Notice2021-20247
Salman Akbar, M.D.; Decision and Order
Primary source
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Published
September 20, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 179 (Monday, September 20, 2021)</title>
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[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Pages 52181-52196]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20247]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-15]
Salman Akbar, M.D.; Decision and Order
On March 2, 2020, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration
(hereinafter, OSC) to Salman Akbar, M.D. (hereinafter, Respondent).
Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1.
The OSC informed Respondent of the immediate suspension of his DEA
Certificate of Registration Number BA5092856 (hereinafter,
registration) and proposed its revocation, the denial of any pending
applications for renewal or modification of such registration, and the
denial of any pending applications for additional DEA registrations
pursuant to 21 U.S.C. 824(a)(4) and 823(f), because Respondent's
``continued registration is inconsistent with the public interest.''
Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this
matter was conducted from July 21-22, 2020 at the DEA Hearing Facility
in Arlington, Virginia, with the parties and their witnesses
participating through video-teleconference. On August 20, 2020, Chief
Administrative Law Judge John J. Mulrooney (hereinafter, Chief ALJ)
issued his Recommended Rulings, Findings of Fact, Conclusions of Law
and Decision (hereinafter, Recommended Decision or RD). On September 9,
2020, the Government and Respondent filed exceptions to the Recommended
Decision (hereinafter, Gov Exceptions and Resp Exceptions,
respectively). Having reviewed the entire record, I find the
Respondent's Exceptions without merit and I adopt the Chief ALJ's
rulings, findings of fact, conclusions of law, and recommended sanction
with minor modifications, where noted herein.\*A\
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\*A\ I have made minor, nonsubstantive, grammatical changes to
the RD. Where I have made substantive changes, omitted language for
brevity or relevance, or where I have added to or modified the Chief
ALJ's opinion, I have noted the edits in brackets, and I have
included specific descriptions of the modifications in brackets or
in footnotes marked with an asterisk and a letter.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of
Registration No. BA5092856 issued to Salman Akbar, M.D. Pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21
U.S.C. 823(f), I further hereby deny any pending application of Salman
Akbar, M.D. to renew or modify this registration, as well as any other
pending application of Salman Akbar, M.D. for registration in Virginia.
This Order is effective October 20, 2021.
Anne Milgram,
Administrator.
The Respondent's Exceptions
In his Posthearing Brief, Respondent acknowledged that the
Government had ``offered sufficient evidence to establish a prima facie
case,'' but he argued that his registration should not be revoked,
because he had ``countered the Government's showing with substantial
mitigating evidence that demonstrates his continued registration will
not be harmful to the public interest.'' ALJ Ex. 20 (Resp Posthearing),
at 1. The Chief ALJ disagreed with Respondent, finding that revocation
was the appropriate remedy, based on Respondent's failure to accept
responsibility for his misconduct and his failure to offer sufficient
remedial evidence. RD, at 33-38. In determining that Respondent had not
adequately accepted responsibility, the Chief ALJ relied in part on
Respondent's statements that he always issues prescriptions within the
usual course of professional practice and for a legitimate medical
purpose. See, e.g., id. at 35 (citing Tr. 427-29).
Respondent takes Exception to the Chief ALJ's reliance on these
statements. Respondent argues that these statements do not negate his
acceptance of responsibility, because he made them ``as a layman
physician and not as a person versed in law.'' Resp Exceptions, at 1.
Respondent asserts that he ``recognized that he failed to meet the
standards of care established by Virginia law,'' but he ``did not . . .
recognize
[[Page 52182]]
that under DEA regulations this meant as a matter of law that the drugs
were not issued for a legitimate medical purpose within the usual
course of professional practice.'' Id. Respondent states that he
``recognizes now that as a legal matter he did not establish a bona
fide doctor-patient relationship, but when testifying he believed as a
matter of fact that he was acting as a doctor attempting to provide
treatment to a patient in need of care.'' Id. at 3.
I reject Respondent's Exception for several reasons. First,
Respondent's statement that he ``recognized that he failed to meet the
standards of care established by Virginia law'' is not supported by the
record. During the following exchange, Respondent repeatedly and
emphatically affirmed that the prescriptions that he issued were within
the usual course of professional practice in Virginia:
Q: And you issued [all of] these prescriptions, you believe,
acting in the ordinary course of professional practice?
A: Absolutely, it was in the course of my medical practice.
Q: And that's again, true for all of the--for the prescription
for tramadol that you issued on July 23, 2019?
A: It's absolutely true.
Q: And that's true for the prescription for tramadol and the
prescription for Ativan that you issued on August 28, 2019?
A: That is correct, and I have no doubts about it.
Q: And do you also believe that you issued the prescriptions for
Ativan and tramadol on September 27, 2019, when in doing so you were
acting in the ordinary course of professional practice for a
physician in Virginia?
A: Absolutely acting in the course of my medical practice.
Q: And you were acting in the usual course of professional
practice on November 5, 2019, when you issued prescriptions to
Patient SD for tramadol and for Ativan?
A: I was acting in the course of my medical practice.
Tr. 428-29. I am also not persuaded by Respondent's implication
that he did not understand that by testifying that he issued
prescriptions ``in the usual course of professional practice in
Virginia,'' he was testifying that the prescriptions were issued in
accordance with Virginia law and the applicable Virginia standard of
care. Respondent did not convey any confusion when he testified that he
``ha[d] no doubts'' that he ``absolutely'' issued the prescriptions in
the usual course of professional practice. Id. If he had misunderstood
what the phrase ``in the usual course of professional practice'' meant,
he could have asked for clarification. This phrase should not have been
foreign to Respondent, because he had just observed the testimony of
the Government's medical expert, who repeatedly testified that
Respondent's prescriptions were not issued in the usual course of
professional practice in Virginia. See, e.g., id. at 205, 214, 218,
220, 231, 255, 258-59, 261, 282-87, 337, 439.
Second, I disagree with Respondent's argument that he was merely
testifying as a layperson who was not well versed in the law, and
therefore, that his statements should not be found as undermining his
acceptance of responsibility. Respondent was not testifying merely as a
layperson, but as a Virginia physician and a DEA registrant who is
expected to be knowledgeable about the basic tenets of medical practice
and the appropriate prescribing of controlled substances. Respondent's
failure to appreciate his obligations under federal and state law
further demonstrates that his continued registration is inconsistent
with the public interest. See, e.g., The Medicine Shoppe, 79 FR 59,504,
59,508-11 (2014). In Medicine Shoppe, the respondent initially accepted
responsibility for his misconduct, but later testified that he ``never
do[es] diversion'' and that he disagreed with the Government's expert's
testimony that he filled unlawful prescriptions. Id. at 59,509-10. The
respondent testified: ``There's no prescription that [the Government's
medical expert] said that I should have [sic] filled that I looked at
it from her point of view.'' Id. at 59,510. Based on this testimony,
the former Deputy Administrator found that the respondent's
``understanding of his obligations as a dispenser of controlled
substances [was] so lacking as to preclude a finding that Respondent's
registration is consistent with the public interest.'' Id. at 59,510
(citing 21 U.S.C. 823(f) and 824(a)(4)). Respondent's testimony in this
case similarly evidences a failure to appreciate his basic obligations
under federal and state law, which demonstrates that his registration
is inconsistent with the public interest.
Finally, I give little weight to Respondent's assertion that he now
recognizes that he did not establish a bona fide doctor-patient
relationship, but when he testified ``he believed as a matter of fact
that he was acting as a doctor attempting to provide treatment to a
patient in need of care.'' Id. at 3. I give little weight to these
statements that were made off of the record. At the hearing,
Respondent's remorse for his misconduct quickly dissipated when he was
cross examined. See, e.g., Tr. 428-29. Moreover, Respondent minimizes
his misconduct in his Exceptions, which undercuts his acceptance of
responsibility and elucidates his lack of familiarity with federal and
state law.\*B\ For example, Respondent states that when he testified,
he believed as a factual matter that he prescribed medication ``for a
legitimate purpose . . . of providing medical care to a patient. . .
who presented with back pain and anxiety.'' Resp Exceptions, at 3
(citing Tr. 380-81). And although Respondent acknowledges that he did
not comply with the Virginia standard of care, he asserts that ``from a
layman's perspective,'' he believed that he was ``acting as a
physician'' who ``was prescribing [] medication for a licit purpose,''
not ``as a common drug dealer giving drugs to anyone willing to pay a
certain price.'' Id.
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\*B\ See George Pursley, M.D., 85 FR 80,162, 80,188 (2020)
(finding that Respondent's attempts to minimize his misconduct
indicated that he ``lack[ed] familiarity with applicable controlled
substance legal requirements'' and ``put into question the value he
assigned to practicing medicine in compliance with the applicable
standard of care'').
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Respondent's attempts to distinguish himself from a ``common drug
dealer'' indicate that he fails to appreciate the egregiousness of his
misconduct. Respondent ignored Patient SD's admissions that he had
taken controlled substances from a friend, and he failed to comply with
even the most basic requirements of the applicable Virginia standard of
care, such as performing a physical examination and establishing a
diagnosis for Patient SD's back pain. See, e.g., Tr. 78-79, 207-211,
228-30. After issuing three tramadol prescriptions to Patient SD,
Respondent asked SD during the fourth visit, ``[W]hat diagnosis are we
using for you? For the back pain. We got to have a diagnosis, and
granted, you aren't getting a whole lot of it from me, but, ah, what
can I use. Do you know any reason why you have back pain?'' Gov't Ex.
13, at 2. Respondent issued a fourth tramadol prescription at that
visit, even though Patient SD said that he had ``no idea'' what was
causing the back pain, and told Respondent that he had been ``pretty
good for a while'' when Respondent asked him where his pain was
located. Id.
Given Respondent's approach to prescribing opioids, I am concerned
that Respondent continues to imply that he was ``attempting to provide
treatment to a patient in need of care'' and not ``dispensing
medications for anyone seeking a fix.'' Resp Exceptions, at 3.
Therefore, I reject Respondent's Exceptions and concur with the Chief
ALJ's conclusions that Respondent did not unequivocally accept
responsibility for his misconduct, and that his
[[Page 52183]]
registration is inconsistent with the public interest.
The issue before the Administrator is whether the record as a whole
establishes that it would be inconsistent with the public interest
under 21 U.S.C. 824(a)(4) and 823(f) to allow Respondent to retain his
DEA registration.
The decision below is based on my consideration of the entire
Administrative Record, including all of the testimony, admitted
exhibits, and the oral and written arguments of counsel. I adopt the
ALJ's Recommended Decision with noted modifications.
David M. Locher, Esq. and John E. Beer bower, Esq., for the Government
Joseph R. Pope, Esq. for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
The Allegations *<SUP>C 1 2</SUP>
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\*C\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
\1\ [Footnote omitted, see supra n.*C]
\2\ [Omitted footnote discussing the administrative tribunal's
jurisdiction over the immediate suspension order.]
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The Government alleges that the Respondent's DEA registration
should be revoked because, over the course of four visits, the
Respondent issued seven illegitimate controlled substance prescriptions
to a DEA undercover Task Force Officer. ALJ Ex. 1, at 2.
The Evidence
Stipulations
The parties entered into factual stipulations which were accepted
by the tribunal. The following factual matters are deemed conclusively
established in this case:
1. The Respondent is registered with DEA as a practitioner to
handle substances in Schedules II through V under DEA COR No.
BA5092856. The Respondent's registered address is 10708 Old Prescott
Road, Richmond, Virginia 23233.\*D\
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\*D\ According to Agency Records, Respondent's registered
address has changed to 909 Hioaks RD, Suite F, Richmond, Virginia
23225-4038.
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2. The Respondent's COR expires by its own terms on June 30,
2020.\3\
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\3\ Counsel for both parties have represented that the
Respondent timely filed an application to renew his DEA registration
in advance of these proceedings. [Citation omitted.]
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3. Oxycodone is a Schedule II controlled substance pursuant to
21 C.F.R Sec. 1308.12(b)(1)(xiii).*\E\ Percocet is a brand name
drug containing oxycodone.
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\E\ This stipulation cites to the version of the regulation that
was effective from February 7, 2019, to August 15, 2019. The
lettering of the regulation's various subsections has changed in
subsequent versions, but there were no substantive changes that
impact my Decision.
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4. Alprazolam is a Schedule IV controlled substance pursuant to
21 CFR 1308.14(c)(2). Xanax is a brand name drug containing
alprazolam.
5. Diazepam is a Schedule IV controlled substance pursuant to 21
CFR 1308.14(c)(16).\*F\ Valium is brand name drug containing
diazepam.
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\*F\ This stipulation cites to the version of the regulation
that was effective from December 14, 2015, to June 16, 2019. The
lettering of the regulation's various subsections has changed in
subsequent versions, but there were no substantive changes to the
regulation that impact my Decision.
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6. Lorazepam is a Schedule IV controlled substance pursuant to
21 C.F.R Sec. 1308.14(c)(30).\*G\ Ativan is a brand name drug
containing lorazepam.
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\*G\ This stipulation cites to the version of the regulation
that was effective from December 14, 2015, to June 16, 2019. The
lettering of the regulation's various subsections has changed in
subsequent versions, but there were no substantive changes to the
regulation that impact my Decision.
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7. Tramadol is a Schedule IV controlled substance pursuant to 21
CFR 1308.14(b)(3).
8. Government Exhibit 1 is a true and correct copy of the
Respondent's patient file for Patient SD.
9. On July 23, 2019, the Respondent issued a prescription to
Patient SD for 20 dosage units of tramadol 50 mg.
10. Government Exhibit 2 is a true and correct copy of the
prescription for 20 dosage units of tramadol 50 mg that the
Respondent issued to Patient SD on July 23, 2019.
11. Government Exhibit 3 contains a true and correct recording
of the Respondent's interaction with Patient SD on July 23, 2019.
12. Government Exhibit 4 is a true and correct transcript of the
Respondent's interaction with Patient SD on July 23, 2019.
13. On August 28, 2019, the Respondent issued prescriptions to
Patient SD for 20 dosage units of tramadol 50 mg and 30 dosage units
of Ativan 0.5 mg.
14. Government Exhibit 5 is a true and correct copy of the
prescriptions the Respondent issued to Patient SD on August 28,
2019.
15. Government Exhibit 6 contains a true and correct video
recording of the Respondent's interaction with Patient SD on August
28, 2019.
16. Government Exhibit 7 is a true and correct transcript of the
Respondent's interaction with Patient SD on August 28, 2019.
17. On September 27, 2019, the Respondent issued prescriptions
to Patient SD for 30 dosage units of tramadol 50 mg and 30 dosage
units of Ativan 0.5 mg.
18. Government Exhibit 8 is a true and correct copy of the
prescriptions the Respondent issued to Patient SD on September 27,
2019.
19. Government Exhibit 9 contains a true and correct video
recording of the Respondent's interaction with Patient SD on
September 27, 2019.
20. Government Exhibit 10 is a true and correct transcript of
the Respondent's interaction with Patient SD on September 27, 2019.
21. On November 5, 2019, the Respondent issued prescriptions to
Patient SD for 30 dosage units of tramadol 50 mg and 30 dosage units
of Ativan 0.5 mg.
22. Government Exhibit 11 is a true and correct copy of the
prescriptions issued to Patient SD on November 5, 2019.
23. Government Exhibit 12 contains a true and correct video
recording of the Respondent's interaction with Patient SD on
November 5, 2019.
24. Government Exhibit 13 is a true and correct transcript of
the Respondent's interaction with Patient SD on November 5, 2019.
25. Patient SD was provided with a document entitled ``Pain
Treatment with Opioid Medications: Patient Agreement'' during his
visit to the Respondent's clinic on November 5, 2019.
26. Government Exhibit 14 is a true and correct copy of the
Virginia Prescription Drug Monitoring Program Audit Report showing
searches by the Respondent for Patient SD.
27. Government Exhibit 16 contains a true and correct copy of
``New Safety Measures Announced for Opioid Analgesics, Prescription
Opioid Cough Products, and Benzodiazepines,'' published by the Food
and Drug Administration (FDA).
28. Government Exhibit 16 contains a true and correct copy of
the FDA label for Ativan.
The Government's Case
The Government's case consisted of the testimony from the lead
Diversion Investigator on the case, the DEA Task Force Officer who made
undercover visits to the Respondent's office, and an expert witness.
Diversion Investigator
As its first witness, the Government called a Diversion
Investigator (hereinafter, DI), who testified that he has been a DI for
seven years, the last two of which have been in the Richmond Field
Office. Tr. 27. DI was the lead investigator in the case against the
Respondent. Id. at 30. He testified that the investigation into the
Respondent's prescribing practices began when DEA received a tip from
an individual who stated that they were a patient of the Respondent.
Id. This individual informed DEA that ``a lot of drug addicts'' seemed
to be frequenting the Respondent's office. Id. This tip was received
and documented by the office's assigned Task Force Officer
(hereinafter, TFO). Id. at 32.
Acting on the tip information, DI consulted numerous databases,
both inside and outside DEA. Id. at 33. One of the databases he checked
was the Virginia Prescription Monitoring Program (hereinafter, the
Virginia PMP or the PMP) database to analyze data for any possible
patterns regarding the Respondent's controlled substance prescribing.
Id. at 33, 63; Gov't Ex. 14. The witness explained that the Virginia
[[Page 52184]]
PMP database allows investigators to determine the prescriptions a
practitioner has issued and where the prescriptions were dispensed. Tr.
33. DI explained that he was searching for potential ``red flags,''
such as prescriptions for high strengths and dosages of medications
that are commonly abused or diverted and prescriptions for high
strengths/dosages of these drugs that are dispensed to multiple people
residing at the same address. Id. at 62. DI testified that the PMP data
regarding the Respondent presented some unusual commonalities among
individuals within the same household who were patients of the
Respondent.\4\ Id. at 63. He testified that, at least in his view at
the time, these data points constituted red flags which warranted
further investigation. Id.
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\4\ The Government did not base its case on multiple patients
living at the same address. This information was offered and
considered strictly to explain information which informed the DI's
investigative progress.
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DI testified that the investigation of the Respondent progressed to
the deployment of a DEA TFO who conducted multiple undercover visits to
the Respondent's practice. Id. at 34. According to DI, TFO made four
undercover visits (hereinafter, UC Visits) to the Respondent's office
using an alias (Scott Davis).\5\ Id. at 34-35. The UC Visits were
conducted on July 23, 2019 (hereinafter, UC Visit #1), August 28, 2019
(hereinafter, UC Visit #2), September 27, 2019 (hereinafter, UC Visit
#3), and November 5, 2019 (hereinafter, UC Visit #4), respectively. Id.
at 35. It is DI's understanding that the UC Visits were recorded by the
TFO using a concealed device, and that controlled substance
prescriptions were issued to the TFO by the Respondent at the
culmination of each visit. Id. at 36; see Gov't Exs. 2, 3, 5, 6, 8, 9,
11, 12. Each of the scrips procured by the TFO from the Respondent's
office were turned over to the Richmond DEA office and maintained in
the DEA evidence system. Tr. 36. The recordings likewise were
maintained in the DEA evidence system, and were subsequently
transcribed by a Federal Bureau of Investigation (hereinafter, FBI)
transcriber. Tr. 36-37, 50; see Gov't Exs. 4, 7, 10, 13.
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\5\ DI Pumphrey confirmed that Scott Davis is a fictitious name.
Tr. 34.
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Using the information acquired during the course of the
investigation, a search warrant was secured by DEA and executed at the
Respondent's clinic on March 3, 2020. Tr. 37. In the course of this
search, the medical records for the TFO under his fictitious name
(Scott Davis or Patient SD) were among the documents identified and
seized. Id.; Gov't Ex. 1. Additionally, DEA requested data from the
Virginia Department of Health Professions, which reflected that the
Respondent had queried the Virginia PMP regarding Patient
SD.<SUP>6 *H</SUP> Tr. 38; Gov't Ex. 14. DI's testimony was used to
authenticate multiple Government exhibits, which included documents
uncovered during the search as well as those produced in the course of
the investigation.\7\ Following the execution of the search warrant,
DEA personnel hired an expert, Dr. John F. Dombrowski, to evaluate what
they had acquired and learned during the course of their investigation.
Tr. 62.
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\6\ [Content of footnote addressed in text.]6
\*H\ This sentence was modified to clarify that DEA requested
Respondent's Virginia PMP queries from the Virginia Department of
Health Professions.
\7\ Government Exhibit 1 contains the medical records that the
Respondent's office maintained under the name Scott Davis (Patient
SD), which were retrieved during the search of the Respondent's
clinic. Tr. 38-39. Government Exhibit 2 is a copy of a prescription
for tramadol written by the Respondent for Patient SD at UC Visit
#1. Id. at 40-41, 42-46. Government Exhibit 3 is a video recording
of UC Visit #1. Id. at 46-48. Government Exhibit 4 is a transcript
of the UC Visit #1 videotape. Id. at 49-50. Government Exhibit 5
contains the prescriptions written for Patient SD at UC Visit #2.
Id. at 51-52. Government Exhibit 6 is the video recording of UC
Visit #2. Id. at 53-54. Government Exhibit 7 is a transcript of the
UC Visit #2 videotape. Id. at 54-55. Government Exhibit 8 contains
the prescriptions for tramadol and Ativan that were written by the
Respondent for Patient SD at UC Visit #2. Id. at 55-56. Government
Exhibit 9 is the video recording of UC Visit #3. Id. at 56-57.
Government Exhibit 10 is a transcript of the UC Visit #3 videotape.
Id. at 57. Government Exhibit 11 is the two prescriptions for
tramadol and Ativan written by the Respondent for Patient SD at UC
Visit #3. Id. at 57-58. Government Exhibit 12 is a video recording
of UC Visit #4. Id. at 58-59. Government Exhibit 13 is the
transcript of the UC Visit #4 videotape. Id. at 59. Government
Exhibit 14 documents the queries to the Virginia PMP made regarding
the Respondent as part of the investigation. Id. at 59. DI confirmed
that he ran the query and received the information on April 3, 2020.
Id. at 59-60. He further testified that this data was a ``special
request'' in that he directly contacted the Virginia Department of
Health Professionals to request this data. Id. at 60. Government
Exhibit 14 is the document he received as a result of this inquiry.
Id. at 60-61.
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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.
TFO
The Government presented the testimony of the agent who conducted
the undercover visits to the Respondent's practice, TFO. TFO testified
that he has been a detective with the City of Greenfield (Wisconsin)
Police Department (GPD) for eighteen years and has been cross-
designated by DEA as a TFO for the past seven years. Tr. 66-69. He was
assigned to assist in the investigation that spawned the current
charges against the Respondent. Id. at 66-68. TFO testified that he is
experienced in undercover work, having personally conducted and
provided testimony regarding somewhere between 100 and 200 undercover
operations. Id. at 69.
TFO testified that he assumed the name Scott Davis (for which he
had a fabricated driver's license) to conduct his operation at the
Respondent's office and that he recorded his UC Visits on audio visual
recording equipment. Id. at 70, 87. TFO testified that following a
preliminary visit with the Respondent's office staff, he appeared for a
July 23, 2019 office visit (UC Visit #1). Id. at 71. Upon his arrival,
the Respondent's office staff had the TFO pay an office visit fee \8\
and fill out a medical questionnaire. Id. at 73; Gov't Ex. 1, at 7.
According to TFO, based on his experience, he completed the
questionnaire in such a way as to monitor whether the prescriber was
fulfilling his responsibility to ensure that pain medications were not
being diverted. Id. at 75-77. Under the heading ``Reason for Visit,''
the TFO put the words ``need new doctor prescription.'' Gov't Ex. 1, at
7; Tr. 119. Although he knew he planned to (falsely) describe back
discomfort to the Respondent, the TFO intentionally declined to check
the box adjacent to ``Back Problems'' in the ``Past Medical History''
section of the form. Gov't Ex. 1, at 7; Tr. 74. Similarly, the TFO left
a blank response to the query, ``Do you use recreational drugs?'' Gov't
Ex. 1, at 7. TFO recounted that neither of these potential diversion
red flags were raised with him by the Respondent or his staff during
any of his UC Visits.\9\ Tr. 74-75.
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\8\ Tr. 75.
\9\ The form demonstrates a miniscule dot outside each of the
respective boxes pertaining to the use of recreational drugs and
back problems. Gov't Ex. 1, at 7; Tr. 120-21, 154-56. The dots are
tiny and do not provide any level of ambiguity as to the responses
(or lack thereof). Indeed, during his testimony, the Respondent,
beyond a general acknowledgement of their existence, Tr. 378, did
not allude to any significance that should be attached to these two
little dots, and no significance is placed on their presence for the
purposes of this recommended decision.
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After completing the medical questionnaire during UC Visit #1, the
TFO was escorted to an exam room by a staff member and had his vitals
taken. Id. at 75, 77, 88. The Respondent met with the TFO after the
staff finished taking his vitals. Id. at 77. The cover story the TFO
presented to the Respondent was that he is an active
[[Page 52185]]
construction worker \10\ who recently moved to the Richmond area from
Milwaukee and needed to establish with a new doctor to refill his
medications. Id. at 78; Gov't Ex. 4, at 2. On his questionnaire, the
TFO indicated a specific strength and dosage of Percocet \11\ under the
``Current Medications'' section. Gov't Ex. 1, at 7. Upon meeting TFO,
the Respondent initiated his contact with ``What's going on? What can I
help you with?'' Gov't Ex. 4, at 2. When the TFO started to explain his
move to the area and need for a new physician (all of which was
contrived), the Respondent interrupted with ``For this kinda stuff?
Percocet?'' and described Percocet as ``[a]lmost outlawed.'' Id.; see
also Tr. 123. The TFO told the Respondent that the Percocet he referred
to on the questionnaire was for his back, and that he moved to perform
construction work in the Richmond area. Gov't Ex. 4, at 2. The
Respondent asked the TFO, ``[s]o where in the back, and how much
Percocet are you needing?'' Id. The TFO volunteered the following
rather startling admission: ``Unfortunately, I had to, uh, like from a
friend or a girlfriend, that sort of thing, get some pills here and
there. Uh, the tramadol's actually been working pretty decent.'' \12\
Id. at 3; Tr. 78-79. Without any follow-up or even apparent reaction to
the revelation that his patient had just admitted to acquiring diverted
drugs,\13\ the Respondent asked him about the source of his back pain,
to which the TFO replied that he did not know, but that at some point
he had fallen from a ladder and recovered by ``just doing [his] job.''
Gov't Ex. 1, at 4; Tr. 79. Later in their conversation, the Respondent
admonished the TFO that ``[j]ust because you fell off of a ladder
doesn't mean anything.'' Gov't Ex. 1, at 7. The witness told the
Respondent that there were no radiation symptoms down the legs.\14\ Id.
at 4. There was some additional discussion about other options and
creams and the Respondent reiterated that ``[t]he rules are so strict
about Percocet. Especially 10 [milligram dosage].'' Id. at 5. After
confirming on multiple occasions that the TFO brought no imaging, and
explaining that he would, at some point, have to procure an x-ray, the
Respondent explained that while he would not be prescribing Percocet,
``I can give you a few tramadols \15\ until you can get an x-ray, and
you're going to have to show me that there is something going on with
your back.'' Id. The TFO testified that he never provided any imaging
to the Respondent at that visit. Tr. 89-90.
---------------------------------------------------------------------------
\10\ Tr. 125.
\11\ The TFO testified that he chose Percocet based on his
understanding that it is a medication that is ``more highly sought
after by addicts.'' Tr. 164.
\12\ The questionnaire contained no reference to tramadol. Gov't
Ex. 1, at 4.
\13\ Tr. 79; Gov't Ex. 1, at 4.
\14\ The TFO testified that he volunteered this in ``trying to
minimize the symptoms.'' Tr. 83.
\15\ Tramadol is a Schedule IV controlled substance. 21 CFR
1308.4(b)(3); Stip. 7.
---------------------------------------------------------------------------
The TFO told the Respondent that he thought he could procure an
``older'' x-ray or MRI \16\ from his former address in Milwaukee, that
he kept working while prescribed oxycodone for a couple of years,\17\
and that since he was on oxycodone for that long, ``it's like, I mean,
I can't just stop.'' \18\ Gov't Ex. 4, at 6, 8. There was no follow-up
from the Respondent regarding the TFO's estimation that he was unable
to ``just stop'' taking oxycodone. Id. The Respondent gave no
indication that he was concerned about potential dependence or
addiction.
---------------------------------------------------------------------------
\16\ Tr. 89-90. The TFO was unable to recall whether he told the
Respondent that he had an x-ray or an MRI. Id. at 79.
\17\ The questionnaire contained no reference to oxycodone.
Gov't Ex. 1, at 4.
\18\ The TFO testified that he told the Respondent he could not
just stop ``because I wanted to show that I was dependent--
potentially addicted but dependent upon that pain medication.'' Tr.
84.
---------------------------------------------------------------------------
When the TFO raised the issue that he has ``a tough time, like
falling asleep, and relaxing at the end of the day,'' the Respondent's
reaction was ``Ok, and here's some Trazadone \19\ for that,''
describing the medication as the ``[m]ost commonly prescribed sleeping
medicine in the country.'' Id. at 6-7. Although at one point during
their brief, eight-minute \20\ time together, the Respondent touched
the TFO's back through his shirt for one-to-two seconds,\21\ no
physical exam was conducted on the undercover officer by anyone at any
time during UC Visit #1. Tr. 77, 83. The Respondent prescribed twenty
50 milligram (mg) tramadol tablets, which the TFO did not fill. Gov't
Ex. 2; Tr. 85-86.
---------------------------------------------------------------------------
\19\ Trazadone is not a controlled substance.
\20\ Tr. 85.
\21\ Tr. 81-82, 90-91, 133. The TFO testified that he was
wearing a T-shirt. Tr. 82.
---------------------------------------------------------------------------
The TFO returned to the Respondent's office for another undercover
visit on August 28, 2019 (UC Visit #2). Tr. 87. Similar to his first UC
Visit, the TFO paid an office visit fee, and was escorted to an exam
room for two-to-three minutes, where his vital signs were taken and he
was asked the reason for his visit. Id. at 89. He was joined in the
exam room by the Respondent shortly thereafter, where the TFO informed
the doctor that he had come for a tramadol refill. Id. at 89. In
response to the Respondent's inquiry about the imaging results the TFO
had agreed to bring, the latter told him that he had located them in
Milwaukee, but neglected to bring them with him. Id. at 89-90, 136;
Gov't Ex. 7, at 2. The Respondent replied, ``Uhhh, I need that.
Alright, I'll just give you twenty for now, and ah, I need you to bring
that . . . . Then I'll give you more.'' Gov't Ex. 7, at 2; see also Tr.
136. The Respondent went on to explain that once he has the opportunity
``to look at'' the imaging ``we could do regular sixty [tablets], if
there is . . . [s]ignificant pathology . . . [o]f your back.'' Gov't
Ex. 7, at 3.
The Respondent asked the TFO if he experienced spasms, but got no
answer. Id. He again touched a spot on the TFO's back through his shirt
for one-to-two seconds, and was told by his patient that he had
identified the locus of pain, ``if it's bothering me, uh, that's where
it is.'' Gov't Ex. 7, at 3; Tr. 90-91, 137. Remarkably, the Respondent
explained his understanding of the prescribing standard to the TFO in
this way:
Alright, right now, I can only list back pain as a diagnosis,
but ya know, in our file we need more than that. Like a herniated
disc, or a compressed disc, or something, ya know? Something more
concrete.
Gov't Ex. 7, at 3. After another assurance that he would bring his
imaging on his next visit, the TFO made the following request: ``Oh,
oh, I was gonna say, c-can I get a scrip for Xanax too?'' explaining
that the tramadol ``helps me during the day, but the Xanax makes me
feel a lot better and relaxed in the evening.'' Id. at 4. A few follow
up questions by the Respondent made it clear that the TFO did not know
(or was not willing to say) what his prior dose of Xanax was. Id. The
Respondent confided in his patient that since the emergence of the
current opioid crisis, ``I don't like to prescribe Xanax anymore,'' and
noted the addictive qualities of Xanax. Id. The Respondent said he
would be willing to prescribe Ativan as a less addictive alternative.
Id. at 4-5; Tr. 92. No mental status exam was conducted. Tr. 92. In
fact, no questions about any mental health conditions were directed to
the TFO. Id. The TFO's response to all of this was to let the
Respondent know that he had also tried Valium in the past, to which the
Respondent replied, ``No, no, no, no, no.'' Gov't Ex. 7, at 4-5. Just
as was true at UC Visit #1, no physical exam was conducted by the
Respondent or any staff member during UC Visit #2. Tr. 89. The TFO was
asked no questions about how he was doing on the previously-prescribed
tramadol, but at the conclusion of his four-minute visit with the
Respondent, he received
[[Page 52186]]
prescriptions for tramadol and Ativan. Gov't Ex. 5, at 1-2.
The TFO paid another undercover visit to the Respondent's practice
on September 27, 2019 (UC Visit #3). Tr. 94. Like his other visits, he
paid his office fee, was escorted to an exam room, had his vitals
taken, and waited for the doctor. Id. at 96. Before the staff member
departed, the TFO did take the opportunity to assure her that he was
presently experiencing neither pain nor anxiety. Id. at 97.
Upon the Respondent's arrival in the exam room, the TFO told him he
was there for tramadol and Ativan refills. Id. Consistent with the
TFO's assurances to the staff member, he told the Respondent, regarding
his back pain, ``I'm feeling pretty good.'' Gov't Ex. 10, at 2; see
also Tr. 98-99, 142, 162. When he re-told the Respondent that he did
not know the cause of his back pain,\22\ the Respondent presented the
following suggestion: ``Why don't we just give you twenty of tramadol?
It's no big deal.'' Gov't Ex. 10, at 2. When the Respondent inquired
about any factors that might exacerbate the back issues, the TFO
responded with, ``Yeah, I mean, like right now I feel ok, but [you
n]ever know.'' Id. The Respondent's reaction to this non-sequitur
answer was to propose various activities that possibly could make this
worse, but this patient was not taking the bait. Id. at 2-3. He merely
offered that ``the Ativan was pretty good.'' Id. at 3. The Respondent's
astonishing response to this colloquy was:
---------------------------------------------------------------------------
\22\ Tr. 97.
Alright, no problem. Ativan is a low, uh, low benzodiazepine,
um, equivalent. Ok. So it's probably a better one to use anyway. Ok?
---------------------------------------------------------------------------
Yeah. I'll increase the number of tramadols to thirty. Ok?
Id. Not surprisingly, the TFO readily concurred in this unsolicited
medication increase, which was unsupported by any discussion about the
relative merits or efficacy of the prior dose of twenty tablets, to
which the Respondent amicably replied, ``You happy? Good.'' Id.
Following some level of banter, doctor and patient ended their time
together. Id. As was true in the other adventures at the Respondent's
office, the TFO provided no imaging or other medical records,\23\ and
no physical exam was performed on the TFO by the Respondent or any
staff member. Tr. 96, 98. One variation in this visit is that the
Respondent did not touch the TFO's back at all. Id. at 98. There was no
inquiry about the efficacy of (or anything else about) the previously-
prescribed tramadol, but at the conclusion of the two minutes the two
men spent together during UC Visit #3, the Respondent issued
prescriptions for Ativan and an increased dosage of tramadol. Id. at
99-102, 162; Gov't Ex. 8, at 1-2.
---------------------------------------------------------------------------
\23\ Tr. 98.
---------------------------------------------------------------------------
The TFO's final undercover visit to the Respondent's office (UC
Visit #4) occurred on November 5, 2019. Tr. 102. As had generally been
the routine, the TFO paid his office visit fee and was taken back into
an exam room by a staff member where vital signs were taken. Id. at
104. In a slight variation from prior experience, the TFO was presented
with a pain management contract \24\ and two questionnaires. Id. at
104-107, 111. The first questionnaire is entitled, ``Generalized
Anxiety Disorder 7-Item (GAD-7) Scale'' (Anxiety Questionnaire), and
the second bore the title, ``Pain Diagram and Pain Rating'' (Pain
Questionnaire). Id.; Gov't Ex. 1, at 12-13. The TFO put extremely low
marks and low frequency of occurrence on both questionnaires,
demonstrating a low level of symptoms. Gov't Ex. 1, at 12-13; Tr. 107,
109-11, 146-52.
---------------------------------------------------------------------------
\24\ Gov't Ex. 1, at 2-3.
---------------------------------------------------------------------------
After the staff member departed, the Respondent entered. Tr. 112.
The TFO told the Respondent that he was feeling ``[n]ot too bad,'' and
that he came in for the ``[s]ame thing as the last few times. Just the
refills.'' Gov't Ex. 13, at 2; Tr. 112. The Respondent told the TFO he
was refreshing his recollection by examining his chart, and narrated
his recall process as follows:
Ok. So what diagnosis are we using for you? For the back pain.
We got to have a diagnosis, and granted, you aren't getting a whole
lot of it from me, but, ah, what can I use[?] Do you know any reason
why you have back pain?
Gov't Ex. 13, at 2. Once again, the TFO assured the Respondent that
he ``ha[d] no idea'' why he had back pain. Id.; see also Tr. 112. He
elaborated that he liked what the Respondent was prescribing,
``[b]ecause it's been pretty good for a while . . . .'' Gov't Ex. 13,
at 2. The TFO pointed to a spot on his back and identified the spot as
the locus of the pain, ``[i]f it would be bothering me.'' Id.
As had become their custom during their visits, the TFO provided
neither imaging nor prior medical records,\25\ but Respondent asked,
``[D]o you mind getting a chest film for me?'' Gov't Ex. 13, at 3.
Beyond a two-to-three second finger push on the back through the TFO's
shirt, no physical examination took place, and no dialogue occurred
regarding the efficacy of the medications prescribed in the past,
physical function, mental health, or pain level. Tr. 113-15. This time,
the TFO pushed back a bit on acquiring an x-ray, citing a current lack
of insurance as an impediment.\26\ Tr. 145. However, the lack of
insurance and concomitant lack of imaging did not serve as an
impediment to the Respondent continuing to write controlled substance
prescriptions, and at the end of the visit, the TFO walked away with
prescriptions for tramadol and Ativan. Gov't Ex. 11; Tr. 115-17.
---------------------------------------------------------------------------
\25\ Tr. 112.
\26\ The Respondent asked the TFO to ``let [him] know when [he
has] insurance so [the Respondent] can set [him] up for that x-
ray.'' Gov't Ex. 13, at 5.
---------------------------------------------------------------------------
The TFO presented as an objective law enforcement officer with no
apparent agenda beyond telling the truth. When asked, he was freely
willing to agree with the Respondent's counsel on numerous points, but
presented the impression of being confident in what he remembered about
the case. Overall, this witness's testimony was sufficiently detailed,
internally consistent, and plausible to be afforded full credibility in
this case.
Dr. John F. Dombrowski, M.D., F.A.S.A.
The Government called Dr. John F. Dombrowski as its final witness.
Tr. 168. Dr. Dombrowski testified that he is currently employed as a
physician at the Washington Pain Center in Washington, DC \27\ Id. He
holds licenses to practice medicine in Maryland, Virginia, Florida, and
the District of Columbia. Id.; Gov't Ex. 15. Dr. Dombrowski received
his medical training at Georgetown University and Yale University
before entering private practice in Richmond, Virginia, and eventually
coming to practice in Washington, DC Tr. 170; Gov't Ex. 15. In addition
to working as a physician, he is presently the CEO of the Washington
Pain Center. Tr. 171; Gov't Ex. 15. In his capacity as a physician, Dr.
Dombrowski performs injection therapy as an anesthesiologist as well as
medication management for chronic pain patients. Tr. 171. He is
additionally the director of several methadone clinics in the
Washington, DC, area, as well as a detox facility in Maryland. Id. at
171-72; Gov't Ex. 15. His primary areas of expertise are
anesthesiology, addiction medicine, and pain medicine. Tr. 172. Dr.
Dombrowski is a member of the American Society of Anesthesiology, the
Interventional Pain Societies, and some other professional
organizations relating to his areas of specialty. Id.; Gov't Ex. 15.
Dr. Dombrowski has board certifications from the American Board of Pain
[[Page 52187]]
Medicine, the American Board of Addiction Medicine, the American Board
of Anesthesiology, the National Board of Medical Examiners, and the
American Board of Preventive Medicine. Tr. 348; Gov't Ex. 15.
Additionally, he maintains a clinical practice and is a DEA registrant.
Tr. 172-73. His practice includes the regular prescribing of controlled
substances, including but not limited to opioids and benzodiazepines.
Id. at 173. In the past, he has provided expert testimony regarding the
medical practice of other physicians.\28\ Id. He has previously opined
professionally on the use of opioid medications to treat chronic pain.
Id. at 174. In forming his expert opinion, Dr. Dombrowski reviewed the
relevant Virginia laws relating to the standard of care for prescribing
opioids for chronic pain. Id. at 175. In the absence of an objection,
Dr. Dombrowski was tendered and accepted as an expert in the applicable
standards of care for prescribing controlled substances within the
usual course of professional practice in Virginia. Id. at 176-77.
---------------------------------------------------------------------------
\27\ Dr. Dombrowski's curriculum vitae (hereinafter, CV) was
received into evidence without objection. Gov't Ex. 15; Tr. 170.
\28\ Dr. Dombrowski estimates that his work as an expert witness
is roughly comprised of sixty percent defense work and forty percent
plaintiff work. Tr. 173-74.
---------------------------------------------------------------------------
Dr. Dombrowski testified that in order to be compliant with the
standard of care in Virginia, a physician must establish a medical
relationship with a patient by taking a thorough history, performing a
physical exam, and acquiring any necessary lab work before prescribing
a controlled substance.\29\ Id. at 179, 211-12. Dr. Dombrowski
described finding a diagnosis as the ``hallmark'' for proper controlled
substance prescribing in Virginia. Id. at 185. According to the
witness, discerning a correct diagnosis, or in other words, divining
the etiology for the pain symptom, ``is everything because once I
determine what the problem is, then I can come up with a host of
modalities to treat that one problem.'' Id. at 199. ``Pain,'' Dr.
Dombrowski explained, ``is just a symptom, it's not the reason.'' Id.
at 200.
---------------------------------------------------------------------------
\29\ Dr. Dombrowski described the taking of a thorough history
and conducting a thorough physical as the ``mainstay'' of the
prescribing standard. Tr. 211.
---------------------------------------------------------------------------
In regard to establishing a valid diagnosis, he testified that a
medical history and physical constitute about eighty percent of a
proper diagnosis. Id. at 179. It is Dr. Dombrowski's view that the
objective aspects of the physical examination ``bolster'' the
subjective observations of the patient. Id. at 182. The physical
examination, as described by Dr. Dombrowski, generally includes some
level of bodily manipulation to attempt to explore and replicate the
pain symptoms, followed by testing to investigate potential issues,
such as neurologic compromise.\30\ Id. at 182-83. The witness described
some of the fairly extensive standard steps required in a proper
physical examination, to include spine palpation, having the patient
stand up and touch their toes, twisting movements of various parts of
the body, conducting a heel-toe walk, a sensory evaluation, and
conducting a straight-leg raise exercise. Id. at 195-97. The witness
also discussed the vital role of testing, such as obtaining an MRI, CT
scan, or other imaging ``to back up your diagnosis.'' \31\ Id. at 211-
12. In response to a query by the Respondent's counsel at the hearing
about a patient presenting with a generalized complaint of back pain,
Dr. Dombrowski supplied the following explanation of some of the
precursor steps required in Virginia to meet the minimum controlled
substance prescribing standard:
---------------------------------------------------------------------------
\30\ The witness acknowledged that there could be a difference
between the comprehensive level of examination conducted during a
first visit to a physician and subsequent visits where the
examination may become more focused. Tr. 192-93, 227.
\31\ In a confusing and peculiar twist, at another point in his
testimony, Dr. Dombrowski also testified that in his opinion,
today's doctors ``get way too many tests [and] don't spend enough
time talking to patients.'' Tr. 329.
So basically what you first want to do is take a thorough
history, before you even get to the exam. Talking about where's the
pain; how has the pain affected you; how has it affected your
quality of life, your activities of daily living; the quality of the
pain in terms of burning, stabbing, aching, et cetera? Where is the
pain located, where does the pain go? Does it run down a leg, does
it remain in your back? Et cetera. And then along with that--before
you even get into the physical, which I'll get to, you also want to
understand . . . how long have you had it for? Is this acute? Is
this chronic? [ ] [W]hat have you tried in the past? Were there x-
rays in the past? Things like that to give me, as a new physician,
some understanding of then how to move forward. Once I understand
the patient's thorough history and getting all that information,
before we even do the exam, then we go do the exam. The exam for
back pain just would be obviously having the patient stand. Ask them
. . . [to] point to where it hurts. And they would then direct me
where it hurts. I would place my hand or hands there, palpate, feel,
in terms . . . of if the muscles are tight or are they soft? If I
push hard, does it reproduce the pain? And then along with that, we
start then having the patient move, to see if movement would cause
pain, such as forward flexion, back extension, or rotation to the
sides. To see if it, again, exacerbates the pain that they have or
mitigates--makes it better. And that gives me an understanding on
what particular diagnosis it is. And then moving forward outside of
the back exam . . . you . . . do a neurologic exam. Again, assessing
for any pain to the extremities. And with that pain, is there
associated weakness? Having them stand on their feet, heels, feeling
their thighs . . . . That's just a cursory exam. There's other
things that we can talk about, but that's a basic exam. I hope that
---------------------------------------------------------------------------
explained it.
Id. at 325-27.
Dr. Dombrowski highlighted the importance of acquiring prior
medical records and probing issues such as past substance abuse in
compiling an adequate medical history. Id. at 183-84. He explained that
prior substance abuse does not necessarily stand as a barrier to pain
treatment, but it could oblige the physician to employ more caution,
potentially requiring such measures as urine drug screens (hereinafter,
UDS) and/or pill counts. Id. at 184, 202.
A mental status evaluation, according to the witness, may also be
required to gauge the patient's true need for pain medication, as well
as a discussion regarding the risks, benefits, and dangers associated
with prescribed drugs. Id. at 184-87. Dr. Dombrowski also testified
that informed consent and the utilization of an opioid contract is a
required controlled substance prescribing standard in Virginia. Id. at
187-88. Documentation of the steps taken, according to Dr. Dombrowski,
is also an element in meeting the controlled substance prescribing
standard in Virginia. Id. at 189-91.
Dr. Dombrowski testified that after reviewing the transcripts of
visits and medical records prepared in connection with the Respondent's
care of the TFO, in his expert opinion, the Respondent's controlled
substance prescribing fell below the applicable standard in Virginia.
Id. at 205, 214, 218, 220, 231, 255, 258-59, 261, 282-87, 337, 439. The
witness determined that a proper physical exam was never conducted, and
that to the extent the progress notes indicated such an exam was
conducted, those notes, when compared to the UC videotapes and
transcripts, are patently false. Id. at 207-211, 228-30. No proper
physical \32\ or mental health diagnoses were ever made or supported by
the charts. Id. at 230, 232-36, 254, 283. Lacking also across board in
the visits is a substance abuse history, a
[[Page 52188]]
psychosocial history, a mental status evaluation, UDS testing, a
documented risk/benefits discussion, an exit strategy discussion, a
medication disposal discussion, or anything approaching a proper,
documented diagnosis. Id. at 212-218, 221-24, 227-28, 237-38, 244-48,
252-60, 277-82, 337, 443. Regarding UC Visit #2, Dr. Dombrowski
specifically observed that the TFO returned to the office well beyond a
time where the prescribed medication would, if taken as directed, have
run out, and despite this lapse, no follow-up was pursued by the
Respondent. Id. at 223-25. The standard of care, according to Dr.
Dombrowski, would require the prescriber to seek clarification from the
patient as to what effect the lapse had on symptom control, or as the
witness put it, ``I mean, do you even need my medication?'' Id. at 224.
UC Visit #3 had the same gapped medication issue, with the same lack of
follow-up on the Respondent's part. Id. at 248-50. The witness
testified that in some cases the Respondent's prescribing fell below
the standard of care by his absence of preliminary ground work, other
times by the relative paucity of (even subjective) symptoms, and other
times by his lack of follow-up questions in the face of indicia that
should have called the bona fides of the patient's intentions and
genuine need for medication into issue. Id. at 268-69, 272-73, 277,
337-38. The Respondent also fell short of the Virginia prescribing
standard of care when he increased the TFO's tramadol dosage with no
documented explanation and no conceivable basis being provided by the
chart entries or interactions as video-recorded at the time of UC Visit
#3. Id. at 255-56.
---------------------------------------------------------------------------
\32\ Dr. Dombrowski also observed that the TFO's pain symptoms
as self-reported in the Pain Questionnaire (Gov't Ex. 1, at 12)
appear to be so minimal that they call into question the
Respondent's decision to prescribe controlled substances to address
them. Tr. 261-65. The Government's expert made the same observations
and conclusions regarding the TFO's purported mental health issues
as self-reported in the Anxiety Questionnaire (Gov't Ex. 1, at 13),
which were likewise so mild as to call into question the decision to
prescribe controlled medications to treat them. Tr. 270-73.
---------------------------------------------------------------------------
Dr. Dombrowski also discussed his observations regarding a PMP
report generated to reflect the Respondent's queries concerning the
TFO. Id. at 225. Specifically, the fact that the Respondent (or his
staff) actually queried the PMP and were, thus, aware that the TFO was
not filling any of the prescriptions he issued needed, at a minimum, to
be explored and resolved with the patient, and his failure to do so
fell below the applicable prescribing standard in Virginia. Id. at 226,
250-51, 273-74, 276-77. Failure by the Respondent to follow up on the
patient's request for specific medications by name also fell below the
applicable standard. Id. at 235-36, 251.
Also below the applicable standard, according to Dr. Dombrowski,
was a failure to comply with follow-up requirements attendant upon the
black box warning issued by the FDA regarding the simultaneous
prescribing of opiates and benzodiazepines.\33\ Id. at 239-44. The
Respondent prescribed this dangerous combination of medicines without
engaging in any precautionary and follow-up steps, such as establishing
and documenting extenuating circumstances. Id. at 239-44, 283.
---------------------------------------------------------------------------
\33\ Gov't Ex. 16.
---------------------------------------------------------------------------
Dr. Dombrowski testified that, in his expert opinion, none of the
controlled substance prescriptions detailed in the Government's case
were issued for a legitimate medical purpose in the normal course of a
professional practice. Id. at 286.
The Government's expert witness presented as a qualified, measured,
knowledgeable expert, with no indications of any agenda beyond a
dispassionate evaluation of the facts applied to the applicable
standard. His testimony was persuasive, and in this case, his opinions
are entitled to controlling weight.
The Respondent's Case
The Respondent's case consisted exclusively of his own
testimony.\34\ He testified that he currently maintains a private
internal medicine practice that treats physical and mental health
issues in what he characterizes as ``an underprivileged and lower
socioeconomic population of the Richmond area, and particularly the
inner city [of] Richmond.'' Tr. 353-54. The Respondent reckons that he
is treating twenty to thirty percent of his private practice patients
with opioids. Id. at 353-56.
---------------------------------------------------------------------------
\34\ The Respondent's CV was received into the record without
objection. Resp't Ex. 1; Tr. 352.
---------------------------------------------------------------------------
In addition to the Respondent's private practice, he testified that
he also works at two rehabilitation hospitals run by Encompass,\35\
which he describes as ``a national corporation that is running
inpatient rehabilitation hospitals as well as outpatient home health
agencies.'' Id. at 365. The Respondent explained that in his hospital
practice he manages the post-acute care of patients discharged from
acute care facilities. Id. The Respondent related that the hospital
aspect of his practice involves pain management to the extent he fills
in for staff physiatrists when they are unavailable.\36\ Id. at 369.
According to the Respondent, between his private practice and hospital
responsibilities, he is currently at work seven days a week. Id. at
368.
---------------------------------------------------------------------------
\35\ The Respondent testified that he has worked at Encompass
hospitals for about three years. Tr. 371.
\36\ The Respondent offered that a post-surgery hip fracture
patient is a common example of where he would regularly provide pain
management and prescribe pain medications, such as tramadol,
oxycodone, or hydrocodone. Tr. 369.
---------------------------------------------------------------------------
The Respondent remembered the TFO and remembered his interactions
with him as patient Scott Davis. Id. at 376, 378-79. In that regard,
the Respondent testified that he was unable to specifically recall
whether he conducted a straight-leg raise on the patient, but was of
the opinion that he would have, because it is his custom to do so. Id.
at 381. The Respondent related that he observed the patient walk
approximately thirty to forty feet inside the office on his way out,
and specifically recalled directing him to office staff to guide him on
procuring an x-ray. Id. at 381-82. He testified that he assessed the
amount of Percocet the TFO disclosed as previously prescribed as a
``large dosage.'' Id. at 378. The Respondent described himself as being
``cognizant of [his patients'] financial struggles'' and attributed his
decision to prescribe pain medication without reviewing imaging as
justified by his desire ``to help a construction worker get through the
day without having to lose his job.'' Id. at 383; see also id. at 426-
27. He also noted, that in his opinion, the risks associated with the
tramadol he prescribed to the TFO are curtailed by the drug's ``very
low addictive potential.'' Id. at 383. It was this same low-addictive-
risk estimation that also persuaded the Respondent to discount the
TFO's admission that he had procured drugs illegally through his friend
and girlfriend. Id. at 384. When prompted by his counsel, the
Respondent expressed recognition that this was an errant course of
action, because ``I have to be very strict with the DEA rules,'' and if
asked to do so again, the Respondent represented that he ``will
wholeheartedly counsel them for a long time.'' Id.
The Respondent acknowledged that, after listening to the testimony
of the Government's expert, his medical examination of the TFO was not
as thorough as it should have been, and that under the circumstances,
his prescribing of Ativan, and combining medications as he did, was a
mistake. Id. at 384-85, 387. The Respondent represented that he
``take[s] responsibility.'' Id. at 385. During his testimony, he
provided assurances that he has (after practicing medicine for
approximately seventeen years) recently taken continuing medical
education courses \37\ so that he now understands the basic elements
for a rudimentary physical examination. Id. at 384-85.
---------------------------------------------------------------------------
\37\ Resp't Exs. 2-5.
---------------------------------------------------------------------------
The Respondent's limited confessions of error notwithstanding, the
issue of
[[Page 52189]]
whether he comprehends and accepts that he was wrong presents as
entirely unclear on this record. He took issue with the TFO's
recollection that he palpated his back for one-to-two seconds,\38\ and
maintained that it was really a six-to-seven second evolution. Id. at
386. The Respondent also quibbled with the time spent with the patient
during UC Visit #3, pushing back on the testimony that it was only two
minutes, suggesting that it may have been three. Id. at 388-89. The
Respondent explained that he prescribed Ativan because he recalled a
reference to anxiety on the TFO's intake form.\39\ Id. at 387. More
fundamentally, when asked if he issued the prescriptions to the TFO for
a legitimate medical purpose, all ambiguity fled him, and he responded
with an unequivocal ``I surely did. There was nothing illegitimate
about it.'' Id. at 427. Additionally, even though the evidence
reflected that the exams memorialized in his progress notes never
occurred during any of the UC Visits, the Respondent would only offer,
``I'm not sure, I may not have [conducted those exams],'' and, ``I may
have, I may not have. I was on autopilot and . . . there may be errors
in the documentation.'' Id. at 430, 432, 433. The Respondent would not
concede that notes reflecting examinations clearly shown as fictional
by the UC Visit recordings were in fact false, offering ``I am not sure
if it is or not'' and ``I cannot be conclusive about it.'' Id. at 432-
34. The strongest admission on this issue that he could muster during
his testimony was the possibility of an ``error in documentation.'' Id.
at 433. Indeed, the Respondent insisted that each charged prescription
was issued for a legitimate medical purpose because ``I do not issue
prescriptions for illegitimate medical purposes,'' and clarified that
he has ``no doubts about it.'' Id. at 427-28. Likewise, the Respondent
was equally committed to the proposition that every one of the charged
prescriptions was issued in the usual course of professional practice,
asserting that he was ``[a]bsolutely acting in the course of [his]
medical practice.'' Id. at 429.
---------------------------------------------------------------------------
\38\ Tr. 81-82, 90-91, 133.
\39\ Gov't Ex. 1, at 7.
---------------------------------------------------------------------------
In addressing the boost in tramadol that occurred unsolicited at
the conclusion of UC Visit #3, the Respondent explained the increase by
saying that he ``became a bit more comfortable with the patient,''
because he was not seeking early refills and he ``felt that [the TFO]
was not diverting any--there was no signs of diversion--no signs of
doctor shopping.'' Id. at 391-92; see also id. at 393-94. The
Respondent's basis for concluding that the patient was not doctor
shopping was based on his review of PMP data. Id. at 392.
Interestingly, a review of PMP data would have also informed the
Respondent that the prescriptions he issued to the TFO were never
actually dispensed, but the Respondent testified that doctor shopping
was essentially his exclusive focus in reviewing PMP data.\40\ The
Respondent ascribed his discounting of the information about the no-
fills based on his view that pharmacies, particularly ``outlying
pharmacies,'' \41\ frequently do not enter dispensing data into the
PMP. Id. at 393. He testified that he declined to follow up on this
potential anomaly because ``[i]t's very time-consuming.'' Id. at 395.
Thus, the Respondent by his own admission ascribed confidence in the
PMP insofar as it reflected no other prescribers, but none to the
extent that the prescribed medications were not being filled. Id. at
393-95.
---------------------------------------------------------------------------
\40\ The Respondent also sought support in reports he obtained
from the PMP administrators regarding the relative percentage of his
controlled substance prescribing compared to his peers. Resp't Ex.
7; Tr. 362-64. However, the value of this evidence was mortally
undermined by the designation on the printout that the Respondent
was being compared to geriatric medicine practitioners. Resp't Ex.
7; Tr. 434-35. The Respondent theorized that his PMP designation may
have been a residual effect from a time when he did a lot of work in
nursing homes. Tr. 436. Dr. Dombrowski persuasively testified that
because physicians treating geriatric patients tend to prescribe
higher amounts of pain medication due to the chronic problems
associated with age, the comparison of geriatric practice with the
Respondent's practice is not a relevant one. Tr. 440-41.
Accordingly, this evidence is of negligible value in these
proceedings.
\41\ There was no indication in the record that the TFO would
have been utilizing an ``outlying pharmacy,'' or what geographic
location constituted a pharmacy to be ``outlying.''
---------------------------------------------------------------------------
On the issue of remedial steps, the Respondent testified that he
has completed numerous continuing medical education courses
(hereinafter, CME) aimed at improving his controlled substance
prescribing practices, and that some of the courses provided him with
valuable information. Resp't Exs. 2-5; Tr. 384-85, 398-415. The
Respondent testified that the CME he completed was done online with a
quiz administered at the conclusion. Tr. 414-21. The Respondent also
offered the corrective action plan (hereinafter, CAP) that he had
apparently filed with the Agency in accordance with 21 U.S.C.
824(c)(3). Resp't Ex. 8; Tr. 421-22. The CAP modestly proposes that the
Respondent will take two specified CMEs (and such other additional CMEs
which may be designated by DEA). Resp't Ex. 8. The CAP further proposes
that the Respondent is willing to undergo a period of ``partial
suspension'' of his COR pending completion of these CMEs that will
restrict him to prescribing under Schedules IV and V. Id.
The Respondent testified that these proceedings have emotionally
affected him in a way that is more grave than the COVID-19 epidemic.
Tr. 424. His sleeping has been affected and he describes himself as
being ``anxious all the time.'' Id. The Respondent offered assurances
that he ``will not prescribe until [he] ha[s] the data,'' and that
although ``[i]n the past, in [his] practice, [he] used to cut people
breaks. [He] will not do that anymore, [he]'ll be 100 percent by the
book and by the rules.'' Id. at 424-25. The Respondent then proposed
the novel argument that he had no intention of ever even using his COR
to prescribe controlled substances (i.e., to conduct the regulated
activity that is authorized by a DEA registration), but that he merely
wanted to maintain his registered status to assist him in securing
employment. Id. at 425-26.
It is beyond argument that the Respondent is the witness with the
most at stake in these proceedings, and thus, is the witness with the
greatest pressures to influence his perspective and testimony. However,
even apart from these considerations, there was much in the
Respondent's presentation that devalued his credibility and the force
that can be attached to his testimony. When faced with examinations
that he noted in his progress notes, which he plainly saw did not take
place in the UC Visit videos, the Respondent was unwilling to admit
what his eyes could scarcely deny: He did not perform the examinations
he documented. Id. at 432-33. Even after agreeing with much of Dr.
Dombrowski's testimony, the Respondent relentlessly adhered to his
position that his prescriptions were issued for a legitimate medical
purpose and in the usual course of a professional medical practice. Id.
at 427-29. His unambiguous commitments to prescribe within the
applicable standard of care in the future were matched with his equally
unambiguous commitment to never prescribe again so long as the Agency
maintains him in status so that he can secure medical employment. Id.
at 424-26. The only thing that appeared sure about the Respondent's
testimony was an apparent commitment to saying anything under oath that
might induce the Agency to continue him in status. That is not to say
that the Respondent's testimony was completely bereft of any
reliability. Indeed, there were biographical and other elements of his
testimony that can be credited, but
[[Page 52190]]
where (as happened not infrequently here) his testimony stands in
conflict with other reliable evidence of record, it must be viewed with
great caution and skepticism.
Other facts required for a disposition of the present case are set
forth in the balance of this decision.
The Analysis
Public Interest Determination: The Standard
Under 21 U.S.C. 824(a)(4), the Agency may revoke the DEA
registration 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 15,227, 15,230 (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 DEA registration 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 registration, 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, [the Respondent] is 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 38,363, 38,364, 38,385 (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 66,972,
66,972-73 (2011); Gregory D. Owens, D.D.S., 74 FR 36,751, 36,757
(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; see also Ronald
Lynch, M.D., 75 FR 78,745, 78,754 (2010) (holding that the respondent's
attempts to minimize misconduct undermined acceptance of
responsibility); George Mathew, M.D., 75 FR 66,138, 66,140, 66,145,
66,148 (2010); George C. Aycock, M.D., 74 FR 17,529, 17,543 (2009);
Krishna-Iyer, 74 FR at 463; Steven M. Abbadessa, D.O., 74 FR 10,077,
10,078 (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 481-82. 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), 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., No. 18-587, 592 U.S. __, slip op. at 22-23
(June 18, 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. 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
[[Page 52191]]
exercise of that discretion. 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).
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 and Four,\42\ and it is under those two
factors that the lion's share of the evidence of record relates.\43\ 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 manner in which the Respondent has managed that
part of his practice relative to prescribing controlled substances and
acts allegedly committed in connection with that practice. Thus, it is
analytically logical to consider Public Interest Factors Two and Four
together. That being said, Factors Two and Four involve analysis of
both common and distinct considerations.
---------------------------------------------------------------------------
\42\ ALJ Ex. 19, at 29.
\43\ 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 20,727, 20,730 (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 16,823, 16,833 n.13 (2011); Dewey C. MacKay, M.D., 75 FR
49,956, 49,973 (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,'' see 21 U.S.C. 823(f)(5),
Factor Five militates neither for nor against the sanction sought by
the Government in this case.
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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
17,673, 17,689 (2011); see MacKay, 75 FR at 49,974 n.35 (holding that
revocation is not precluded merely because the conduct was
``unintentional, innocent, or devoid of improper motive'').
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 U.S.C. 829; 21 CFR
1306.04(a). 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 relating 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. Aycock, 74 FR at
17,541 (citing Gonzales, 546 U.S. at 274); 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.'' Aycock, 74 FR at 17,541 (citing 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).
While true that the CSA authorizes the ``regulat[ion of] medical
practice insofar 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, an evaluation of cognizant state standards is essential. Joseph
Gaudio, M.D., 74 FR 10,083, 10,090 (2009); Kamir Garces-Mejias, M.D.,
72 FR 54,931, 54,935 (2007); United Prescription Servs., Inc., 72 FR
50,397, 50,407 (2007). In this adjudication, the evaluation of the
Respondent's prescribing practices must be consistent with the CSA's
recognition of state regulation of the medical profession and its bar
on physicians from engaging in unlawful prescribing. Aycock, 74 FR at
17,541. The analysis must be ``tethered securely'' to state law and
federal regulations in application of the public interest factors, and
may not be based on a mere disagreement between experts as to the most
efficacious way to prescribe controlled substances to treat chronic
pain. Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009) (citing
Gonzales, 546 U.S. at 272, 274).
Under the CSA, it is fundamental that a practitioner 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.'' Mackay, 75 FR at
49,973 (internal quotations omitted); Stodola, 74 FR at 20731; Shyngle,
74 FR at 6057-58 (citing Moore, 423 U.S. at 141-43). The CSA generally
looks to state law to determine whether a bona fide doctor-patient
relationship was established and maintained. Stodola, 74 FR at 20,731;
Shyngle, 74 FR at 6058; Garces-Mejias, 72 FR at 54,935; United
Prescription Servs., 72 FR at 50407.
Here, the relevant provisions of state law largely mirror the CSA
and its regulations where they do not go
[[Page 52192]]
beyond it. Compare Va. Code Ann. Sec. 54.1-3303(C) with 21 CFR
1304.06(a). Section 54.1-3303(A), like its CSA counterpart,\44\ limits
controlled substance prescribing to licensed practitioners. The
Virginia Code also requires that a bona fide patient-practitioner
relationship precede the issuing of all prescriptions (controlled and
non-controlled) \45\ 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 prior to prescribing, the
practitioner must have:
---------------------------------------------------------------------------
\44\ 21 U.S.C. 802(21), 823(f).
\45\ Regarding the prescribing of controlled substances, the
Virginia Code specifically requires compliance with federal
telemedicine provisions which do not impact the current proceedings.
Va. Code Ann. Sec. 54.1-3303(B).
(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. 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.
The Virginia Administrative Code provides further direction for
practitioners prescribing opioids for chronic pain. 18 Va. Admin. Code
Sec. 85-21-60. Under this provision:
Prior to initiating management of chronic pain with a controlled
substance containing an opioid, a medical history and physical
examination, to include a mental status examination, shall be
performed and documented in the medical record, including: (1) The
nature and intensity of the pain; (2) current and past treatments
for pain; (3) underlying or coexisting diseases or conditions; (4)
the effect of the pain on physical and psychological function,
quality of life, and activities of daily living; (5) psychiatric,
addiction, and substance misuse history of the patient and any
family history of addiction or substance misuse; (6) a urine drug
screen or serum medication level; (7) a query of the [PMP]; (8) an
assessment of the patient's history and risk of substance misuse;
and (9) a request for prior applicable records.
Va. Admin. Code Sec. 85-21-60(A). Furthermore, prior to opioid
drug treatment initiation, the prescribing doctor is required to
counsel the patient on known risks and benefits of opioid therapy,
patient responsibilities regarding storing and disposal, and a
treatment exit strategy. Id.
The applicable Virginia Code provisions are completely consistent
with the standards as outlined by the Government's expert, Dr.
Dombrowski. Tr. 179, 183-88, 199, 211-12. Beyond the specified elements
of the requisite relationship, history, examination, counseling, and
follow-up care, Dr. Dombrowski explained that informed consent, exit
strategy counseling, and adequate documentation also comprise vital
parts of the prescribing standards in Virginia. Tr. 184-91. Beyond the
Respondent's unsupported protestations that all of his controlled
substance prescribing has been legal,\46\ the testimony of the
Government's expert stands uncontroverted on the present record. When
an administrative tribunal elects to disregard the uncontradicted
opinion of an expert, it runs the risk of improperly declaring itself
as an interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554
(6th Cir. 1966). There is no shortage of reliable expert knowledge in
the present record, it is uncontroverted, and it is not favorable to
the Respondent.
---------------------------------------------------------------------------
\46\ Tr. 427-29.
---------------------------------------------------------------------------
In reviewing the evidence of record (including the stipulations of
the parties), and applying the consistent and unchallenged controlled
substance prescribing standards applicable in Virginia, the evidence
preponderantly establishes the Respondent's registration and
practitioner status, as well as the Government's allegations that he
prescribed controlled substances to the TFO during the course of four
undercover visits. Accordingly, OSC allegations 3, 6, 7, 8, 9, 11, 12,
15, 16, 19, and 20 are SUSTAINED.
The OSC in this case also alleges that the Respondent engaged in
unprofessional conduct as that term is defined in the Virginia
Code.\47\ ALJ Ex. 1, at ]] 10, 14, 18, 22. [Specifically, the OSC
alleges violations of four subsections of Va. Code Ann. Sec. 54.1-
2915. ALJ Ex. 1 at ] 5.c (stating that ``Va. Code Ann. Sec. 54.1-
2915(A) defin[es] unprofessional conduct as including, among other
things: [3] `[i]ntentional or negligent conduct in the practice of any
branch of the healing arts that causes or is likely to cause injury to
a patient or patients;' [12] `[c]onducting his practice in a manner
contrary to the standards of ethics of his branch of the healing arts;'
\*I\ [13] `[c]onducting his practice in such a manner as to be a danger
to the health and welfare of his patients or to the public;' and [17]
`[v]iolating any provision of statute or regulation, state or federal,
relating to the manufacture, distribution, dispensing, or
administration of drugs''); id. at ]] 6 (stating that Respondent issued
four prescriptions in violation of ``federal and Virginia law noted in
paragraphs 4-5, above'').\*J\ I find that Respondent violated
subsections three and thirteen, based on Dr. Dombrowski's testimony
confirming that Respondent engaged in conduct that was likely to injure
Patient SD, as well as Dr. Dombrowski's testimony that Respondent
committed numerous treatment failures that led to the prescribing of
controlled substances outside of the applicable standard of
[[Page 52193]]
care in Virginia and not for a legitimate medical purpose. Tr. 286; see
also, e.g., id. at 207-11.\*K\ Additionally, I find that Respondent
violated subsection seventeen based on my finding above that Respondent
violated state and federal law. Therefore, OSC allegations 10, 14, 18,
and 22 are SUSTAINED.]<SUP>48 49</SUP>
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\47\ [Footnote omitted.]
\*I\ Although Dr. Dombrowski testified that Respondent did not
comply with ethical standards, see Tr. 287, the Government did not
notify Respondent of this testimony in the OSC or in its prehearing
statements. Therefore, I do not consider the Government's
allegations with respect to subsection twelve in my public interest
analysis.
\*J\ I find that the OSC provided adequate notice of the
Virginia Code subsections that the Government charged Respondent
with having violated. Although the Chief ALJ did not sustain these
allegations based in part, because there were ``multiple potential
factual scenarios [ ] available under a single statutory scheme,''
and the Government did not sufficiently specify the application of
the facts to the alleged violations, see RD, at 30, upon further
review, I find that the Government quoted from four subsections of
Va. Code Ann. Sec. 54.1-2915(A) in paragraph five, and then
identified the prescriptions in paragraph six that violated the
state laws enumerated in paragraph five. See OSC, at ]] 5.c, 6. The
Government afforded Respondent the opportunity to prepare a defense
by identifying each subsection of the Virginia Code at issue, and by
providing a factual basis for its allegations that Respondent could
have harmed or injured a patient. See, e.g., OSC, at 5-7 (noting
that Respondent prescribed opioids and benzodiazepines concurrently,
and that the concurrent prescribing of these drugs ``poses a
significant risk of addiction or other adverse consequences'');
Gov't Prehearing, at 19, 22, 25 (same); id. at 14 (stating that Dr.
Dombrowski was expected to testify that ``Respondent's actions put
Patient S.D. at risk for harm, including addiction or other adverse
medical outcomes;'') see also Darrell Risner, D.M.D., 61 FR 728, 730
(1996) (``[T]he parameters of the hearing are determined by the
prehearing statements.''). Although I agree that the charging
documents would have benefited from further explanation, I find that
the prehearing statement and the OSC together provided adequate
notice in order for the Respondent to ``be timely informed of . . .
the matters of fact and law asserted.'' 5 U.S.C. 554(b)(3); see also
21 CFR 1301.37(c) (requiring that the OSC ``contain a statement of
the legal basis for [a] hearing and for the denial, revocation, or
suspension of registration and a summary of the matters of fact and
law asserted''). Previous Agency Decisions have stated that ``[t]he
primary function of notice is to afford [a] respondent an
opportunity to prepare a defense by investigating the basis of the
complaint and fashioning an explanation that refutes the charge of
unlawful behavior.'' Wesley Pope, M.D., 82 FR 14,944, 14,947 (2017)
(internal citation omitted). Because I have found that these
allegations were adequately noticed, I have added this section
addressing these allegations.
\*K\ The RD states that ``DEA is without authority to hold that
a registrant has committed unprofessional conduct regarding the
practice of medicine, a clear function of the state's police
powers.'' RD, at 30 (citing Gonzales, 546 U.S. at 274). While I
agree with the Chief ALJ that findings on these matters often
require expertise in assessing unprofessional conduct that the
Agency lacks, the state law violations in this case were supported
by the unrebutted testimony of a Virginia medical expert, Dr.
Dombrowski. Dr. Dombrowski testified that Respondent prescribed a
dangerous combination of controlled substances without ``engaging in
any precautionary and follow-up steps,'' Tr. 239-44, 283, and he
confirmed that Respondent's conduct was likely to cause injury to
Patient SD. Id. at 286. Therefore, I find that Dr. Dombrowski's
testimony provides a basis for sustaining these state law
violations.
Although I am considering these additional allegations of
violations of state law, they ultimately do not add substantially to
my analysis under Factors Two and Four. I agree with the Chief ALJ
that these violations further support my conclusion that
Respondent's prescribing fell below the applicable standard of care
in Virginia. See RD, at 31 n.49 (``[C]onduct which falls within a
state's definition of unprofessional conduct (or is otherwise
improper under state law), which supports the proposition that a
practitioner's prescribing fell below the applicable standard of
care (as is the case here), will generally be supportive of a
finding that a registrant's controlled substance prescribing was in
violation of the CSA.'').
\48\ [Footnote omitted.]
\49\ [Content of footnote discussed above, see supra n.*K.]
---------------------------------------------------------------------------
In the OSC, the Government also charged the Respondent with an
additional violation of state law in asserting that the Respondent was
in violation of the Virginia Code for failing to prescribe naloxone
\50\ (the Virginia Naloxone Regulation). ALJ Ex. 1 at ]] 13, 17, 21.
This is a novel charge for this tribunal.\51\ The Virginia Naloxone
Regulation, in pertinent part, states that when initiating opioid
treatment, a practitioner shall ``[p]rescribe naloxone for any patient
when risk factors of overdose, substance abuse, doses in excess of 120
[morphine milligram equivalent] per day, or concomitant
benzodiazepine[s] are present.'' 18 Va. Admin. Code Sec. 85-21-
70(B)(3).\*L\
---------------------------------------------------------------------------
\50\ [The RD took official notice, pursuant to 5 U.S.C. 556(e)
and 21 CFR 1316.59(e), that naloxone was an opioid antagonist that
is commonly used to counter the effects of an opioid overdose and/or
adverse reaction. RD, at 31 n.50 (citing 81 FR 44,714 (2016)). The
RD notified the parties that they may file objections to this
official notice within fifteen calendar days from receipt of the RD.
Id. Neither party filed objections, so I adopt the Chief ALJ's
finding.]
\51\ The Government's expert witness, Dr. Dombrowski, did not
include the prescribing of naloxone within the elements required to
satisfy the Virginia controlled substance prescribing standard of
care.
\*L\ Text deleted for consistency with my finding below that the
violation of the Virginia Naloxone Regulation is sufficiently
related to the CSA's core purposes to be considered under Factor
Four.
---------------------------------------------------------------------------
An analysis of the relative merits of this novel allegation are
best considered within the framework of Public Interest Factor Four
(compliance with applicable state laws relating to controlled
substances). 21 U.S.C. 823(f)(4). The actions of a regulatory agency
must bear a rational relationship to the purposes of the statute it is
charged with enforcing. See Judulang v. Holder, 556 U.S. 42, 63 (2011)
(invalidating Board of Immigration Appeals decision making practice
where the ``rule [was] unmoored from the purposes and concerns of the
immigration laws''). [Consequently, when the Agency has analyzed
whether state law violations are relevant to its Factor Four analysis,
it has considered whether those state laws have a rational relationship
to the core purposes of the CSA in preventing drug abuse and
diversion.]\*M\ Pharmacy Doctors Enterprises d/b/a Zion Clinic
Pharmacy, 83 FR 10,876, 10,900 (2018) [(stating that the state law
provisions at issue ``go to the heart of the controlled substance anti-
diversion mission--drug abuse prevention and control'')].*\N\ *\O\
---------------------------------------------------------------------------
\*M\ Modified for clarification.
\*N\ Citations omitted. I have also deleted text for consistency
with my finding below that the violation of the Virginia Naloxone
Regulation is sufficiently related to the CSA's core purposes to be
considered under Factor Four.
\*O\ We have previously identified the CSA's core purposes of
preventing drug abuse and diversion by analyzing the statute's
legislative history. See, e.g., John O. Dimowo, M.D., 85 FR 15,800,
15,810 n.K, M (2020); Fred Samimi, M.D., 79 FR 18,698, 18,709-10
(2014). As further discussed herein, it is axiomatic that another
core purpose of the CSA is to protect patients from the drug-related
deaths and injuries that may result from drug abuse and diversion.
This core purpose is evident in the CSA's legislative history and
underlies the entire statute.
In 1984, Congress expanded DEA's authority to deny
practitioners' applications for DEA registrations by adding the
public interest factors to Section 823. Controlled Substances
Penalties Amendments Act of 1984, Public Law 98-473, 511, 98 Stat.
1837, 2073 (1984) (codified at 21 U.S.C. 823(f)(1)-(5)). Prior to
the addition of these public interest factors, DEA's grounds to deny
a practitioner's application were limited. DEA was required to grant
an application unless the applicant was not ``authorized to dispense
. . . [controlled substances] under the law of the State in which
they practice[d].'' Controlled Substances Act, Public Law 91-513,
303, 84 Stat. 1236, 1255 (1970) (codified at 21 U.S.C. 823(f)). The
Senate Report explained that because of DEA's ``very limited''
grounds for denial, the Controlled Substances Act had not been very
effective at addressing diversion at the practitioner level, where
eighty to ninety percent of diversion occurs. Senate Report, at 261-
62, 1984 U.S.C.C.A.N., at 3443-44. Thus, the public interest factors
were added to ``strengthen the Government's authority to regulate
controlled substances.'' Senate Report, at 262, 1984 U.S.C.C.A.N.,
at 3444.
The Senate Report observed that ``[i]t is estimated that between
60 and 70 percent of all drug-related deaths and injuries involve
drugs that were originally part of the legitimate drug production
and distribution chain.'' Senate Report, at 260, 1984 U.S.C.C.A.N.,
at 3442. The CSA seeks to prevent these drug-related deaths and
injuries by ``maintaining . . . [a] 'closed' system at the
practitioner level. Senate Report, at 262, 1984 U.S.C.C.A.N., at
3444. The CSA's focus on patient safety is evident in the Senate
Report's discussion of the procedures for scheduling drugs. The
Senate Report observes that it is important to have swift procedures
for scheduling new drugs, because of the ``significant health
problem[s]'' that may result when an ``as yet uncontrolled drug
rapidly enters the illicit market.'' Id. Indeed, drugs are
designated as controlled substances precisely because of their
potential to harm patients. See, e.g., Senate Report, at 261, 1984
U.S.C.C.A.N., at 3443 (noting that drugs are placed into one of five
schedules ``based on the severity of the abuse potential of a
particular drug, the extent to which it leads to physical or
psychological dependence, and has an accepted medical use . . .'').
Thus, at its core, the CSA seeks to protect patients from the
adverse health consequences that may result from dangerous and
addictive drugs. Therefore, as found below, my consideration under
Factor Four of a state law violation that significantly increases
the risk of these adverse consequences is related to a core purpose
of the CSA.
---------------------------------------------------------------------------
[As explained above, my consideration of a violation of a state law
under Factor Four must bear a rational relationship to a core purpose
of the CSA, as does my consideration of all the public interest
factors. See Judulang v. Holder, 556 U.S. at 63. Additionally, the
language of Factor Four requires that the state law be ``relat[ed] to
controlled substances.'' These two concepts are easily conflated, but
they are importantly distinct. In this case, I find that Respondent's
violation of the Virginia Naloxone Regulation \52\ bears a rational
relationship to a core purpose of the CSA such that it is appropriate
for me to consider it under Factor Four, and also that the state
regulation is ``relat[ed] to controlled substances'' as the statute
requires. 21 U.S.C. 823(a)(4). Respondent's failure to prescribe
naloxone put Patient SD at risk for overdose or death resulting from
concurrent opioid and benzodiazepine prescriptions.*\P\ Thus,
Respondent's violation of this regulation bears a rational relationship
to the core purposes of the CSA of preventing the abuse of controlled
substances and the adverse health consequences that might result from
such abuse.
---------------------------------------------------------------------------
\52\ 18 Va. Admin. Code Sec. 85-21-70(B)(3).
*\P\ Respondent issued concurrent prescriptions to Patient SD
for opioids and benzodiazepines on August 28, 2019; September 27,
2019; and November 5, 2019, but he failed to prescribe naloxone, as
required by state law. Tr. 93-94, 101, 116; Gov't Ex. 5, 8, 11; 18
Va. Admin. Code Sec. 85-21-70(B)(3) (requiring naloxone to be
prescribed when opioids and benzodiazepines are prescribed
concurrently).
---------------------------------------------------------------------------
I have omitted the RD's discussion of the purpose of the Virginia
Naloxone Regulation and its legislative history,
[[Page 52194]]
because I have concluded that the regulation, as applied to the facts
of this case, supplies a sufficient nexus to controlled substances to
be appropriately considered under Factor Four. In analyzing the
legislative intent of the state law, the RD was likely addressing a
particular Agency decision, which stated that in determining whether a
state law is ``related to controlled substances'' under Factor Four,
``the mere fact that a violation of a state rule occurs in the context
of the dispensing of controlled substances does not necessarily mean
that the violation has a sufficient nexus to the CSA's core purpose of
preventing the diversion and abuse of controlled substances.'' Fred
Samimi, M.D., 79 FR 18,698, 18,710 (2014) (citing 21 U.S.C. 823(f)(4).
As explained above, I concur that a violation of state law must have a
rational relationship to the core purposes of the CSA in order for me
to consider it under Factor Four; however, that important concept
should not be conflated with whether the state law is ``relat[ed] to
controlled substances'' as required by the statute, which is what
seemed to happen when the former Administrator in Samimi cited to the
intent of the state law itself as the basis for finding that the law in
that case was not sufficiently related to controlled substances. Id.
(finding that the particular state law's ``provisions [were] not
directed at preventing diversion''). Nothing in the CSA itself nor its
legislative history requires such a limited view of ``laws relating to
controlled substances,'' and although these sentences in Samimi could
be read to imply that the Agency would be required to assess the state
law's purpose, I can find no reason to analyze the legislative intent
of every state law alleged for consideration under Factor Four. See 21
U.S.C. 823(f)(4).
In fact, the Agency has--both prior to and subsequent to the Samimi
decision--frequently considered violations of state statutes that are
applicable to all medications, not just controlled substances, under
Factor Four without analyzing the legislative intent of these statutes.
See, e.g., Joseph Gaudio, M.D., 74 FR 10,083, 10,091 (2009)
(considering under Factor Four the respondent's violation of a state
law that stated that it is ``unprofessional conduct'' for a physician
to ``provid[e] treatment . . . via electronic or other means unless the
licensee has performed a history and physical examination of the
patient . . .''); Carol Hippenmeyer, M.D., 86 FR 33,748, 33,768
(considering under Factor Four the respondent's violation of state laws
stating that it is ``unprofessional conduct'' for a physician to fail
to ``maintain adequate medical records'' and to ``prescrib[e] . . . a
prescription medication . . . to a person unless the [physician] first
conducts a physical or mental health status examination of that person
or has previously established a doctor-patient relationship''). The
core purpose of these statutes may not be directed at preventing the
abuse and diversion of controlled substances; however, when the state
addresses prescribing that presents a risk of diversion or substance
abuse, these are the statutes that are charged. For example, the
Arizona Medical Board frequently cites violations of the state laws
requiring physicians to maintain adequate medical records and perform
physical examinations in disciplinary actions against physicians who
are prescribing controlled substances without taking appropriate steps
to prevent diversion.\*Q\
---------------------------------------------------------------------------
\*Q\ See Hippenmeyer, 86 FR at 33,768 n.62 (citing, e.g., In the
Matter of Brian R. Briggs, M.D., No. MD-15-0164A, 2017 WL 554258
(Feb. 2, 2017) (issuing a Letter of Reprimand and placing respondent
on probation for prescribing controlled substances to a live-in
girlfriend--who was also receiving opioids from other providers--
without maintaining medical records and without ``perform[ing] and
document[ing] an appropriate physical and mental examination''); In
the Matter of Warren Moody, M.D., No. MD-07-0874A, 2007 WL 3375035
(Oct. 16, 2007) (summarily suspending physician's license for
various forms of misconduct, including prescribing controlled
substances to friends without maintaining medical records); In the
Matter of David Landau, M.D., No. MD-17-0777A, 2018 WL 2192279 (Apr.
16, 2018) (issuing a Letter of Reprimand against a physician for
various forms of misconduct, including prescribing controlled
substances to a friend without maintaining adequate medical
records).
---------------------------------------------------------------------------
Therefore, a broad interpretation of ``laws relating to controlled
substances'' in Section 823(f)(4) is consistent with previous Agency
Decisions. It is also consistent with the Supreme Court's
interpretation of the phrase ``relating to'' in other contexts.
According to the Supreme Court, the phrase ``in relation to'' is to be
interpreted expansively, and means ``with reference to'' or ``as
regards.'' Smith v. United States, 508 U.S. 223, 237 (1993).\*R\
---------------------------------------------------------------------------
\*R\ The Smith decision involved an offer to trade an automatic
weapon for cocaine. 508 U.S. at 225. The decision addressed the
question of whether the exchange of a firearm for cocaine
constitutes using a firearm ``during and in relation to . . . [a]
drug trafficking crime'' within the meaning of 18 U.S.C. 924(c)(1).
Id. The Supreme Court's analysis cited prior Supreme Court and
appellate court decisions interpreting the phrase ``in relation to''
and concluding that the phrase should be interpreted expansively.
Id. at 237; see, e.g., District of Columbia v. Greater Washington
Board of Trade, 506 U.S. 125, 129 (1992) (``We have repeatedly
stated that a law `relate[s] to' a covered employee benefit plan . .
. `if it has a connection with or reference to such a plan.' . . .
This reading is true to the ordinary meaning of `relate to' . . .
and thus gives effect to the `deliberately expansive' language
chosen by Congress.''); United States v. Harris, 959 F.2d 246, 261
(D.C. Cir. 1992) (per curiam) (``The only limitation is that the
guns be used ``in relation'' to the drug trafficking crime involved,
which we think requires no more than the guns facilitate the
predicate offense in some way.''); United States v. Phelps, 877 F.2d
28 (9th Cir. 1989) (concluding that the situation was ``unusual''
and not covered, the court stated that ``the phrase 'in relation to'
is broad'').
The Supreme Court also cited a dictionary definition in its
analysis. 508 U.S. at 237-38. It stated that ``[a]ccording to
Webster's, 'in relation to' means `with reference to' or `as
regards.' '' Id. at 237. It concluded, thus, that the phrase ``in
relation to,'' at a minimum, ``clarifies that the firearm must have
some purpose or effect with respect to the drug trafficking crime;
its presence or involvement cannot be the result of accident or
coincidence.'' Id. at 238. The Court also stated that ``the gun at
least must `facilitate[e], or ha[ve] the potential of facilitating,'
the drug trafficking offense.'' Id.
---------------------------------------------------------------------------
Thus, prior Agency Decisions and Supreme Court precedent support my
conclusion that the Virginia Naloxone Regulation is related to
controlled substances under Factor Four and that Respondent's violation
of the regulation is relevant to my Factor Four analysis under the
CSA.] \53\ \54\ \55\ *\S\
---------------------------------------------------------------------------
\53\ [Footnote omitted.]
\54\ [Footnote omitted.]
\55\ [Footnote omitted.]
*\S\ As found above, there is substantial record evidence that
Respondent issued controlled substance prescriptions outside the
usual course of the professional practice and beneath the applicable
standard of care in Virginia and in violation of state law. I,
therefore, have concluded that Respondent engaged in misconduct
which supports the revocation of his registration. See Wesley Pope,
82 FR 14,944, 14,985 (2017).
For purposes of the imminent danger inquiry, my findings also
lead to the conclusion that Respondent has ``fail[ed] . . . to
maintain effective controls against diversion or otherwise comply
with the obligations of a registrant'' under the CSA. 21 U.S.C.
824(d)(2). At the time the Government issued the OSC, the Government
had clear evidence that Respondent repeatedly issued prescriptions
without having a sound rationale or legitimate medical purpose for
doing so, which establishes ``a substantial likelihood of an
immediate threat that death, serious bodily harm, or abuse of a
controlled substance . . . [would] occur in the absence of the
immediate suspension'' of Respondent's registration. Id.
---------------------------------------------------------------------------
Recommendation
The evidence of record preponderantly establishes that the
Respondent has committed acts which render his continued registration
inconsistent with the public interest. See 21 CFR 1301.44(e)
(establishing the burden of proof in DEA administrative proceedings).
Because the Government has met its burden in demonstrating that the
revocation it seeks is authorized, to avoid sanction the Respondent
must show that given the totality of the facts and circumstances
revocation is not warranted. See Med. Shoppe-Jonesborough, 73 FR at
387. In order to rebut the Government's prima facie case, the
Respondent must demonstrate
[[Page 52195]]
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. He has accomplished neither objective.
Agency precedent is clear that a respondent must unequivocally
admit fault as opposed to a ``generalized acceptance of
responsibility.'' The Medicine Shoppe, 79 FR 59,504, 59,510 (2014); see
also Lon F. Alexander, M.D., 82 FR 49704, 49,728 (2017). To satisfy
this burden, a respondent must ``show true remorse'' or an
``acknowledgment of wrongdoing.'' Alexander, 82 FR at 49,728 (citing
Michael S. Moore, 76 FR 45,867, 45,877 (2011); Wesley G. Harline, 65 FR
5665, 5671 (2000)). The Agency has made it clear that unequivocal
acceptance of responsibility is paramount for avoiding a sanction.
Dougherty, 76 FR at 16,834 (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, 664 F.3d at 822; Hoxie, 419 F.3d at
483.
As discussed, supra, on the issue of remedial steps aimed at the
avoidance of reoccurrence, the Respondent, in addition to promises that
he will be compliant in the future, has submitted into evidence the CAP
\56\ he previously filed with the Agency, as well as several
certificates showing completion from some CME courses that the
Respondent completed online. Resp't Exs. 2-8; Tr. 414-21. The
Respondent's CAP contains a somewhat minimalist proposal that he will
take two specified CMEs (and other additional CMEs designated by DEA).
Resp't Ex. 8. The CAP further proposes that the Respondent is willing
to undergo a period of ``partial suspension'' of his COR pending
completion of these CMEs that will restrict him to prescribing under
Schedules IV and V. Id. In addition to these rather modest plans for
remedial action, the Respondent (to the apparent surprise of everyone
at the hearing) tendered a remarkable, novel, and illogical proposal.
He offered that if the Agency would only grant him a registration to
handle controlled substances, he would covenant never to actually use
it. Tr. 425-26. The Respondent explained that he seeks the
reinstatement and continuation of his COR, not to conduct the regulated
activity it authorizes, but rather, because he considers it a necessary
prerequisite to securing or continuing employment as a physician. Id.
---------------------------------------------------------------------------
\56\ Resp't Ex. 8.
---------------------------------------------------------------------------
Suffice it to say that the Respondent's remedial action plans are
unimpressive at best, and in the case of his attempt to secure a non-
functional COR, illogical and cynical, but inasmuch as the evidence of
record fails to demonstrate an unequivocal acceptance of
responsibility, the issue of remedial steps could hardly be considered
as case dispositive. The Agency has consistently held that for either
prong (acceptance of responsibility and remedial steps) to be
considered in sanction amelioration, both prongs must have been
established. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); Jones
Total Health Care Pharmacy, L.L.C., & SND Health Care, 81 FR 79,188,
79,202-03 (2016); Hassman, 75 FR at 8236. If one prong is absent, the
other becomes irrelevant. Both or neither has been the rule for many
years. The Respondent quibbled on the precise amount of seconds devoted
to palpations,\57\ and refused to accept that examinations, which were
documented in the paperwork but clearly absent from the UC Visit
videotapes, did not take place.\58\ As discussed in considerable
detail, supra, even after sitting through the Government's evidence,
the Respondent maintains that all of the controlled substance
prescriptions he ever issued (including those issued during the four UC
Visits established in these proceedings) were legitimate and within the
usual course of a professional practice. Tr. 427-29. The Respondent
presented as a practitioner who genuinely believes he did nothing
really that wrong. As he described it, he ``used to cut people
`breaks,''' but ``will not do that anymore . . . .'' Tr. 424-25. The
Respondent's closing brief representation that ``he has fully accepted
responsibility . . .'' \59\ is simply not supported by the record.
Without plumbing the depths of what constitutes an unequivocal
acceptance of responsibility, it is clear that a terse ``[yes], I do''
response to an inquiry from his counsel about whether he made ``a
mistake'' by what he characterized as prescribing a ``low[-]addictive
potential'' and low-overdose potential drug to the undercover patient
so the hapless patient could ``get through the day and get through
[his] work,'' \60\ misses the mark.
---------------------------------------------------------------------------
\57\ Tr. 388-89.
\58\ Tr. 430-33.
\59\ ALJ Ex. 20, at 15.
\60\ Id.
---------------------------------------------------------------------------
While the transgressions alleged and proved here are serious and
numerous, it is arguable that a true, unequivocal acceptance of
responsibility, coupled with a thoughtful plan of remedial action could
have gone a long way to supporting a creditable case for sanction
lenity. Indeed, while true that the Agency's precedents hold the lack
of an unambiguous acceptance of responsibility and a remedial action
plan as a cold bar to the avoidance of a sanction,\61\ the wisdom of
the Agency's policy is vindicated in this case by the reality that the
Respondent still believes that he has never issued a controlled
substance prescription that was not legitimate and not within the usual
course of a professional practice. The only potential he sees for error
appears to be his innate kindness, which caused him to ``cut breaks''
to his fellow man. He was confronted with progress notes written in his
own hand detailing the results of examinations that he never
administered, yet he would not concede his mendacity. As highlighted by
the Government in its closing brief,\62\ the Respondent's generation of
false chart information supports the fair inference that he was
attempting to create a justification for controlled substance
prescriptions he understood to be unsupportable under the law. See Syed
Jawed Akhter-Zaidi, M.D., 80 FR 42,963, 49,964 (2015) (holding that
where a practitioner creates a false record when prescribing a
controlled substance, there is a presumption that the practitioner
[``falsified the records in order to justify the prescribing of
controlled substances, and that in prescribing the controlled
substances, Respondent acted outside the usual course of professional
practice and lacked a legitimate medical purpose'']). He spent tiny
minutes of time with the TFO before issuing controlled substances and
dickered about the amount of seconds actually devoted to the
interaction and the palpations. This is a man who believes he made no
true mistakes. The Agency is thus faced with a choice of imposing a
registration sanction or imposing none and therein creating a strong
likelihood that it will be instituting new proceedings, charging the
same conduct against the same doctor soon thereafter. To the extent the
Respondent, after being present at this hearing, does not see that he
was not acting as a reliable registrant, it is highly unlikely that he
will see the light in a month, a week, or a day from an Agency action
that affords him another chance. To be sure, the Respondent credibly
testified that getting caught and being put into proceedings caused a
certain degree of
[[Page 52196]]
emotional consternation,\63\ but that is not the same as accepting
responsibility, which is something he clearly is unwilling to do. On
this point there is little room for logical, dispassionate dissent.
Thus, in the face of a prima facie case, without the Respondent meeting
the evidence with a convincing, unequivocal acceptance of
responsibility and proposing thoughtful, concrete remedial measures
geared toward avoiding future transgressions, the record supports the
imposition of a sanction. That a sanction is supported does not end the
inquiry, however.
---------------------------------------------------------------------------
\61\ Hassman, 75 FR at 8236.
\62\ ALJ Ex. 19, at 34.
\63\ Tr. 424.
---------------------------------------------------------------------------
In determining whether and to what extent imposing a sanction is
appropriate, consideration must also 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
38,364, 38,385. Considerations of specific and general deterrence in
this case militate in favor of revocation. As discussed, supra, the
Respondent has made it clear that he feels that he was not so much
wrong as misunderstood and, in a way, nitpicked. As discussed, supra,
he feels his prescriptions were legitimate, if lenient. Tr. 424-425.
Although he uttered words in support of regret, where a person does not
accept as true the errors shown to him by hard evidence, the hopes of
true future deterrence are diminished, and mortally so. The interests
of specific deterrence, therefore, compel the imposition of a sanction.
Likewise, 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 38,385. To
continue the Respondent's registration privileges on the present record
would send a message to the regulated community that it is acceptable
to spend less than ten minutes, and sometimes less than two minutes
with a patient, conduct no exams, document exams not conducted, procure
neither prior records nor objective testing, prescribe dangerous
controlled substances, increase the dosages without basis or regret,
and continue to do so even in the face of information that the
purported patient is not even filling the prescriptions. The interests
of general deterrence militate powerfully in favor of a sanction on
this record.
Regarding the egregiousness of the Respondent's conduct, as
discussed, supra, the Respondent did virtually nothing to satisfy (or
even further) his responsibilities as a DEA registrant on four
occasions. He had no basis for a valid diagnosis, he had no prior
medical records, called no prior treating physician, had no imaging,
conducted no examination to speak of, doctored up phony examination
results, ignored evidence that the prescriptions were not being filled
by his purported patient, disregarded the gaps where the patient would
have been without the medicine he was prescribing (even if it had been
dispensed and taken as directed), and actually increased the dosage for
no articulated reason beyond the fuzzy concept that he had an increased
level of ``comfort[ ]'' \64\ (based apparently on little more than the
TFO's decision to keep coming back for more drugs). Even disregarding
the very real likelihood that these four UC Visits presented a vivid
snapshot of the Respondent's practice in general, the blithe manner in
which he doled out controlled medicine to this undercover officer was
nothing short of astonishing. The egregiousness of the established
transgressions in this case, and the reckless abandon with which the
Respondent ignored his obligations provides a unique window into the
systemic gravity of the current opioid crisis.
---------------------------------------------------------------------------
\64\ Tr. 391-94.
---------------------------------------------------------------------------
A balancing of the statutory public interest factors, coupled with
consideration of the Respondent's failure to meaningfully accept
responsibility, the absence of record evidence of thoughtful and
continuing remedial measures to guard against recurrence, and the
Agency's interest in deterrence, supports the conclusion that this
Respondent should not continue to be entrusted with a registration.
Accordingly, it is respectfully recommended that the Respondent's
DEA COR should be REVOKED, and any pending applications for renewal
should be DENIED.
Dated: August 20, 2020.
John J. Mulrooney, II,
U.S. Chief Administrative Law Judge.
[FR Doc. 2021-20247 Filed 9-17-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 20, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.