[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]
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
*\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
*\B\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ The findings and recommendations in this Recommended
Decision are restricted to the charged and preponderantly
established misconduct.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\9\ No corroborating medical records or other documentation was
offered by the Respondent in support of his wife's purported medical
issues.
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\22\ See 21 CFR 1301.44(e).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
*\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.
---------------------------------------------------------------------------
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