[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2986-3020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 *<SUP>B</SUP>
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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.] <SUP>2 3</SUP> 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:

----------------------------------------------------------------------------------------------------------------
                                                                                                     Quantity
              Date written                           Drug                       Dosage              (number of
                                                                                                     tablets)
----------------------------------------------------------------------------------------------------------------
1.3.17..................................  Alprazolam................  .5 mg.....................             120
1.4.17..................................  Oxycodone.................  30 mg.....................              84
1.4.17..................................  Oxymorphone...............  15 mg.....................              56
2.3.17..................................  Alprazolam................  .5 mg.....................             112
2.6.17..................................  Carisoprodol..............  350 mg....................              56
2.6.17..................................  Oxycodone.................  30 mg.....................              84
2.6.17..................................  Oxymorphone...............  15 mg.....................              56
3.3.17..................................  Alprazolam................  .5 mg.....................             112
3.6.17..................................  Oxycodone.................  30 mg.....................              84
3.6.17..................................  Carisoprodol..............  350 mg....................              56
3.6.17..................................  Oxycodone.................  30 mg.....................              84
3.6.17..................................  Oxymorphone...............  15 mg.....................              56
4.3.17..................................  Alprazolam................  .5 mg.....................             112
4.4.17..................................  Carisoprodol..............  350 mg....................              56
4.4.17..................................  Oxycodone.................  30 mg.....................              84
4.4.17..................................  Oxymorphone...............  15 mg.....................              56
----------------------------------------------------------------------------------------------------------------

    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:

----------------------------------------------------------------------------------------------------------------
                                                                                                     Quantity
              Date written                           Drug                       Dosage              (number of
                                                                                                     tablets)
----------------------------------------------------------------------------------------------------------------
1.4.17..................................  Alprazolam................  .25 mg....................              28
1.6.17..................................  Oxycodone.................  15 mg.....................              84
1.30.17.................................  Alprazolam................  .25 mg....................              28
2.3.17..................................  Oxycodone.................  15 mg.....................              84
2.3.17..................................  Oxycodone.................  7.5 mg....................              28
3.1.17..................................  Alprazolam................  .25 mg....................              28
3.1.17..................................  Oxycodone.................  7.5 mg....................              28
3.4.17..................................  Oxycodone.................  15 mg.....................              84
3.13.17.................................  Alprazolam................  .25 mg....................              28
3.14.17.................................  Oxycodone.................  15 mg.....................              28
3.14.17.................................  Oxycodone.................  7.5 mg....................              28
4.25.17.................................  Alprazolam................  .25 mg....................              28
4.28.17.................................  Oxycodone.................  15 mg.....................              21
4.28.17.................................  Oxycodone.................  7.5mg.....................               7
5.8.17..................................  Oxycodone.................  15 mg.....................              84
5.8.17..................................  Oxycodone.................  7.5 mg....................              28
----------------------------------------------------------------------------------------------------------------

    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:

----------------------------------------------------------------------------------------------------------------
                                                                                                     Quantity
              Date written                           Drug                       Dosage              (number of
                                                                                                     tablets)
----------------------------------------------------------------------------------------------------------------
10.21.16................................  Oxycodone.................  30 mg.....................              84
10.21.16................................  Oxymorphone...............  7.5 mg....................              56
11.18.16................................  Oxycodone.................  30 mg.....................              84
11.18.16................................  Oxymorphone...............  7.5 mg....................              56
12.16.16................................  Oxycodone.................  30 mg.....................              84
12.16.16................................  Oxymorphone...............  7.5 mg....................              56
11.22.17................................  Oxycodone.................  30 mg.....................              84
11.22.17................................  Oxymorphone...............  7.5 mg....................              56
12.18.17................................  Oxycodone.................  30 mg.....................              84
12.18.17................................  Oxymorphone...............  7.5 mg....................              56
1.19.18.................................  Oxycodone.................  30 mg.....................              84
1.19.18.................................  Oxymorphone...............  7.5 mg....................              56
2.16.18.................................  Oxycodone.................  30 mg.....................              84
2.16.18.................................  Oxymorphone...............  7.5 mg....................              56
3.16.18.................................  Oxycodone.................  30 mg.....................              84
3.16.18.................................  Oxymorphone...............  7.5 mg....................              56
----------------------------------------------------------------------------------------------------------------

    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)
----------------------------------------------------------------------------------------------------------------
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\
---------------------------------------------------------------------------

    \7\ The surrender is signed by the Respondent individually.
---------------------------------------------------------------------------

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

    \8\ [Omitted for privacy.]
---------------------------------------------------------------------------

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

    *\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.
---------------------------------------------------------------------------

    *\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).
---------------------------------------------------------------------------

    \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.] <SUP>32 33</SUP>
---------------------------------------------------------------------------

    *\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 Respondent explained 
he and his staff had carried forward results from prior examinations to 
later visit records with new findings added, which Dr. Kennedy opined 
was not permissible. Tr. 623-28; supra ``The Analysis, Accurate and 
Complete Medical Records.''
    Dr. Kennedy noted UC's chart identified him with a ``long-standing 
history of insomnia and anxiety,'' however the chart contained no 
examination that 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. Similarly, the visit 
of October 17, 2017, by UC contains extensive medical findings, but 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 
then prescribes Elavil, or amitriptyline [which is not a controlled 
substance and is not at issue in this case.] 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 state that a physical examination 
took place at the level one visits when no physical examination 
occurred, 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. At UC's second 
visit, 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.'' Tr. 59. He was not weighed, nor was 
his blood pressure taken. 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. I credit Dr. Kennedy's

[[Page 3011]]

opinion regarding the results of non-existent tests.
    On the basis of the deficient physical exam, Dr. Kennedy opined 
that prescribing controlled substances to UC was not justified. 
Although the Respondent prescribed a much lower MME than UC had 
purportedly been on before, it was not consistent with the Tennessee 
standard, which would require 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. On a positive note, UC's chart 
revealed an exploration of alternate treatment by prescribing 
Meloxicam, and offering injections. Tr. 228-29.
    The Respondent testified he prepared an adequate written treatment 
plan with appropriate treatment goals and therapy. Tr. 590-91. However, 
Dr. Kennedy opined 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. I find Dr. Kennedy's assessments credible.*\V\
---------------------------------------------------------------------------

    *\V\ Omitted. The ALJ found that the diagnosis of C.R. with 
insomnia was appropriate. The issue relevant to this case is whether 
or not there was a recognized medical indication for the use of 
oxycodone. The medication prescribed as a result of the insomnia 
diagnosis was not a controlled substance and was not directly at 
issue in this case. Accordingly, it is not necessary to determine 
whether the records contained sufficient evidence to support the 
insomnia diagnosis, because it is not relevant to the case.
---------------------------------------------------------------------------

    [In accordance with Dr. Kennedy's credible and unrebutted expert 
testimony, and for the reasons above, I find that the three oxycodone 
prescriptions Respondent issued to UC were issued outside the usual 
course of professional practice and beneath the standard of care. The 
basis for Dr. Kennedy's opinion and my finding is that Respondent 
failed to: Take an adequate medical history including an assessment of 
UC's pain history and potential for substance abuse; perform and 
document an adequate physical examination; and 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. Additionally, and 
in accordance with Dr. Kennedy's testimony, I find that the relevant 
prescriptions issued by Respondent were outside the usual course of 
professional practice and beneath the standard of care due to 
Respondent's failure to maintain complete and accurate records for UC.]

Allegations Common to the Five Remaining Patients

    With respect to the Respondent's treatment of M.H., C.F., M.P., 
B.C., and M.W. (``the five patients''), the Government alleges the 
prescriptions for controlled substances were not issued in the course 
of professional practice inasmuch as the Respondent 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 that 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.'' The Respondent 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) conduct 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, the Respondent's conduct violated TENN. CODE ANN. Sec.  63-6-
214(b)(12) and TENN. COMP. R. & REGS. 0880-02 .14(6)(e)(3)(i)-(v).
    The Government further alleges the prescriptions the Respondent 
issued to 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 accepted and 
prevailing medical standards in Tennessee, and thus, were issued 
outside the usual course of professional practice. The Respondent's 
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, the 
Respondent failed to take reasonable steps to guard against diversion 
of controlled substances. See David A. Ruben, M.D., 78 FR at 38,382; 
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).

Allegations as to Specific Patients

    As to the allegations regarding each of the subject patients, in 
his Posthearing Brief (PHB), the Respondent argues the Government's 
case suffers weakness by the Government's failure to present the 
relevant patients' testimony, testimony of relevant pharmacists, any 
evaluation regarding the volume of the Respondent's prescriptions in 
relation to other physicians, the absence of any complaints to law 
enforcement, and no physician testimony that the subject patients were 
seeking detox due to the Respondent's excessive prescribing.*\W\
---------------------------------------------------------------------------

    *\W\ It is also noted that Respondent did not offer any of this 
testimony in an attempt to rebut the Government's case.
---------------------------------------------------------------------------

    In the context of the allegations and evidence, none of the above 
constitutes necessary evidence to prove the allegations. Indeed, I 
struggle to see any relevance to such evidence in the context of the 
allegations made.
Patient M.W.
    The Government alleged that the Respondent regularly and improperly 
issued prescriptions for large quantities and dosages of oxycodone, 
oxymorphone, alprazolam, and carispoprodol to Patient M.W. The 
Government further alleged 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 Government 
alleged that the Respondent failed to: (1) Order and obtain diagnostic 
studies; and (2) adequately address numerous instances in which the 
patient had inconsistent drug screens indicating possible diversion, 
abuse, and/or use of illegal controlled substances. The Government 
further alleged that much of the medical record for M.W. was fabricated 
and appeared to be copied from records of other patients, whose records 
contained identically worded assessments. Finally, the Government 
alleged the Respondent documented that the patient provided ``informed 
consent'' when no informed consent document could be located. 
Additionally, the Government alleged the Respondent failed to address 
substantial evidence that M.W. was engaged in abuse and/or diversion of 
controlled substances, a violation of TENN. CODE ANN. 63-6-214(b)(13).
    In support, the Government offered the testimony of its expert, Dr. 
Kennedy.

[[Page 3012]]

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 credibly 
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. The Respondent testified M.W. was first seen in 
January 2013. Tr. 595. M.W. was a gunshot victim to whom the Respondent 
prescribed alprazolam. This, according to Respondent, was based on the 
history and physical exam. Tr. 593, 635-36; GX 9 at 69. The Respondent 
claimed he 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 Respondent 
claimed that he prepared a written treatment plan. Tr. 601.
    Yet, Dr. Kennedy countered there were no findings in the record 
that 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. Dr. Kennedy 
testified that 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 written treatment plan. 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. 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. This finding was bolstered by ``wildly'' 
inconsistent UDS results. 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 will be dismissed, the history of present illness 
reports the 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 in the medical records. Tr. 259-60.
    The Respondent explained that the evaluation of the patient's 
potential for drug abuse is an ongoing evaluation with UDS, involving 
office screens, confirmatory lab screens, and pill counts. Tr. 596-98, 
600. Respondent testified that once a lab-confirmed 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.\43\ 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 
claimed 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 without identifying any specific information. Tr. 
637-38. Dr. Kennedy later conceded that M.W. was reinstated consistent 
with the Respondent's described office protocol. Tr. 459-60. The 
Respondent continued to prescribe him alprazalam, amitriptyline, 
oxycodone, oxymorphone and Soma. As noted earlier, Respondent's 
documentation of these events and his handling of M.W.'s inconsistent 
UDS was clearly outside the Tennessee standards.
---------------------------------------------------------------------------

    \43\ The Respondent's explanation of the Tennessee standards was 
admitted, not as expert testimony, as the Respondent had not been 
qualified as an expert to opine on the Tennessee standards, but as 
reflecting his understanding of the guidelines to explain why he 
took or declined to take certain action.
---------------------------------------------------------------------------

    Regarding the alprazolam prescriptions, Dr. Kennedy found it 
unjustified based on the information supporting the anxiety diagnosis. 
Tr. 260-61, 442-44; 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 other patients. Tr. 261-62. In 
his PHB, the Respondent argued that Dr. Kennedy conceded a gunshot 
victim would have PTSD; however, I credit Dr. Kennedy's opinion that 
the chart did not justify the alprazolam prescription.
    Although Dr. Kennedy opined M.W. should have been physically 
examined periodically during his treatment, the charts suggest he was 
not examined again following his first examination. 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, and the 
subject prescriptions were issued outside the usual course of 
professional practice. Tr. 267-68. I credit Dr. Kennedy's opinions in 
finding the Respondent's subject actions fell below the Tennessee 
standards, and the controlled substances were prescribed outside the 
Tennessee standards.
    [In accordance with Dr. Kennedy's credible and unrebutted expert 
testimony, and for the reasons above, I find that the twenty-six 
identified prescriptions for alprazolam, carisoprodol, oxycodone, and 
oxymorphone that Respondent issued to M.W. were issued outside the 
usual course of professional practice and beneath the standard of care. 
The basis for Dr. Kennedy's opinion and my finding is that Respondent 
failed to: Take an adequate medical history including an assessment of 
M.W.'s pain history and potential for substance abuse; perform and 
document an adequate physical examination; and create a legitimate 
written treatment plan for M.W.'s individual needs. Tr. 265. In 
accordance with Dr. Kennedy's testimony, I further find that the 
relevant prescriptions issued by Respondent were outside the usual 
course of professional practice and beneath the standard of care due to 
Respondent's failure to maintain complete and accurate records for M.W. 
Tr. 265-66. Finally, in accordance with Dr. Kennedy's testimony, I find 
that M.W. exhibited evidence of drug abuse or chemical dependency that 
was not adequately addressed by Respondent. Tr. 264-64.]
Patient C.F.
    The Government alleged that from August 2014 through August 2018, 
the Respondent regularly issued prescriptions for oxycodone and 
alprazolam to C.F. The Government further alleged that no credible 
physical examination had been performed on C.F. and that the exam 
results, as well

[[Page 3013]]

as medical history, did not justify the continued prescribing of 
controlled substances. The Government further alleged 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 Government further alleged that 
the Respondent ignored suspicious drug screen results which indicated 
illegal drug use. The Government alleged 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. 
Although the Respondent documented that the patient provided ``informed 
consent,'' no informed consent document could be located. Additionally, 
the Government alleged the Respondent failed to address substantial 
evidence that C.F. was engaged in abuse and/or diversion of controlled 
substances, a violation of TENN. CODE ANN. 63-6-214(b)(13).
    The Respondent explained that Patient C.F. had a stab wound to the 
chest, requiring heart surgery, resulting in residual chronic pain. Tr. 
601. The Respondent reported he took a medical history, performed a 
physical exam, an 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.
    Dr. Kennedy testified that the chart revealed C.F. was being 
treated for chronic pain due to trauma, and unspecified inflammatory 
polyarthropathy. Tr. 268; GX 12. Dr. Kennedy conceded C.F. had suffered 
stab wounds to the chest requiring open heart surgery, which can cause 
long-term neuropathic pain. Tr. 451-53. Although in his PHB, the 
Respondent characterizes Dr. Kennedy's criticism of the Respondent's 
subject treatment as failing to order tests, Dr. Kennedy had more 
extensive criticism than that. Dr. Kennedy opined that the history, 
physical exams, the pain and physical and psychological functioning, 
the potential for substance abuse, written treatment plan, and 
alternate treatment considerations were each inadequate, and did not 
justify the controlled substance prescriptions.\44\ Tr. 269-70, 285, 
455; GX 11 at 106; GX 12, at 7. Dr. Kennedy noted the Respondent did 
not discuss the risks and benefits of controlled substance medications. 
Tr. 285. 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 duplicated so often 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 inconsistent UDSs for C.F., collected on July 2, 
2018, and thereafter. Tr. 273-80, 282; GX 11 at 9, 23, 24, 25, 28, 33, 
44, 47, 54, 69, 78, 111, 117; GX 20. Even more concerning, C.F.'s UDS 
result was negative for all of the medications she was prescribed. Tr. 
275-77. C.F. also tested positive for cocaine and marihuana. 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,'' Dr. 
Kennedy credibly testified that this was insufficient under Tennessee 
standards to address C.F.'s drug abuse and diversion. Tr. 280, 284. I 
credit Dr. Kennedy's assessment regarding the Respondent's deficient 
handling of C.F.'s ongoing drug abuse and diversion.
---------------------------------------------------------------------------

    \44\ The Agency has previously found based on the expert 
testimony that where the respondent: (1) ``gave inadequate 
examinations or none at all;'' (2) ignored the results of tests; and 
(3) ``took no precautions against misuse and diversion'' of 
controlled substances, the evidence established that the respondent 
exceeded the bounds of professional practice. Carlos Gonzalez, M.D., 
76 FR 63,118, 63,141 (2011) (citing United States v. Moore, 423 U.S. 
122, 135, 142-43 (1975)).
---------------------------------------------------------------------------

    On May 3, 2017, C.F. tested positive for buprenorphine, a 
medication typically used to treat opioid use disorder. Tr. 281-82. The 
Respondent had not prescribed it. Although the Respondent explained 
that the MED prescribed to C.F. was a relatively low dose, Tr. 603-05; 
in light of C.F.'s continued drug abuse and diversion, Dr. Kennedy 
opined that the Respondent continued to improperly prescribe controlled 
substances without making a bona fide effort to cure C.F.'s addiction. 
Tr. 284. I agree.
    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 issued to C.F. were outside the usual course of 
professional practice. Tr. 287. For the reasons detailed, I concur. I 
credit Dr. Kennedy's expert opinions and find that the Respondent's 
subject prescribing to C.F. was in violation of Tennessee regulations, 
and below the Tennessee standards.
    [In accordance with Dr. Kennedy's credible and unrebutted expert 
testimony, and for the reasons above, I find that the sixteen 
identified prescriptions for alprazolam and oxycodone that Respondent 
issued to C.F. were issued outside the usual course of professional 
practice and beneath the standard of care. The basis for Dr. Kennedy's 
opinion and my finding is that Respondent failed to: Take an adequate 
medical history including an assessment of C.F.'s pain history and 
potential for substance abuse; perform and document an adequate 
physical examination; and create a legitimate written treatment plan 
for C.F.'s individual needs and discuss the risks and benefits of using 
controlled substances. In accordance with Dr. Kennedy's testimony, I 
further find that the relevant prescriptions issued by Respondent were 
outside the usual course of professional practice and beneath the 
standard of care due to Respondent's failure to maintain complete and 
accurate records for C.F. Finally, in accordance with Dr. Kennedy's 
testimony, I find that C.F. exhibited evidence of drug abuse or 
chemical dependency that was not adequately addressed by Respondent.]
Patient B.C.
    The Government alleges that from August 2014 through August 2018, 
the Respondent regularly issued prescriptions for large quantities of 
oxycodone, oxymorphone, alprazolam, and carisoprodol to B.C. The 
Government further alleged that no credible physical examination had 
been performed on B.C. and that the exam results, as well as medical 
history, did not justify the continued prescribing of controlled 
substances. The Government further alleged that no meaningful follow-up 
physical exam was repeated, that confirmatory diagnostic studies were 
not ordered, and that the Respondent failed to determine a chronic pain 
etiology. The Government further alleged that the Respondent ignored 
suspicious drug screen results which indicated illegal drug use. The 
Government alleged that much of the medical record for B.C. was 
fabricated and seemed to be copied from records of other patients whose 
records

[[Page 3014]]

contained identically worded assessments. Although the Respondent 
documented that the patient provided ``informed consent,'' no informed 
consent document could be located.
    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, on December 19, 2012,\45\ a 
potentially challenging patient. Tr. 458-59. Although not revealed in 
the chart, Respondent testified that B.C. had previously been a patient 
of the Respondent. The Respondent maintained that he 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.
---------------------------------------------------------------------------

    \45\ The Respondent noted the pain management guidelines have 
changed since then. Tr. 605. [It appears that Tennessee has been 
regulating authority for physicians to prescribe for treatment of 
pain since 2014. As the changes seem to have taken place well before 
the prescribing of the controlled substances at issue in this case, 
this information is not material to my decision.]
---------------------------------------------------------------------------

    Dr. Kennedy disagreed, claiming the Respondent did not take an 
adequate medical history. Tr. 304. Although a physical exam was 
evident, Dr. Kennedy testified that it was insufficient and non-
supportive to justify prescribing the medications prescribed. Tr. 290-
91, 304; GX 13 at 169; GX 14 at 7; GX 22. Dr. Kennedy asserted the 
Respondent did not make an adequate assessment of pain, and physical 
and psychological function, of 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, but the records did include 
hospital records. Tr. 303, 459-60. 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. Tr. 628-29; GX 13 at 
5. The Respondent explained that some records were lost in 2014.\46\ 
Tr. 630. However, the missing records were not recreated despite B.C. 
being a long-term patient. Tr. 630.
---------------------------------------------------------------------------

    \46\ I ruled the evidence of lost files in 2014 inadmissible as 
unnoticed and not reasonably anticipated by the Government, 
representing surprise.
---------------------------------------------------------------------------

    The Respondent explained why he obtained and kept pharmacy 
printouts in his records. 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.
    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. 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 which was not 
resolved. Tr. 293-94; GX 13 at 188.
    Dr. Kennedy noted the actual pain level was left blank at nine 
consecutive encounters, suggesting it is being added later, a further 
indication of fabricated records. Tr. 294-95; GX 13 at 159; GX 14 at 8. 
Dr. Kennedy opined the Respondent did not maintain accurate and 
complete records. Tr. 306. 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. This is outside the usual course of 
professional practice. B.C. continued to have inconsistent UDS results, 
which were insufficiently addressed by the Respondent. Tr. 297-98; GX 
13 at 33, 79, 150, 155, 156, 158, 164, 165. The Respondent countered 
that 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. Although ruling out 
doctor shopping is appropriate and necessary action, it does not excuse 
the failure to adequately address B.C.'s drug abuse and other red 
flags. I credit Dr. Kennedy's findings, and I find that 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.
    [In accordance with Dr. Kennedy's credible and unrebutted expert 
testimony, and for the reasons above, I find that the eighteen 
identified prescriptions for alprazolam, oxymorphone, carisoprodol, and 
oxycodone that Respondent issued to B.C. were issued outside the usual 
course of professional practice and beneath the standard of care. The 
basis for Dr. Kennedy's opinion and my finding is that Respondent 
failed to: Take an adequate medical history including an assessment of 
B.C.'s pain history and potential for substance abuse; perform and 
document an adequate physical examination; and create a legitimate 
written treatment plan for B.C.'s individual needs and discuss the 
risks and benefits of using controlled substances. In accordance with 
Dr. Kennedy's testimony, I further find that the relevant prescriptions 
issued by Respondent were outside the usual course of professional 
practice and beneath the standard of care due to Respondent's failure 
to maintain complete and accurate records for B.C. Finally, in 
accordance with Dr. Kennedy's testimony, I find that B.C.'s records 
included unresolved inconsistent drug screens, a red flag that was not 
adequately addressed by Respondent.]
Patient M.H.
    The Government alleges that from August 2014 through February 2018, 
the Respondent regularly issued prescriptions for large quantities of 
alprazolam, carisoprodol, oxycodone, and oxymorphone to M.H. The 
Government further alleges the Respondent diagnosed M.H. with ``chronic 
pain syndrome'' even though the Respondent made no attempt to diagnose 
a specific pain etiology. The Government further alleged that 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 
physical examination and medical history did not justify the continued 
prescribing of controlled substances. The Government alleged the 
Respondent ignored a major surgical intervention that occurred in 
September 2016 as well as an abnormal drug screen. As such, the 
Government 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 Government alleged 
that, in some cases, the Respondent failed to repeat certain physical 
exams after the initial encounter with M.H., despite the fact the 
Respondent provided him with prescriptions for controlled substances 
for more than three years.
    The Respondent explained Patient M.H. presented with a post gunshot 
wound to the abdomen and chronic low

[[Page 3015]]

back pain secondary to degenerative disc disease. Tr. 608. According to 
Respondent, 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 testified 
that he prescribed a lower MME than the surgeon prescribed post-
operative at Vanderbilt. Tr. 611.
    Dr. Kennedy identified his summary chart for Patient M.H. Tr. 309; 
GX 15; GX 16. The chart reveals 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 and, in Dr. Kennedy's 
opinion, do not support any chronic pain diagnosis. Tr. 311. The 
records reveal M.H. suffered a gunshot wound in 2008, and although 
serious, Dr. Kennedy opined that 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 because the Respondent 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. 312, 326-28. The Respondent did not conduct any 
periodic reviews, or discuss the risks and benefits of the use of 
controlled substances. Tr. 328. M.H. had inconsistent UDSs. Tr. 314-20; 
GX 15 at 36, 39, 40, 47, 49, 53, 56, 63. Although several inconsistent 
UDS were noted in the chart, there were typically no notes of 
discussions. The Respondent failed to adequately address the UDS. Tr. 
314-20.
    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 from the hospital. GX 15 at 48. Despite his recent, major 
surgery, there is no mention of the surgery in the encounter notes. Tr. 
322-23. The encounter notes are identical to all the other encounter 
notes for M.H. Tr. 323; GX 15 at 48. The Respondent conceded his 
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 explained that the subject findings were based on 
``history.'' Tr. 638. Put another way, Respondent carried forward the 
exam indications from the pre-surgery visit to the post-surgery visit.
    There is no updated physical exam, as Dr. Kennedy opined would be 
required. Tr. 324. The PE and HPI notes are the same as those the four 
months prior to the spinal surgery, which is not credible. Tr. 324-25, 
491-92; GX 15 at 49, 51. Dr. Kennedy opined that 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 
M.H. was addicted to controlled substances, yet the Respondent 
continued prescribing them without making a bona fide effort to cure 
the addiction. Tr. 325. The Respondent conceded the chart reports that 
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 in 
that instance. Tr. 640. However, even if the inconsistent UDS result 
were at the point of care, as discussed supra, the record discloses 
there were eight of them, some of which went completely unaddressed 
within the records. I credit Dr. Kennedy's opinion that the 
Respondent's failure to resolve the red flag arising from inconsistent 
UDS rendered the subsequent prescribing outside the Tennessee standard 
of care.
    Dr. Kennedy opined the subject prescriptions were issued outside 
the usual course of professional practice. Tr. 329-30, 493. I credit 
Dr. Kennedy's findings, and find that the Respondent's controlled 
substance prescribing were in violation of Tennessee regulations and 
the Tennessee standards.
    [In accordance with Dr. Kennedy's credible and unrebutted expert 
testimony, and for the reasons above, I find that the approximately 
fifteen identified prescriptions for alprazolam, oxycodone, and 
oxymorphone that Respondent issued to M.H. were issued outside the 
usual course of professional practice and beneath the standard of care. 
The basis for Dr. Kennedy's opinion and my finding is that Respondent 
failed to: Take an adequate medical history including an assessment of 
M.H.'s pain history and potential for substance abuse; perform and 
document an adequate physical examination; and create a legitimate 
written treatment plan for M.H.'s individual needs and discuss the 
risks and benefits of using controlled substances. In accordance with 
Dr. Kennedy's testimony, I further find that the relevant prescriptions 
issued by Respondent were outside the usual course of professional 
practice and beneath the standard of care due to Respondent's failure 
to maintain complete and accurate records for M.H. Finally, in 
accordance with Dr. Kennedy's testimony, I find that M.H. exhibited 
evidence of drug abuse or chemical dependency that was not adequately 
addressed by Respondent.]
Patient M.P.
    The Government alleges that from September 2016 through April 2018, 
the Respondent regularly issued prescriptions for large quantities of 
oxycodone and oxymorphone to M.P. The Government alleges that the 
Respondent failed to request and obtain past medical records, the 
Respondent failed to order any radiographic studies, and that the 
physical examinations of M.P., including follow-up exams, were 
substandard and not credible. The Government alleged that the 
Respondent failed to document any evidence to support a pain etiology 
and that the Respondent failed to properly address M.P.'s substance 
abuse disorder despite the fact that she suffered a heroin overdose in 
the Respondent's waiting room. As a result, the Government alleged 
there were no objective findings to justify the continued prescribing 
of oxycodone and oxymorphone. The Government alleges 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. The Respondent also documented that the patient provided 
``informed consent'' when no informed consent document could be located 
in the medical record. Additionally, the Government alleged the 
Respondent failed to address substantial evidence that M.P. was engaged 
in abuse and/or diversion of controlled substances, a violation of 
TENN. CODE ANN . Sec.  63-6-214(b)(13).
    The Respondent explained 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 by the patient. Tr. 642. The Respondent claimed that he 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.
    Dr. Kennedy countered, noting he reviewed the prescriptions issued. 
Tr. 348-49; GX 21. He opined that the chart, including the number of

[[Page 3016]]

inconsistent UDS, reveals that M.P. was 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 and 
issued outside the usual course of professional practice. Tr. 352, 488-
89.
    Dr. Kennedy reported M.P. was being treated for low back, neck, hip 
and shoulder pain. Tr. 331; GX 8. 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. Dr. 
Kennedy opined that Respondent 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. Dr. Kennedy stated that M.P.'s employment as a server, working 
45-60 hours per week is inconsistent with her ``occupational 
disability'' score of 9 or 10, 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. 
Instead the PE notes duplicated throughout the records appears. 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 explained that 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. There is no documentary proof records were ever requested.
    Dr. Kennedy concluded the Respondent did not maintain accurate and 
complete records as to M.P. Tr. 350. 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.B. had been 
terminated from a prior physician, a red flag. Tr. 343. The records did 
reveal a monitoring of the Tennessee PDMP, and a successful pill count, 
both positive steps by the Respondent. 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.
    The Respondent explained those events. He testified that M.P. came 
to the clinic overdosing on heroin. Tr. 342, 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. Following the heroin 
overdose, the determination was made that she needed treatment of 
Suboxone and no further opioid prescriptions. Tr. 616. 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. He stated that 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 them home without observation by the physician. Tr. 612-14. 
According to Respondent, M.P. was initially receptive to drug 
treatment, but later changed clinics. Tr. 615.
    Dr. Kennedy viewed Respondent's prescribing of Suboxone as 
dangerous and outside the standard of care. 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 (Suboxone), which in conjunction with heroin could result 
in permanent withdrawal. Tr. 343. The Respondent argues in his PHB that 
a successful UDS was conducted. However, I do not find a successful UDS 
in the record prior to the Respondent prescribing Suboxone. There were 
inconsistent UDS in the records for M.P. Tr. 346-; GX 7 at 48, 59. I 
credit Dr. Kennedy's findings. The Respondent's prescribing to M.B. was 
in violation of Tennessee regulations and Tennessee standards. The 
Suboxone prescription without determining her heroin level was 
dangerous and outside the course of professional practice. The 
Respondent's failure to timely address M.P.'s inconsistent UDS results 
was outside the Tennessee standards.
    [In accordance with Dr. Kennedy's credible and unrebutted 
testimony, and for the reasons above, I find that the sixteen 
identified prescriptions for oxycodone and oxymorphone and the 
prescription for buprenorphine that Respondent issued to M.P. were 
issued outside the usual course of professional practice and beneath 
the standard of care. The basis for Dr. Kennedy's opinion and my 
finding is that Respondent failed to: Take an adequate medical history 
including an assessment of M.P.'s pain history and potential for 
substance abuse; perform and document an adequate physical examination; 
and create a legitimate written treatment plan for M.P.'s individual 
needs and discuss the risks and benefits of using controlled 
substances. In accordance with Dr. Kennedy's testimony, I further find 
that the relevant prescriptions issued by Respondent were outside the 
usual course of professional practice and beneath the standard of care 
due to Respondent's failure to maintain complete and accurate records 
for M.P. Finally, in accordance with Dr. Kennedy's testimony, I find 
that M.P. exhibited evidence of drug abuse or chemical dependency that 
was not adequately addressed by Respondent until after she overdosed in 
his office.]

Material Falsification

    In its GSPHS, the Government alleged that, on November 6, 2019, the 
Respondent made a material misrepresentation in his renewal application 
for his Tennessee-based DEA COR, W18070589C. Specifically, 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. An affirmative answer to 
question 3 would trigger an investigation by a diversion investigator 
whether to issue the registration or to deny it. The Respondent 
answered ``No'' to question 3.
    In support, the Government cites to the State of Tennessee 
Department of Health, Notice of Charges and Memorandum for Assessment 
of Civil Penalties, dated May 2018. GX 29. [In this document, the state 
requested that ``Respondent's certificate to operate a Pain Management 
Clinic . . . be suspended, revoked, or otherwise disciplined.'' GX 29, 
at 25.] A year later

[[Page 3017]]

in May 2019, the Chancery Court for the State of Tennessee, 20th 
Judicial District, Davidson County, Part 3, issued an order Reversing 
Denial of Stay, but Accompanying Stay with Conditions. GX 27. The stay 
was conditioned upon the Respondent ``not writing any prescriptions 
during the pendency of the stay; . . . and/or not providing direct 
patient care including but not limited to diagnosing, treating, 
operating on or prescribing for any person.'' GX 27, at 2. Therefore, 
as of May 2019, the Conditions preclude the Respondent from writing 
prescriptions or providing direct patient care during the pendency of 
the stay and were reportable restrictions. When asked on his November 
6, 2019 application whether Respondent had ever had a state 
professional license or controlled substance registration revoked, 
suspended, or restricted or had any such action pending, he was 
required to, but did not, disclose these events.*<SUP>X 47</SUP> 
Therefore, I find clear, unequivocal, and convincing evidence that 
Respondent submitted a registration application containing a false 
answer to the third Liability question.
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    *\X\ Omitted text. The Government also alleged that Respondent's 
surrender of his pain clinic's license also warranted an affirmative 
response to question 3 on Respondent's personal application. I find 
that I do not need to reach a decision on this evidence as the 
Government has already presented ample evidence that Respondent 
materially falsified his application when he failed to report that 
his authority to dispense controlled substances was restricted.
    \47\ [Omitted the original text containing this footnote.]
---------------------------------------------------------------------------

    [My finding about Respondent's submission of a false answer 
involves restrictions on Respondent's state license to dispense 
controlled substances. Id. In setting the requirements for obtaining a 
practitioner's registration, Congress directed that ``[t]he Attorney 
General shall register practitioners . . . if the applicant is 
authorized to dispense . . . controlled substances under the laws of 
the State in which he practices.'' 21 U.S.C. 823(f). Accordingly, it is 
clear that having authorization to dispense controlled substances is a 
prerequisite to my ability to grant an applicant's application. 
Respondent's false response to the third Liability question directly 
implicated my statutorily-mandated analysis and my decision by 
depriving me of legally relevant facts when I evaluated Respondent's 
registration renewal application. See Frank Joseph Stirlacci, M.D., 85 
FR 45,229, 45,235 (2020). Accordingly, I find, based on the CSA and the 
analysis underlying multiple Supreme Court decisions explaining 
``materiality,'' that the falsity Respondent submitted was material. 
Frank Joseph Stirlacci, M.D., 85 FR at 45,235.] *<SUP>Y</SUP> 
*<SUP>Z</SUP>
---------------------------------------------------------------------------

    *\Y\ This language replaces the ALJ's original analysis for 
clarity.
    *\Z\ Omitted ALJ's discussion of the pain clinic's license. See 
supra n. *X. I have also consolidated the ALJ's original section 
entitled ``Conditions of Stay'' with the preceding paragraph for 
brevity.
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Government's Burden of Proof and Establishment of a Prima Facie Case

    Based upon my review of each of the allegations by the Government, 
it is necessary to determine if it has met its prima facie burden of 
proving the requirements for a sanction pursuant to 21 U.S.C. 824(a)(4) 
and 21 U.S.C. 823(f). At the outset, I find that the Government has 
demonstrated and met its burden of proof in support of its allegations 
relating to the prescribing of controlled substances to patients UC, 
M.P., M.W., C.F., B.C., and M.H. The Government has also sustained 
their burden as to the material misrepresentation allegation.

Public Interest Determination: The Standard

    [Under Section 304 of the CSA, ``[a] registration . . . to . . . 
dispense a controlled substance . . . may be suspended or revoked by 
the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render his registration under section 823 
of this title inconsistent with the public interest as determined by 
such section.'' 21 U.S.C. 824(a)(4).] \48\ Evaluation of the following 
factors have been mandated by Congress in determining whether 
maintaining such registration would be inconsistent with the ``the 
public interest:''
---------------------------------------------------------------------------

    \48\ [This text replaces the ALJ's original text and omits his 
original footnote for clarity.]

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f). ``These factors are . . . considered in the 
disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
    Any one or a combination of factors may be relied upon, and when 
exercising authority as an impartial adjudicator, the Agency may 
properly give each factor whatever weight it deems appropriate in 
determining whether a registrant's registration should be revoked. Id. 
(citation omitted); David H. Gillis, M.D., 58 FR 37507, 37508 (1993); 
see also Morall v. DEA at 173-74; Henry J. Schwarz, Jr., M.D., 54 FR 
16422, 16424 (1989). Moreover, the Agency is ``not required to make 
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d at 482; see 
also Morall, 412 F.3d at 173. [Omitted for brevity.] The balancing of 
the public interest factors ``is not a contest in which score is kept; 
the Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest . . . .'' Krishna-Iyer, M.D., 74 FR at 462.
    The Government's case invoking the public interest factors of 21 
U.S.C. 823(f) seeks the revocation of the Respondent's COR based 
primarily on conduct most aptly considered under Public Interest 
Factor's [Two and] Four.\49\
---------------------------------------------------------------------------

    \49\ [Where the record contains no evidence of a recommendation 
by a state licensing board that absence does not weigh for or 
against revocation. See Roni Dreszer, M.D., 76 FR 19,434, 19,444 
(2011) (``The fact that the record contains no evidence of a 
recommendation by a state licensing board does not weigh for or 
against a determination as to whether continuation of the 
Respondent's DEA certification is consistent with the public 
interest.''). Here, to the extent that Tennessee's decision not to 
revoke or suspend Respondent's individual authority to handle 
controlled substances could weigh in his favor, I find that any such 
weight would be significantly reduced by the circumstances of the 
loss of his practice's license, and the pending nature of the state 
action on his individual license.] Likewise, the record contains no 
evidence that the Respondent has been convicted of a crime related 
to controlled substances (Factor Three).
---------------------------------------------------------------------------

[Factors Two and Four: The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances] *\AA\
---------------------------------------------------------------------------

    *\AA\ The ALJ only evaluated the evidence under Factor 4. 
However, Respondent's dispensing experience is clearly relevant to 
my determination as to whether or not Respondent's continued 
registration is consistent with the public interest, and I have made 
changes throughout this section accordingly.
---------------------------------------------------------------------------

    According to the Controlled Substances Act's (hereinafter, CSA) 
implementing regulations, a lawful controlled substance order or 
prescription is one that is ``issued for a legitimate medical purpose 
by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a). The Supreme Court has 
stated, in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription,

[[Page 3018]]

that ``the prescription requirement . . . ensures patients use 
controlled substances under the supervision of a doctor so as to 
prevent addiction and recreational abuse . . . [and] also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    I found above that the Government's expert credibly testified as 
supported by Tennessee law, that the standard of care requires a 
practitioner, before prescribing controlled substances, to take an 
adequate medical history including an assessment of the patient's pain 
history and potential for substance abuse; perform and document an 
adequate physical examination; and create a legitimate written 
treatment plan for the patient's individual needs and to discuss the 
risks and benefits of the use of controlled substances with the 
patient. Additionally, I found that practitioners are required to 
maintain complete and accurate records for their patients. I also found 
above that Respondent issued approximately ninety-five controlled 
substance prescriptions outside the usual course of professional 
practice and beneath the standard of care. This is because for each of 
the relevant prescriptions, I found that the Respondent failed to take 
an adequate medical history including an assessment of each patient's 
pain history and potential for substance abuse; perform and document an 
adequate physical examination; and/or create a legitimate written 
treatment plan for each patient's individual needs and/or discuss the 
risks and benefits of using controlled substances with the patient. I 
also found that each of the relevant prescriptions 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.
    Respondent repeatedly issued prescriptions without complying with 
the applicable standard of care and state law thus demonstrating that 
his conduct was not an isolated occurrence, but occurred with multiple 
patients. See Kaniz Khan Jaffery, 85 FR 45,667, 45,685 (2020). For 
example, Respondent's medical records for each of the individuals at 
issue had verbatim language repeated throughout the relevant time frame 
stating, ``Patient has a long standing h/o insomnia and anxiety for 
several years. Anxiety symptoms include sob, palpitations, sweating, 
dizziness, shaking, insomnia, irritability, pacing, moodiness and 
feeling faint. Right now no headache, no dizziness, no nausea, no 
vomiting, no abdominal pain, no diarrhoea [sic.], no constipation, no 
sob, no chest pain, no palpitations.'' GX 9, at 85; GX 11, at 39; Tr. 
286-87. This verbatim language was included in each patient's record 
and in UC's records to which UC testified credibly that he did not 
report having any of the anxiety symptoms identified in the chart.
    Agency decisions highlight the Agency's interpretation that 
``[c]onscientious documentation is repeatedly emphasized as not just a 
ministerial act, but a key treatment tool and vital indicator to 
evaluate whether the physician's prescribing practices are `within the 
usual course of professional practice.' '' Cynthia M. Cadet, M.D., 76 
FR 19,450, 19,464 (2011). DEA's ability to assess whether controlled 
substances registrations are consistent with the public interest is 
predicated upon the ability to consider the evidence and rationale of 
the practitioner at the time that he prescribed a controlled 
substance--adequate documentation is critical to that assessment. See 
Kaniz-Khan Jaffery, 85 FR at 45,686. Further, as Dr. Kennedy testified, 
``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. Therefore, recordkeeping is not only 
important for compliance, but also for the safety of the patients.
    DEA decisions have found that ``just because misconduct is 
unintentional, innocent, or devoid of improper motive, [it] does not 
preclude revocation or denial. Careless or negligent handling of 
controlled substances creates the opportunity for diversion and [can] 
justify the revocation of an existing registration . . .'' Bobby D. 
Reynolds, N.P., Tina L. Killebrew, N.P., & David R. Stout, N.P., 80 FR 
28,643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51,592, 
51,601 (1998). ``Diversion occurs whenever controlled substances leave 
`the closed system of distribution established by the CSA . . . .' '' 
Id. (citing Roy S. Schwartz, 79 FR 34,360, 34,363 (2014)). In this 
case, I have found that Respondent issued controlled substance 
prescriptions without complying with his obligations under the CSA and 
Tennessee law. See George Mathew, M.D., 75 FR 66,138, 66,148 (2010)).
    With regard to Tennessee law, I find that in issuing controlled 
substances prescriptions that were outside the usual course of 
professional practice and beneath the standard of care, Respondent 
issued prescriptions that were ``not in the course of professional 
practice'' in violation of TENN. CODE ANN. Sec.  63-6-2l4(b)(12). The 
Tennessee 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). 
I found above that respondent failed to conduct an adequate assessment 
and consideration of the pain and potential for substance abuse and 
failed to conduct a physical examination for each of the individuals at 
issue including UC. 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.'' I found above that respondent failed to prepare 
a tailored written treatment plan for each of the individuals at issue 
including UC. Tennessee guidelines also requires the physician to 
``discuss the risks and benefits of the use of controlled substances,'' 
which I found above that Respondent failed to do for UC, C.F., B.C., 
M.H., and M.P., and ``keep [c]omplete and accurate records of the 
care,'' which Respondent failed to do for each of the individuals at 
issue including UC. Id. at 0880-02-.14(6)(e)(3)(ii)-(v).
    Additionally, TENN. CODE ANN. Sec.  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.'' Crediting Dr. Kennedy's 
testimony, I found above that Respondent acted outside the bounds of 
this law with regard to patients M.W., C.F., M.H., and M.P.]
    The evidence is clear the Respondent violated the Tennessee 
regulations alleged, and the Tennessee professional standards. The 
Tennessee regulations are related to controlled substances. [Overall, I 
find that in issuing ninety-five prescriptions beneath the

[[Page 3019]]

applicable standard of care and outside the usual course of 
professional practice in Tennessee, Respondent violated 21 CFR 
1306.04(a) in addition to Tennessee law, and these violations of law 
weigh against Respondent's continued registration under Public Interest 
Factors 2 and 4.] \50\
---------------------------------------------------------------------------

    \50\ An expert's opinion that a doctor's treatment of patients 
fell below the standard of care is probative of whether the doctor 
violated 21 CFR 1306.04(a). Bienvenido Tan, M.D., 76 FR 17,673, 
17,681 (2011).
---------------------------------------------------------------------------

Sanctions <SUP>*BB</SUP>
---------------------------------------------------------------------------

    *\BB\ I am replacing portions of the Sanction section in the RD 
with preferred language regarding prior Agency decisions; however, 
the substance is primarily the same.
---------------------------------------------------------------------------

    [Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration is inconsistent with 
the public interest, the burden shifts to the Respondent to show why he 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18,882, 18,910 (2018) (collecting cases). Respondent has made minimal 
effort to establish that he can be entrusted with a registration.
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales v. Oregon, 546 U.S. 243, 
259 (2006). A clear purpose of this authority is to ``bar[ ] doctors 
from using their prescription-writing powers as a means to engage in 
illicit drug dealing and trafficking.'' Id. at 270.
    In efficiently executing the revocation and suspension authority 
delegated to me under the CSA for the aforementioned purposes, I review 
the evidence and arguments Respondent submitted to determine whether or 
not he has presented ``sufficient mitigating evidence to assure the 
Administrator that he can be trusted with the responsibility carried by 
such a registration.'' Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 
(2007) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988)). `` 
`Moreover, because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 
1995), [the Agency] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [the registrant's] actions and 
demonstrate that [registrant] will not engage in future misconduct.' '' 
Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting Medicine Shoppe, 73 
FR 364, 387 (2008)); see also Jackson, 72 FR at 23,853; John H. 
Kennedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (1995).
    The issue of trust is necessarily a fact-dependent determination 
based on the circumstances presented by the individual respondent; 
therefore, the Agency looks at factors, such as the acceptance of 
responsibility and the credibility of that acceptance as it relates to 
the probability of repeat violations or behavior and the nature of the 
misconduct that forms the basis for sanction, while also considering 
the Agency's interest in deterring similar acts. See Arvinder Singh, 
M.D., 81 FR 8247, 8248 (2016).]
    While the Respondent has conceded that his medical charts contained 
several errors he never accepted responsibility for [the violations I 
have found]. His testimony defending the identical indications among 
his patients in support of his anxiety and insomnia diagnoses was not 
at all credible. The lack of a credible explanation for the inclusion 
of results in UC's chart of tests and examinations which did not take 
place weighs heavily against a finding of acceptance of responsibility. 
Furthermore, although he testified, he did not address the material 
falsification allegation. I therefore find that any acceptance of 
responsibility has neither been unequivocal nor complete.
    [In all, Respondent failed to explain why, in spite of his 
misconduct, he can be entrusted with a registration. ``The degree of 
acceptance of responsibility that is required does not hinge on the 
respondent uttering ``magic words'' of repentance, but rather on 
whether the respondent has credibly and candidly demonstrated that he 
will not repeat the same behavior and endanger the public in a manner 
that instills confidence in the Administrator.'' Jeffrey Stein, M.D., 
84 FR 46,968, 49,973 (2019). Here, having considered Respondent's case 
and statements, I am left with no confidence in Respondent's future 
compliance with the CSA.]

Egregiousness and Deterrence

    [The Agency also looks to the egregiousness and extent of the 
misconduct which are significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR at 18,910 (collecting 
cases).] I find that the proven misconduct is egregious and that 
deterrence considerations weigh in favor of revocation. [Respondent 
issued approximately 95 prescriptions for controlled substances outside 
the usual course of professional practice and beneath the standard of 
care.] The proven misconduct involved fabricated medical charts, 
failure to meaningfully address serious and ongoing indications of drug 
abuse and diversion by several of his patients, as well as other red 
flags. The proven misconduct also involved the material falsification 
of his application for his CSA registration renewal in Tennessee.*\CC\
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    *\CC\ Remaining analysis of egregiousness omitted for relevance.
---------------------------------------------------------------------------

    [In sanction determinations, the Agency has historically considered 
its interest in deterring similar acts, both with respect to the 
respondent in a particular case and the community of registrants. See 
Joseph Gaudio, M.D., 74 FR 10,083, 10,095 (2009); Singh, 81 FR at 8248. 
I find that considerations of both specific and general deterrence 
weigh in favor of revocation in this case.] Allowing the Respondent to 
retain his COR despite the proven misconduct would send the wrong 
message to the regulated community. Imposing a sanction less than 
revocation would create the impression that registrants can maintain 
DEA registration despite ignoring obvious signs of abuse, diversion and 
other serious red flags, the wholesale failure to maintain adequate, 
complete and accurate medical charts, and after making a material 
falsification on a renewal application. Revoking the Respondent's COR 
communicates to registrants that the DEA takes all of these failings 
under the CSA seriously and that severe violations will result in 
severe sanctions.
    [Omitted.] *\DD\
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    *\DD\ I agree with the ALJ that Respondent's testimony lacked 
credibility and I have given it little-to-no weight in reaching my 
decision. However, in light of Respondent's failure to unequivocally 
accept responsibility, it is not necessary for me to assess whether 
Respondent's testimony also lacked candor and I have therefore 
omitted the ALJ's discussion of this topic.
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Loss of Trust

    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 at 387. The Respondent's material misrepresentation compounds the 
Respondent's instant burden. Although the Respondent offered some 
evidence of mitigation, even if considered, it has not overcome the 
loss of trust resulting from the allegations found herein.

[[Page 3020]]

[There is simply no evidence that Respondent's behavior is not likely 
to recur in the future such that I can entrust him with a CSA 
registration; in other words, the factors weigh in favor of revocation 
as a sanction.]

Recommendation

    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for revocation. In evaluating Factors 
[Two and] Four of 21 U.S.C. 823(f), I find that the Respondent's COR is 
inconsistent with the public interest. Furthermore, I find that the 
Respondent has failed to overcome the Government's prima facie case by 
unequivocally accepting responsibility and establishing that he can be 
trusted with a registration.
    Therefore, I recommend that the Respondent's DEA COR Control No. 
BO4959889 should be revoked, and that any pending applications for 
modification or renewal of the existing registration, including the 
pending application for a new DEA COR Control No. W18070589C, and any 
applications for additional registrations, be denied.

Mark M. Dowd,
U.S. Administrative Law Judge.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of 
Registration No. BO4959889 issued to Samson K. Orusa, M.D. Pursuant to 
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 
21 U.S.C. 823(f), I further hereby deny any other pending applications 
for renewal or modification of this registration, the pending 
application for new DEA COR Control No. W18070589C, as well as any 
other pending application of Samson K. Orusa, M.D., for registration in 
Tennessee. This Order is effective February 18, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-00952 Filed 1-18-22; 8:45 am]
BILLING CODE 4410-09-P