Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52181 

*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. 

Evaluate whether and if so how the 

quality, utility, and clarity of the 

information to be collected can be 

enhanced; and 

Minimize the burden of the collection 

of information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. 

Overview of This Information 

Collection 

Type of Information Collection: 

Revision of a currently approved 

collection. 

The Title of the Form/Collection: 

Report of Multiple Sale or Other 

Disposition of Pistols and Revolvers. 

The agency form number, if any, and 

the applicable component of the 

Department sponsoring the collection: 

Form number: ATF Form 3310.4. 

Component: Bureau of Alcohol, 

Tobacco, Firearms and Explosives, U.S. 

Department of Justice. 

Affected public who will be asked or 

required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: Federal Government and State, 

Local, or Tribal Government. 

Abstract: The Report of Multiple Sale 

or Other Disposition of Pistols and 

Revolvers—ATF Form 3310.4 is used to 

report multiple sale or other disposition 

of two or more pistols, revolvers, or any 

combination of pistols or revolvers to an 

unlicensed person, whether it occurs 

one time or within five consecutive 

business days. 

An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: An estimated 82,011 

respondents will complete this form 

approximately 6.33365 times annually, 

and it will take each respondent 

approximately 15 minutes to complete 

their responses. 

An estimate of the total public burden 

(in hours) associated with the 

collection: The estimated annual public 

burden associated with this collection is 

129,857 hours, which is equal to 82,011 

(# of respondents) * 6.33365 (# of 

responses per respondent) * .25 (15 

mins). 

An Explanation of the Change in 

Estimates: The increase in total 

respondents, responses, and burden 

hours, by 4,106, 63,495, and 15,873 

hours respectively, is due to the revision 

of agency estimates, and a general 

increase in the number of respondents 

since the last renewal in 2018. 

If additional information is required 

contact: Melody Braswell, Department 

Clearance Officer, United States 

Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 

Square, 145 N Street NE, Mail Stop 

3E.405A, Washington, DC 20530. 

Dated: September 14, 2021. 

Melody Braswell, 

Department Clearance Officer for PRA, U.S. 

Department of Justice. 

[FR Doc. 2021–20187 Filed 9–17–21; 8:45 am] 

BILLING CODE 4410–FY–P 

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 videoteleconference. 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

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 

52182 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

*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’’). 

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. 

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 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52183 

*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.] 

*DAccording to Agency Records, Respondent’s 

registered address has changed to 909 Hioaks RD, 

Suite F, Richmond, Virginia 23225–4038. 

3Counsel for both parties have represented that 

the Respondent timely filed an application to renew 

his DEA registration in advance of these 

proceedings. [Citation omitted.] 

EThis 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. 

*FThis 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. 

*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. 

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. 

Beerbower, 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 *C12

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

2. The Respondent’s COR expires by its 

own terms on June 30, 2020.3

3. Oxycodone is a Schedule II controlled 

substance pursuant to 21 C.F.R 

§ 1308.12(b)(1)(xiii).*E Percocet is a brand 

name drug containing oxycodone. 

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. 

6. Lorazepam is a Schedule IV controlled 

substance pursuant to 21 C.F.R 

§ 1308.14(c)(30).*G Ativan is a brand name 

drug containing lorazepam. 

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 

52184 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

4The 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. 

5 DI Pumphrey confirmed that Scott Davis is a 

fictitious name. Tr. 34. 

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. 

8Tr. 75. 

9The 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. 

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. 

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. 

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. 

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. 

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 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52185 

10Tr. 125. 

11The 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. 

12The questionnaire contained no reference to 

tramadol. Gov’t Ex. 1, at 4. 

13Tr. 79; Gov’t Ex. 1, at 4. 

14The TFO testified that he volunteered this in 

‘‘trying to minimize the symptoms.’’ Tr. 83. 

15Tramadol is a Schedule IV controlled 

substance. 21 CFR 1308.4(b)(3); Stip. 7. 

16Tr. 89–90. The TFO was unable to recall 

whether he told the Respondent that he had an xray or an MRI. Id. at 79. 

17The questionnaire contained no reference to 

oxycodone. Gov’t Ex. 1, at 4. 

18The 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. 

19Trazadone is not a controlled substance. 

20Tr. 85. 

21Tr. 81–82, 90–91, 133. The TFO testified that 

he was wearing a T-shirt. Tr. 82. 

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. 

The TFO told the Respondent that he 

thought he could procure an ‘‘older’’ xray 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. 

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, eightminute 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. 

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-totwo 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 previouslyprescribed tramadol, but at the 

conclusion of his four-minute visit with 

the Respondent, he received 

52186 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

22Tr. 97. 23Tr. 98. 

24 Gov’t Ex. 1, at 2–3. 

25Tr. 112. 

26The 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. 

27 Dr. Dombrowski’s curriculum vitae 

(hereinafter, CV) was received into evidence 

without objection. Gov’t Ex. 15; Tr. 170. 

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: 

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. 

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. 

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. 

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 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52187 

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. 

29 Dr. Dombrowski described the taking of a 

thorough history and conducting a thorough 

physical as the ‘‘mainstay’’ of the prescribing 

standard. Tr. 211. 

30The 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. 

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. 

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. 

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. 

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 straightleg 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: 

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 

52188 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

33 Gov’t Ex. 16. 

34The Respondent’s CV was received into the 

record without objection. Resp’t Ex. 1; Tr. 352. 

35The Respondent testified that he has worked at 

Encompass hospitals for about three years. Tr. 371. 

36The 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. 37Resp’t Exs. 2–5. 

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. 

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. 

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. 

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 postacute 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. 

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. 

The Respondent’s limited confessions 

of error notwithstanding, the issue of 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52189 

38Tr. 81–82, 90–91, 133. 

39 Gov’t Ex. 1, at 7. 

40The 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. 

41There 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.’’ 

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. 

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. 

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 

52190 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

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. ShoppeJonesborough, 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 KrishnaIyer, 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 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52191 

42ALJ Ex. 19, at 29. 43The 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. 

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 § 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. 

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 doctorpatient 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 

52192 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

44 21 U.S.C. 802(21), 823(f). 

45Regarding 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. § 54.1–3303(B). 

46Tr. 427–29. 

47 [Footnote omitted.] 

*IAlthough 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. § 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. 

beyond it. Compare Va. Code Ann. 

§ 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 patientpractitioner relationship precede the 

issuing of all prescriptions (controlled 

and non-controlled) 45 in the state. Va. 

Code Ann. § 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: 

(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 followup 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 § 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 § 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. 

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. § 54.1– 

2915. ALJ Ex. 1 at ¶ 5.c (stating that 

‘‘Va. Code Ann. § 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 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52193 

*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.] 

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.] 

51The 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. 

*LText 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. *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. *OWe 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. 52 18 Va. Admin. Code § 85–21–70(B)(3). 

*PRespondent 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 § 85– 

21–70(B)(3) (requiring naloxone to be prescribed 

when opioids and benzodiazepines are prescribed 

concurrently). 

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

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 § 85–21–70(B)(3).*L

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

[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. 

I have omitted the RD’s discussion of 

the purpose of the Virginia Naloxone 

Regulation and its legislative history, 

52194 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

*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). 

*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. 

53 [Footnote omitted.] 

54 [Footnote omitted.] 

55 [Footnote omitted.] 

*SAs 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. 

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

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

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

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. ShoppeJonesborough, 73 FR at 387. In order to 

rebut the Government’s prima facie 

case, the Respondent must demonstrate 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52195 

56Resp’t Ex. 8. 

57Tr. 388–89. 

58Tr. 430–33. 

59ALJ Ex. 20, at 15. 

60 Id. 

61Hassman, 75 FR at 8236. 

62ALJ Ex. 19, at 34. 

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. 

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. 

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 

52196 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

63Tr. 424. 64Tr. 391–94. 

1The Request for Hearing is stamped received on 

July 30, 2019. 

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. 

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. 

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 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 19–31] 

Lisa M. Jones, N.P.; Dismissal of 

Proceedings 

I. Introduction 

On June 28, 2019, a former Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to Lisa Mae Jones, N.P. 

(hereinafter, Applicant), of Mount Airy, 

North Carolina. Administrative Law 

Judge Exhibit (hereinafter, ALJX) 1 

(Order to Show Cause (hereinafter, 

OSC)), at 1. The OSC proposed the 

denial of Applicant’s application 

(Application No. W19018692M) for a 

DEA certificate of registration 

(hereinafter, North Carolina-based 

registration application) and ‘‘any other 

applications for any other DEA 

registrations’’ on the ground that she 

‘‘materially falsified’’ her application 

‘‘in violation of 21 U.S.C. 824(a)(1) and 

823(f).’’ Id. 

The substantive ground for the 

proceeding, as more specifically alleged 

in the OSC, is that Applicant’s ‘‘failure 

to disclose the disciplinary actions 

taken against . . . [her] nursing licenses 

(viz., the denial of . . . [her] application 

in Illinois and the fact that . . . [her] 

Tennessee and Iowa nursing licenses 

were placed on probation) constitutes 

material falsification of . . . [her] 

application for a DEA Certificate of 

Registration.’’ Id. at 4. 

The OSC notified Applicant of her 

right to request a hearing on the 

allegations or to submit a written 

statement while waiving her right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. at 4 (citing 21 

CFR 1301.43). The OSC also notified 

Applicant of the opportunity to file a 

corrective action plan. OSC, at 5 (citing 

21 U.S.C. 824(c)(2)(C)). Applicant 

requested a hearing. ALJX 2 (Request for 

Hearing dated July 22, 2019), ALJX 4 

(Order for Prehearing Statements dated 

July 23, 2019), at 1 (stating that counsel 

for Applicant filed a hearing request on 

July 22, 2019).1

The matter was placed on the docket 

of the Office of Administrative Law 

Judges and assigned to the Chief 

Administrative Law Judge (hereinafter, 

ALJ), John J. Mulrooney, II. The Chief 

ALJ noted thirteen stipulations agreed 

upon by the parties and ‘‘conclusively 

accepted as fact in these proceedings.’’ 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge dated 

November 21, 2019 (hereinafter, RD), at 

4–5. The second and third stipulations 

state that Applicant ‘‘is currently 

licensed in the State of North Carolina 

as a Nurse Practitioner under Approval 

No. 5011528’’ and that her ‘‘North 

Carolina Approval (license) expires by 

its own terms on May 31, 2020.’’ Id. at 

4.