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Notice2022-00952

Samson K. Orusa, M.D.; Decision and Order

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Published

January 19, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2986-3020]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00952]

[[Page 2985]]

Vol. 87

Wednesday,

No. 12

January 19, 2022

Part II

Department of Justice

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Drug Enforcement Administration

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Samson K. Orusa, M.D.; Decision and Order; Notice

Federal Register / Vol. 87 , No. 12 / Wednesday, January 19, 2022 /
Notices

[[Page 2986]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-26]

Samson K. Orusa, M.D.; Decision and Order

On May 31, 2019, a former Assistant Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause (hereinafter, OSC) to Samson K. Orusa (hereinafter,
Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1,
(OSC) at 1. The OSC proposed revocation of Respondent's DEA Certificate
of Registration Number BO4959889 (hereinafter, registration or COR),
the denial of any pending applications for renewal or modification of
such registration, and the denial of any pending applications for
additional DEA registrations including the pending application for COR
Number W18070589C pursuant to 21 U.S.C. 824(a)(4) and 823(f), because
Respondent's continued ``registrations are inconsistent with the public
interest.'' Id. (citing 21 U.S.C. 823(f)).
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this
matter was conducted on September 9, 2020, October 15, 2020, and
October 21, 2020, via video teleconference technology. On December 8,
2020, Administrative Law Judge Mark M. Dowd, (hereinafter, ALJ) issued
his Recommended Rulings, Findings of Fact, Conclusions of Law and
Decision (hereinafter, Recommended Decision or RD) and neither party
filed exceptions. I issue the final order in this case following the
RD. Having reviewed the entire record, I adopt the ALJ's Recommended
Decision with minor modifications, as noted herein.*\A\
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*\A\ I have made minor, nonsubstantive, grammatical changes to
the RD and nonsubstantive conforming edits. Where I have made
substantive changes, omitted language for brevity or relevance, or
where I have added to or modified the Chief ALJ's opinion, I have
noted the edits in brackets, and I have included specific
descriptions of the modifications in brackets or in footnotes marked
with an asterisk and a letter. Within those brackets and footnotes,
the use of the personal pronoun ``I'' refers to myself--the
Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge *B
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*\B\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
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The Drug Enforcement Administration (DEA) Assistant Administrator,
filed an Order to Show Cause (OSC) \1\ on May 31, 2019, the Certificate
of Registration (COR), No. BO4959889, of Samson K. Orusa, M.D.
(Respondent), proposing to revoke the Respondent's COR pursuant to 21
U.S.C. 824(a)(4) on the ground that the Respondent's registration is
inconsistent with the public interest, as defined in 21 U.S.C. 823(f).
[Omitted.] 2 3 In its Supplemental Pre-hearing Statement
(GSPHS), the Government further alleged that the Respondent made a
material falsification in his renewal application of November 6, 2019,
in violation of 21 U.S.C. 824(a)(1). ALJ Ex. 53, 54.\4\ A hearing was
conducted in this matter on September 9, 2020, October 15, 2020, and
October 21, 2020, via video teleconference technology.\5\
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\1\ ALJ Ex. 1.
\2\ [Omitted.]
\3\ [Omitted.]
\4\ Allegations brought in the OSC and Government's Prehearing
Statements provide sufficient notice to the Respondent to defend
against. Jose G. Zavaleta, M.D., 78 FR 27431, 27439 (2013) (Where
the Government did not allege material falsification on the
respondent's application in the Order to Show Cause, but did raise
the issue in its Supplemental Pre-hearing Statement, the respondent
was on notice that the issue would be considered at the hearing).
\5\ Although in his Posthearing Brief, the Respondent suggests
the hearing was ``truncated'', there was nothing abbreviated or
shortened as to the proceeding, which is now over 18 months and
counting, or as to the hearing. Neither party was limited as to
their time for presentation or number of witnesses. The hearing
ended on October 21, 2020, at 4:30 p.m., with 90 minutes remaining
in the day. I did inform the parties that we would be finishing the
hearing within the month of October, and to make their arrangements
accordingly.
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The issue to be decided by the Administrator is whether the record
as a whole establishes by a preponderance of the evidence that the DEA
Certificate of Registration, No. BO4959889, issued to Respondent should
be revoked, and any pending applications for modification or renewal of
the existing registration should be denied, and any pending
applications for additional registrations should be denied, because his
continued registration would be inconsistent with the public interest
under 21 U.S.C. 823(f) and 824(a)(4) and because he materially
falsified his application under 21 U.S.C. 824(a)(1).
After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.

The Allegations

Overview

1. The Respondent is registered with the DEA as a Practitioner
authorized to handle controlled substances in Schedules II-V under DEA
registration number BO4959889 at 261 Stonecrossing Drive, Clarksville,
Tennessee 37042. His DEA COR BO4959889 expired by its terms on December
31, 2019.
2. On July 6, 2018, the Respondent submitted an application
(Application Control No. Wl8070589C) to the DEA for a new DEA COR (the
``Application''). This application seeks a new DEA COR under his
Kentucky medical license at 316 Pappy Drive, Oak Grove, Kentucky
42262.\6\
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\6\ See ALJ Ex. 65, Order Granting the Government's Motion for
Partial Summary Disposition (June 18, 2020).
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3. Presently, the Respondent is licensed in the State of Tennessee
as a medical doctor with license number 28275. The Respondent's
Tennessee medical license expires by its own terms on March 31, 2020.
The Respondent is also licensed in the State of Kentucky as a physician
with license number 33408. The Respondent's Kentucky medical license
expires by its own terms on February 29, 2020.
4. As a licensed medical doctor in Tennessee, the Respondent is
subject to TENN. CODE ANN. 63-6-6214(b)(12) through (14), as those
provisions pertain to ``dispensing, prescribing, or otherwise
distributing'' controlled substances. Specifically, section 63-6-
214(b)(12) prohibits a physician from prescribing controlled substances
``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.''
Accordingly, section 63-6-214(b)(13) prohibits a physician from
prescribing controlled substances to a person ``addicted to the habit
of using controlled substances ``without'' making a bona fide effort to
cure the [patient's] habit.'' To determine a violation of these
provisions, the Tennessee Board of Medical Examiners uses a non-
exhaustive list of guidelines (``the guidelines'') found in TENN. COMP.
R. & REGS. 0880-02-.14(6)(e). The guidelines require that a physician
(1) take a documented medical history; (2) conduct a physical
examination; and (3) perform an adequate ``assessment and consideration
of the [patient's] pain, physical and psychological function, any
history and potential for substance abuse, coexisting diseases and
conditions, and the presence of a recognized medical indication for the
use of a dangerous drug or controlled substance.'' TENN. COMP. R. &
REGS.

[[Page 2987]]

0880-02-.14(6)(e)(3)(i). Additionally, Rule 0880-02-.14(6)(e) requires
physicians to create a ``written treatment plan tailored for the
individual needs of the patient'' that considers the patient's
``pertinent medical history and physical examination as well as the
need for further testing, consultation, referrals, or use of other
treatment modalities.'' It also requires the physician to ``discuss the
risks and benefits of the use of controlled substances,'' do a
``documented periodic review of the care . . . at reasonable
intervals,'' and ``keep [c]omplete and accurate records of the care.''
Id. at 0880-02-.14(e)(3)(ii)-(v).
5. On October 3, 2017, the Respondent issued a prescription for 42-
ten milligram tablets of oxycodone to UC, a Tennessee state law
enforcement officer working in an undercover capacity. The Respondent
issued this prescription following a brief meeting with UC, during
which he performed a cursory and inadequate physical examination and
reviewed medical records which did not justify the prescribing of
oxycodone in the amount and dosage which he prescribed. He also failed
to: (1) Take an adequate medical history; (2) assess the patient's
pain, physical and psychological function; (3) assess the patient's
history and potential for substance abuse, coexisting diseases and
conditions, and the presence of a recognized medical indication for the
use of oxycodone. The Respondent further failed to create a legitimate
written treatment plan for the patient's individual needs or discuss
the risks and benefits of the use of oxycodone with the patient.
6. Additionally, on October 18, 2017, the Respondent's office
provided UC with a prescription which the Respondent signed and dated
October 18, 2017, for 84-ten milligram tablets of oxycodone. This
occurred after UC paid $377 for an office visit during which no
physical examination occurred and virtually no medical information was
obtained or communicated. Additionally, on November 20, 2017, the
Respondent's office provided UC with a prescription which he signed and
dated November 20, 2017, for 84-ten milligram tablets of oxycodone.
This occurred after UC paid for another office visit during which no
physical examination occurred and no medical information was obtained
or communicated.
7. With respect to the prescriptions the Respondent issued to UC,
he issued these prescriptions without: (1) Taking a medical history or
performing a minimally sufficient physical examination; (2) assessing
the patient's pain, physical and psychological function; and (3)
assessing the patient's history and potential for substance abuse,
coexisting diseases and conditions, and the presence of a recognized
medical indication for the use of oxycodone. The Respondent further
failed to create and follow a legitimate written treatment plan for the
patient's individual needs or discuss the risks and benefits of the use
of oxycodone with the patient. Also, by falsely indicating that UC was
physically examined on October 18 and November 20 of 2017, he violated
TENN. COMP. R. & REGS. 0880-02-.14(6)(e)(3)(v).
8. In addition to the medical records for UC, medical records for
more than 20 of the Respondent's patients were reviewed by a qualified
medical expert (``reviewing expert'') who concluded that the
Respondent's continued prescribing of controlled substances to these
patients was without a legitimate medical purpose and/or outside the
usual course of professional practice. Below are examples of some of
the patient records which were reviewed:
a. Patient M.H.: From August 2014 through February 2018, the
Respondent regularly issued prescriptions for large quantities of
alprazolam, carisoprodol, oxycodone, and oxymorphone to M.H. A
representative sample of those prescriptions follows below:

According to the reviewing expert, the Respondent diagnosed M.H.
with ``chronic pain syndrome'' even though he made no attempt to
diagnose a specific pain etiology. The reviewing expert found that the
Respondent failed to obtain diagnostic studies and current medical
records from M.H.'s other medical providers and that the results of the
Respondent's physical examination and medical history did not justify
the continued prescribing of controlled substances. The reviewing
expert also noted that he ignored a major surgical intervention that
occurred in September 2016 as well as an abnormal drug screen. As such,
the reviewing expert concluded that much of the medical record for M.H.
was fabricated and seemed to be copied from records of other patients
whose records contained identically worded assessments. The Respondent
also documented that the patient provided ``informed consent,'' when no
informed consent document could be located. The expert also found that,
in some cases, the Respondent failed to repeat certain physical exams
after his initial encounter with M.H., despite the fact he provided him
with prescriptions for controlled substances for more than three years.

[[Page 2988]]

b. Patient C.F.: From August 2014 through August 2018, the
Respondent regularly issued prescriptions for oxycodone and alprazolam
to C.F. A representative sample of those prescriptions follows below:

The reviewing expert found that no credible physical examination
had been performed on C.F. and that the exam results, as well as
medical history, did not justify the continued prescribing of
controlled substances. The expert further found that no meaningful
follow-up physical exam was repeated, that supported diagnostic studies
were not ordered, and that the Respondent failed to determine a chronic
pain etiology. The expert also found that he ignored suspicious drug
screen results which indicated illegal drug use. The reviewing expert
concluded that much of the medical record for C.F. was fabricated and
seemed to be copied from records of other patients whose records
contained identically worded assessments. The Respondent also
documented that the patient provided ``informed consent'' when no
informed consent document could be located.
c. Patient M.P.: From September 2016 through April 2018, the
Respondent regularly issued prescriptions for large quantities of
oxycodone and oxymorphone to M.P. A representative sample of those
prescriptions follows below:

The reviewing expert found that he failed to request and obtain
past medical records, he failed to order any radiographic studies, and
that his physical examinations of M.P., including follow-up exams, were
substandard and not credible. The expert found that he failed to
document any evidence to support a pain etiology and that he failed to
properly address M.P.'s substance abuse disorder despite the fact that
she suffered a heroin overdose in his waiting room. As a result, the
expert found no objective findings to justify the continued prescribing
of oxycodone and oxymorphone. The reviewing expert also concluded that
much of the medical record for M.P. was fabricated and seemed to be
copied from records of other patients whose records contained
identically worded assessments. He also documented that the patient
provided ``informed consent'' when no informed consent document could
be located.
d. Patient B.C.: From August 2014 through August 2018, the
Respondent regularly issued prescriptions for large quantities of
oxycodone, oxymorphone, alprazolam, and carisoprodol to B.C. A
representative sample of those prescriptions follows below:

[[Page 2989]]

----------------------------------------------------------------------------------------------------------------
Quantity
Date written Drug Dosage (number of
tablets)
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4.10.18................................. Alprazolam................ 1 mg...................... 84
4.16.18................................. Oxycodone................. 30 mg..................... 84
4.21.18................................. Oxymorphone............... 30 mg..................... 56
4.27.18................................. Alprazolam................ 1 mg...................... 84
5.14.18................................. Oxycodone................. 30 mg..................... 21
5.21.18................................. Oxymorphone............... 30 mg..................... 14
5.22.18................................. Oxycodone................. 30 mg..................... 84
5.26.18................................. Oxymorphone............... 30 mg..................... 56
6.12.18................................. Alprazolam................ 1 mg...................... 5
6.12.18................................. Alprazolam................ 1 mg...................... 84
6.19.18................................. Oxycodone................. 30 mg..................... 21
6.22.18................................. Oxycodone................. 30 mg..................... 84
6.22.18................................. Oxymorphone............... 30 gm..................... 56
6.22.18................................. Carisoprodol.............. 350 mg.................... 56
7.9.18.................................. Alprazolam................ 1 mg...................... 84
7.25.18................................. Carisoprodol.............. 350 mg.................... 56
7.25.18................................. Oxycodone................. 30 mg..................... 84
7.25.18................................. Oxymorphone............... 30 mg..................... 56
----------------------------------------------------------------------------------------------------------------

The reviewing expert found that the physical examination and
medical history did not justify the continued prescribing of controlled
substances. The expert found that he failed to: (1) Obtain the
patient's past medical records; (2) order radiologic and other studies
that would support the treatment; (3) adequately address the fact that
B.C. lied about his scheduled medications during his initial encounter;
and (4) pursue a specific pain diagnosis. The expert also found that he
failed to document the patient's response to the medication which he
prescribed. The reviewing expert also concluded that much of the
medical record for B.C. was fabricated and seemed to be copied from
records of other patients whose records contained identically worded
assessments.
e. Patient M.W.: From January 2014 through August 2018, the
Respondent regularly issued prescriptions for large quantities and
dosages of oxycodone, oxymorphone, alprazolam, and carispoprodol to
M.W. A representative sample of those prescriptions follows below:

----------------------------------------------------------------------------------------------------------------
Quantity
Date written Drug Dosage (number of
tablets)
----------------------------------------------------------------------------------------------------------------
4.3.17.................................. Alprazolam................ 2 mg...................... 56
4.4.17.................................. Carisoprodol.............. 350 mg.................... 28
4.4.17.................................. Oxycodone................. 30 mg..................... 56
4.4.17.................................. Oxycodone................. 15 mg..................... 56
4.28.17................................. Alprazolam................ 2 mg...................... 56
5.2.17.................................. Oxycodone................. 30 mg..................... 56
5.26.17................................. Alprazolam................ 2 mg...................... 56
7.7.17.................................. Alprazolam................ 2 mg...................... 56
7.31.17................................. Oxycodone................. 30 mg..................... 56
8.4.17.................................. Alprazolam................ 2 mg...................... 56
10.18.17................................ Alprazolam................ 2 mg...................... 56
12.12.17................................ Alprazolam................ 2 mg...................... 56
1.19.18................................. Alprazolam................ 2 mg...................... 56
2.12.18................................. Alprazolam................ 2 mg...................... 56
3.30.18................................. Oxymorphone............... 15 mg..................... 56
4.6.18.................................. Alprazolam................ 2 mg...................... 56
4.27.18................................. Oxycodone................. 30 mg..................... 28
4.27.18................................. Oxymorphone............... 15 mg..................... 56
5.15.18................................. Alprazolam................ 2 mg...................... 56
5.29.18................................. Oxycodone................. 30 mg..................... 28
5.29.18................................. Oxymorphone............... 15 mg..................... 56
6.15.18................................. Alprazolam................ 2 mg...................... 56
7.2.18.................................. Oxycodone................. 30 mg..................... 56
7.2.18.................................. Oxymorphone............... 15 mg..................... 56
8.29.18................................. Alprazolam................ 2 mg...................... 56
8.29.18................................. Oxycodone................. 30 mg..................... 56
----------------------------------------------------------------------------------------------------------------

With respect to M.W., the reviewing expert found that the initial
physical examination and medical history did not justify the continued
prescribing of controlled substances and the subsequent physical
examinations did not meaningfully evidence any chronic pain condition.
The expert also found that he failed to: (1) Order and obtain
diagnostic studies; and (2) adequately address numerous instances in
which the patient had abnormal drug screens indicating possible
diversion, abuse, and/or use of illegal controlled substances. The
reviewing expert also concluded that much of the medical record for
M.W. was fabricated and seemed to be copied from records of

[[Page 2990]]

other patients whose records contained identically worded assessments.
The Respondent also documented that the patient provided ``informed
consent'' when no informed consent document could be located.
9. With respect to the Respondent's treatment of M.H., C.F., M.P.,
B.C., and M.W. (``the five patients''), the prescriptions for
controlled substances which he issued were not issued in the course of
professional practice inasmuch as he failed to: (1) Take an adequate
medical history; (2) perform a sufficient physical examination; and (3)
perform an adequate ``assessment and consideration of the [patients']
pain, physical and psychological function, any history and potential
for substance abuse, coexisting diseases and conditions, and the
presence of a recognized medical indication for the use of a dangerous
drug or controlled substance.'' The Respondent also failed to create a
``written treatment plan tailored for the individual needs'' of each of
the five patients which considered each of the patient's ``pertinent
medical history and physical examination as well as the need for
further testing, consultation, referrals, or use of other treatment
modalities.'' He also failed to: (1) ``Discuss the risks and benefits
of the use of controlled substances'' with patients M.H., C.F., M.P.,
B.C., and M.W.; (2) do a ``documented periodic review of the[ir] care .
. . at reasonable intervals in view of the individual circumstances''
of each patient; and (3) keep ``[c]omplete and accurate records of the
care provided.'' As such, his conduct violated TENN. CODE ANN. Sec.
63-6-214(b)(12) and TENN. COMP. R. & REGS. 0880-02 .14(6)(e)(3)(i)-(v).
10. With respect to C.F., M.P., and M.W., the Respondent failed to
address substantial evidence that the patients were engaged in abuse
and/or diversion of controlled substances, a violation of TENN. CODE
ANN. Sec. 63-6-214(b)(l3).
11. The prescriptions the Respondent issued to UC, M.H., C.F.,
M.P., B.C., and M.W. failed to comply with Tennessee state law in that
they did not conform to accept and prevailing medical standards in
Tennessee, and thus, were issued outside the usual course of
professional practice. His conduct, viewed as a whole, ``completely
betrayed any semblance of legitimate medical treatment.'' Jack A.
Danton, D.O., 76 FR 60,900, 60,904 (2011). By issuing these
prescriptions for controlled substances, he failed to take reasonable
steps to guard against diversion of controlled substances. See David A.
Ruben, M.D., 78 FR 38,363, 38,382 (2013); Beinvenido Tan, M.D., 76 FR
17,673, 17,689 (2011); Dewey C. Mackay, M.D., 75 FR 49,956, 49,974
(2010); Physicians Pharmacy, L.L.C., 77 FR 47,096 (2012).
12. Even a single act of knowing diversion is sufficient for the
Agency to revoke a registration. See Dewey C. Mackay, 75 FR at 49,977.
Detailed above are numerous acts of alleged unlawful prescribing, any
one of which could independently establish the sort of intentional
diversion on the part that would justify the revocation of his DEA
registration and the denial of his pending application as inconsistent
with the public interest. See 21 U.S.C. 824(a)(4), 823(f).
13. In addition to the legal authorities cited above, the following
cases and Final Orders provide a summary of the legal basis for this
action: United States v. Moore, 423 U.S. 122, 135, 143 (1975); Randall
L. Wolff, M.D., 77 FR 5,106 (February 1, 2012); Jack A. Danton, D.O.,
76 FR 60,900 (September 30, 2011); Robert F. Hunt, D.O., 75 FR 49,995
(August 16, 2010); Linda Sue Cheek, M.D., 76 FR 66,972 (2011); Kathy A.
Moral, 69 FR 59,956 (2004); Rebecca Sotelo, 70 FR 28,580 (2005);
Patrick W. Stodola, M.D., 85 FR 20,727 (2009); Bob's Pharmacy and
Diabetic Supplies, 74 FR 19,599 (2009); Nirmal Saran, M.D., 73 FR
78,827 (2008).
14. With regard to the Respondent's application for a new DEA COR
in Kentucky, there are additional grounds for denying his application
insofar as he lacks state authority to handle controlled substances in
that state. On January 15, 2019, the Commonwealth of Kentucky, Board of
Medical Licensure, issued an Emergency Order of Restriction prohibiting
him from ``prescribing, dispensing, or otherwise professionally
utilizing controlled substances.'' See 201 KY. ADMIN. REGS. 9:240 1 and
3. Thus, he is currently without authority to handle controlled
substances in the Commonwealth of Kentucky, the state in which he has
applied for a new DEA COR. Consequently, the DEA must deny his
application for a DEA COR based on his lack of authority to handle
controlled substances in the Commonwealth of Kentucky. 21 U.S.C.
824(a)(3); 21 CFR 1301.37(b). See e.g., Kenneth C. Beal, Jr., D.D.S. 83
FR 34,877 (2018); Mehdi Nikparvarfard, M.D., 83 FR 14,503 (2018); Leia
A. Frickey, M.D., 82 FR 37,113 (2017); Alaaeldin A. Babiker, M.D., 81
FR 50,723 (2016); James Dustin Chaney, D.O., 81 FR 47,416 (2016); Irwin
August, D.O., 81 FR 3,158 (2016); Wayne D. Longmore, M.D., 77 FR 67,669
(2012); Jovencio L. Raneses, M.D., 75 FR 11,563 (2010); John B.
Freitas, D.O., 74 FR 17,524 (2009); Worth S. Wilkinson, M.D., 71 FR
30,173 (2006).

Material Falsification

In its Supplemental Prehearing Statement, the Government alleged
that, on November 6, 2019, the Respondent made a material falsification
on his renewal application for his Tennessee-based DEA COR, #59889.
Specifically, the Government alleged that in response to liability
question three, the Respondent answered ``no'', which he knew or should
have known to be a false response. GX 26. Liability question three
queries whether the applicant has ever surrendered for cause, or had a
state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or have
any such action pending. The Government alleged that an affirmative
answer to Question Three would trigger an investigation by a diversion
investigator whether to issue the registration or to deny it. The
Respondent answered ``No'' to question 3. A false ``no'' answer can
result in an improperly issued registration. GX 26.
In support, the Government cites to the State of Tennessee
Department of Health, Notice of Charges and Memorandum for Assessment
of Civil Penalties, see GX 29, an order from the Chancery Court for the
State of Tennessee, 20th Judicial District, Davidson County, Part 3,
reversing Denial of Stay, but Accompanying Stay with Conditions. GX 27.
The Government contends that as of May 2019, the Conditions preclude
the Respondent from writing prescriptions or providing direct patient
care during the pendency of the stay. The Government also cites an
Agreed Order with the State of Tennessee, GX 27, in which the
Respondent was required to surrender his Pain Management Certificate, a
professional license, in 2018, and prior to his application for
registration in November, 2019. GX 26; GX 28. The Government alleges
that, although GX 28 related to the surrender of the pain clinic
license, and GX 26 was the Respondent's personal application, as the
Respondent applied for the pain clinic license himself, it constitutes
a surrender of his own license, warranting an affirmative response to
Question Three of his DEA application. GX 26.\7\
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\7\ The surrender is signed by the Respondent individually.
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The Hearing

Government's Opening Statement

The Government characterized the Respondent as a willing enabler of
drug

[[Page 2991]]

abuse and diversion. Tr. 20. Rather than maintaining medical records
lacking in detail, the Respondent's records, although detailed, were
fabricated. The Government's expert reviewed twenty-four patient charts
and discovered identical language throughout. Some phrases were
repeated more than 100 times. Undercover \8\ will testify that tests
described in his chart were not performed. Test results were repeated
during three visits in which he was not seen by the Respondent. The
same identical test results were repeated in other patient charts. The
Government's expert will testify that the Respondent prescribed
controlled substances without a legitimate medical purpose and outside
the usual course of professional practice, on the basis of the subject
medical charts. He will further testify that the charts reveal multiple
red flags of abuse and diversion, which were largely ignored by the
Respondent. Rather, he created records which were deceptive, dishonest,
and in some cases, dangerous. Tr. 20.
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\8\ [Omitted for privacy.]
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Respondent's Opening Statement

Samson Orusa contends that he is a fine physician, who cares deeply
about his patients. Tr. 24. He spends a lot of time getting to know his
patients to insure he understands their issues relating to pain
management. His system is to use a number of documents, which the
patients fill out prior to the Respondent seeing them, in order to get
a full picture of each patient. These include the initial visit sheet,
and a 41-page pain management physical exam sheet. He would go through
these documents with the patient painstakingly. These forms take hours
to fill out and to review.
The undercover agent presented himself to the Respondent under
false colors, under an assumed identity, and with an MRI, which the
Respondent could not confirm. He claimed to be from Missouri, a state
without a PDMP. He reported he had used over-the-counter medications to
treat his pain, and falsely claimed he had previously been prescribed
Schedule II controlled substances, painting the picture that he needed
Schedule II pain medications from the Respondent. The evidence will
fail to show that the Respondent has done anything outside the bounds
of normal medical practice.
Furthermore, the Government's case relies solely on the opinion of
its expert, Dr. Kennedy, who we maintain is not an expert in the field
of pain management, and whose qualifications are limited to family
practice. He holds himself out to be a diplomat with the American
Academy of Pain Management, which is a defunct organization. He has
never completed a fellowship in pain management. He is not board-
certified in pain management, and would not be qualified in the State
of Tennessee to be a medical director of a pain clinic. The Respondent
maintains Dr. Kennedy's opinion testimony should be afforded no weight
in these proceedings.\9\ Tr. 24
---------------------------------------------------------------------------

\9\ The Respondent's written motion to exclude the testimony of
Dr. Kennedy was carried until the Government offered Dr. Kennedy as
an expert witness at the hearing. Tr. 24-25, 26. The Respondent's
Motion to Exclude was denied on its merits in conjunction with his
objection to having Dr. Kennedy qualified as an expert witness. Tr.
201, 211-12. Contrary to the Respondent's claims, the motion was not
denied as untimely.
---------------------------------------------------------------------------

Government's Case-in-Chief

The Government presented its case-in-chief through the testimony of
four witnesses. First, the Government presented UC. Secondly, the
Government presented the testimony of Dr. Gene Kennedy. Thirdly, the
Government presented the testimony of a DEA Special Agent assigned to
this matter. Finally, the Government presented testimony of a DEA
Diversion Investigator assigned to this matter.

Undercover

[UC testified regarding his education, credentials, and employment
background with the Tennessee Bureau of Investigation].*\C\ He has
conducted approximately twenty to thirty investigations as the lead
case agent in cases involving allegations of fraud, physicians
prescribing narcotics without medical necessity, and physicians
prescribing outside the scope of processional practice. Tr. 31-32.
[Omitted.] \10\ He provided lower back pain as a false symptom in this
case, specifically because he has ``absolutely no back pain
whatsoever.'' Tr. 112-11.
---------------------------------------------------------------------------

*\C\ In this section, I have omitted some biographical and
investigation-related information to protect the identity and
methodology of UC.
\10\ [Omitted original text in which footnote appeared.]
---------------------------------------------------------------------------

Undercover was contacted by a Special Agent (SA) with the United
States Department of Health, Office of Inspector General (SA-DOH) who
asked him to make an appointment with the Respondent in the late summer
of 2017. Tr. 34; 98.\11\ The initial goal in these types of cases is to
get an appointment to see the doctor. Tr. 34. The ultimate goal is to
see if the physician will write the undercover agent a prescription for
a controlled substance. Tr. 34, 101.
---------------------------------------------------------------------------

\11\ He is familiar with the DEA Physician's Manual. Tr. 98.
---------------------------------------------------------------------------

In this particular investigation, UC contacted the Respondent's
office and spoke with the receptionist over the phone, who told him
that he would be scheduled for a new patient visit and was required to
bring certain items on that day including; (1) an MRI report, (2) the
last three chart notes from a previous physician, (3) the discharge
summary from his previous pain management clinic, and (4) a printout of
the last three months from his pharmacy. Tr. 35. UC already had some of
the items, such as the MRI report, but there were other items he needed
to put together. Tr. 34-35. The MRI that UC had was authentic, as it
was his actual MRI that was performed on September 2, 2016. Tr. 35-37,
106. The only thing he altered was the ordering physician and patient
name of ``Chris Rutledge.'' Tr. 35-37.
The patient records that he presented to the Respondent were
fabricated. Tr. 37-38. DOH-SA and another SA consulted with a nurse
practitioner who worked for TBI and instructed the agents to generate
medical records that would be indicative of someone who was seeing a
nurse practitioner for pain. Tr. 38, 108; GX 6. UC then provided his
personal information including his date of birth and his medical
complaints for the agent to create a medical record. The only medical
record provided to the Respondent's office was signed by ``S.C.,'' who
was not practicing medicine at that time. Tr. 38, 133.
UC visited the Respondent's office on October 3, 2017, and recorded
video and audio of the visit. Tr. 40; 42-43.\12\ He set up an
appointment for 8:00 a.m. and was told to bring the necessary
documents. Tr. 40. UC showed up for the appointment at approximately
8:00 a.m.\13\ and gave the documents he had to the receptionist, and
explained why he was missing two documents.\14\ Tr. 38-40, 108; GX
4.\15\ The receptionist gave him about twenty pages of paperwork and
asked him to sit in the waiting room to fill it out. At some point he
was called up by one of the

[[Page 2992]]

employees \16\ who made a comment about one of the pages in UC's
medical record appeared to be ``whited out'' and the employee then made
a statement that there are ``people that are trying to bring down [the
Respondent]'' and the Respondent would therefore ``be reluctant to
write any medications.'' Tr. 41; GX 3. The receptionist then told UC to
have a seat and he would be called back for triage to get his vitals.
Tr. 41-42, 44. UC paid for this visit with $311 of cash. Tr. 49,
110.\17\
---------------------------------------------------------------------------

\12\ At this point, Government offered Government Exhibit 3. The
time stamp for the video of the October 3, 2017 visit is 5:05:42.
Tr. 74.
\13\ UC noted that he did not present in any ``unusual way'' to
show that he had a disability, limp, change or change his gait. Tr.
46.
\14\ As discussed supra, UC was asked to bring in a discharge
summary, which is a report that a pain management clinic creates
when the clinic releases a patient. Tr. 38-39, 108. He ultimately
did not provide this document to the Respondent's office, stating
that he was unable to obtain it. Tr. 39. He also stated that did not
provide the printout showing the last three months of pharmaceutical
history, because he was unable to get it. Tr. 39-40.
\15\ No one asked for these records after his visit and he never
produced the pharmacy records. Tr. 55.
\16\ At this point in the testimony, Judge Dowd stated that UC
was not allowed to read from his report directly. UC clarified that
although he ``did have it open,'' he had not ``looked at it yet.''
Tr. 41.
\17\ At this point in the testimony, the Government played a
video. Tr. 51; GX 4. Judge Dowd instructed the court reporter not to
transcribe the audio of the video, as the recording itself is the
best evidence. UC confirmed that the transcript of the proceedings
was a fair and accurate representation of the recording. Tr. 55; GX
4.
---------------------------------------------------------------------------

UC filled out a pain disability index and ranked his pain level as
a nine out of ten, which was not a truthful response to how he felt at
the time. Tr. 47, 101, 109-10, 123. As to his goals, his second goal
was to ``sleep through the night'' but he did not check the box for
insomnia. Tr. 134-35, 139. Despite this contradiction, no one in the
office asked about this. Tr. 139.\18\ He also filled out a Zung Self-
Rating Depression Scale, selecting random answers. Tr. 102. He also
filled out a drug use questionnaire regarding his drug history with the
intention of presenting a picture of a person who is in pain. Tr.102-
03. He also filled out an agreement for opioid maintenance therapy and
for cancer and non-cancer patients. Tr. 103. He also filled out an
American Chronic Pain Association form including a chronic problem list
and reported that he was only taking Advil, an over-the-counter, anti-
inflammatory and pain medication of three pills, three times a day,
with the understanding that if he was performing well with the over-
the-counter medicine, a doctor would likely not give him a
prescription. Tr. 103-105, 123. He also filled out a multi-page pain
management physical form, which was blank \19\ in his seized medical
record. Tr. 105, 128. He could not recall if the Respondent went
through every form with him, but did remember the Respondent asking him
a couple questions. Tr. 105. He also recalled telling the Respondent
that he had taken prescription hydrocodone in the past and it had
helped him. Tr. 123.
---------------------------------------------------------------------------

\18\ UC had noted that he may have stated that he did not sleep
well because he was awakened by his pain.
\19\ UC noted that there were several forms that were blank in
the copies he had.
---------------------------------------------------------------------------

At one point, a female wearing scrubs took his blood pressure,
asked about his weight, provided him a specimen cup, and instructed him
to go into the bathroom located inside the waiting room. Tr. 44-45. UC
then produced a urine sample. Tr. 45.
The time that passed from when UC spoke with the employee about his
``fabricated'' records with the ``white-out'' page until he met with
the Respondent, was about seven hours, only leaving the office for
approximately forty-five minutes to get lunch. Tr. 48-49, 100.
[Omitted to protect law enforcement techniques]. UC told the
Respondent where his pain was located and if it hurt he would respond
that he had pain in that area, but did not make any face or wince.
There was less than sixty seconds of any kind of physical touching
between himself and the Respondent, which he testified was brief
compared with other physicians.
The Respondent asked what his previous diagnosis was and he
responded with arthritis and degenerative disk disease. Tr. 105-06.\20\
During this visit, UC learned that the office staff had tried to
contact his pharmacy and was unable to do so. Tr. 108-09. UC explained
to the Respondent that he would try to get a hold of them and the
Respondent's stated that his office would make another attempt. Tr.
109. They also discussed the alternative treatment of injections for
UC's back pain, but UC refused to get the injections. Tr. 117, 127. UC
told the Respondent that he had fallen off a truck sometime in 2013,
was seeing Dr. Chapman in Pierce City, Missouri, and he moved to
Tennessee about one month prior to his first visit on October 3, 2017.
Tr. 117-18. None of these statements were true. Tr. 117-18. UC also
shared a story about his aunt breaking her hip and him going to the
clinic to obtain records, that he was unable to do so because the
clinic was shut down, and that his aunt still lived in Missouri. Tr.
118. None of these statements were true. Tr. 118. UC admitted that he
stated all of these lies in order to achieve his stated goal to get a
prescription from this visit and also noted that ``[u]ndercover
operations inherently rely upon some falsehoods in all aspects of law
enforcement.'' Tr. 119-21.\21\
---------------------------------------------------------------------------

\20\ In fact, a physician had previously told UC that he may
have arthritis, UC was not given a diagnosis of degenerative disk
disease. Tr. 106-107.
\21\ At this point in the testimony, on cross-examination, the
Respondent's counsel made a comparison to an undercover agent
purchasing heroin from a dealer and the Tribunal inquired of the
Respondent's counsel as to the relevance of his questioning. Tr.
121. The Respondent's counsel asserted that UC had lied to the
Respondent to achieve his goal of getting a prescription. Tr. 121.
The Tribunal asserted that ``in principle this is an undercover
operation. [That is] the whole point of it.'' Tr. 122.
---------------------------------------------------------------------------

He received a prescription for 42 oxycodone 10-milligram tablets,
thirty minutes after he left the exam room, from one of the
receptionists, despite not asking for oxycodone. Tr. 56-57; GX 18. He
also received prescriptions for Meloxicam and flexeril. Tr. 57-58; GX
18.\22\ He filled the oxycodone prescription, but not the other
prescriptions. Tr. 57, 58.\23\
---------------------------------------------------------------------------

\22\ UC confirmed that this Government Exhibit 18 was a fair and
accurate copy of the prescription he received on October 3, 2017.
\23\ UC asserted that he did not expect to get controlled
substances on this first visit, as he usually does not expect to get
them, but from what he had ``been told regarding the clinic, it [did
not] shock him.'' Tr. 125. If he had not received prescriptions that
first visit, it would not have deterred him from making future
appointments as it usually takes several appointments to build up to
the point where the undercover agent receives controlled substances.
Tr. 125. There is no set number for visits, but in cases where he
has been the case agent, he has looked for a progression from other
modalities of treatment first being offered and then elevating to
drugs like hydrocodone to oxycodone, elevating the dosage or the
quantities over time. Tr. 126-27.
---------------------------------------------------------------------------

UC went back to the office for a second visit on October 15, 2017,
which was supposed to be his well-care visit between receiving his two
narcotic prescriptions. Tr. 58-59. He did not make an appointment. He
showed up at the office, and made a $25 payment to the receptionist.
Tr. 59. He was called back to the triage room where the nurse asked him
his weight, to which he replied, ``210,'' and if his blood pressure was
ok, to which he responded, ``yes.'' The nurse then directed him back to
the waiting room. He was later called to the exam room.
This visit was recorded in the same manner as the visit on October
3, 2017. Tr. 59-60; GX 4 at 4.\24\ When he entered

[[Page 2993]]

the room, the Respondent asked if it was UC's first well visit or
primary care visit and UC affirmed it was. Tr. 71. The Respondent asked
if UC was taking other medications and he stated that he was not taking
medications other than pain medications. The Respondent asked whether
UC was sleeping well and he responded ``not really.'' The Respondent
then stated that he would write him a prescription for pain medications
to help him sleep. UC asked what it was, and the Respondent stated,
``amitriptyline.'' That marked the end of the encounter. Tr. 71. There
was no further medical examination or physical examination of his lower
back, of any of his extremities, or an examination to determine if he
had muscle pain. Tr. 71-72.
---------------------------------------------------------------------------

\24\ UC stated that Government Exhibit 4 is a transcript of his
interaction with the Respondent on that date and is a fair and
accurate representation of their encounter. Tr. 60; GX 4 at 4. The
transcript reflects that the video was difficult to hear. The
Respondent's counsel objected to the video being put into evidence
if the video could not be properly played before the Tribunal. Tr.
64-66. The Tribunal noted the objection and allowed the Government's
counsel to proceed. The video was replayed and UC asserted that he
was able to hear the tape. The Tribunal overruled the objection and
noted that the Respondent's counsel could cross examine UC. The
Government later moved Government Exhibits 4 and 17 into the record.
Tr. 69. The Tribunal admitted pages 1, 2, and 3 of Exhibit 4 and
part of Government Exhibit 17, but noted that it was ``not convinced
that [the] audio is intelligible, fully audible, without
interference, because [it] ha[s] nothing but interference'' on the
Tribunal's end. Tr. 70. On Day 3 of the hearing, the Tribunal
reconsidered its earlier ruling on the limited admissibility of GX 4
and 17, and admitted the exhibits in their entirety, noting that the
video/audio (GX 4) was played successfully at the hearing to all
participants, except the Tribunal and court reporter, which the
Tribunal attributed to a VTC issue and not to a defect in the DVD
itself. [I have reviewed the contents of the DVD and find that the
videos play successfully.]
---------------------------------------------------------------------------

UC had a third visit on October 18, 2017, when he was scheduled to
get the refills for his narcotic medications. Tr. 75. He went to the
Respondent's office and first attempted to pay with cash, but had to
secure a debit card. Tr. 75-76. He wrote his name on a clipboard, paid
the $377 fee for the office visit, and about an hour later his name was
called and he got his prescription. Tr. 76. He was at the clinic for
approximately two and half hours and was not examined by any medical
personnel nor did he provide any medical records. Tr. 77. He received a
prescription for eighty-four tablets of ten milligrams of oxycodone.
Tr. 78, GX 18 at 3, 4. This dosage was less than the Lortab of four
times a day. He also received the ``euphoria drug'' of Xanax that he
had falsely claimed he was receiving in Missouri. Tr. 112.
Upon reviewing the medical records, UC noted that despite his
records stating that ``Mr. Rutledge . . . has had a history of insomnia
and anxiety for several years,'' he did not report anxiety symptoms of
shortness of breath, of having palpitations, sweating, dizziness, or
shaking. Tr. 79-80; GX 5. The medical record also reflects that he had
a headache that day, despite the fact that UC did not report having a
headache, dizziness, nausea, or vomiting. Tr. 80; GX 5. No one
questioned UC as to whether he had abdominal pain, diarrhea, and
constipation. Tr. 80-81. UC reviewed Government Exhibit 5 and noted
that he was not asked about any of these symptoms. Tr. 81. He also
assumes that the office accessed and checked the Tennessee controlled
substance data bank on his first visit as this was in his medical
records, but he was not specifically informed of it. Tr. 110. He also
believes that the UC's assumed identity has never had a controlled
substance filled in Tennessee. Tr. 111. He also believes there was no
Missouri prescription database at that time, where he asserted he was
from, so the office could not obtain information from there. And the
fact that Missouri did not have a state-controlled prescription
monitoring program in Missouri was a factor as to why the persona of
UC's assumed identity was somebody from Missouri. Tr. 110-11.
At the appointment on October 17, 2017, UC did not have his blood
pressure checked, was not weighed, did not have his chest examined, and
did not have his breathing measured or evaluated. Tr. 82. On October
18, 2017, UC did not discuss muscle pain, back pain, nor a Review of
Systems (ROS). Tr. 82-83. No one examined his chest, or his breathing.
Tr. 83.
UC had another visit on November 15, 2017, which was another well-
visit. Tr. 84. He paid $25, waited for some time, was called back and
asked about his weight and if his blood pressure was okay. He
specifically asked the nurse if he was dismissed and after she said
yes, he left. He did not receive any prescriptions that day. Tr. 85.
Despite what the medical records say regarding this visit, there was no
medical examination conducted on that day, including of his chest, or
breathing. Tr. 86, 90; GX 5.
UC had another visit on November 20, 2017, for a medication visit.
Tr. 87; GX at 10. UC walked in, put his name on a clip board, paid some
money, waited a certain amount of time for his name to be called, and
went to the window to obtain his prescriptions. Tr. 88. On this
particular day, he was asked to provide a urine sample. Tr. 88, 92. He
received a cup from the nurse, went into the bathroom for his
unsupervised urine test, and provided a urine sample. He had brought a
vial of a substance that would cause him to test positive for
Oxycodone, put that in the urine sample, and returned the sample to the
nurse as instructed. Tr. 88, 92; GX 3. He believes that, despite the
added substance, his urine drug screen came back negative *\D\ and the
Respondent never discussed this screen with UC nor did anyone else at
the practice. Tr. 91-92; GX 3.\25\ He received a prescription for
oxycodone for eighty-four tablets of ten milligrams from one of the
receptionists, who provided the prescription to him as well as several
others. Tr. 89. GX 18 at 4. UC did not meet with the Respondent that
day. The medical records say ROS, but none of the systems were examined
during this visit. Tr. 91.
---------------------------------------------------------------------------

*\D\ The Government did not fully explain this portion of its
case which I find to be immaterial. Ultimately, inconsistent UDS
results were not relevant to Dr. Kennedy's opinion that the
prescriptions issued to UC were issued outside of the standard of
care nor were they relevant to my findings in this decision.
\25\ Although the Respondent objected to Government Exhibit 3
being offered into evidence based on hearsay, the Tribunal overruled
the objection finding that any hearsay statements in this exhibit
have been properly authenticated. Tr. 94. The Tribunal also noted
that UC could be cross-examined regarding his report.
---------------------------------------------------------------------------

Besides verbalizing and writing down that his pain was nine out of
ten, UC did not do anything to indicate that his pain was actually that
level. Tr. 94-95; GX 3, 18. He did not present any falsified records
showing he had a history of filling controlled substance prescriptions
in any state \26\ and never produced pharmacy records showing his
prescription history. Tr. 133. In UC's experience of working with
people who abuse drugs or obtain drugs to sell them, he has found that
these people are pretty savvy about filling out their forms when they
go to the doctor. Tr. 133-34.
---------------------------------------------------------------------------

\26\ UC noted in the Patient Pain History form that he had
previous medications including hydrocodone between November 2016 and
September 2017, Xanax from approximately August 16, 2016 through
September 2017, and oxycodone from August 2017 to September 2017.
---------------------------------------------------------------------------

Dr. Gene Kennedy

Dr. Kennedy, who is licensed in Georgia, is a family practitioner
by training and has treated patients for pain since being licensed. Tr.
202. Dr. Kennedy was offered, and qualified, as an expert in the field
of pain management. Tr. 201, 211-12, 216. Although not board certified
in pain management, he has been treating people for pain full-time
since 2004 or 2005, when he opened his own pain management clinic. Tr.
178-80, 202-03, 427.\27\ He has treated all types of pain patients:
Patients suffering acute post-surgical pain; patients suffering from
back pain; cancer patients; and patients referred by other pain
management physicians. Tr. 180-81, 355. He has prescribed assorted
controlled substances, including opioids to treat pain, including
Schedule I. Tr. 181. He treats patients over 120 MME. He noted only UC
and C.F. were being treated below 120 MME. Tr. 427-28. He has

[[Page 2994]]

prescribed benzodiazepines. He performs pain injections. Tr. 357.
---------------------------------------------------------------------------

\27\ Although not dispositive in this setting, Dr. Kennedy's
credentials would not permit him to be a director of a pain clinic
in Tennessee, without annually consulting with a board certified
pain management specialist. Tr. 204-05, 428-30.
---------------------------------------------------------------------------

He has previously been qualified as an expert witness in
administrative hearings of the Alabama Medical Board, the Georgia
Medical Board, DEA, FBI and DOJ. On thirteen occasions he has testified
regarding whether a physician has properly prescribed controlled
substances. GX 24. He has served as an adjunct lecturer regarding the
proper prescribing of controlled substances to DEA, at the National
Advocacy Center, and on behalf of the DOJ. Tr. 185. He estimated over
half of his income comes from the work and lectures given to Government
agencies. Tr. 359. In 2018, he estimates he was paid over $100,000 by
the Government. Tr. 432. For the instant case, he is being paid $450
per hour for an estimated forty hours of preparation plus courtroom
hours. Tr. 434-36. He has also lectured regarding the PDMP to medical
residents and physicians and taught a course to pharmacists in
Tennessee regarding legitimate prescribing. Tr. 185. He is familiar
with Tennessee law pertaining to prescribing controlled substances, and
has relied on the following sources in developing his opinions herein:
Tennessee Pain Clinic Guidelines, the Federation of State Model Policy,
AMA Guidelines, the DEA Practitioner's Manual. Tr. 183, 360-62. He was
hired by the DEA to offer an expert opinion on the Respondent's
prescribing and of the medical practice, on the basis of material the
government provided him. This material included approximately twenty
charts, surveillance videos, and pharmacy reports. The surveillance
videos involved undercover encounters between UC and the Respondent.
Tr. 184; GX 8-23.
Dr. Kennedy is familiar with the standard of care for a physician
prescribing controlled substances in Tennessee. This standard requires
an adequate medical history, including all the historical information
helpful in developing a diagnosis, course of treatment and in
understanding the risks involved. Tr. 189, 195. The standard requires
diagnostic testing, if indicated. Tr. 196. The standard requires the
physician to perform a physical exam. Tr. 190, 200-01. The standard
requires a physician to maintain medical records for patients to whom
controlled substances are prescribed. Tr. 196. These medical records
should contain a pain history, a history of drug abuse and termination
by other physicians, a physical exam pertinent to the patient's
complaint, efforts at obtaining state pharmacy reports, the physician's
thoughtful assessment of the patient's condition, and an individualized
treatment plan. Tr. 196-98. Dr. Kennedy noted the importance of
maintaining complete and accurate patient records. Tr. 353. With
patients sometimes on high doses of potentially dangerous controlled
substances, the charts must be accurate and honest, so any practitioner
who views the charts can make an accurate assessment of the patient's
conditions. Tr. 353-54.
In reviewing the subject medical records, Dr. Kennedy recognized
indications of possible abuse and diversion, including patients unable
to produce past medical records, a cloudy history of drug abuse. Tr.
191-92. Dr. Kennedy noted that the Tennessee standard precludes a
physician from prescribing controlled substances to a patient with a
habit of improperly using them, without first making a bona fide effort
to cure the patient's addiction. Tr. 199. When a benzodiazepine and an
opioid are prescribed in combination, the physician would have a
heightened sense of vigilance, which would need to be documented within
the chart. Tr. 190. Urine drug screening (UDS) is a common practice in
pain management treatment. Tr. 192. It can reveal whether a patient is
taking a medication he is prescribed and whether he is taking
medications or illegal drugs he is not prescribed. Tr. 193-94. The
standard of care would require, at minimum, that the physician document
in the records the inconsistent UDS, and describe his plan of action.
Tr. 194-95.
Dr. Kennedy reviewed the chart and the undercover videos for
Patient UC, who was the undercover agent. Tr. 216-17, 363; GX 6. Dr.
Kennedy acknowledged that in scheduling the first visit, the
Respondent's staff instructed UC to bring certain medical records to
his first visit: The previous three physician notes, his discharge
summary, the record of the previous three months prescriptions and an
MRI, an appropriate protocol in Dr. Kennedy's opinion. Tr. 364-65; GX 3
at 1. Dr. Kennedy did not believe the medical chart justified the
prescribing of controlled substances. Tr. 230-31, 240; GX 18 at 1, 3.
Although an actual MRI report of UC, Dr. Kennedy found the MRI report
internally inconsistent, which did not justify controlled substance
medication. Tr. 387-94, 483-86. UC was being treated for complaints of
back pain. However, Dr. Kennedy opined that the physical exam detailed
in the chart was not sufficient under Tennessee standards, and the exam
performed revealed a normal back.*\E\ Tr. 217, 231, 237, 396-97, 440.
On rebuttal, Dr. Kennedy reiterated this assessment after listening to
the Respondent's explanation. Tr. 651-52. After filling out extensive
paperwork, the initial examination by the Respondent consisted of
observing the UC, touching his back and causing the patient to lift his
leg. Tr. 217-18, 359-60; GX 6 at 6. Dr. Kennedy did not believe UC's
chart reflected the Respondent maintained a truthful and accurate
record of the treatment. Tr. 232; GX 3; 4. Dr. Kennedy noted the taking
of vital signs and a general exam within the chart, however he observed
that from viewing the video of this visit, such exam was not performed
as described, or not performed at all. Tr. 218-19, 232-33, 379-81; GX 6
at 4. The prior medical history reported by UC, was facially suspicious
and constituted a red flag. Tr. 238. UC reportedly, came from a clinic,
which has since shut down, and provided medical records from a Nurse
Practitioner, whose license has been suspended. Tr. 238. Dr. Kennedy
opined that UC's obfuscation, false and misleading statements to the
Respondent and staff, did not relieve the Respondent's obligation to
investigate any suspicious circumstances. Tr. 375-78, 382.
---------------------------------------------------------------------------

*\E\ Dr. Kennedy testified that an adequate back exam would have
required Respondent to look ``for something that is out of place,
muscle spasms, . . . perform lumbar range of motion maneuvers where
the patient essentially bends at the waist in various directions.
Additionally, . . . a straight leg raised test, . . . neurologic
exam, which makes comment on their motor deficits and their
sensorium as pertains to their complaint of low back pain.''
---------------------------------------------------------------------------

Dr. Kennedy noted that the physical exam included in this first
visit by UC was repeated verbatim in most of the 20 or so charts he
reviewed. Tr. 220; GX 7 at 65 (M.B.), GX 9 at 69 (M.W.). Dr. Kennedy
noted UC's chart identified him with a ``long-standing history of
insomnia and anxiety,'' however the chart contained no examination,
which would support such findings. Tr. 233-34; GX 5 at 4. Additionally,
the reported symptoms of the anxiety finding, ``palpitations, sweating,
dizziness, shaking'' was repeated almost universally throughout the
medical records reviewed as to patients diagnosed with insomnia and
anxiety. Tr. 233-34. Although UC reported his pain level at 9 or 10,
the exam results do not support that, nor did the video of this
encounter. Tr. 234-35, 238. Similarly, the visit of October 17, 2017,
by UC contains extensive medical findings, although the video of that
visit does not support those findings. Tr. 235-37; GX 5 at 5. The video
does reveal the Respondent asking UC, ``how is your sleep,'' to which
UC responds, ``not good.'' Tr. 236. The Respondent

[[Page 2995]]

then prescribed Elavil, also called amitriptyline. Tr. 236. Dr. Kennedy
made a similar observation as to extensive medical findings on
subsequent visits, in which UC was not seen by the Respondent. Tr. 235-
37; GX 5 at 3-5. Although the medical records reflect physical
examination took place at the level one visits, the Respondent
explained that it was permissible in medical record-keeping to carry
forward results from prior examinations to later visit records, with
new findings added. Tr. 623-28. Dr. Kennedy disagreed, noting that it
is never permissible for charts to reflect examination results, when no
exam occurred. Tr. 652-53.
On the basis of the deficient physical exam, Dr. Kennedy opined
that prescribing controlled substances to UC was not justified.*\F\
Although the Respondent prescribed a much lower MME than UC had
purportedly been on previously, it was not consistent with the
Tennessee standard, which would include observation, looking for
spasms, lumbar range of motion maneuvers, straight leg raise test,
neurologic exam and motor deficits. Tr. 221-25, 239, 382-83; GX 5 at 6.
Other deficiencies in the records that caused the controlled substance
prescriptions for UC to be unjustified included the deficiency in the
prior medical records provided by UC Tr. 228. UC's chart revealed an
exploration of alternate treatment, by prescribing Meloxicam. Tr. 228-
29. However, UC's chart did not include an adequate treatment plan. Tr.
229. The records reveal a deficient discussion regarding the risks and
benefits of controlled substance medication. Tr. 231. Dr. Kennedy
deemed the diagnosis of degenerative disc disease unjustified on the
basis of the chart and MRI. Tr. 240-42; GX 5 at 2, 6; GX 6 at 12.
---------------------------------------------------------------------------

*\F\ Dr. Kennedy actually offered several bases for his opinion
that all of the controlled substances Respondent prescribed to C.R.
were issued outside the usual course of professional practice. Tr.
239. Specifically, Dr. Kennedy identified Respondent's failures to
perform a sufficient physical examination; to adequately assess the
patient's pain, physical, and psychological function; to
sufficiently examine the patient's history; to assess a recognized
medical indication for the use of oxycodone; to create or follow a
legitimate written treatment plan; to discuss the risks and benefits
of using oxycodone with the patient; to maintain truthful and
accurate medical records; or to resolve red flags arising from the
medical records C.R. provided, which stated that C.R. had been
treated at a clinic that had closed by a nurse practitioner, whose
license had been suspended. Tr. 237-39.
---------------------------------------------------------------------------

Dr. Kennedy prepared reports or charts containing his review of the
relevant medical evidence in this case. His findings accurately reflect
the original medical records, which are in evidence. His chart was
admitted as a chart of voluminous records under Fed. R. Evid. 1006. Tr.
225-28; GX 6 at 2.
Patient M.W.
Dr. Kennedy identified his ``chart review'' for M.W. Tr. 243-44; GX
9, 10. M.W. was diagnosed with low back pain, yet Dr. Kennedy opined
that the records did not support such diagnosis. Tr. 245-46; GX 9 at
14; GX 10 at 3. The notes did reference back to M.W.'s initial
encounter. Tr. 441. There were no findings in the record which would
support a chronic pain condition and justify prescribing controlled
substances. Tr. 246-47. Dr. Kennedy found no credible physical exam to
justify the diagnosis. Tr. 247, 265. The Respondent did not assess
M.W.'s pain level, physical and psychological functioning, history,
potential for drug abuse, or coexisting diseases. Tr. 265. The
Respondent did not follow a legitimate treatment plan. Tr. 265. The
physical exam findings were generally normal findings, except for
limited range of motion at the lumbar spine. Tr. 247; GX 10 at 7. M.W.
reported a pain level, at worst, at 10 of 10, and at best, 6 of 10. Tr.
248-49; GX 9 at 19; GX 10 at 8. M.W.'s reported pain level was
inconsistent with the generally normal results of the physical exam.
Tr. 249-50.
The electronic medical record for this visit does not contain the
handwritten information recorded in GX 10 at 8. Tr. 250-51; GX 10 at 9.
Instead, the results of the physical exam mirror those findings made
for UC, rendering M.W.'s chart not credible. Tr. 251-52. Additionally,
the record contained ``wildly abnormal'' *\G\ UDS results that were
``not meaningfully addressed.'' Tr. 252-55; GX 9 at 2-4, 9-11, 84, 96,
102. After a series of inconsistent UDS, the Respondent noted in M.W.'s
chart that M.W. was dismissed from pain management with one month
notice. Tr. 258; GX 9 at 84. Yet, at the same visit in which he had
been notified he would be dismissed, the history of present illness
(HPI) reports patient is compliant and consistent. Tr. 258. Dr. Kennedy
deemed the chart not credible, accordingly. Tr. 259. However, despite
being dismissed, M.W. continued to be seen for months afterwards,
without any further explanation. Tr. 259-60. Dr. Kennedy later conceded
that M.W. was reinstated consistent with the Respondent's office
protocol. Tr. 449-50. The Respondent continued to prescribe him
Alprazalam, amitriptyline, oxycodone, oxymorphone and Soma. Regarding
the Alprazalam prescription, Dr. Kennedy found it unjustified based on
the information supporting the anxiety diagnosis. Tr. 260-61, 442-44;
Tr. 261; GX 9 at 85. Dr. Kennedy noted the indications for anxiety were
not supported by the findings within the chart, and mirrored those in
the charts for UC and the other patients. Tr. 261-62. Although Dr.
Kennedy opined M.W. should have been physically examined ``on a regular
basis'' during his treatment, the charts suggest he was not examined
again following his first examination.*\H\ Tr. 262. Dr. Kennedy further
opined that as M.W. was a 25 year-old diagnosed with degenerative disc
disease, the Tennessee standards would require diagnostic testing, such
as an MRI to confirm the diagnosis. Tr. 262, 447-48. Dr. Kennedy found
M.W.'s chart ``not credible and fabricated.'' Tr. 263-64, 266; GX 10 at
5, 23. He noted that of 93 of 98 total visits shared the identical
findings for the physical exams and ROS. Tr. 264. Similarly, Dr.
Kennedy found the diagnosis of insomnia not credible. Tr. 264. A
finding of drug abuse and chemical dependency would have been
supportable, but such indications were not sufficiently addressed by
the Respondent. Tr. 264-65. The credible findings within M.W.'s chart
did not support the prescribing of controlled substances,*\I\ and the
subject prescriptions were issued without medical justification and
outside the usual course of professional practice. Tr. 266-68.
---------------------------------------------------------------------------

*\G\ For example, regarding the UDS at GX 9, 2-4, M.W. was
prescribed oxycodone, carisoprodol, alprazolam, and ozymorphone. GX
9, 2-4. The drug screen results were negative for the prescribed
drugs alprazolam and carisoprodol and, as Dr. Kennedy testified,
positive for non-prescribed substances including ``morphine,
positive for hydromorphone, positive for oxymorphone, . . . positive
for THC. . . .'' Tr. 251-52.
*\H\ Dr. Kennedy testified that the little documentation there
was suggesting a physical exam could have been performed was ``not
credible'' because it was ``repeated documentation that we have
described before.'' Tr. 262.
*\I\ Specifically, Dr. Kennedy testified that Respondent failed:
To perform a sufficient physical examination; to adequately assess
the patient's pain, physical, and psychological function; to
sufficiently examine the patient's history and potential for
substance abuse; to identify a recognized medical indication for the
use of the controlled substance prescriptions; to create or follow a
legitimate written treatment plan; and to adequately address M.W.'s
exhibited evidence of drug abuse. Tr. 264-66.
---------------------------------------------------------------------------

Patient C.F.
Dr. Kennedy identified the summary chart he prepared on Patent C.F.
Tr. 268; GX 12. C.F. was being treated for chronic pain due to trauma,
unspecified inflammatory polyarthropathy. C.F. had suffered stab wounds
to the chest requiring open heart surgery, which can cause long-term
neuropathic pain. Tr. 451-53. Dr. Kennedy opined the history,

[[Page 2996]]

physical exams, the pain and physical and psychological functioning,
the potential for substance abuse, written treatment plan, and
alternate treatment considerations were inadequate, and did not justify
the controlled substance prescriptions. Tr. 269-70, 285, 455; GX 11 at
106; GX 12 at 7. The Respondent did not discuss the risks and benefits
of controlled substance medications [and did not keep accurate records
of the care he provided.] Tr. 285-86. The physical exam notes revealed
essentially normal findings, however the electronic records for this
visit failed to include these findings. Tr. 271; GX 11 at 69. Instead,
under physical exam, the same language often duplicated in the records,
is included. Tr. 272. There were no credible follow up physical exams,
supporting studies, and no reasonable pain etiology. Tr. 272; GX 12 at
5, 6. The ROS indications were identically repeated in other charts.
Tr. 272-73. Dr. Kennedy noted that the language in the general exam,
``patient is alert and oriented'' is similarly repeated 102 times
throughout the records. Dr. Kennedy reported an inconsistent UDS for
C.F., collected on July 2, 2018, and many thereafter. Tr. 273-80, 282;
GX 11 at 9, 23, 24, 25, 28, 33, 44, 47, 54, 69, 78, 111, 117; GX 20.
C.F.'s UDS result was negative for all of the medications he was
prescribed. Tr. 275-77. C.F. also tested positive for cocaine and
marijuana. Tr. 277, 280. An inconsistent drug screen on July 26, 2017,
is not mentioned in the medical records. Tr. 288-89. Although the
records repeatedly noted that, ``patient counseled at length on
unsatisfactory UDS,'' this was insufficient under Tennessee standards
in addressing C.F.'s drug abuse and diversion [because it did not
document ``anything specific.''] Tr. 280, 284. On May 3, 2017, C.F.
tested positive for buprenorphine, a medication typically used for
opioid use disorder. Tr. 281-82. The Respondent had not prescribed it
[and failed to investigate or address the issue.] Tr. 282. Dr. Kennedy
opined that the Respondent continued to improperly prescribe controlled
substance without making a bona fide effort to cure C.F.'s addiction.
Tr. 284. The Respondent prescribed alprazolam for anxiety and insomnia.
Tr. 286; GX 11 at 39. However, the supporting indications are identical
to the other patients who were diagnosed with anxiety and insomnia. Tr.
286-87. The Respondent did not maintain complete and accurate records
for C.F. Tr. 286. Dr. Kennedy concluded that the controlled substance
prescriptions to C.F. were outside the usual course of professional
practice. Tr. 287.
Patient B.C.
Dr. Kennedy identified his summary chart for B.C. Tr. 289-90; GX
13; GX 14. B.C. was being treated for chronic pain syndrome. B.C. was
referred from the Clark County Jail, a potentially challenging patient.
Tr. 458-59. The Respondent did not take an adequate medical history.
Tr. 304. Although documentation of some physical exam was evident, it
was insufficient and non-supportive to justify prescribing the
medications prescribed.*\J\ Tr. 290-91, 304; GX 13 at 169; GX 14 at 7;
GX 22. He did not make an adequate assessment of pain, physical and
psychological function, history of substance abuse, coexisting diseases
and conditions, written treatment plan, or alternate treatments. Tr.
304-06. He did not conduct any periodic reviews, or discuss the risks
and benefits of the use of controlled substances. Tr. 306. There were
no radiologic studies ordered. Tr. 303. There were no prior medical
records ordered or obtained, yet the records did include hospital
records. Tr. 303, 459-60. Dr. Kennedy noted indications from the ROS
were duplicated throughout the records. Of 141 encounters, the ROS
language was duplicated 140 times, while the physical exam language was
duplicated 134 times. Tr. 291-92. He did not maintain accurate and
complete records. Tr. 306. B.C. had serious health issues, including
Hodgkins lymphoma, a cancer of the lymphatic system. Tr. 293. Dr.
Kennedy identified a document in the chart indicating B.C. had been
dismissed from a prior physician, a clear red flag [for which there was
no ``evidence in the medical record that [the] red flag was
investigated.''] Tr. 293-94; GX 13 at 188.
---------------------------------------------------------------------------

*\J\ Dr. Kennedy testified that the documented physical exam was
insufficient, because ``there are no positive objective physical
findings that rise to the level of requiring medications
prescribed.'' Tr. 291. He further testified, that based on B.C.'s
known medical problems, ``[it is] not impossible that this patient
had a chronic pain condition. But I would note that over the course
of 140 encounters the chart does not mention, . . . on a single
occasion where [we are] consistently talking about what specific
pain the patient is experiencing.'' Tr. 305. Accordingly, Dr.
Kennedy testified, the medical record did not support a recognized
medical indication for the use of the prescribed controlled
substances. Id.
---------------------------------------------------------------------------

Dr. Kennedy noted that B.C.'s pain level was left blank in the
medical record for nine consecutive encounters, suggesting [``that
[the] information is not actually being obtained and that the
documentation is simply being inserted in the chart.''] Tr. 294-95; GX
13 at 159; GX 14 at 8. One entry reveals, ``patient lied about his
prescriptions,'' an alarming red flag left unaddressed by the
Respondent. Tr. 296; GX 13 at 169. Despite noting that the ``patient
lied,'' the Respondent issued controlled medications and ``held'' up
UDS for a month. Tr. 297. Dr. Kennedy opined that this prescribing was
outside the usual course of professional practice. B.C. continued to
have inconsistent UDS results, which were insufficiently addressed by
the Respondent.*\K\ Tr. 297-98; GX 13 at 33, 79, 150, 155, 156, 158,
164, 165. The information contained in B.C.'s chart did not justify the
controlled medications prescribed by the Respondent, nor support that
they were issued in the usual course of professional practice. Tr. 307-
08.
---------------------------------------------------------------------------

*\K\ According to Dr. Kennedy, the medical records say ``the
patient is counseled at length, but again, [there is] nothing
specific about what the counseling entailed or any decision made
based on it.'' Tr. 301.
---------------------------------------------------------------------------

Patient M.H.
Dr. Kennedy identified his summary chart for Patient M.H. Tr. 309;
GX 15; GX 16. M.H. was being treated for chronic pain syndrome. GX 15
at 62, 63. The physical exam indications are identical to those
repeated throughout the medical records. Tr. 311. The indications do
not support any chronic pain diagnosis. Tr. 311. The records reveal
M.H. suffered a gunshot wound in 2008, and although serious, would not
in itself justify pain medication eight years later. Tr. 323. Dr.
Kennedy assessed the Respondent's treatment as outside the scope of
acceptable medical practice.*\L\ Tr. 312. He did not make an adequate
assessment of pain, and physical and psychological function, of medical
history, of history of substance abuse, coexisting diseases and
conditions, periodic review of care, written treatment plan or
alternate treatments. Tr. 326-28. He did not conduct any periodic
reviews, or discuss the risks and benefits of the use of controlled
substances. Tr. 328. M.H. had inconsistent UDS. Tr. 314-20; GX 15 at
36, 39, 40, 47, 49, 53, 56, 63. Although several inconsistent UDS were
noted in the chart, they were not typically mentioned. The Respondent
failed to adequately address the UDS. Tr. 314-20.
---------------------------------------------------------------------------

*\L\ My findings in this matter are based solely on Respondent's
prescribing of controlled substances, not Respondent's prescribing
of non-controlled substances or his overall treatment of patients.
---------------------------------------------------------------------------

During his treatment with the Respondent, M.H. underwent a serious
and complex spinal surgery, a major surgery. Tr. 320-22, 462-63. GX 15
at 26; GX 16 at 9. M.H. was seen by the Respondent the day after his
release

[[Page 2997]]

from the hospital. GX 15 at 48. Despite his recent, major surgery,
there is no mention of the surgery in the encounter notes.*\M\ Tr. 322-
23. The encounter notes are identical to all the other encounter notes
reviewed. Tr. 323; GX 15 at 48. There is no updated physical exam, as
would be required by the standard of care. Tr. 324. The PE and HPI
notes are the same as those the 4 months prior to the spinal surgery,
which is not credible. Tr. 324-25, 491-92; GX 15 at 49, 51. The
Respondent did not maintain accurate and complete records as to M.H.
Tr. 328. Dr. Kennedy reviewed the prescriptions issued. Tr. 325; GX 19
at 1-13. He opined that the chart, including the number of inconsistent
UDS, reveals that there was ``a significant probability'' that M.H. was
addicted to the habit of using controlled substances, yet the
Respondent continued prescribing them without making a bona fide effort
to cure the addiction. Tr. 325. The subject prescriptions were issued
outside the usual course of professional practice. Tr. 329-30, 493.
---------------------------------------------------------------------------

*\M\ Dr. Kennedy opined that the ``spinal surgery . . .
definitely supported being on scheduled medications. [But] [t]hat's
not even referenced in the medical record.'' Tr. 328. Accordingly,
Dr. Kennedy opined that Respondent failed to document a ``recognized
medical indication for the use of the controlled substances, which
were prescribed.'' Id.
---------------------------------------------------------------------------

Patient M.P.
Dr. Kennedy identified his summary chart for Patient M.P. Tr. 331;
GX 8. M.P. was being treated for low back, neck, hip and shoulder pain.
She was later diagnosed with degenerative disc disease and right
shoulder pain. Although a physical exam was performed, it was
inadequate to substantiate the diagnoses. Tr. 331-34, 339-40, 343; GX 7
at 2. A mechanical shoulder exam and range of motion back and neck exam
should have been performed. Tr. 335. He did not make an adequate
assessment of pain, nor physical and psychological function, of medical
history, of history of substance abuse, coexisting diseases and
conditions, periodic review of care, written treatment plan nor
alternate treatments. Tr. 349-51. He did not conduct any periodic
reviews, nor discuss the risks and benefits of the use of controlled
substances. Tr. 349-50. Her employment as a server, working forty to
sixty-five hours per week is inconsistent with her ``occupational
disability'' score of 9 or 10, which Dr. Kennedy described as a
significant conflict. Tr. 344-45; GX 7 at 3, 9, 10. Dr. Kennedy noted
the hand-written exam notes did not appear in the electronic medical
records, Tr. 325-36; GX 7 at 68, rather, the medical records reflected
the same PE notes duplicated throughout the medical records for all of
the patients at issue. Tr. 336, 351. The pain level is reported as 9,
which is inconsistent with the PE indications. Dr. Kennedy indicated
notes generated at the initial visit appeared to be a reminder to
obtain certain prior medical records from Dr. M. Tr. 337, 468; GX 7 at
1, 68. Those same notes appear in the record repeatedly thereafter. Tr.
337; GX 7 at 59. Other than the requested pharmacy report, the prior
records were never obtained. Tr. 338-39. The Respondent did not
maintain accurate and complete records as to M.P., [and the chart
contained language that was verbatim as other medical charts.] Tr. 350-
51.
At M.P.'s initial visit, a UDS was performed revealing inconsistent
results, which were never addressed in the records. Tr. 338; GX 7 at
19, 68. Notes reveal M.P. had been terminated from a prior physician,
which is a red flag. Tr. 343. The records did reveal a monitoring of
the Tennessee PDMP, and a successful pill count. Tr. 470. There were
emergency room notes, which revealed she was admitted on April 17,
2018, and released on April 18 for apparent heroin overdose, which
occurred in the Respondent's waiting room. Tr. 340-41; GX 7 at 25. [Dr.
Kennedy testified that, aside from the ER records, ``there is not a
note in the chart that specifically refers to this patient overdosing
or going unresponsive in the waiting room.'' Tr. 341.] At the next
encounter, the Respondent discontinued the previous prescriptions for
controlled substances, discussed drug rehab with M.P., which she
declined to pursue, and prescribed buprenorphine, an opioid abuse
treatment. Tr. 342. Dr. Kennedy viewed this course of action as
dangerous and outside the standard. Tr. 342, 371-73, 465-66. As the
patient was shown to be on heroin, a UDS would be necessary to
determine if she had heroin in her system before prescribing
buprenorphine, which in conjunction with heroin could result in
permanent withdrawal. Tr. 343. There were inconsistent UDS in the
records for M.P. Tr. 346; GX 7 at 48, 59.
Dr. Kennedy reviewed the prescriptions issued. Tr. 348-49; GX 21.
He opined that the chart, including the number of inconsistent UDS,
reveals that [Respondent should have been concerned that M.P. had a
habit of being] addicted to controlled substances, yet the Respondent
continued prescribing them without making a bona fide effort to cure
the addiction, until after she overdosed on heroin. Tr. 348. The
subject prescriptions, as well as those prescribed to the other charged
patients, were dangerous *\N\ and were issued without medical
justification and outside the usual course of professional practice.
Tr. 352, 488-89.
---------------------------------------------------------------------------

*\N\ Dr. Kennedy went on to testify that all of the controlled
substances prescribed to the individuals at issue (other than the
undercover) were ``dangerous.'' Tr. 352. He stated, ``[c]ontrolled
substances are dangerous. . . . [In the] context that we're talking
about, because of the abnormal drug screens that were essentially
ignored, and the documentation about the patient's status was not
done. In the face of sometimes very alarming patient red flags, I
would say that it was clearly dangerous.'' Id. Dr. Kennedy further
opines, ``none of the medical records are credible and . . .
maintaining a patient on scheduled medications . . . sometimes at
high dosages, without having honest, accurate, complete medical
records is dangerous.'' Tr. 352-53. This is because, according to
Dr. Kennedy, ``those medical records will instruct other people who
look at them as to what the motivation was for the treatment . . .
[a]nd if what is documented in the medical record simply doesn't
made sense or is something that is in conflict . . . [t]hat can . .
. present a dangerous situation.'' Tr. 353.
---------------------------------------------------------------------------

DEA Special Agent (SA1)

SA1 is a Special Agent with the Drug Enforcement Administration,
and has been for ten years. Tr. 498. He attended the Special Agent
Academy in 2009. Tr. 498. He has been involved in three or four
investigations surrounding prescriptions. Tr. 498. He served as case
agent for the current investigation. The first search warrant was
executed on February 27, 2018, at the clinic and at the Respondent's
residence in Clarksville, Tennessee, where paper records, patient
files, financial records and digital evidence from several computers
were seized. Tr. 500. The second warrant was served on the Respondent's
clinic in Millersville, Tennessee in September, 2018. Tr. 500. SA1
authenticated GX 5 as seized from the Respondent's clinic. Tr. 502-03.
SA1 noted that some medical documents provided by UC to the clinic were
not found during the searches. Tr. 503-04. SA1 authenticated GX 7 as
medical records of M.P. seized from the Respondent's clinic. Tr. 505.
SA1 authenticated GX 9, as the medical records of M.W. seized from the
Respondent's clinic. Tr. 506. SA1 authenticated GX 11 as medical
records of C.F. seized from the Respondent's clinic. Tr. 507. SA1
authenticated GX 13, as the medical records of B.C. seized from
Respondent's clinic. Tr. 508. SA1 authenticated GX 15, as the medical
records of M.H. seized from the Respondent's clinic. Tr. 509-10. These
complete records were supplied to the Government's medical expert, Dr.

[[Page 2998]]

Kennedy. Tr. 511-12. Additionally supplied to the expert were PDMP
reports, the missing records supplied to the clinic by UC and the video
of the undercover encounters. Tr. 512.

DEA Diversion Investigator (DI)

DI is a Diversion Investigator with the Drug Enforcement
Administration. Tr. 519-20. She has been with DEA for ten years. She
has been involved in 15-20 investigations involving physicians
prescribing controlled substances. As part of the current
investigation, she collected relevant prescriptions, and processed the
documents in support of the Order to Show Cause. Tr. 520. She
identified the Respondent's DEA Registration. GX 1. She authenticated
GX 18, which include the prescriptions the Respondent issued to UC,
which she obtained from various pharmacies. Tr. 521-22. She
authenticated GX 19, which are the prescriptions the Respondent issued
to M.H., which DI obtained from various pharmacies. Tr. 523-24. She
authenticated GX 20, which are the prescriptions the Respondent issued
to C.F., which DI obtained from various pharmacies. Tr. 524-25. She
authenticated GX 21, which are the prescriptions the Respondent issued
to M.P., which DI obtained from various pharmacies. Tr. 526. She
authenticated GX 22, which are the prescriptions the Respondent issued
to B.C., which DI obtained from various pharmacies. Tr. 527. She
authenticated GX 23, which are the prescriptions the Respondent issued
to M.W., which DI obtained from various pharmacies. Tr. 528. She
authenticated the Respondent's application for renewal of his DEA
Registration for the State of Tennessee, # 59889, which was submitted
on November 6, 2019. Tr. 529-30; GX 26.
She explained the significance of Question Three on the
application, a ``liability'' question. It queries whether the applicant
has ever surrendered for cause, or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or have any such action pending.
Tr. 530-31. An affirmative answer to Question Three would trigger an
investigation by a diversion investigator whether to issue the
registration or to deny it. The Respondent answered ``No'' to Question
Three. Tr. 531; GX 26.
She also authenticated GX 29, the State of Tennessee Department of
Health, Notice of Charges and Memorandum for Assessment of Civil
Penalties. Tr. 531-32. She also authenticated GX 27, an order from the
Chancery Court for the State of Tennessee, 20th Judicial District,
Davidson County, Part 3, reversing Denial of Stay, but Accompanying
Stay with Conditions. Tr. 532-33. DI noted that as of May 2019, the
Conditions preclude the Respondent from writing prescriptions or
providing direct patient care during the pendency of the stay. Tr. 533-
34. DI authenticated GX 28, An Agreed Order with the State of
Tennessee, in which the Respondent was required to surrender his Pain
Management Certificate, a professional license, in 2018, and prior to
his application for registration in 2019. Tr. 534-35; GX 26; GX 28. DI
authenticated GX 25, an Emergency Order of Restriction from the
Commonwealth of Kentucky board of License, issued on January 15, 2019,
which again predates his subject DEA application, and is a further
restriction on a professional license. Tr. 537-39.\28\ DI explained
that although GX 28 related to the surrender of the pain clinic license
and GX 26 was the Respondent's personal application, as the Respondent
applied for the pain clinic license himself, it constitutes a surrender
of his license, warranting an affirmative response to question 3 of his
DEA application. Tr. 542-43; GX 26. Additionally, the surrender is
signed by the Respondent individually. Tr. 545.
---------------------------------------------------------------------------

\28\ Although relevant testimony herein, the January 15, 2019
restriction as to the Respondent's Kentucky license does not
constitute a ground for the material falsification allegation. It
was neither charged in the OSC or the Government's Pre-hearing
Statements. Nor was it noticed by the Government at the time of its
offering as a proposed additional charge under the principle of
``litigation by consent.'' Where the Government has not provided
notice of a particular charge yet produces evidence on that charge,
and does not argue that the issue was litigated by consent, the
charge cannot form the basis for revocation. Cove Inc., d/b/a
Allwell Pharmacy, 80 FR 29,037, 29,039 (2015).
---------------------------------------------------------------------------

Respondent's Case-in-Chief

The Respondent presented his case-in-chief through the testimony of
one witness, the Respondent, Samson K. Orusa, M.D.

Samson K. Orusa, M.D.

Dr. Orusa was born in Bayelsa, Nigeria. Tr. 547. Dr. Orusa finished
his medical education at a fully accredited medical school in Benin
City, Nigeria and worked for a year in Nigeria. Tr. 548. He completed a
one-year rotational internship in internal medicine, pediatrics,
surgery and OBGYN at the University of Port-Harcourt Teaching Hospital.
Tr. 549-50. He then spent a year doing outpatient care at a rural
primary healthcare center. Thereafter, he entered private practice in
Lagos, Nigeria in 1989. In 1992, Dr. Orusa immigrated to the United
States to advance his medical training. He completed a three-year
residency program in internal medicine at Columbia University, College
of Physicians and Surgeons in 1996. Tr. 551. He obtained his Tennessee
medical license, and with his certification in internal medicine, he
was hired at a clinic in Clarksville, Tennessee. Tr. 552, 555. He was
admitted to practice at Memorial Hospital. In 1997, he opened his own
clinic in Clarksville, where he had a general medical practice. In
2004, he began concentrating on pain management. Tr. 553. In 2017, he
was board certified by the American Board of Interventional Pain
Physicians as a specialist in interventional pain medicine. Tr. 553,
555. His extensive training involved the use of deep injections, spinal
nerve blocks, nerve injections, foraminal blocks, and epidural
injections. Tr. 553-54. By 2018, he held sufficient certification to
operate his own pain clinic in Tennessee. Tr. 555.
From 1998 to 2017, the clinic transitioned from primary care to
pain management, but even by 2017, he still had primary care patients.
Tr. 557-58. Initial visits required appointment, which were scheduled
for the first thing in the morning. Returning pain patients were
permitted to walk in without appointments. Tr. 558. He has had a staff
of ten, including a nurse practitioner and physician's assistant. Tr.
559. By 2017, his pain management practice included deep tissue
injections, cervical, lumbar and thoracic nerve blocks, sacroiliac
joint injections, and bursitis injections. Tr. 60. In 2018, the
frequency of injections increased as the Respondent began performing
injections under fluoroscopy. Tr. 560.
The Respondent had a protocol for new pain patients. Tr. 561. Some
of these protocols were in writing, but not produced at the hearing.
Tr. 620. They were required to bring a referral letter or letter of
dismissal from their previous physician, any imaging reports, records
from their last three medical visits and their pain medication. Tr.
561-62, 572. If the patient did not produce the materials, the clinic
staff would attempt to obtain them. Tr. 564-66. The initial visit
typically takes all day, as the patient must fill out extensive
documentation (twenty pages with 252 questions), which is necessary for
diagnosis and selection of treatment. Tr. 566-67. Seventy-five
questions relate strictly to pain. It includes pain disability index,
depression assessment, drug-use history and social history. There is a
pain management agreement. Tr. 571-72. The staff explains the side
effects, the addiction process and the

[[Page 2999]]

resources to help with addiction. Tr. 572.
The charts often contained the exact same language for indications
of anxiety and insomnia. Tr. 633-34. The Respondent explained that the
language was often identical as anxiety patients typically share the
same symptoms. Tr. 634-36.

Undercover

The Respondent took a medical history, a condition-specific
physical exam for low back pain, reviewed the MRI (GX 6) of UC. Tr.
575-80. The Respondent noted that his physical exam of UC was not
captured by the video of the encounter. The camera was pointed at the
wall. Tr. 581-82. The Respondent spent no more than fifteen minutes
with UC in the examination room. Tr. 621. The Respondent performed the
required assessments related to pain, physical and psychological
function, and history and potential for drug abuse. Tr. 582. This
involved the paperwork UC filled out, authenticating that paperwork,
the triage of UC by staff, UDS, and a final review of the paperwork by
the Respondent with the patient. Tr. 583, 584. Although UC's chart
contains an entry that his pharmacy printout was reviewed, the
Respondent conceded that no pharmacy printout was reviewed and that
such entry was in error. Tr. 631-32; GX 5 at 6. UC was a challenge as
the clinic he reported had been closed, and he could not obtain the
pharmacy information, so the Respondent could not verify that source.
Tr. 583-85.
The Respondent expected his patients to be honest and truthful with
him, consistent with the DEA Physician's Manual, which requires
patients to be honest with their doctors. Tr. 586-87. The Respondent
explained that a patient's pain is very subjective. After reviewing his
paperwork, including the MRI, examining UC, and speaking with him, the
Respondent had no reason not to treat him as someone who had genuine
pain. Tr. 588. UC's statement that he had used controlled substances
for his pain and that ibuprofen was not working supported the
conclusion that his pain was long-standing, and warranted a Schedule II
medication. As UC's prior medical records could not be confirmed, the
Respondent prescribed a dosage appropriate to a patient just starting
opioid treatment. Tr. 589-90. The Respondent testified that he prepared
a written treatment plan with appropriate treatment goals and therapy.
Tr. 590-91.
The Respondent explained that his electronic medical record often
referred to other records. For example under history of present illness
(HPI), he would often reference the initial encounter paperwork as
included in the electronic record. Tr. 592. He also explained that he
performed a physical exam at the initial visit of each of his patients,
as required by the Tennessee pain management guidelines. Tr. 594.
Physical exams thereafter are at the discretion of the physician. Tr.
594. Although UC had five visits to the clinic, only two involved
encounters with the Respondent. The other three visits were ``level
one'' visits, in which UC met with the Respondent's staff only. Tr.
622-28, 645-50. Although the medical records reflect a physical
examination took place at the level one visits, the Respondent
explained that it was permissible in medical record-keeping to carry
forward results from prior examinations to later visit records, with
new findings added. Tr. 623-28.
Patient M.W.
M.W. was first seen in January 2013. Tr. 595. M.W. was a gunshot
victim to whom the Respondent prescribed alprazolam. This was based on
the history and physical exam. Tr. 593. Tr. 635-36; GX 9 at 69. The
Respondent obtained a medical history, conducted a physical exam,
performed an adequate pain, physical, and psychological assessment,
history and potential for substance abuse. Tr. 596. The evaluation of
the patient's potential for drug abuse is an ongoing evaluation with
UDS, involving both office screens, confirmatory lab screens, and pill
counts. Tr. 596-98, 600. Once an inconsistent UDS is discovered, the
Respondent initiates a dismissal process. Tr. 598-600. The Tennessee
pain management guidelines leave it to the physician's discretion on
the handling of confirmed inconsistent UDS results. Tr. 598-99. The
Respondent gives the patient a month to come into compliance. Tr. 600.
If he has a consistent UDS within the month, the patient is permitted
to remain in treatment. Tr. 601. The Respondent was able to bring M.W.
back into compliance through counseling; however, the chart only
documents that the patient was counseled as to the inconsistent UDS.
Tr. 637-38. The Respondent prepared a written treatment plan. Tr. 601.
Patient C.F.
Patient C.F. had a stab wound to the chest, requiring heart
surgery, resulting in residual chronic pain. Tr. 601. The Respondent
took a medical history, performed a physical exam, adequate pain,
physical and psychological assessments, and evaluated her history and
potential for substance abuse. Tr. 601-02. The Respondent noted that he
had the benefit of confirmatory records from Vanderbilt University
Medical Center. Tr. 602. The Respondent explained that the MED
prescribed to C.F. was a relatively low dose of 82.5, noting the 120
MED threshold in which primary care physicians in Tennessee must
consult with pain management specialists. Tr. 603-05.
Patient B.C.
Patient B.C. was referred from jail on December 19, 2012. The
Respondent noted the pain management guidelines have changed since
then. Tr. 605. The Respondent explained why he kept pharmacy printouts
in his records because they are easier and quicker to obtain than
medical records. Tr. 606. The pharmacy printout informs how long the
patient has been prescribed medications, changes in dosage, and the
prescriber. Tr. 607. Each of the Respondent's patient records contained
the instruction, ``rule out doctor shopping,'' which was a prompt to
review the Tennessee PDMP to determine if the patient was obtaining
controlled substances from multiple physicians. Tr. 608.
The Respondent took a medical history, performed a physical exam,
adequate pain, physical and psychological assessments, and evaluated
his history and potential for substance abuse, and prepared a written
treatment plan. Tr. 608. Although the Respondent described the
extensive forms each patient is required to fill out at the initial
visit, some of the described forms, which were referenced in B.C.'s
chart, were missing from the Respondent's records as relates to B.C.
Tr. 628-29; GX 13 at 5. The Respondent explained that some records were
lost in 2014. Tr. 630. The missing records were not recreated as B.C.
was a long-term patient. Tr. 630.
Patient M.H.
Patient M.H. presented with a post gunshot wound to the abdomen and
chronic low back pain secondary to degenerative disc disease. Tr. 608.
He had already been treated for pain management. He had a history of
extensive spinal surgery at Vanderbilt University Medical Center,
including a laminectomy. Tr. 609-11. The Respondent prescribed a lower
MME than the surgeon prescribed post-operative at Vanderbilt. Tr. 611.
The Respondent's medical findings as to Patient M.H. for the visit just
prior to M.H.'s major back surgery are the same as the Respondent's
findings for the visit the day after the surgery. Tr. 637-38; GX 15 at
48-50. The Respondent

[[Page 3000]]

explained that the subject findings were based on history. Tr. 638.
The chart reports M.H. has been ``compliant,'' however, on the next
page of the chart, it reports M.H. had an inconsistent UDS. Tr. 638-40;
GX 15 at 48-49. The Respondent explained that the inconsistent UDS
related to the point of care test, not the confirmatory lab test, so
the chart was accurate. Tr. 640. M.H.'s chart contains apparently
inconsistent findings of long-term insomnia, but with an entry of
sleeping well. Tr. 640-41; GX 15 at 47-48. The Respondent conceded
these were inconsistent entries. Tr. 641.
Patient M.P.
Patient M.P. was being managed for chronic pain. In her initial
visit, she reported conflicting information regarding whether she had
been in drug rehab treatment. Tr. 641-42; GX 7. The Respondent
explained that he could only rely on the information provided. Tr. 642.
Initially, in September of 2016, the Respondent requested dismissal
records, an X-ray and an MRI from Dr. M. Tr. 642-44; GX 7 at 48. Yet,
eighteen months later, the Respondent still had not received the
requested records. Tr. 644; GX 7 at 59.
Ultimately, she came to the clinic overdosing on heroin. Tr. 611-
12. She had to be resuscitated until EMS was able to reverse the
effects of heroin with Narcan. Tr. 612. In the post-overdose notes the
Respondent took an extensive history again regarding her drug use. He
directed she cannot be on pain management but must be on opioid abuse
treatment. So, the Respondent started her on Suboxone. Tr. 613. The
Respondent explained his understanding of Suboxone induction. The first
type of induction therapy is by observation. You give the patient
Suboxone and observe them until they reach the point of withdrawal. The
other form of induction is to give the patient Suboxone and send her
home without observation by the physician. Tr. 612-14. M.P. was
initially receptive to drug treatment, but later changed clinics. Tr.
615.
The Respondent took a medical history, performed a physical exam,
adequate pain, physical and psychological assessments, and evaluated
her history and potential for substance abuse, and prepared a written
treatment plan. Tr. 615-17. Following the heroin overdose, the
determination was made that she needed treatment of Suboxone and no
further opioid prescriptions. Tr. 616.

The Facts

Stipulations of Fact

The Government and the Respondent have agreed to 1, 2 in part, 3,
4, 5, 6, 7 stipulations, which I recommend be accepted as fact in these
proceedings:
1. The Respondent is registered with the DEA as a Practitioner
authorized to handle controlled substances in Scheduled II-V under DEA
COR No. BO4959889 at 261 Stonecrossing Drive, Clarksville, Tennessee
37042. DEA COR. No. B04959889 expires by its terms in December 31,
2019.*\O\
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*\O\ According to Agency records, this application is pending
renewal and has not expired.
---------------------------------------------------------------------------

2. On July 6, 2018, the Respondent submitted an application (No.
W18070589C) for a new DEA COR at 316 Pappy Drive, Oak Grove, Kentucky
42262. On January 15, 2019, the Commonwealth of Kentucky, Board of
Medical Licensure, issued an Emergency Order of Restriction prohibiting
Respondent from ``prescribing, dispensing, or otherwise professionally
utilizing controlled substances.'' See 201 KY. ADMIN. REGS 9:240
Section 1 and 3. Thus the Respondent is currently without authority to
handle controlled substances in the Commonwealth of Kentucky.
3. Soma is a brand name of carisoprodol, a Schedule IV controlled
substance.
4. Percocet is a brand name for oxycodone, a Schedule II controlled
substance.
5. Oxycodone is a Schedule II controlled substance.
6. Oxymorphone is a Schedule II controlled substance.
7. Alprazolam is a Schedule IV controlled substance.

Findings of Fact

The factual findings below are based on a preponderance of the
evidence, including the detailed, credible, and competent testimony of
the aforementioned witnesses, the exhibits entered into evidence, and
the record before me.
The Government's case was largely based on (1) several undercover
visits to Respondent's medical office by UC; (2) the medical charts and
prescriptions pertaining to UC as well as to five other patients, M.H.,
M.W., C.F., B.C. and M.P.; and (3) the testimony of Gene Kennedy, M.D.,
the Government's expert.
The Undercover Operation
1. UC is currently an Assistant Special Agent in Charge with the
Tennessee Bureau of Investigation. Tr. 30. [Omitted to preserve
identity of UC.]
2. UC testified that he was contacted by a Special Agent with the
United States Department of Health and Human Services, Office of the
Inspector General, to conduct an undercover operation at Respondent's
clinic. Tr. 33-34. In preparation for this operation, UC contacted
Respondent's clinic to set up an appointment. Tr. 34. He was told to
bring several items to the appointment, including an MRI report, prior
``chart notes'' from his previous physician, a discharge summary from
his previous physician, and documentation showing his last three months
of prescriptions. Tr. 35.
October 3, 2017 Visit
3. UC testified he arrived at Respondent's office on October 3,
2017, at approximately 8:00 a.m. Tr. 40. He testified that he paid $311
for this appointment. Tr. 49. He recorded portions of the visit on a
``covert video camera device embedded'' in a cell phone case. Tr. 42-
43. Upon arrival, he provided an MRI report from September 2, 2016,
that he testified was ``authentic in the sense that it was my physical
MRI.'' However, the physician's name on the report had been altered.
Tr. 35, 37; GX 6 at 8-9. UC also provided ``fabricated'' medical
records which appeared to be signed by a nurse practitioner in
Missouri. This nurse practitioner, according to UC, was no longer
practicing in October 2017. Tr. 37-8; GX 6 at 10-11. UC did not provide
a discharge summary or any prescription information. Tr. 39-40; 133.
Nor did he provide any documents to show he had undergone a prior
physical examination. Tr. 133.
4. After providing the materials, UC was given what he estimated to
be approximately twenty pages of paperwork to fill out, none of which
was included in his medical file seized later by DEA. Tr. 40; GX 5.
However, UC took photographs of the forms before turning them in. Tr.
100. When asked to state his pain level, UC testified he told the
clinic staff that it was ``9'' out of ``10'' (``9/10''), but when he
was examined, he exhibited no overt indications of pain. Tr. 47, 56.
95. In fact, on one of the forms, he listed his quality of life as nine
out of ten. Tr. 131-32. On another form, he rated his pain disability
as only two out of ten. Tr. 132. On one form, he also denied he
suffered from insomnia, Tr. 132-33, but wrote on another form that he
sought to work without pain and sleep through the night. Tr. 135. No
one questioned him about these contradictions. Tr. 139. UC acknowledged
that he filled out

[[Page 3001]]

forms at his first appointment on October 3, 2017, and took photographs
of the forms. Tr. 100. The completed documents, however, were not part
of the Respondent's medical file seized by DEA and were not offered as
exhibits by either party. Tr. 100; GX 5.
5. UC testified that one of the Respondent's employees apparently
questioned the authenticity of the records he provided, stating that
people are trying to ``bring down Dr. Orusa.'' Tr. 41-42. This employee
was not named, but was identified as the person depicted in GX 30. UC
testified that, after providing the paperwork, his vital signs were
recorded, including his blood pressure. He was also asked about his
weight and asked to give a urine sample. Tr. 44-45.
6. UC described the October 3, 2017 visit as follows. He testified
that he made no attempt to demonstrate that he had a disability. He did
not limp or change his gait. Tr. 45-46. Though UC arrived at the clinic
at approximately 8:00 a.m., he did not meet with Respondent until
approximately 4:00 p.m. Tr. 47-48. During UC's encounter with
Respondent, UC informed Respondent that the last ``pain clinic'' he
visited was ``Dr. Chapman in Pierce, City, Missouri, and had recently
``closed down.'' GX 4 at 1. He also told Respondent that the person who
ordered his MRI was ``Dr. Morgan,'' a fictitious person. Tr. 37; GX 4
at 2. There was also a discussion about UC providing ``pharmacy
information.'' GX 4 at 3. UC told Respondent he would ``get those
records if I need to'' but did not know the pharmacy's phone number.
7. UC testified that he did not produce any additional records. Tr.
55. UC testified that, during his meeting with Respondent, he saw
Respondent ``going through some forms on the counter,'' but could not
determine what Respondent was reviewing. Tr. 105. UC testified that he
told Respondent he fell while unloading a truck in 2013. Tr. 117; GX at
1. He told Respondent that he was managing his pain with over-the-
counter medications. Tr. 104. Though he told Respondent that he could
``barely function,'' he did not ``elaborate'' and there was no further
discussion about this statement. Tr. 124; GX at 2; GX 17. UC testified
that, in response to Respondent's question about a previous diagnosis,
he told Respondent that a previous medical provider told him he had
degeneration of some sort and ``some arthritis.'' Tr. 105-06; GX at 1.
8. UC testified that Respondent performed a cursory physical exam
described as ``less than 60 seconds of any kind of physical touching.''
Tr. 56. He testified that Respondent instructed him to remain seated
and UC ``just told [Respondent] where the pain was. If he did something
and asked me if it hurt I would respond that I felt pain in that
area.'' Tr. 56. He testified that he made no ``faces'' and did not
``wince'' when touched. Following the exam, Respondent inquired about
UC's past pharmacy records. UC told Respondent. ``I'll get those
records if I need to.'' Tr. 108-09; GX at 3. UC testified that
Respondent wanted to do ``injections,'' but UC refused. Tr. 117.
According to the transcript of the meeting, UC told Respondent that he
hated needles. GX at 3.
9. Approximately 30 minutes after he left the exam room, UC
received a prescription for 42 tablets of 10 mg oxycodone, even though
he never asked for oxycodone. GX 18 at 1; Tr. 57. During the encounter
with Respondent, UC said that he had previously been given hydrocodone,
Xanax (alprazolam) and ``oxys.'' GX 4 at 2. He also told Respondent
that he was currently managing his pain with ``Advil this past month''
and had been ``miserable.'' Id. UC testified that he also received two
other prescriptions for non-controlled substances, including Flexeril
(cyclobenzaprine) and meloxicam. Tr. 58.
10. When asked why, he told Respondent he had lower back pain as
opposed to pain in some other area, UC testified that, due to his
exercise schedule, which including running five to seven miles each
day, a practitioner might find objective evidence to justify complaints
of knee, ankle, or shoulder pain. Here, he testified, he had
``absolutely no back pain whatsoever.'' Tr. 114-15. He testified that,
if Respondent's clinic had been ``doing their job,'' he would ``not
expect to walk out with a prescription.'' Tr. 105. Also, in his
experience as an undercover operative, he testified that ``more often
than not'' he has been refused prescriptions for controlled substances
on the first visit. Tr. 123-24.
11. A video recording of UC's meeting with Respondent was played
during the hearing. GX 17. UC testified that the video portion was a
fair and accurate recording of his ``entire encounter with'' Respondent
on October 3, 2017. Tr. 55. UC also testified that the transcript of
that encounter (GX 4) was an accurate representation of the recording.
Both the recording and the transcript were accepted into the official
record. GX 4, 17; Tr. 70-71, 187-88.
October 17, 2017 Visit
12. UC testified that, in order to receive more ``narcotic
prescriptions,'' he was required to come in for a ``well-care'' visit
before making an appointment during which he would receive narcotics.
Tr. 57-58. On October 17, 2017, he returned to the clinic and paid $25
for the visit. Tr. 57-59; GX 4, GX 17. He was then called back to a
``triage room'' and asked about his weight and blood pressure. Tr.
59.*\P\ He saw the Respondent for ``about one minute,'' during which
Respondent asked him if he slept well. When he responded, ``not
really,'' Respondent wrote him a prescription for amitriptyline. Tr.
59; GX at 4. This encounter was also recorded. GX 17. UC testified
that, during this visit, no physical exam was performed. Tr. 71-72. He
testified that no one examined his lower back, extremities, or checked
his muscles. Tr. 72.
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*\P\ This section of the Recommended Decision included several
superscript numbers in the body of the text without any
corresponding text in footnotes. As I believe that the superscript
text was likely the result of a scrivener's error, I have deleted
them throughout this section without further demarcation.
---------------------------------------------------------------------------

October 18, 2017 Visit
13. UC testified that, on October 18, 2017, he returned to the
clinic for refills of narcotic medications. Tr. 74. Because the clinic
would no longer accept cash, he secured a debit card to pay for the
appointment, which cost $377. Tr. 75-76. During the October 18, 2017
appointment, UC waited approximately two and a half hours. He was not
examined and he met with medical personnel only for the purpose of
paying the fee and receiving his prescription. There was no discussion
about his medical condition and he provided no medical records. Tr. 76-
77. At the end of this visit, he received a prescription for 84 tablets
of 10 mg oxycodone, twice as much as he received 15 days earlier. Tr.
78; GX 18 at 3-4.
November 15, 2017 Visit
14. UC testified that, on November 15, 2017, he returned to the
clinic for a fourth time. On this visit, he testified that he paid $25,
``waited for some amount of time,'' was ``asked'' about his weight and
blood pressure, and was dismissed. Tr. 83-84.
November 20, 2017
15. UC testified that, on November 20, 2017, he returned to the
clinic for a fifth time. He described this as a ``medication visit.''
Tr. 87. UC testified that, during this visit, he wrote down his name on

[[Page 3002]]

a clipboard, ``paid a certain amount of money,'' and waited a ``certain
amount of time'' before he was given his prescriptions. Tr. 87-8. UC
testified that he was asked to provide a urine sample to which he added
``a vial of a substance that would cause me to test positive for
oxycodone.'' Tr. 88. At this visit, he received another prescription
for 84 tablets of 10 mg oxycodone. GX 18 at 4; Tr. 89.
Falsified Medical Records
16. UC identified numerous entries in his medical record that
indicated his medical chart had been fabricated. For instance, on
October 17, 2017, Respondent wrote that UC exhibited a number of
``[a]nxiety symptoms'' such as shortness of breath, ``palpitations,
sweating, dizziness, [and] shaking.'' GX 5 at 5. UC testified that he
never reported any of these symptoms. Tr. 79-80. Respondent also wrote
that UC reported ``no headache, no dizziness, no nausea, no vomiting,
no abdominal pain, no diarrhea, no constipation, no [shortness of
breath], no chest pain, [and] no palpitations.'' GX 5 at 5. UC
testified that he was never asked about any of these symptoms. Tr. 80-
81. UC was also asked about a notation for October 17, 2017, where his
weight and blood pressure were recorded. GX 5 at 5. He testified that
he was neither weighed, nor did anyone measure his blood pressure on
that day. Also, on October 17, 2017, Respondent wrote ``Chest: no
deformities, no asymmetry, no rales, no wheezes, normal vesicular
breath sounds.'' GX 5 at 5. UC testified that no one ever examined his
chest or evaluated his breathing. Tr. 81-82.
17. Regarding the medical records for October 18, 2017,
Respondent's entries for this appointment were identical to those made
the day before. Again, he wrote ``ROS for MSS is positive for muscle
pain, back pain, joint pain, and body aches and pain.'' GX 5 at 4.
Respondent again repeated the same notations about UC's chest and
breathing. However, all of this was created on a day when UC did not
see the Respondent. Nor was UC examined by anyone else at the clinic
that day. Tr. 82-83.
18. With respect to the November 15, 2017 visit, Respondent
repeated the same notations even though, as UC testified, no exams were
performed and Respondent was not there to see him. Nevertheless,
Respondent wrote out a list of symptoms in the section marked ``HPI,''
GX 5 at 4, which correspond to the visit on November 15, 2017. Again,
UC testified that none of these symptoms were ever discussed and no
examination was performed. Tr. 86. Likewise, with respect to
Respondent's notes in the section marked ``PE'' (physical exam),'' UC
testified that no one examined his chest or breathing. Tr. 86-87.
19. Finally, regarding the November 20, 2017 visit, Respondent
wrote, as he had four times previously, that UC was ``positive for
muscle pain, back pain, joint pain and body aches.'' GX 5 at 3. UC
testified that no physical exam was performed on this day. Tr. 90-91.
Respondent also, for the fifth time, described a physical examination
(section ``PE'') that was never performed. GX 5 at 3; Tr. 91.
20. UC also testified about the results of his urine drug
screening. He noted that, despite adding an oxycodone solution to his
urine on November 20, 2017, his records showed ``UDS ALL NEG.'' Tr. 91-
92; GX 5 at 3. UC also testified that there was no discussion about
this result. Tr. 92.
Expert Review
21. Dr. Kennedy testified as the Government's expert. Dr. Kennedy
owns a pain management clinic on St. Simons Island, Georgia; has
treated more than 1000 patients, but his current practice involves
fewer than 100 patients. Tr. 143-46. He testified that he has treated
patients with post-surgical issues, patients with cancer pain, and
patients with back pain. Tr. 178-80. Most of his patients, he
testified, need to have their medications ``managed.'' Tr. 143-44. Dr.
Kennedy testified that he has been practicing pain management for
approximately 15 years. Tr. 145, 179-80. He is licensed to practice
medicine in Georgia and runs a ``state licensed pain management
clinic.'' Tr. 146; GX 24. Dr. Kennedy is not board certified. Tr. 373.
22. Dr. Kennedy testified that, in his practice, he prescribes
controlled substances, including opioids such as oxycodone and
hydrocodone. Tr. 181. He has treated insomnia and/or anxiety with
benzodiazepines, such as lorazepam, diazepam, and alprazolam. Tr. 181-
82. He has also prescribed muscle relaxants such as carisoprodol. Tr.
181-82.
23. Dr. Kennedy has also lectured on controlled substances
``numerous times'' at the DEA training facility in Quantico. He has
taught at the National Advocacy Center, and at various DEA and
Department of Justice (``DOJ'') ``venues'' around the country. Tr. 184-
85. He also taught a course for pharmacists in Tennessee. Tr. 185.
24. Dr. Kennedy testified he has served as an expert witness in
numerous cases, including those involving physicians alleged to have
improperly prescribed controlled substances. Tr. 182. He estimates he
has testified 13-14 times. Id.
25. As the Government's expert, Dr. Kennedy reviewed the medical
charts for patients UC (GX 5), M.P. (GX 7), M.W. (GX 9), C.F. (GX 11),
B.C. (GX 13), and M.W. (GX 15). He also reviewed the prescriptions for
these patients (GX 18-23), the undercover video created by UC, the
transcripts (GX 17 and 4) of that video, and UC's reports of his
undercover visits (GX 3). Tr. 183-84, 186-89; 213-16.
26. Dr. Kennedy explained that, according to the minimal standard
of care for prescribing controlled substances in Tennessee, a physician
must: (1) Take an adequate medical history; (2) perform a physical
examination; (3) obtain past medical records; (4) order diagnostic
testing if indicated; [and (5) maintain complete and accurate medical
records.] Tr. 189-90, 195-96, 353.
27. Dr. Kennedy testified that, according to the minimal standard
of care, a physician's medical records should contain the following;
(1) past medical records or attempts to obtain past medical records;
(2) a ``pain history'' or ``collection of statements pertaining
directly'' to the patient's pain history; (3) history of ``drug abuse,
chemical dependency, [or] alcoholism;'' (4) records of a physical
examination ``that is specific and pertinent to the problem;'' (5)
patient assessment; (6) treatment plan; and (7) efforts to obtain state
pharmacy reports. Tr. 197. He also testified he was familiar with
Tennessee regulations requiring a physician to keep accurate and
complete medical records. Tr. 201.
28. Dr. Kennedy testified that, in cases where physicians prescribe
opioids in combination with benzodiazepines, a physician must have a
``heightened sense of vigilance managing the patient'' and this should
be noted in the medical record. Tr. 190-91.
29. Dr. Kennedy testified that there are indications of possible
drug abuse and/or diversion in patients whose medical histories are
``difficult to obtain'' as well as patients with ``cloudy histories of
drug abuse.'' Tr. 191-92. He discussed urine drug screening (``UDS'')
and how a physician must respond if a patient's UDS result shows an
``abnormality, it's not simply enough to just to say a patient's urine
is positive for cocaine or positive for methamphetamine. The physician
also has an obligation to say that the patient is positive for this
substance, and I discussed it with the patient, and I'm going to do
this if it happens again or I'm going to adjust the medications or

[[Page 3003]]

not adjust the medications. And it has to be something that is utilized
as a diagnostic treatment.'' Tr. 194. Dr. Kennedy further testified
that the above information should be documented in the medical record.
Id.
30. Dr. Kennedy testified that, prior to testifying in this matter,
he reviewed Tennessee regulations pertaining to the prescribing of
controlled substances. He confirmed that these regulations included
requirements that a physician must (1) take the patient's documented
medical history; (2) perform a physical examination; (3) perform an
adequate assessment and consideration of the patient's pain, physical,
and psychological function: And (4) take a history for the potential of
substance abuse.*\Q\ Tr. 200. Dr. Kennedy also testified that he was
familiar with rules prohibiting a physician from prescribing controlled
substances to a person addicted to the habit of using controlled
substances without making a bona fide effort to the cure the patient's
habit. Tr. 199.
---------------------------------------------------------------------------

*\Q\ I find that Dr. Kennedy credibly testified that the
applicable standard of care in Tennessee is as described in Finding
of Fact Nos. 26-27 supra. The requirements of the Tennessee
regulations are clearly components of and incorporated into the
standard of care set forth by Dr. Kennedy at Finding of Fact Nos.
26-27. TENN. COMP. R. & REGS. 0880-02-.14(6)(e)(3)(i). Further, Dr.
Kennedy's expert testimony is unrebutted in this proceeding.
---------------------------------------------------------------------------

31. Based on his qualifications and expertise, his knowledge of
Tennessee regulations and statutes, and his experience as an operator
of a pain management clinic, Dr. Kennedy was accepted as an expert in
pain management qualified to give an expert opinion regarding
Respondent's prescribing of controlled substances. Tr. 211-12; 216.
Undercover
32. With respect to the undercover officer, Dr. Kennedy testified
he reviewed the video recording UC made during his visits to
Respondent's clinic on October 3 and October 17 of 2017 (GX 17); UC's
investigative reports for all five of his visits to Respondent's
clinic; the patient medical file pertaining to patient UC; and the
prescriptions issued to UC by the Respondent. GX 3, 5, 17-18; Tr. 184-
86, 216, 239.
33. Dr. Kennedy testified that, based on his review, UC was being
treated for back pain. He testified that the physical exam was
inadequate, describing it as ``cursory in that it consisted of
essentially observing'' UC, ``touching his back, and having him lift
his leg once.'' Tr. 217. Dr. Kennedy testified that a minimally
adequate exam would include ``observing the patient's back, looking for
muscle spasms, performing ``lumbar range of motion maneuvers where the
patient . . . bends at the waist in various directions,'' doing a
neurologic exam, and doing a ``straight leg raised test having the
patient laying supine on the table.'' Tr. 224-25. Dr. Kennedy concluded
that, based on the medical records, there were no ``positive findings
on physical examination.'' Tr. 226. In other words, he testified,
Respondent's ``physical exam findings'' failed to support a ``pain
ideology'' and certainly could not justify a reported pain level of 9/
10. Tr. 226-27, 234. With respect to the Respondent's diagnosis (GX 5
at 2) of ``[d]egeneration of [l]umbar [i]ntervertebral [d]isc . . .
[l[umbar [s]pondylosis . . ., and [i]nsomnia,'' Dr. Kennedy noted that
even the MRI failed to mention degenerative disc disease and Dr.
Kennedy could identify no other findings to justify that diagnosis. Tr.
240-42. And though spondylosis could be severe enough to ``be causing
symptoms,'' Dr. Kennedy testified that there was no evidence that these
symptoms existed. Tr. 242. Dr. Kennedy also testified that neither UC's
MRI report, nor the prior medical records, justified the prescribing of
controlled substances. Tr. 228, 230.
34. Looking at Respondent's medical record for patient UC, Dr.
Kennedy further concluded that the record was rife with fabrications as
the following testimony indicates: ``. . . if you look it says on the
second line, chest, no deformities, no asymmetry. The only way to
determine [this] is to look at them with their shirt off. And this
patient was not required to disrobe . . . there is also no indication .
. . that the heart and lungs were evaluated. But there are heart and
lung evaluations as well as the chest appearance . . . . you couldn't
see everything, but clearly listening to the audio, I didn't hear any
breathe in, breathe out, anything that would indicate to me that there
was a physical exam that included these things.'' Tr. 218-19. Dr.
Kennedy further noted that the description of UC's general exam in the
section marked ``PE'' (GX 5 at 6) was not only inaccurate, but was
identical to language he found in more than 20 medical charts he
reviewed for other patients. Likewise, Dr. Kennedy disputed the truth
of the information supposedly used to support a finding that UC
suffered from insomnia. Tr. 233. This was further confirmed by UC's
testimony, in which he testified that he neither reported nor
manifested any of the listed ``insomnia'' symptoms. Tr. 79-80, 134-35,
139. Dr. Kennedy also testified that the physical exam depicted in the
video (GX 17) as well as UC's subsequent encounters could not possibly
support the repeated findings corresponding to visits on October 17 and
18, as well as the visits on November 15 and 20. GX 5 at 3-5; Tr. 235-
37.
35. Dr. Kennedy testified that UC, as an undercover patient, also
manifested various ``red flags'' for possible drug abuse and/or
diversion. Tr. 230. He noted that UC's prior medical records showed
only a ``single office visit'' (GX 6 at 10) from a provider in another
state and documentation from the encounter showed a ``completely normal
physical exam with no positive findings at all.'' Tr. 220-31. Dr.
Kennedy testified that a patient who comes from a clinic that has
closed and provides medical records from a practitioner whose license
has been suspended are red flags for diversion. He further noted that
none of these red flags was ``significantly'' addressed by Respondent
prior to prescribing oxycodone. Tr. 238.
36. In summary, Dr. Kennedy testified that, with respect to UC,
Respondent: (1) Failed to discuss the risks and benefits of the use of
oxycodone; (2) failed to maintain truthful and accurate medical
records; (3) failed to assess the patient's pain, physical and
psychological function; (4) failed to assess the patient's history and
potential for substance abuse; (5) failed to assess any co-existing
diseases, conditions in the presence of a recognized medical indication
for the use of oxycodone; and (6) failed to create and follow a
legitimate written treatment plan for the patient's individual needs.
Tr. 231-32, 237-38. Dr. Kennedy further concluded that Respondent's
prescribing of controlled substances to UC was outside the usual course
of professional practice. Tr. 239. Additionally, Dr. Kennedy concluded
that the prescriptions issued to UC lacked a medical justification. Tr.
239; see also GX 6 (Dr. Kennedy's expert report on patient UC), 18
(prescriptions issued to UC).
Patient M.W.
37. Dr. Kennedy testified that Respondent treated M.W. for lower
back and limb pain. Tr. 245. M.W. was prescribed alprazolam,
carisoprodol (Soma), oxycodone, and oxymorphone. GX 23. In his review,
Dr. Kennedy stated that there was nothing that meaningfully supported a
chronic pain condition. Id. Dr. Kennedy discussed a form in M.W.'s file
titled ``Pain Management Physical Exam.'' (GX 9 at 14/GE 10 at 7). He
testified that the form

[[Page 3004]]

indicated only ``normal findings'' and ``acute findings.'' Tr. 247.
Yet, the patient reported a pain level of 10/10. Tr. 248-49; GX 9 at
19; GX 10 at 8. As Dr. Kennedy testified, in order to support such a
high pain level, there would have to be ``very, very significant
findings on lumbar exam.'' For instance, he testified, he would not
expect to see a patient whose ``gait is normal.'' Tr. 250. Dr. Kennedy
also testified that it would be unusual to see a 25 year old patient
with degenerative disc disease. In that case, he testified, he would
expect Respondent to order radiologic studies to confirm the diagnosis.
Tr. 262-63; GX 10.
38. Dr. Kennedy also found nothing in M.W.'s medical chart to
justify the continuing prescribing of alprazolam. Tr. 260-62. Rather,
he found ``identical language [to] that [which] was used to diagnose
insomnia'' for UC. Tr. 261; see also GX 9 at 84 (``HPI'' entry);
compare to GX 5 at 5 (same). There was no evidence, Dr. Kennedy
testified, that M.W. suffered from insomnia. Tr. 264.
39. Dr. Kennedy also testified that there were numerous red flags
in M.W.'s medical chart for abuse and/or diversion. Specifically,
M.W.'s chart showed a ``wildly abnormal'' drug screen in which M.W.
tested positive for morphine, hydromorphone, and THC in March 2016. He
was also negative for carisoprodol and alprazolam, two drugs he was
being prescribed and was supposed to be taking. Tr. 251-52; GX 9 at 2-
4. Based on the medical record, Dr. Kennedy testified that this
abnormal result was not ``meaningfully addressed.'' Tr. 252. Elsewhere
in the chart, there were other examples of abnormal drug screens. On
March 28, 2016, Respondent wrote ``UDS pos for oxy-unsat.'' GX 9 at
102. Then, according to an UDS lab report dated May 11, 2017, M.W.
tested negative for four controlled substances he had been prescribed,
including oxycodone, oxymorphone, alprazolam, and carisoprodol (Soma).
GX 9 at 10. Inexplicably, six days before M.W. provided the specimen,
Respondent wrote that M.W. was negative for all prescribed drugs. GX 9
at 85. On May 31, 2017, Respondent wrote that M.W. is ``dismissed''
with ``one month notice,'' but noted on the same day that M.W. was
``compliant and consistent.'' GX 9 at 83-84. However, less than a month
later, the ``dismissal [was] reversed.'' GX 9 at 83. Dr. Kennedy said,
``[i]f the patient is negative for the medication and its metabolites
of essentially everything that's prescribed, there's a problem.'' Tr.
260. Dr. Kennedy testified that this was evidence of drug abuse, which
Respondent failed to adequately address. Tr. 265.
40. With respect to M.W.'s medical records, Dr. Kennedy again cited
numerous inconsistences that questioned Respondent's credibility. For,
instance, he testified that the findings on the handwritten physical
exam form (GX 9 at 14) did not match those listed in Respondent's
electronic medical record (GX 10 at 9). Instead, Dr. Kennedy found the
same language in M.W.'s chart that was present in UC's medical chart
and in the charts for other patients he reviewed. Tr. 250-51. Dr.
Kennedy noted that, out of 98 different encounters, Respondent repeated
the same notes 93 times. Tr. 264. This, he testified, rendered the
medical file ``not credible.'' Tr. 251. Dr. Kennedy also cited the fact
that Respondent described M.W. as ``compliant and consistent'' the same
day he tested negative for all the controlled drugs he was supposed to
be taking. Tr. 258-59. Again, he described the inconsistency as
``simply not credible.'' Tr. 259.
41. In summary, Dr. Kennedy testified that, with respect to M.W.,
Respondent: (1) Failed to perform an adequate physical examination; (2)
failed to assess the patient's pain, physical, psychological function;
(3) failed to assess the patient's history and potential for substance
abuse, coexisting diseases and conditions; and (4) failed to create a
legitimate written treatment plan for the patient's individual needs.
Tr. 265. He further testified that Respondent failed to maintain a
truthful and accurate medical record for M.W. Tr. 265-66. Dr. Kennedy
testified that the controlled substances in GX 23 were prescribed to
M.W. outside the usual course of professional practice. Tr. 266-68.
Lastly, Dr. Kennedy testified that his opinions applied to all the
prescriptions in GX 23. Tr. 266.
Patient C.F.
42. Dr. Kennedy testified that patient C.F. was treated for
``chronic pain due to trauma, unspecified inflammatory
polyarthropathy.'' Tr. 269. However, he testified that C.F.'s physical
examination did not support the controlled substances prescribed. Id.
Dr. Kennedy noted that, while C.F. had scars, her muscle strength was
normal as well as her tendon reflexes, and her fine touch sensation.
Also, he testified that C.F.'s ``[l]eg raise tests were normal
bilaterally'' and her gait was normal. Tr. 270; GX 11 at 106. Dr.
Kennedy also testified that the findings in Respondent's ``Pain
Management Physical Exam'' (GX 11 at 106) were not accurately reflected
in Respondent's electronic medical record. Tr. 271. Rather, he
testified, that portion of Respondent's medical record contained
findings ``present in the other charts that we've already discussed.''
Tr. 271-72; GX 11 at 69. Dr. Kennedy also testified that he could find
no evidence of any credible follow-up physical exams being performed
even though C.F. remained a patient for nearly four years. Tr. 272. Nor
did he find any evidence that Respondent ordered any supporting
studies. Id.
43. Dr. Kennedy testified regarding the long term prescribing of
alprazolam to C.F. He testified that there was no justification for
this since the objective findings to support a diagnosis of insomnia
and/or anxiety were identical to those found in medical records for
other patients, including those pertaining to UC. GX 11 at 39; Tr. 286-
87.
44. Dr. Kennedy testified he also found evidence of possible abuse/
diversion that Respondent never adequately addressed. In GX 11 at 117,
a laboratory report dated July 9, 2018, shows that C.F. tested negative
for prescribed controlled medications, a result that Respondent himself
labeled as ``Unsat.'' GX 11 at 117; Tr. 274. According to Respondent's
own records, this test was taken just three days after C.F. was
prescribed alprazolam, oxycodone, and oxymorphone. GX 11 at 9; Tr. 274-
75. Pursuant to a report dated July 7, 2017, C.F. tested negative for
alprazolam and positive for hydrocodone. GX 11 at 111; Tr. 275. On June
30, 2017, Respondent's records showed C.F. was prescribed alprazolam,
but hydrocodone is not listed. GX 11 at 25; Tr. 275-76. Dr. Kennedy
testified that, according to notes from a subsequent visit on July 26,
2017, the abnormal drug screen result is never mentioned. GX 11 at 23;
Tr. 288-89.
45. Additionally, Dr. Kennedy testified that, according to a lab
report dated July 13, 2014, C.F. tested positive for a diazepam
metabolite, negative for alprazolam, and positive for cocaine,
oxycodone, oxymorphone, and THC. GX 11 at 79; Tr. 276-278. However, at
the next visit on August 11, 2014, Respondent's medical records made no
reference to these abnormal results. GX 11 at 69; Tr. 278-79.
46. Regarding C.F.'s multiple unsatisfactory drug screens, Dr.
Kennedy testified that it is insufficient for a physician to simply
document that the patient was counseled. Rather, he testified, the
doctor needs to document how the abnormalities are ``going to affect
treatment.'' Tr. 283-84. Dr. Kennedy testified that ``repeating over
and over that the patient was counseled. . . leads to the impression

[[Page 3005]]

. . . that it's not making any difference to the prescriptions for
schedule medications that are being provided.'' Id.
47. Regarding C.F.'s medical record, Dr. Kennedy testified that
Respondent's description of his review of systems (``ROS'') was
repeated throughout C.F.'s chart and found in numerous other charts.
Tr. 272-73. Likewise, the section labeled ``Gen exam'' was repeated 102
times and also found in other charts. Tr. 273. Also, as stated above,
Respondent's description of the physical exam failed to reflect the
actual handwritten notes but rather mirrored what had been written
about other patients, including UC.
48. In summary, regarding patient C.F., Dr. Kennedy testified that
Respondent: (1) Failed to take an adequate medical history; (2) failed
to perform an adequate physical examination; (3) failed to perform an
adequate assessment in consideration of the patient's pain, physical,
and psychological function; (4) failed to take an adequate history and
evaluate the potential for substance abuse; (5) failed to create a
written treatment plan tailored for the individual needs of the
patient; (6) failed to consider the patient's pertinent medical history
and physical examination as well as the need for further testing,
consultation, referrals, or use of other treatment modalities, (7)
failed to discuss the benefits and risks of the use of controlled
substances; (8) failed to conduct a documented periodic review of the
care at reasonable intervals in view of the individual circumstances of
each patient; (9) failed to keep complete and accurate records of the
care provided; and (10) continued to issue prescriptions for controlled
substances without making a bona fide effort to cure the patient's
habit. Tr. 284-86.
49. Dr. Kennedy further testified that, for the reasons in Finding
of Fact no. 48 and given C.F.'s numerous abnormal drug screen results,
the issuing of prescriptions for controlled substances to C.F.,
including those in GX 20, were issued ``outside the scope of acceptable
medical practice.'' Tr. 287.
Patient B.C.
50. Dr. Kennedy testified that B.C. was treated for ``chronic pain
syndrome.'' Tr. 290. He testified that he found no handwritten notes
reflecting a physical exam and that the electronic records showed
results that were ``non-supportive'' of a chronic pain condition. Tr.
290-91. Dr. Kennedy explained that the electronic records, in the
category of ``systems review,'' reflected 141 encounters with
Respondent and the ``system review documentations was repeated 140
times.'' He also testified that the ``physical exam documentation was
repeated ``approximately 134 times.'' According to Dr. Kennedy, this
same documentation was found, verbatim, in other charts. Tr. 292.
51. Though Dr. Kennedy acknowledged that B.C. seemed to have
serious medical ``problems,'' such as Hodgkin's lymphoma, a cancer of
the lymphatic system, Respondent's notes, inexplicably, failed to
reflect those problems. Dr. Kennedy noted, for instance, that the
review of systems for B.C. showed, among other things, that B.C.'s
``endocrine'' was ``negative.'' Tr. 292-93; see, e.g., GX 13 at 169.
Dr. Kennedy also took issue with the fact that Respondent, after
repeatedly reporting a nonsensical pain level of ``/10'' over the
course of nine sequential encounters,'' began to record a pain level of
10/10 without medication and 8/10 with medication. Tr. 295-96. Dr.
Kennedy testified that, despite B.C. being dismissed from another
physician, there was also no attempt to obtain prior medical records.
Tr. 304.
52. Dr. Kennedy testified that there were numerous red flags in
B.C.'s chart for abuse and/or diversion. First, B.C. had been dismissed
from a previous physician, GX 13 at 188, Tr. 293-94, an issue that was
not investigated. Tr. 294. Respondent also noted that B.C. lied about
his prescriptions at the first encounter--another issue that does not
appear to have been addressed. Tr. 296; GX 13 at 169. In fact, Dr.
Kennedy testified that the record, despite evidence of B.C.'s
untruthfulness, appears to show that Respondent prescribed controlled
substances to B.C. without ordering a UDS screen, something that ``is
outside the course of usual medical practice.'' Tr. 297; GX 13 at 169.
Dr. Kennedy testified that there were also abnormal drug screen
results. On February 20, 2013, B.C. was positive only for oxycodone
when he was also prescribed alprazolam. Tr. 298; GX 13 at 166. A note
dated March 26, 2013, indicated ``unsatisfactory benzo only UDS.'' Tr.
298-99; GX 13 at 165. On August 19, 2013, B.C. was positive for opioids
only, another unsatisfactory result. Tr. 299; GX 13 at 158. Dr. Kennedy
identified more abnormal results, including one where B.C. testified
positive only for benzodiazepines when he was also being prescribed
oxycodone. Tr. 299; GX 13 at 156-57. In another note, B.C. tested
positive only for oxycodone when he was also being prescribed
alprazolam. GX 13 at 155-65 (October 6, 2014 entry); Tr. 300. On
December 22, 2014, Respondent noted that B.C. was negative for all
drugs, another unsatisfactory result. Tr. 300-01; GX 13 at 150. And
though the record indicates the patient was counseled, Dr. Kennedy
testified that there was ``nothing specific about what the counseling
entailed or any decisions'' made as a result. Tr. 301.
53. Dr. Kennedy also testified that B.C. had been in jail, another
red flag. Tr. 301-02. Dr. Kennedy testified that, in this case, a
``reasonable physician would provide documentation that supports that
this was addressed and taken into account in pursuing a treatment
plan.'' Tr. 302-03.
54. Dr. Kennedy noted numerous instances where the medical chart,
instead of recording an actual pain level, listed a nonsensical pain
level of ``/10.'' Tr. 294-95.
55. In summary, Dr. Kennedy testified that Respondent's examination
of B.C. did not support a chronic pain condition. He testified that
Respondent: (1) Failed to take an adequate medical history; (2) failed
to perform a sufficient physical examination; (3) failed to perform an
adequate assessment in consideration of the patient's pain, physical
and psychological function; (4) failed to take an adequate history for
the potential for substance abuse, coexisting diseases and condition;
(5) failed to show the presence of a recognized medical indication for
the use of a dangerous drug or controlled substance; (6) failed to
create a written treatment plan tailored to the individual needs of the
patient; (7) failed to adequately address the need for further testing,
consultation, referrals or other treatment modalities; (8) failed to
discuss the risks and benefits of the use of controlled substances; (9)
failed to do a documented periodic review of his care at reasonable
intervals in view of the individual circumstances; and (10) failed to
keep complete and accurate records of the care provided. Tr. 304-06.
Dr. Kennedy testified that, in his view, there was no medical
justification for issuing prescriptions for controlled substances to
B.C. and, as a result, the prescriptions were issued outside the usual
course of professional practice. Tr. 307-08; GX 22.
Patient M.H.
56. Dr. Kennedy testified that M.H. was being treated for ``chronic
pain syndrome.'' Tr. 309. He testified that Respondent performed a
physical exam; however, the findings were identical to those for other
patients. See GX 15 at 62-63 (sections marked ``PE'' for February 4,
2015, and April 1, 2015); Tr. 310-11. Moreover, Dr. Kennedy testified
that these findings did not support a chronic pain condition and that
the

[[Page 3006]]

treatment was ``outside the scope of acceptable medical practice.'' Tr.
311-12. Dr. Kennedy also testified about an ``extremely'' unusual
situation in which M.H. underwent extensive spinal surgery and was
discharged from the hospital on October 4, 2016. However, the medical
chart entry dated October 5, 2016, shows no mention of the surgery and
no evidence that a physical exam was performed. Tr. 320-22, 323-24; GX
15 at 26 (hospital notes), at 48 (encounter note for October 5, 2016).
Dr. Kennedy described the situation as follows: ``this whole thing is
about scheduled medications to begin with. This is ostensibly a chronic
pain patient. He has been discharged from the hospital the day before
this encounter after having had a major, major spinal surgery. And not
only it is not mentioned in this encounter note, but essentially this
encounter note is normal and identical to all the other encounter
notes.'' Tr. 322-23. Dr. Kennedy also found no justification for the
continued prescribing of alprazolam. As with the other patients, the
factual findings related to insomnia/anxiety were identical to the
findings found in charts of the other patients discussed during the
hearing. GX 15 at 49 (section marked HPI).
57. Dr. Kennedy testified that he also found evidence of abnormal
drug screens, even on M.H.'s initial visit. Tr. 313-14; GX 15 at 63. On
some occasions, M.H. tested positive for illicit substances. See GX 15
at 56 (positive for THC, cocaine, PCP); GX 15 at 53 (positive for
amphetamines); Tr. 314-15. In other cases, he tested negative for drugs
that had been prescribed. GX 15 at 51 (positive for opiates and
oxycodone when patient also prescribed alprazolam and carisoprodol); GX
15 at 49 (same); GX 15 at 47 (same); GX 15 at 40 (UDS negative for all
drugs while patient was prescribed oxycodone oxymorphone, alprazolam,
and carisoprodol); GX 15 at 39 (UDS negative for all drugs); GX 15 at
36 (UDS positive only for oxycodone). In these cases, Dr. Kennedy
testified, there was no evidence that Respondent addressed the
abnormalities other than to order repeat tests. Tr. 313-20.
58. Dr. Kennedy also reviewed the prescriptions for M.H. identified
as GX 19. These included alprazolam, oxymorphone, carisoprodol, and
oxycodone. Tr. 325-27.
59. Dr. Kennedy testified that, in his view, Respondent prescribed
controlled substances to M.H. despite evidence that M.H. may have been
addicted to the habit of using controlled substances. Tr. 327. He
testified that Respondent made no effort to cure M.H.'s habit. Id. Dr.
Kennedy further testified that Respondent: (1) Failed to perform an
adequate assessment in consideration of the patient's pain, physical
and psychological function; (2) failed to evaluate the patient's
history and potential for substance abuse; (3) failed to determine a
recognized medication indication for the use of controlled substances;
(4) failed to create a written treatment plan tailored for the
individual needs of the patient; (5) failed to consider the need for
further testing, consultation, referrals, or use of other treatment
modalities; (6) failed to discuss the risks and benefits of the use of
controlled substances; (7) failed to do a documented periodic review of
the patient's care at reasonable intervals in view of the individual
circumstances of each patient; and (8) failed to keep complete and
accurate records of the care provided to M.H. Tr. 327-29.
60. Dr. Kennedy testified that the controlled substances issued to
M.H. were not issued in the usual course of professional practice. Tr.
329.
Patient M.P.
61. Dr. Kennedy testified that M.P. was being treated for low back,
neck, hip, and shoulder pain. Tr. 331. Dr. Kennedy testified that the
physical exam used to justify prescribing controlled substances for
M.P. was inadequate. Tr. 334. As he explained, M.P. was diagnosed with
degenerative disc disease and right shoulder pain. To determine whether
M.P. had shoulder pain, Dr. Kennedy testified, a physician would have
to test the patient's ``range of motion as far as extension, flexion,
abduction . . . tenderness to palpation specific to the shoulder.'' Tr.
335. With respect to degenerative disc disease, Dr. Kennedy testified
that Respondent should have found, for example, that the ``dorsal
lumber and C-spine range of motion'' was ``decreased in all
directions.'' Id. Dr. Kennedy testified he saw no such findings in
Respondent's medical record. Tr. 334-35. Dr. Kennedy also testified
that M.P.'s pain level was inconsistent with other information in the
record.
62. Dr. Kennedy also testified that, throughout M.P.'s medical
records, Respondent expressed a need to obtain M.P.'s prior medical
records, but Respondent never followed through. GX 7 at 1, 59, 68; Tr.
337-38. This included obtaining M.P.'s x-rays, MRI report, and the
dismissal form from her prior physician. Id.
63. Dr. Kennedy testified that M.P. manifested signs of abuse/
diversion which were not adequately addressed. Initially, M.P. tested
positive for buprenorphine, benzodiazepines, oxycodone, and THC. GX 7
at 68. According to the pharmacy report, which was part M.P.'s medical
chart, buprenorphine had never been prescribed. Tr. 338-39; GX 7 at 19.
Dr. Kennedy also discussed that there was mention of ``termination
paperwork from a previous physician,'' another red flag for abuse and/
or diversion. Tr. 342. Dr. Kennedy pointed out ``highly conflicting''
information in M.P.'s medical chart. Tr. 345. For instance, M.P. listed
her occupational disability as both ``9'' and ``10,'' but stated she
works ``45-60 hours weekly'' as a waitress. GX 7 at 9-10. Dr. Kennedy
also questioned M.P.'s truthfulness when she denied that she had ever
been in a drug treatment program (GX 7, 13). However, following a
heroin overdose, she told Respondent that she refused to go into such a
program because she had tried drug treatment before. GX 7 at 57
(section marked ``HPI''). Dr. Kennedy also pointed out several abnormal
drug screen results. In GX 7, page 58, there is a reference to a
positive test for THC, opioids, and benzodiazepines, none of which had
been prescribed. Tr. 347.
64. M.P. overdosed on heroin in Respondent's waiting room. GX 7 at
25; Tr. 340-41. However, according to Dr. Kennedy, Respondent
incorrectly treated M.P. with Suboxone (buprenorphine).
65. Dr. Kennedy testified that Respondent repeatedly issued
prescriptions for controlled substances to M.P. despite the fact she
was addicted to the habit of using controlled substances. Tr. 348.
Also, up until the point M.P. overdosed on heroin, Respondent made no
effort to cure M.P.'s habit. Tr. 348-49. Dr. Kennedy also testified
that, with respect to M.P., Respondent: (1) Failed to perform a
sufficient physical examination; (2) failed to perform an adequate
assessment in consideration of the patient pain, physical and
psychological function; (3) failed to record an adequate history of
potential substance abuse; (4) failed to determine a recognized medical
indication for the use of controlled substances; (5) failed to create a
written treatment plan tailored for the individual needs of the
patient; (6) failed to take a pertinent medical history and perform a
physical examination as well as perform further testing, consultation,
referrals. And the use of other treatment modalities; (7) failed to
discuss the risk and benefits of the use of controlled substances; (8)
failed to do a documented periodic review of M.P.'s care at reasonable
intervals in view of the individual circumstances; and (9) failed to
keep

[[Page 3007]]

complete an accurate medical records of the care provided to M.P. Tr.
348-50.
66. Dr. Kennedy also testified that the prescriptions issued to
M.P., including those in GX 21, were issued outside the usual course of
professional practice, and that Respondent lacked a medical
justification for issuing the prescriptions. Tr. 352.
67. With respect to patients, B.C, C.F., M.H., M.W., and M.P., Dr.
Kennedy testified that the prescribing of controlled substances to
these patients was dangerous. Tr. 352. As a basis for that opinion, he
cited: (1) Abnormal drug screens that were ``essentially ignored,'' (2)
the lack of documentation about the patients' status; (3) medical
records that were not credible; (4) and maintaining patients on
scheduled medications, sometimes at high dosages ``without having
honest, accurate, complete medical records.'' Tr. 352-53. He testified
that ``[b]ecause medical records will instruct other people who look''
at the patients later, a medical record that ``simply doesn't make
sense or [has] something that is in conflict,'' can ``present a
dangerous situation.'' Tr. 353.
Respondent's Falsification
68. DI testified that Respondent submitted an application to renew
his DEA COR (No. BO4959889) on November 6, 2019. Tr. 529; GX 26. She
testified that Respondent answered ``no'' to the third liability
question on the application. Specifically, the question sought to
determine whether Respondent had ever ``surrendered for cause or had a
state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation.'' Tr.
530.
69. DI introduced a document outlining an administrative action
against Respondent, titled ``Notice of Charges and Memorandum for
Assessment of Civil Penalties,'' submitted May 1, 2019, by the
Tennessee Department of Health. GX 29; Tr. 531. As the document states,
Respondent was charged with, among other things, prescribing
``narcotics and other medications and controlled substances in amounts
and/or duration that were not medically necessary, advisable, or
justified for a diagnosed condition.'' GX 29 at 5.
70. DI introduced a document from the Chancery Court for the State
of Tennessee, 20th Judicial District, Davidson County, Part III
(``Chancery Court''), staying the proceedings brought by the Tennessee
Department of Health, [omitted] and imposing restrictions on
Respondent's license as conditions of the stay. Those restrictions
included prohibiting Respondent from: (1) Writing prescriptions; (2)
supervising or collaborating with any mid-level practitioners for the
writing of prescriptions; and (3) providing direct patient care
including but not limited to diagnosing, treating, operating on or
prescribing for any person. GX 27 at 2-3; Tr. 533-34. The order is
dated May 17, 2019, approximately three months before Respondent
submitted his renewal application. GX 27 at 4.
71. DI introduced a document, titled Agreed Order, dated August 21,
2018. GX 28. DI testified that the Order provided that Respondent must
surrender his Tennessee Pain Management Clinic Certificate (``Pain
Clinic Certificate''), No. 246, as a result of violations related to
the prescribing of controlled substances. Id. at 5-7.
72. DI testified, as a result of having surrendered his Pain Clinic
Certificate and the restrictions placed upon his medical license by the
Chancery Court, that Respondent did not answer truthfully on his
renewal application. Tr. 536.

Analysis

Findings as to Allegations

The Government alleges that the Respondent's COR should be revoked,
and any applications should be denied, because the Respondent [has
committed such acts as would render his registration inconsistent with
the public interest. 21 U.S.C. 824(a)(4); 21 U.S.C. 823(f) and in
particular the Government relies on Public Interest Factors Two (the
Respondent's experience conducting regulated activity) and Four (the
Respondent's compliance with state and federal laws related to
controlled substances)]. ALJ Ex. 1.\29\ In the adjudication of a
revocation of a DEA COR, the DEA bears the burden of proving that the
requirements for such revocation are satisfied. 21 CFR 1301.44(e).
Where the Government has sustained its burden and established that a
respondent has committed acts that render his registration inconsistent
with the public interest, to rebut the Government's prima facie case, a
respondent must both accept responsibility for his actions and
demonstrate that he will not engage in future misconduct. Patrick W.
Stodola, M.D., 74 FR 20,727, 20,734 (2009).
---------------------------------------------------------------------------

\29\ In its GPHB, the Government argues Factors Two and Four
should be combined for a joint analysis.
---------------------------------------------------------------------------

Acceptance of responsibility and remedial measures are assessed in
the context of the ``egregiousness of the violations and the [DEA's]
interest in deterring similar misconduct by [the] Respondent in the
future as well as on the part of others.'' David A. Ruben, M.D., 78 FR
38,363, 38,364 (2013). Where the Government has sustained its burden
and established that a registrant has committed acts inconsistent with
the public interest, that registrant must present sufficient mitigating
evidence to assure the Administrator that he can be entrusted with the
responsibility commensurate with such a registration. Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008).
The Agency's conclusion that ``past performance is the best
predictor of future performance'' has been sustained on review, Alra
Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the
Agency's consistent policy of strongly weighing whether a registrant
who has committed acts inconsistent with the public interest has
accepted responsibility and demonstrated that he or she will not engage
in future misconduct. Hoxie v. DEA, 419 F.3d 477, 482-83 (6th Cir.
2005); see also Ronald Lynch, M.D., 75 FR 78,745, 78,754 (2010)
(holding that the Respondent's attempts to minimize misconduct
undermined acceptance of responsibility); George C. Aycock, M.D., 74 FR
17,529, 17,543 (2009) (finding that much of the respondent's testimony
undermined his initial acceptance that he was ``probably at fault'' for
some misconduct); Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009)
(noting, on remand, that despite the respondent's having undertaken
measures to reform her practice, revocation had been appropriate
because the respondent had refused to acknowledge her responsibility
under the law); Medicine Shoppe-Jonesborough, 73 FR 364 at 387 (noting
that the respondent did not acknowledge recordkeeping problems, let
alone more serious violations of federal law, and concluding that
revocation was warranted).*\R\
---------------------------------------------------------------------------

*\R\ Remaining text omitted for brevity and clarity.
---------------------------------------------------------------------------

Tennessee Law

As a licensed medical doctor in Tennessee, the Respondent was
subject to TENN. CODE ANN. Sec. 63-6-214(b)(12) through (14),\30\ as
those provisions

[[Page 3008]]

pertain to ``dispensing, prescribing, or otherwise distributing''
controlled substances. Specifically, section 63-6-2 l 4(b)(12)
prohibits a physician from prescribing controlled substances ``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.'' Additionally,
section 63-6-214(b)(13) prohibits a physician from prescribing
controlled substances to a person ``addicted to the habit of using
controlled substances'' without ``making a bona fide effort to cure the
[patient's] habit.'' To determine a violation of these provisions, the
Tennessee Board of Medical Examiners uses a nonexhaustive list of
guidelines (``the guidelines'') found in TENN. COMP. R. & REGS. 0880-
02-.14(6)(e).\31\ The guidelines require that a physician: (1) Take a
documented medical history; (2) conduct a physical examination; and (3)
perform an adequate ``assessment and consideration of the [patient's]
pain, physical and psychological function, any history and potential
for substance abuse, coexisting diseases and conditions, and the
presence of a recognized medical indication for the use of a dangerous
drug or controlled substance.'' TENN. COMP. R. & REGS. 0880-
02-.14(6)(e)(3)(i). Additionally, Rule 0880-02-.14 (6)(e) requires
physicians to create a ``written treatment plan tailored for the
individual needs of the patient'' that considers the patient's
``pertinent medical history and physical examination as well as the
need for further testing, consultation, referrals, or use of other
treatment modalities.'' It also requires the physician to ``discuss the
risks and benefits of the use of controlled substances,'' complete a
``documented periodic review of the care . . . at reasonable
intervals,'' and ``keep [c]omplete and accurate records of the care.''
Id. at 0880-02-.14(6)(e)(3)(ii)-(v).
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\30\ T. C. A. Sec. 63-6-214. License denial, suspension, or
revocation; grounds; examination; investigations; abstract of
record; report; standard of care; disclosure of records; screening
panels; hearings; orders
(a) The board has the power to: (1) Deny an application for a
license to any applicant who applies for the same through
reciprocity or otherwise; (2) Permanently or temporarily withhold
issuance of a license; (3) Suspend, or limit or restrict a
previously issued license for such time and in such manner as the
board may determine; (4) Reprimand or take such action in relation
to disciplining an applicant or licensee, including, but not limited
to, informal settlements, private censures and warnings, as the
board in its discretion may deem proper; or (5) Permanently revoke a
license.
(b) The grounds upon which the board shall exercise such power
include, but are not limited to: . . . (12) Dispensing, prescribing
or otherwise distributing any controlled substance or any other drug
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; (13) Dispensing, prescribing or otherwise distributing to
any person a controlled substance or other drug if such person is
addicted to the habit of using controlled substances without making
a bona fide effort to cure the habit of such patient; (14)
Dispensing, prescribing or otherwise distributing any controlled
substance, controlled substance analogue or other drug to any person
in violation of any law of the state or of the United States; . . .
(emphasis added).
\31\ Tenn. Comp. R. & Regs. 0880-02-.14 SPECIALLY REGULATED
AREAS AND ASPECTS OF MEDICAL PRACTICE. [Omitted text of guidelines
for brevity.]
---------------------------------------------------------------------------

Exclusion of the Respondent's Testimony

The Government objected to the Respondent's testimony *\S\ because
prior to the hearing Respondent identified that he may testify
regarding the material falsification allegation, but said he would not
testify regarding the prescribing allegations as he has another matter
pending. However, at the hearing, the Respondent sought to present
testimony regarding the allegations surrounding his prescribing. He did
not offer testimony regarding the material falsification allegation.
[The ALJ permitted all portions of the Respondent's testimony that
could have been reasonably anticipated by the Government and I have
considered Respondent's testimony in reaching my decision. I find it
unnecessary to reach any further conclusions and have omitted the
remainder of the ALJ's analysis for brevity, as the Government did not
take exception to the ALJ's ultimate decision.] 32 33
---------------------------------------------------------------------------

*\S\ Text omitted for brevity.
\32\ [Omitted original text in which footnote appeared.]
\33\ [Omitted original text in which footnote appeared.]
---------------------------------------------------------------------------

Accurate and Complete Medical Records

The Government alleges that the Respondent failed to maintain
accurate and complete medical records for each of the subject patients,
as mandated by the relevant Tennessee regulations and standard of care.
The medical records contain the results of physical examinations and
other tests, which did not occur on the reported dates. The records are
rife, across all of the subject patients, with identical findings,
suggesting the subject examinations either did not take place, or the
results were not reported accurately.
In explaining the identical anxiety and insomnia indications
written in each of his patients' charts to justify benzodiazepines, the
Respondent testified that his patients exhibited the same symptoms
which is common among anxiety patients. However, the fact that UC's
chart reflected that he had the same anxiety indications and other
indications identical to the other five patients, despite the fact that
he testified credibly that he did not complain of any anxiety symptoms,
greatly reduces the credibility of the Respondent's subject
explanations. Tr. 79-80. Indeed, most of the indications within UC's
chart were unreported by him.\34\ UC reviewed Government Exhibit 5 and
noted that he was not asked about any of the reported symptoms. Tr. 81.
As to why individual patients had the same indications within the chart
for long periods of time, the Respondent maintains that the subject
record findings were carried forward from prior tests, as permitted by
the Tennessee standard of care. [However, Dr. Kennedy testified,
``there is no regulation anywhere that allows a physician [to] document
physical exam findings that he did not perform. That's not acceptable
under any regulations.'' Tr. 652.]
---------------------------------------------------------------------------

\34\ UC noted that despite his records stating that ``[UC] . . .
has had a history of insomnia and anxiety for several years,'' he
did not report anxiety symptoms of shortness of breath, of having
palpitations, sweating, dizziness, or shaking. Tr. 79-80; GX 5. The
medical record also reflects that he had a headache that day,
despite the fact that UC did not report having a headache,
dizziness, nausea, or vomiting. Tr. 80; GX 5. No one questioned UC
as to whether he had abdominal pain, diarrhea, and constipation. Tr.
80-81.
---------------------------------------------------------------------------

Similarly, the Respondent justified reporting test results when no
tests occurred, as he claimed was permitted by the Tennessee standard.
Prior test results were simply carried forward within the electronic
medical record. I credit Dr. Kennedy's opinion that reporting test
results purported to have occurred on a particular date, which did not
then occur, is contrary to the Tennessee standard of care. Even a
casual review of the relevant Tennessee regulations reveals the
prominence of the Tennessee physician's obligation to accurately
document. He is required to establish a ``written treatment plan
tailored for the individual needs of the patient'' that considers the
patient's ``pertinent medical history and physical examination as well
as the need for further testing, consultation, referrals, or use of
other treatment modalities.'' It also requires the physician to perform
a ``documented periodic review of the care . . . at reasonable
intervals,'' and ``keep [c]omplete and accurate records of the care.''
Id. at 0880-02-.14(6)(e)(3)(ii)-(v).
Common sense itself would refute the Respondent's position.
Indications and exam results carried forward, perhaps for months or
even years, defeats the whole purpose of medical records, which is to
inform the practitioner and other potential treating practitioners of
the patient's true and present condition, progression of disease or
efficacy of treatment. [Dr. Kennedy testified that

[[Page 3009]]

here the documentation did not ``make sense'' and was ``in conflict,''
which ``present[s] a dangerous situation'' for ``other people who look
at [the records].'' Tr. 353. Based on this testimony, one could
conclude that wrong records are worse than no records at all, as they
would mislead other treating practitioners. And as Dr. Kennedy
testified, here ``you have a medical record which shows consistently
documentation . . . that did not occur, that is outside the scope of
acceptable medical practice, and it does not support legitimate
prescribing of scheduled agents.'' Tr. 652.]
The Respondent has conceded there are factual errors in the subject
records. Although UC's chart contains an entry that his pharmacy
printout was reviewed, the Respondent conceded that no pharmacy
printout was reviewed and that such entry was in ``error.'' Tr. 631-32;
GX 5 at 6. M.H.'s chart contains the inconsistent finding of long-term
insomnia, but with an entry of sleeping well. Tr. 640-41; GX 15 at 47-
48. The Respondent conceded they were inconsistent entries. Tr. 641.
Additionally, while M.W.'s chart reflects he had been dismissed, M.W.
continued to be seen for months afterwards, without any further
explanation documented in the record. Tr. 259-60. And, Respondent
reported a ``history of insomnia for several years'' for M.H.; however,
this note first appears 19 months into treatment. GX 15; Tr. 49.
Additionally, there are conflicts between the Respondent's written
notes and the electronic medical records. Documents UC filled out are
missing from his chart that was seized from the Respondent. The
electronic medical record for a visit by M.W. does not contain the
handwritten information recorded in GX 10 at 8. Tr. 250-51; GX 10 at 9.
Instead, the results of the physical exam mirror those findings made
for UC, rendering M.W.'s chart not credible. Tr. 251-52. The physical
exam notes written for C.F. revealed essentially normal findings,
however the electronic records for this visit failed to include these
findings. Tr. 271; GX 11 at 69. Instead, under physical exam, the same
language that is duplicated so often in the records, appears. Tr. 272.
Dr. Kennedy noted the hand-written exam notes for M.H. did not appear
in the electronic medical records. Tr. 325-36; GX 7 at 68. Instead the
same physical exam notes duplicated throughout the records appear. Tr.
336, 351. So, at times, verbatim records were repeatedly and
inaccurately inputted into the electronic medical records when actual,
accurate indications were available.
Dr. Kennedy noted the actual pain level was left blank at nine
consecutive encounters with B.C., suggesting it was being added later
and that the record was being fabricated. Tr. 294-95; GX 13 at 159; GX
14 at 8.
For these reasons and those discussed below, I find the Government
has sustained its burden in proving the Respondent failed to maintain
accurate and complete medical records as to the subject patients, in
violation of TENN. COMP. R. & REGS. Rule 0880-02-.14 (6)(e).*\T\ [I
further find that each of the relevant prescriptions at issue in this
matter were issued outside the usual course of professional practice
and beneath the standard of care due to Respondent's failure to
maintain complete and accurate records.]
---------------------------------------------------------------------------

*\T\ Omitted for brevity.
---------------------------------------------------------------------------

Undercover

The Government alleges the Respondent failed to perform an adequate
physical exam; take an adequate medical history; assess UC's pain,
physical and psychological function; assess the patient's history and
potential for substance abuse, coexisting diseases and conditions, and
the presence of a recognized medical indication for the use of
oxycodone; and failed to create a legitimate written treatment plan for
UC's individual needs or to discuss the risks and benefits of the use
of oxycodone with UC. At three level one visits, the chart falsely
reflects the results of physical exams, which did not occur. The
Government alleges the Respondent's continued prescribing of controlled
substances to UC was without a legitimate medical purpose and/or
outside the usual course of professional practice.
Dr. Kennedy reviewed the chart and the undercover videos for UC,
the undercover agent. Tr. 216-17, 363; GX 6. Dr. Kennedy acknowledged
that in scheduling the first visit, the Respondent's staff instructed
UC to bring certain medical records to his first visit, the previous
three physician notes, his discharge summary, the record of the
previous three months prescriptions and an MRI, an appropriate protocol
in Dr. Kennedy's opinion. Tr. 364-65; GX 3 at 1.
The Respondent testified that he took a medical history, a
condition-specific physical exam for low back pain, and reviewed the
MRI (GX 6) of UC. Tr. 575-80.\35\ The Respondent agreed that he spent
no more than fifteen minutes with UC in the examination room. Tr. 621.
The Respondent maintains that he performed the required assessments
related to pain, physical and psychological function, and history and
potential for drug abuse. Tr. 582. This involved reviewing the
paperwork UC filled out, authenticating that paperwork, the triage of
UC by staff, UDS, and a final review of the paperwork by the Respondent
with the patient. Tr. 583, 584. UC recalled the Respondent going over
his paperwork with him, but could not remember the extent of the
review. According to UC, the triage by other staff was minimal,
sporadic or non-existent. Tr. 59. UC cited Dr. Morgan, who did not
exist, in his medical history paperwork, yet the staff did not discover
that fact. None of UC's paperwork could be authenticated, as designed.
UC's history was similarly designed to be a ``dead end.'' Tr. 238.
[Accordingly, I find Respondent's testimony that he authenticated UC's
paperwork to lack credibility.] There was no review of UC's
psychological functioning, although he was diagnosed with anxiety.\36\
The Respondent's instant claims are belied by the record.
---------------------------------------------------------------------------

\35\ The Respondent noted that his physical exam of C.R. was not
captured by the video of the encounter. The camera was pointed at
the wall. Tr. 581-82.
\36\ Where practitioner asked his patient whether there was
``any other medication he took for anxiety,'' and where the
practitioner made no effort to determine the extent of the patient's
symptoms before prescribing Xanax to him, the practitioner was not
engaged in the legitimate practice of medicine but instead was
dealing drugs. Henri Wetselaar, M.D., 77 FR 57,126, 57,132 (2012).
---------------------------------------------------------------------------

The Respondent explained that a patient's pain is very subjective.
After reviewing his paperwork, including the MRI, examining UC and
speaking with him, the Respondent claimed that he had no reason not to
treat him as someone who has genuine pain. Tr. 588. UC's statement that
he had used controlled substances for his pain and that ibuprofen was
not working supported the conclusion that his pain was long standing,
and warranted a Schedule II medication. [Omitted for relevance.]
Dr. Kennedy opined that UC's medical chart did not justify the
prescribing of controlled substances.\37\ Tr. 230-31, 240; GX 18 at 1,
3. Although there was an actual MRI report of UC, Dr. Kennedy found the
MRI report internally inconsistent [which Dr. Kennedy testified should
have caused Respondent to question the MRI.] Tr. 387-94. Dr. Kennedy
opined that it

[[Page 3010]]

would be outside the usual course of professional practice to prescribe
controlled substances based on this MRI alone.*\U\ Tr. 483-86.\38\ UC
was being treated for complaints of back pain. However, Dr. Kennedy
opined that the physical exam detailed in the chart was not sufficient
under Tennessee standards, and the exam that was performed revealed,
essentially, a normal back. Tr. 217, 231, 237, 396-97, 440. On
rebuttal, Dr. Kennedy reiterated this assessment after listening to the
Respondent's explanation. Tr. 651-52.
---------------------------------------------------------------------------

\37\ The Respondent cautioned that in reviewing his electronic
medical record, it often referred to other records. For example,
under history of present illness (HPI), he would often reference the
initial encounter paperwork, as included by reference, in the
electronic record. Tr. 592.
*\U\ This sentence has been modified for clarity.
\38\ The Agency has previously found based on credible expert
testimony that relying exclusively on MRI results for prescribing
controlled substances is unprofessional conduct in the applicable
state. Zvi H. Perper, M.D., 77 FR 64,131, 64,140 (2012).
---------------------------------------------------------------------------

The Respondent explained his treatment of UC. After the UC filled
out extensive paperwork, the initial examination by the Respondent
consisted of observing UC, touching his back and causing the patient to
lift his leg. Tr. 217-18, 359-60; GX 6 at 6. Dr. Kennedy noted the
taking of vital signs and a general exam within the chart; however, he
observed that from viewing and listening to the video of this visit,
such exam was not performed as described, or not performed at all. Tr.
218-19, 379-81; GX 6, 4.\39\ The prior medical history reported by UC
was facially suspicious and constituted a red flag. Tr. 238. UC
reportedly came from a clinic, which had been shut down, and provided
medical records from a Nurse Practitioner whose license had been
suspended. Tr. 238. The Respondent conceded UC was a challenge, as the
clinic he reported had been closed, and he could not obtain the
pharmacy information, so the Respondent could not verify that source.
Tr. 583-85. As UC's prior medical records could not be confirmed, the
Respondent claimed that he prescribed a dosage appropriate to a patient
just starting opioid treatment. Tr. 589-90.
---------------------------------------------------------------------------

\39\ The Agency has previously found that falsifying a patient's
medical record to indicate that respondent performed a physical exam
but where video/audio recordings show that a physical was never
conducted demonstrate that respondent knowingly violated the CSA.
Jeri Hassman, M.D., 75 FR 8194, 8236 (2010); Bernard Wilberforce
Shelton, M.D., 83 FR 14,028, 14,042 (2018).
---------------------------------------------------------------------------

The Respondent expected his patients to be honest and truthful with
him consistent with the DEA Physician's Manual, which requires patients
to be honest with their doctors. Tr. 586-87.\40\ In his Post-hearing
Brief, the Respondent continues to complain of the use of an undercover
agent, who operated under ``false colors'' to ensnare the Respondent,
and his disappointment that the Tribunal does not share his sentiment.
The fact of the matter is, there is nothing illegal or improper
regarding the Government's use of undercover agents.\41\ Even if I
shared the Respondent's sentiment, and opined that the use of
undercover agents was somehow unfair, this is not a court of
equity.\42\ We operate strictly by statute and regulation [and here the
evidence clearly establishes that Respondent's prescribing to UC was
outside the usual course of professional practice and beneath the
standard of care in violation of the CSA and its implementing
regulations.]
---------------------------------------------------------------------------

\40\ ``A practitioner who ignores the warning signs that her
patients are either personally abusing or diverting controlled
substances commits `acts inconsistent with the public interest,' 21
U.S.C. 824(a)(4), even if she is merely gullible or na[iuml]ve.''
Krishna-Iyer, M.D., 74 FR 460 n.3.
\41\ [Omitted for relevance.]
\42\ Administrative Law Judges of the DEA ``lack the authority
to exercise equitable powers'' in determining whether a registration
is consistent with the public interest. The Main Pharmacy, 80 FR
29,022, 29,024 (2015).
---------------------------------------------------------------------------

Dr. Kennedy opined that UC's obfuscation, false and misleading
statements to the Respondent and staff, did not relieve the
Respondent's obligation to investigate any suspicious circumstances.
Tr. 375-78, 382. The Respondent misperceives his role. [Omitted for
relevance.] Physicians must be wary of patients seeking controlled
substances for abuse and diversion. Although the Respondent's staff was
suspicious of UC's prior records, as they appeared to have been
altered, their concern appeared to be that the UC was perhaps law
enforcement, ``try[ing] to bring the Respondent down,'' rather than
someone attempting to divert or abuse controlled substances. UC
presented as a patient with no verified history, his paperwork
contained indications of alteration, he complained of pain without
overt indications; yet, the Respondent opined that the record supported
his conclusion that UC was legitimately in pain. Dr. Kennedy disagreed
and opined that it is the practitioner's responsibility to investigate
suspicious circumstances and to resolve them prior to prescribing
controlled substances.
Dr. Kennedy noted that the physical exam included in this first
visit by UC was repeated verbatim in most of the approximately twenty
charts he reviewed. Tr. 220; GX 7 at 65 (M.B.), GX 9 at 69 (M.W.). The
Respondent explained that he performed a physical exam at the initial
visit of each of his patients, as required by the Tennessee pain
management guidelines. Tr. 594. Physical exams thereafter are at the
discretion of the physician. Tr. 594. Although UC had five visits to
the clinic, only two involved encounters with the Respondent. The other
three visits were ``level one'' visits, in which UC met with the
Respondent's staff only. Tr. 622-28, 645-50. Although the medical
records reflect a physical examination took place at the level one
visits, there was no physical exam. Instead, the R

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