Jennifer L. St. Croix, M.D.; Decision and Order, 19010-19027 [2021-07410]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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]


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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.
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    \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.
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    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.
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    \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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    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).
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    \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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    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).
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    \4\ The Chief ALJ's Corrected Page Order was filed on May 11, 
2018.
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    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.
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    \5\ I reviewed, and agree with, the ultimate rulings and 
conclusions of all of the Chief ALJ's procedural decisions.
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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.
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    \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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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.
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    \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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    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.
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    \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.
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    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].'').
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    \10\ This was Respondent's registered address at the time.
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    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.
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    \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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    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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