the
benzodiazepine prescriptions were
contraindicated. According to Dr.
Chambers, ‘‘benzodiazepines can
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.
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.
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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,
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.
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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.
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
34 Dr. Chambers testified that ‘‘zanie bars is
normal street usage for Xanax.’’ Tr. 154.
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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.
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.
In support of his opinion, Dr.
Chambers found Respondent’s diagnosis
of M.G. with ADD to be problematic inlight-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
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.
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 fortytwo of those prescriptions at the hearing in this
matter. See GX 4.
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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.
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
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.
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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.
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
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
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.
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.
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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 checkmarks, . . . father has leukemia.’’ Tr.
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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,
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.
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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.
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
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.
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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
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.
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
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.
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 fortythree of those prescriptions at the hearing in this
matter. See GX 10.
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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.
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
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.
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.
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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
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
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.
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.
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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.
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.
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
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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.
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 twohundred 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
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.
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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
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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 lowincome 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).
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. [§ ] 824(a)
. . . are satisfied.’’ 21 CFR 1301.44(e).
In this matter, while I have considered
all of the factors,55 the relevant evidence
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).
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
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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.
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).
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
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.
56 Similarly, La. Admin. Code tit. 46, Pt. LIII,
§ 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, § 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.’’
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24009
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, § 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
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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,
§ 2745(B)(1) for the same reasons that I
found she violated 21 CFR 1306.04(a).
La. Admin. Code tit. 46, Pt. LIII,
§ 2745(B)(1). I also find that the record
contains substantial evidence that
Respondent’s actions violated La.
Admin. Code tit. 46, Pt. XLVII,
§ 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
§ 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, § 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
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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, § 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
fac
¸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,
§ 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, § 2745(B)(1), and
La. Admin. Code tit. 46, Pt. XLVII,
§ 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,
§ 2745(B)(1), and La. Admin. Code tit.
46, Pt. XLVII, § 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
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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 highvolume 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 twohundred 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
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no effort to establish that she can be
trusted with a registration.
The CSA authorizes the Attorney
General to ‘‘promulgate and enforce any
rules, regulations, and procedures
which he may deem necessary and
appropriate for the efficient execution of
his functions under this subchapter.’’ 21
U.S.C. 871(b). This authority
specifically relates ‘‘to ‘registration’ and
‘control,’ and ‘for the efficient execution
of his functions’ under the statute.’’
Gonzales v. Oregon, 546 U.S. 243, 259
(2006). A clear purpose of this authority
is to ‘‘bar[§ ] doctors from using their
prescription-writing powers as a means
to engage in illicit drug dealing and
trafficking.’’ Id. at 270.
In efficiently executing the revocation
and suspension authority delegated to
me under the CSA for the
aforementioned purposes, I review the
evidence and 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 factdependent 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
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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 exhusband 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.
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.’’).
The Agency also looks to the
egregiousness and extent of the
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.
58 See Jones Total Health Care Pharmacy, L.L.C.,
81 FR 79,202–03.
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
24011
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.
E:\FR\FM\05MYN1.SGM
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24012
Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Notices
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Michele L. Martinho, M.D.; Decision
and Order
On December 4, 2019, the Drug
Enforcement Administration
(hereinafter, DEA or Government)
Administrative Law Judge Mark M.
Dowd (hereinafter, ALJ), issued a
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
(hereinafter, RD) on the action to revoke
the DEA Certificate of Registration
Number BM9434440 of Michele L.
Martinho, M.D. The ALJ transmitted the
record to me on January 7, 2020, and
asserted that no exceptions were filed
by either party. ALJ Transmittal Letter,
at 1. Having reviewed and considered
the entire administrative record before
me, I adopt the ALJ’s RD with minor
modifications, where noted herein.*
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby dismiss the Order to
Show Cause issued to Michele L.
Martinho, M.D. This Order is effective
immediately.
D. Christopher Evans,
Acting Administrator.
Paul E. Soeffing, Esq., for the
Government
Douglas M. Nadjari, Esq. and David
Durso, Esq., for the Respondent
*A I have made minor, nonsubstantive,
grammatical changes to the RD. Where I have made
any substantive changes, omitted language for
brevity or relevance, or where I have added to or
modified the ALJ’s opinion, I have bracketed the
modified language and explained the edit in a
footnote marked with an asterisk and a letter in
alphabetical order.
VerDate Sep<11>2014
23:06 May 04, 2021
Jkt 253001
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
The Assistant Administrator,
Diversion Control Division, Drug
Enforcement Administration (DEA),
issued an Order to Show Cause (OSC),1
dated February 26, 2019, seeking to
revoke the Respondent’s Certificate of
Registration (COR), number
BM9434440, pursuant to 21 U.S.C.
824(a)(5), and deny any applications for
renewal or modification of such
registration and any applications for any
other DEA registrations pursuant to 21
U.S.C. 824(a)(5), because the
Respondent has been excluded from
participation in a program pursuant to
section 1320a–7(a) of Title 42. The
Respondent requested a hearing on
March 13, 2019,2 and prehearing
proceedings were initiated.3 A hearing
was conducted in this matter on October
3, 2019, at the DEA Hearing Facility in
Arlington, Virginia.
The issue ultimately to be adjudicated
by the Acting Administrator, with the
assistance of this recommended
decision, is whether the record as a
whole establishes by a preponderance of
the evidence that the Respondent’s
subject registration with the DEA should
be revoked pursuant to 21 U.S.C.
824(a)(5).
After carefully considering the
testimony elicited at the hearing, the
admitted exhibits, the arguments of
counsel, and the record as a whole, I
have set forth my recommended
findings of fact and conclusions of law
below.
The Allegations
In the OSC, the Government contends
that the DEA should revoke the
Respondent’s DEA COR because she has
been excluded from participation in a
program pursuant to section 1320a–7(a)
of Title 42.
Specifically, the Government alleges
the following:
1. The Respondent is registered with
the DEA as a practitioner in Schedules
II through V under DEA COR
BM9434440. The Respondent’s COR
expires by its terms on January 31, 2020.
2. On June 14, 2017, the Respondent
was found guilty in the United States
District Court for the District of New
Jersey of ‘‘Transporting in Aid of-Travel
Act-Accepting Bribes in Violation of the
Travel Act.’’ Judgment was entered in
U.S. v. Michele Martinho, No. 2:14–CR–
00271–SRC–1 (D.N.J. filed June 14,
2017).
1 ALJ
Ex. 1.
Ex. 2.
3 ALJ Ex. 3.
2 ALJ
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
3. Based on the Respondent’s
conviction, the U.S. Department of
Health and
Human Services, Office of Inspector
General (‘‘HHS/OIG’’), by letter dated
July 31, 2018, mandatorily excluded the
Respondent from participation in
Medicare, Medicaid, and all federal
health care programs for a minimum
period of five years pursuant to 42
U.S.C. 1320a–7(a), effective August 20,
2018. Notwithstanding the fact that the
underlying conduct for which the
Respondent was convicted had no
nexus to controlled substances,
mandatory exclusion from Medicare,
Medicaid, and all federal health care
programs by HHS/OIG warrants
revocation of the Respondent’s
registration pursuant to 21 U.S.C.
824(a)(5).
The Hearing
Government’s Opening Statement
In the Government’s Opening
Statement, the Government indicated
that revocation is sought for the
Respondent’s COR involving Schedules
II through V, pursuant to 21 U.S.C.
824(a)(5). Tr. 10. The facts in this matter
are undisputed and have been
stipulated to by the parties. Id. The
Respondent was found guilty in U.S.
District Court of transporting in aid of
the Travel Act and accepting bribes in
violation of the Travel Act. Id. The
following year, HHS/OIG mandatorily
excluded the Respondent from
participation in Medicare, Medicaid,
and all federal health care programs. Id.
at 10–11. Pursuant to 42 U.S.C. 1320a–
7(a), the Respondent’s exclusion
remains in effect, which is the basis
upon which the DEA seeks to revoke the
Respondent’s COR. Id. at 11.
Respondent’s Opening Statement
The Respondent asserted in her
opening statement that this matter is not
about controlled substances, and it has
nothing to do with the issuance of
prescriptions or record keeping for
controlled substances. Id. at 11. The
Respondent admitted that the
Government is correct that she accepted
cash payments in exchange for referring
blood work to a particular lab, that she
pleaded guilty to a single count
violation of the Travel Act, and that she
has been excluded by HHS/OIG from
participation in Medicare, Medicaid,
and all federal health care programs. Id.
at 11–12. The Respondent maintained
that the evidence will show that the she
can be entrusted to maintain and
properly use her DEA COR. Id. at 12.
Revocation in this matter is not
mandatory. Id. at 12. The Respondent
E:\FR\FM\05MYN1.SGM
05MYN1
]]>Agencies
[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).
---------------------------------------------------------------------------
\1\ I find that the Government's service of the OSC was
adequate.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
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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
