[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21165-21174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07688]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-17]


Noah David, P.A.; Decision and Order

    On March 9, 2020, a former Assistant Administrator, Diversion 
Control Division, of the Drug Enforcement Administration (hereinafter, 
DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to 
Noah David, P.A. (hereinafter, Respondent) of Richmond, Virginia. 
Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (OSC), at 1. The 
OSC proposed the revocation of Respondent's DEA Certificate of 
Registration No. MD3130717 (hereinafter, COR or registration) and the 
denial of ``any pending application for renewal or modification of such 
registration and any applications for any other DEA registrations, 
pursuant to 21 U.S.C. 824(a)(4), because [Respondent's] registration is 
inconsistent with the public interest, as that term is defined in 21 
U.S.C. 823(f).'' Id.
    On April 7, 2020, the Respondent timely requested a hearing, which 
commenced (and ended) on September 22, 2020, at the DEA Hearing 
Facility in Arlington, Virginia with the parties, counsel, and 
witnesses participating via video teleconference (VTC). On December 8, 
2020, Chief Administrative Law Judge John J. Mulrooney, II 
(hereinafter, the Chief ALJ) issued his Recommended Rulings, Findings 
of Fact, Conclusions of Law and Decision of the Administrative Law 
Judge (hereinafter, Recommended Decision or RD). By letter dated 
January 5, 2021, the ALJ certified and transmitted the record to me for 
final Agency action. In that letter, the ALJ advised that neither party 
filed exceptions. Having reviewed the entire record, I adopt the ALJ's 
rulings, findings of fact, as modified, conclusions of law and 
recommended sanction with minor modifications, where noted herein.*\A\
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    *\A\ I have made minor modifications to the RD. I have 
substituted initials or titles for the names of witnesses and 
patients to protect their privacy and I have made minor, 
nonsubstantive, grammatical changes 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 ALJ's 
opinion, I have noted the edits with an asterisk, and I have 
included specific descriptions of the modifications in brackets 
following the asterisk or in footnotes marked with a letter and an 
asterisk. 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

John J. Mulrooney, II

Chief Administrative Law Judge

December 8, 2020

    *\B\ 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.
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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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I. Findings of Fact

A. Allegations

    The Government alleges that the Respondent's COR should be revoked 
because he has committed acts which render his continued registration 
against the public interest. ALJX 1, at 1. Specifically, the Government 
contends that on numerous occasions between April 2014 and November 
2018, the Respondent unlawfully prescribed controlled substances to his 
wife without establishing a bona fide practitioner-patient relationship 
and without properly documenting treatment. Id. at 3-4. The Government 
additionally alleges that the Respondent conspired with colleagues to 
unlawfully receive controlled substances. Id. at 4.

B. Stipulations

    The parties entered into a robust set of factual stipulations which 
were accepted by the tribunal. Accordingly, the following factual 
matters are deemed conclusively established in this case:
    1. The Respondent is registered with the DEA as a practitioner to 
handle controlled substances in Schedules II-V under DEA COR No. 
MD3130717 at 5211 West Broad Street, Suite 101, Richmond, Virginia 
23230-3000.
    2. DEA COR No. MD3130717 was issued on May 15, 2019 and expires by 
its own terms on June 30, 2022.
    3. The Respondent is presently licensed as a physician assistant in 
Virginia under License No. 0110004505, which expires April 30, 2021.
    4. Respondent Exhibit 1 is a true and correct copy of the 
Respondent's COR.
    5. The Respondent prescribed the following controlled substances on 
the following dates to his wife, B.D.:

(1) 11/28/2018: Oxycodone-Acetaminophen 5-325, 36 tablets
(2) 11/20/2018: Oxycodone-Acetaminophen 5-325, 36 tablets
(3) 11/08/2018: Oxycodone-Acetaminophen 5-325, 36 tablets
(4) [10/30/2018: Oxycodone-Acetaminophen 5-325, 36 tablets]
(5) 10/01/2018: Oxycodone-Acetaminophen 10-325, 18 tablets
(6) 9/21/2018: Oxycodone-Acetaminophen 10-325, 18 tablets
(7) 9/13/2018: Oxycodone-Acetaminophen 10-325, 18 tablets
(8) 9/06/2018: Oxycodone-Acetaminophen 5-325, 60 tablets
(9) 8/22/2018: Oxycodone-Acetaminophen 5-325, 60 tablets
(10) 8/17/2018: Oxycodone-Acetaminophen 5-325, 60 tablets
(11) 7/23/2018: Oxycodone-Acetaminophen 5-325, 42 tablets
(12) 7/10/2018: Oxycodone-Acetaminophen 5-325, 84 tablets
(13) 7/03/2018: Oxycodone-Acetaminophen 10-325, 18 tablets
(14) 5/30/2018: Acetaminophen-Codeine #3, 60 tablets
(15) 5/30/2018: Acetaminophen-Codeine #3, 60 tablets (refill)
(16) 5/30/2018: Acetaminophen-Codeine #3, 60 tablets (refill)
(17) 5/21/2018: Oxycodone-Acetaminophen 5-325, 12 tablets
(18) 5/08/2018: Diazepam 5mg, 30 tablets
(19) 4/24/2018: Oxycodone-Acetaminophen 10-325, 28 tablets
(20) 3/16/2018: Oxycodone-Acetaminophen 10-325, 28 tablets
(21) 2/15/2018: Oxycodone-Acetaminophen 10-325, 28 tablets
(22) 2/09/2018: Oxycodone-Acetaminophen 10-325, 12 tablets
(23) 1/23/2018: Oxycodone-Acetaminophen 10-325, 28 tablets
(24) 1/19/2018: Oxycodone-Acetaminophen 10-325, 12 tablets
(25) 1/05/2018: Oxycodone-Acetaminophen

[[Page 21166]]

10-325, 42 tablets
(26) 1/03/2018: Oxycodone-Acetaminophen 10-325, 12 tablets
(27) 12/22/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(28) 12/08/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(29) 11/21/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(30) 11/08/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(31) 10/25/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(32) 10/06/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(33) 9/22/2017: Oxycodone-Acetaminophen 10-325, 42 tablets
(34) 9/14/2017: Diazepam 5mg, 90 tablets
(35) 8/28/2017: Oxycodone-Acetaminophen 10-325, 56 tablets
(36) 8/11/2017: Oxycodone-Acetaminophen 10-325, 56 tablets
(37) 7/27/2017: Oxycodone-Acetaminophen 10-325, 56 tablets
(38) 7/18/2017: Oxycodone-Acetaminophen 10-325, 21 tablets
(39) 7/06/2017: Oxycodone-Acetaminophen 10-325, 28 tablets
(40) 6/16/2017: Oxycodone-Acetaminophen 10-325, 25 tablets
(41) 6/05/2017: Oxycodone-Acetaminophen 10-325, 28 tablets
(42) 5/22/2017: Oxycodone-Acetaminophen 10-325, 48 tablets
(43) 5/08/2017: Lorazepam 2mg, 60 tablets
(44) 4/06/2017: Oxycodone-Acetaminophen 10-325, 48 tablets
(45) 2/24/2017: Carisoprodol 250 mg, 90 tablets
(46) 2/24/2017: Diazepam 2mg, 90 tablets
(47) 2/07/2017: Oxycodone-Acetaminophen 10-325, 60 tablets
(48) 12/28/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(49) 12/02/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(50) 11/11/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(51) 10/24/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(52) 10/06/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(53) 9/26/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(54) 9/14/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(55) 8/29/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(56) 8/16/2016: Hydrocodone-Acetaminophen 10-325, 30 tablets
(57) 7/21/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(58) 6/24/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(59) 6/24/2016: Diazepam 2mg, 60 tablets
(60) 6/10/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(61) 5/13/2016: Oxycodone-Acetaminophen 10-325, 60 tablets
(62) 4/21/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(63) 3/25/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(64) 2/25/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(65) 2/05/2016: Oxycodone-Acetaminophen 10-325, 30 tablets
(66) 10/12/2015: Oxycodone-Acetaminophen 10-325, 12 tablets
(67) 10/09/2015: Oxycodone-Acetaminophen 10-325, 12 tablets
(68) 9/25/2015: Oxycodone-Acetaminophen 10-325, 15 tablets
(69) 5/29/2015: Oxycodone-Acetaminophen 10-325, 60 tablets
(70) 5/29/2015: Diazepam 5mg, 60 tablets
(71) 4/05/2015: Oxycodone-Acetaminophen 7.5-325, 60 tablets
(72) 2/15/2015: Oxycodone-Acetaminophen 7.5-325, 30 tablets
(73) 12/21/2014: Oxycodone-Acetaminophen 7.5-325, 30 tablets
(74) 11/01/2014: Oxycodone-Acetaminophen 7.5-325, 90 tablets
(75) 9/11/2014: Hydrocodone-Acetaminophen 7.5-325. 45 tablets
(76) 7/24/2014: Hydrocodone-Acetaminophen 7.5-325, 30 tablets
(77) 6/04/2014: Hydrocodone-Acetaminophen 7.5-325, 15 tablets
(78) 4/15/2014: Hydrocodone-Acetaminophen 7.5-325, 30 tablets

    6. The Respondent acted outside the usual course of professional 
practice in Virginia by issuing controlled substance prescriptions to 
his wife without establishing a bona fide practitioner-patient 
relationship and by failing to perform comprehensive examinations.
    7. The Respondent acted outside the usual course of professional 
practice in Virginia by issuing controlled substance prescriptions to 
his wife without properly documenting the treatment of his wife.
    8. The Respondent received prescriptions for controlled substances 
from L.K., P.A. on February 15, 2018, December 3, 2018, and December 4, 
2018.
    9. The Respondent received a prescription for a controlled 
substance from J.A., P.A., on September 14, 2018.
    10. Oxycodone is a Schedule II controlled substance pursuant to 21 
CFR 1308.12(b)(1)(xiv) and Va. Code Ann. Sec.  54.1-3448.
    11. Hydrocodone is a Schedule II controlled substance pursuant to 
21 CFR 1308.12(b)(1)(vi) and Va. Code Ann. Sec.  54.1-3448.
    12. On March 3, 2019, the Respondent completed the Professional 
Boundaries and Ethics Course--Extended Edition, a continuing medical 
education course conducted by the Professional Boundaries Institute 
(PBI).
    13. Respondent Exhibit 2 is a true and correct copy of the 
Respondent's certificate of completion for the PBI Professional 
Boundaries and Ethics Course--Extended Edition continuing medical 
education course.
    14. The Respondent completed a PBI Maintenance and Accountability 
Seminars continuing medical education course of July 11, 2019.
    15. Respondent Exhibit 3 is a true and correct copy of the 
Respondent's certificate of completion for the PBI Maintenance and 
Accountability Seminars continuing medical education course.
    16. The Respondent completed a VCU Health's Safe Opiate Prescribing 
continuing medical education course on January 1, 2019.
    17. Respondent Exhibit 4 is a true and correct copy of the 
Respondent's certificate of completion for VCU Health's Safe Opiate 
Prescribing continuing medical education course.

C. Government's Case

    The Government's case consisted of testimony from a diversion 
investigator assigned to the case that yielded these proceedings and a 
senior investigator from the Virginia Department of Health Professions.
1. Diversion Investigator R.P.
    The Government presented the testimony of Diversion Investigator 
RP. (hereinafter, the DI). The DI testified that he has been a DI for 
approximately seven years and is currently stationed at the Richmond 
field office. Tr. 11-12. The DI's testimony narrated the course of the 
investigation and authenticated a number of Government Exhibits. Id. at 
11-40.
    The DI testified that he worked with Task Force Officer C.E. 
(hereinafter, the TFO) in the investigation into the Respondent, a 
physician assistant (PA). Id. at 13-14. Their investigation began when 
the TFO was contacted by Senior Investigator K.L. at the Department of 
Health Professions (DHP). Id. at 13, 15. Senior Investigator K.L. 
informed DEA that during a DHP investigation of the Respondent, the 
Respondent admitted to ``issuing prescriptions without legitimate use'' 
to his wife, father-in-law, a family friend, and a colleague's 
spouse.\1\ Id. at 15. She then provided a copy of her investigative 
report to DEA. Id. at 15.
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    \1\ The findings and recommendations in this Recommended 
Decision are restricted to the charged and preponderantly 
established misconduct.
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    In investigating the Respondent's prescribing history, the DI 
generated a report from the Prescription Monitoring Program (PMP) 
regarding the Respondent's prescribing. Id. at 16. The DI noted that 
the Respondent issued his first prescription to his wife approximately 
a month-and-a-half after he received his DEA COR. Id. at 16-17. The DI 
also accessed the PMP to generate a report relative to the controlled 
substance prescriptions that

[[Page 21167]]

had been issued to Respondent's wife.\2\ Id. at 17. The report revealed 
that over eighty-five prescriptions were written for her by the 
Respondent during the previous period of almost five years. Id. at 17. 
Seventy-two of those eighty-five prescriptions were for pain 
medications. Id. at 18. The DI testified that in analyzing the report, 
he perceived patterns wherein the Respondent, in the DI's view, 
prescribed a high quantity of controlled substances for what the DI 
classified as a relatively short span of time. Id. at 18-19. The DI 
concluded that this pattern could support a possible indication of drug 
diversion. Id. The DI found it further curious that the controlled 
substance prescriptions that the Respondent wrote to his wife used both 
her maiden name and married name, so that, in the DI's assessment of 
things, the Respondent ``was actually issuing prescriptions to what 
appeared at face value to be two different individuals.'' Id. at 20.
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    \2\ The BD PMP Report, which temporally included all controlled 
substance prescriptions written to her from January 1, 2014 to the 
date it was generated on December 18, 2018, was received into the 
record. GX 3.
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    In addition to a brief encounter with the Respondent, the DI 
interviewed three individuals: The pharmacist who filed the initial 
complaint with DHP; a PA coworker of the Respondent, R.K.; and a 
supervising physician at Radiology Associates of Richmond (RAR), the 
radiology practice where the Respondent was employed during the events 
that form the basis of this case.\3\ Id. at 23-31.
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    \3\ The DI attempted to interview another PA, J.A., but learned 
that he was on vacation out of the country and the DI did not 
attempt to interview him when he returned. Id. at 31.
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    The pharmacist told the DI that she noticed that the Respondent was 
receiving controlled substance prescriptions from colleagues, and that 
he was writing prescriptions to his wife under her married and maiden 
name. Id. at 23-24. During her interview with the DI, R.K. admitted 
that she issued several prescriptions to the Respondent without 
performing a medical exam or documenting the prescriptions and 
treatment.\4\ Id. at 25-26. Regarding one of the prescriptions, R.K. 
explained that she wrote the scrip because the Respondent had hurt his 
hand; ``she could visibly see that it was affecting his procedures'' 
but she ``did not perform an examination, [and] she wrote a 
prescription based off of what she had observed from afar.'' Id. at 28. 
The DI testified that R.K. told him that she issued prescriptions to 
the Respondent because ``she trusted him. She trusted that he wasn't 
taking advantage of her because he had . . . mentored her . . . when 
she first came into her profession'' and ``she didn't think that he 
would ask her to do anything that was wrong or illegal.'' Id. at 25-26. 
R.K. also related to the DI that as the Respondent continued to request 
more prescriptions, she became hesitant and progressively uncomfortable 
with writing him prescriptions, but continued to anyway. Id. at 28.
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    \4\ The DI testified that the interview took place at the U.S. 
Attorney's Office and was attended by the TFO, an Assistant U.S. 
Attorney (AUSA), and a legal representative from RAR. Id. at 26-27. 
R.K. was not under arrest during the interview, forced to answer any 
questions, or offered anything in exchange for cooperating with the 
DI or the AUSA. Id. at 26-28.
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    During his interview, the supervising physician, who supervised the 
Respondent towards the end of the Respondent's time at RAR, told the DI 
that the Respondent ``received training on issuing legitimate 
prescriptions.'' Id. at 29-30. According to the DI, the supervising 
physician also said that he ``had no reason to believe that [the 
Respondent] had misinterpreted what the regulations were when it comes 
to issuing prescriptions.'' \5\ Id.
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    \5\ The DI testified that the supervising physician was not 
forced to answer any questions, the interview took place at the U.S. 
Attorney's Office, and was attended by the TFO, an AUSA, and a legal 
representative from RAR. Id. at 30-31.
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    The DI presented as an objective regulator and investigator with no 
discernable motive to fabricate or exaggerate. The testimony of this 
witness was sufficiently detailed, plausible, and internally consistent 
to be afforded full credibility in this case.
2. Senior Investigator K.L.
    The Government also presented testimony from DHP Senior 
Investigator K.L. (hereinafter, the DHP SI). The DHP SI testified that 
she has been a senior investigator with DHP \6\ for eighteen years, a 
registered nurse for over thirty years, a master's prepared registered 
nurse for over twenty-five years, and is currently stationed as an 
investigator in Henrico County. Id. at 44-45 and 48.
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    \6\ The DHP SI explained that DHP is ``the licensing and 
discipline entity for the Commonwealth of Virginia that licenses 
healthcare provider[s],'' including physician assistants. Id. at 46-
47.
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    The Respondent came to the attention of DHP when the previously-
mentioned pharmacist filed a formal complaint on or around December 
2018 and the DHP SI was assigned to conduct the investigation. Id. at 
52-54 and 61-62. The DHP SI testified that during the course of her 
investigation, she obtained the Respondent's PMP report, collected 
copies of relevant controlled substance scrips, and interviewed the 
previously-mentioned pharmacist, RAR employees, and the Respondent. Id. 
at 55. Around the end of January 2019, the DHP SI interviewed the 
Respondent and questioned him on the prescriptions he issued to his 
wife and the prescriptions written in his name by his PA colleagues, 
R.K. and J.A. Id. at 63-65. During the course of their conversation, 
the Respondent informed the DHP SI that some of the controlled 
substance prescriptions he received from his colleagues were to treat 
hand pain and cold congestion, but conceded that at no time did his PA 
colleagues perform any sort of assessment or exam. Id. at 65.
    According to the DHP SI, the PA colleagues confirmed that ``they 
did not conduct any type of exam on [the Respondent] and [that] they 
did not document any of their assessments on him when they provided the 
prescriptions that he personally requested them to write.'' Id. at 57. 
One of the medications that R.K. wrote for the Respondent was a 
combination of codeine and guaifenesin, which heightened the concern of 
the previously-mentioned pharmacist because the medication was not even 
dispensable as written. Id. at 66-67. J.A. told the DHP SI that the 
Respondent approached him for medication, supposedly to treat a 
migraine. Id. at 69-70. J.A. related to the DHP SI that he knew the 
controlled substance the Respondent requested was not a typical 
treatment for migraines, and so decided that he would only prescribe a 
limited quantity of four pills. Id. at 70.
    The DHP SI's investigation culminated in a report for the Virginia 
Board of Medicine that reflected that the Respondent wrote controlled 
substance prescriptions to his wife with no corroborating records, and 
that the Respondent received controlled substance prescriptions from 
his PA colleagues with no corroborating records. Id. at 67-68.
    Like the DI, the DHP SI presented as an objective regulator and 
investigator with no discernable motive to fabricate or exaggerate. The 
testimony of this witness was sufficiently detailed, plausible, and 
internally consistent to be afforded full credibility in this case.

D. Respondent's Case

    The Respondent's affirmative case at the hearing consisted 
exclusively of his own testimony. The Respondent testified that he 
received his Bachelor of Arts degree in Biology from Lewis & Clark 
College in 2003, followed by a Master's degree in Physician Assistant 
Studies from James Madison University in 2013. Tr. 87. He has been a 
licensed physician assistant in Virginia since 2014. Id. at 90-91. 
After receiving his

[[Page 21168]]

license, the Respondent worked at the Center for Gastrointestinal 
Health in Petersburg, Virginia. Id. at 87-88, 94. At this first job the 
Respondent possessed the requisite authority to prescribe controlled 
substances, but by his recollection an occasion to do so never arose. 
Id. at 94-95. The Respondent testified that he left this job amicably 
in March 2015 in order to find another job that would provide family 
health benefits. Id. at 95.
    In March 2015, the Respondent began working for RAR in Richmond, 
Virginia, where he specialized in interventional radiology. Id. at 96. 
As a physician assistant at RAR, the Respondent exercised his COR 
authority to prescribe controlled substances. Id. at 97. Although RAR 
is a practice devoted to interventional radiology, he explained that 
the procedure-based nature of the practice did sometimes call for the 
prescribing of post-procedure controlled pain medications under 
established protocols. Id. at 98-99. The Respondent explained that at 
RAR, prescribing within the usual course of professional practice meant 
``[f]ollowing the protocols of the supervising physician.'' Id. at 99-
100. The protocols involved meeting with the supervising physician and 
acquiring from the physician a written treatment plan for each patient. 
Id. at 100. The Respondent also testified that in the course of 
prescribing a patient a controlled substance he would conduct an 
``extremely'' comprehensive exam, including a full history and 
physical, and then ``thoroughly'' document the findings of the 
examinations. Id. at 100. Once he was notified of DHP's investigation 
into him, the Respondent transparently notified his supervisors at RAR. 
Id. at 101. He was initially put on administrative leave, but then was 
afforded the option to resign from the practice, which he exercised in 
February 2019. Id. at 101.
    In April 2019, the Respondent secured employment at Alliance 
Physical Therapy, a physical therapy clinic.\7\ Id. at 102. The 
Respondent explained that Alliance Physical Therapy has a strong policy 
against prescribing controlled substances to patients, and that he 
``wanted that job because [he] knew that this was something that just 
[he] needed to not do. And [he] needed it not to be available.'' \8\ 
Id. at 102. However, in one instance, extenuating circumstances arose 
that required prescribing Tramadol to a patient, which the Respondent 
prescribed only after conferring with his supervising physician who 
then made the decision to prescribe a controlled substance. Id. at 103-
04.
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    \7\ The Respondent testified that he worked at Alliance Physical 
Therapy for one year before he was furloughed in April 2020 due to 
the COVID-19 pandemic. Id. at 102, 104. He has since interviewed 
with Commonwealth Radiology, ``another radiologist/interventional 
radiology group,'' and the Respondent testified that he was 
transparent with his potential future employers regarding the 
relevant investigations. Id. at 105.
    \8\ The issue of why the Respondent, who is seeking to continue 
his status as a DEA registrant, needed to isolate himself from 
conducting the regulated activity he now seeks to preserve was never 
developed at the hearing.
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    In addressing the allegations brought by the Government, the 
Respondent admitted to improperly prescribing controlled substances to 
his wife and offered testimony to potentially help clarify the 
surrounding circumstances. In 2012, when the Respondent noticed that 
his wife (B.D.) had developed a severe limp after running, and upon his 
insistence, his wife consulted an orthopedist. Id. at 105. The 
orthopedist diagnosed B.D. with a CAM lesion on the head of her femur 
and subsequently performed surgery to reconstruct her hip and treat the 
CAM lesion. Id. at 105-07. According to the Respondent,\9\ after the 
surgery his wife experienced increased pain and developed arthritis, 
which was diagnosed by orthopedist Dr. J.H. Id. at 107-09. Dr. J.H. 
treated B.D. with non-steroidal anti-inflammatories (NSAIDs), but she 
developed an ulcer. Id. at 109-10. To address her pain, B.D. then took 
part in physical therapy, yoga, swimming, different types of NSAIDs, 
Tylenol, and then received injections. Id. at 110. The Respondent 
testified that injections helped with his wife's symptoms, but not 
long-term. Id. at 110-11. In April 2014, after being treated by Dr. 
J.H. throughout, and not seeking care from another physician, B.D. was 
``at her wits' end,'' ``was distraught,'' ``was in pain every day,'' 
``was having a hard time just getting around the house,'' ``things got 
desperate,'' and she asked the Respondent for something to relieve her 
pain. Id. at 111-12. The Respondent wrote his wife a controlled 
substance prescription, but upon circumspection, if he ``could go back, 
[he] certainly would not do it again.'' Id. at 112.
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    \9\ No corroborating medical records or other documentation was 
offered by the Respondent in support of his wife's purported medical 
issues.
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    The Respondent openly admitted that the controlled substance 
prescriptions he wrote to his wife between April 2014 and November 2018 
were unlawful, unethical, unprofessional, wrong, and not valid, and 
that he even knew it was wrong at the time.\10\ Id. at 113-14. In 
explaining his logic behind writing prescriptions that were unlawful 
and wrong, the Respondent offered the following:
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    \10\ The Respondent also admitted that he prescribed controlled 
substances to his wife while she was pregnant and that issuing such 
prescriptions while she was pregnant without proper supervision was 
potentially dangerous (although the wife's obstetrician was aware of 
the narcotics she was taking). Id. at 152-54.

    I mean, it was really a matter of convenience. I saw her quality 
of life improve. And it just snowballed because of convenience. And 
through the years of doing it, my anxiety was--got worse and worse. 
I knew--I knew it was wrong. And it's really just--it's fortunate it 
didn't hurt our relationship, but it made my life quite distraught. 
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Id. at 114 (emphasis supplied).

    Counsel for the Respondent read through Allegations 8-11 from the 
OSC, asking for each whether the Respondent understood the allegation 
and whether the Respondent agreed with the allegation. Id. at 133-36. 
The Respondent testified that he understood and agreed with Allegations 
8-11. Id. at 133-36.
    The Respondent also admitted to improperly receiving controlled 
substance prescriptions from his PA colleagues. It is the Respondent's 
recollection that he first approached R.K. for a controlled substance 
prescription after he underwent hand surgery and his treating surgeon 
denied him pain medication.\11\ Id. at 137-38. The Respondent explained 
that acquiring the prescription from R.K. was wrong and that he knew he 
was asking her to violate RAR's protocols that required PAs to 
prescribe controlled substances under the guidance of a physician. Id. 
at 139-40. The Respondent also openly admitted that he agreed with the 
Government's allegations that he did not have a bona fide practitioner-
patient relationship with his PA colleagues, that they did not document 
the treatment they rendered to him, and that he received the controlled 
substance prescriptions from them outside the usual course of 
professional practice. Id. at 143-44. In his own words, the Respondent 
described his conduct in regards to receiving the relevant 
prescriptions from his PA colleagues as ``unprofessional.'' Id. at 144-
45. The Respondent testified that he took advantage of his colleagues 
because he knew he could not get the prescriptions he wanted from a 
doctor and that he knew his PA colleagues were not keeping medical 
records of his treatment because they could be disciplined for doing 
so. Id. at 151-52. Based on his PA colleagues' conduct, the Respondent 
agreed that they both

[[Page 21169]]

knew that their conduct in prescribing controlled substances to the 
Respondent was improper. Id. at 153.
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    \11\ Again, the Respondent offered no form of corroboration for 
any of the medical conditions he ascribed to himself or his wife.
---------------------------------------------------------------------------

    The Respondent testified that in the wake of the allegations 
against him, he took three continuing medical education (CME) courses 
to improve his practice. RX 2-4; Tr. 117-119, 127-28. He completed an 
in-person, thirty-four hour professional boundaries course on March 1 
through March 3, 2019. RX 2; Tr. at 118. The Respondent testified that 
the course taught him about ``getting in the habit of saying no'' as 
foundational for operating within professional boundaries. Tr. at 118. 
The Respondent also testified that he participated in a twelve-week 
telephonic-contact course on maintenance and accountability that was 
completed on July 11, 2019 (Phone Follow-up Exercise). RX 3; Tr. at 
122-23. The Phone Follow-up Exercise was an extension of the first and 
consistent of twelve one-hour weekly seminars conducted via telephone. 
Tr. at 122-23. The Respondent explained that the Phone Follow-up 
Exercise afforded him the opportunity to express the remorse, 
embarrassment, and anger he felt over his actions, as well as share the 
tools he was developing to maintain professional boundaries (including 
taking a position at a practice with a non-narcotic policy, refusing a 
prescription pad, and having a habit of saying no). Id. at 126-27. In 
addition to the professional boundaries course and the Phone Follow-up 
Exercise, the Respondent testified that he completed a two-hour online 
course in safe opiate prescribing through Virginia Commonwealth 
University's medical school.\12\ RX 4; Tr. at 127-29.
---------------------------------------------------------------------------

    \12\ Inexplicably, the opiate prescribing course certificate 
indicates that the course was conducted on ``July 11, 2017-December 
31, 2020.'' RX 4.
---------------------------------------------------------------------------

    The Respondent also testified that moving forward, he intends to 
comply with all laws regarding controlled substances and that he ``will 
only prescribe when appropriate and only to patients when it's well 
documented and for an appropriate reason.'' Tr. at 132. He acknowledged 
the severity of his repeated intentional acts, but also feels that this 
has only ever been a personal issue and that his misguidance has never 
lapsed over into affecting the public. Id. at 147-48.
    As is generally the case, the Respondent unarguably possesses the 
greatest interest in the outcome of these proceedings, and hence, the 
greatest motivation to enhance, modify, or even fabricate his 
testimony. While the Respondent's testimony was generally consistent, 
it was not always free from confusing aspects. He stated and admitted 
that he issued controlled substances to his wife for years knowing that 
it was wrong, and explained that he understood that it was unlawful, 
unprofessional, and wrong, which is information that he undoubtedly 
possessed while the misconduct was underway. The Respondent presented 
as a knowledgeable professional who, at all times relevant, understood 
the rules, but yet engaged in an extended course of conduct that he 
knew was unprofessional, illegal, and dangerous.\13\ He even allowed 
that his actions caused him a considerable level of consternation. The 
Respondent's testimony that he was aware of and adhered to detailed 
examination and prescribing protocols regarding RAR patients stands in 
no small measure of conflict with his extended level of unlawful 
prescribing, punctuated by the calculated practice of interchanging his 
wife's maiden and married names. Odd also was the Respondent's 
assertion that after the commencement of the DHP investigation he began 
working at a physical therapy clinic that has a strong policy against 
prescribing controlled substances to patients. He explained that he 
``wanted that job because [he] knew that this was something that just 
[he] needed to not do. And [he] needed it not to be available.'' Tr. 
102. The testimony is almost reminiscent of an addictive personality 
seeking to avoid the temptation of the focus of the addiction; and yet, 
the Respondent seeks to continue prescribing controlled substances. In 
an apparent abandonment of his prescribing avoidance, upon his COVID-
related furlough, the Respondent is currently pursuing employment at 
Commonwealth Radiology, where, if successful, it appears his duties 
will mirror those at RAR, including his controlled substance 
prescribing responsibilities. It is not so much that the Respondent is 
incredible, he is not that. It is more that his presentation was 
confusing, and at times enigmatic.
---------------------------------------------------------------------------

    \13\ Indeed, no physician who treated his wife before or after 
his misconduct prescribed controlled substances for her.
---------------------------------------------------------------------------

    Other facts necessary for a disposition of this case are set forth 
in the balance of this Recommended Decision.

II. Discussion

A. Public Interest Determination: The Standard

    Under 21 U.S.C. 824(a)(4), the Agency may revoke the COR of a 
registrant if the registrant ``has committed such acts as would render 
his registration . . . inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4). Congress has circumscribed the definition of public 
interest in this context by directing consideration of the following 
factors:

    (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 to be 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 COR should be revoked. Id.; see Morall v. DEA, 412 F.3d 
165, 173-74 (D.C. Cir. 2005). Moreover, the Agency is ``not required to 
make findings as to all of the factors,'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); Morall, 412 F.3d at 173, and is not required to 
discuss consideration of each factor in equal detail, or even every 
factor in any given level of detail, Trawick v. DEA, 861 F.2d 72, 76 
(4th Cir. 1988) (holding that the Administrator's obligation to explain 
the decision rationale may be satisfied even if only minimal 
consideration is given to the relevant factors, and that remand is 
required only when it is unclear whether the relevant factors were 
considered at all). 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 . . . .'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
    In adjudicating a revocation of a DEA COR, the DEA has the burden 
of proving that the requirements for the revocation it seeks are 
satisfied. 21 CFR 1301.44(e). Where the Government has met this burden 
by making a prima facie case for revocation of a registrant's COR, the 
burden of production then shifts to the registrant to show that, given 
the totality of the facts and circumstances in the record, revoking the 
registrant's COR would not be appropriate. Med. Shoppe-Jonesborough, 73 
FR 364, 387 (2008). Further, ``to rebut the Government's prima facie 
case, [a registrant] is

[[Page 21170]]

required not only to accept responsibility for [the established] 
misconduct, but also to demonstrate what corrective measures [have 
been] undertaken to prevent the re-occurrence of similar acts.'' Jeri 
Hassman, M.D., 75 FR 8194, 8236 (2010); accord Krishna-Iyer, 74 FR at 
464 n.8. In determining whether and to what extent a sanction is 
appropriate, consideration must be given to both the egregiousness of 
the offense established by the Government's evidence and the Agency's 
interest in both specific and general deterrence. David A. Ruben, M.D., 
78 FR 38363, 38364, 38385 (2013).
    Normal hardships to the registrant, and even to the surrounding 
community, which are attendant upon lack of registration, are not a 
relevant consideration. See Linda Sue Cheek, M.D., 76 FR 66972, 66972-
73 (2011); Gregory D. Owens, D.D.S., 74 FR 36751, 36757 (2009). 
Further, the Agency's conclusion that ``past performance is the best 
predictor of future performance'' has been sustained on review in the 
courts, 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, 419 F.3d at 483.\14\
---------------------------------------------------------------------------

    \14\ The Agency has repeatedly upheld this policy. See Ronald 
Lynch, M.D., 75 FR 78745, 78754 (2010) (holding that the 
respondent's attempts to minimize misconduct undermined acceptance 
of responsibility); George Mathew, M.D., 75 FR 66138, 66140, 66145, 
66148 (2010); George C. Aycock, M.D., 74 FR 17529, 17543 (2009); 
Krishna-Iyer, 74 FR at 463; Steven M. Abbadessa, D.O., 74 FR 10077, 
10078 (2009); Med. Shoppe-Jonesborough, 73 FR at 387.
---------------------------------------------------------------------------

    Although the burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S. 
91, 100-03 (1981), the Agency's ultimate factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence,'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing 
two inconsistent conclusions from the evidence'' does not limit the 
Administrator's ability to find facts on either side of the contested 
issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092 
(8th Cir. 1989) (internal citation omitted), all ``important aspect[s] 
of the problem,'' such as a respondent's defense or explanation that 
runs counter to the Government's evidence, must be considered, 
Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); 
see Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996). The ultimate 
disposition of the case ``must be `in accordance with' the weight of 
the evidence, not simply supported by enough evidence `to justify, if 
the trial were to a jury, a refusal to direct a verdict when the 
conclusion sought to be drawn from it is one of fact for the jury.' '' 
Steadman, 450 U.S. at 99 (quoting Consolo v. FMC, 303 U.S. 607, 620 
(1966)).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in 
application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008), 
cert. denied, 555 U.S. 1139 (2009); cf. Dep't of Homeland Security v. 
Regents of Univ. of Cal., 140 S. Ct. 1891, 1913 (2020) (holding that an 
agency must carefully justify significant departures from prior policy 
where reliance interests are implicated). It is well settled that, 
because the Administrative Law Judge has had the opportunity to observe 
the demeanor and conduct of hearing witnesses, the factual findings set 
forth in this Recommended Decision are entitled to significant 
deference, see Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 
(1951), and that this Recommended Decision constitutes an important 
part of the record that must be considered in the Agency's final 
decision, see Morall, 412 F.3d at 179. However, any recommendations set 
forth herein regarding the exercise of discretion are by no means 
binding on the Administrator and do not limit the exercise of that 
discretion. See 5 U.S.C. 557(b); River Forest Pharmacy, Inc. v. DEA, 
501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the 
Administrative Procedure Act Sec.  8(a) (1947).

B. Factors Two and Four: The Respondent's Experience Dispensing 
Controlled Substances and Compliance With Federal, State, and Local Law

    The Government has founded its theory for sanction exclusively 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), and it is under 
those two factors that the lion's share of the evidence of record 
relates.\15\ In this case, the gravamen of the allegations in the OSC, 
as well as the factual concentration of much of the evidence presented, 
share as a principal focus the Respondent's prescribing of controlled 
substances to his (non-patient) wife, and his role in receiving 
controlled substance prescriptions issued to him by his DEA registrant 
co-workers. The structure of the Government's theory, and the 
Respondent's case to meet that theory, renders it analytically logical 
to consider Public Interest Factors Two and Four together regarding the 
Respondent's prescribing, and Factor Four independently with respect to 
the role the Respondent played in securing controlled substance 
prescriptions from his colleagues. That being said, Factors Two and 
Four involve analysis of both common and distinct considerations.
---------------------------------------------------------------------------

    \15\ The record contains no recommendation from any state 
licensing board or professional disciplinary authority (Factor One), 
but, aside from cases establishing a complete lack of state 
authority, the presence or absence of such a recommendation has not 
historically been a case-dispositive issue under the Agency's 
precedent. Patrick W. Stodola, M.D., 74 FR 20727, 20730 (2009); 
Krishna-Iyer, 74 FR at 461. Similarly, there is no record evidence 
of a conviction record relating to regulated activity (Factor 
Three). Even apart from the fact that the plain language of this 
factor does not appear to emphasize the absence of such a conviction 
record, myriad considerations are factored into a decision to 
initiate, pursue, and dispose of criminal proceedings by federal, 
state, and local prosecution authorities which lessen the logical 
impact of the absence of such a record. See Robert L. Dougherty, 
M.D., 76 FR 16823, 16833 n.13 (2011); Dewey C. MacKay, M.D., 75 FR 
49956, 49973 (2010) (``[W]hile a history of criminal convictions for 
offenses involving the distribution or dispensing of controlled 
substances is a highly relevant consideration, there are any number 
of reasons why a registrant may not have been convicted of such an 
offense, and thus, the absence of such a conviction is of 
considerably less consequence in the public interest inquiry.''), 
aff'd, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011); Ladapo O. 
Shyngle, M.D., 74 FR 6056, 6057 n.2 (2009). Therefore, the absence 
of criminal convictions militates neither for nor against the 
revocation sought by the Government. Because the Government's 
allegations and evidence fit squarely within the parameters of 
Factors Two and Four and do not raise ``other conduct which may 
threaten the public health and safety,'' 21 U.S.C. 823(f)(5), Factor 
Five militates neither for nor against the sanction sought by the 
Government in this case.
---------------------------------------------------------------------------

    Regarding Factor Two, the Respondent is a credentialed and 
experienced physician assistant who has been treating patients, in 
various capacities, for around six years. Tr. 90. Likewise, the 
evidence of record points to issues regarding controlled substance 
prescribing to his wife (B.D.) and himself; and there is no evidence of 
record that the Respondent has been the subject of discipline by state 
or federal authorities relative to his controlled substance prescribing 
to legitimate patients.*\C\ While there is no evidence to contradict 
the Respondent's contention that he has never let his prescribing 
deficiencies seep over into other aspects of his medical practice,

[[Page 21171]]

the Agency has long found that benign experience cannot overcome 
intentional misconduct, and that the misconduct established by record 
evidence is considered under both Factors Two and Four. See Roberto 
Zayas, M.D., 82 FR 21410, 21422 n.27 (2017) (announcing that 
``misconduct is misconduct whether it is relevant under Factor Two, 
Factor Four, or Factor Five, or multiple factors''). It is beyond 
argument that every scrap of established misconduct in this case is of 
the intentional variety. Thus, the balance of the evidence related to 
Factor Two [ ]will be considered below together with Factor Four.
---------------------------------------------------------------------------

    *\C\ Omitted for brevity.
---------------------------------------------------------------------------

    As discussed, supra, Factor Four compels consideration of the 
Respondent's compliance with state and federal laws related to 
controlled substances. The DEA regulations provide that to be 
effective, a prescription must be issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice. 21 CFR 1306.04(a). The Supreme Court has opined that, ``the 
prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006). 
Further, the Agency's authority to revoke a registration is not limited 
to instances where a practitioner has intentionally diverted controlled 
substances. Bienvenido Tan, 76 FR 17673, 17689 (2011); see Dewey C. 
MacKay, 75 FR at 49974 (holding that revocation is not precluded merely 
because the conduct was ``unintentional, innocent, or devoid of 
improper motive'') (citation omitted).
    To effectuate the dual goals of conquering drug abuse and 
controlling both legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the [Controlled 
Substances Act (CSA)].'' Gonzales v. Raich, 545 U.S. 1, 13 (2005). 
Consistent with the maintenance of that closed regulatory system, 
subject to limited exceptions not relevant here, a controlled substance 
may only be dispensed upon a prescription issued by a practitioner, and 
such a prescription is unlawful unless it 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); see 21 U.S.C. 
829. Furthermore, ``[a]n order purporting to be a prescription issued 
not in the usual course of professional treatment . . . is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and the 
person knowingly . . . issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' 21 CFR 1306.04(a).
    The prescription requirement is designed to ensure that controlled 
substances are used under the supervision of a doctor, as a bulwark 
against the risk of addiction and recreational abuse. George C. Aycock, 
M.D., 74 FR 17529, 17541 (2009) (citing Gonzales, 546 U.S. at 274); see 
also United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting 
that evidence established that a physician exceeded the bounds of 
professional practice when he gave inadequate examinations or none at 
all, ignored the results of the tests he did make, and took no 
precautions against misuse and diversion). The prescription requirement 
likewise stands as a proscription against doctors ``peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales, 546 
U.S. at 274. A registered practitioner is authorized to dispense, which 
the CSA defines as ``to deliver a controlled substance to an ultimate 
user . . . by, or pursuant to the lawful order of a practitioner.'' 21 
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 
(2007). The courts have sustained criminal convictions based on the 
issuing of illegitimate prescriptions where physicians conducted no 
physical examinations or sham physical examinations. United States v. 
Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 
1113 (2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 
1986).
    ``Under the CSA, it is fundamental that a practitioner must 
establish and maintain a [bona fide] doctor-patient relationship in 
order to act in the usual course of . . . professional practice and to 
issue a prescription for a legitimate medical purpose.'' Dewey C. 
Mackay, M.D., 75 FR 49956, 49973 (2010) (citation omitted); Stodola, 74 
FR at 20731; Shyngle, 74 FR at 6057-58. The CSA generally looks to 
state law to determine whether a bona fide doctor-patient relationship 
was established and maintained. Stodola, 74 FR at 20731; Shyngle, 74 FR 
at 6058; Kamir Garces-Mejias, M.D., 72 FR 54931, 54935 (2007); United 
Prescription Servs., Inc., 72 FR 50397, 50407 (2007).
    The CSA authorizes the ``regulat[ion of] medical practice so far as 
it bars doctors from using their prescription-writing powers as a means 
to engage in illicit drug dealing and trafficking as conventionally 
understood,'' Gonzales, 546 U.S. at 909-10, and the Agency also 
evaluates cognizant state standards. Joseph Gaudio, M.D., 74 FR 10083, 
10090 (2009); Garces-Mejias, 72 FR at 54935; United Prescription 
Services, Inc., 72 FR 50397, 50407 (2007).*\D\
---------------------------------------------------------------------------

    *\D\ Omitted for brevity.
---------------------------------------------------------------------------

    Here, the relevant provisions of Virginia state law largely mirror 
the CSA and its regulations where they do not go beyond it. Compare Va. 
Code Ann. Sec.  54.1-3303(C) with 21 CFR 1304.06(a). The Virginia Code 
requires a bona fide patient-practitioner relationship to exist for the 
issuance of any prescriptions (controlled and non-controlled) in the 
state. Va. Code Ann. Sec.  54.1-3303(B). The elements of a bona fide 
patient-practitioner relationship are spelled out in the code and 
require that the practitioner must have:

    (i) Obtained or caused to be obtained a medical or drug history 
of the patient;
    (ii) provided information to the patient about the benefits and 
risks of the drug being prescribed;
    (iii) performed or caused to be performed an appropriate 
examination of the patient, either physically or by the use of 
instrumentation and diagnostic equipment through which images and 
medical records may be transmitted electronically; and
    (iv) initiated additional interventions and follow-up care, if 
necessary, especially if a prescribed drug may have serious side 
effects.

Id.
    Except in cases involving a medical emergency, the examination 
required pursuant to clause (iii) shall be performed by the 
practitioner prescribing the controlled substance, a practitioner who 
practices in the same group as the practitioner prescribing the 
controlled substance, or a consulting practitioner. Id. Further, all 
treatment, both with and without controlled substances, must be 
properly documented in order to fall within the standard of care as 
articulated by the state. Va. Admin. Code Sec.  85-50-177 (requiring 
``timely, accurate, legible and complete records''). The Virginia Code 
also prohibits a practitioner from . . . prescrib[ing] a controlled 
substance to himself or a family member, other than Schedule VI as 
defined in Sec.  54.1-3455 of the Code of Virginia, unless the 
prescribing occurs in an emergency situation or in isolated settings 
where there is no other qualified practitioner available to the 
patient, or it is for a single episode of an acute illness through one 
prescribed course of medication. Va. Admin. Code Sec.  85-50-176(B). 
This provision additionally specifies that when such treatment of

[[Page 21172]]

self or family does occur, it must be properly documented to 
demonstrate compliance with the criteria for a bona fide patient-
practitioner relationship. Va. Admin. Code Sec.  85-50-176(C).
    Further, the Virginia Administrative Code cites twenty-four 
separate categories of unprofessional conduct that can result in 
disciplinary action. Va. Admin. Code Sec.  54.1-2915. Within these 
myriad categories, the state has prohibited: ``[p]rescribing or 
dispensing any controlled substance with intent or knowledge that it 
will be used otherwise than medicinally, . . . or with intent to evade 
any law with respect to the sale, use, or disposition of such drug;'' 
\16\ violating any state or federal law ``relating to the manufacture, 
distribution, dispensing, or administration of drugs;'' \17\ and 
``[v]iolating or cooperating with others in violating any of the 
provisions of Chapters 1 (Sec.  54.1-100 et seq.), 24 (Sec.  54.1-2400 
et seq.) and this chapter [(Sec.  54.1-2900 et seq.)] or regulations of 
the Board.'' \18\ ``Cooperating'' is not defined in the Virginia 
Administrative Code, but by consciously electing to eschew the term 
``conspiracy,'' \19\ it is logical to assume that Virginia seeks a 
broader sweep of conduct that is easier to establish.
---------------------------------------------------------------------------

    \16\ Va. Admin. Code Sec.  54.1-2915(A)(8).
    \17\ Va. Admin. Code Sec.  54.1-2951(A)(17).
    \18\ Va. Admin. Code Sec.  54.1-2951(A)(18) (emphasis added).
    \19\ Civil conspiracy in this context requires a more rigorous 
showing that two or more persons combined to accomplish, by some 
concerted action, some criminal or unlawful purpose or some lawful 
purpose or some lawful purpose by a criminal or unlawful means. Cf. 
Shirvinski v. United States Coast Guard, 673 F.3d 308, 320 (4th Cir. 
2012).
---------------------------------------------------------------------------

    In this case, the Respondent stipulated that he ``acted outside the 
usual course of professional practice in Virginia by issuing controlled 
substance prescriptions to his wife (B.D.) without establishing a bona 
fide practitioner-patient relationship[,] by failing to perform 
comprehensive examinations[, and] without properly documenting the 
treatment of his wife (B.D.).'' Stips 6, 7. Further, during the 
hearing, the Respondent stated that he understood and agreed with 
Allegations 8-11. Tr. 133-36. Accordingly, OSC Allegations 4 and 8-11 
are sustained.
    Regarding the controlled substance prescriptions issued to the 
Respondent by his PA colleagues, the parties stipulated that the 
Respondent received controlled substance prescriptions from his PA 
colleagues on every date alleged in the OSC. Stips 8, 9. The 
Government's theory, in essence, is that by importuning his PA 
colleagues to write controlled substance prescriptions for his personal 
use, without routing the matter through the physicians who supervise 
those PA practitioners, the evidence sustains the gentle standard of 
``cooperating with others'' \20\ to facilitate their violation of the 
aforementioned state and federal laws relating to the dispensing of 
drugs. This aspect of the Government's theory here is enhanced by the 
highly-regulated nature of controlled substance prescribing and the 
Respondent's status as a COR holder/PA in the same office as his PA 
colleagues. The Respondent's awareness of standard office practices and 
his fellow PAs, coupled with his experience, equipped him with the 
knowledge of how a direct request to his colleagues would likely be 
received and acted upon by his PA colleagues. The Respondent freely 
acknowledged during the hearing that he did not have a bona fide 
practitioner-patient relationship as a patient of his PA colleagues, 
that they did not document the treatment they rendered to him, and that 
he received the controlled substance prescriptions from them outside 
the usual course of professional practice. Tr. 143-44. Respondent's PA 
colleagues also told investigators that they issued the prescriptions 
to the Respondent without performing a medical exam or documenting the 
prescriptions and treatment. Id. at 25-26, 57. Notably, the Respondent 
admitted that he took advantage of his PA colleagues because he knew he 
could get the scrips he wanted and that they would not document the 
treatment when he asked them for the scrips. Id. at 151-52. He 
described his own conduct in this regard as ``unprofessional.'' Id. at 
144-45. Further, in his closing brief, the Respondent stated that he 
``unequivocally accept[s] responsibility'' for the ``soliciting of 
controlled substance treatment from colleagues'' and for ``the 
misconduct and wrongfulness of his actions relative to the Government's 
allegations relating to [his] conspiracy with his colleagues.'' ALJX 15 
at 7. Accordingly, OSC Allegations 5 and 12-14 are sustained.*\E\
---------------------------------------------------------------------------

    \20\ Va. Code Ann. Sec.  54.1-2915(A)(18). [Although not 
directly on point, it appears that the Virginia Medical Board has 
applied cooperating with others broadly as the Chief ALJ suggests. 
See e.g., In re: Pankaj Merchia, M.D., Virginia Department of Health 
Professions, Board of Medicine, 2017 WL 2537574 (2017) (affirmed, 
Pankaj Merchia v. Virginia Board of Medicine, Va. Ct. App. 2018 WL 
6313710 (2018) (not reported) (sustaining Board's finding under Va. 
Code Ann. Sec.  54.1-2915(A)(18)) holding a practitioner responsible 
for not releasing patients' medical records even though he was not 
in charge of the recordkeeping functions.)]
    *\E\ Although I agree with the Chief ALJ that substantial 
evidence supports these violations, and I note that Respondent did 
not take exception to his finding, the facts on the record regarding 
Respondent's unlawful prescribing to his wife over the course of 
several years alone offer more than enough support for my ultimate 
conclusion that Respondent's registration is inconsistent with the 
public interest.
---------------------------------------------------------------------------

    Inasmuch as the Respondent's state licensure and COR status are the 
subject of factual stipulations,\21\ OSC Allegations 1 and 2 are also 
sustained.
---------------------------------------------------------------------------

    \21\ Stips. 1, 2, 3.
---------------------------------------------------------------------------

    Thus, a balancing of Factors Two and Four militate strongly in 
favor of the imposition of the revocation sanction sought by the 
Government.

III. Sanction

    The evidence of record preponderantly establishes that the 
Respondent has committed acts which render his continued registration 
inconsistent with the public interest. See 21 U.S.C. 824(a)(4). Since 
the Government has met its burden \22\ in demonstrating that the 
revocation it seeks is authorized, to avoid sanction, it becomes 
incumbent upon the Respondent to demonstrate that given the totality of 
the facts and circumstances revocation is not warranted. See Med. 
Shoppe-Jonesborough, 73 FR at 387. That is, upon the preponderant 
establishment of the Government's prima facie case, the burden shifts 
to the Respondent to show why he should continue to be entrusted with a 
DEA registration. See Kaniz F. Khan-Jaffery, M.D., 85 FR 45667, 45689 
(2020); Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018). Although 
by no means the only requirement, in order to rebut the Government's 
prima facie case, the Respondent must demonstrate not only an 
unequivocal acceptance of responsibility but also a demonstrable plan 
of action to avoid similar conduct in the future. See Hassman, 75 FR at 
8236. While those two elements are key, the focus is, and must always 
be, rooted in a determination as to whether the Agency can have 
confidence that the Respondent can continue to be entrusted with the 
weighty and dangerous responsibilities of a registrant. Cf., Khan-
Jaffery, M.D., 85 FR at 45689; Smith, M.D., 83 FR at 18910. While 
analytical frameworks applied to prior Agency actions provide useful 
guidance and helpful structure, such tools cannot distract the Agency 
from its critical mission to keep the public safe by only issuing and 
maintaining CORs in cases where the public is adequately protected.
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    \22\ See 21 CFR 1301.44(e).
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    Agency decisions are clear that a respondent must ``unequivocally 
admit fault'' as opposed to a ``generalized

[[Page 21173]]

acceptance of responsibility.'' The Medicine Shoppe, 79 FR 59504, 59510 
(2014); see also Lon F. Alexander, M.D., 82 FR 49704, 49728 (2017). To 
satisfy this burden, the respondent must ``show true remorse'' or an 
``acknowledgment of wrongdoing.'' Leslie, 68 FR at 15528. The Agency 
has made it clear that unequivocal acceptance of responsibility is 
paramount for avoiding a sanction. Robert L. Dougherty, M.D., 76 FR 
16823, 16834 (2011) (citing Krishna-Iyer, 74 FR at 464). This feature 
of the Agency's interpretation of its statutory mandate on the exercise 
of its discretionary function under the CSA has been sustained on 
review. Jones Total Health Care Pharmacy, LLC v. DEA, 881 F.3d 823, 
830-31 (11th Cir. 2018); MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 
2011); Hoxie, 419 F.3d at 483.

A. Acceptance of Responsibility

    On the issue of acceptance, although (as discussed, supra) the 
Respondent's testimony carried with it an intermittently confusing 
quality, it could not be fairly said that, taken as a whole (to 
include, at least to some extent, the attorney-authorized admissions in 
his closing brief) \23\ that the Respondent did not accept 
responsibility. He did.*\F\
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    \23\ ALJX 15.
    *\F\ I agree with the Chief ALJ that Respondent generally 
accepted responsibility, did not make excuses, pass blame or 
mitigate his misconduct--other than perhaps in his self-portrayal as 
merely someone who has trouble saying ``no.'' See infra III.B. It is 
noted that prior Agency decisions have made it clear that in order 
to avoid sanction once the Government has established a prima facie 
case, a registrant must do more than say the right thing on the 
stand and in filings. ``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 46968, 
49973 (2019).
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    Regarding the required demonstration of remedial measures aimed at 
the avoidance of recurrence, the Respondent (predictably) promised that 
he would foreswear prescribing to his wife, friends, and relatives, and 
would presumably no longer seek to importune colleagues to authorize 
the dispensing of powerful drugs for his personal use. Additionally, 
the Respondent completed a three-day professional boundaries course, 
participated in the Phone Follow-up Exercise, and took an opiate 
prescribing course. RX 2-4.*\G\ A fundamental issue here is not so much 
that the Respondent did not make a remedial plan of sorts, the issue is 
that the record demonstrates no information that the Respondent learned 
in the courses what he admittedly did not know while he was committing 
the misconduct. That is to say, he required no course to provide him 
with the revelation that writing prescriptions for powerful pain 
medications to his non-patient wife was a breach of his state and 
federal obligations. It was obvious that he knew this was the case by 
the deceitful practices he employed in alternating between his wife's 
maiden and married names. He admitted that the entire enterprise was 
causing him consternation, and yet he persevered in this unprofessional 
debacle for four-and-a-half years. Likewise, he did not suddenly gain 
understanding that having his PA colleagues (one of whom he was 
mentoring) prescribe controlled substances for him was beyond the pale. 
The Respondent understood every one of these lessons at the outset of 
the story. No moment of sudden realization and enlightenment was borne 
of two courses and a Phone Follow-up Exercise. The problem is that the 
Respondent is as aware of his obligations now as he was when his 
professional life spiraled out of control. A registrant who gains 
specialized knowledge in the intricacies of documentation from 
coursework, or incorporates process changes in his/her practice to 
address a diversion risk are examples of scenarios where a remedial 
plan can carry significant influence. On this record, where the 
Respondent knew what to do during every moment of the period in 
question, the weight that can logically be attached to his remedial 
steps must be significantly diminished. Stated differently, he knew 
then and he knows now, and the ``remedial plan'' offered here is 
essentially an exercise in going through the motions.
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    *\G\ Further, I note that these courses were specifically marked 
with American Medical Association (AMA) credits, which as Respondent 
admitted were ``the type of credits we all need for continuing 
education.'' Tr. 121. Although the subject matter of the courses is 
certainly relevant to Respondent's compliance with the CSA, and in 
particular, relevant to correcting his misconduct, I do not find 
significant value to the important question of whether he can be 
entrusted with a CSA registration in remedial measures that meet 
continuing education requirements. The record did not expand on 
whether he had used these credits for that purpose. If he had, that 
would certainly weigh against my consideration of them as remedial 
measures in this action. However, even if he did not use them for 
this dual purpose, I agree with the Chief ALJ that the remedial plan 
that Respondent offered was not adequate to ensure that I can 
entrust him with a registration.
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B. Specific and General Deterrence

    The issue here is appropriately resolved in the remaining 
guideposts of the Agency's analytical framework. In determining whether 
and to what extent imposing a sanction is appropriate, consideration 
must be given to the Agency's interest in both specific and general 
deterrence and the egregiousness of the offenses established by the 
Government's evidence. Ruben, 78 FR at 38364, 38385. Each of these 
concepts bears separate consideration here. It is reasonable to 
conclude that, at least for the present, the Respondent is unlikely to 
re-commit these specific transgressions. His wife is being treated by a 
qualified physician (who is not prescribing controlled substances), and 
his former coworkers presumably know enough now not to trust him in the 
future. Thus, the issue of specific deterrence does not particularly 
favor the imposition of a sanction here. [The Chief ALJ found that 
specific deterrence does not particularly favor the imposition of a 
sanction here. Although I agree that Respondent might not be able to 
repeat the exact same behavior he conducted, I am not convinced by his 
remedial measures or the minimal consequences that he has faced thus 
far that he will not repeat similar behavior in mishandling his 
registration for personal gain. There is ample evidence on the record 
that Respondent knew what he was doing was unlawful. He admits as much. 
As discussed herein, he repeated the misconduct in prescribing 
controlled substances to his wife for several years, and made efforts 
to hide his behavior. He preyed on his colleague whom he had mentored--
taking advantage of the imbalance of power in their relationship in 
order to obtain controlled substances when his own doctor had denied 
them. When Respondent proclaimed that he ``is not the yes guy 
anymore,'' Tr. 126, due to his apparently-enlightening ethics class, he 
implied that his misbehavior was linked to a lack of boundaries due to 
his over-accommodating personality, and he urged me to believe that 
suddenly he has re-established those boundaries--that he has broken 
``the habit and create[d] new habits to be able to perform within 
professional boundaries.'' Tr. 118. However, contrary to this favorable 
self-portrayal, the egregious behavior on the record demonstrates more 
artful and intentional deceit than simply refusing to say no. All of 
the misconduct herein occurred after practitioners acting in the course 
of their professional practice had refused to prescribe controlled 
substances. See Tr. 138. Further, Respondent covered his tracks and 
manipulated relationships. As sympathetic as Respondent would make the 
situation sound--that he ``wanted to help [his wife],'' who was in 
pain, Tr.

[[Page 21174]]

142--the fact is that he repeatedly demonstrated behavior that is 
untrustworthy. I am not convinced that the few days of training that he 
took in ethics was so impactful as to have reformed him in the manner 
that he suggests. Therefore, I find that the issue of specific 
deterrence weighs in favor of revocation.
    Regarding general deterrence,] as the regulator in this field, the 
Agency bears the responsibility to deter similar misconduct on the part 
of others for the protection of the public at large. Ruben, 78 FR at 
38385. To the extent that no sanction is imposed, the unambiguous 
message to the regulated community would be that four-and-a-half years 
of enabling the (apparently inappropriate) use of powerful controlled 
drugs for a spouse, while employing the artifice of alternating scrip 
names, and only stopping when state and federal regulatory authorities 
are tipped off by a pharmacist, carries with it no consequence. The 
Respondent's case in this regard might have been somewhat fortified if 
the level of cunning or the duration of the malfeasance had been more 
constrained, but the record is what it is.

C. Egregiousness

    Considerations of egregiousness likewise support revocation. The 
Respondent carried on prescribing for his wife (even during her 
pregnancy) for four-and-a-half years, which is a significant amount of 
time to carry on with conduct that a person knows is straight-up wrong. 
The prescribing was not a one-off, an act of momentary desperation, or 
a misguided accident borne of professional ignorance, and there was no 
eureka moment. Like pressing his advantage with the PA colleague he 
mentored, the Respondent's acts were consistently intentional. The 
intentional nature of the Respondent's acts undermines the ability of 
the Agency, at least at present, to have confidence that he will 
responsibly exercise the responsibilities of a DEA registrant.
    Accordingly, it is respectfully recommended that the Respondent's 
DEA COR should be revoked, and any pending applications for renewal 
should be denied.

    Dated: December 8, 2020.

John J. Mulrooney, II,

Chief Administrative Law Judge.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a)(4) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate 
of Registration No. MD3130717 issued to Noah David, P.A. Further, 
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 deny any pending application of 
Noah David, P.A. to renew or modify this registration, as well as any 
other pending application of Noah David, P.A. for registration in 
Virginia. This Order is effective May 11, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-07688 Filed 4-8-22; 8:45 am]
BILLING CODE 4410-09-P