Jennifer L. St. Croix, M.D.; Decision and Order, 19010-19027 [2021-07410]
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19010
Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American cultural items. The National
Park Service is not responsible for the
determinations in this notice.
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History and Description of the Cultural
Items
Sometime before 1968, three cultural
items were removed from Tennessee. In
1968, these items were given to the
Bixby Memorial Free Library by Ernst
Bilhuber, a Euro-American collector of
Native American objects and resident of
the Vergennes area. The three items are
one bowl portion of a Bird Effigy Pipe
(inventory number 1968.1.20), one Fish
Effigy Bowl (inventory number
1968.1.134), and one Chickasaw Red
Bird Effigy Footed Water Jug (inventory
number 1968.1.140).
The Bird Effigy Pipe is made of brown
sandstone. The pipe is carved to
resemble the head of a bird, and the
bowl is carved into the top of the head.
A stem for smoking would have been
attached to the bird’s neck. The Fish
Effigy Bowl is made of Mississippian
grayware. The object is round with a
fish head protruding from one end and
fish tail protruding from the opposite
side. There are also several ‘‘fins’’
protruding from the sides of the bowl.
The Chickasaw people have a link to
the southeastern United States,
including Tennessee, as documented in
the Treaty of 1816. During consultation
with representatives of The Chickasaw
Nation, the three objects listed in this
notice were recognized by the
Chickasaw team as funerary in nature,
and similar to previously repatriated
associated funerary objects that had
been removed from ancestral burials in
their homelands, which encompass the
Tennessee area. Consequently, the
Bixby Memorial Free Library has
determined that a relationship of shared
group identity can reasonably be traced
between The Chickasaw Nation and the
Muskogean linguistic cultures
connected with the items listed in this
notice.
Determinations Made by the Bixby
Memorial Free Library
Officials of the Bixby Memorial Free
Library have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B),
the three cultural items described above
are reasonably believed to have been
placed with or near individual human
remains at the time of death or later as
part of the death rite or ceremony and
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are believed, by a preponderance of the
evidence, to have been removed from a
specific burial site of a Native American
individual.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the unassociated funerary
objects and The Chickasaw Nation.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to claim these cultural items
should submit a written request with
information in support of the claim to
Patricia Reid, Bixby Memorial Free
Library, 258 Main Street, Vergennes, VT
05491, telephone (802) 877–2211, email
patricia.reid@bixbylibrary.org, by May
12, 2021. After that date, if no
additional claimants have come
forward, transfer of control of the
unassociated funerary objects to The
Chickasaw Nation may proceed.
The Bixby Memorial Free Library is
responsible for notifying The Chickasaw
Nation that this notice has been
published.
Dated: March 26, 2021.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2021–07407 Filed 4–9–21; 8:45 am]
BILLING CODE 4312–52–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–31]
Jennifer L. St. Croix, M.D.; Decision
and Order
I. Introduction
On April 12, 2017, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Jennifer L.
St. Croix, M.D. (hereinafter,
Respondent), of Covington, Tennessee.
OSC, at 1. The OSC proposed the
revocation of Respondent’s DEA
Certificate of Registration No.
FS2669868 and the denial of ‘‘any
pending application to modify or renew
such registration pursuant to 21 U.S.C.
823(f) and 824(a)(4) for the reason that
. . . [her] continued registration is
inconsistent with the public interest as
that term is defined in 21 U.S.C. 823(f).’’
Id.
The substantive grounds for the
proceeding, as alleged in the OSC, are
that Respondent ‘‘ ‘committed such acts
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as would render . . . [her] registration
. . . inconsistent with the public
interest.’ See 21 U.S.C. 824(a)(4).’’ Id. at
3. Specifically, the OSC alleged that
Respondent violated the commitments
she made to DEA when she executed a
three-year Memorandum of Agreement
(hereinafter, MOA) effective June 25,
2011. Id. at 2. According to the OSC,
Respondent’s MOA commitments, to
‘‘abide by all Federal, State, and local
laws and regulations pertaining to
controlled substances’’ and to ‘‘maintain
a log of all controlled substances
prescribed, administered or dispensed
to patients at . . . [her] registered
premises or elsewhere, including call-in
prescriptions, for review by DEA
personnel at any time,’’ were what
permitted her to maintain an
unrestricted registration. Id.
First, according to the OSC,
Respondent continued to issue
‘‘prescriptions to individuals who are
intimate or close acquaintances, and
provided prescription drug logs to DEA
that were noncompliant with the terms
of the June 2011 MOA’’ due to the
falsities included in ten of them.1 Id. The
OSC also alleged that Respondent failed
to maintain medical records pertaining
to her prescribing of controlled
substances, and that she prescribed
controlled substances to an individual
with whom she had a ‘‘romantic
interaction.’’ Id. The authorities that the
OSC listed for these allegations are 21
U.S.C. 843(a)(4)(A), 21 CFR 1306.04(a),
Tenn. Code Ann. § 63–6–214(b)(1),
Tenn. Code Ann. § 63–6–214(b)(12),
Tenn. Comp. R. & Regs. R. 0880–2–
.14(6)(a)(4) and (e), and Tenn. Tenn.
Comp. R. & Regs. R. 0880–2–.14(8)(a)
(adopting opinion 8.14 of the American
Medical Association Code of Ethics). Id.
at 2–3.
Second, the OSC alleged that
Respondent failed to submit MOArequired prescription drug logs to DEA
for six months even though ‘‘DEA’s
subsequent review of prescription data
revealed that . . . [she] issued
controlled substance prescriptions
during’’ those months.2 Id. at 3. The OSC
cited 21 U.S.C. 823(f)(5) as the statutory
basis for this allegation. Id.
Third, according to the OSC,
Respondent ‘‘stored controlled
substances in an exterior storage shed at
1 The charged falsities were alleged to be in
Respondent’s drug log submissions dated August,
October, and November of 2012, February, May,
June, July, October, and November of 2013, and
January 2014. OSC, at 2.
2 The six months during which Respondent
allegedly issued controlled substance prescriptions
without submitting prescription drug logs to DEA
were February, March, and April 2012 and January,
March, and April 2013. OSC, at 3.
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. . . [her] private residence . . . for
dispensing from . . . [her] private
residence . . . sometime between March
7, 2013 and November 6, 2013.’’ Id. The
OSC cited 21 CFR 1301.12(a) as the
basis for the allegation that Respondent
stored controlled substances at an
unregistered location. Id.
Fourth, the OSC charged Respondent
with violating 21 CFR 1301.71(a), failure
to provide effective controls or
procedures to guard against the theft or
diversion of controlled substances, due
to her admission that ‘‘the door to . . .
shed did not close securely.’’ Id.
Fifth, connected to the charge that
Respondent purchased controlled
substances ‘‘for dispensing from . . .
[her] private residence,’’ the OSC
alleged that Respondent ‘‘did not
conduct an initial inventory of
controlled substances received on
March 7, 2013, nor did . . . [she]
maintain records of . . . [her]
dispensing these drugs as required by 21
CFR 1304.03(a) and (b), 1304.04(g),
1304.11(b) and (e), and 1304.21(a). Id.
In sum, the OSC alleged that
Respondent’s actions, when judged
under 21 U.S.C. 823(f)(2), (f)(4) and
(f)(5), ‘‘render[ ] . . . [her] continued
registration with the DEA to handle
controlled substances inconsistent with
the public interest.’’ Id. at 3–4.
The OSC notified Respondent of her
right to request a hearing on the
allegations or to submit a written
statement while waiving her right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified
Respondent of the opportunity to file a
corrective action plan. OSC, at 4–5
(citing 21 U.S.C. 824(c)(2)(C)).
The matter was placed on the docket
of the Office of Administrative Law
Judges and assigned to Chief
Administrative Law Judge (hereinafter,
ALJ) John J. Mulrooney, II. The parties
submitted ten stipulations.3
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
(hereinafter, RD), at 3–4. In addition, the
Chief ALJ took official notice of two
documents concerning Respondent
issued by the Tennessee Board of
Medical Examiners (hereinafter, TBME)
after giving the parties notice of his
intent to do so and receiving no
objection. Official Notice Order dated
March 1, 2018, attaching Notice of
3 The tenth stipulation states that ‘‘Respondent
did not treat patients referred to in the record as
Patient JJ or Patient NJ at Methodist Fayette
Hospital, Baptist Memorial Hospital, and/or
McNairy Regional Hospital. RD, at 4; see also infra
section II.D.
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Charges and Memorandum of
Assessment of Civil Penalty and Costs
dated June 3, 2016 (hereinafter, Notice
of Charges) and Final Order dated May
24, 2017 (hereinafter, TBME Final
Order).
The hearing in this matter took place
in Nashville, Tennessee on March 13
and 14, 2018. The Chief ALJ filed the
RD on May 10, 2018.4 RD, at 1. Noting
that Respondent had already been
‘‘afforded the administrative grace’’ of a
MOA, the Chief ALJ recommended that
Respondent’s registration be revoked
and that any pending applications for its
renewal be denied. Id. at 68, 70.
Respondent filed exceptions to the RD
on May 30, 2018. Letter of the Chief ALJ
to the Acting Administrator dated June
7, 2018, at 1. The Government neither
filed exceptions nor responded to
Respondent’s Exceptions. Id. After the
Chief ALJ certified the record and
transmitted it to me, Respondent, on
July 12, 2018, submitted a Motion to
Consider Amended Corrective Action
Plan (hereinafter, MCACAP).
Having examined and considered the
record in its entirety, I agree with the
conclusion of the Chief ALJ that
Respondent’s registration should be
revoked and that all pending
applications for its renewal or
modification should be denied.5 I make
the following findings.
II. Findings of Fact
A. Respondent’s Controlled Substance
Registration
The parties stipulated that
Respondent is ‘‘currently registered . . .
as a practitioner in Schedules II–V
under DEA registration number FS
2669868’’ in Covington, Tennessee.6
Prehearing Ruling dated June 12, 2017
(hereinafter, Prehearing Ruling), at 1;
RD, at 3. The parties and the Chief ALJ
further agreed that Respondent’s
registration ‘‘remains current based
upon Respondent’s submission of an
application for renewal of registration
on January 31, 2017.’’ 7 RD, at 3; see also
Order Denying the Government’s
4 The Chief ALJ’s Corrected Page Order was filed
on May 11, 2018.
5 I reviewed, and agree with, the ultimate rulings
and conclusions of all of the Chief ALJ’s procedural
decisions.
6 The parties agreed to nine additional
stipulations. Prehearing Ruling, at 1–2; RD, at 3–4.
Eight of these nine concern the scheduling history
of oxycodone, Percocet, Tussionex, Lortab, Xanax,
Soma, Ambien, and phentermine. Id.
7 The parties also agreed that Respondent
submitted a request to modify the registered address
of her registration from Tennessee to the Virgin
Islands on January 31, 2017. Prehearing Ruling, at
1–2; RD, at 3.
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Motion for Termination of Proceedings
dated July 25, 2017, at 6.
B. The Investigation of Respondent
In March of 2011, Respondent applied
for a registration. GX 3 (MOA), at 1. The
ensuing investigation of the application
resulted in four allegations ‘‘which if
proven in an administrative hearing,
could constitute grounds to deny . . .
[Respondent’s] application for
registration.’’ Id. at 1; see also id. at 1–
2. According to the four allegations,
Respondent was arrested in Colorado
and Nebraska for felony drug possession
and in Wisconsin for aggravated battery/
intent to cause great harm, and
Respondent ‘‘admitted to prescribing
controlled substances to friends and
family members including her mother in
law as well as some neighbors and
friends of her former husband,’’
‘‘admitted to working for a
Telemedicine Organization in which the
legitimacy of many of the prescriptions
could be called into question,’’ and
admitted that her relationship with her
ex-husband ‘‘resulted in often
questionable behavior in regards to
prescribing . . . [and] her being around
illegal drugs at times.’’ Id. at 1–2.
According to the MOA, DEA agreed to
grant Respondent’s application for a
registration in Schedules II through V
and Respondent agreed to five specific
courses of conduct. Id. at 2–3.8 First,
Respondent agreed ‘‘to abide by all
Federal, State and local laws and
regulations pertaining to controlled
substances’’ as well as the ‘‘additional
obligations imposed upon . . . [her]
pursuant to’’ the MOA. Id. at 2. Second,
Respondent agreed that ‘‘she will not
prescribe, administer or dispense any
controlled substances to family
members’’ and that, if she does, she
agreed ‘‘to immediately execute a DEA
Form 104, Voluntary Surrender of
Controlled Substances Privileges,
thereby relinquishing all authority to
prescribe, administer or dispense
controlled substances.’’ Id.
Third, Respondent agreed to
‘‘maintain a log of all controlled
substances prescribed, administered or
dispensed to patients at her registered
premises or elsewhere, including call-in
prescriptions, for review by DEA
personnel at any time.’’ Id. The MOA
specified the elements to be captured in
the log—patient, date, and the name,
strength, and quantity of the prescribed
controlled substance—and how
8 Respondent also agreed to multiple specific
matters such as having advice of Counsel and
‘‘knowledge of the events descried herein,’’
comprehending all of the MOA, and entering the
MOA voluntarily. GX 3, at 2; see id. 2–4.
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Respondent was to maintain and
transmit the log to DEA. Id.
Fourth, Respondent agreed that ‘‘DEA
personnel may enter her office and/or
registered location at any time during
regular business hours without prior
notice to verify compliance with’’ the
MOA. Id. Respondent specifically
agreed ‘‘to permit entry of DEA
personnel without an Administrative
Inspection Warrant or other written
notices or other means of entry.’’ Id.
Fifth, Respondent agreed ‘‘to
immediately notify the DEA prior to any
change of business address and/or
change in status of her State medical
license and/or state controlled
substance authority’’ and ‘‘to promptly
notify the DEA of any change of address
or requests for modification of
registration.’’ Id. at 3. Respondent
agreed to make these notifications in
writing and to transmit them to the
specific Diversion Group Supervisor ‘‘by
certified mail with return receipt
requested.’’ Id.
The MOA’s terms included that it was
the ‘‘full and complete agreement’’ of
Respondent and DEA, that ‘‘[n]o other
promises or agreements will be binding
unless placed in writing and signed by
both parties,’’ and that the ‘‘terms and
provisions . . . [were] executed in good
faith.’’ Id.
In March of 2014, according to the
testimony of the Diversion Investigator
assigned to the matter (hereinafter, DI),
a Tennessee Department of Health
employee (hereinafter, TDHI)
investigating a complaint against
Respondent contacted DEA. Tr. 38–39.
TDHI’s investigative work was related to
allegations that Respondent reported
controlled substances as stolen and was
providing medical care to her boyfriend,
J.J., and his brother, N.J. Id. at 40. The
DEA investigation that led to the
issuance of this OSC ensued.
C. The Government’s Case
The Government’s case includes
fifteen exhibits, one of which has twelve
parts, and two witnesses, DI and
Stephen Loyd, M.D. All but one of the
Government’s exhibits—GX 10—were
admitted into the record. When the
Government initially moved the
admission of GX 10, purporting it to be
J.J.’s medical record, the Chief ALJ
sustained Respondent’s objections,
citing foundation and relevance. Id. at
132–33 (Chief ALJ ruling that ‘‘I’ll
sustain the objection . . . I have every
confidence that it is the document that
. . . [DI] received from . . . [TDHI]. But
I just don’t know what . . . [TDHI] sent
him or what the purpose of it was or
where she got it. And that being the
case, then I wouldn’t know how to use
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the document. . . . [F]or the time
being, . . . [GX 10] I’m going to exclude
based on the objections without
prejudice for . . . [Government
Counsel] to make, as I said, another run
at it.’’); see also id. at 127–131. The
Government did not end up being
successful at introducing GX 10.
DI followed up on the telephone call
he received from TDHI by gathering
information. He obtained a copy of the
MOA. DI served an administrative
subpoena on the Tennessee Department
of Health Controlled Substance
Monitoring Database (hereinafter,
CSMD) to obtain a list of controlled
substance prescriptions that Respondent
issued. Infra. He secured a copy of the
DEA Form 106 that Respondent
submitted about the theft or loss of
controlled substances, GX 5 (hereinafter,
DEA theft report). Id. at 45–49. The DEA
theft report shows that Respondent
reported the theft or loss of Testosterone
Cyp, Zolpidem Tartrate, Phentermine,
and Alprazolam. GX 5, at 1–2.
I agree with the Chief ALJ’s
assessment of DI’s credibility, that DI
‘‘presented as an objective, experienced
regulator with no apparent agenda, who
provided answers that, even in some
difficult areas . . . rang true.’’ RD, at 14.
I also agree with the Chief ALJ that DI
‘‘resisted the temptation to embellish
the statements purportedly made by the
Respondent, . . . [J.J., and N.J.] although
it was arguably clear that doing so
would have strengthened the case for a
sanction.’’ Id. Accordingly, I agree with
the Chief ALJ and find that DI’s
‘‘testimony was sufficiently detailed,
plausible, and internally consistent to
be afforded full credibility in these
proceedings,’’ and I make corresponding
findings of fact as a result. Id.
DI investigated how it came to be that
Respondent possessed the controlled
substances that she reported as stolen
on the DEA theft report. Tr. 50–73. Over
Respondent’s objections, the
Government successfully moved the
admission of the entire twelve-page
packet of McKesson Medical-Surgical
Inc. (hereinafter, McKesson), parent of
Moore Medical Inc. (hereinafter, Moore
Medical purchase packet), ‘‘records of
all purchases made’’ by Respondent.9
9 Respondent objected to the admission of page 6
of GX 6 on the grounds of scope (Respondent is
‘‘not charged with a crime in using the hospital’s
credit card, as stated here’’) and prejudice, arguing
that the page ‘‘should not be considered by the
Court in assessing penalties against’’ Respondent.
Tr. 56, 66; see also id. at 56–59, 66–69. In admitting
the entirety of GX 6, the Chief ALJ stated that ‘‘[i]t
seems to me to eliminate that part of it [page 6]
would leave an analytical hole in the documents
that were provided. . . . I don’t know how the
evidence is going to turn out, but if the evidence
turns out that this unauthorized use of a credit card
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GX 6. The first two pages of the Moore
Medical purchase packet are the
Declaration of a McKesson employee
whose job responsibilities include
‘‘obtaining [McKesson] documentation
and information in response to
subpoenas and other requests.’’ Id. at 1–
2; Tr. 51–53. According to the
Declaration, the rest of GX 6 had
originally been produced in response to
a Grand Jury Subpoena served in March
2017. Tr. 50–69.
The third page of the Moore Medical
purchase packet is the ‘‘Controlled
Substance Report’’ showing the
controlled substances shipped to
Respondent in March 2013. GX 6, at 3;
Tr. 53–54. According to the Controlled
Substance Report, Zolpidem,
Testosterone Cyp, Phentermine,
Carisoprodol, and Alprazolam were
shipped to Respondent at ‘‘969
Tennessee Avenue South, Parsons TN
38361.’’ 10 GX 6, at 3. DI testified that he
compared the content of the DEA theft
report, GX 5, with the content of this
‘‘Controlled Substance Report’’ and
concluded that the quantity of the
controlled substances reported on the
DEA theft report is identical to the
quantity of controlled substances
received from Respondent’s purchase
from Moore Medical. Tr. 49–50. (‘‘I
looked at the number where they listed
the quantity lost and compared that to
a[n] invoice that I obtained under
subpoena from Moore Medical, and the
numbers of the amounts that were taken
or reported as taken in this agreed with
what was the number of containers that
were taken or delivered to . . .
[Respondent].’’).
The fourth page of the Moore Medical
purchase packet includes much of the
same information as appears on the
third page plus the date Respondent
ordered the controlled substances,
February 26, 2013, and the method of
payment, ‘‘credit card.’’ GX 6, at 4; Tr.
54. The fifth page of the Moore Medical
purchase packet shows, among other
things, that Respondent’s ‘‘Company
Name’’ in the McKesson records is ‘‘St.
Croix LLC.’’ GX 6, at 5; see also Tr. 55–
56. The fifth page also shows the
shipping address as ‘‘969 Tennessee
Ave South, Decauter [sic] Cgh.’’ GX 6,
at 5; see also Tr. 55–56.
The sixth page of the Moore Medical
purchase packet summarizes a
is relevant because she wasn’t supposed to be
getting those drugs, and it was all part of a plan to
keep them in an unauthorized way, and that reflects
on her, I probably would consider that. But the fact
that she violated some rule about a credit card,
that’s not charged, and I don’t think it impacts
much beyond arguably credibility.’’ Id. at 68. I agree
with the Chief ALJ.
10 This was Respondent’s registered address at the
time.
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telephone call from an individual at
Decatur County General Hospital on
March 5, 2013. GX 6, at 6; Tr. 59–60.
According to that ‘‘Account Note,’’ the
individual ‘‘wanted to advise us’’ of his
belief that Respondent, a ‘‘contractor at
the Hospital,’’ placed an Order and ‘‘has
left with the product.’’ GX 6, at 6; see
also Tr. 56, 59–60. It states that the
individual is ‘‘going to contact their
Local Police to file charges.’’ GX 6, at 6;
see also Tr. 59–60. Page 6 of the Moore
Medical purchase packet also suggests
that ‘‘Decauter Cgh’’ means ‘‘Decatur
County General Hospital.’’ GX 6, at 6;
Tr. 59–60.
The seventh page of the Moore
Medical purchase packet includes two
views of Respondent’s registration,
FS2669868, showing the expiration date
of February 28, 2014. GX 6, at 7; Tr. 60.
The address on the registration captured
on this page is ‘‘969 Tennessee Avenue
South, Parsons, TN 38361–0000.’’ GX 6,
at 7; see also GX 2, at 1 (DEA
Certification of Respondent’s
Registration History stating that ‘‘969
Tennessee Avenue’’ was Respondent’s
registered address as of June 13, 2011,
and that Respondent’s registered
address changed on January 3, 2014).
The eighth page of the Moore Medical
purchase packet is titled ‘‘Declaration of
Controlled Substances Purchases,’’ is
signed by Respondent, and is dated
February 12, 2013. GX 6, at 8; Tr. 60–
61. The Declaration includes
information appearing on previous
pages of GX 6: ‘‘Jennifer St. Croix, M.D./
St. Croix LLC’’ (for ‘‘customer name’’),
‘‘969 Tennessee Ave S, Parsons TN
38361’’ (for ‘‘address, city and state’’),
and ‘‘FS2669868’’ (for ‘‘DEA registration
#’’). GX 6, at 8. Respondent ‘‘declare[d]
and attest[ed]’’ that she ‘‘fully complies
with all federal and state laws and
regulations on the dispensing of
controlled substances including but not
limited to dispensing to patients only
pursuant to a legitimate prescription
issued in the course of an established
doctor-patient relationship . . . and
only for a legitimate medical purpose.’’
Id. Regarding her purchase of so-called
‘‘Lifestyle Drugs,’’ such as Phentermine
and Alprazolam, Respondent stated that
her ‘‘requirements for [their] purchase[ ]
. . . are necessary for [the] [a]ddition of
Age Management Medicine, weight loss
& wellness to private practice.’’ Id.; see
also Tr. 60–61 (DI’s testimony that this
record is used to ‘‘verify a reasoning
behind the purchase from a practitioner
to verify that what they’re ordering is for
a legitimate purpose or get the reasoning
behind ordering the controlled
substances.’’). Respondent ‘‘certifie[d]’’
that she ‘‘made sufficient inquiry to be
able to make this declaration truthfully,
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accurately, and without material
omissions.’’ GX 6, at 8. She also
‘‘affirm[ed] by signing this declaration
that the above is true and correct to the
best of . . . [her] knowledge and belief.’’
Id.
The ninth through twelfth pages of
the Moore Medical purchase packet
contain the label ‘‘invoice.’’ Id. at 9–12.
In two places on the ninth page, the
record shows Respondent’s home
address. Id. at 9; Tr. 62, 65. The ninth
page also shows the ‘‘ship to’’ registered
address for the order, the same address
as Respondent’s registered address,
which is also the address of Decatur
County General Hospital. GX 6, at 9; Tr.
62, 65. The data points addressed in the
invoice are item number, item
description, order quantity, ship
quantity, ‘‘B/O Qty,’’ dollar unit price,
‘‘U/M,’’ ‘‘$ Extended,’’ sales tax, and
‘‘ship from.’’ GX 6, at 9, 11–12. The
items described on the invoice are both
controlled substances and medicines
that are not controlled. Id. The invoice
does not list the controlled substances
separately from the medicines that are
not controlled. Id.
DI testified that his investigation
included attempting to contact the
individual with Decatur County General
Hospital whose call was memorialized
as an ‘‘Account Note’’ on the sixth page
of the Moore Medical purchase packet.
Tr. 70–72. According to DI, he ended up
speaking with the Decatur County
General Hospital Chief Executive Officer
who succeeded that individual
(hereinafter, DCGH CEO). Id. at 71–72.
A result of that telephone conversation
with DCGH was DI’s receipt of an
‘‘incident report’’ indicating to him
‘‘that there was possibly the diversion of
controlled substances.’’ 11 Id. at 73. DI
testified that his follow-up included an
unannounced interview of Respondent
at her residence on May 19, 2014.12 Id.
at 73–74.
DI testified that during the interview,
Respondent admitted that she had
ordered a ‘‘small amount’’ of controlled
substances, telling DI she did so because
‘‘she was thinking about starting her
own private practice,’’ although she
added that she never did. Id. at 76. DI
testified that Respondent told him that
‘‘she received the controlled substances
at Decatur County General [Hospital],
she brought them to her residence and
secured them in an outside storage shed
that was behind her residence.’’ Id. at
77. DI testified that if Respondent were
11 The Government did not offer the ‘‘incident
report’’ into evidence and, therefore, I am not
considering it.
12 DI testified that another Diversion Investigator
assisted him with the interview of Respondent. Tr.
74–75.
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19013
‘‘going to administer or if she’s going to
dispense controlled substances or she’s
going to hold controlled substances for
dispensing, she would have to have a
registration there’’ but, to his
knowledge, Respondent’s residence was
never a DEA registered location. Id. at
76, 78; see also GX 2, 1–2. DI recounted
that Respondent said ‘‘she didn’t look in
the storage shed again until she went
there to conduct an inventory that was
requested by the Tennessee Department
of Health Office of Investigations.’’ Tr.
77–78. At that time, she learned that the
controlled substances were missing
from the shed. GX 4 (Memphis Police
Department Incident Report dated
November 6, 2013) (hereinafter,
Memphis Police Incident Report), at 1,
3; see also Tr. 121–22. According to the
Memphis Police Incident Report,
Respondent told the police that the
controlled substances went missing
‘‘anytime between March and . . .
[November 6, 2013] as she never goes
into the shed.’’ GX 4, at 3. The Memphis
Police Incident Report also stated that
‘‘There was no scene to process. There
was no damage to the shed, as the door
was unlocked.’’ Id.
According to DI, Respondent asked if
he would like to see the shed where she
had stored the controlled substances
and took the two Diversion Investigators
‘‘behind her residence outside’’ to the
shed that was ‘‘built onto the back of her
townhouse’’ and was ‘‘about the size of
a closet . . . [p]robably about four feet
across, maybe four feet deep[,] and
maybe eight feet tall.’’ Tr. 79–81; see
also id. at 154 (shed was attached to
Respondent’s residence). The shed did
not have a window, DI stated. Id. at 84.
DI testified that the shed ‘‘was probably
about 30 yards or so’’ from the street
and that ‘‘[t]here was no fence or
anything at the rear of her house. It was
just open all the way back, and there
were other townhouses that were
adjacent to hers that opened up to this
area.’’ Id. at 79; see also id. at 82–83. DI
described the shed’s door as a ‘‘hollowcore door’’ with ‘‘just a regular
doorknob that would be operated with
a key,’’ but stated that Respondent ‘‘just
turned it and opened it right up.’’ Id. at
81–82. DI testified that the door ‘‘was
rather beat up, and the frame of the door
was kind of damaged some, and also
where the lock was, . . . [Respondent]
stated that it didn’t shut very well.’’ Id.
at 82; see also id. at 83–84 (DI adding
that the shed door ‘‘looked like it would
be fairly easy to open up’’ and that he
could not ‘‘positively say’’ that he saw
any signs of break-in).
DI testified that his interview of
Respondent also addressed controlled
substance recordkeeping requirements.
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Id. at 84–85. He testified that he asked
Respondent if she had created an initial
inventory and that her response was
‘‘she had never created a regulatory or
an initial inventory.’’ Id. at 85–87.
DI testified that Respondent told him
she is not treating any family members.
Id. at 88. He stated that she admitted
treating J.J. and N.J., telling DI she
treated them ‘‘on the side,’’ and referred
to J.J. as her boyfriend with whom she
had a romantic relationship ‘‘for a brief
time.’’ Id. at 89; see also id. at 182–85,
189, 199–200; contra GX 6, at 8
(Respondent’s declaration and
attestation that she ‘‘dispens[es
controlled substances] to patients only
pursuant to a legitimate prescription
issued in the course of an established
doctor-patient relationship’’). DI
testified that J.J. also stated that he had
a romantic relationship with
Respondent ‘‘for a brief period of time.’’
Id. at 196–97. DI stated that N.J. said ‘‘he
saw . . . [Respondent] either at his
brother’s [J.J.’s] house—on one occasion
he saw her at a pharmacy . . . in a
parking lot.’’ Id. at 198–99. Both J.J. and
N.J., during DI’s interviews of them, told
DI that ‘‘the drugs [Respondent
prescribed for them] were based on a
complaint of injuries that they had.’’ Id.
at 201–02. DI testified that Respondent
told him she did not maintain medical
records for either J.J. or N.J. Id. at 89; see
also id. at 188–90.
When DI followed up on
Respondent’s statement that she did not
maintain medical records, he learned
from an attorney in the Office of General
Counsel of the Tennessee Department of
Health that the attorney had received a
medical record purportedly for J.J. from
Respondent’s previous Counsel. Id. at
127–28. DI testified that the attorney
emailed him what she had received
from Respondent’s previous Counsel. Id.
at 128–30; GX 10. DI stated that the
purported chart ‘‘didn’t have a name on
it.’’ Tr. 129. He testified that, since
Respondent ‘‘had told me that she had
not kept patient charts for N.J. or J.J.
when I interviewed her at her residence
. . . [,] I was doubtful about where these
charts—the alleged—the charts may
have come from . . . [o]r if they had
been created after the fact.’’ Id. at 133.
Respondent’s Counsel objected to the
admission of GX 10 because, she stated,
it was ‘‘represented as a complete
medical chart’’ for J.J. Id. at 131. The
Chief ALJ sustained her objection based
on foundation and relevance. Id. at 132–
33. His ruling, he advised, was without
prejudice for Government’s Counsel to
‘‘make . . . another run at it.’’ Id. at 132.
Government’s Counsel subsequently
presented arguments to the Chief ALJ
for the admission of GX 10. Id. at 136–
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37. His argument included that
Respondent had noticed she would be
relying on ‘‘virtually the same exhibit’’
as a medical record for J.J. consisting of
five more pages than GX 10. Id. at 138–
39. The Chief ALJ did not change his
ruling; GX 10 was never admitted. Id. at
139–42. I agree with this and the other
evidentiary rulings of the Chief ALJ
during the hearing.
As already discussed, DI stated that
he served a subpoena on the CSMD
seeking a ‘‘listing of all the prescriptions
that . . . [Respondent] had listed in the
CSMD’’ for the period of June 2011
through March or April 2014. Id. at 91.
He testified that he found ‘‘several
prescriptions that were attributed to’’ J.J.
and N.J. Id. at 92. Then, DI testified, he
obtained the original prescriptions
issued to J.J. and N.J. from the
pharmacies where they were filled. Id.
at 93. He stated that he issued
subpoenas to the three hospitals on
whose paper the prescriptions were
purportedly written seeking medical
records for J.J. and N.J.13 Id. at 94. The
three ‘‘no-record’’ responses that DI
received from the hospitals were
admitted into evidence. GX 8.
DI also subpoenaed the prescriptions
that Respondent issued to J.J. and N.J.
Tr. 99–101. DI identified GX 9 as
consisting of copies of eighteen original
controlled substance prescriptions, front
and back, that Respondent issued for J.J.
Id. at 99–100. The eighteen controlled
substance prescriptions were issued for
Percocet, Zolpidem, Alprazolam, and
Tussionex. GX 9. The prescriptions in
GX 9 were issued on either ‘‘Methodist
Healthcare Discharge Prescription
Orders,’’ ‘‘McNairy Regional Hospital
Elite Emergency Services,’’ or ‘‘Baptist
Memorial Hospital—Tipton’’ paper. Id.
DI also testified that GX 11 consists of
copies of original controlled substance
prescriptions that Respondent issued for
N.J. Tr. 101. According to GX 11,
Respondent issued controlled substance
prescriptions to N.J. for Tussionex and
Lortab. GX 11. The prescriptions in GX
11 were issued on either ‘‘Methodist
Healthcare Discharge Prescription
Orders’’ or ‘‘Baptist Memorial Hospital
Tipton Discharge Medications’’
paperwork. Id.
DI testified that GX 12a through GX
12l contain ‘‘copies of some of the
prescription logs that were submitted to
the [DEA] Nashville District Office.’’ Tr.
104–05. He clarified that the contents of
GX 12a through GX 12l ‘‘list N.J. and J.J.,
I believe.’’ Id. at 106.
During his testimony, DI pointed out
that Respondent’s April 2014 MOA13 The six subpoenas were admitted into
evidence. GX 7.
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required drug log does not include a
controlled substance prescription that
Respondent issued to N.J. for Tussionex
on April 30, 2014.14 Compare GX 11, at
5 and GX 12l, at 10; Tr. 116–17.
Regarding the OSC charge that
Respondent failed to provide six MOArequired drug logs, DI described during
his testimony the steps he took to
ascertain whether DEA received those
logs. Tr. 106–14; see also id. at 148–52.
He also testified that, given his belief
that Respondent sent the drug logs to
DEA by certified or registered mail, he
asked her about certified return receipt
cards when he interviewed Respondent
at her residence. Id. at 147; see also id.
at 148 (DI’s testimony that Respondent
told him that ‘‘she sent everything in
certified mail.’’). ‘‘[S]he went to a back
portion of her house and came back
with about four or five cards,’’ he
reported. Id. at 147. When DI asked her
if she had any more cards, she answered
in the negative. Id.
After DI’s testimony, the Government
called Stephen Loyd, M.D., its second
and final witness. Id. at 203–83. Dr.
Loyd is a practitioner whose medical
license in Tennessee and DEA
registration were in good standing and
were never subject to discipline. Id. 206.
His professional experience includes
being a hospital ‘‘residency program
director for internal medicine,’’
practicing hospital medicine, and
working in a hospital emergency
department. Id. at 231. Dr. Loyd testified
that ‘‘the course that’s required for every
physician in the State of Tennessee on
controlled substances, I teach.’’ Id. at
249–50. Having read and analyzed all of
the record evidence, I agree with the
Chief ALJ’s determination to recognize
Dr. Loyd as an expert in internal
medicine with an emphasis on the
proper prescribing of controlled
substances in Tennessee.15 Id. at 214.
Dr. Loyd testified that the 1995 Policy
Statement of the Tennessee Board of
Medical Examiners, entitled
‘‘Management of Prescribing with
Emphasis on Addictive or DependenceProducing Drugs,’’ GX 15 (hereinafter,
Tennessee Controlled Substance
Prescribing Policy Statement), applies to
Respondent’s allegedly unlawful
controlled substance prescribing as
Tennessee’s chronic pain guidelines did
not go into effect until after the time
period alleged in the OSC. Id. at 211–
12; see also id. at 281–82. I agree with
14 Government Counsel ‘‘withdrew’’ his statement
to the Chief ALJ that ‘‘[w]e’ll go through’’ the other
pages of GX 11 and GX 12l to identify any other
discrepancies between GX 11 and GX 12l. Tr. 119–
20.
15 Respondent’s Counsel did not object to this
determination. Tr. 214.
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Dr. Loyd’s assessment and the
application of the Tennessee Controlled
Substance Prescribing Policy Statement
to this proceeding.
Dr. Loyd correctly characterized the
Tennessee Controlled Substance
Prescribing Policy Statement as setting
out the nine ‘‘steps that were accepted
practice for the proper prescribing of
when . . . [controlled substance]
medications were indicated’’ for acute
or chronic pain. Id. at 215–16. He
explained the first step, having a
‘‘workup sufficient to support a
diagnosis,’’ as the ‘‘establishment of a
proper diagnosis that would indicate a
need for a controlled substance for
pain.’’ Id. at 216; GX 15, at 1. Dr. Loyd
testified that the workup sufficient to
support a diagnosis begins with the
patient’s chief complaint, ‘‘[a]ll of the
things surrounding that chief complaint,
the who, what, where, when, why, how,
around that chief complaint,’’ and ‘‘then
the history of present illness.’’ Tr. 224.
He noted that pain is a symptom, not a
disease, and ‘‘so the first part . . . is
establishing a diagnosis as to the root of
the pain, so you can address that, rather
than the symptom.’’ Id. at 218.
For pain patients in general, including
chronic pain patients, Dr. Loyd testified
that ‘‘it’s vitally important that you have
some kind of subjective statements from
the patient as to the limitations the pain
is causing and their activities of daily
living.’’ Id. at 224. Knowing the
patient’s limitations caused by the pain
is important, he explained, because the
purpose of a practitioner’s intervention
is ‘‘to try to improve that patient’s
functioning with whatever condition
that they have.’’ Id. at 225. If the
patient’s limitations are ‘‘very little,’’ he
suggested that the associated risks
would render a controlled substance
intervention inappropriate. Id. He also
suggested that the efficacy of the
intervention is judged by the
intervention’s impact or lack of impact
on the patient’s limitations caused by
the pain. Id.
In a similar vein, Dr. Loyd
summarized the second and third steps
as concerning ‘‘the use of noncontrolled substance modalities to try to
address the pain issues first, before
moving onto a controlled substance.’’ Id.
at 216.
Regarding the fourth step, Dr. Loyd
pointed out that ‘‘the reality here is that
these [controlled substance]
medications are very effective, but they
also have abuse potential.’’ Id. at 217.
As such, he testified, ‘‘you have to
weigh the risk versus benefits, and so
. . . there are some things that you need
to do to try to ascertain your patients’
risk for abusing one of these prescribed
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controlled substances.’’ Id. ‘‘One of the
big risk factors for misusing prescribed
controlled substances,’’ he explained,
‘‘is someone that has a history or a
family history of substance use
disorder,’’ including alcohol and
prescription pills. Id. at 226. Urine drug
screens, he testified, are ‘‘sometimes the
truth serum for that history’’ and assist
with the practitioner’s determination of
whether an ‘‘underlying substance use
disorder . . . [is] really the problem,
instead of the problem that they’re
presenting.’’ Id. at 227–28; see also id.
at 230. Dr. Loyd reported that, initially,
he will ‘‘usually do a 10 or 12 panel
[urine drug screen] that has a mixture of
prescribed drugs, as well as illicit drugs,
and the common illicit drugs are on
there, methamphetamine, cocaine,
marijuana.’’ Id. at 228–29.
Subsequently, if he prescribed a
controlled substance for treatment, the
urine drug screen he orders will test ‘‘to
make sure those drugs are in their
system’’ and, if not, he ‘‘want[s] to know
where they’re going. And most of the
time that’s diversion.’’ Id. at 229; see
also id. at 230 (Someone would ‘‘pretty
much live under a rock not to know
what’s going on in our state in
Tennessee right now with regards to
prescription drug abuse. So we have a
lot of pills that are diverted.’’).
Along these lines, Dr. Loyd described
the fifth step, obtaining informed
consent ‘‘as to the risk of developing a
dependence and addiction on the
prescribed medication, even if it’s for [a]
legitimate medical need.’’ Id. at 218. Dr.
Loyd explained that ‘‘the approach has
been to start with the least invasive,
least dangerous things first, so as in the
treatment of any disease, you want to be
as least invasive as possible.’’ 16 Id.
Regarding the standard of care for the
general practice of medicine, Dr. Loyd
described the initial patient visit as
when the practitioner ‘‘establish[es] the
framework and the groundwork of
where you’re starting, and subsequent
medical visits will be . . . based on the
intervention that you make in the first
medical visit and what kind of
improvements or not improvements that
you have at subsequent visits.’’ Id. at
223. Further, he characterized patient
safety as the practitioner’s ‘‘first
consideration,’’ citing to the Hippocratic
Oath as ‘‘First, do no harm’’ and then
‘‘Second, then try to help.’’ Id. at 224.
Dr. Loyd also testified about the
importance of obtaining medical records
from previous treating practitioners. Id.
16 ‘‘Somebody has chest pain, you don’t move
straight to open-heart surgery,’’ Dr. Loyd
analogized. Tr. 218. ‘‘There are things that you do
prior to that and open-heart may be where you
wind up, but definitely not where you start.’’ Id.
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at 225. A practitioner uses the
information in other practitioners’
treatment records to inform what
treatment to prescribe and what
treatments not to prescribe. Id. at 225–
26.
Dr. Loyd testified that he worked with
physician contractors in a hospital
setting. Id. at 231. He testified that, in
his experience, hospital physician
contractors work in a group and report
to the contractor head of the group. Id.
at 232. The contractor group head, in
turn, is ‘‘accountable to the hospital for
the services they contract for,’’ Dr, Loyd
continued. Id. He specifically testified
that contractor physicians are ‘‘subject
to the record-keeping that’s required by
the accrediting bodies, Joint
Commission, as well as Medicare,
Medicaid, all the insurance companies
and most commonly, the hospital that
you’re working for, and you’re also
subject to peer review within that same
hospital.’’ Id. at 232–33. Regarding
record-keeping, Dr. Loyd testified that
‘‘there’s a lot of risk with . . . not
maintaining a patient record and safety
would be the biggest one.’’ Id. at 235–
36. He continued that ‘‘it will violate
. . . standards from accrediting bodies,
such as Joint Commission.’’ Id. at 236.
Concluding, Dr. Loyd added that ‘‘you
also get into the fact that if you don’t
have a medical record and you billed for
that service to an insurance company,
you don’t have the documentation to
support a level of care for that
reimbursement, so that gets into what’s
considered to be fraud.’’ Id.
Dr. Loyd continued to testify in
increasing detail about the importance
of maintaining medical records, or
patient charts, during his testimony
about GX 9 (prescriptions Respondent
issued to J.J.), GX 11 (prescriptions
Respondent issued to N.J.), and GX 14
(Dr. Loyd’s report on Respondent’s
controlled substance prescribing for N.J.
dated October 1, 2016). Medical records
are the ‘‘crux,’’ he stated, the
‘‘foundation of what we’re trying to do
here.’’ Tr. 240. He explained that they
are ‘‘going to establish . . . history,
present illness, past medical history,
surgical history, social history, physical
examination, assessment and plan, . . .
[and they are] going to validate how a
diagnosis was arrived at and the
subsequent treatment plan for that
diagnosis . . . [and] for a lot of other
things, other than that.’’ Id. Dr. Loyd
testified that he would expect
Respondent to take a history, including
a personal drug history, conduct a
physical examination, make a diagnosis,
start any intervention with a treatment
that has the highest potential for benefit
and the lowest amount of risk, and
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establish and document informed
consent before prescribing a controlled
substance. Id. at 241–44.
As memorialized in his report
regarding N.J., GX 14, Dr. Loyd
explained that he received copies of
three controlled substance prescriptions
Respondent issued to N.J., but no
medical record by Respondent about
N.J. ‘‘so I couldn’t comment as to the
thoroughness of the history, the
appropriateness of the diagnosis.’’ Id. at
246; see also id. at 241 (discussing the
controlled substances that Respondent
prescribed for N.J.) As such, Dr. Loyd’s
report summarizing his ‘‘findings for the
material that . . . [he] reviewed that
day’’ was five sentences, including the
statement that ‘‘[t]here were no medical
records to support the history, physical
examination and thought process that
led to the prescribing of these
medications.’’ Id. at 246; GX 14, at 1. Dr.
Loyd’s report concluded that
‘‘[e]ssentially, the controlled substances
were prescribed with nothing to support
their use’’ and, thus, that the
‘‘controlled substances prescribed for
. . . [N.J.] were prescribed outside the
scope of accepted medical practice and
were not for a legitimate medical
purpose.’’ GX 14, at 1.
Respondent’s Counsel, among other
things, asked Dr. Loyd whether he had
been ‘‘advised since the preparation of
. . . [his] report that there are, in fact,
medical records that exist for N.J.’’ and
whether he had ‘‘seen those records.’’ 17
Tr. 259. Dr. Loyd responded
affirmatively to both questions. Id. at
259–60. He testified that he did not
supplement his initial report after
seeing those records. Id. at 260. Dr. Loyd
also indicated that he was provided
‘‘nothing [on which] to base’’ an opinion
about whether N.J. ‘‘exhibited any signs
of drug dependency, . . . drug abuse
. . . [or] drug-seeking behavior . . . [, or
whether N.J. was] diverting these drugs
to anyone else . . . [or] suffered any
harm because of these prescriptions.’’
Id. at 260–61.
Thereafter, Government’s Counsel
asked Dr. Loyd whether the ‘‘proposed’’
N.J. medical records included ‘‘any
personal history of substance abuse with
regard to any of the prescriptions that
were issued.’’ Id. at 261, 271. Dr. Loyd
answered that ‘‘[t]here was a block on
the ED chart that asked about substance
use and . . . [N.J.] denied alcohol or
. . . [illicit] drugs. So she did do it,
yes.’’ Id. at 271. He continued his
17 The Government did not mention a medical
record for N.J. in its Exhibit List or in either of its
Pre-Hearing Statements. Presumably, Respondent
provided her Counsel with the medical records for
N.J. about which Respondent’s Counsel asked Dr.
Loyd. Tr. 259.
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answer by stating that he would have
expected to see documentation of
follow-up to verify this information due
to the ‘‘potential health risk for sure in
combining substances that work in the
central nervous system’’ with alcohol
use since it would increase the ‘‘risk of
a bad outcome.’’ Id. at 273. He testified,
though, that he did not see any
documentation of Respondent’s having
addressed with N.J. the potential risks of
mixing the controlled substances she
prescribed for him with alcohol and of
dependence and/or addiction with
prolonged use. Id. at 273–74.
Government’s Counsel asked Dr. Loyd
whether the ‘‘proposed’’ N.J. medical
records indicated ‘‘any settings where
. . . [N.J.] was purportedly treated.’’ Id.
at 267; see also id. at 274. Dr. Loyd
opined the ‘‘emergency department as
well as I can tell.’’ Id. at 267–68. He also
testified that he would expect a medical
record’s statement about the setting at
which medical treatment was provided
to be accurate. Id. at 275. Dr. Loyd also
testified that he ‘‘was surprised that
once that initial [emergency
department] visit happened, that from
then on . . . [N.J.’s respiratory and pain
issues were] not taken care of in a
primary care setting . . . or his primary
care physician or a pain medicine
specialist setting.’’ 18 Id. at 269. He
indicated that he ‘‘absolutely’’ would
have expected to see coordination of
treatment between an emergency
department physician and a primary
care physician given N.J.’s extended
period of treatment in an emergency
room setting, but found no evidence of
it in the ‘‘proposed’’ N.J. medical
records. Id. He also noted that,
‘‘whenever we’re talking about a case
like this, . . . [seeking treatment at the
emergency department] would have
been a red flag that somebody is coming
in here explicitly for narcotics.’’ Id. at
278. He elaborated by asking ‘‘why are
they not presenting to their other doctor,
to their primary care physician, who
knows them much better than we do.’’
Id.
Government’s Counsel asked Dr. Loyd
whether he saw any evidence of urine
drug screening in the ‘‘proposed’’ N.J.
medical records. Id. at 269–70. Dr. Loyd
testified that he would have expected to
see urine drug screening ‘‘[g]iven that a
controlled substance was prescribed on
multiple occasions,’’ but he did not. Id.
Dr. Loyd stated that he would have
expected N.J. to give informed consent
‘‘prior to the prescribing [of] controlled
18 Dr. Loyd stated that he has seen patients use
emergency departments for medical treatment due
to ‘‘economic reasons,’’ such as no health
insurance. Tr. 277–78.
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substances,’’ but that he ‘‘did not see
informed consent in the [proposed N.J.]
medical record.’’ Id. at 270. He
elaborated by testifying that N.J.’s family
history of alcoholism, alcohol abuse, or
alcohol misuse put N.J. ‘‘by definition at
increased risk to misuse prescribed
controlled substances’’ such that he
would want to give N.J. ‘‘informed
consent of the risk and benefits of using
. . . [controlled] medication including
his risk for possible misuse and
development of subsequent dependence
and/or addiction.’’ Id. at 270–71.
Further, Government’s Counsel asked
Dr. Loyd whether he saw any evidence
in the ‘‘proposed’’ N.J. medical records
that Respondent had ‘‘explore[d]
limitations on N.J.’s activities as a result
of pain.’’ Id. at 276. Dr. Loyd responded
that he thought, although he ‘‘could
have misread this,’’ that ‘‘there was
concern of whether or not . . . [N.J.]
would be able to maneuver himself with
regards to his weapon.’’ 19 Id.; see also
id. at 268 (Dr. Loyd’s testimony about
N.J.’s ‘‘proposed’’ medical records that
‘‘there was some concern that he was
having problems with maneuvering in
his job with regards to . . . the pain that
he was having.’’). Dr. Loyd testified that
he saw nothing in N.J.’s ‘‘proposed’’
medical records that Respondent
explored any treatment modality for N.J.
other than a controlled substance. Id. at
276. Dr. Loyd also testified that
Respondent did not document, in the
‘‘proposed’’ N.J. medical records, that
she followed up with N.J. during any
subsequent visit about whether the
controlled substance prescription she
issued for him was effective by, for
example, asking him whether he was
able to maneuver as he needed to do his
job after starting the controlled
substance therapy. Id. at 276–77.
Dr. Loyd summarized the
‘‘fundamental issues’’ he had with the
‘‘proposed’’ N.J. medical records ‘‘as far
as the proper prescribing [of] controlled
substance[s],’’ stating that the ‘‘root of
the issue is really in the establishment
of the diagnosis being such that it would
have required a controlled substance
before trying any other non-controlled
substance modality for treatment.’’ Id. at
274. He testified that, after reviewing
the ‘‘proposed’’ medical records for N.J.,
he did not change his opinion that
Respondent prescribed controlled
substances for N.J. for no legitimate
purpose. Id. at 277.
I agree with the Chief ALJ that Dr.
Loyd ‘‘presented as knowledgeable,
objective, and thoughtful in his answers,
19 The testimonies of both DI and Dr. Loyd
indicate that N.J. worked for the Sheriff, possibly
as a Deputy Sheriff. Tr. 200, 268.
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without any indication of an agenda.’’
RD, at 17. In this Decision/Order, I give
controlling weight to Dr. Loyd’s
testimony as did the Chief ALJ because
Dr. Loyd ‘‘has extensive experience
practicing, writing, and lecturing on the
subject matter of his testimony.’’ Id.
Further, I note that Respondent did not
put on a case or proffer a witness, let
alone an expert, to rebut Dr. Loyd’s
testimony. As such, in addition to the
independent persuasiveness of Dr.
Loyd’s testimony, his testimony is
unrebutted in the record before me.
D. Respondent’s Case
Immediately after the Government
rested, Respondent’s Counsel moved for
summary disposition on the ground that
the Government had not established a
prima facie case. Tr. 285–86. Among
other things, the motion was based on
the theory that the Government
introduced no evidence that the drug
logs Respondent submitted to DEA were
‘‘falsified,’’ as opposed to simply ‘‘not
correct,’’ because the incorrect material
was not a mandated data point in the
MOA. Id. at 286–87. The motion argued
that the MOA does not prohibit
Respondent from issuing controlled
substance prescriptions to J.J. because it
only prohibits prescribing to ‘‘family
members,’’ and boyfriends, friends, and
‘‘intimate acquaintances’’ are not
‘‘family members.’’ Id. at 287.
The summary disposition motion
argued that the Government failed to
establish a violation based on
Respondent’s medical care of J.J. ‘‘in
that those records are not before the
Court . . . ‘‘[s]o there’s really nothing to
consider.’’ Id. at 287–88. The summary
disposition motion explicitly
acknowledged the existence of the
charge that Respondent created no
medical records for N.J. while claiming
that ‘‘any criticisms were not . . .
presented to [Respondent] as far as the
quality of the care, the need for those
prescriptions and so she, therefore, was
not prepared to respond to those.’’ 20 Id.
at 288.
Regarding the allegation that
Respondent did not store controlled
substances securely, the summary
disposition motion argued that
‘‘according to the [G]overnment’s own
witness, if . . . [Respondent] kept . . .
[controlled substances] in a locked,
secure cabinet within the shed, that
20 The summary disposition motion stated that DI
‘‘did not determine that the drugs were being
diverted or there was nothing indicating it was for
anything other than a legitimate medical purpose
from his perspective as a non-physician.’’ Tr. 288.
She added that N.J., himself, ‘‘offer[ed]’’ that there
was a legitimate medical purpose for the controlled
substance prescriptions. Id.
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would have been in compliance with
the . . . plain language of the
regulations.’’ Id. at 289. According to
the motion, ‘‘[t]here is no evidence that
. . . [Respondent] dispensed any
medications from this residence, that
she operated any business or that she
intended to operate a business’’ and,
therefore, ‘‘many of the regulations that
were cited . . . [in the OSC] are not
applicable.’’ 21 Id.
The summary disposition motion
counted initial inventory requirements
among the ‘‘many’’ inapplicable
regulations cited in the OSC. Id. at 291.
Referring to the legal argument that the
invoice Respondent received in
connection with the Moore Medical
purchase satisfied the ‘‘initial
inventory’’ requirement, the motion
admitted that the invoice ‘‘failed to
specify’’ whether the ‘‘inventory’’ was
taken at the beginning or the end of the
day. Id. The motion minimized this
deficiency, arguing that ‘‘this was not an
ongoing concern,’’ that Respondent
‘‘was the only one who had control of
these drugs,’’ and that ‘‘[i]f this case is
about the fact she didn’t say whether it
was the beginning or the end of the day,
I mean that’s not why we’re here.’’ Id.
at 291–92. According to the motion,
Respondent ‘‘had not yet commenced a
business.’’ Id. at 294. ‘‘I think they’re
reading way too much into’’ the
declaration in the Moore Medical
purchase packet, the motion argued, and
‘‘[t]here’s no evidence that she had any
kind of any ongoing—that she had a
medical clinic that she was operating,
that she . . . dispense[d] any of these
drugs . . . [– s]he didn’t charge for
seeing patients, which is—that’s
conducting a business.’’ Id. The motion
argued that ‘‘[t]hese regulations are
designed for people who are seeing
patients and dispensing these drugs and
documenting the distribution thereof’’
and ‘‘[i]t’s imposing far too many
requirements on somebody who is just
anticipating doing so in the future.’’ Id.;
see also id. at 295.
The Chief ALJ provided input during
the presentation of Respondent’s
summary disposition motion. Tr. 290–
310. The Chief ALJ pointed out the
weaknesses and deficiencies of the
motion’s arguments while agreeing with
their strengths. Id. For example, the
Chief ALJ agreed that the burden is on
the Government to present a prima facie
case, and stated clearly that the
‘‘question is, in viewing the evidence in
21 According to Respondent’s summary
disposition argument, her residence ‘‘was not a
principal place of business or professional practice.
She did not manufacture, distribute, import, export,
or dispense drugs at that location. That is
undisputed under the record.’’ Tr. 289.
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the light most favorable to the
[G]overnment, have they put some
evidence on everything they would
need to make out a prima facie case.’’
Id. at 295; see also id. at 299 (Chief
ALJ’s statements pointing to record
evidence countering the argument that
the Government had not met its burden
for the allegation that Respondent did
not submit all of the MOA-required drug
logs); id. at 300–01 (Chief ALJ’s
assessment of whether the Government
presented sufficient evidence to
establish its case, and views on the
appropriateness of a sanction); id. at
301–03 (discussion involving
Respondent’s Counsel and Chief ALJ
about the record evidence to date about
MOA compliance); id. at 303–05
(conversation between Respondent’s
Counsel and the Chief ALJ about
unlawful prescribing allegations); id. at
305–07 (focused analysis of the existing
record evidence and stipulation
concerning the documentation of
Respondent’s controlled substance
prescribing); id. at 307–09 (targeted
discussion of ‘‘nonsense’’ and
‘‘anomalies’’ in Respondent’s controlled
substance prescribing documentation).
In addition to hearing the back-andforth between her Counsel and the Chief
ALJ, Respondent also had the benefit of
hearing the position of Government’s
Counsel on several issues, substantive
and procedural. Id. at 310–15. For
example, Government’s Counsel
repeatedly argued that Respondent’s
Counsel had presented argument about
her ‘‘theory of the case,’’ as opposed to
‘‘sworn testimony.’’ Id. at 310–11. He
explicitly addressed the Government’s
position that, ‘‘as the record stands now,
there are no patient charts in the record
[for either J.J. or N.J.,] one of the charges
. . . in the charging documents.’’ Id. at
313.
The analyses and discussions that
took place in Respondent’s presence
also included the Chief ALJ’s ruling on
Respondent’s motion for summary
disposition. Id. at 311–12, 314–15, 322–
29. In denying Respondent’s summary
disposition motion, the Chief ALJ
provided input on specific matters at
issue in the proceeding. First, he
specifically stated that the Government
had ‘‘put forth some evidence that some
information on the dispensing logs,
including the location where patients
N.J. and J.J. were treated may be
inaccurate.’’ Id. at 324. The Chief ALJ
added that, for the Government to
prevail on this allegation, ‘‘there is no
requirement that purported falsehoods
be restricted to information that was
specifically required by the terms of the
MOA.’’ Id.
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Second, the Chief ALJ stated that he
was reserving Respondent’s motion as to
whether Respondent violated the MOA
by prescribing controlled substances to
J.J., assuming that Respondent and J.J.
were romantically involved. Id. at 324–
25. The Chief ALJ noted that the
Government cited to ‘‘authority under
Tennessee law that prescribing to a
patient . . . [with] whom the physician
has a romantic involvement falls below
the applicable standard of care in
prescribing, and thus this aspect of the
motion is denied.’’ Id. at 325. He also
noted that ‘‘a precise timeline of the
romantic involvement [between
Respondent and J.J.] was not
established.’’ Id. Third, the Chief ALJ
also stated that the Government
presented ‘‘at least some evidence that
controlled substance prescribing to
patient J.J. in the face of a potential
romantic relationship and in the
absence of medical documentation . . .
could place the prescribing as outside
the course of a professional practice and
without a legitimate medical purpose[ ],
and in violation of Tennessee state
law.’’ Id. at 325–26.
Fourth, on the allegation of unlawful
controlled substance prescribing to N.J.,
the Chief ALJ similarly denied
Respondent’s motion, stating that the
Government presented ‘‘at least some
evidence that the prescribing was done
without medical documentation, and
even if medical documentation that had
been previously presented by the
Respondent, albeit presented late were
presumed valid, that it was inadequate
to establish that the prescribing was
done for [a] legitimate medical purpose
and within the course of a professional
practice.’’ Id. at 326.
Fifth, the Chief ALJ denied
Respondent’s motion for summary
disposition on the allegation that
Respondent failed to provide DEA with
all of the drug logs required by the
MOA. Id. at 326–27. He stated that DI
testified about how the relevant DEA
office processes mail and about the
search DI conducted for Respondent’s
drug logs. Id. at 327.
Sixth, the Chief ALJ stated that the
Government presented ‘‘some evidence
that the Respondent did maintain
controlled substances in this residential
outside shed’’ and reserved the ‘‘legal
issue as to whether their registration
was required.’’ Id. Seventh, also
regarding the allegation that Respondent
stored controlled substances in a shed
with inadequate security, the Chief ALJ
denied Respondent’s summary
disposition motion because the
Government presented ‘‘some evidence
that the Respondent stored controlled
substances in a shed with a modest lock
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under conditions that arguably did not
satisfy the security requirements set
forth in the regulations actually or
substantially.’’ Id. at 328.
Eighth, the Chief ALJ denied
Respondent’s motion concerning the
initial controlled substance inventory
requirement because the Government
presented ‘‘some evidence that the
Respondent admitted to DI . . . that she
never prepared or maintained an initial
inventory as well as evidence in a
declarations signed by the Respondent
that she was expanding an already
existing practice.’’ Id. at 328–29. He
added that ‘‘an invoice prepared by the
vendor would not satisfy her inventory
obligation under the regulations.’’ 22 Id.
at 329.
After the Chief ALJ ruled on her
motion for summary disposition,
Respondent stipulated that she did not
treat J.J. or N.J. at a hospital. Id. at 330–
31; see also supra n.3. She also obtained
the Chief ALJ’s approval to receive into
evidence her corrective action plan as
Administrative Law Judge Exhibit 29.
Tr. 334–35 (Chief ALJ’s statement that
the ‘‘corrective action plan is not
something that the administrative law
judge deals with,’’ ‘‘[i]t’s not part of
what I have to recommend,’’ ‘‘I can
include it in the record or not,’’ and ‘‘[i]t
needs to go to the Office of Diversion
Control.’’).
Thereafter, Respondent’s Counsel
advised the Chief ALJ that Respondent
was not going to present a case, stating
that her client ‘‘would like to accept
responsibility for her errors in this case’’
and ‘‘[w]e would just request leniency
in your recommendations.’’ Tr. 335. The
Chief ALJ appropriately pointed out
that, for a respondent to prevail, prior
Agency decisions require a respondent’s
unequivocal acceptance of
responsibility and the submission of
appropriate remedial measures. Id. at
336–37 (Chief ALJ’s statements,
including ‘‘I want to make you aware of
it. . . . I just wanted to raise that with
you before you’ve rested.’’). Respondent
reaffirmed her decision to rest after
consulting again with her Counsel
during a break that the Chief ALJ took
specifically for that purpose. Id. at 337–
39.
Accordingly, I find that Respondent’s
decision not to present a case was
communicated to the Chief ALJ after she
had been present at the hearing, after
she had the opportunity to observe and
hear the Government’s evidence in
support of the OSC’s allegations, and
22 When Respondent’s Counsel asked for the
Chief ALJ’s ruling on the allegation that Respondent
did not complete dispensing logs, he indicated that
his ruling was subsumed in the rulings he issued.
Tr. 329.
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after she had the opportunity to hear the
Chief ALJ’s ruling denying her motion
for summary disposition. I find that
Respondent’s decision not to present a
case was communicated after the Chief
ALJ received her corrective action plan
into evidence and after she stipulated
that she never treated J.J. or N.J. in a
hospital. I further find that after
Respondent’s decision not to present a
case was first communicated to the
Chief ALJ, the Chief ALJ offered his
interpretation of past Agency decisions’
statements about the unequivocal
acceptance of responsibility and his
practical reflection that her not
presenting a case ‘‘cuts off any other
evidence coming in.’’ Id. at 338. I also
find that, after the Chief ALJ offered his
interpretation and practical reflection,
Respondent’s Counsel asked for and
received ‘‘a few minutes to confer with
my client in response to Your Honor’s
comments.’’ Id. at 337. Finally, I find
that Respondent consulted with her
Counsel before the initial
communication of her decision not to
present a case, and had the additional
opportunity to consult with her Counsel
after the Chief ALJ offered his
interpretation and practical reflection.
Id. at 338 (Respondent’s Counsel,
responding to the Chief ALJ’s question
about how much time ‘‘will be enough’’
to confer with her client about whether
to present a case, stating that ‘‘I mean,
we’ve discussed it, so there’s not much
additional we need to discuss, but just
in light of the point Your Honor has
raised, I want to just make sure that I
have an opportunity for her to talk about
this before making any final
decisions.’’).
Respondent’s decision not to present
a case means that there are no factual
disagreements between witnesses’
testimonies that I need to resolve.
E. Allegation That Respondent
Continued To Issue Controlled
Substance Prescriptions to Individuals
Who Are Intimate or Close
Acquaintances, and to an Individual
With Whom She had a ‘‘Romantic
Interaction’’ in Violation of Tenn.
Comp. R. & Regs. R. 0880–2–.14(8)(a)
and Tenn. Code Ann. § 63–6–214(b)(1)
The OSC charged Respondent with
‘‘issuing prescriptions to individuals
who are intimate or close
acquaintances.’’ OSC, at 2. DI testified
that both Respondent and J.J. told him
that they were in a romantic
relationship for a brief period time.23 I
credit DI’s testimony. I find, however,
23 When DI interviewed him, N.J. also stated that
Respondent and J.J. were girlfriend-boyfriend. Tr.
199.
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that this evidence of a boyfriendgirlfriend relationship, a romantic
relationship, or any other record
evidence detail neither the parameters
of the romantic involvement of
Respondent and J.J. nor the period of
time of that romantic involvement.
F. Allegations That Respondent
Provided Controlled Substance
Prescription Drug Logs to DEA With
Falsified Entries ‘‘Noncompliant With
Terms of the June 2011 MOA’’ in
Violation of 21 U.S.C. 843(a)(4)(A), and
‘‘Provid[ed] Misleading Information to
Investigating Agents’’ Implicating 21
U.S.C. 823(f)(5)
The OSC alleged that Respondent’s
drug log submissions to DEA for August,
October, and November of 2012,
February, May, June, July, October, and
November of 2013, and January 2014
contained false entries ‘‘noncompliant
with the terms of the June 2011 MOA’’
because they ‘‘represented that . . .
[she] issued controlled substance
prescriptions to J.J. and his brother N.J.
. . . while treating these individuals at
Methodist Fayette Hospital in
Somerville, Tennessee; Baptist
Memorial Hospital in Covington,
Tennessee; and/or McNairy Regional
Hospital in Selmer, Tennessee.’’ OSC, at
2. It also alleged that Respondent
‘‘provid[ed] misleading information to
investigating agents, 21 U.S.C.
823(f)(5).’’ Id. at 3.
I find that the record evidence
includes twelve instances when
Respondent submitted drug logs to DEA
with entries concerning J.J. and/or N.J.
whose cover transmittal letters and
specific J.J. and N.J. entries falsely,
according to one of the parties’
stipulations, indicate that ‘‘[a]ll
prescriptions were written while on
duty as the ER physician at the named
hospital for registered patients.’’ GX
12a, at 1, 4, and 5 (October 2012, two
for J.J. and two for N.J.); GX 12b, at 1
and 4 (November 2012, two for J.J.); GX
12c, at 1, 6, and 7 (February 2013, two
for J.J. and one for N.J.); GX 12d, at 1,
9, and 16 (April–May 2013, two for J.J.
and one for N.J.); GX 12e, at 1, 7, and
18 (May–June 2013, two for J.J. and one
for N.J.); GX 12f, at 1 and 9 (July 2013,
one for N.J.); GX 12g, at 1, 6, and 17
(August 2013, two for J.J. and one for
N.J.); GX 12h, at 1 and 3 (October 2013,
two for J.J.); GX 12i, at 1, 4, and 7
(November 2013, two for J.J.); GX 12j, at
1 and 2 (January 2014, one for J.J.); GX
12k, at 1 and 5 (February 2014, one for
J.J.); GX 12l, at 1 and 3 (April 2014, one
for J.J.); see also supra, section II.C. and
section II.D. (discussing the stipulation
reached during the hearing). Likewise, I
find that the stipulation Respondent
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agreed to during the hearing that she did
not treat J.J. or N.J. at a hospital is
Respondent’s implicit admission that
those twelve cover transmittal letters
she sent DEA with the MOA-required
drug logs contained in GX 12a through
GX 12l and the individual entries for J.J.
and N.J. in those drug logs are not fully
accurate. Supra, section II.D. (discussing
the stipulation reached during the
hearing).
Accordingly, I find substantial
unrebutted record evidence that
Respondent provided controlled
substance prescription drug logs to DEA
with falsified entries, thereby providing
misleading information to DEA
investigators.
G. Allegation That Respondent Issued
Controlled Substance Prescriptions to
J.J. and N.J. for No Legitimate Medical
Purpose and Outside the Usual Course
of Professional Practice in Violation of
21 CFR 1306.04(a), Tenn. Comp. R. &
Regs. R. 0880–2–.14(6)(a)(4) and (e), and
Tenn. Code Ann. § 63–6–214(b)(12)
The OSC alleged that Respondent
‘‘issued controlled substances . . . [to
J.J. and N.J.] for no legitimate medical
purpose and outside the usual course of
professional practice,’’ citing provisions
of federal and state law. OSC, at 2. I find
that DI’s unrebutted testimony, in
conjunction with GX 7, GX 8, and GX
9, establish that Respondent issued
controlled substance prescriptions to J.J.
on paperwork from a hospital at which
Respondent did not treat J.J. GX 7, GX
8, GX 9, Tr. 99–103; see also supra,
section II.D. (discussing the stipulation
reached during the hearing). I further
find that these prescriptions were
written over the course of eighteen
months and were for Percocet (eleven
prescriptions for this Schedule II
controlled substance), Tussionex (two
prescriptions for this Schedule II
controlled substance), Zolpidem (one
prescription for this Schedule IV
controlled substance), and Alprazolam
(four prescriptions for this Schedule IV
controlled substance).
I also find that DI’s unrebutted
testimony, in conjunction with GX 7,
GX 8, and GX 11, establish that
Respondent issued controlled substance
prescriptions to N.J. on paperwork from
a hospital at which Respondent did not
treat N.J. GX 7, GX 8, GX 11, Tr. 100–
03; see also supra, section II.D
(discussing the stipulation reached
during the hearing).
As already discussed, the Exhibits
entered into the record do not include
medical records purporting to be either
for J.J. or for N.J. I note that this matter
is due, in part, to Respondent’s
successful objection to the admission of
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a proposed Government exhibit
purporting to be Respondent’s medical
record for J.J. and to her decision during
the administrative hearing not to
present a case.24 Supra section II.D.
Accordingly, I find that substantial
record evidence shows that Respondent
did not adequately document in a
medical record her controlled substance
prescribing for either J.J. or N.J.25
H. Allegation That Respondent Failed
To Maintain Medical Records Pertaining
to Her Prescribing of Controlled
Substances to N.J. in Violation of Tenn.
Comp. R. & Regs. R. 0880–2–
.14(6)(e)(3)(i) and Tenn. Code Ann.
§ 63–6–214(b)(12)
Similarly, the OSC alleged that
Respondent ‘‘fail[ed] to maintain
treatment records pertaining to . . .
[her] prescribing of controlled
substances to N.J.’’ OSC, at 2. The
record certified to me contains no
admitted exhibit constituting a medical
record that Respondent created for N.J.
The unrebutted record evidence shows
that DI subpoenaed the medical records
of the three hospitals at which
Respondent served as a contract
emergency medicine physician and that
all three of the hospitals provided a ‘‘no
record’’ response for N.J. medical
records. GX 7, GX 8. This OSC charge
puts the Government in a position of
proving a negative. Despite this hurdle,
I find substantial record evidence that
Respondent did not maintain medical
records adequately documenting her
controlled substance prescribing for N.J.
There are six reasons for my finding.
First, as already discussed, I find that
the relevant three hospitals sent ‘‘no
record’’ responses after receiving DI’s
subpoenas for N.J. medical records.
Second, I find that, if medical records
existed concerning her controlled
substance prescribing for N.J.,
Respondent certainly would know about
them and be able to raise their existence
in furtherance of her defense against the
24 The record also shows the awareness of
Respondent’s Counsel of a ‘‘proposed’’ medical
record for N.J. and her decision not to take steps
to have it introduced into the record. Supra section
II.C; infra section II.H.
25 In addition, this Agency has applied, and I
apply here, the ‘‘adverse inference rule.’’ As the
D.C. Circuit explained, ‘‘Simply stated, the rule
provides that when a party has relevant evidence
within his control which he fails to produce, that
failure gives rise to an inference that the evidence
is unfavorable to him.’’ Int’l Union, United Auto.,
Aerospace & Agric. Implement Workers of Am.
(UAW) v. Nat’l Labor Relations Bd., 459 F.2d 1329,
1336 (D.C. Cir. 1972). The Court reiterated this rule
in Huthnance v. District of Columbia, 722 F.3d 371,
378 (D.C. Cir. 2013). According to this legal
principle, Respondent’s decision not to provide
evidence within her control gives rise to an
inference that the evidence is unfavorable to
Respondent.
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OSC. She chose not to do so and she did
not do so. Instead, after raising the
matter herself by questioning Dr. Loyd
about whether he was ‘‘advised since
the preparation of . . . [his expert]
report that there are, in fact, medical
records that exist for N.J.’’ and asking
him whether he has ‘‘seen those
records,’’ Respondent chose not to delve
into the content of ‘‘those records’’ or
Dr. Loyd’s opinion of them. Tr. 259–61.
Instead, she asked him about whether
he updated his expert report, (he
answered in the negative), she
questioned him further about the
content of his expert report, and she
inquired about matters not addressed in
his expert report before ending her
cross-examination. Id. at 260–61. After
the Government’s second question on
re-direct, she objected about not having
received Dr. Loyd’s ‘‘new opinions’’
because he had not supplemented his
expert report and claimed to be ‘‘blindsided’’ and ‘‘sandbagged.’’ Id. at 261–67.
After the Chief ALJ announced his
finding that she had ‘‘opened the door’’
and denied her objections, decisions
with which I agree, Respondent heard
the Government’s extensive re-direct of
Dr. Loyd.
Third, I find that that Government redirect of Dr. Loyd focused largely on the
insufficiency of the ‘‘proposed’’ medical
records for N.J. as documentation for the
prescribing of controlled substances. Id.
at 267–77. The re-direct explored what
the ‘‘proposed’’ N.J. medical record
indicated about N.J.’s multiple visits to
Respondent, a physician practicing
emergency medicine, as opposed to
visits to a primary care physician, and
the lack of evidence of coordination of
treatment between Respondent and
N.J.’s primary care physician. Id. at 267–
69. It addressed the lack of urine drug
screening despite the multiple
controlled substance prescriptions and
the lack of documented informed
consent. Id. at 269–70. The re-direct also
explored the lack of evidence that
Respondent addressed with N.J. his
increased risk of misusing controlled
substances given his family history of
substance use disorder, the lack of
evidence that Respondent followed up
on N.J.’s report of ‘‘occasional alcohol
use,’’ and the lack of evidence that
Respondent warned N.J. about the
potential risk of mixing alcohol and
controlled substances. Id. at 270–74. It
concerned the lack of evidence that
Respondent explored with N.J.
treatment modalities other than
controlled substances and the lack of
evidence that Respondent asked N.J.
about the impact of the controlled
substance therapy on his mobility. Id. at
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276–77. Finally, it concluded with Dr.
Loyd’s testimony that his review of the
‘‘proposed’’ N.J. patient chart did not
change his opinion that Respondent
prescribed controlled substances to N.J.
without a legitimate medical purpose.
Id. at 277. Despite her hearing the
damaging testimony the Government
elicited from Dr. Loyd on re-direct,
Respondent declined the opportunity
for re-cross, allowing this damaging
testimony to stand, unrebutted. Id. at
279.
Fourth, I apply the ‘‘adverse inference
rule,’’ as the Agency has done in the
past, to the fact that Respondent did not
offer into evidence any medical records
she created in conjunction with her
controlled substance prescribing for N.J.
As the D.C. Circuit explained, ‘‘Simply
stated, the rule provides that when a
party has relevant evidence within his
control which he fails to produce, that
failure gives rise to an inference that the
evidence is unfavorable to him.’’ Int’l
Union, United Auto., Aerospace &
Agric. Implement Workers of Am.
(UAW) v. Nat’l Labor Relations Bd., 459
F.2d 1329, 1336 (D.C. Cir. 1972). The
Court reiterated this rule in Huthnance
v. District of Columbia, 722 F.3d 371,
378 (D.C. Cir. 2013). According to this
legal principle, Respondent’s decision
not to provide evidence within her
control gives rise to an inference that
any such evidence is unfavorable to her.
Fifth, I find that Respondent, after
hearing Dr. Loyd’s damaging expert
testimony, agreed to a joint stipulation
admitting that she did not treat N.J. (or
J.J.) at any of the three hospitals at
which Respondent practiced as a
contract emergency physician at the
time and to which DI had issued
subpoenas for J.J. and N.J. medical
records. Tr. 330–31. In this context, the
stipulation is damaging to Respondent’s
OSC defense because the record
evidence was that Respondent wrote the
controlled substance prescriptions she
issued to N.J. (and J.J.) on the paper of
one of these three hospitals. GX 9 and
GX 11. The stipulation thus highlights
an irregularity in Respondent’s
controlled substance prescribing for N.J.
(and J.J.).
Sixth, for all of these reasons, I find
that Respondent was aware of the
existence of the ‘‘proposed’’ N.J.
medical records and did not seek their
admission because she did not consider
them to be records that adequately
documented her controlled substance
prescribing for N.J.
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I. Allegation That Respondent Violated
the Terms of the MOA by Failing To
Provide Drug Logs to DEA for Periods
During Which She Issued Controlled
Substance Prescriptions, Implicating 21
U.S.C. 823(f)(5)
The OSC alleged that Respondent
‘‘failed to provide drug logs to DEA in
February, March, and April 2012; and
January, March and April 2013’’
although she ‘‘issued controlled
substance prescriptions during the
above periods.’’ OSC, at 3. The record
includes documentary evidence that
Respondent issued a controlled
substance prescription, for Tussionex, to
N.J. on April 30, 2014. GX 11, at 5. The
drug log that Respondent submitted to
DEA for April 2014, however, does not
include this Tussionex prescription
issued to N.J. on April 30, 2014. GX 12l.
Accordingly, I find that Respondent
submitted to DEA a drug log for April
2014 that did not comply with the MOA
because it did not include the April 30,
2014 controlled substance prescription
she issued to N.J. for Tussionex.
At the hearing, the Government
suggested, but subsequently ‘‘withdrew’’
its suggestion, that Respondent issued
other controlled substance prescriptions
that she did not document in a drug log
submitted to DEA. Tr. 117, 119–20. I
compared the prescriptions Respondent
issued for J.J. and N.J. according to GX
9 and GX 11 with Respondent’s drug
logs in the record, GX 12a through GX
12l. The only discrepancy that I found,
based on the prescriptions in the record
for which there is a drug log in the
record, is the same prescription about
which DI testified: To N.J. for
Tussionex, dated April 30, 2014.
Further, I found two prescriptions,
one each in GX 9 (J.J.) and GX 11 (N.J.)
for which there is no Respondent drug
log in the record: To J.J. for Alprazolam
dated January 16, 2013, and to N.J. for
Tussionex dated September 13, 2012.
Both September 2012 and January 2013
are months covered by the MOA’s drug
log requirement. The issue, therefore, is
whether Respondent provided DEA
with a drug log for the months of
September 2012 and January 2013 or
whether, as Respondent suggests, she
provided DEA a drug log for those
months but DEA misfiled them.
DI’s unrefuted testimony is that
Respondent admitted to him that she
used certified mail to send her drug logs
to DEA, and that Respondent did not
provide DI with certified mail proof of
having sent the missing MOA-required
drug logs to DEA. Supra section II.C. As
already discussed, the Agency has
applied, and I am applying here, the
‘‘adverse inference rule.’’ Supra section
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II.G. and section II.H. According to that
rule, Respondent’s failure to provide
relevant evidence within her control, in
this case certified mail proof of having
sent the September 2012 and January
2013 MOA-required drug logs to DEA,
gives rise to an inference that the
evidence is unfavorable to her. My
application of the ‘‘adverse inference
rule’’ is particularly appropriate in this
case because the MOA requires
Respondent to maintain her controlled
substance prescribing, administering,
and dispensing records ‘‘in a separate
file or log, in chronological order,’’ a
copy of which shall be sent to DEA
monthly. GX 3, at 2. In other words, the
MOA requirement to which Respondent
agreed calls for her to maintain the
controlled substance records and to
send a copy of them to DEA monthly.
Id. As such, Respondent should have
had a complete set of the MOA-required
records to provide the DI on his
demand, not merely incomplete proof
that she sent DEA the MOA-required
logs every month by certified mail.
Accordingly, I find that the record
includes substantial evidence that
Respondent did not provide drug logs to
DEA for the months of September 2012
and January 2013 even though she
issued a controlled substance
prescription in each of those two
months. The OSC noticed the lack of a
drug log for January 2013, so I sustain
that specific OSC charge. OSC, at 3. The
OSC did not notice the lack of a drug
log for September 2012, so I do not
consider my finding that Respondent
did not provide a drug log to DEA for
that month in this Decision and Order.
I do not sustain the other charges in
paragraph 4 of the OSC due to the lack
of substantial record evidence to
support them. Id.
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J. Allegation That Respondent Stored
Controlled Substances at an
Unregistered Location in Violation of 21
CFR 1301.12(a)
The OSC alleged that Respondent
stored controlled substances in an
exterior storage shed at her residence,
an unregistered location. OSC, at 3.
Respondent admitted that she stored
controlled substances in the exterior
storage shed attached to her residence.
See, e.g., GX 4, at 3; see also supra
section II.C. The record includes no
evidence that the address of
Respondent’s residence and attached
shed appears on a certificate of
registration issued to her. GX 1
(Facsimile of Respondent’s DEA
Certificate of Registration), at 1; GX 2
(Certification of Respondent’s
Registration History), at 1–2; GX 4, at 1
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(address of Respondent’s residence and
attached shed).
Further, Respondent represented to a
controlled substance supplier that she
required the controlled substances she
was purchasing for her ‘‘private
practice’’ of medicine, and gave that
controlled substance supplier ‘‘St Croix
LLC’’ as her company’s name. GX 6, at
8, 5. After having those controlled
substances shipped to the address on
her registration, the address of one of
the hospitals at which she worked as a
contract physician, she moved the
controlled substances to a shed attached
to her residence. GX 6, at 6, 8; GX 2, at
1; TBME Final Order, at 2. She admitted
‘‘writing prescriptions for controlled
substances for . . . J.J. who she treated
at her home.’’ TBME Final Order, at 3.
She subsequently reported that the
controlled substances had been stolen
from the shed attached to her residence.
GX 4, at 1, 3.
Accordingly, I find that the record
includes substantial evidence that
Respondent stored controlled
substances at the shed attached to her
residence, an unregistered location.
K. Allegation That Respondent Failed
To Provide Effective Controls or
Procedures To Guard Against the Theft
or Diversion of Controlled Substances as
Required by 21 CFR 1301.71(a)
The OSC alleged that Respondent
‘‘failed to provide effective controls or
procedures to guard against the theft or
diversion of controlled substances as
required by 21 CFR 1301.71(a). OSC, at
3. The undisputed record evidence is
that Respondent reported to the
Memphis Police Department the ‘‘theft’’
of controlled substances from the ‘‘shed
attached to . . . [her] residence.’’ GX 4,
at 1–3. According to the Memphis
Police Department Incident Report,
‘‘[t]here was no damage to the shed, as
the door was unlocked.’’ Id. at 3. DI also
testified that the shed had a ‘‘regular
doorknob that would be operated with
a key,’’ among other things. Tr. 81; see
also supra section II.C. Accordingly, I
find that the record includes substantial
evidence that Respondent stored
controlled substances in an
inadequately-secured shed, that she
reported the theft of the controlled
substances from that shed, and that
controlled substances she stored in the
shed attached to her residence were
stolen from that shed.
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19021
L. Allegations That Respondent Did Not
Conduct an Initial Inventory of
Controlled Substances Received on
March 7, 2013, and That Respondent
Did Not Maintain Records of the
Controlled Substances She Dispensed as
Required by 21 CFR 1304.03(a) and (b),
1304.04(g), 1304.11(b) and (e), and
1304.21(a)
The OSC alleged that Respondent
‘‘did not conduct an initial inventory of
controlled substances received on
March 7, 2013.’’ OSC, at 3. The record
evidence does not include an initial
inventory, or any inventory, of the
controlled substances Respondent
purchased and received that meets
regulatory requirements. Further,
according to DI’s uncontroverted
testimony, Respondent admitted to him
that ‘‘she had never created a regulatory
or an initial inventory.’’ Id. at 86–87.
Accordingly, I find both that
Respondent did not conduct an initial
inventory of the controlled substances
she received on March 7, 2013, and that
she admitted she did not conduct such
an initial inventory.
The OSC also alleged that Respondent
did not ‘‘maintain records of . . . [her]
dispensing’’ of the controlled substances
she received on March 7, 2013. OSC, at
3. The record does not include
substantial evidence that Respondent
dispensed any of the controlled
substances she received on March 7,
2013. Supra section II.C. Accordingly, I
find that this allegation is not supported
by substantial record evidence.
III. Discussion
Allegation That Respondent’s
Registration Is Inconsistent With the
Public Interest
Under Section 304 of the Controlled
Substances Act (hereinafter, CSA), ‘‘[a]
registration . . . to . . . distribute[ ] or
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,’’
which is 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 . . .
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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.
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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 Akhtar-Zaidi, 841 F.3d at 711;
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 appellate courts
have recognized, findings under a single
factor are sufficient to support the
revocation of a registration. MacKay,
664 F.3d at 821.
Under DEA’s regulation, ‘‘[a]t any
hearing for the revocation . . . of a
registration, the . . . [Government] shall
have the burden of proving that the
requirements for such revocation . . .
pursuant to . . . 21 U.S.C. [§] 824(a)
. . . are satisfied.’’ 21 CFR 1301.44(e).
In this matter, while I have considered
all of the factors, the Government’s
evidence in support of its prima facie
case is confined to Factors One, Two,
Four, and Five.26 I find that the
26 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 decisions have noted, there are
a number of reasons why a person who has engaged
in criminal misconduct may never have been
convicted of an offense under this factor, let alone
prosecuted for one. Dewey C. MacKay, M.D., 75 FR
49,956, 49,973 (2010), pet. for rev. denied, MacKay
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Government’s evidence satisfies its
prima facie burden of showing that
Respondent’s continued registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 824(a)(4) and 21
U.S.C. 823(f). I further find that
Respondent chose not to put on a case
to rebut the Government’s prima facie
case.
A. Factor One—Recommendation of the
Appropriate State Licensing Board
Factor One calls for consideration of
the ‘‘recommendation of the appropriate
state licensing board or professional
disciplinary authority’’ in the public
interest determination. 21 U.S.C.
823(f)(1). The record evidence does not
include a direct recommendation to the
Agency from the TBME about
Respondent’s continued registration.
As already discussed, the Chief ALJ,
without objection from either party,
took official notice of the TBME Final
Order concerning Respondent. Supra
section I. The TBME Final Order
concerns some of the matters addressed
in the OSC and in this proceeding: The
MOA, Respondent’s purchase of
controlled substances and the
Declaration of Controlled Substances
Purchases in the Moore Medical
purchase packet, the Memphis Police
Incident Report, and Respondent’s
controlled substance prescribing for J.J.
TBME Final Order, at 2–3. The TBME
found facts sufficient to establish that
Respondent engaged in unprofessional,
dishonorable or unethical conduct in
violation of Tenn. Code Ann. § 63–6–
214(b)(1), failed to create and maintain
medical records in violation of Tenn.
Comp. Rules & Regs. 0880–02–.15(4)(a),
and violated Tenn. Comp. Rules & Regs.
0880–02–.15(4)(d) by failing to include,
in all medical records produced in the
course of the practice of medicine for all
patients, all information and
documentation listed in Tenn. Code
Ann. § 63–2 101(c)(4) and such
additional information necessary to
ensure that a subsequent reviewing or
treating physician can both ascertain the
basis for the diagnoses, treatment plan
and outcomes, and provide continuity
of care.
The TBME ordered the reprimand of
Respondent’s Tennessee medical
license, ordered her to complete
successfully multiple specific medical
courses, ordered her to ‘‘maintain good
and lawful conduct,’’ and ordered her to
pay assessed civil penalties and costs.
Id. at 5–6.
v. Drug Enf’t Admin., 664 F.3d 808 (10th Cir. 2011).
Agency decisions 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.
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While the TBME Final Order is not a
‘‘direct recommendation’’ for purposes
of Factor One, it does indicate a
recommendation on a subset of the
allegations and evidence before me.
John O. Dimowo, M.D., 85 FR 15,800,
15,810 (2020).27 I apply the same
analysis and reach the same conclusion
here given the differences between the
allegations and evidence set out in the
TBME Final Order and the allegations
and evidence before me. In sum, while
the terms of the TBME Final Order are
not dispositive of the public interest
inquiry in this case and are minimized
due to the differences in the evidence in
the TBME Final Order and the
uncontroverted record evidence before
me, I consider the TBME Final Order’s
reprimand of Respondent’s Tennessee
medical license and give it minimal
weight in Respondent’s favor since the
TBME charges could have resulted in
the suspension or revocation of her
medical license.28 Notice of Charges, at
1.
Factors Two and/or Four—The
Respondent’s Experience in Dispensing
Controlled Substances and Compliance
With Applicable Laws Related to
Controlled Substances
1. Allegation That Respondent
Continued To Issue Controlled
Substance Prescriptions to Individuals
Who Are Intimate or Close
Acquaintances, and to an Individual
With Whom She Had a ‘‘Romantic
Interaction’’ in Violation of Tenn.
Comp. R. & Regs. R. 0880–2–.14(8)(a)
and Tenn. Code Ann. § 63–6–214(b)(1)
The first Tennessee authority the OSC
cited for this allegation adopts Opinion
8.14 of the American Medical
Association Code of Ethics. This
Opinion concerns observing
professional boundaries and meeting
professional responsibilities. https://
journalofethics.ama-assn.org/article/
ama-code-medical-ethics-opinionsobserving-professional-boundaries-andmeeting-professional/2015-05.29
27 The John O. Dimowo, M.D. Agency decision
stands for the proposition that ‘‘[a]lthough statutory
analysis [of the CSA] may not definitively settle
. . . [the breadth of the cognizable state
‘recommendation’ referenced in Factor One], the
most impartial and reasonable course of action is
to continue to take into consideration all actions
indicating a recommendation from an appropriate
state.’’ 85 FR at 15,810.
28 Respondent’s Exceptions to Recommended
Rulings, Findings of Fact, Conclusions of Law, and
Decision of the Administrative Law Judge dated
May 30, 2018 (hereinafter, Resp Exceptions), at 14.
29 American Medical Association Code of Ethics
Opinion 8.14 was updated in March of 1992 and
then again in June of 2016. The text of Opinion 8.14
on the website that is dated 2015, therefore, was in
effect at the time relevant to the allegations
underlying this proceeding.
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According to the Opinion, ‘‘sexual
contact that occurs concurrent with the
patient-physician relationship
constitutes sexual misconduct.’’ AMA
Code of Ethics Opinion 8.14 (2015).
As already discussed, the Government
did not present substantial evidence
that Respondent issued controlled
substance prescriptions to J.J.
concurrent with a period during which
they engaged in sexual contact. Supra
section II.E. Accordingly, I find that the
Government did not present sufficient
evidence to support this allegation and,
therefore, I find that there is no factual
basis in the record to support this
allegation.
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2. Allegation That Respondent Issued
Controlled Substance Prescriptions to
J.J. and N.J. for No Legitimate Medical
Purpose and Outside the Usual Course
of Professional Practice in Violation of
21 CFR 1306.04(a), Tenn. Comp. R. &
Regs. R. 0880–2–.14(6)(a)(4) and (e), and
Tenn. Code Ann. § 63–6–214(b)(12), and
3. Allegation That Respondent Failed To
Maintain Medical Records Pertaining to
Her Prescribing of Controlled
Substances to N.J. in Violation of Tenn.
Comp. R. & Regs. R. 0880–2–
.14(6)(e)(3)(i) and Tenn. Code Ann.
§ 63–6–214(b)(12).
According to the CSA, ‘‘Except as
authorized by this subchapter, it shall
be unlawful for any person knowingly
or intentionally . . . to . . . distribute,
. . . dispense, or possess with intent to
. . . distribute[ ] or dispense, a
controlled substance.’’ 21 U.S.C.
841(a)(1). The CSA’s implementing
regulations state, among other things,
that a lawful controlled substance order
or prescription is one that is ‘‘issued for
a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a).
Respondent’s registration is for her
medical practice in Tennessee. As such,
I also evaluate the record evidence
according to the applicable laws and
standard of care in Tennessee.30 The
Government alleged that Respondent
violated the standard of care in
Tennessee, citing Tenn. Comp. R. &
Regs. R. 0880–2–.14(6)(a)(4) and (e),
Tenn. Code Ann. § 63–6–214(b)(12), and
Tennessee Controlled Substance
Prescribing Policy Statement, GX 15.31
According to these Tennessee
authorities, a physician may be
30 See Gonzales v. Oregon, 546 U.S. 243, 269–71
(2006).
31 Respondent did not offer any exhibit
purporting to address or memorialize the Tennessee
standard of care. She did not object when the Chief
ALJ proposed to take official notice of GX 15. Tr.
332–33.
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disciplined for prescribing a controlled
substance ‘‘not in the course of
professional practice, or not in good
faith to relieve pain and suffering, or not
to cure an ailment, physical infirmity or
disease, or in amounts and/or for
durations not medically necessary,
advisable or justified for a diagnosed
condition.’’ Tenn. Code Ann. § 63–6–
214(b)(12). These Tennessee authorities
state that the prescribing of a controlled
substance will be presumed to be
legitimate if, among other things, it
takes place ‘‘[a]fter a documented
medical history . . . and physical
examination . . . including an
assessment and consideration of the
pain, physical and psychological
function, any history, any potential for
substance abuse, coexisting diseases and
conditions, and the presence of a
recognized medical indication for the
use of a . . . controlled substance.’’
Tenn. Comp. R. & Regs. R. 0880–2–
.14(6)(e)(3)(i); see also supra section
II.C. (standard of care testimony of Dr.
Loyd); GX 15, at 1–2 (Tennessee
Controlled Substance Prescribing Policy
Statement that ‘‘It is not what you
prescribe, but how well you manage the
patient’s care, and document that care
in legible form, that is important,’’
‘‘What the Board does have is the
expectation that physicians will create a
record that shows: –Proper indication
for the use of drug or other therapy;
–Monitoring of the patient where
necessary; –The patient’s response to
therapy based on follow-up visits; and
–All rationale for continuing or
modifying the therapy,’’ ‘‘Before
beginning a regimen of controlled drugs,
make a determination through trial or
through a documented history that nonaddictive modalities are not appropriate
or they do not work,’’ and ‘‘To reiterate,
one of the most frequent problems faced
by a physician when he or she comes
before the Board or other outside review
bodies is inadequate records.’’); GX 14
(‘‘There were no medical records to
support the history, physical
examination and thought process that
led to the prescribing of these
medications. Essentially, the controlled
substances were prescribed with
nothing to support their use. The
controlled substances prescribed for N.J.
were prescribed outside the scope of
accepted medical practice and were not
for a legitimate medical purpose.’’); Tr.
277 (the ‘‘proposed’’ medical records for
N.J. did not change Dr. Loyd’s opinion
that Respondent prescribed controlled
substances for N.J. for no legitimate
purpose); id. at 240 (Dr. Loyd’s
testimony that the medical record is the
‘‘crux.’’ It is the foundation that
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19023
establishes history, present illness, past
medical history, surgical history, social
history, physical examination,
assessment and plan, and that is going
to validate how a diagnosis was arrived
at and the subsequent treatment plan for
that diagnosis.).
I already found that the substantial
record evidence is that Respondent did
not document in a medical record her
controlled substance prescribing for
either J.J. or N.J., and that there is
substantial record evidence that
Respondent did not maintain records
adequately documenting her controlled
substance prescribing for N.J. Supra
sections II.C., II.G., and II.H. Based
alone on a subset of the Tennessee legal
requirements for legitimate controlled
substance prescribing, the
uncontroverted record evidence is that
Respondent’s prescribing of controlled
substances for J.J. and N.J. was not
legitimate. For example, it did not take
place after Respondent documented a
medical history for, and physical exam
of, either J.J. or N.J. Supra sections II.C.
and II.G. In fact, as the record evidence
does not even include a medical record
for J.J. or N.J., Respondent’s controlled
substance prescribing does not, by
definition, satisfy applicable Tennessee
legal authorities.32 Accordingly, I
sustain both of these OSC charges,
finding that Respondent’s controlled
substance prescribing for J.J. and N.J.
was not for a legitimate medical purpose
and was outside the usual course of
professional practice in Tennessee.
4. Allegation That Respondent Stored
Controlled Substances at an
Unregistered Location in Violation of 21
CFR 1301.12(a)
The regulations implementing the
CSA require that a ‘‘separate registration
is required for each principal place of
business or professional practice at one
general physical location where
controlled substances are . . .
dispensed by a person.’’ 21 CFR
1301.12(a). The CSA defines ‘‘dispense’’
to ‘‘include[e] the prescribing . . . of a
controlled substance’’—a fact that
Respondent’s arguments and exceptions
downplay. 21 U.S.C. 802(10); see also
OSC, at 3; Resp Exceptions, at 1–4.
Respondent asks me to find that her
storage of controlled substances in the
shed attached to her residence was
lawful because her residence was not a
principal place of business or
professional practice and she did not
‘‘dispense’’ controlled substances from
32 For all of these reasons, I reject Respondent’s
claim that it is a ‘‘legal fiction’’ that Respondent had
‘‘no medical records’’ for J.J. and N.J. Resp
Exceptions, at 12.
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there. Id. According to her Exceptions,
Respondent only had the ‘‘intention of
eventually opening a private practice’’
and ‘‘[t]here is simply no evidence in
the record that Respondent issued a
single prescription for a controlled
substance from her residence.’’ Id. at 1,
4. I decline to do so.
First, Respondent submitted no record
evidence, let alone substantial record
evidence, providing a factual basis for
her argument. Indeed, the substantial
record evidence includes Respondent’s
representation that she was engaged in
private practice, called St. Croix LLC,
and that her justification for purchasing
controlled substances was to support
the ‘‘addition’’ of age management
medicine, weight loss, and wellness to
her private practice. GX 6, at 8; see also
TBME Final Order, at 3 (Respondent’s
admission that she wrote controlled
substance prescriptions for J.J. whom
‘‘she treated at her home’’). Second, her
argument conflicts with a core principle
of the CSA, the establishment of a
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).
Respondent’s proposal would be a
danger to public health and safety as it
would allow the storage of controlled
substances anywhere, as long as no
dispensing took place at the location.
Respondent offers no convincing
argument that the CSA gives me
authority to adopt her proposal. Further,
there is none and I decline to establish
such a dangerous policy.
I already found that the record
includes substantial, uncontroverted
evidence, including Respondent’s
admission, that Respondent stored
controlled substances at an unregistered
location. Supra section II.J. I found
substantial, uncontroverted evidence
that Respondent represented to her
controlled substance supplier that the
controlled substances she ordered were
required for her ‘‘private practice.’’ Id. I
also found substantial, uncontroverted
evidence that Respondent admitted
writing controlled substance
prescriptions for J.J. whom she admitted
she treated at her home. Id.
Accordingly, I sustain the OSC charge
that Respondent stored controlled
substances at an unregistered location.
5. Allegation That Respondent Failed To
Provide Effective Controls or Procedures
To Guard Against the Theft or Diversion
of Controlled Substances as Required by
21 CFR 1301.71(a)
According to 21 CFR 1301.71(a), ‘‘[a]ll
applicants and registrants shall provide
effective controls and procedures to
guard against theft and diversion of
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controlled substances.’’ As already
discussed, I found substantial record
evidence that Respondent stored
controlled substances in an
inadequately secured shed and that she
reported the theft of the controlled
substances from that shed. Supra
section II.K. By itself, the fact that
controlled substances were stolen from
the shed in which Respondent stored
them is substantial record evidence that
she did not provide ‘‘effective’’ controls
or procedures to guard against theft or
diversion of controlled substances. If
more evidence were required, the
uncontroverted record evidence also
details the out-in-the-open location of
the shed in which Respondent chose to
put the controlled substances she had
purchased and the minimally protective
door, knob, and lock Respondent put
between the outside world and the
controlled substances. Supra section
II.C. and section II.K. For all of these
reasons, I reject Respondent’s claims
that the shed was ‘‘securely locked . . .
[and] substantially constructed.’’ Resp
Exceptions, at 8–11.
Accordingly, I find that Respondent
failed to provide effective controls or
procedures against the theft or diversion
of controlled substances in violation of
21 CFR 1301.71(a).
6. Allegations That Respondent Did Not
Conduct an Initial Inventory of
Controlled Substances Received on
March 7, 2013 and That Respondent Did
Not Maintain Records of the Controlled
Substances She Dispensed as Required
by 21 CFR 1304.03(a) and (b),
1304.04(g), 1304.11(b) and (e), and
1304.21(a)
The OSC alleges that Respondent did
not conduct an initial inventory of the
controlled substances she received on
March 7, 2013. I already found both that
Respondent did not conduct an initial
inventory of the controlled substances
she received on March 7, 2013, and that
she admitted she did not conduct such
an initial inventory. Supra section II.L.
Among her arguments concerning this
allegation, Respondent posited that it is
acceptable to use the Moore Medical
purchase invoice for the controlled
substances as an initial inventory. See,
e.g., Tr. 292–93; Resp Exceptions, at 7–
8. I reject Respondent’s arguments and
her positions that minimize the
inventory requirement in general. I also
reject Respondent’s dismissal of the
deficiency, the failure to specify
whether the inventory was taken at the
beginning or the end of the day, that
renders the Moore Medical purchase
invoice an insufficient substitute for an
initial inventory. See, e.g., Tr. 291–95.
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I note, however, that Respondent
accurately pointed out that the portion
of the regulation stating that inventories
‘‘may be taken either as of opening of
business or as of the close of business
on the inventory date and it shall be
indicated on the inventory’’ was not
alleged in the OSC. Tr. 292; 21 CFR
1304.11(a). I agree that the OSC did not
notice section 1304.11(a) and that
Respondent did not consent to litigate
it. Accordingly, although I found
substantial evidence that Respondent
violated this inventory requirement, I
find that the OSC did not give
Respondent adequate notice of 21 CFR
1304.11(a) and, as a result, I do not
sustain the OSC allegation that
Respondent did not conduct an initial
inventory of the controlled substances
she received on March 7, 2013.33
The OSC also alleges that Respondent
did not maintain records of the
controlled substances she dispensed. 21
CFR 1304.03(b). The Government,
however, did not present substantial
evidence that Respondent dispensed
controlled substances. Supra section
II.L. I find that a predicate to finding
substantial evidence that Respondent
did not maintain records of the
controlled substances she dispensed is
substantial evidence that Respondent
actually dispensed controlled
substances. Accordingly, the record
does not include substantial evidence
that Respondent dispensed controlled
substances and, therefore, there is no
factual basis on which the allegation
that Respondent failed to maintain
dispensing records may stand.
Factor Five—Respondent’s ‘‘Conduct
Which May Threaten the Public Health
and Safety.’’
1. Allegations That Respondent
Provided Prescription Drug Logs to DEA
With Falsified Entries ‘‘Noncompliant
With Terms of the June 2011 MOA’’ in
Violation of 21 U.S.C. 843(a)(4)(A), and
‘‘Provid[ed] Misleading Information to
Investigating Agents’’ Implicating 21
U.S.C. 823(f)(5)
The OSC cites 21 U.S.C. 843(a)(4)(A)
as the basis for the allegation that
Respondent provided non-MOA
compliant falsified controlled substance
prescription drug logs to DEA. OSC, at
2. The Government has not, however,
established the existence of each of the
33 Citing 21 CFR 1304.11(b), Respondent argues in
her exceptions that she was not under a duty to
conduct an initial inventory for the controlled
substances she received on March 7, 2013. Resp
Exceptions, at 4–7. I disagree with Respondent’s
arguments for the reasons already discussed and
reiterate that I am not sustaining the OSC’s initial
inventory allegation solely because it was not
noticed adequately.
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elements of 21 U.S.C. 843(a)(4)(A). For
example, according to the provision, the
furnished or omitted ‘‘false or
fraudulent material information’’ must
pertain to ‘‘any application, report,
record, or other document required to be
made, kept, or filed.’’ 21 U.S.C.
843(a)(4)(A). The Government did not
establish that Respondent’s controlled
substance drug logs constitute a
document ‘‘required to be made, kept, or
filed’’ under any provision from 21
U.S.C. 801 through 21 U.S.C. 971. In
sum, the Government has not
established all of the elements of 21
U.S.C. 843(a)(4)(A) and, therefore, the
Government has not proven that this
provision applies to the facts of this
case. Accordingly, I do not sustain the
OSC allegation based on 21 U.S.C.
843(a)(4)(A).34
I already found that there is
substantial record evidence that
Respondent provided misleading
information to investigating DEA agents.
Supra section II.F. This misleading
information ‘‘may threaten the public
health and safety’’ by, for example,
impeding DEA’s investigative efforts.
Accordingly, I shall consider
Respondent’s provision of misleading
information to DEA under Factor Five.
21 U.S.C. 823(f)(5).
2. Allegation That Respondent Violated
the Terms of the MOA by Failing To
Provide Drug Logs to DEA for Periods
During Which She Issued Controlled
Substance Prescriptions, Implicating 21
U.S.C. 823(f)(5)
The MOA that Respondent signed
calls for her to ‘‘maintain a log of all
controlled substances prescribed,
administered or dispensed to patients at
her registered premises or elsewhere,’’
for her to ‘‘maintain’’ the controlled
substance prescribing, administering,
and dispensing information ‘‘in a
separate file or log, in chronological
order,’’ and for her to send a copy of the
log to DEA every month. GX 3, at 2. The
uncontroverted record evidence is that
Respondent did not comply fully with
this requirement. Supra section II.I. (my
findings that Respondent submitted to
DEA an incomplete controlled
substance prescription drug log for
April 2014 and that Respondent did not
provide a drug log to DEA for the month
of January 2013, even though the record
contains substantial evidence that she
issued a controlled substance
prescription in that month).
34 Given my decision not to sustain the 21 U.S.C.
843(a)(4)(A) allegation, I need not address
Respondent’s exception to the Chief ALJ’s
conclusion that Respondent ‘‘intentionally or
knowingly submitted false information’’ to DEA.
Resp Exceptions, at 11–12.
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Respondent’s argument that she sent
DEA the MOA-required logs rings
hollow because the MOA also requires
that she maintain the required
information herself. Had she done so,
she would have been able to provide DI
with complete evidence of her full
compliance with the MOA controlled
substance prescription drug log
requirement. As she apparently did not,
or at least chose not to submit evidence
that she did, I find that Respondent
failed to provide fully-compliant
controlled substance prescription drug
logs to DEA for periods during which
she issued controlled substance
prescriptions. Accordingly, I shall
consider Respondent’s failure to comply
fully with the MOA controlled
substance prescription drug log
requirement under Factor Five. 21
U.S.C. 823(f)(5).
Summary of Factors One, Two, Four,
and Five
As found above concerning Factor
One, while the TBME Final Order is not
a ‘‘direct recommendation’’ for purposes
of Factor One, it indicates a
recommendation on a subset of the
allegations and evidence before me. As
such, while the terms of the TBME Final
Order are not dispositive of the public
interest inquiry in this case and are
minimized due to the differences in the
evidence laid out in the TBME Final
Order and the uncontroverted record
evidence before me, I consider the
TBME Final Order’s reprimand of
Respondent’s Tennessee medical license
minimally in her favor because the
TBME charges could have resulted in
the suspension or revocation of her
medical license.
Regarding Factors Two and Four, the
Government did not establish with
substantial evidence that Respondent
engaged in ‘‘sexual misconduct’’ by
issuing controlled substance
prescriptions to J.J. ‘‘concurrent’’ with
having ‘‘sexual contact’’ with him. The
Government also did not establish with
substantial evidence that Respondent
failed to maintain records of the
controlled substances she dispensed.
Although there is substantial record
evidence that Respondent did not
conduct an initial inventory of the
controlled substances she received on
March 7, 2013, I am not weighing this
charge against her due to OSC notice
insufficiencies.
Also regarding Factors Two and Four,
there is substantial evidence in the
record before me that Respondent
issued controlled substance
prescriptions over the course of eighteen
months, including fifteen Schedule II
controlled substances, for no legitimate
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19025
medical purpose and outside the usual
course of professional practice, that
Respondent failed to maintain medical
records pertaining to her prescribing of
controlled substances, that Respondent
stored controlled substances at an
unregistered location, and that
Respondent failed to provide effective
controls or procedures to guard against
the theft or diversion of controlled
substances.
Regarding Factor Five, although the
Government did not establish all of the
elements of a violation of 21 U.S.C.
843(a)(4)(A), the Government did put
substantial evidence into the record that
Respondent submitted a drug log to
DEA that did not include every
controlled substance prescription she
issued during the period covered by the
drug log. The Government also put
substantial evidence into the record that
Respondent did not comply with the
MOA by failing to provide a drug log to
DEA for a month during which she
issued a controlled substance
prescription. The Government also put
substantial evidence into the record that
Respondent included misleading
information in the drug logs she
submitted to DEA about the locations at
which she issued controlled substance
prescriptions. OSC, at 3.
Accordingly, I conclude that it would
be ‘‘inconsistent with the public
interest’’ for Respondent to have a
registration due to the substantial
evidence of her violations of the CSA
and its implementing regulations. 21
U.S.C. 824(a)(4) and 21 U.S.C. 823(f);
see Wesley Pope, 82 FR 14,944, 14,985
(2017).
Sanction
Where, as here, the Government
presented a prima facie case that it
would be ‘‘inconsistent with the public
interest’’ for Respondent to retain a
registration, and Respondent did not
rebut the Government’s prima facie
case, the ‘‘burden of proof shifts’’ to
Respondent ‘‘to show why . . . [she]
can be trusted with a registration.’’ Jones
Total Health Care Pharmacy, LLC v.
Drug Enf’t Admin., 881 F.3d 823, 830
(11th Cir. 2018), quoting Akhtar-Zaidi v.
Drug Enf’t Admin., 841 F.3d 707, 711
(6th Cir. 2016); see also MacKay v. Drug
Enf’t Admin., 664 F.3d 808, 816 (10th
Cir. 2011) (quoting Volkman v. Drug
Enf’t Admin., 567 F.3d 215, 222 (6th Cir.
2009) quoting Hoxie v. Drug Enf’t
Admin., 419 F.3d 477, 482 (6th Cir.
2005)). Further, past performance is the
best predictor of future performance
and, when a registrant has ‘‘failed to
comply with . . . [her] responsibilities
in the past, it makes sense for the
agency to consider whether . . . [she]
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will change . . . [her] behavior in the
future.’’ Pharmacy Doctors Enterprises,
Inc. v. Drug Enf’t Admin., 789 F. App’x,
724, 733 (citing Jones Total Health Care
Pharmacy, LLC v. Drug Enf’t Admin.,
881 F.3d at 831 (citing MacKay v. Drug
Enf’t Admin., 664 F.3d at 820 (‘‘[T]hat
consideration is vital to whether
continued registration is in the public
interest.’’) and Alra Labs., Inc. v. Drug
Enf’t Admin., 54 F.3d 450, 452 (7th Cir.
1995) (‘‘An agency rationally may
conclude that past performance is the
best predictor of future performance.’’)).
Circuit courts have also approved the
Agency’s acceptance of responsibility
requirement. Pharmacy Doctors
Enterprises, Inc. v. Drug Enf’t Admin.,
789 F. App’x, at 732; Jones Total Health
Care Pharmacy, LLC v. Drug Enf’t
Admin., 881 F.3d at 830 (citing MacKay
v. Drug Enf’t Admin., 664 F.3d at 820
(‘‘The DEA may properly consider
whether a physician admits fault in
determining if the physician’s
registration should be revoked.’’); see
also Jeffrey Stein, M.D., 84 FR 46,968,
46,972–73 (2019) (unequivocal
acceptance of responsibility); Jayam
Krishna-Iyer, M.D., 74 FR 459, 463
(2009) (collecting cases). The Agency
has decided that the egregiousness and
extent of the misconduct are significant
factors in determining the appropriate
sanction. Garrett Howard Smith, M.D.,
83 FR 18,882, 18,910 (2018) (collecting
cases); Samuel Mintlow, M.D., 80 FR at
3652 (‘‘Obviously, the egregiousness
and extent of a registrant’s misconduct
are significant factors in determining the
appropriate sanction.’’). The Agency has
also considered the need to deter similar
acts in the future by Respondent and by
the community of registrants. Id.
In terms of egregiousness, the
violations that the record evidence
shows Respondent committed go to the
heart of the CSA—not complying with
the closed regulatory system devised to
‘‘prevent the diversion of drugs from
legitimate to illicit channels’’ and not
prescribing controlled substances in
compliance with the applicable
standard of care and in the usual course
of professional practice. Gonzales v.
Raich, 545 U.S. at 13–14, 27.
Respondent did not testify. As already
noted, after the Chief ALJ issued his
Recommended Decision, in which he
concluded that Respondent’s acceptance
of responsibility through her Counsel
was ‘‘ineffectual’’ and did not ‘‘point[ ]
to anything that she was
acknowledg[ing] that she did wrong,’’
Respondent submitted her MCACAP.
Supra section I; RD, at 66. In the
MCACAP, Respondent submitted a
signed and notarized Affidavit dated
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July 11, 2018. In the Affidavit,
Respondent stated that she:
accept[ed] responsibility for the mistakes and
inadvertent errors in judgment I made that
are the subject of this matter, including, but
not necessarily limited to: a. Failing to
appreciate the importance of accurate recordkeeping as it relates to the logs required by
my 2011 Memorandum of Agreement with
the DEA; b. Failing to keep better treatment
records for J.J. and N.J.; c. Failing to keep
better prescription records for J.J. and N.J.; d.
Failing to have more thorough and detailed
treatment plans for J.J. and N.J.; [and] e.
Listing J.J. and N.J. as patients of any hospital
in my DEA logs.
MCACAP Affidavit, at 2. While
Respondent’s Affidavit-based
acceptance of responsibility points to
areas in which she admits to making
‘‘mistakes and inadvertent errors of
judgment,’’ she admits that her Affidavit
does not go to the trouble of naming all
of her ‘‘mistakes and inadvertent errors
of judgment.’’ Id. Further, the Affidavit
describes the areas for which she takes
responsibility in general terms only, and
the areas do not include all of the
violations the Government proved with
substantial evidence. For example,
while Respondent’s Affidavit states that
she failed to ‘‘keep better treatment
records,’’ ‘‘keep better prescription
records,’’ and ‘‘have more thorough and
detailed treatment plans,’’ the record
certified to me contains no ‘‘treatment
records,’’ no ‘‘prescription records,’’ and
no ‘‘treatment plans’’ whatsoever. Supra
section II.G. and II.H.
DEA agreed to grant Respondent’s last
application for a registration upon her
execution of the MOA. MOA, at 2
(‘‘Upon execution by all parties to this
agreement, DEA agrees to grant . . .
[Respondent’s] application for DEA
registration in Schedules II through
V.’’). A term of the MOA is that
Respondent ‘‘agrees to abide by all
Federal, State and local laws and
regulations pertaining to controlled
substances.’’ Id. As already discussed, I
found that Respondent failed to abide
by ‘‘all Federal, State and local laws and
regulations pertaining to controlled
substances.’’ Supra sections III.B.2.,
III.B.3., III.B.4., III.B.5., III.C.1., and
III.C.2. Yet, while the MCACAP
indicates that Respondent subsequently
attended and passed the courses
required by the TBME Final Order plus
others, nothing in the MCACAP and
certified record convinces me that
Respondent learned from those courses
and will apply consistently going
forward what those courses taught about
the CSA’s recordkeeping requirements
and prescribing controlled substances in
compliance with the applicable
standard of care and in the usual course
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of professional practice. For example,
Respondent’s Affidavit states that she
acknowledges ‘‘failing to seek legal and
compliance counsel, as well as
educating . . . [herself] on the pertinent
rules and regulations of controlled
substance, prior to taking any actions
related to my desire to open a private
practice.’’ Id. Instead of being
reassuring, this portion of Respondent’s
acknowledgement is very concerning
because it exhibits her view that her
need to become educated on the
‘‘pertinent rules and regulations of
controlled substances’’ is tied to her
opening a private practice, not to her
being entrusted with a registration.
Further, Respondent’s Affidavit does
not address her ordering controlled
substances for delivery at her registered
address and her removal of those
controlled substances from her
registered address to the shed attached
to her home. Even after reading the
MCACAP and Respondent’s Affidavit, I
see nothing in them or in the record
certified to me suggesting that
Respondent appreciates that Congress
passed, and the President of the United
States signed into law, a statute that
requires registrants to take specific
actions to keep controlled substances in
a closed regulatory system created to
‘‘prevent the diversion of drugs from
legitimate to illicit channels.’’ There is
little in the record before me showing
that Respondent appreciates the
difference between ordering controlled
substances and ordering groceries.35 In
sum, given Respondent’s failure to
comply with the MOA’s provisions and
her failure to demonstrate her ability to
apply the information conveyed in the
courses Respondent attended and
passed, it is not reasonable for me, at
this time, to believe that Respondent’s
future handling and prescribing of
controlled substances will comply with
legal requirements.36 Alra Labs., Inc. v.
35 Respondent’s eighth Exception asserts that the
‘‘record as a whole establishes that the continued
registration of Respondent . . . would be consistent
with the public interest.’’ Resp Exceptions, at 13.
The Exception does not elaborate on this assertion,
and the fact that Respondent did not present a case
contributes substantially to the assertion’s
incredibility. The Exception’s statements that J.J.
and N.J. ‘‘affirmed that the prescriptions issued by
Respondent were to treat them for injuries they
had’’ and that the ‘‘Government produced no
competent evidence that the prescriptions were not
for legitimate medical needs’’ are not helpful. The
legitimacy of controlled substance prescriptions is
assessed by applicable federal and state legal
standards and standards of care, not by the opinions
of those to whom the prescriptions were issued.
Supra section II.G., II.H., III.B.2., and III.B.3; see
also Resp Exceptions, at 13–14.
36 I do not consider remedial measures when a
Respondent does not unequivocally accept
responsibility. Respondent’s MCACAP presentation
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Drug Enf’t Admin., 54 F.3d at 452 (‘‘An
agency rationally may conclude that
past performance is the best predictor of
future performance.’’). Accordingly, I
shall order that Respondent’s
registration be revoked and that all
pending applications to renew or
modify Respondent’s registration, and
any application for a new registration in
Tennessee, be denied.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a)(4) and 21 U.S.C. 823(f), I hereby
revoke DEA Certificate of Registration
No. FS2669868 issued to Jennifer L. St.
Croix, M.D. I further hereby deny any
pending application of Jennifer L. St.
Croix, M.D., to renew or modify this
registration, as well as any other
pending application of Jennifer L. St.
Croix, M.D. for registration in
Tennessee. This Order is effective May
12, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–07410 Filed 4–9–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
Publication of Model Notices for Health
Care Continuation Coverage Provided
Pursuant to the Consolidated Omnibus
Budget Reconciliation Act (COBRA)
and Other Health Care Continuation
Coverage, as Required by the
American Rescue Plan Act of 2021,
Notice
Employee Benefits Security
Administration, Department of Labor.
ACTION: Notice of the availability of the
model health care continuation coverage
notices required by the American
Rescue Plan Act of 2021.
AGENCY:
On March 11, 2021, President
Biden signed the American Rescue Plan
Act of 2021 (ARP). Section 9501(a)(5)(D)
and (6)(D) of ARP directs the
Department of Labor (Department) to
develop model notices for use by group
health plans and other entities that,
pursuant to the ARP, must provide
notices of the availability of premium
reductions and additional election
periods for health care continuation
coverage. This document announces the
availability of the model notices.
DATES: April 12, 2021.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
of remedial efforts was limited, unpersuasive, and
not reassuring.
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FOR FURTHER INFORMATION CONTACT:
David Sydlik, Office of Health Plan
Standards and Compliance Assistance,
Employee Benefits Security
Administration, (202) 693–8335. This is
not a toll-free number.
SUPPLEMENTARY INFORMATION:
I. Background
The Consolidated Omnibus Budget
Reconciliation Act of 1985 (COBRA)
created the health care continuation
coverage provisions of title I of the
Employee Retirement Income Security
Act of 1974 (ERISA), the Internal
Revenue Code (Code), and title XXII of
the Public Health Service Act (PHS Act).
These provisions are commonly referred
to as the COBRA continuation
provisions, and the continuation
coverage that they mandate is
commonly referred to as COBRA
continuation coverage. Under the ARP,
premium assistance is available to
certain individuals who are eligible for
COBRA continuation coverage due to a
qualifying event that is a reduction in
hours or an involuntary termination. If
an individual qualifies for the premium
assistance, the individual need not pay
any of the COBRA premium otherwise
due to the plan. This premium
assistance is available for COBRA
continuation coverage for periods of
coverage from April 1, 2021 through
September 30, 2021. Group health plans
subject to the COBRA continuation
provisions are subject to the ARP’s
premium assistance provisions, notice
requirements, and an additional election
period. Federal COBRA continuation
coverage provisions do not apply to
group health plans sponsored by
employers with fewer than 20
employees. However, participants and
beneficiaries of group health plans
sponsored by employers with fewer
than 20 employees may be eligible for
the premium assistance under state laws
that provide comparable coverage, often
referred to as ‘‘mini-Cobra,’’ with an
alternative notice required under the
ARP for these plans not subject to
federal COBRA laws.1
1 Under COBRA, group health plans must provide
covered employees and their families with certain
notices explaining their COBRA rights. A group
health plan must provide covered employees and
qualified beneficiaries with a notice which
describes their right to COBRA continuation
coverage and how to make an election (election
notice). The ARP provides that COBRA election
notices already provided for qualifying events
occurring during this time period but which did not
include information on the availability of the
premium assistance are not complete. As such, the
end of the 60-day period for electing COBRA
continuation coverage is measured from when a
complete notice is provided. Moreover, although
under COBRA a timely election generally requires
a plan to make coverage available retroactively to
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
19027
The ARP requires group health plans
to provide four notices: (1) A ‘‘General
Notice,’’ (2) an ‘‘Alternative Notice,’’ (3)
a ‘‘Notice in Connection with Extended
Election Periods,’’ and (4) a ‘‘Notice of
Expiration of Period of Premium
Assistance.’’ Under ARP section
9501(a)(5)(B), the General Notice, the
Alternative Notice, and the Notice in
Connection with Extended Election
Periods must include:
• A prominent description of the
availability of the premium assistance,
including any conditions on the
entitlement;
• a form to request treatment as an
‘‘Assistance Eligible Individual’’ 2;
• the name, address, and telephone
number of the plan administrator (and
any other person with relevant
information about the premium
assistance);
• a description of the obligation of
individuals paying reduced premiums
who become eligible for other coverage
to notify the plan and the penalty for
failing to meet this obligation; and
• (if applicable) a description of the
opportunity to switch coverage options.
The Notice in Connection with
Extended Election Periods must also
include a description of the extended
election period. The ARP also requires
group health plans to provide a Notice
of Expiration of Period of Premium
Assistance to individuals whose
premium assistance is coming to an end
(whether due to the expiration of their
COBRA continuation coverage or the
expiration of the period of premium
assistance), which must explain that the
premium assistance for such individual
will expire soon; include a prominent
identification of the date of such
expiration; and explain that such
individual may be eligible for coverage
without any premium assistance
through—(I) COBRA continuation
coverage; or (II) coverage under a group
health plan. This notice must be
provided within the period that is 45
days before the date of such expiration
and ending on the day that is 15 days
before the date of such expiration. The
Departments of Labor and the Treasury
share jurisdiction for enforcement of the
COBRA continuation provisions. The
Department of Labor is committed to
the date of the loss of coverage, the ARP allows an
individual to elect COBRA continuation coverage
with premium assistance for a period beginning on
or after April 1, 2021.
2 In general, an ‘‘Assistance Eligible Individual’’
is, with respect to coverage beginning April 1, 2021
and ending September 30, 2021, an individual who
is eligible for COBRA continuation coverage as a
result of a reduction in hours or an involuntary
termination of employment; and who elects COBRA
coverage (when first offered or during the
additional election period).
E:\FR\FM\12APN1.SGM
12APN1
Agencies
[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 19010-19027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07410]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-31]
Jennifer L. St. Croix, M.D.; Decision and Order
I. Introduction
On April 12, 2017, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to
Jennifer L. St. Croix, M.D. (hereinafter, Respondent), of Covington,
Tennessee. OSC, at 1. The OSC proposed the revocation of Respondent's
DEA Certificate of Registration No. FS2669868 and the denial of ``any
pending application to modify or renew such registration pursuant to 21
U.S.C. 823(f) and 824(a)(4) for the reason that . . . [her] continued
registration is inconsistent with the public interest as that term is
defined in 21 U.S.C. 823(f).'' Id.
The substantive grounds for the proceeding, as alleged in the OSC,
are that Respondent `` `committed such acts as would render . . . [her]
registration . . . inconsistent with the public interest.' See 21
U.S.C. 824(a)(4).'' Id. at 3. Specifically, the OSC alleged that
Respondent violated the commitments she made to DEA when she executed a
three-year Memorandum of Agreement (hereinafter, MOA) effective June
25, 2011. Id. at 2. According to the OSC, Respondent's MOA commitments,
to ``abide by all Federal, State, and local laws and regulations
pertaining to controlled substances'' and to ``maintain a log of all
controlled substances prescribed, administered or dispensed to patients
at . . . [her] registered premises or elsewhere, including call-in
prescriptions, for review by DEA personnel at any time,'' were what
permitted her to maintain an unrestricted registration. Id.
First, according to the OSC, Respondent continued to issue
``prescriptions to individuals who are intimate or close acquaintances,
and provided prescription drug logs to DEA that were noncompliant with
the terms of the June 2011 MOA'' due to the falsities included in ten
of them.\1\ Id. The OSC also alleged that Respondent failed to maintain
medical records pertaining to her prescribing of controlled substances,
and that she prescribed controlled substances to an individual with
whom she had a ``romantic interaction.'' Id. The authorities that the
OSC listed for these allegations are 21 U.S.C. 843(a)(4)(A), 21 CFR
1306.04(a), Tenn. Code Ann. Sec. 63-6-214(b)(1), Tenn. Code Ann. Sec.
63-6-214(b)(12), Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(a)(4) and (e),
and Tenn. Tenn. Comp. R. & Regs. R. 0880-2-.14(8)(a) (adopting opinion
8.14 of the American Medical Association Code of Ethics). Id. at 2-3.
---------------------------------------------------------------------------
\1\ The charged falsities were alleged to be in Respondent's
drug log submissions dated August, October, and November of 2012,
February, May, June, July, October, and November of 2013, and
January 2014. OSC, at 2.
---------------------------------------------------------------------------
Second, the OSC alleged that Respondent failed to submit MOA-
required prescription drug logs to DEA for six months even though
``DEA's subsequent review of prescription data revealed that . . .
[she] issued controlled substance prescriptions during'' those
months.\2\ Id. at 3. The OSC cited 21 U.S.C. 823(f)(5) as the statutory
basis for this allegation. Id.
---------------------------------------------------------------------------
\2\ The six months during which Respondent allegedly issued
controlled substance prescriptions without submitting prescription
drug logs to DEA were February, March, and April 2012 and January,
March, and April 2013. OSC, at 3.
---------------------------------------------------------------------------
Third, according to the OSC, Respondent ``stored controlled
substances in an exterior storage shed at
[[Page 19011]]
. . . [her] private residence . . . for dispensing from . . . [her]
private residence . . . sometime between March 7, 2013 and November 6,
2013.'' Id. The OSC cited 21 CFR 1301.12(a) as the basis for the
allegation that Respondent stored controlled substances at an
unregistered location. Id.
Fourth, the OSC charged Respondent with violating 21 CFR
1301.71(a), failure to provide effective controls or procedures to
guard against the theft or diversion of controlled substances, due to
her admission that ``the door to . . . shed did not close securely.''
Id.
Fifth, connected to the charge that Respondent purchased controlled
substances ``for dispensing from . . . [her] private residence,'' the
OSC alleged that Respondent ``did not conduct an initial inventory of
controlled substances received on March 7, 2013, nor did . . . [she]
maintain records of . . . [her] dispensing these drugs as required by
21 CFR 1304.03(a) and (b), 1304.04(g), 1304.11(b) and (e), and
1304.21(a). Id.
In sum, the OSC alleged that Respondent's actions, when judged
under 21 U.S.C. 823(f)(2), (f)(4) and (f)(5), ``render[ ] . . . [her]
continued registration with the DEA to handle controlled substances
inconsistent with the public interest.'' Id. at 3-4.
The OSC notified Respondent of her right to request a hearing on
the allegations or to submit a written statement while waiving her
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified Respondent of the opportunity to
file a corrective action plan. OSC, at 4-5 (citing 21 U.S.C.
824(c)(2)(C)).
The matter was placed on the docket of the Office of Administrative
Law Judges and assigned to Chief Administrative Law Judge (hereinafter,
ALJ) John J. Mulrooney, II. The parties submitted ten stipulations.\3\
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge (hereinafter, RD), at 3-4. In addition,
the Chief ALJ took official notice of two documents concerning
Respondent issued by the Tennessee Board of Medical Examiners
(hereinafter, TBME) after giving the parties notice of his intent to do
so and receiving no objection. Official Notice Order dated March 1,
2018, attaching Notice of Charges and Memorandum of Assessment of Civil
Penalty and Costs dated June 3, 2016 (hereinafter, Notice of Charges)
and Final Order dated May 24, 2017 (hereinafter, TBME Final Order).
---------------------------------------------------------------------------
\3\ The tenth stipulation states that ``Respondent did not treat
patients referred to in the record as Patient JJ or Patient NJ at
Methodist Fayette Hospital, Baptist Memorial Hospital, and/or
McNairy Regional Hospital. RD, at 4; see also infra section II.D.
---------------------------------------------------------------------------
The hearing in this matter took place in Nashville, Tennessee on
March 13 and 14, 2018. The Chief ALJ filed the RD on May 10, 2018.\4\
RD, at 1. Noting that Respondent had already been ``afforded the
administrative grace'' of a MOA, the Chief ALJ recommended that
Respondent's registration be revoked and that any pending applications
for its renewal be denied. Id. at 68, 70. Respondent filed exceptions
to the RD on May 30, 2018. Letter of the Chief ALJ to the Acting
Administrator dated June 7, 2018, at 1. The Government neither filed
exceptions nor responded to Respondent's Exceptions. Id. After the
Chief ALJ certified the record and transmitted it to me, Respondent, on
July 12, 2018, submitted a Motion to Consider Amended Corrective Action
Plan (hereinafter, MCACAP).
---------------------------------------------------------------------------
\4\ The Chief ALJ's Corrected Page Order was filed on May 11,
2018.
---------------------------------------------------------------------------
Having examined and considered the record in its entirety, I agree
with the conclusion of the Chief ALJ that Respondent's registration
should be revoked and that all pending applications for its renewal or
modification should be denied.\5\ I make the following findings.
---------------------------------------------------------------------------
\5\ I reviewed, and agree with, the ultimate rulings and
conclusions of all of the Chief ALJ's procedural decisions.
---------------------------------------------------------------------------
II. Findings of Fact
A. Respondent's Controlled Substance Registration
The parties stipulated that Respondent is ``currently registered .
. . as a practitioner in Schedules II-V under DEA registration number
FS 2669868'' in Covington, Tennessee.\6\ Prehearing Ruling dated June
12, 2017 (hereinafter, Prehearing Ruling), at 1; RD, at 3. The parties
and the Chief ALJ further agreed that Respondent's registration
``remains current based upon Respondent's submission of an application
for renewal of registration on January 31, 2017.'' \7\ RD, at 3; see
also Order Denying the Government's Motion for Termination of
Proceedings dated July 25, 2017, at 6.
---------------------------------------------------------------------------
\6\ The parties agreed to nine additional stipulations.
Prehearing Ruling, at 1-2; RD, at 3-4. Eight of these nine concern
the scheduling history of oxycodone, Percocet, Tussionex, Lortab,
Xanax, Soma, Ambien, and phentermine. Id.
\7\ The parties also agreed that Respondent submitted a request
to modify the registered address of her registration from Tennessee
to the Virgin Islands on January 31, 2017. Prehearing Ruling, at 1-
2; RD, at 3.
---------------------------------------------------------------------------
B. The Investigation of Respondent
In March of 2011, Respondent applied for a registration. GX 3
(MOA), at 1. The ensuing investigation of the application resulted in
four allegations ``which if proven in an administrative hearing, could
constitute grounds to deny . . . [Respondent's] application for
registration.'' Id. at 1; see also id. at 1-2. According to the four
allegations, Respondent was arrested in Colorado and Nebraska for
felony drug possession and in Wisconsin for aggravated battery/intent
to cause great harm, and Respondent ``admitted to prescribing
controlled substances to friends and family members including her
mother in law as well as some neighbors and friends of her former
husband,'' ``admitted to working for a Telemedicine Organization in
which the legitimacy of many of the prescriptions could be called into
question,'' and admitted that her relationship with her ex-husband
``resulted in often questionable behavior in regards to prescribing . .
. [and] her being around illegal drugs at times.'' Id. at 1-2.
According to the MOA, DEA agreed to grant Respondent's application
for a registration in Schedules II through V and Respondent agreed to
five specific courses of conduct. Id. at 2-3.\8\ First, Respondent
agreed ``to abide by all Federal, State and local laws and regulations
pertaining to controlled substances'' as well as the ``additional
obligations imposed upon . . . [her] pursuant to'' the MOA. Id. at 2.
Second, Respondent agreed that ``she will not prescribe, administer or
dispense any controlled substances to family members'' and that, if she
does, she agreed ``to immediately execute a DEA Form 104, Voluntary
Surrender of Controlled Substances Privileges, thereby relinquishing
all authority to prescribe, administer or dispense controlled
substances.'' Id.
---------------------------------------------------------------------------
\8\ Respondent also agreed to multiple specific matters such as
having advice of Counsel and ``knowledge of the events descried
herein,'' comprehending all of the MOA, and entering the MOA
voluntarily. GX 3, at 2; see id. 2-4.
---------------------------------------------------------------------------
Third, Respondent agreed to ``maintain a log of all controlled
substances prescribed, administered or dispensed to patients at her
registered premises or elsewhere, including call-in prescriptions, for
review by DEA personnel at any time.'' Id. The MOA specified the
elements to be captured in the log--patient, date, and the name,
strength, and quantity of the prescribed controlled substance--and how
[[Page 19012]]
Respondent was to maintain and transmit the log to DEA. Id.
Fourth, Respondent agreed that ``DEA personnel may enter her office
and/or registered location at any time during regular business hours
without prior notice to verify compliance with'' the MOA. Id.
Respondent specifically agreed ``to permit entry of DEA personnel
without an Administrative Inspection Warrant or other written notices
or other means of entry.'' Id. Fifth, Respondent agreed ``to
immediately notify the DEA prior to any change of business address and/
or change in status of her State medical license and/or state
controlled substance authority'' and ``to promptly notify the DEA of
any change of address or requests for modification of registration.''
Id. at 3. Respondent agreed to make these notifications in writing and
to transmit them to the specific Diversion Group Supervisor ``by
certified mail with return receipt requested.'' Id.
The MOA's terms included that it was the ``full and complete
agreement'' of Respondent and DEA, that ``[n]o other promises or
agreements will be binding unless placed in writing and signed by both
parties,'' and that the ``terms and provisions . . . [were] executed in
good faith.'' Id.
In March of 2014, according to the testimony of the Diversion
Investigator assigned to the matter (hereinafter, DI), a Tennessee
Department of Health employee (hereinafter, TDHI) investigating a
complaint against Respondent contacted DEA. Tr. 38-39. TDHI's
investigative work was related to allegations that Respondent reported
controlled substances as stolen and was providing medical care to her
boyfriend, J.J., and his brother, N.J. Id. at 40. The DEA investigation
that led to the issuance of this OSC ensued.
C. The Government's Case
The Government's case includes fifteen exhibits, one of which has
twelve parts, and two witnesses, DI and Stephen Loyd, M.D. All but one
of the Government's exhibits--GX 10--were admitted into the record.
When the Government initially moved the admission of GX 10, purporting
it to be J.J.'s medical record, the Chief ALJ sustained Respondent's
objections, citing foundation and relevance. Id. at 132-33 (Chief ALJ
ruling that ``I'll sustain the objection . . . I have every confidence
that it is the document that . . . [DI] received from . . . [TDHI]. But
I just don't know what . . . [TDHI] sent him or what the purpose of it
was or where she got it. And that being the case, then I wouldn't know
how to use the document. . . . [F]or the time being, . . . [GX 10] I'm
going to exclude based on the objections without prejudice for . . .
[Government Counsel] to make, as I said, another run at it.''); see
also id. at 127-131. The Government did not end up being successful at
introducing GX 10.
DI followed up on the telephone call he received from TDHI by
gathering information. He obtained a copy of the MOA. DI served an
administrative subpoena on the Tennessee Department of Health
Controlled Substance Monitoring Database (hereinafter, CSMD) to obtain
a list of controlled substance prescriptions that Respondent issued.
Infra. He secured a copy of the DEA Form 106 that Respondent submitted
about the theft or loss of controlled substances, GX 5 (hereinafter,
DEA theft report). Id. at 45-49. The DEA theft report shows that
Respondent reported the theft or loss of Testosterone Cyp, Zolpidem
Tartrate, Phentermine, and Alprazolam. GX 5, at 1-2.
I agree with the Chief ALJ's assessment of DI's credibility, that
DI ``presented as an objective, experienced regulator with no apparent
agenda, who provided answers that, even in some difficult areas . . .
rang true.'' RD, at 14. I also agree with the Chief ALJ that DI
``resisted the temptation to embellish the statements purportedly made
by the Respondent, . . . [J.J., and N.J.] although it was arguably
clear that doing so would have strengthened the case for a sanction.''
Id. Accordingly, I agree with the Chief ALJ and find that DI's
``testimony was sufficiently detailed, plausible, and internally
consistent to be afforded full credibility in these proceedings,'' and
I make corresponding findings of fact as a result. Id.
DI investigated how it came to be that Respondent possessed the
controlled substances that she reported as stolen on the DEA theft
report. Tr. 50-73. Over Respondent's objections, the Government
successfully moved the admission of the entire twelve-page packet of
McKesson Medical-Surgical Inc. (hereinafter, McKesson), parent of Moore
Medical Inc. (hereinafter, Moore Medical purchase packet), ``records of
all purchases made'' by Respondent.\9\ GX 6. The first two pages of the
Moore Medical purchase packet are the Declaration of a McKesson
employee whose job responsibilities include ``obtaining [McKesson]
documentation and information in response to subpoenas and other
requests.'' Id. at 1-2; Tr. 51-53. According to the Declaration, the
rest of GX 6 had originally been produced in response to a Grand Jury
Subpoena served in March 2017. Tr. 50-69.
---------------------------------------------------------------------------
\9\ Respondent objected to the admission of page 6 of GX 6 on
the grounds of scope (Respondent is ``not charged with a crime in
using the hospital's credit card, as stated here'') and prejudice,
arguing that the page ``should not be considered by the Court in
assessing penalties against'' Respondent. Tr. 56, 66; see also id.
at 56-59, 66-69. In admitting the entirety of GX 6, the Chief ALJ
stated that ``[i]t seems to me to eliminate that part of it [page 6]
would leave an analytical hole in the documents that were provided.
. . . I don't know how the evidence is going to turn out, but if the
evidence turns out that this unauthorized use of a credit card is
relevant because she wasn't supposed to be getting those drugs, and
it was all part of a plan to keep them in an unauthorized way, and
that reflects on her, I probably would consider that. But the fact
that she violated some rule about a credit card, that's not charged,
and I don't think it impacts much beyond arguably credibility.'' Id.
at 68. I agree with the Chief ALJ.
---------------------------------------------------------------------------
The third page of the Moore Medical purchase packet is the
``Controlled Substance Report'' showing the controlled substances
shipped to Respondent in March 2013. GX 6, at 3; Tr. 53-54. According
to the Controlled Substance Report, Zolpidem, Testosterone Cyp,
Phentermine, Carisoprodol, and Alprazolam were shipped to Respondent at
``969 Tennessee Avenue South, Parsons TN 38361.'' \10\ GX 6, at 3. DI
testified that he compared the content of the DEA theft report, GX 5,
with the content of this ``Controlled Substance Report'' and concluded
that the quantity of the controlled substances reported on the DEA
theft report is identical to the quantity of controlled substances
received from Respondent's purchase from Moore Medical. Tr. 49-50. (``I
looked at the number where they listed the quantity lost and compared
that to a[n] invoice that I obtained under subpoena from Moore Medical,
and the numbers of the amounts that were taken or reported as taken in
this agreed with what was the number of containers that were taken or
delivered to . . . [Respondent].'').
---------------------------------------------------------------------------
\10\ This was Respondent's registered address at the time.
---------------------------------------------------------------------------
The fourth page of the Moore Medical purchase packet includes much
of the same information as appears on the third page plus the date
Respondent ordered the controlled substances, February 26, 2013, and
the method of payment, ``credit card.'' GX 6, at 4; Tr. 54. The fifth
page of the Moore Medical purchase packet shows, among other things,
that Respondent's ``Company Name'' in the McKesson records is ``St.
Croix LLC.'' GX 6, at 5; see also Tr. 55-56. The fifth page also shows
the shipping address as ``969 Tennessee Ave South, Decauter [sic]
Cgh.'' GX 6, at 5; see also Tr. 55-56.
The sixth page of the Moore Medical purchase packet summarizes a
[[Page 19013]]
telephone call from an individual at Decatur County General Hospital on
March 5, 2013. GX 6, at 6; Tr. 59-60. According to that ``Account
Note,'' the individual ``wanted to advise us'' of his belief that
Respondent, a ``contractor at the Hospital,'' placed an Order and ``has
left with the product.'' GX 6, at 6; see also Tr. 56, 59-60. It states
that the individual is ``going to contact their Local Police to file
charges.'' GX 6, at 6; see also Tr. 59-60. Page 6 of the Moore Medical
purchase packet also suggests that ``Decauter Cgh'' means ``Decatur
County General Hospital.'' GX 6, at 6; Tr. 59-60.
The seventh page of the Moore Medical purchase packet includes two
views of Respondent's registration, FS2669868, showing the expiration
date of February 28, 2014. GX 6, at 7; Tr. 60. The address on the
registration captured on this page is ``969 Tennessee Avenue South,
Parsons, TN 38361-0000.'' GX 6, at 7; see also GX 2, at 1 (DEA
Certification of Respondent's Registration History stating that ``969
Tennessee Avenue'' was Respondent's registered address as of June 13,
2011, and that Respondent's registered address changed on January 3,
2014).
The eighth page of the Moore Medical purchase packet is titled
``Declaration of Controlled Substances Purchases,'' is signed by
Respondent, and is dated February 12, 2013. GX 6, at 8; Tr. 60-61. The
Declaration includes information appearing on previous pages of GX 6:
``Jennifer St. Croix, M.D./St. Croix LLC'' (for ``customer name''),
``969 Tennessee Ave S, Parsons TN 38361'' (for ``address, city and
state''), and ``FS2669868'' (for ``DEA registration #''). GX 6, at 8.
Respondent ``declare[d] and attest[ed]'' that she ``fully complies with
all federal and state laws and regulations on the dispensing of
controlled substances including but not limited to dispensing to
patients only pursuant to a legitimate prescription issued in the
course of an established doctor-patient relationship . . . and only for
a legitimate medical purpose.'' Id. Regarding her purchase of so-called
``Lifestyle Drugs,'' such as Phentermine and Alprazolam, Respondent
stated that her ``requirements for [their] purchase[ ] . . . are
necessary for [the] [a]ddition of Age Management Medicine, weight loss
& wellness to private practice.'' Id.; see also Tr. 60-61 (DI's
testimony that this record is used to ``verify a reasoning behind the
purchase from a practitioner to verify that what they're ordering is
for a legitimate purpose or get the reasoning behind ordering the
controlled substances.''). Respondent ``certifie[d]'' that she ``made
sufficient inquiry to be able to make this declaration truthfully,
accurately, and without material omissions.'' GX 6, at 8. She also
``affirm[ed] by signing this declaration that the above is true and
correct to the best of . . . [her] knowledge and belief.'' Id.
The ninth through twelfth pages of the Moore Medical purchase
packet contain the label ``invoice.'' Id. at 9-12. In two places on the
ninth page, the record shows Respondent's home address. Id. at 9; Tr.
62, 65. The ninth page also shows the ``ship to'' registered address
for the order, the same address as Respondent's registered address,
which is also the address of Decatur County General Hospital. GX 6, at
9; Tr. 62, 65. The data points addressed in the invoice are item
number, item description, order quantity, ship quantity, ``B/O Qty,''
dollar unit price, ``U/M,'' ``$ Extended,'' sales tax, and ``ship
from.'' GX 6, at 9, 11-12. The items described on the invoice are both
controlled substances and medicines that are not controlled. Id. The
invoice does not list the controlled substances separately from the
medicines that are not controlled. Id.
DI testified that his investigation included attempting to contact
the individual with Decatur County General Hospital whose call was
memorialized as an ``Account Note'' on the sixth page of the Moore
Medical purchase packet. Tr. 70-72. According to DI, he ended up
speaking with the Decatur County General Hospital Chief Executive
Officer who succeeded that individual (hereinafter, DCGH CEO). Id. at
71-72. A result of that telephone conversation with DCGH was DI's
receipt of an ``incident report'' indicating to him ``that there was
possibly the diversion of controlled substances.'' \11\ Id. at 73. DI
testified that his follow-up included an unannounced interview of
Respondent at her residence on May 19, 2014.\12\ Id. at 73-74.
---------------------------------------------------------------------------
\11\ The Government did not offer the ``incident report'' into
evidence and, therefore, I am not considering it.
\12\ DI testified that another Diversion Investigator assisted
him with the interview of Respondent. Tr. 74-75.
---------------------------------------------------------------------------
DI testified that during the interview, Respondent admitted that
she had ordered a ``small amount'' of controlled substances, telling DI
she did so because ``she was thinking about starting her own private
practice,'' although she added that she never did. Id. at 76. DI
testified that Respondent told him that ``she received the controlled
substances at Decatur County General [Hospital], she brought them to
her residence and secured them in an outside storage shed that was
behind her residence.'' Id. at 77. DI testified that if Respondent were
``going to administer or if she's going to dispense controlled
substances or she's going to hold controlled substances for dispensing,
she would have to have a registration there'' but, to his knowledge,
Respondent's residence was never a DEA registered location. Id. at 76,
78; see also GX 2, 1-2. DI recounted that Respondent said ``she didn't
look in the storage shed again until she went there to conduct an
inventory that was requested by the Tennessee Department of Health
Office of Investigations.'' Tr. 77-78. At that time, she learned that
the controlled substances were missing from the shed. GX 4 (Memphis
Police Department Incident Report dated November 6, 2013) (hereinafter,
Memphis Police Incident Report), at 1, 3; see also Tr. 121-22.
According to the Memphis Police Incident Report, Respondent told the
police that the controlled substances went missing ``anytime between
March and . . . [November 6, 2013] as she never goes into the shed.''
GX 4, at 3. The Memphis Police Incident Report also stated that ``There
was no scene to process. There was no damage to the shed, as the door
was unlocked.'' Id.
According to DI, Respondent asked if he would like to see the shed
where she had stored the controlled substances and took the two
Diversion Investigators ``behind her residence outside'' to the shed
that was ``built onto the back of her townhouse'' and was ``about the
size of a closet . . . [p]robably about four feet across, maybe four
feet deep[,] and maybe eight feet tall.'' Tr. 79-81; see also id. at
154 (shed was attached to Respondent's residence). The shed did not
have a window, DI stated. Id. at 84. DI testified that the shed ``was
probably about 30 yards or so'' from the street and that ``[t]here was
no fence or anything at the rear of her house. It was just open all the
way back, and there were other townhouses that were adjacent to hers
that opened up to this area.'' Id. at 79; see also id. at 82-83. DI
described the shed's door as a ``hollow-core door'' with ``just a
regular doorknob that would be operated with a key,'' but stated that
Respondent ``just turned it and opened it right up.'' Id. at 81-82. DI
testified that the door ``was rather beat up, and the frame of the door
was kind of damaged some, and also where the lock was, . . .
[Respondent] stated that it didn't shut very well.'' Id. at 82; see
also id. at 83-84 (DI adding that the shed door ``looked like it would
be fairly easy to open up'' and that he could not ``positively say''
that he saw any signs of break-in).
DI testified that his interview of Respondent also addressed
controlled substance recordkeeping requirements.
[[Page 19014]]
Id. at 84-85. He testified that he asked Respondent if she had created
an initial inventory and that her response was ``she had never created
a regulatory or an initial inventory.'' Id. at 85-87.
DI testified that Respondent told him she is not treating any
family members. Id. at 88. He stated that she admitted treating J.J.
and N.J., telling DI she treated them ``on the side,'' and referred to
J.J. as her boyfriend with whom she had a romantic relationship ``for a
brief time.'' Id. at 89; see also id. at 182-85, 189, 199-200; contra
GX 6, at 8 (Respondent's declaration and attestation that she
``dispens[es controlled substances] to patients only pursuant to a
legitimate prescription issued in the course of an established doctor-
patient relationship''). DI testified that J.J. also stated that he had
a romantic relationship with Respondent ``for a brief period of time.''
Id. at 196-97. DI stated that N.J. said ``he saw . . . [Respondent]
either at his brother's [J.J.'s] house--on one occasion he saw her at a
pharmacy . . . in a parking lot.'' Id. at 198-99. Both J.J. and N.J.,
during DI's interviews of them, told DI that ``the drugs [Respondent
prescribed for them] were based on a complaint of injuries that they
had.'' Id. at 201-02. DI testified that Respondent told him she did not
maintain medical records for either J.J. or N.J. Id. at 89; see also
id. at 188-90.
When DI followed up on Respondent's statement that she did not
maintain medical records, he learned from an attorney in the Office of
General Counsel of the Tennessee Department of Health that the attorney
had received a medical record purportedly for J.J. from Respondent's
previous Counsel. Id. at 127-28. DI testified that the attorney emailed
him what she had received from Respondent's previous Counsel. Id. at
128-30; GX 10. DI stated that the purported chart ``didn't have a name
on it.'' Tr. 129. He testified that, since Respondent ``had told me
that she had not kept patient charts for N.J. or J.J. when I
interviewed her at her residence . . . [,] I was doubtful about where
these charts--the alleged--the charts may have come from . . . [o]r if
they had been created after the fact.'' Id. at 133.
Respondent's Counsel objected to the admission of GX 10 because,
she stated, it was ``represented as a complete medical chart'' for J.J.
Id. at 131. The Chief ALJ sustained her objection based on foundation
and relevance. Id. at 132-33. His ruling, he advised, was without
prejudice for Government's Counsel to ``make . . . another run at it.''
Id. at 132. Government's Counsel subsequently presented arguments to
the Chief ALJ for the admission of GX 10. Id. at 136-37. His argument
included that Respondent had noticed she would be relying on
``virtually the same exhibit'' as a medical record for J.J. consisting
of five more pages than GX 10. Id. at 138-39. The Chief ALJ did not
change his ruling; GX 10 was never admitted. Id. at 139-42. I agree
with this and the other evidentiary rulings of the Chief ALJ during the
hearing.
As already discussed, DI stated that he served a subpoena on the
CSMD seeking a ``listing of all the prescriptions that . . .
[Respondent] had listed in the CSMD'' for the period of June 2011
through March or April 2014. Id. at 91. He testified that he found
``several prescriptions that were attributed to'' J.J. and N.J. Id. at
92. Then, DI testified, he obtained the original prescriptions issued
to J.J. and N.J. from the pharmacies where they were filled. Id. at 93.
He stated that he issued subpoenas to the three hospitals on whose
paper the prescriptions were purportedly written seeking medical
records for J.J. and N.J.\13\ Id. at 94. The three ``no-record''
responses that DI received from the hospitals were admitted into
evidence. GX 8.
---------------------------------------------------------------------------
\13\ The six subpoenas were admitted into evidence. GX 7.
---------------------------------------------------------------------------
DI also subpoenaed the prescriptions that Respondent issued to J.J.
and N.J. Tr. 99-101. DI identified GX 9 as consisting of copies of
eighteen original controlled substance prescriptions, front and back,
that Respondent issued for J.J. Id. at 99-100. The eighteen controlled
substance prescriptions were issued for Percocet, Zolpidem, Alprazolam,
and Tussionex. GX 9. The prescriptions in GX 9 were issued on either
``Methodist Healthcare Discharge Prescription Orders,'' ``McNairy
Regional Hospital Elite Emergency Services,'' or ``Baptist Memorial
Hospital--Tipton'' paper. Id.
DI also testified that GX 11 consists of copies of original
controlled substance prescriptions that Respondent issued for N.J. Tr.
101. According to GX 11, Respondent issued controlled substance
prescriptions to N.J. for Tussionex and Lortab. GX 11. The
prescriptions in GX 11 were issued on either ``Methodist Healthcare
Discharge Prescription Orders'' or ``Baptist Memorial Hospital Tipton
Discharge Medications'' paperwork. Id.
DI testified that GX 12a through GX 12l contain ``copies of some of
the prescription logs that were submitted to the [DEA] Nashville
District Office.'' Tr. 104-05. He clarified that the contents of GX 12a
through GX 12l ``list N.J. and J.J., I believe.'' Id. at 106.
During his testimony, DI pointed out that Respondent's April 2014
MOA-required drug log does not include a controlled substance
prescription that Respondent issued to N.J. for Tussionex on April 30,
2014.\14\ Compare GX 11, at 5 and GX 12l, at 10; Tr. 116-17.
---------------------------------------------------------------------------
\14\ Government Counsel ``withdrew'' his statement to the Chief
ALJ that ``[w]e'll go through'' the other pages of GX 11 and GX 12l
to identify any other discrepancies between GX 11 and GX 12l. Tr.
119-20.
---------------------------------------------------------------------------
Regarding the OSC charge that Respondent failed to provide six MOA-
required drug logs, DI described during his testimony the steps he took
to ascertain whether DEA received those logs. Tr. 106-14; see also id.
at 148-52. He also testified that, given his belief that Respondent
sent the drug logs to DEA by certified or registered mail, he asked her
about certified return receipt cards when he interviewed Respondent at
her residence. Id. at 147; see also id. at 148 (DI's testimony that
Respondent told him that ``she sent everything in certified mail.'').
``[S]he went to a back portion of her house and came back with about
four or five cards,'' he reported. Id. at 147. When DI asked her if she
had any more cards, she answered in the negative. Id.
After DI's testimony, the Government called Stephen Loyd, M.D., its
second and final witness. Id. at 203-83. Dr. Loyd is a practitioner
whose medical license in Tennessee and DEA registration were in good
standing and were never subject to discipline. Id. 206. His
professional experience includes being a hospital ``residency program
director for internal medicine,'' practicing hospital medicine, and
working in a hospital emergency department. Id. at 231. Dr. Loyd
testified that ``the course that's required for every physician in the
State of Tennessee on controlled substances, I teach.'' Id. at 249-50.
Having read and analyzed all of the record evidence, I agree with the
Chief ALJ's determination to recognize Dr. Loyd as an expert in
internal medicine with an emphasis on the proper prescribing of
controlled substances in Tennessee.\15\ Id. at 214.
---------------------------------------------------------------------------
\15\ Respondent's Counsel did not object to this determination.
Tr. 214.
---------------------------------------------------------------------------
Dr. Loyd testified that the 1995 Policy Statement of the Tennessee
Board of Medical Examiners, entitled ``Management of Prescribing with
Emphasis on Addictive or Dependence-Producing Drugs,'' GX 15
(hereinafter, Tennessee Controlled Substance Prescribing Policy
Statement), applies to Respondent's allegedly unlawful controlled
substance prescribing as Tennessee's chronic pain guidelines did not go
into effect until after the time period alleged in the OSC. Id. at 211-
12; see also id. at 281-82. I agree with
[[Page 19015]]
Dr. Loyd's assessment and the application of the Tennessee Controlled
Substance Prescribing Policy Statement to this proceeding.
Dr. Loyd correctly characterized the Tennessee Controlled Substance
Prescribing Policy Statement as setting out the nine ``steps that were
accepted practice for the proper prescribing of when . . . [controlled
substance] medications were indicated'' for acute or chronic pain. Id.
at 215-16. He explained the first step, having a ``workup sufficient to
support a diagnosis,'' as the ``establishment of a proper diagnosis
that would indicate a need for a controlled substance for pain.'' Id.
at 216; GX 15, at 1. Dr. Loyd testified that the workup sufficient to
support a diagnosis begins with the patient's chief complaint, ``[a]ll
of the things surrounding that chief complaint, the who, what, where,
when, why, how, around that chief complaint,'' and ``then the history
of present illness.'' Tr. 224. He noted that pain is a symptom, not a
disease, and ``so the first part . . . is establishing a diagnosis as
to the root of the pain, so you can address that, rather than the
symptom.'' Id. at 218.
For pain patients in general, including chronic pain patients, Dr.
Loyd testified that ``it's vitally important that you have some kind of
subjective statements from the patient as to the limitations the pain
is causing and their activities of daily living.'' Id. at 224. Knowing
the patient's limitations caused by the pain is important, he
explained, because the purpose of a practitioner's intervention is ``to
try to improve that patient's functioning with whatever condition that
they have.'' Id. at 225. If the patient's limitations are ``very
little,'' he suggested that the associated risks would render a
controlled substance intervention inappropriate. Id. He also suggested
that the efficacy of the intervention is judged by the intervention's
impact or lack of impact on the patient's limitations caused by the
pain. Id.
In a similar vein, Dr. Loyd summarized the second and third steps
as concerning ``the use of non-controlled substance modalities to try
to address the pain issues first, before moving onto a controlled
substance.'' Id. at 216.
Regarding the fourth step, Dr. Loyd pointed out that ``the reality
here is that these [controlled substance] medications are very
effective, but they also have abuse potential.'' Id. at 217. As such,
he testified, ``you have to weigh the risk versus benefits, and so . .
. there are some things that you need to do to try to ascertain your
patients' risk for abusing one of these prescribed controlled
substances.'' Id. ``One of the big risk factors for misusing prescribed
controlled substances,'' he explained, ``is someone that has a history
or a family history of substance use disorder,'' including alcohol and
prescription pills. Id. at 226. Urine drug screens, he testified, are
``sometimes the truth serum for that history'' and assist with the
practitioner's determination of whether an ``underlying substance use
disorder . . . [is] really the problem, instead of the problem that
they're presenting.'' Id. at 227-28; see also id. at 230. Dr. Loyd
reported that, initially, he will ``usually do a 10 or 12 panel [urine
drug screen] that has a mixture of prescribed drugs, as well as illicit
drugs, and the common illicit drugs are on there, methamphetamine,
cocaine, marijuana.'' Id. at 228-29. Subsequently, if he prescribed a
controlled substance for treatment, the urine drug screen he orders
will test ``to make sure those drugs are in their system'' and, if not,
he ``want[s] to know where they're going. And most of the time that's
diversion.'' Id. at 229; see also id. at 230 (Someone would ``pretty
much live under a rock not to know what's going on in our state in
Tennessee right now with regards to prescription drug abuse. So we have
a lot of pills that are diverted.'').
Along these lines, Dr. Loyd described the fifth step, obtaining
informed consent ``as to the risk of developing a dependence and
addiction on the prescribed medication, even if it's for [a] legitimate
medical need.'' Id. at 218. Dr. Loyd explained that ``the approach has
been to start with the least invasive, least dangerous things first, so
as in the treatment of any disease, you want to be as least invasive as
possible.'' \16\ Id.
---------------------------------------------------------------------------
\16\ ``Somebody has chest pain, you don't move straight to open-
heart surgery,'' Dr. Loyd analogized. Tr. 218. ``There are things
that you do prior to that and open-heart may be where you wind up,
but definitely not where you start.'' Id.
---------------------------------------------------------------------------
Regarding the standard of care for the general practice of
medicine, Dr. Loyd described the initial patient visit as when the
practitioner ``establish[es] the framework and the groundwork of where
you're starting, and subsequent medical visits will be . . . based on
the intervention that you make in the first medical visit and what kind
of improvements or not improvements that you have at subsequent
visits.'' Id. at 223. Further, he characterized patient safety as the
practitioner's ``first consideration,'' citing to the Hippocratic Oath
as ``First, do no harm'' and then ``Second, then try to help.'' Id. at
224.
Dr. Loyd also testified about the importance of obtaining medical
records from previous treating practitioners. Id. at 225. A
practitioner uses the information in other practitioners' treatment
records to inform what treatment to prescribe and what treatments not
to prescribe. Id. at 225-26.
Dr. Loyd testified that he worked with physician contractors in a
hospital setting. Id. at 231. He testified that, in his experience,
hospital physician contractors work in a group and report to the
contractor head of the group. Id. at 232. The contractor group head, in
turn, is ``accountable to the hospital for the services they contract
for,'' Dr, Loyd continued. Id. He specifically testified that
contractor physicians are ``subject to the record-keeping that's
required by the accrediting bodies, Joint Commission, as well as
Medicare, Medicaid, all the insurance companies and most commonly, the
hospital that you're working for, and you're also subject to peer
review within that same hospital.'' Id. at 232-33. Regarding record-
keeping, Dr. Loyd testified that ``there's a lot of risk with . . . not
maintaining a patient record and safety would be the biggest one.'' Id.
at 235-36. He continued that ``it will violate . . . standards from
accrediting bodies, such as Joint Commission.'' Id. at 236. Concluding,
Dr. Loyd added that ``you also get into the fact that if you don't have
a medical record and you billed for that service to an insurance
company, you don't have the documentation to support a level of care
for that reimbursement, so that gets into what's considered to be
fraud.'' Id.
Dr. Loyd continued to testify in increasing detail about the
importance of maintaining medical records, or patient charts, during
his testimony about GX 9 (prescriptions Respondent issued to J.J.), GX
11 (prescriptions Respondent issued to N.J.), and GX 14 (Dr. Loyd's
report on Respondent's controlled substance prescribing for N.J. dated
October 1, 2016). Medical records are the ``crux,'' he stated, the
``foundation of what we're trying to do here.'' Tr. 240. He explained
that they are ``going to establish . . . history, present illness, past
medical history, surgical history, social history, physical
examination, assessment and plan, . . . [and they are] going to
validate how a diagnosis was arrived at and the subsequent treatment
plan for that diagnosis . . . [and] for a lot of other things, other
than that.'' Id. Dr. Loyd testified that he would expect Respondent to
take a history, including a personal drug history, conduct a physical
examination, make a diagnosis, start any intervention with a treatment
that has the highest potential for benefit and the lowest amount of
risk, and
[[Page 19016]]
establish and document informed consent before prescribing a controlled
substance. Id. at 241-44.
As memorialized in his report regarding N.J., GX 14, Dr. Loyd
explained that he received copies of three controlled substance
prescriptions Respondent issued to N.J., but no medical record by
Respondent about N.J. ``so I couldn't comment as to the thoroughness of
the history, the appropriateness of the diagnosis.'' Id. at 246; see
also id. at 241 (discussing the controlled substances that Respondent
prescribed for N.J.) As such, Dr. Loyd's report summarizing his
``findings for the material that . . . [he] reviewed that day'' was
five sentences, including the statement that ``[t]here were no medical
records to support the history, physical examination and thought
process that led to the prescribing of these medications.'' Id. at 246;
GX 14, at 1. Dr. Loyd's report concluded that ``[e]ssentially, the
controlled substances were prescribed with nothing to support their
use'' and, thus, that the ``controlled substances prescribed for . . .
[N.J.] were prescribed outside the scope of accepted medical practice
and were not for a legitimate medical purpose.'' GX 14, at 1.
Respondent's Counsel, among other things, asked Dr. Loyd whether he
had been ``advised since the preparation of . . . [his] report that
there are, in fact, medical records that exist for N.J.'' and whether
he had ``seen those records.'' \17\ Tr. 259. Dr. Loyd responded
affirmatively to both questions. Id. at 259-60. He testified that he
did not supplement his initial report after seeing those records. Id.
at 260. Dr. Loyd also indicated that he was provided ``nothing [on
which] to base'' an opinion about whether N.J. ``exhibited any signs of
drug dependency, . . . drug abuse . . . [or] drug-seeking behavior . .
. [, or whether N.J. was] diverting these drugs to anyone else . . .
[or] suffered any harm because of these prescriptions.'' Id. at 260-61.
---------------------------------------------------------------------------
\17\ The Government did not mention a medical record for N.J. in
its Exhibit List or in either of its Pre-Hearing Statements.
Presumably, Respondent provided her Counsel with the medical records
for N.J. about which Respondent's Counsel asked Dr. Loyd. Tr. 259.
---------------------------------------------------------------------------
Thereafter, Government's Counsel asked Dr. Loyd whether the
``proposed'' N.J. medical records included ``any personal history of
substance abuse with regard to any of the prescriptions that were
issued.'' Id. at 261, 271. Dr. Loyd answered that ``[t]here was a block
on the ED chart that asked about substance use and . . . [N.J.] denied
alcohol or . . . [illicit] drugs. So she did do it, yes.'' Id. at 271.
He continued his answer by stating that he would have expected to see
documentation of follow-up to verify this information due to the
``potential health risk for sure in combining substances that work in
the central nervous system'' with alcohol use since it would increase
the ``risk of a bad outcome.'' Id. at 273. He testified, though, that
he did not see any documentation of Respondent's having addressed with
N.J. the potential risks of mixing the controlled substances she
prescribed for him with alcohol and of dependence and/or addiction with
prolonged use. Id. at 273-74.
Government's Counsel asked Dr. Loyd whether the ``proposed'' N.J.
medical records indicated ``any settings where . . . [N.J.] was
purportedly treated.'' Id. at 267; see also id. at 274. Dr. Loyd opined
the ``emergency department as well as I can tell.'' Id. at 267-68. He
also testified that he would expect a medical record's statement about
the setting at which medical treatment was provided to be accurate. Id.
at 275. Dr. Loyd also testified that he ``was surprised that once that
initial [emergency department] visit happened, that from then on . . .
[N.J.'s respiratory and pain issues were] not taken care of in a
primary care setting . . . or his primary care physician or a pain
medicine specialist setting.'' \18\ Id. at 269. He indicated that he
``absolutely'' would have expected to see coordination of treatment
between an emergency department physician and a primary care physician
given N.J.'s extended period of treatment in an emergency room setting,
but found no evidence of it in the ``proposed'' N.J. medical records.
Id. He also noted that, ``whenever we're talking about a case like
this, . . . [seeking treatment at the emergency department] would have
been a red flag that somebody is coming in here explicitly for
narcotics.'' Id. at 278. He elaborated by asking ``why are they not
presenting to their other doctor, to their primary care physician, who
knows them much better than we do.'' Id.
---------------------------------------------------------------------------
\18\ Dr. Loyd stated that he has seen patients use emergency
departments for medical treatment due to ``economic reasons,'' such
as no health insurance. Tr. 277-78.
---------------------------------------------------------------------------
Government's Counsel asked Dr. Loyd whether he saw any evidence of
urine drug screening in the ``proposed'' N.J. medical records. Id. at
269-70. Dr. Loyd testified that he would have expected to see urine
drug screening ``[g]iven that a controlled substance was prescribed on
multiple occasions,'' but he did not. Id. Dr. Loyd stated that he would
have expected N.J. to give informed consent ``prior to the prescribing
[of] controlled substances,'' but that he ``did not see informed
consent in the [proposed N.J.] medical record.'' Id. at 270. He
elaborated by testifying that N.J.'s family history of alcoholism,
alcohol abuse, or alcohol misuse put N.J. ``by definition at increased
risk to misuse prescribed controlled substances'' such that he would
want to give N.J. ``informed consent of the risk and benefits of using
. . . [controlled] medication including his risk for possible misuse
and development of subsequent dependence and/or addiction.'' Id. at
270-71.
Further, Government's Counsel asked Dr. Loyd whether he saw any
evidence in the ``proposed'' N.J. medical records that Respondent had
``explore[d] limitations on N.J.'s activities as a result of pain.''
Id. at 276. Dr. Loyd responded that he thought, although he ``could
have misread this,'' that ``there was concern of whether or not . . .
[N.J.] would be able to maneuver himself with regards to his weapon.''
\19\ Id.; see also id. at 268 (Dr. Loyd's testimony about N.J.'s
``proposed'' medical records that ``there was some concern that he was
having problems with maneuvering in his job with regards to . . . the
pain that he was having.''). Dr. Loyd testified that he saw nothing in
N.J.'s ``proposed'' medical records that Respondent explored any
treatment modality for N.J. other than a controlled substance. Id. at
276. Dr. Loyd also testified that Respondent did not document, in the
``proposed'' N.J. medical records, that she followed up with N.J.
during any subsequent visit about whether the controlled substance
prescription she issued for him was effective by, for example, asking
him whether he was able to maneuver as he needed to do his job after
starting the controlled substance therapy. Id. at 276-77.
---------------------------------------------------------------------------
\19\ The testimonies of both DI and Dr. Loyd indicate that N.J.
worked for the Sheriff, possibly as a Deputy Sheriff. Tr. 200, 268.
---------------------------------------------------------------------------
Dr. Loyd summarized the ``fundamental issues'' he had with the
``proposed'' N.J. medical records ``as far as the proper prescribing
[of] controlled substance[s],'' stating that the ``root of the issue is
really in the establishment of the diagnosis being such that it would
have required a controlled substance before trying any other non-
controlled substance modality for treatment.'' Id. at 274. He testified
that, after reviewing the ``proposed'' medical records for N.J., he did
not change his opinion that Respondent prescribed controlled substances
for N.J. for no legitimate purpose. Id. at 277.
I agree with the Chief ALJ that Dr. Loyd ``presented as
knowledgeable, objective, and thoughtful in his answers,
[[Page 19017]]
without any indication of an agenda.'' RD, at 17. In this Decision/
Order, I give controlling weight to Dr. Loyd's testimony as did the
Chief ALJ because Dr. Loyd ``has extensive experience practicing,
writing, and lecturing on the subject matter of his testimony.'' Id.
Further, I note that Respondent did not put on a case or proffer a
witness, let alone an expert, to rebut Dr. Loyd's testimony. As such,
in addition to the independent persuasiveness of Dr. Loyd's testimony,
his testimony is unrebutted in the record before me.
D. Respondent's Case
Immediately after the Government rested, Respondent's Counsel moved
for summary disposition on the ground that the Government had not
established a prima facie case. Tr. 285-86. Among other things, the
motion was based on the theory that the Government introduced no
evidence that the drug logs Respondent submitted to DEA were
``falsified,'' as opposed to simply ``not correct,'' because the
incorrect material was not a mandated data point in the MOA. Id. at
286-87. The motion argued that the MOA does not prohibit Respondent
from issuing controlled substance prescriptions to J.J. because it only
prohibits prescribing to ``family members,'' and boyfriends, friends,
and ``intimate acquaintances'' are not ``family members.'' Id. at 287.
The summary disposition motion argued that the Government failed to
establish a violation based on Respondent's medical care of J.J. ``in
that those records are not before the Court . . . ``[s]o there's really
nothing to consider.'' Id. at 287-88. The summary disposition motion
explicitly acknowledged the existence of the charge that Respondent
created no medical records for N.J. while claiming that ``any
criticisms were not . . . presented to [Respondent] as far as the
quality of the care, the need for those prescriptions and so she,
therefore, was not prepared to respond to those.'' \20\ Id. at 288.
---------------------------------------------------------------------------
\20\ The summary disposition motion stated that DI ``did not
determine that the drugs were being diverted or there was nothing
indicating it was for anything other than a legitimate medical
purpose from his perspective as a non-physician.'' Tr. 288. She
added that N.J., himself, ``offer[ed]'' that there was a legitimate
medical purpose for the controlled substance prescriptions. Id.
---------------------------------------------------------------------------
Regarding the allegation that Respondent did not store controlled
substances securely, the summary disposition motion argued that
``according to the [G]overnment's own witness, if . . . [Respondent]
kept . . . [controlled substances] in a locked, secure cabinet within
the shed, that would have been in compliance with the . . . plain
language of the regulations.'' Id. at 289. According to the motion,
``[t]here is no evidence that . . . [Respondent] dispensed any
medications from this residence, that she operated any business or that
she intended to operate a business'' and, therefore, ``many of the
regulations that were cited . . . [in the OSC] are not applicable.''
\21\ Id.
---------------------------------------------------------------------------
\21\ According to Respondent's summary disposition argument, her
residence ``was not a principal place of business or professional
practice. She did not manufacture, distribute, import, export, or
dispense drugs at that location. That is undisputed under the
record.'' Tr. 289.
---------------------------------------------------------------------------
The summary disposition motion counted initial inventory
requirements among the ``many'' inapplicable regulations cited in the
OSC. Id. at 291. Referring to the legal argument that the invoice
Respondent received in connection with the Moore Medical purchase
satisfied the ``initial inventory'' requirement, the motion admitted
that the invoice ``failed to specify'' whether the ``inventory'' was
taken at the beginning or the end of the day. Id. The motion minimized
this deficiency, arguing that ``this was not an ongoing concern,'' that
Respondent ``was the only one who had control of these drugs,'' and
that ``[i]f this case is about the fact she didn't say whether it was
the beginning or the end of the day, I mean that's not why we're
here.'' Id. at 291-92. According to the motion, Respondent ``had not
yet commenced a business.'' Id. at 294. ``I think they're reading way
too much into'' the declaration in the Moore Medical purchase packet,
the motion argued, and ``[t]here's no evidence that she had any kind of
any ongoing--that she had a medical clinic that she was operating, that
she . . . dispense[d] any of these drugs . . . [- s]he didn't charge
for seeing patients, which is--that's conducting a business.'' Id. The
motion argued that ``[t]hese regulations are designed for people who
are seeing patients and dispensing these drugs and documenting the
distribution thereof'' and ``[i]t's imposing far too many requirements
on somebody who is just anticipating doing so in the future.'' Id.; see
also id. at 295.
The Chief ALJ provided input during the presentation of
Respondent's summary disposition motion. Tr. 290-310. The Chief ALJ
pointed out the weaknesses and deficiencies of the motion's arguments
while agreeing with their strengths. Id. For example, the Chief ALJ
agreed that the burden is on the Government to present a prima facie
case, and stated clearly that the ``question is, in viewing the
evidence in the light most favorable to the [G]overnment, have they put
some evidence on everything they would need to make out a prima facie
case.'' Id. at 295; see also id. at 299 (Chief ALJ's statements
pointing to record evidence countering the argument that the Government
had not met its burden for the allegation that Respondent did not
submit all of the MOA-required drug logs); id. at 300-01 (Chief ALJ's
assessment of whether the Government presented sufficient evidence to
establish its case, and views on the appropriateness of a sanction);
id. at 301-03 (discussion involving Respondent's Counsel and Chief ALJ
about the record evidence to date about MOA compliance); id. at 303-05
(conversation between Respondent's Counsel and the Chief ALJ about
unlawful prescribing allegations); id. at 305-07 (focused analysis of
the existing record evidence and stipulation concerning the
documentation of Respondent's controlled substance prescribing); id. at
307-09 (targeted discussion of ``nonsense'' and ``anomalies'' in
Respondent's controlled substance prescribing documentation).
In addition to hearing the back-and-forth between her Counsel and
the Chief ALJ, Respondent also had the benefit of hearing the position
of Government's Counsel on several issues, substantive and procedural.
Id. at 310-15. For example, Government's Counsel repeatedly argued that
Respondent's Counsel had presented argument about her ``theory of the
case,'' as opposed to ``sworn testimony.'' Id. at 310-11. He explicitly
addressed the Government's position that, ``as the record stands now,
there are no patient charts in the record [for either J.J. or N.J.,]
one of the charges . . . in the charging documents.'' Id. at 313.
The analyses and discussions that took place in Respondent's
presence also included the Chief ALJ's ruling on Respondent's motion
for summary disposition. Id. at 311-12, 314-15, 322-29. In denying
Respondent's summary disposition motion, the Chief ALJ provided input
on specific matters at issue in the proceeding. First, he specifically
stated that the Government had ``put forth some evidence that some
information on the dispensing logs, including the location where
patients N.J. and J.J. were treated may be inaccurate.'' Id. at 324.
The Chief ALJ added that, for the Government to prevail on this
allegation, ``there is no requirement that purported falsehoods be
restricted to information that was specifically required by the terms
of the MOA.'' Id.
[[Page 19018]]
Second, the Chief ALJ stated that he was reserving Respondent's
motion as to whether Respondent violated the MOA by prescribing
controlled substances to J.J., assuming that Respondent and J.J. were
romantically involved. Id. at 324-25. The Chief ALJ noted that the
Government cited to ``authority under Tennessee law that prescribing to
a patient . . . [with] whom the physician has a romantic involvement
falls below the applicable standard of care in prescribing, and thus
this aspect of the motion is denied.'' Id. at 325. He also noted that
``a precise timeline of the romantic involvement [between Respondent
and J.J.] was not established.'' Id. Third, the Chief ALJ also stated
that the Government presented ``at least some evidence that controlled
substance prescribing to patient J.J. in the face of a potential
romantic relationship and in the absence of medical documentation . . .
could place the prescribing as outside the course of a professional
practice and without a legitimate medical purpose[ ], and in violation
of Tennessee state law.'' Id. at 325-26.
Fourth, on the allegation of unlawful controlled substance
prescribing to N.J., the Chief ALJ similarly denied Respondent's
motion, stating that the Government presented ``at least some evidence
that the prescribing was done without medical documentation, and even
if medical documentation that had been previously presented by the
Respondent, albeit presented late were presumed valid, that it was
inadequate to establish that the prescribing was done for [a]
legitimate medical purpose and within the course of a professional
practice.'' Id. at 326.
Fifth, the Chief ALJ denied Respondent's motion for summary
disposition on the allegation that Respondent failed to provide DEA
with all of the drug logs required by the MOA. Id. at 326-27. He stated
that DI testified about how the relevant DEA office processes mail and
about the search DI conducted for Respondent's drug logs. Id. at 327.
Sixth, the Chief ALJ stated that the Government presented ``some
evidence that the Respondent did maintain controlled substances in this
residential outside shed'' and reserved the ``legal issue as to whether
their registration was required.'' Id. Seventh, also regarding the
allegation that Respondent stored controlled substances in a shed with
inadequate security, the Chief ALJ denied Respondent's summary
disposition motion because the Government presented ``some evidence
that the Respondent stored controlled substances in a shed with a
modest lock under conditions that arguably did not satisfy the security
requirements set forth in the regulations actually or substantially.''
Id. at 328.
Eighth, the Chief ALJ denied Respondent's motion concerning the
initial controlled substance inventory requirement because the
Government presented ``some evidence that the Respondent admitted to DI
. . . that she never prepared or maintained an initial inventory as
well as evidence in a declarations signed by the Respondent that she
was expanding an already existing practice.'' Id. at 328-29. He added
that ``an invoice prepared by the vendor would not satisfy her
inventory obligation under the regulations.'' \22\ Id. at 329.
---------------------------------------------------------------------------
\22\ When Respondent's Counsel asked for the Chief ALJ's ruling
on the allegation that Respondent did not complete dispensing logs,
he indicated that his ruling was subsumed in the rulings he issued.
Tr. 329.
---------------------------------------------------------------------------
After the Chief ALJ ruled on her motion for summary disposition,
Respondent stipulated that she did not treat J.J. or N.J. at a
hospital. Id. at 330-31; see also supra n.3. She also obtained the
Chief ALJ's approval to receive into evidence her corrective action
plan as Administrative Law Judge Exhibit 29. Tr. 334-35 (Chief ALJ's
statement that the ``corrective action plan is not something that the
administrative law judge deals with,'' ``[i]t's not part of what I have
to recommend,'' ``I can include it in the record or not,'' and ``[i]t
needs to go to the Office of Diversion Control.'').
Thereafter, Respondent's Counsel advised the Chief ALJ that
Respondent was not going to present a case, stating that her client
``would like to accept responsibility for her errors in this case'' and
``[w]e would just request leniency in your recommendations.'' Tr. 335.
The Chief ALJ appropriately pointed out that, for a respondent to
prevail, prior Agency decisions require a respondent's unequivocal
acceptance of responsibility and the submission of appropriate remedial
measures. Id. at 336-37 (Chief ALJ's statements, including ``I want to
make you aware of it. . . . I just wanted to raise that with you before
you've rested.''). Respondent reaffirmed her decision to rest after
consulting again with her Counsel during a break that the Chief ALJ
took specifically for that purpose. Id. at 337-39.
Accordingly, I find that Respondent's decision not to present a
case was communicated to the Chief ALJ after she had been present at
the hearing, after she had the opportunity to observe and hear the
Government's evidence in support of the OSC's allegations, and after
she had the opportunity to hear the Chief ALJ's ruling denying her
motion for summary disposition. I find that Respondent's decision not
to present a case was communicated after the Chief ALJ received her
corrective action plan into evidence and after she stipulated that she
never treated J.J. or N.J. in a hospital. I further find that after
Respondent's decision not to present a case was first communicated to
the Chief ALJ, the Chief ALJ offered his interpretation of past Agency
decisions' statements about the unequivocal acceptance of
responsibility and his practical reflection that her not presenting a
case ``cuts off any other evidence coming in.'' Id. at 338. I also find
that, after the Chief ALJ offered his interpretation and practical
reflection, Respondent's Counsel asked for and received ``a few minutes
to confer with my client in response to Your Honor's comments.'' Id. at
337. Finally, I find that Respondent consulted with her Counsel before
the initial communication of her decision not to present a case, and
had the additional opportunity to consult with her Counsel after the
Chief ALJ offered his interpretation and practical reflection. Id. at
338 (Respondent's Counsel, responding to the Chief ALJ's question about
how much time ``will be enough'' to confer with her client about
whether to present a case, stating that ``I mean, we've discussed it,
so there's not much additional we need to discuss, but just in light of
the point Your Honor has raised, I want to just make sure that I have
an opportunity for her to talk about this before making any final
decisions.'').
Respondent's decision not to present a case means that there are no
factual disagreements between witnesses' testimonies that I need to
resolve.
E. Allegation That Respondent Continued To Issue Controlled Substance
Prescriptions to Individuals Who Are Intimate or Close Acquaintances,
and to an Individual With Whom She had a ``Romantic Interaction'' in
Violation of Tenn. Comp. R. & Regs. R. 0880-2-.14(8)(a) and Tenn. Code
Ann. Sec. 63-6-214(b)(1)
The OSC charged Respondent with ``issuing prescriptions to
individuals who are intimate or close acquaintances.'' OSC, at 2. DI
testified that both Respondent and J.J. told him that they were in a
romantic relationship for a brief period time.\23\ I credit DI's
testimony. I find, however,
[[Page 19019]]
that this evidence of a boyfriend-girlfriend relationship, a romantic
relationship, or any other record evidence detail neither the
parameters of the romantic involvement of Respondent and J.J. nor the
period of time of that romantic involvement.
---------------------------------------------------------------------------
\23\ When DI interviewed him, N.J. also stated that Respondent
and J.J. were girlfriend-boyfriend. Tr. 199.
---------------------------------------------------------------------------
F. Allegations That Respondent Provided Controlled Substance
Prescription Drug Logs to DEA With Falsified Entries ``Noncompliant
With Terms of the June 2011 MOA'' in Violation of 21 U.S.C.
843(a)(4)(A), and ``Provid[ed] Misleading Information to Investigating
Agents'' Implicating 21 U.S.C. 823(f)(5)
The OSC alleged that Respondent's drug log submissions to DEA for
August, October, and November of 2012, February, May, June, July,
October, and November of 2013, and January 2014 contained false entries
``noncompliant with the terms of the June 2011 MOA'' because they
``represented that . . . [she] issued controlled substance
prescriptions to J.J. and his brother N.J. . . . while treating these
individuals at Methodist Fayette Hospital in Somerville, Tennessee;
Baptist Memorial Hospital in Covington, Tennessee; and/or McNairy
Regional Hospital in Selmer, Tennessee.'' OSC, at 2. It also alleged
that Respondent ``provid[ed] misleading information to investigating
agents, 21 U.S.C. 823(f)(5).'' Id. at 3.
I find that the record evidence includes twelve instances when
Respondent submitted drug logs to DEA with entries concerning J.J. and/
or N.J. whose cover transmittal letters and specific J.J. and N.J.
entries falsely, according to one of the parties' stipulations,
indicate that ``[a]ll prescriptions were written while on duty as the
ER physician at the named hospital for registered patients.'' GX 12a,
at 1, 4, and 5 (October 2012, two for J.J. and two for N.J.); GX 12b,
at 1 and 4 (November 2012, two for J.J.); GX 12c, at 1, 6, and 7
(February 2013, two for J.J. and one for N.J.); GX 12d, at 1, 9, and 16
(April-May 2013, two for J.J. and one for N.J.); GX 12e, at 1, 7, and
18 (May-June 2013, two for J.J. and one for N.J.); GX 12f, at 1 and 9
(July 2013, one for N.J.); GX 12g, at 1, 6, and 17 (August 2013, two
for J.J. and one for N.J.); GX 12h, at 1 and 3 (October 2013, two for
J.J.); GX 12i, at 1, 4, and 7 (November 2013, two for J.J.); GX 12j, at
1 and 2 (January 2014, one for J.J.); GX 12k, at 1 and 5 (February
2014, one for J.J.); GX 12l, at 1 and 3 (April 2014, one for J.J.); see
also supra, section II.C. and section II.D. (discussing the stipulation
reached during the hearing). Likewise, I find that the stipulation
Respondent agreed to during the hearing that she did not treat J.J. or
N.J. at a hospital is Respondent's implicit admission that those twelve
cover transmittal letters she sent DEA with the MOA-required drug logs
contained in GX 12a through GX 12l and the individual entries for J.J.
and N.J. in those drug logs are not fully accurate. Supra, section
II.D. (discussing the stipulation reached during the hearing).
Accordingly, I find substantial unrebutted record evidence that
Respondent provided controlled substance prescription drug logs to DEA
with falsified entries, thereby providing misleading information to DEA
investigators.
G. Allegation That Respondent Issued Controlled Substance Prescriptions
to J.J. and N.J. for No Legitimate Medical Purpose and Outside the
Usual Course of Professional Practice in Violation of 21 CFR
1306.04(a), Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(a)(4) and (e), and
Tenn. Code Ann. Sec. 63-6-214(b)(12)
The OSC alleged that Respondent ``issued controlled substances . .
. [to J.J. and N.J.] for no legitimate medical purpose and outside the
usual course of professional practice,'' citing provisions of federal
and state law. OSC, at 2. I find that DI's unrebutted testimony, in
conjunction with GX 7, GX 8, and GX 9, establish that Respondent issued
controlled substance prescriptions to J.J. on paperwork from a hospital
at which Respondent did not treat J.J. GX 7, GX 8, GX 9, Tr. 99-103;
see also supra, section II.D. (discussing the stipulation reached
during the hearing). I further find that these prescriptions were
written over the course of eighteen months and were for Percocet
(eleven prescriptions for this Schedule II controlled substance),
Tussionex (two prescriptions for this Schedule II controlled
substance), Zolpidem (one prescription for this Schedule IV controlled
substance), and Alprazolam (four prescriptions for this Schedule IV
controlled substance).
I also find that DI's unrebutted testimony, in conjunction with GX
7, GX 8, and GX 11, establish that Respondent issued controlled
substance prescriptions to N.J. on paperwork from a hospital at which
Respondent did not treat N.J. GX 7, GX 8, GX 11, Tr. 100-03; see also
supra, section II.D (discussing the stipulation reached during the
hearing).
As already discussed, the Exhibits entered into the record do not
include medical records purporting to be either for J.J. or for N.J. I
note that this matter is due, in part, to Respondent's successful
objection to the admission of a proposed Government exhibit purporting
to be Respondent's medical record for J.J. and to her decision during
the administrative hearing not to present a case.\24\ Supra section
II.D. Accordingly, I find that substantial record evidence shows that
Respondent did not adequately document in a medical record her
controlled substance prescribing for either J.J. or N.J.\25\
---------------------------------------------------------------------------
\24\ The record also shows the awareness of Respondent's Counsel
of a ``proposed'' medical record for N.J. and her decision not to
take steps to have it introduced into the record. Supra section
II.C; infra section II.H.
\25\ In addition, this Agency has applied, and I apply here, the
``adverse inference rule.'' As the D.C. Circuit explained, ``Simply
stated, the rule provides that when a party has relevant evidence
within his control which he fails to produce, that failure gives
rise to an inference that the evidence is unfavorable to him.''
Int'l Union, United Auto., Aerospace & Agric. Implement Workers of
Am. (UAW) v. Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C.
Cir. 1972). The Court reiterated this rule in Huthnance v. District
of Columbia, 722 F.3d 371, 378 (D.C. Cir. 2013). According to this
legal principle, Respondent's decision not to provide evidence
within her control gives rise to an inference that the evidence is
unfavorable to Respondent.
---------------------------------------------------------------------------
H. Allegation That Respondent Failed To Maintain Medical Records
Pertaining to Her Prescribing of Controlled Substances to N.J. in
Violation of Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(e)(3)(i) and Tenn.
Code Ann. Sec. 63-6-214(b)(12)
Similarly, the OSC alleged that Respondent ``fail[ed] to maintain
treatment records pertaining to . . . [her] prescribing of controlled
substances to N.J.'' OSC, at 2. The record certified to me contains no
admitted exhibit constituting a medical record that Respondent created
for N.J. The unrebutted record evidence shows that DI subpoenaed the
medical records of the three hospitals at which Respondent served as a
contract emergency medicine physician and that all three of the
hospitals provided a ``no record'' response for N.J. medical records.
GX 7, GX 8. This OSC charge puts the Government in a position of
proving a negative. Despite this hurdle, I find substantial record
evidence that Respondent did not maintain medical records adequately
documenting her controlled substance prescribing for N.J. There are six
reasons for my finding.
First, as already discussed, I find that the relevant three
hospitals sent ``no record'' responses after receiving DI's subpoenas
for N.J. medical records. Second, I find that, if medical records
existed concerning her controlled substance prescribing for N.J.,
Respondent certainly would know about them and be able to raise their
existence in furtherance of her defense against the
[[Page 19020]]
OSC. She chose not to do so and she did not do so. Instead, after
raising the matter herself by questioning Dr. Loyd about whether he was
``advised since the preparation of . . . [his expert] report that there
are, in fact, medical records that exist for N.J.'' and asking him
whether he has ``seen those records,'' Respondent chose not to delve
into the content of ``those records'' or Dr. Loyd's opinion of them.
Tr. 259-61. Instead, she asked him about whether he updated his expert
report, (he answered in the negative), she questioned him further about
the content of his expert report, and she inquired about matters not
addressed in his expert report before ending her cross-examination. Id.
at 260-61. After the Government's second question on re-direct, she
objected about not having received Dr. Loyd's ``new opinions'' because
he had not supplemented his expert report and claimed to be ``blind-
sided'' and ``sandbagged.'' Id. at 261-67. After the Chief ALJ
announced his finding that she had ``opened the door'' and denied her
objections, decisions with which I agree, Respondent heard the
Government's extensive re-direct of Dr. Loyd.
Third, I find that that Government re-direct of Dr. Loyd focused
largely on the insufficiency of the ``proposed'' medical records for
N.J. as documentation for the prescribing of controlled substances. Id.
at 267-77. The re-direct explored what the ``proposed'' N.J. medical
record indicated about N.J.'s multiple visits to Respondent, a
physician practicing emergency medicine, as opposed to visits to a
primary care physician, and the lack of evidence of coordination of
treatment between Respondent and N.J.'s primary care physician. Id. at
267-69. It addressed the lack of urine drug screening despite the
multiple controlled substance prescriptions and the lack of documented
informed consent. Id. at 269-70. The re-direct also explored the lack
of evidence that Respondent addressed with N.J. his increased risk of
misusing controlled substances given his family history of substance
use disorder, the lack of evidence that Respondent followed up on
N.J.'s report of ``occasional alcohol use,'' and the lack of evidence
that Respondent warned N.J. about the potential risk of mixing alcohol
and controlled substances. Id. at 270-74. It concerned the lack of
evidence that Respondent explored with N.J. treatment modalities other
than controlled substances and the lack of evidence that Respondent
asked N.J. about the impact of the controlled substance therapy on his
mobility. Id. at 276-77. Finally, it concluded with Dr. Loyd's
testimony that his review of the ``proposed'' N.J. patient chart did
not change his opinion that Respondent prescribed controlled substances
to N.J. without a legitimate medical purpose. Id. at 277. Despite her
hearing the damaging testimony the Government elicited from Dr. Loyd on
re-direct, Respondent declined the opportunity for re-cross, allowing
this damaging testimony to stand, unrebutted. Id. at 279.
Fourth, I apply the ``adverse inference rule,'' as the Agency has
done in the past, to the fact that Respondent did not offer into
evidence any medical records she created in conjunction with her
controlled substance prescribing for N.J. As the D.C. Circuit
explained, ``Simply stated, the rule provides that when a party has
relevant evidence within his control which he fails to produce, that
failure gives rise to an inference that the evidence is unfavorable to
him.'' Int'l Union, United Auto., Aerospace & Agric. Implement Workers
of Am. (UAW) v. Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C.
Cir. 1972). The Court reiterated this rule in Huthnance v. District of
Columbia, 722 F.3d 371, 378 (D.C. Cir. 2013). According to this legal
principle, Respondent's decision not to provide evidence within her
control gives rise to an inference that any such evidence is
unfavorable to her.
Fifth, I find that Respondent, after hearing Dr. Loyd's damaging
expert testimony, agreed to a joint stipulation admitting that she did
not treat N.J. (or J.J.) at any of the three hospitals at which
Respondent practiced as a contract emergency physician at the time and
to which DI had issued subpoenas for J.J. and N.J. medical records. Tr.
330-31. In this context, the stipulation is damaging to Respondent's
OSC defense because the record evidence was that Respondent wrote the
controlled substance prescriptions she issued to N.J. (and J.J.) on the
paper of one of these three hospitals. GX 9 and GX 11. The stipulation
thus highlights an irregularity in Respondent's controlled substance
prescribing for N.J. (and J.J.).
Sixth, for all of these reasons, I find that Respondent was aware
of the existence of the ``proposed'' N.J. medical records and did not
seek their admission because she did not consider them to be records
that adequately documented her controlled substance prescribing for
N.J.
I. Allegation That Respondent Violated the Terms of the MOA by Failing
To Provide Drug Logs to DEA for Periods During Which She Issued
Controlled Substance Prescriptions, Implicating 21 U.S.C. 823(f)(5)
The OSC alleged that Respondent ``failed to provide drug logs to
DEA in February, March, and April 2012; and January, March and April
2013'' although she ``issued controlled substance prescriptions during
the above periods.'' OSC, at 3. The record includes documentary
evidence that Respondent issued a controlled substance prescription,
for Tussionex, to N.J. on April 30, 2014. GX 11, at 5. The drug log
that Respondent submitted to DEA for April 2014, however, does not
include this Tussionex prescription issued to N.J. on April 30, 2014.
GX 12l. Accordingly, I find that Respondent submitted to DEA a drug log
for April 2014 that did not comply with the MOA because it did not
include the April 30, 2014 controlled substance prescription she issued
to N.J. for Tussionex.
At the hearing, the Government suggested, but subsequently
``withdrew'' its suggestion, that Respondent issued other controlled
substance prescriptions that she did not document in a drug log
submitted to DEA. Tr. 117, 119-20. I compared the prescriptions
Respondent issued for J.J. and N.J. according to GX 9 and GX 11 with
Respondent's drug logs in the record, GX 12a through GX 12l. The only
discrepancy that I found, based on the prescriptions in the record for
which there is a drug log in the record, is the same prescription about
which DI testified: To N.J. for Tussionex, dated April 30, 2014.
Further, I found two prescriptions, one each in GX 9 (J.J.) and GX
11 (N.J.) for which there is no Respondent drug log in the record: To
J.J. for Alprazolam dated January 16, 2013, and to N.J. for Tussionex
dated September 13, 2012. Both September 2012 and January 2013 are
months covered by the MOA's drug log requirement. The issue, therefore,
is whether Respondent provided DEA with a drug log for the months of
September 2012 and January 2013 or whether, as Respondent suggests, she
provided DEA a drug log for those months but DEA misfiled them.
DI's unrefuted testimony is that Respondent admitted to him that
she used certified mail to send her drug logs to DEA, and that
Respondent did not provide DI with certified mail proof of having sent
the missing MOA-required drug logs to DEA. Supra section II.C. As
already discussed, the Agency has applied, and I am applying here, the
``adverse inference rule.'' Supra section
[[Page 19021]]
II.G. and section II.H. According to that rule, Respondent's failure to
provide relevant evidence within her control, in this case certified
mail proof of having sent the September 2012 and January 2013 MOA-
required drug logs to DEA, gives rise to an inference that the evidence
is unfavorable to her. My application of the ``adverse inference rule''
is particularly appropriate in this case because the MOA requires
Respondent to maintain her controlled substance prescribing,
administering, and dispensing records ``in a separate file or log, in
chronological order,'' a copy of which shall be sent to DEA monthly. GX
3, at 2. In other words, the MOA requirement to which Respondent agreed
calls for her to maintain the controlled substance records and to send
a copy of them to DEA monthly. Id. As such, Respondent should have had
a complete set of the MOA-required records to provide the DI on his
demand, not merely incomplete proof that she sent DEA the MOA-required
logs every month by certified mail.
Accordingly, I find that the record includes substantial evidence
that Respondent did not provide drug logs to DEA for the months of
September 2012 and January 2013 even though she issued a controlled
substance prescription in each of those two months. The OSC noticed the
lack of a drug log for January 2013, so I sustain that specific OSC
charge. OSC, at 3. The OSC did not notice the lack of a drug log for
September 2012, so I do not consider my finding that Respondent did not
provide a drug log to DEA for that month in this Decision and Order. I
do not sustain the other charges in paragraph 4 of the OSC due to the
lack of substantial record evidence to support them. Id.
J. Allegation That Respondent Stored Controlled Substances at an
Unregistered Location in Violation of 21 CFR 1301.12(a)
The OSC alleged that Respondent stored controlled substances in an
exterior storage shed at her residence, an unregistered location. OSC,
at 3. Respondent admitted that she stored controlled substances in the
exterior storage shed attached to her residence. See, e.g., GX 4, at 3;
see also supra section II.C. The record includes no evidence that the
address of Respondent's residence and attached shed appears on a
certificate of registration issued to her. GX 1 (Facsimile of
Respondent's DEA Certificate of Registration), at 1; GX 2
(Certification of Respondent's Registration History), at 1-2; GX 4, at
1 (address of Respondent's residence and attached shed).
Further, Respondent represented to a controlled substance supplier
that she required the controlled substances she was purchasing for her
``private practice'' of medicine, and gave that controlled substance
supplier ``St Croix LLC'' as her company's name. GX 6, at 8, 5. After
having those controlled substances shipped to the address on her
registration, the address of one of the hospitals at which she worked
as a contract physician, she moved the controlled substances to a shed
attached to her residence. GX 6, at 6, 8; GX 2, at 1; TBME Final Order,
at 2. She admitted ``writing prescriptions for controlled substances
for . . . J.J. who she treated at her home.'' TBME Final Order, at 3.
She subsequently reported that the controlled substances had been
stolen from the shed attached to her residence. GX 4, at 1, 3.
Accordingly, I find that the record includes substantial evidence
that Respondent stored controlled substances at the shed attached to
her residence, an unregistered location.
K. Allegation That Respondent Failed To Provide Effective Controls or
Procedures To Guard Against the Theft or Diversion of Controlled
Substances as Required by 21 CFR 1301.71(a)
The OSC alleged that Respondent ``failed to provide effective
controls or procedures to guard against the theft or diversion of
controlled substances as required by 21 CFR 1301.71(a). OSC, at 3. The
undisputed record evidence is that Respondent reported to the Memphis
Police Department the ``theft'' of controlled substances from the
``shed attached to . . . [her] residence.'' GX 4, at 1-3. According to
the Memphis Police Department Incident Report, ``[t]here was no damage
to the shed, as the door was unlocked.'' Id. at 3. DI also testified
that the shed had a ``regular doorknob that would be operated with a
key,'' among other things. Tr. 81; see also supra section II.C.
Accordingly, I find that the record includes substantial evidence that
Respondent stored controlled substances in an inadequately-secured
shed, that she reported the theft of the controlled substances from
that shed, and that controlled substances she stored in the shed
attached to her residence were stolen from that shed.
L. Allegations That Respondent Did Not Conduct an Initial Inventory of
Controlled Substances Received on March 7, 2013, and That Respondent
Did Not Maintain Records of the Controlled Substances She Dispensed as
Required by 21 CFR 1304.03(a) and (b), 1304.04(g), 1304.11(b) and (e),
and 1304.21(a)
The OSC alleged that Respondent ``did not conduct an initial
inventory of controlled substances received on March 7, 2013.'' OSC, at
3. The record evidence does not include an initial inventory, or any
inventory, of the controlled substances Respondent purchased and
received that meets regulatory requirements. Further, according to DI's
uncontroverted testimony, Respondent admitted to him that ``she had
never created a regulatory or an initial inventory.'' Id. at 86-87.
Accordingly, I find both that Respondent did not conduct an initial
inventory of the controlled substances she received on March 7, 2013,
and that she admitted she did not conduct such an initial inventory.
The OSC also alleged that Respondent did not ``maintain records of
. . . [her] dispensing'' of the controlled substances she received on
March 7, 2013. OSC, at 3. The record does not include substantial
evidence that Respondent dispensed any of the controlled substances she
received on March 7, 2013. Supra section II.C. Accordingly, I find that
this allegation is not supported by substantial record evidence.
III. Discussion
Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
Under Section 304 of the Controlled Substances Act (hereinafter,
CSA), ``[a] registration . . . to . . . distribute[ ] or 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,'' which is
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 . . .
[[Page 19022]]
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 Akhtar-Zaidi, 841 F.3d at 711; 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 appellate courts have recognized, findings under a
single factor are sufficient to support the revocation of a
registration. MacKay, 664 F.3d at 821.
Under DEA's regulation, ``[a]t any hearing for the revocation . . .
of a registration, the . . . [Government] shall have the burden of
proving that the requirements for such revocation . . . pursuant to . .
. 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In
this matter, while I have considered all of the factors, the
Government's evidence in support of its prima facie case is confined to
Factors One, Two, Four, and Five.\26\ I find that the Government's
evidence satisfies its prima facie burden of showing that Respondent's
continued registration would be ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4) and 21 U.S.C. 823(f). I further find
that Respondent chose not to put on a case to rebut the Government's
prima facie case.
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\26\ 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
decisions have noted, there are a number of reasons why a person who
has engaged in criminal misconduct may never have been convicted of
an offense under this factor, let alone prosecuted for one. Dewey C.
MacKay, M.D., 75 FR 49,956, 49,973 (2010), pet. for rev. denied,
MacKay v. Drug Enf't Admin., 664 F.3d 808 (10th Cir. 2011). Agency
decisions 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.
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A. Factor One--Recommendation of the Appropriate State Licensing Board
Factor One calls for consideration of the ``recommendation of the
appropriate state licensing board or professional disciplinary
authority'' in the public interest determination. 21 U.S.C. 823(f)(1).
The record evidence does not include a direct recommendation to the
Agency from the TBME about Respondent's continued registration.
As already discussed, the Chief ALJ, without objection from either
party, took official notice of the TBME Final Order concerning
Respondent. Supra section I. The TBME Final Order concerns some of the
matters addressed in the OSC and in this proceeding: The MOA,
Respondent's purchase of controlled substances and the Declaration of
Controlled Substances Purchases in the Moore Medical purchase packet,
the Memphis Police Incident Report, and Respondent's controlled
substance prescribing for J.J. TBME Final Order, at 2-3. The TBME found
facts sufficient to establish that Respondent engaged in
unprofessional, dishonorable or unethical conduct in violation of Tenn.
Code Ann. Sec. 63-6-214(b)(1), failed to create and maintain medical
records in violation of Tenn. Comp. Rules & Regs. 0880-02-.15(4)(a),
and violated Tenn. Comp. Rules & Regs. 0880-02-.15(4)(d) by failing to
include, in all medical records produced in the course of the practice
of medicine for all patients, all information and documentation listed
in Tenn. Code Ann. Sec. 63-2 101(c)(4) and such additional information
necessary to ensure that a subsequent reviewing or treating physician
can both ascertain the basis for the diagnoses, treatment plan and
outcomes, and provide continuity of care.
The TBME ordered the reprimand of Respondent's Tennessee medical
license, ordered her to complete successfully multiple specific medical
courses, ordered her to ``maintain good and lawful conduct,'' and
ordered her to pay assessed civil penalties and costs. Id. at 5-6.
While the TBME Final Order is not a ``direct recommendation'' for
purposes of Factor One, it does indicate a recommendation on a subset
of the allegations and evidence before me. John O. Dimowo, M.D., 85 FR
15,800, 15,810 (2020).\27\ I apply the same analysis and reach the same
conclusion here given the differences between the allegations and
evidence set out in the TBME Final Order and the allegations and
evidence before me. In sum, while the terms of the TBME Final Order are
not dispositive of the public interest inquiry in this case and are
minimized due to the differences in the evidence in the TBME Final
Order and the uncontroverted record evidence before me, I consider the
TBME Final Order's reprimand of Respondent's Tennessee medical license
and give it minimal weight in Respondent's favor since the TBME charges
could have resulted in the suspension or revocation of her medical
license.\28\ Notice of Charges, at 1.
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\27\ The John O. Dimowo, M.D. Agency decision stands for the
proposition that ``[a]lthough statutory analysis [of the CSA] may
not definitively settle . . . [the breadth of the cognizable state
`recommendation' referenced in Factor One], the most impartial and
reasonable course of action is to continue to take into
consideration all actions indicating a recommendation from an
appropriate state.'' 85 FR at 15,810.
\28\ Respondent's Exceptions to Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision of the Administrative Law
Judge dated May 30, 2018 (hereinafter, Resp Exceptions), at 14.
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Factors Two and/or Four--The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
1. Allegation That Respondent Continued To Issue Controlled Substance
Prescriptions to Individuals Who Are Intimate or Close Acquaintances,
and to an Individual With Whom She Had a ``Romantic Interaction'' in
Violation of Tenn. Comp. R. & Regs. R. 0880-2-.14(8)(a) and Tenn. Code
Ann. Sec. 63-6-214(b)(1)
The first Tennessee authority the OSC cited for this allegation
adopts Opinion 8.14 of the American Medical Association Code of Ethics.
This Opinion concerns observing professional boundaries and meeting
professional responsibilities. https://journalofethics.ama-assn.org/article/ama-code-medical-ethics-opinions-observing-professional-boundaries-and-meeting-professional/2015-05.\29\
[[Page 19023]]
According to the Opinion, ``sexual contact that occurs concurrent with
the patient-physician relationship constitutes sexual misconduct.'' AMA
Code of Ethics Opinion 8.14 (2015).
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\29\ American Medical Association Code of Ethics Opinion 8.14
was updated in March of 1992 and then again in June of 2016. The
text of Opinion 8.14 on the website that is dated 2015, therefore,
was in effect at the time relevant to the allegations underlying
this proceeding.
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As already discussed, the Government did not present substantial
evidence that Respondent issued controlled substance prescriptions to
J.J. concurrent with a period during which they engaged in sexual
contact. Supra section II.E. Accordingly, I find that the Government
did not present sufficient evidence to support this allegation and,
therefore, I find that there is no factual basis in the record to
support this allegation.
2. Allegation That Respondent Issued Controlled Substance Prescriptions
to J.J. and N.J. for No Legitimate Medical Purpose and Outside the
Usual Course of Professional Practice in Violation of 21 CFR
1306.04(a), Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(a)(4) and (e), and
Tenn. Code Ann. Sec. 63-6-214(b)(12), and
3. Allegation That Respondent Failed To Maintain Medical Records
Pertaining to Her Prescribing of Controlled Substances to N.J. in
Violation of Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(e)(3)(i) and Tenn.
Code Ann. Sec. 63-6-214(b)(12).
According to the CSA, ``Except as authorized by this subchapter, it
shall be unlawful for any person knowingly or intentionally . . . to .
. . distribute, . . . dispense, or possess with intent to . . .
distribute[ ] or dispense, a controlled substance.'' 21 U.S.C.
841(a)(1). The CSA's implementing regulations state, among other
things, that a lawful controlled substance order or prescription is one
that is ``issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice.''
21 CFR 1306.04(a).
Respondent's registration is for her medical practice in Tennessee.
As such, I also evaluate the record evidence according to the
applicable laws and standard of care in Tennessee.\30\ The Government
alleged that Respondent violated the standard of care in Tennessee,
citing Tenn. Comp. R. & Regs. R. 0880-2-.14(6)(a)(4) and (e), Tenn.
Code Ann. Sec. 63-6-214(b)(12), and Tennessee Controlled Substance
Prescribing Policy Statement, GX 15.\31\
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\30\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006).
\31\ Respondent did not offer any exhibit purporting to address
or memorialize the Tennessee standard of care. She did not object
when the Chief ALJ proposed to take official notice of GX 15. Tr.
332-33.
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According to these Tennessee authorities, a physician may be
disciplined for prescribing a controlled substance ``not in the course
of professional practice, or not in good faith to relieve pain and
suffering, or not to cure an ailment, physical infirmity or disease, or
in amounts and/or for durations not medically necessary, advisable or
justified for a diagnosed condition.'' Tenn. Code Ann. Sec. 63-6-
214(b)(12). These Tennessee authorities state that the prescribing of a
controlled substance will be presumed to be legitimate if, among other
things, it takes place ``[a]fter a documented medical history . . . and
physical examination . . . including an assessment and consideration of
the pain, physical and psychological function, any history, any
potential for substance abuse, coexisting diseases and conditions, and
the presence of a recognized medical indication for the use of a . . .
controlled substance.'' Tenn. Comp. R. & Regs. R. 0880-
2-.14(6)(e)(3)(i); see also supra section II.C. (standard of care
testimony of Dr. Loyd); GX 15, at 1-2 (Tennessee Controlled Substance
Prescribing Policy Statement that ``It is not what you prescribe, but
how well you manage the patient's care, and document that care in
legible form, that is important,'' ``What the Board does have is the
expectation that physicians will create a record that shows: -Proper
indication for the use of drug or other therapy; -Monitoring of the
patient where necessary; -The patient's response to therapy based on
follow-up visits; and -All rationale for continuing or modifying the
therapy,'' ``Before beginning a regimen of controlled drugs, make a
determination through trial or through a documented history that non-
addictive modalities are not appropriate or they do not work,'' and
``To reiterate, one of the most frequent problems faced by a physician
when he or she comes before the Board or other outside review bodies is
inadequate records.''); GX 14 (``There were no medical records to
support the history, physical examination and thought process that led
to the prescribing of these medications. Essentially, the controlled
substances were prescribed with nothing to support their use. The
controlled substances prescribed for N.J. were prescribed outside the
scope of accepted medical practice and were not for a legitimate
medical purpose.''); Tr. 277 (the ``proposed'' medical records for N.J.
did not change Dr. Loyd's opinion that Respondent prescribed controlled
substances for N.J. for no legitimate purpose); id. at 240 (Dr. Loyd's
testimony that the medical record is the ``crux.'' It is the foundation
that establishes history, present illness, past medical history,
surgical history, social history, physical examination, assessment and
plan, and that is going to validate how a diagnosis was arrived at and
the subsequent treatment plan for that diagnosis.).
I already found that the substantial record evidence is that
Respondent did not document in a medical record her controlled
substance prescribing for either J.J. or N.J., and that there is
substantial record evidence that Respondent did not maintain records
adequately documenting her controlled substance prescribing for N.J.
Supra sections II.C., II.G., and II.H. Based alone on a subset of the
Tennessee legal requirements for legitimate controlled substance
prescribing, the uncontroverted record evidence is that Respondent's
prescribing of controlled substances for J.J. and N.J. was not
legitimate. For example, it did not take place after Respondent
documented a medical history for, and physical exam of, either J.J. or
N.J. Supra sections II.C. and II.G. In fact, as the record evidence
does not even include a medical record for J.J. or N.J., Respondent's
controlled substance prescribing does not, by definition, satisfy
applicable Tennessee legal authorities.\32\ Accordingly, I sustain both
of these OSC charges, finding that Respondent's controlled substance
prescribing for J.J. and N.J. was not for a legitimate medical purpose
and was outside the usual course of professional practice in Tennessee.
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\32\ For all of these reasons, I reject Respondent's claim that
it is a ``legal fiction'' that Respondent had ``no medical records''
for J.J. and N.J. Resp Exceptions, at 12.
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4. Allegation That Respondent Stored Controlled Substances at an
Unregistered Location in Violation of 21 CFR 1301.12(a)
The regulations implementing the CSA require that a ``separate
registration is required for each principal place of business or
professional practice at one general physical location where controlled
substances are . . . dispensed by a person.'' 21 CFR 1301.12(a). The
CSA defines ``dispense'' to ``include[e] the prescribing . . . of a
controlled substance''--a fact that Respondent's arguments and
exceptions downplay. 21 U.S.C. 802(10); see also OSC, at 3; Resp
Exceptions, at 1-4. Respondent asks me to find that her storage of
controlled substances in the shed attached to her residence was lawful
because her residence was not a principal place of business or
professional practice and she did not ``dispense'' controlled
substances from
[[Page 19024]]
there. Id. According to her Exceptions, Respondent only had the
``intention of eventually opening a private practice'' and ``[t]here is
simply no evidence in the record that Respondent issued a single
prescription for a controlled substance from her residence.'' Id. at 1,
4. I decline to do so.
First, Respondent submitted no record evidence, let alone
substantial record evidence, providing a factual basis for her
argument. Indeed, the substantial record evidence includes Respondent's
representation that she was engaged in private practice, called St.
Croix LLC, and that her justification for purchasing controlled
substances was to support the ``addition'' of age management medicine,
weight loss, and wellness to her private practice. GX 6, at 8; see also
TBME Final Order, at 3 (Respondent's admission that she wrote
controlled substance prescriptions for J.J. whom ``she treated at her
home''). Second, her argument conflicts with a core principle of the
CSA, the establishment of a 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). Respondent's proposal
would be a danger to public health and safety as it would allow the
storage of controlled substances anywhere, as long as no dispensing
took place at the location. Respondent offers no convincing argument
that the CSA gives me authority to adopt her proposal. Further, there
is none and I decline to establish such a dangerous policy.
I already found that the record includes substantial,
uncontroverted evidence, including Respondent's admission, that
Respondent stored controlled substances at an unregistered location.
Supra section II.J. I found substantial, uncontroverted evidence that
Respondent represented to her controlled substance supplier that the
controlled substances she ordered were required for her ``private
practice.'' Id. I also found substantial, uncontroverted evidence that
Respondent admitted writing controlled substance prescriptions for J.J.
whom she admitted she treated at her home. Id. Accordingly, I sustain
the OSC charge that Respondent stored controlled substances at an
unregistered location.
5. Allegation That Respondent Failed To Provide Effective Controls or
Procedures To Guard Against the Theft or Diversion of Controlled
Substances as Required by 21 CFR 1301.71(a)
According to 21 CFR 1301.71(a), ``[a]ll applicants and registrants
shall provide effective controls and procedures to guard against theft
and diversion of controlled substances.'' As already discussed, I found
substantial record evidence that Respondent stored controlled
substances in an inadequately secured shed and that she reported the
theft of the controlled substances from that shed. Supra section II.K.
By itself, the fact that controlled substances were stolen from the
shed in which Respondent stored them is substantial record evidence
that she did not provide ``effective'' controls or procedures to guard
against theft or diversion of controlled substances. If more evidence
were required, the uncontroverted record evidence also details the out-
in-the-open location of the shed in which Respondent chose to put the
controlled substances she had purchased and the minimally protective
door, knob, and lock Respondent put between the outside world and the
controlled substances. Supra section II.C. and section II.K. For all of
these reasons, I reject Respondent's claims that the shed was
``securely locked . . . [and] substantially constructed.'' Resp
Exceptions, at 8-11.
Accordingly, I find that Respondent failed to provide effective
controls or procedures against the theft or diversion of controlled
substances in violation of 21 CFR 1301.71(a).
6. Allegations That Respondent Did Not Conduct an Initial Inventory of
Controlled Substances Received on March 7, 2013 and That Respondent Did
Not Maintain Records of the Controlled Substances She Dispensed as
Required by 21 CFR 1304.03(a) and (b), 1304.04(g), 1304.11(b) and (e),
and 1304.21(a)
The OSC alleges that Respondent did not conduct an initial
inventory of the controlled substances she received on March 7, 2013. I
already found both that Respondent did not conduct an initial inventory
of the controlled substances she received on March 7, 2013, and that
she admitted she did not conduct such an initial inventory. Supra
section II.L.
Among her arguments concerning this allegation, Respondent posited
that it is acceptable to use the Moore Medical purchase invoice for the
controlled substances as an initial inventory. See, e.g., Tr. 292-93;
Resp Exceptions, at 7-8. I reject Respondent's arguments and her
positions that minimize the inventory requirement in general. I also
reject Respondent's dismissal of the deficiency, the failure to specify
whether the inventory was taken at the beginning or the end of the day,
that renders the Moore Medical purchase invoice an insufficient
substitute for an initial inventory. See, e.g., Tr. 291-95.
I note, however, that Respondent accurately pointed out that the
portion of the regulation stating that inventories ``may be taken
either as of opening of business or as of the close of business on the
inventory date and it shall be indicated on the inventory'' was not
alleged in the OSC. Tr. 292; 21 CFR 1304.11(a). I agree that the OSC
did not notice section 1304.11(a) and that Respondent did not consent
to litigate it. Accordingly, although I found substantial evidence that
Respondent violated this inventory requirement, I find that the OSC did
not give Respondent adequate notice of 21 CFR 1304.11(a) and, as a
result, I do not sustain the OSC allegation that Respondent did not
conduct an initial inventory of the controlled substances she received
on March 7, 2013.\33\
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\33\ Citing 21 CFR 1304.11(b), Respondent argues in her
exceptions that she was not under a duty to conduct an initial
inventory for the controlled substances she received on March 7,
2013. Resp Exceptions, at 4-7. I disagree with Respondent's
arguments for the reasons already discussed and reiterate that I am
not sustaining the OSC's initial inventory allegation solely because
it was not noticed adequately.
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The OSC also alleges that Respondent did not maintain records of
the controlled substances she dispensed. 21 CFR 1304.03(b). The
Government, however, did not present substantial evidence that
Respondent dispensed controlled substances. Supra section II.L. I find
that a predicate to finding substantial evidence that Respondent did
not maintain records of the controlled substances she dispensed is
substantial evidence that Respondent actually dispensed controlled
substances. Accordingly, the record does not include substantial
evidence that Respondent dispensed controlled substances and,
therefore, there is no factual basis on which the allegation that
Respondent failed to maintain dispensing records may stand.
Factor Five--Respondent's ``Conduct Which May Threaten the Public
Health and Safety.''
1. Allegations That Respondent Provided Prescription Drug Logs to DEA
With Falsified Entries ``Noncompliant With Terms of the June 2011 MOA''
in Violation of 21 U.S.C. 843(a)(4)(A), and ``Provid[ed] Misleading
Information to Investigating Agents'' Implicating 21 U.S.C. 823(f)(5)
The OSC cites 21 U.S.C. 843(a)(4)(A) as the basis for the
allegation that Respondent provided non-MOA compliant falsified
controlled substance prescription drug logs to DEA. OSC, at 2. The
Government has not, however, established the existence of each of the
[[Page 19025]]
elements of 21 U.S.C. 843(a)(4)(A). For example, according to the
provision, the furnished or omitted ``false or fraudulent material
information'' must pertain to ``any application, report, record, or
other document required to be made, kept, or filed.'' 21 U.S.C.
843(a)(4)(A). The Government did not establish that Respondent's
controlled substance drug logs constitute a document ``required to be
made, kept, or filed'' under any provision from 21 U.S.C. 801 through
21 U.S.C. 971. In sum, the Government has not established all of the
elements of 21 U.S.C. 843(a)(4)(A) and, therefore, the Government has
not proven that this provision applies to the facts of this case.
Accordingly, I do not sustain the OSC allegation based on 21 U.S.C.
843(a)(4)(A).\34\
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\34\ Given my decision not to sustain the 21 U.S.C. 843(a)(4)(A)
allegation, I need not address Respondent's exception to the Chief
ALJ's conclusion that Respondent ``intentionally or knowingly
submitted false information'' to DEA. Resp Exceptions, at 11-12.
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I already found that there is substantial record evidence that
Respondent provided misleading information to investigating DEA agents.
Supra section II.F. This misleading information ``may threaten the
public health and safety'' by, for example, impeding DEA's
investigative efforts. Accordingly, I shall consider Respondent's
provision of misleading information to DEA under Factor Five. 21 U.S.C.
823(f)(5).
2. Allegation That Respondent Violated the Terms of the MOA by Failing
To Provide Drug Logs to DEA for Periods During Which She Issued
Controlled Substance Prescriptions, Implicating 21 U.S.C. 823(f)(5)
The MOA that Respondent signed calls for her to ``maintain a log of
all controlled substances prescribed, administered or dispensed to
patients at her registered premises or elsewhere,'' for her to
``maintain'' the controlled substance prescribing, administering, and
dispensing information ``in a separate file or log, in chronological
order,'' and for her to send a copy of the log to DEA every month. GX
3, at 2. The uncontroverted record evidence is that Respondent did not
comply fully with this requirement. Supra section II.I. (my findings
that Respondent submitted to DEA an incomplete controlled substance
prescription drug log for April 2014 and that Respondent did not
provide a drug log to DEA for the month of January 2013, even though
the record contains substantial evidence that she issued a controlled
substance prescription in that month).
Respondent's argument that she sent DEA the MOA-required logs rings
hollow because the MOA also requires that she maintain the required
information herself. Had she done so, she would have been able to
provide DI with complete evidence of her full compliance with the MOA
controlled substance prescription drug log requirement. As she
apparently did not, or at least chose not to submit evidence that she
did, I find that Respondent failed to provide fully-compliant
controlled substance prescription drug logs to DEA for periods during
which she issued controlled substance prescriptions. Accordingly, I
shall consider Respondent's failure to comply fully with the MOA
controlled substance prescription drug log requirement under Factor
Five. 21 U.S.C. 823(f)(5).
Summary of Factors One, Two, Four, and Five
As found above concerning Factor One, while the TBME Final Order is
not a ``direct recommendation'' for purposes of Factor One, it
indicates a recommendation on a subset of the allegations and evidence
before me. As such, while the terms of the TBME Final Order are not
dispositive of the public interest inquiry in this case and are
minimized due to the differences in the evidence laid out in the TBME
Final Order and the uncontroverted record evidence before me, I
consider the TBME Final Order's reprimand of Respondent's Tennessee
medical license minimally in her favor because the TBME charges could
have resulted in the suspension or revocation of her medical license.
Regarding Factors Two and Four, the Government did not establish
with substantial evidence that Respondent engaged in ``sexual
misconduct'' by issuing controlled substance prescriptions to J.J.
``concurrent'' with having ``sexual contact'' with him. The Government
also did not establish with substantial evidence that Respondent failed
to maintain records of the controlled substances she dispensed.
Although there is substantial record evidence that Respondent did not
conduct an initial inventory of the controlled substances she received
on March 7, 2013, I am not weighing this charge against her due to OSC
notice insufficiencies.
Also regarding Factors Two and Four, there is substantial evidence
in the record before me that Respondent issued controlled substance
prescriptions over the course of eighteen months, including fifteen
Schedule II controlled substances, for no legitimate medical purpose
and outside the usual course of professional practice, that Respondent
failed to maintain medical records pertaining to her prescribing of
controlled substances, that Respondent stored controlled substances at
an unregistered location, and that Respondent failed to provide
effective controls or procedures to guard against the theft or
diversion of controlled substances.
Regarding Factor Five, although the Government did not establish
all of the elements of a violation of 21 U.S.C. 843(a)(4)(A), the
Government did put substantial evidence into the record that Respondent
submitted a drug log to DEA that did not include every controlled
substance prescription she issued during the period covered by the drug
log. The Government also put substantial evidence into the record that
Respondent did not comply with the MOA by failing to provide a drug log
to DEA for a month during which she issued a controlled substance
prescription. The Government also put substantial evidence into the
record that Respondent included misleading information in the drug logs
she submitted to DEA about the locations at which she issued controlled
substance prescriptions. OSC, at 3.
Accordingly, I conclude that it would be ``inconsistent with the
public interest'' for Respondent to have a registration due to the
substantial evidence of her violations of the CSA and its implementing
regulations. 21 U.S.C. 824(a)(4) and 21 U.S.C. 823(f); see Wesley Pope,
82 FR 14,944, 14,985 (2017).
Sanction
Where, as here, the Government presented a prima facie case that it
would be ``inconsistent with the public interest'' for Respondent to
retain a registration, and Respondent did not rebut the Government's
prima facie case, the ``burden of proof shifts'' to Respondent ``to
show why . . . [she] can be trusted with a registration.'' Jones Total
Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th
Cir. 2018), quoting Akhtar-Zaidi v. Drug Enf't Admin., 841 F.3d 707,
711 (6th Cir. 2016); see also MacKay v. Drug Enf't Admin., 664 F.3d
808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enf't Admin., 567
F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug Enf't Admin., 419
F.3d 477, 482 (6th Cir. 2005)). Further, past performance is the best
predictor of future performance and, when a registrant has ``failed to
comply with . . . [her] responsibilities in the past, it makes sense
for the agency to consider whether . . . [she]
[[Page 19026]]
will change . . . [her] behavior in the future.'' Pharmacy Doctors
Enterprises, Inc. v. Drug Enf't Admin., 789 F. App'x, 724, 733 (citing
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d at
831 (citing MacKay v. Drug Enf't Admin., 664 F.3d at 820 (``[T]hat
consideration is vital to whether continued registration is in the
public interest.'') and Alra Labs., Inc. v. Drug Enf't Admin., 54 F.3d
450, 452 (7th Cir. 1995) (``An agency rationally may conclude that past
performance is the best predictor of future performance.'')).
Circuit courts have also approved the Agency's acceptance of
responsibility requirement. Pharmacy Doctors Enterprises, Inc. v. Drug
Enf't Admin., 789 F. App'x, at 732; Jones Total Health Care Pharmacy,
LLC v. Drug Enf't Admin., 881 F.3d at 830 (citing MacKay v. Drug Enf't
Admin., 664 F.3d at 820 (``The DEA may properly consider whether a
physician admits fault in determining if the physician's registration
should be revoked.''); see also Jeffrey Stein, M.D., 84 FR 46,968,
46,972-73 (2019) (unequivocal acceptance of responsibility); Jayam
Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (collecting cases). The
Agency has decided that the egregiousness and extent of the misconduct
are significant factors in determining the appropriate sanction.
Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018) (collecting
cases); Samuel Mintlow, M.D., 80 FR at 3652 (``Obviously, the
egregiousness and extent of a registrant's misconduct are significant
factors in determining the appropriate sanction.''). The Agency has
also considered the need to deter similar acts in the future by
Respondent and by the community of registrants. Id.
In terms of egregiousness, the violations that the record evidence
shows Respondent committed go to the heart of the CSA--not complying
with the closed regulatory system devised to ``prevent the diversion of
drugs from legitimate to illicit channels'' and not prescribing
controlled substances in compliance with the applicable standard of
care and in the usual course of professional practice. Gonzales v.
Raich, 545 U.S. at 13-14, 27.
Respondent did not testify. As already noted, after the Chief ALJ
issued his Recommended Decision, in which he concluded that
Respondent's acceptance of responsibility through her Counsel was
``ineffectual'' and did not ``point[ ] to anything that she was
acknowledg[ing] that she did wrong,'' Respondent submitted her MCACAP.
Supra section I; RD, at 66. In the MCACAP, Respondent submitted a
signed and notarized Affidavit dated July 11, 2018. In the Affidavit,
Respondent stated that she:
accept[ed] responsibility for the mistakes and inadvertent errors in
judgment I made that are the subject of this matter, including, but
not necessarily limited to: a. Failing to appreciate the importance
of accurate record-keeping as it relates to the logs required by my
2011 Memorandum of Agreement with the DEA; b. Failing to keep better
treatment records for J.J. and N.J.; c. Failing to keep better
prescription records for J.J. and N.J.; d. Failing to have more
thorough and detailed treatment plans for J.J. and N.J.; [and] e.
Listing J.J. and N.J. as patients of any hospital in my DEA logs.
MCACAP Affidavit, at 2. While Respondent's Affidavit-based acceptance
of responsibility points to areas in which she admits to making
``mistakes and inadvertent errors of judgment,'' she admits that her
Affidavit does not go to the trouble of naming all of her ``mistakes
and inadvertent errors of judgment.'' Id. Further, the Affidavit
describes the areas for which she takes responsibility in general terms
only, and the areas do not include all of the violations the Government
proved with substantial evidence. For example, while Respondent's
Affidavit states that she failed to ``keep better treatment records,''
``keep better prescription records,'' and ``have more thorough and
detailed treatment plans,'' the record certified to me contains no
``treatment records,'' no ``prescription records,'' and no ``treatment
plans'' whatsoever. Supra section II.G. and II.H.
DEA agreed to grant Respondent's last application for a
registration upon her execution of the MOA. MOA, at 2 (``Upon execution
by all parties to this agreement, DEA agrees to grant . . .
[Respondent's] application for DEA registration in Schedules II through
V.''). A term of the MOA is that Respondent ``agrees to abide by all
Federal, State and local laws and regulations pertaining to controlled
substances.'' Id. As already discussed, I found that Respondent failed
to abide by ``all Federal, State and local laws and regulations
pertaining to controlled substances.'' Supra sections III.B.2.,
III.B.3., III.B.4., III.B.5., III.C.1., and III.C.2. Yet, while the
MCACAP indicates that Respondent subsequently attended and passed the
courses required by the TBME Final Order plus others, nothing in the
MCACAP and certified record convinces me that Respondent learned from
those courses and will apply consistently going forward what those
courses taught about the CSA's recordkeeping requirements and
prescribing controlled substances in compliance with the applicable
standard of care and in the usual course of professional practice. For
example, Respondent's Affidavit states that she acknowledges ``failing
to seek legal and compliance counsel, as well as educating . . .
[herself] on the pertinent rules and regulations of controlled
substance, prior to taking any actions related to my desire to open a
private practice.'' Id. Instead of being reassuring, this portion of
Respondent's acknowledgement is very concerning because it exhibits her
view that her need to become educated on the ``pertinent rules and
regulations of controlled substances'' is tied to her opening a private
practice, not to her being entrusted with a registration.
Further, Respondent's Affidavit does not address her ordering
controlled substances for delivery at her registered address and her
removal of those controlled substances from her registered address to
the shed attached to her home. Even after reading the MCACAP and
Respondent's Affidavit, I see nothing in them or in the record
certified to me suggesting that Respondent appreciates that Congress
passed, and the President of the United States signed into law, a
statute that requires registrants to take specific actions to keep
controlled substances in a closed regulatory system created to
``prevent the diversion of drugs from legitimate to illicit channels.''
There is little in the record before me showing that Respondent
appreciates the difference between ordering controlled substances and
ordering groceries.\35\ In sum, given Respondent's failure to comply
with the MOA's provisions and her failure to demonstrate her ability to
apply the information conveyed in the courses Respondent attended and
passed, it is not reasonable for me, at this time, to believe that
Respondent's future handling and prescribing of controlled substances
will comply with legal requirements.\36\ Alra Labs., Inc. v.
[[Page 19027]]
Drug Enf't Admin., 54 F.3d at 452 (``An agency rationally may conclude
that past performance is the best predictor of future performance.'').
Accordingly, I shall order that Respondent's registration be revoked
and that all pending applications to renew or modify Respondent's
registration, and any application for a new registration in Tennessee,
be denied.
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\35\ Respondent's eighth Exception asserts that the ``record as
a whole establishes that the continued registration of Respondent .
. . would be consistent with the public interest.'' Resp Exceptions,
at 13. The Exception does not elaborate on this assertion, and the
fact that Respondent did not present a case contributes
substantially to the assertion's incredibility. The Exception's
statements that J.J. and N.J. ``affirmed that the prescriptions
issued by Respondent were to treat them for injuries they had'' and
that the ``Government produced no competent evidence that the
prescriptions were not for legitimate medical needs'' are not
helpful. The legitimacy of controlled substance prescriptions is
assessed by applicable federal and state legal standards and
standards of care, not by the opinions of those to whom the
prescriptions were issued. Supra section II.G., II.H., III.B.2., and
III.B.3; see also Resp Exceptions, at 13-14.
\36\ I do not consider remedial measures when a Respondent does
not unequivocally accept responsibility. Respondent's MCACAP
presentation of remedial efforts was limited, unpersuasive, and not
reassuring.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a)(4) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate
of Registration No. FS2669868 issued to Jennifer L. St. Croix, M.D. I
further hereby deny any pending application of Jennifer L. St. Croix,
M.D., to renew or modify this registration, as well as any other
pending application of Jennifer L. St. Croix, M.D. for registration in
Tennessee. This Order is effective May 12, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-07410 Filed 4-9-21; 8:45 am]
BILLING CODE 4410-09-P