Salman Akbar, M.D.; Decision and Order

Published date20 September 2021
Citation86 FR 52181
Record Number2021-20247
SectionNotices
CourtDrug Enforcement Administration
Federal Register, Volume 86 Issue 179 (Monday, September 20, 2021)
[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
                [Notices]
                [Pages 52181-52196]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [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 *C 1 2
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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.6 *H 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:
                ---------------------------------------------------------------------------
                 \222\ 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.
                ---------------------------------------------------------------------------
                 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.]48 49
                ---------------------------------------------------------------------------
                 \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.
                ---------------------------------------------------------------------------
                 \664\ 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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