Hamada Makarita, D.D.S.; Denial of Application, 45691-45699 [2020-16355]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45691-45699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16355]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-41]


Hamada Makarita, D.D.S.; Denial of Application

I. Introduction

    On June 29, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Hamada Makarita, D.D.S. 
(hereinafter, Applicant), of McLean, Virginia. Administrative Law Judge 
Exhibit (hereinafter, ALJX) 1 (Order to Show Cause (hereinafter, OSC)), 
at 1. The OSC proposes the denial of Applicant's application for a DEA 
certificate of registration (hereinafter, registration) alleging that 
he does not have authority to handle Schedule II to IV controlled 
substances in Virginia, he has been convicted of felony counts related 
to controlled substances, and his registration would be inconsistent 
with the public interest.\1\ Id. (citing 21 U.S.C. 823(f) and 824(a)).
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    \1\ According to Applicant's request for a hearing, ALJX 2, 
Applicant's original registration application only concerned 
Schedule V controlled substances. ALJX 2, at 1. Applicant 
subsequently revised that application, the hearing request states, 
to include Schedule II through IV controlled substances. Id. ``In 
light of his inability to prescribe Schedule II through IV 
substances due to the findings and ruling of the Board of Dentistry 
of Virginia,'' Applicant's hearing request continues, he ``hereby 
withdraws his amended request for permission to prescribe Schedule 
II through IV substances'' and ``now requests only to have authority 
to prescribe Schedule V substances.'' Id.; see also ALJX 8 
(Prehearing Ruling dated Aug. 31, 2017), at 2 (Stipulation No. 4), 
infra n.2.
     The Recommended Rulings, Findings of Fact, Conclusions of Law, 
and Decision of the Administrative Law Judge in this matter 
(hereinafter, RD) states that Applicant's hearing request was 
``timely filed.'' RD, at 2; see also Transcript page (hereinafter, 
Tr.) 5 (noting that Applicant filed a hearing request on July 31, 
2017).
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    The substantive grounds at issue in this proceeding, as more 
specifically alleged in the OSC, include that Applicant, ``[o]n April 
12, 2013, . . . [was] convicted of eight felony counts in the United 
States District Court for the Eastern District of Virginia, Alexandria 
Division, six of which were related to controlled substances,'' one of 
which was for health care fraud, and one of which was for aggravated 
identity theft. OSC, at 2-3 (citing 21 U.S.C. 823(f)(3) and 824(a)(2) 
and (a)(4)). The OSC also alleges that Applicant ``fail[ed] to accept 
responsibility for . . . [his] convictions.'' OSC, at 3.
    Regarding the allegation that Applicant's registration would be 
inconsistent with the public interest, the OSC alleges twelve findings 
of fact by the Virginia Board of Dentistry (hereinafter, VBD) 
concerning Applicant's prescribing controlled substances without or 
beyond a legitimate dental purpose. Id. at 4-5 (citing 21 U.S.C. 841(a) 
and 842(a), 21 CFR 1306.04(a), and Virginia Code secs. 54.1-2706, 54.1-
3303(A), and 54.1-3408(A)). The OSC also alleges that Applicant 
``refused to accept responsibility for . . . [his] unlawful 
prescriptions.'' OSC, at 5.
    The OSC notified Applicant of his right to request a hearing on the 
allegations or to submit a written statement while waiving his right to 
a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 5-6 (citing 21 
CFR 1301.43). The OSC also notified Applicant of the opportunity to 
file a corrective action plan. OSC, at 6 (citing 21 U.S.C. 
824(c)(2)(C)).
    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to Chief Administrative Law Judge (hereinafter, 
ALJ) John J. Mulrooney, II. The parties initially submitted seven 
stipulations.\2\ RD, at 3; ALJX 8, at 1-2 (original).
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    \2\ In the stipulations, Applicant is referred to as 
``Respondent.''
    ``1. On September 20, 2016, the Respondent filed an application 
for a DEA COR, Control No. W16093263C, seeking registration as a 
practitioner in Schedule V with a registered address of 4103 Chain 
Bridge Road, Suite LL 100, Fairfax, Virginia 22030.
    ``2. The Respondent currently possesses Dental License number 
0401007149 from the Commonwealth of Virginia. His dental license 
expires on its own terms on March 31, 2018.
    ``3. The Respondent lacks authority in the Commonwealth of 
Virginia to handle Schedule II, III, or IV Controlled Substances.
    ``4. In the Respondent's Request for Hearing, he withdrew a 
prior request for Schedule II-IV authority.
    ``5. On April 12, 2013, the Respondent was convicted of eight 
felony counts in the United States District Court for the Eastern 
District of Virginia, Alexandria Division.
    ``6. The Respondent applied for reinstatement of his state 
dental license in 2016. The Virginia Board of Dentistry made a 
number of findings on September 22, 2016, regarding the Respondent's 
treatment of a number of patients.
    ``7. Following the hearing, the Board reinstated the 
Respondent's state dental license with conditions on September 22, 
2016.''
    On September 20, 2017, the parties filed additional Joint 
Stipulations, ALJX 10, agreeing to the authenticity of four of the 
seven Government Exhibits (hereinafter, GX) and five Applicant 
Exhibits (hereinafter, RX). ALJX 10, at 1-2.
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    The hearing in this matter lasted one day and took place in 
Arlington, Virginia on October 10, 2017. The Chief ALJ filed his RD on 
January 19, 2018. Neither party filed exceptions to the RD and the time 
for filing exceptions has expired. Letter of the Chief ALJ to the 
Acting Administrator, dated Feb. 14, 2018, at 1.
    Having examined and considered the record in its entirety, I agree 
with the Chief ALJ that substantial record evidence establishes 
Applicant's six federal felony convictions relating to the dispensing 
of controlled substances, the Fourth Circuit's affirmance of those 
felony convictions, and Applicant's completion of his appeals of those 
convictions. I find substantial record evidence of the VBD's finding 
that Applicant illegally prescribed over 2,700 dosage units of Schedule 
II through IV controlled substances. I find that Applicant did not 
unequivocally accept responsibility for all of this proven controlled 
substance-related wrongdoing. Accordingly, I conclude that granting 
Applicant's request for a

[[Page 45692]]

Schedule V registration would be ``inconsistent with the public 
interest.'' \3\ I make the following findings.
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    \3\ I reviewed, and agree with, the Chief ALJ's pre-hearing, 
hearing, and post-hearing rulings and orders.
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II. Findings of Fact

A. Applicant's State Dental License and Controlled Substance 
Authorization

    Applicant is licensed as a dentist in the Commonwealth of Virginia. 
See, e.g., RX 6 (Letter from the Commonwealth of Virginia, Department 
of Health Professionals to Applicant referencing ``Case No.: 178272--
Inspection Report/Records Audit'' dated September 29, 2017), at 1. 
According to the online records of the Commonwealth of Virginia, of 
which I take official notice, Applicant's dental license is currently 
active. It expires on March 31, 2021.\4\ Virginia Department of Health 
Professions License Lookup, https://dhp.virginiainteractive.org/Lookup/ 
Index (last visited July 21, 2020).
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    \4\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Applicant may dispute my finding by filing 
a properly supported motion for reconsideration of finding of fact 
within fifteen calendar days of the date of this Order. Any such 
motion shall be filed with the Office of the Administrator and a 
copy shall be served on the Government. In the event Applicant files 
a motion, the Government shall have fifteen calendar days to file a 
response. Any such motion and response shall be filed and served by 
email on the other party at the email address the party submitted 
for receipt of communications related to this administrative 
proceeding, and on the Office of the Administrator, Drug Enforcement 
Administration at [email protected].
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    After Applicant served his sentence and was released from federal 
custody, the VBD limited Applicant's authorization to issue controlled 
substance prescriptions to Schedule V. GX 3 (Order Before the Virginia 
Board of Dentistry In Re Hamada R. Makarita, D.D.S., License Number: 
0401-007149, Case Number: 86781, 136371, 143367, 152192, dated, 
entered, and mailed on September 22, 2016 (hereinafter, VBD Order)), at 
11; see also Tr. 51. According to the VBD Order, this limitation on 
Applicant's prescribing and dispensing authority was to last for two 
years from the date of the VBD Order, September 22, 2016. GX 3, at 12.

B. The Investigation of Applicant

    A DEA field investigation of Applicant began because he responded 
``yes'' to ``a few liability questions on an application.'' \5\ Tr. 15; 
see also id. at 15-17 (describing the internal DEA processes that ensue 
when an applicant provides a ``no'' answer and a ``yes'' answer to a 
liability question). Applicant answered ``yes'' to three questions. The 
first question to which Applicant answered ``yes'' asks, in pertinent 
part, ``Has the applicant ever been convicted of a crime in connection 
with controlled substance(s) under state or federal law?'' GX 7, at 3; 
see also Tr. 21-22. Under ``nature of incident'' regarding his ``yes'' 
answer to the first liability question, Applicant wrote:
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    \5\ Application liability questions ask about ``past history'' 
such as a felony criminal conviction, an action against a state 
license, and an action against a registration. Tr. 15-16.

    I found out my office manager was using my DEA license to call 
in rx to herself and friends and I called the FBI and she convinced 
the FBI agent I was the on [sic] who told her to. This was a lie. 
The judge said I was responsible for my ploys [sic] actions so I was 
convicted of conspiracy to distribute narcotics. She said I gave her 
permission which is not true at all or why would i [sic] have called 
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the authorities and go to a lawyer and fire her?

GX 1, at 2. Concerning ``result,'' in connection with the first 
liability question, Applicant wrote:

    I voluntarily surrendered my DEA license and also I am applying 
only for schedule 5 drugs so I can treat my patients with NSAids 
[sic] for pain and antibiotics. I had my hearing with the board of 
Dentistry last week and my license was reinstated. It was a 
mandatory suspension because of the conviction. I will be pressing 
charges against this office manager again! I only wish to have 
permission for schedule 5 for now as it is a must to teat [sic] 
infections etc with antibiotics as well as NSAIDS for pain.

Id.
    The second question to which Applicant answered ``yes'' asks, ``Has 
the applicant ever surrendered (for cause) or had a federal controlled 
substance registration revoked, suspended, restricted or denied, or is 
any such action pending?'' GX 7, at 3. For ``nature of incident'' 
regarding his ``yes'' answer to the second liability question, 
Applicant's submission was the same as his submission for the first 
liability question. GX 1, at 2. Likewise, Applicant wrote the same 
``result'' concerning the second liability question as he wrote for the 
first liability question. Id.
    The third question to which Applicant answered ``yes'' asks, ``Has 
the applicant ever surrendered (for cause) or had a state professional 
license or controlled substance registration revoked, suspended, 
denied, restricted, or placed on probation, or is any such action 
pending?'' GX 7, at 3. Concerning ``nature of incident'' regarding his 
``yes'' answer to the third liability question, Applicant wrote:

    Due to conviction, the state dental board had to suspend (not 
revoke) my license because it is in the statutes. Although they had 
not hear [sic] day case until last week in full, and once they did 
and were presented with proofs of who was the culprit, they 
reinstated my license with no fines at all.

GX 1, at 3. For the ``result'' concerning the third liability question, 
Response wrote, ``License was suspended April 36, [sic] 2013 and 
reinstated Sep 15, 2016.'' Id.

C. The Felony Criminal Convictions and VBD Findings

    According to Government counsel, the ``basis of the Government's 
prima facie case'' is that Applicant was convicted in federal court of 
dispensing controlled substances in violation of the Controlled 
Substances Act (hereinafter, CSA) and that the VBD ``found that he 
committed those unlawful actions.'' \6\ Tr. 10. In his opening 
statement, counsel for Applicant stated that ``[w]e don't deny that . . 
. [Applicant] was convicted and there are Board findings against him.'' 
\7\ Id. at 11. The uncontested criminal convictions and VBD findings 
are set out in Government Exhibits (hereinafter, GX) 2, 3, and 5, 
discussed infra section II.D.
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    \6\ Government counsel argued in his opening statement that 
Applicant ``has not accepted responsibility for his actions'' as 
evidenced by ``his application to the DEA and his pre-hearing 
statements and his conversations with the original Investigator.'' 
Tr. 10.
    \7\ Applicant's Counsel continued by stating that the federal 
convictions and VBD findings stemmed from Schedule II and III 
``related issues,'' that Applicant has ``never been accused of or 
found guilty of or had any adverse . . . [VBD] findings concerning 
Schedule . . . [V] substances,'' that Schedule V ``substances 
typically are not the types of drugs that are sought out by addicts 
and people of that type, nor are those the types of drugs that lead 
to great financial wealth or anything of that nature,'' and, 
therefore, ``given the circumstances and given the work that . . . 
[Applicant] has done . . . , we believe it is consistent with the 
public interest to allow him to now dispense Schedule . . . [V] 
substances.'' Tr. 11-12.
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    There is factual agreement among the witnesses on a number of 
matters. When there is factual disagreement, I apply my credibility 
determinations and the credibility recommendations of the Chief ALJ.

D. The Government's Case

    The Government called one witness, the DEA Diversion Investigator 
case agent (hereinafter, DI). The

[[Page 45693]]

Government's case included seven exhibits, all of which were accepted 
into the record.\8\
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    \8\ The parties agreed to the authenticity of four of the 
Government's Exhibits. ALJX 10; see also supra n.2.
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    DI's testimony addressed Applicant's application, the process of 
referring that application for investigation, and her investigation of 
the application, including her obtaining documents relevant to the 
application and her communicating with Applicant. Id. at 14-33.
    DI testified that she had email and telephonic contact with 
Applicant. Id. at 28-33. According to DI, Applicant told her that ``he 
did want to go before the judge,'' and that the judge told him that 
``he was responsible, so he was convicted.'' Id. at 31. She testified 
that Applicant told her that ``he never abused, sold drugs or anything 
like that'' and that ``he wanted to present his case to the 
[administrative law] judge and not just apply for Schedule 5, but for 2 
through 4 as well.'' Id.; see also GX 4 (Feb. 7, 2107 Letter from 
Applicant amending his September 20, 2016 Registration Application ``to 
all schedules . . . as opposed to just schedule V''), at 1; GX 6 (Nov. 
20, 2016 Email from Applicant to DI stating that ``I have never abused, 
sold drugs, or anything like that'' and ``I wish . . . also not just 
[sic] apply for schedule 5 but for all of it''), at 1.
    On cross examination, as clarified on redirect, DI recounted her 
recollection that Applicant admitted, in his application for a DEA 
registration, to having been criminally convicted.\9\ Tr. 34, 42. She 
testified that she did not find ``any inconsistencies or issues'' about 
Applicant's background on his application. Id. at 34-35. She stated 
that she did not recall the involvement of a Schedule V controlled 
substance in Applicant's criminal convictions or in the VBD findings. 
Id. at 35. In her experience, she testified, Schedule II through V 
controlled substances are diverted by doctors, and ``pill mill-style 
doctors'' prescribe more Schedule II through IV controlled substances 
than Schedule V controlled substances. Id. at 35-37. She testified that 
she did not check whether Applicant uses or was ever prescribed a 
controlled substance, and that she did not recall whether the federal 
indictment or the VBD charges alleged that Applicant abused a 
controlled substance.\10\ Id. at 37-38.
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    \9\ On re-direct, DI clarified that Applicant's application 
accurately admitted to the existence of criminal convictions, and 
that she had not addressed the accuracy of Applicant's description 
of the facts underlying those convictions. Tr. 42.
    \10\ Regarding whether Applicant abused drugs in Schedules II, 
III, or IV, the Fourth Circuit's per curiam decision upholding 
Applicant's criminal convictions describes Count 10 as charging 
Applicant with illegally distributing or dispensing a controlled 
substance to his former office manager. United States v. Makarita, 
576 F. App'x 252, 256 (4th Cir. 2014) (hereinafter, Fourth Circuit 
Conviction Affirmance) (GX 5, at 4). The Fourth Circuit Conviction 
Affirmance describes evidence that Applicant wrote a prescription 
for ``several boxes of [f]entanyl patches'' for his former office 
manager to fill and deliver to him, and that Applicant applied one 
of the patches to his body in the former office manager's presence. 
Id. Also according to the Fourth Circuit Conviction Affirmance, 
Applicant ``corroborated'' this evidence, testifying that ``I was 
hoping this was something I could use as a treatment modality to use 
for any oral pain. That's why I used it on myself. I said, `I want 
to see if it helps my back.' '' Id.
     According to the prosecution's expert witness in the criminal 
case, Dr. Lawrence Singer, fentanyl is ``outside the scope of 
dentistry or oral surgery and `is only appropriate for a chronic 
pain patient who has cancer pain or . . . something extremely 
debilitating and may be chronically ill.' '' 576 F. App'x at 257 (GX 
5, at 5). Based on Dr. Singer's testimony, Applicant's admission 
that he used the fentanyl patch on his back to see if it might 
relieve oral pain implicates illegal prescribing, dispensing, and 
use of a Schedule II controlled substance. See Tr. 11 (``I will tell 
the court that you will hear testimony today from . . . [Applicant] 
regarding . . . his own needs or lack of needs for medication.''). 
It also evidences Applicant's lack of candor during the DEA 
investigation and administrative hearing about his history of 
controlled substance use. Id. at 31 (DI testimony) and 111 
(Applicant's testimonial denial); GX 6, at 1 (Applicant's written 
denial); 576 F. App'x at 255 (GX 5, at 4) (recounting testimony of 
former dental assistant at Eight Felony Conviction Trial).
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    I agree with the Chief ALJ that DI ``presented testimony that was 
detailed, plausible, internally consistent, and devoid of any 
indication of any cognizable motive to fabricate. She gave every 
appearance of an impartial investigator/regulator, was forthcoming and 
candid in her responses to questions, and her testimony is accepted 
here as fully credible.'' RD, at 13.
    The Government's admitted documentary evidence consists of 
documents detailing the disposition of the felony criminal charges 
brought against Applicant, the Circuit Court's affirmance of the 
charges of which Applicant was convicted, and the VBD's findings of 
fact, conclusions of law, and Order concerning Applicant's medical 
license and controlled substance prescribing authority. GX 2, 3, and 5, 
respectively. The Government also put in the record Applicant's 
correspondence with DEA and DI related to his registration application 
and background information to help contextualize that correspondence. 
GX 1, 4, 6, and 7.
    GX 2 consists of six sheets concerning Applicant's eight felony 
convictions in the Eastern District of Virginia. GX 2 (Judgment, United 
States v. Makarita, No. 1:12cr00223-001 (E.D. Va. Apr. 12, 2013) 
(hereinafter, Eight Felony Conviction Trial)). The first sheet is the 
``Judgment in a Criminal Case.'' Id. at 1. It shows that Applicant was 
``found guilty as to Count(s) 1, 2, 3, 10, 12, 13, 14, and 15 of the 
Indictment,'' all of which are felonies. Id. The second sheet shows 
that Applicant was sentenced to twenty-five months of imprisonment. Id. 
at 2. The third sheet shows that Applicant was put on supervised 
release for three years. Id. at 3.
    The first count listed on the Judgment of the Eight Felony 
Conviction Trial is conspiracy to distribute and dispense controlled 
substances in violation of 21 U.S.C. 846. Id. at 1. Applicant appealed 
his conviction on this count arguing that ``there was insufficient 
evidence to support his conviction . . . because the evidence failed to 
demonstrate any agreement to illegally distribute controlled substances 
between him and any other individual.'' 576 F. App'x at 262-63 (GX 5, 
at 9). According to the Fourth Circuit Conviction Affirmance, however, 
Applicant's ``conviction for conspiracy is supported by substantial 
evidence.'' 576 F. App'x at 263 (GX 5, at 9). The Eight Felony 
Conviction Trial testimony of two of Applicant's former employees, his 
former office manager and his former dental assistant, ``established 
that . . . [Applicant] entered into an agreement with each of them to 
pick up prescriptions in their own names and deliver them to . . . 
[Applicant], either for him to illicitly deliver to others, or for his 
own personal use.'' \11\ Id. In the face of the conflicting testimony 
of Applicant, ``the jury elected to credit . . . [the two former 
employees'] testimony'' over Applicant's. Id.
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    \11\ As already discussed, testimony the United States elicited 
about the conspiracy count was presented by Applicant's former 
office manager. She testified that she filled prescriptions 
Applicant wrote for boxes of fentanyl patches, delivered them to 
Applicant, and witnessed Applicant apply one patch to his body at 
the dental office. 576 F. App'x at 255 (GX 5, at 3). The former 
office manager also testified that Applicant had her print 
``multiple prescriptions for controlled substances from the office 
computer for . . . [his] various family members, patients, and 
friends.'' Id.
     Applicant's former dental assistant similarly testified that 
Applicant wrote a Valium prescription in her name and instructed her 
to fill it so that he could give it to his girlfriend. 576 F. App'x 
at 255 (GX 5, at 4). The former dental assistant also testified that 
Applicant wrote a Vicodin prescription in her name and instructed 
her to fill it so that he could use it himself. Id. She also 
testified that she learned during the federal investigation of 
Applicant that he had ``written several other prescriptions in her 
name which were filled at various pharmacies.'' Id.

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[[Page 45694]]

    The Eight Felony Conviction Trial ``Judgment in a Criminal Case'' 
sheet shows that the second, third, tenth, twelfth, and thirteenth 
counts are for dispensing controlled substances in violation of 21 
U.S.C. 841(a)(1). GX 2, at 1. Applicant also appealed his conviction on 
these counts arguing that there was ``insufficient evidence to support 
his distribution offenses.'' 576 F. App'x at 263 (GX 5, at 10). The 
Fourth Circuit Conviction Affirmance found Applicant's argument to be 
``without merit,'' stating ``after a careful review of the record, we 
conclude substantial evidence clearly supports that . . . [Applicant] 
distributed and dispensed a variety of controlled substances for 
recreational purposes and not for a legitimate medical and dental 
purpose.'' \12\ Id.
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    \12\ Testimony the United States elicited about the unlawful 
distribution and dispensing counts included testimony from a patient 
whose relationship with Applicant later became romantic. 576 F. 
App'x at 256 (GX 5, at 4). She testified that ``she would call . . . 
[Applicant] to get prescriptions for Vicodin and Valium for 
recreational use, and she would consume these controlled substances 
as well as alcohol while on dates'' with Applicant. Id. She 
testified that, to obtain these prescriptions, she had to ``hang 
out'' with Applicant. She stated that on at least one occasion, she 
combined Vicodin with alcohol and ``blacked out.'' Id. Shortly after 
one such occurrence, she testified, Applicant sent her photographs 
he had taken of her ``while she was incapacitated, which depicted 
her nude except for a jacket and a single boot, lying apparently 
unconscious on his bed.'' Id. She testified that she was using the 
controlled substances, with Applicant's knowledge, ``solely for 
recreational purposes.'' Id. Dr. Singer testified that Applicant 
performed ``minor dental procedures'' on this patient/girlfriend 
``that would result in `mild discomfort' at most.'' Id. The expert 
also testified that ``between 2007 and 2008 . . . [Applicant] 
prescribed . . . [for this patient/girlfriend] `several hundred 
pills total' in prescriptions that `were maybe a couple dozen,' '' 
and that the patient/girlfriend's ``patient record was devoid of any 
clinical notes to support this treatment.'' Id.
     The fentanyl patch testimony of Applicant's former office 
manager was also relevant to these counts. Dr. Singer found that 
Applicant ``wrote prescriptions . . . [for her] for what [a]ll 
amounted to a few hundred--several hundred doses of narcotics.' '' 
576 F. App'x at 257 (GX 5, at 5). According to the expert, a 
fentanyl patch is ``outside the scope of dentistry or oral surgery 
and `is only appropriate for a chronic pain patient who has cancer 
pain or . . . something extremely debilitating and may be 
chronically ill.' '' Id.
     Likewise, the testimony of Applicant's former dental assistant/
patient was relevant to these counts. Dr. Singer opined that 
Applicant had no clinical notes to support the writing of Valium or 
Vicodin prescriptions for her. Id. The expert concluded that ``these 
prescriptions were not written within the bounds of dental practice 
for a legitimate dental purpose.'' Id.
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    The fourteenth felony count in the indictment of Applicant is 
health care fraud, a violation of 18 U.S.C. 1347. Id. The fifteenth 
felony count is aggravated identity theft under 18 U.S.C. 1028A. These 
counts charged Applicant with submitting dental service reimbursement 
requests under the name of a dentist previously affiliated with the 
practice to circumvent the health insurance plan's exclusion of 
services provided to family members. 576 F. App'x at 258 (GX 5, at 5-
6). The corroborated testimony received during the Eight Felony 
Conviction Trial included that Applicant would forge the dentist's 
signature on the reimbursement checks, sign the checks to himself, and 
deposit the checks in his personal or business bank account. 576 F. 
App'x at 258, 264 (GX 5, at 6, 10). The Fourth Circuit Conviction 
Affirmance concluded that the ``evidence was more than sufficient to 
show that . . . [Applicant] made the false representations . . . 
knowingly and willfully, in order to receive money to which he was 
otherwise not entitled.'' 576 F. App'x at 264 (GX 5, at 10). The 
restitution ordered upon Applicant's conviction was $91,629.38. GX 2, 
at 6.
    Applicant challenged the health care fraud conviction on two 
grounds. First, he argued that he was not bound by the terms of the 
health insurance plan because he was not a party to the contract. 576 
F. App'x at 263 (GX 5, at 10). The Fourth Circuit Conviction Affirmance 
rejected this argument, stating that being a party to an insurance 
contract ``is not relevant to whether . . . [Applicant] formed the 
specific intent to commit health care fraud.'' 576 F. App'x at 264 (GX 
5, at 10). Second, Applicant claimed that the record evidence was 
insufficient to support a finding that the health insurance plan was a 
``health care benefit program'' as defined by the criminal statute. Id. 
The Fourth Circuit Conviction Affirmance disagreed, concluding that 
Applicant's health care fraud conviction was supported by ``substantial 
evidence.'' \13\ 576 F. App'x at 264 (GX 5, at 10-11).
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    \13\ The Fourth Circuit Conviction Affirmance also addressed, 
and found meritless, Applicant's claims of error based on Brady v. 
Maryland. 576 F. App'x at 259-62 (GX 5, at 7-9). Its analysis of the 
error claims addressed, among other things, Applicant's former 
office manager and her testimony in the Eight Felony Conviction 
Trial. According to the Fourth Circuit Conviction Affirmance, 
Applicant's counsel ``conducted a thorough cross examination'' of 
the former office manager. 576 F. App'x at 260-61 (GX 5, at 7-8). 
The areas covered by the ``zealous'' cross examination included 
Applicant's having terminated her for making a false statement to an 
insurance company, her submitting a false r[eacute]sum[eacute] to a 
local doctor, her submitting a false bill to an insurance company 
and pocketing the reimbursement check, her forging Applicant's 
signature on prescriptions, her making inconsistent statements to 
the grand jury, her submission of fraudulent insurance claims for 
her sister, her conviction for writing false checks, and her 
embezzling from Applicant's 401(k) plan. 576 F. App'x at 261 (GX 5, 
at 8).
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    In sum, the Fourth Circuit Conviction Affirmance found no 
reversible error and affirmed the results of the Eight Felony 
Conviction Trial. 576 F. App'x at 254 (GX 5, at 3).
    GX 3 is the VBD Order regarding Applicant's state dental license. 
Applicant testified about his post-release preparations for, and his 
participation in, the ``14-hour [VBD] hearing nonstop . . . [that] 
lasted until 2:00 a.m.'' Tr. 50-51. The Order notes Applicant's 
appearance at the hearing ``not represented by legal counsel.'' GX 3, 
at 1. The VBD's post-hearing Order reinstated, indefinitely suspended, 
and then stayed the indefinite suspension of Applicant's dental license 
``contingent upon continued compliance'' with specified terms and 
conditions. Id. at 10-11. As already discussed, those terms and 
conditions include ``not prescrib[ing] or dispens[ing] Schedule II, 
III, and IV controlled substances for a period of two (2) years from 
the date of this Order.'' Id. at 11. The terms and conditions also 
include timely completion of VBD Executive Director-approved, face-to-
face, interactive continuing education programs in Principles of 
Pharmacology and Prescription Writing (seven hours), Treatment of 
Medically Compromised Patients (four hours), Diagnosis and Treatment 
Planning Protocol (ten hours), and Ethics for the Dental Professional 
(seven hours), and undergoing annual random audits of ten patient 
charts for two years.\14\ Id.
---------------------------------------------------------------------------

    \14\ The Order also imposed on Applicant administrative costs of 
$5,000.00. GX 3, at 12.
---------------------------------------------------------------------------

    The ``Findings of Fact'' section of the VBD Order spans eight 
pages. GX 3, at 1-8. It lists, among other things, eight categories of 
fact findings about Applicant's illegal actions related to controlled 
substances from 2006 through 2011.\15\ The categories are (1) providing 
a Schedule III controlled substance to a patient outside of his dental 
office without a legitimate dental purpose on multiple occasions, (2) 
prescribing Schedule II through IV controlled substances to eight 
patients

[[Page 45695]]

and an individual on multiple occasions without a legitimate dental 
purpose, (3) prescribing Schedule II and IV controlled substances under 
the name of an office employee and asking that employee to pick up 
those prescriptions from the pharmacy for him, (4) instructing the 
office employee to lie to investigators about these pain medications by 
stating that Applicant had written them for the employee, (5) 
excessively prescribing Schedule II, III, and IV controlled substances 
to two patients beyond a legitimate dental purpose, (6) prescribing to 
two patients Schedule II controlled substances without a legitimate 
purpose around the time of office appointments at which x-rays were 
taken but neither treatment nor the prescriptions were noted in the 
patient's dental record, (7) prescribing Schedule II controlled 
substances to six patients without recording the prescriptions in the 
patient's dental record, and (8) accessing the Virginia Prescription 
Monitoring Program to obtain information about multiple patients 
without patient authorization and without a legitimate dental 
purpose.\16\ Id. at 2-6. In sum, the VBD Order documents Applicant's 
unlawful dispensing of 2,711 dosage units of controlled substances in 
Schedule II (1,740 dosage units), Schedule III (290 dosage units), and 
Schedule IV (681 dosage units).
---------------------------------------------------------------------------

    \15\ The VBD Order also documents fact findings about 
Applicant's provision of care and treatment to a patient that was 
recorded in a fraudulently created patient record under an alias, 
fraudulent contracting of health insurance coverage for eleven 
individuals, and provision of dental treatment to a 92 year old 
patient without consulting and/or documenting any consultation with 
the patient's physician concerning the patient's heart defect or 
heart murmur and atrial fibrillation, without explaining the 
proposed treatment plan, providing an estimate, or obtaining 
consent, without appropriately documenting the patient's treatment 
records, without billing for the correct (lower cost) metal used, 
and without explaining deceptive or misleading abbreviations in 
correspondence to the patient. GX 3, at 2, 7-8.
    \16\ Applicant admitted to a VBD investigator that, after 
writing eight prescriptions for a total of 150 dosage units of 
hydrocodone without recording them in the patient's dental record, 
he ``subsequently determined'' that the ``patient'' was ``exhibiting 
drug-seeking behaviors and that he did not write any prescriptions'' 
for the ``patient'' thereafter. GX 3, at 6.
---------------------------------------------------------------------------

E. Applicant's Case

    At the hearing, Applicant testified and called one other witness, 
his current assistant. Tr. 9, 55. He also introduced five exhibits 
concerning ``the circumstances and . . . the work that . . . 
[Applicant] has done.'' Id. at 12.
    During his testimony, Applicant described his credentials and 
professional affiliations, the establishment and nature of his current 
dental practice, when he would prescribe Schedule V controlled 
substances in his current practice, and his ``feel[ing] like . . . [he 
is currently] helping . . . [patients] 80 percent of the way versus if 
they had muscle relaxants to take at night . . . which helps them not 
clench and grind and so forth from being in the wrong bite position. 
That would help them.'' \17\ Id. at 44-45, 54-57, 45-46, 46-48, and 48, 
respectively.
---------------------------------------------------------------------------

    \17\ Applicant testified that his practice has ``around 300'' 
patients, ``a good 40 percent'' of whom he treated prior to being 
criminally convicted, and that ``the patients who are returning . . 
. still come'' even though he does not prescribe controlled 
substances. Tr. 56-57. He denied that he expects his ``income to 
change significantly or at all'' if DEA allows him to prescribe 
Schedule V controlled substances and represented that, prior to 
being criminally convicted, ``[z]ero . . . percent'' of his income 
``was derived from Schedule 2 through 5 prescriptions.'' Id. at 113-
14. Applicant stated that ``the only thing that would change is the 
patients would be more comfortable with the muscle relaxants, that's 
it.'' Id. at 113.
---------------------------------------------------------------------------

    Applicant admitted that he was convicted of eight federal felonies 
in the Eastern District of Virginia and, regarding fault, stated, ``The 
buck stops here. It's a hundred percent my fault.'' Id. at 48-49. He 
elaborated on why he was at fault by stating, ``I am responsible to 
guard my DEA number, to prescribe and document properly anything I 
prescribe that's controlled and I was perhaps a little bit lax about 
it.'' Id. at 49. Applicant admitted that ``it's easier before to blame 
others. But, you know, when I had a lot of time to reflect, it was 100 
percent me because I'm the boss, I own the practice. Everything should 
be my responsibility.'' Id. at 49-50.
    Applicant admitted that the VBD ``suspended . . . [his] license 
because of the convictions.'' Id. at 50. The VBD suspension was 
``automatic'' and he ``had never met with them at the time,'' he 
stated. Id. After a ``14-hour [VBD] hearing nonstop . . . [that] lasted 
until 2:00 a.m.,'' the VBD reinstated his license, although only 
allowing him to prescribe Schedule V controlled substances. Id. at 50-
51. In the course of his testimony about the requirements imposed on 
him by the VBD, Applicant described the one-on-one courses he paid 
$13,500 to take at Virginia Commonwealth University, recounted a pre-
conviction experience he had with a drug-seeking ``soccer Mom,'' and 
detailed his reaction to patient push-back he received when he 
prescribed five Vicodin.\18\ Id. at 57-88, 78-82, 76-77, respectively.
---------------------------------------------------------------------------

    \18\ ``I've had patients tell me if I give them five Vicodin, 
they say `Five? My physician gives me 90.' I say, `Well, yeah, I'm 
not your physician,' you know. So, I don't know who needs 90, but 
those kind of things can end up on the streets.'' Tr. 76.
---------------------------------------------------------------------------

    Applicant testified that he had just received a letter from the VBD 
about the unannounced inspection that was conducted pursuant to Term #3 
of the VBD Order and the ensuing VBD review of the inspection report 
and patient records. Id. at 108-09. According to the letter, the VBD 
found Applicant ``to be in compliance with Term #3 of . . . [the] Order 
and no violations were noted. Case No. 178272 is CLOSED with no further 
action necessary.'' RX 6, at 1 [emphasis in original]. Although the VBD 
informed Applicant that he would be subject to another audit, one that 
would be announced, Applicant testified that he had paid the $5,000 VBD 
administrative fee and that there were no other VBD conditions with 
which he still had to comply. Tr. 110-11.
    Applicant testified about other courses, such as in cosmetic 
dentistry, he has taken, stating that ``I do a lot of continuing 
education . . . . I'm constantly taking courses all over the country.'' 
Id. at 88; RX 3. He also discussed the post-conviction speeches he 
presented and articles he wrote. Id. at 90-97, 98-103, 124-130; RX 4; 
RX 5. Applicant testified that he ``just wanted to get that information 
out there,'' so that it would not ``happen to anyone else.'' Tr. 91. He 
stated that his ``whole point about it is, you are responsible. . . . 
[I]t doesn't matter if one of your employees does something, if you are 
lax about where you keep your prescription pad, it comes back to haunt 
you, it comes back to bite you, it's a privilege to have the DEA 
license.'' \19\ Id. at 92. He also stated that his ``problem'' was that 
he did not ``properly document prescriptions.'' Id. at 94. ``[H]ow to 
properly document. . . . [Y]ou think it's a pain in the butt, try what 
I went through, that's a pain in the butt,'' he testified. Id.
---------------------------------------------------------------------------

    \19\ Applicant's article entitled ``Fraud and Embezzlement in 
the Dental Office--Part 2,'' for example, offers a variety of 
suggestions about how to prevent fraud, such as obtaining background 
checks before hiring employees, reviewing credit card statements, 
and using software application audit trails. RX 4, at 4.
---------------------------------------------------------------------------

    Applicant specifically addressed what he had ``previously said in 
an email or on an application,'' presumably concerning his amending the 
DEA application he submitted from requesting only Schedule V authority 
to requesting Schedule II through V authority. Id. at 50. ``[P]art of 
it was I had just finished a grueling process . . .--when I was 
released, of preparing for the . . . [VBD] . . . for reinstatement 
because they suspended my license because of the convictions,'' he 
began. Id. ``[J]ust rehashing everything in my mind and going through 
everything with the . . . [VBD],'' he continued. Id. Applicant also 
stated that, ``when I went onto the application . . . and that was just 
fresh in my mind that it was, you know, there are some things that 
happen in the office that were still my responsibility.'' \20\ Id. at 
51. Prefacing his final points with the note that he was not 
represented by counsel at the time, he stated that ``the way I thought 
about it was I could apply for my DEA,

[[Page 45696]]

because they said I could apply for my DEA license . . . [and] `Okay, 
but I just won't prescribe Schedule anything but Schedule 5,' you know, 
I didn't really know at the time,'' he testified. Id. at 51-52.
---------------------------------------------------------------------------

    \20\ While not stated explicitly, this portion of Applicant's 
testimony appears to concern his DEA application.
---------------------------------------------------------------------------

    Applicant listed the changes he made in his practice since his 
felony convictions. He stated that ``[e]verything is in a locked safe . 
. . , you need a key and a combination . . . [, and] [t]here's a camera 
on it.'' Id. at 97. He testified that ``you can't print 
prescriptions,'' ``[t]here's no prescriptions lying around anywhere,'' 
and ``I document like crazy.'' Id.; see also id. at 118-19.
    Applicant testified that the only time he took a controlled 
substance was ``15 years ago or something . . . [when] the oral surgeon 
prescribed . . . [him] Tylenol #3 or something back then.'' Id. at 111. 
He stated that he has never been treated for addiction to any narcotics 
or any drugs, and that he has ``zero'' drug problem. Id. On cross 
examination, he testified that, before the criminal convictions, he 
only directed staff to pick up blood pressure and cholesterol 
prescriptions for him from the pharmacy; ``never, ever . . . any 
medication that was not prescribed to'' him. Id. at 115.
    The Chief ALJ, who observed Applicant's demeanor during the 
hearing, assessed Applicant's credibility and included his observations 
and conclusions in the RD. According to the Chief ALJ, ``Even beyond 
the obvious reality that, as the applicant, the . . . [Applicant] has 
the most at stake regarding the outcome of the proceedings, his 
presentation conflicted with the incontrovertible evidence, was 
blatantly self-serving, and struck as inconsistent even with his own 
exhibits.'' RD, at 25. The Chief ALJ concluded that ``there was some 
testimony of the . . . [Applicant] that can certainly be credited in 
this recommended decision, such as biographical information . . . . 
Where his recitation of relevant facts conflicts with incontrovertible 
evidence, such as facts subsumed by his convictions and the findings 
rendered by the . . . [VBD], his testimony is not just legally 
incapable of belief; it is factually unworthy of credibility.'' Id.
    My review and analysis of the record are consistent with the Chief 
ALJ's conclusions. For example, according to the record transcript, 
Applicant testified that the only time he took a controlled substance 
was ``15 years ago or something . . . [when] the oral surgeon 
prescribed . . . [him] Tylenol #3 or something back then.'' Tr. 111. 
According to the Fourth Circuit Conviction Affirmance, however, 
Applicant ``corroborated'' his former office manager's testimony that 
he applied a fentanyl patch to his body in her presence.\21\ 576 F. 
App'x at 256 (GX 5, at 4).
---------------------------------------------------------------------------

    \21\ Fentanyl is a Schedule II controlled substance.
---------------------------------------------------------------------------

    By way of further example, the Chief ALJ asked Applicant whether it 
would be incorrect ``if someone said that . . . [he] intentionally 
wrote up prescriptions or gave them to people for other than a 
legitimate medical purpose.'' Tr. 121. Applicant agreed, ``That would 
be wrong.'' Id. As already discussed, however, both the Fourth Circuit 
Conviction Affirmance and the VBD Order conclusively found that 
Applicant intentionally wrote controlled substance prescriptions for 
other than a legitimate medical purpose. 576 F. App'x at 256-57 (GX 5, 
at 4-5); GX 3, at 2-5.
    Applicant's lack of credibility is exhibited in ways in addition to 
blatant conflicts between his record testimony and the records of the 
Eight Felony Conviction Trial, the Fourth Circuit Conviction 
Affirmance, and the VBD Order. For example, Applicant could have sought 
access to, and potentially introduced into the record, Prescription 
Drug Monitoring files to support his answer to his own counsel's 
question about whether he ever took Schedule II or Schedule III 
controlled substances. Tr. 111. There are no such files in the record, 
however. Neither did Applicant submit any evidence explaining why he 
did not seek to obtain or offer any such corroborating evidence.
    By way of further example, Applicant testified that the software 
used in his dental office, Dentrix, includes an audit trail, ``[s]o, 
everything that's put in there cannot be erased.'' Id. at 100. 
Applicant detailed that ``if somebody prints a prescription out and 
deletes it out of the system, . . . [Dentrix] documents that somebody, 
under their login, printed a prescription and deleted it. Id. at 100-
01. Applicant even testified that he showed evidence from Dentrix to 
the VBD and the VBD stated ``why is this even an issue,'' whereas he 
``told the FBI about those digital records and they just never did 
anything about it.'' Id. at 122. Yet, although Applicant suggested that 
Dentrix audit trails would exonerate him, the record in this matter 
does not contain a single Dentrix audit trail. The record also does not 
contain Applicant's explanation as to his failure to offer the 
exonerating evidence he claimed exists.
    In sum, I agree with the Chief ALJ's credibility assessment of 
Applicant. Further, I afford no weight to Applicant's claims of 
innocence when he failed to produce the documentary evidence that he 
testified exists and supports those innocence claims.\22\
---------------------------------------------------------------------------

    \22\ This Agency has applied, and I apply here, the ``adverse 
inference rule.'' As the D.C. Circuit explained, ``Simply stated, 
the rule provides that when a party has relevant evidence within his 
control which he fails to produce, that failure gives rise to an 
inference that the evidence is unfavorable to him.'' Int'l Union, 
United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. 
Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C. Cir. 1972). The 
Court reiterated this rule in Huthnance v. District of Columbia, 722 
F.3d 371, 378 (D.C. Cir. 2013). According to this legal principle, 
Applicant's decision not to provide evidence within his control 
gives rise to an inference that any such evidence is unfavorable to 
Applicant.
---------------------------------------------------------------------------

    The second witness Applicant called was his current assistant, a 
certified dental assistant (hereinafter, CDA), whose employment with 
him began after his release from incarceration. Id. at 138. CDA 
testified about her job responsibilities and stated that Applicant gave 
her ``general information'' about ``what happened and that his license 
was suspended and he couldn't practice for some time.'' Id. at 137-38. 
She testified that Applicant keeps his prescription pads in a safe, 
that there is a camera trained on the safe, and that a key and a 
combination are needed to open the safe. Id. at 139. CDA stated that 
the dental office uses the ``Dentrix system,'' but that only Applicant 
knows the passwords to it. Id. at 140. She denied seeing Applicant 
prescribe a controlled substance or take a controlled substance, and 
seeing Applicant use anyone else's prescription pad or DEA number. Id. 
at 141-42. CDA testified that Applicant never asked her to ``phone in 
any sort of Schedule[d] substances.'' Id. at 142. She stated that she 
has heard patients ask Applicant to prescribe ``something stronger than 
ibuprofen or Motrin or Tylenol'' and that Applicant replied to ``just 
take Advil and Tylenol.'' Id. at 142-43.
    I agree with the Chief ALJ's assessment that CDA's ``testimony 
presented no basis to conclude that she was not credible. She appeared 
candid and forthright, and her testimony was sufficiently detailed, 
internally consistent, and plausible to be fully credited.'' RD, at 27.

F. Allegation That Applicant Was Convicted of Felonies Related to 
Controlled Substances

    As already discussed, the OSC charged that Applicant's application 
for a registration should be denied due to his having been convicted of 
six felonies related to controlled substances. OSC, at 1. Applicant 
does not dispute that he was criminally convicted of eight felonies in 
the Eastern District of

[[Page 45697]]

Virginia. Tr. 48-49. Based on the uncontroverted evidence in the 
record, I find that six of these undisputed felony convictions, 
Applicant's convictions for conspiracy to dispense controlled 
substances illegally under 21 U.S.C. 846 and for illegally distributing 
or dispensing controlled substances under 21 U.S.C. 841(a)(1), relate 
to controlled substances.\23\ GX 2; GX 5; see also GX 3, at 1-2.
---------------------------------------------------------------------------

    \23\ I agree with the Chief ALJ's conclusions that, in this 
case, the felony convictions for health care fraud and aggravated 
identity theft are not sufficiently related to controlled 
substances. RD, at 35.
---------------------------------------------------------------------------

III. Discussion

A. The Controlled Substances Act and the Public Interest Factors

    Pursuant to section 303(f) of the CSA, ``[t]he Attorney General 
shall register practitioners . . . to dispense . . . controlled 
substances . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Section 303(f) further provides that an 
application for a practitioner's registration may be denied upon a 
determination that ``the issuance of such registration . . . would be 
inconsistent with the public interest.'' Id. In making the public 
interest determination, the CSA requires consideration of the following 
factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant'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.

Id.
    These factors are considered in the disjunctive. Robert A. Leslie, 
M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id. Moreover, while I am required to 
consider each of the factors, I ``need not make explicit findings as to 
each one,'' and I ``can `give each factor the weight . . . [I] 
determine[ ] is appropriate.' '' MacKay v. Drug Enf't Admin., 664 F.3d 
808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enf't Admin., 567 
F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug Enf't Admin., 419 
F.3d 477, 482 (6th Cir. 2005)). In other words, the public interest 
determination ``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; what 
matters is the seriousness of the registrant's misconduct.'' Peter A. 
Ahles, M.D., 71 FR 50097, 50098-99 (2006).
    Pursuant to section 304(a)(2), the Attorney General is authorized 
to suspend or revoke a registration ``upon a finding that the 
registrant . . . has been convicted of a felony under this subchapter 
or subchapter II of this chapter or any other law of the United States 
. . . relating to any substance defined in this subchapter as a 
controlled substance or a list I chemical.'' 21 U.S.C. 824(a)(2). It is 
well established that the various grounds for revocation or suspension 
of an existing registration that Congress enumerated in this section 
are also properly considered in deciding whether to grant or deny an 
application under section 303. See Richard J. Settles, D.O., 81 FR 
64940, 64945 (2016); Arthur H. Bell, D.O., 80 FR 50035, 50037 (2015); 
Mark P. Koch, D.O., 79 FR 18714, 18734-35 (2014); The Lawsons, Inc., t/
a The Medicine Shoppe Pharmacy, 72 FR 74334, 74338 (2007); Samuel S. 
Jackson, D.D.S., 72 FR 23848, 23852 (2007); Alan R. Schankman, M.D., 63 
FR 45260, 45260 (1998); Kuen H. Chen, M.D., 58 FR 65401, 65402 (1993).
    The Government has the burden of proof in this proceeding. 21 CFR 
1301.44. Both parties submitted documentary evidence. All of the 
documentary evidence was admitted without objection. See, e.g., ALJX 
10, at 1-2 (stipulating to the authenticity of certain evidence). The 
admitted documentary evidence implicates Factors One, Two, Three, and 
Four. Of these relevant factors, the OSC first alleges Applicant's 
controlled substance felony convictions. OSC, at 2-3. Accordingly, 
Factor Three is discussed first, followed by Factor One, and then 
Factors Two and Four.

B. Factor Three--Applicant's Felony Convictions Relating to Controlled 
Substances

    As already discussed, I found that Applicant's convictions for 
conspiracy to dispense controlled substances and for illegally 
distributing or dispensing controlled substances are six felony 
convictions relating to controlled substances. Supra section II.F. I 
further find that Applicant's convictions for conspiracy to dispense 
controlled substances and for illegally distributing or dispensing 
controlled substances are six felony convictions ``relating to'' 
controlled substances as those terms are defined in 21 U.S.C. 
824(a)(2). 21 U.S.C. 846 and 841(a)(1); William J. O'Brien, III, D.O., 
82 FR 46527, 46529 (2017). In addition, with respect to the record 
evidence, I find that these six felony convictions constitute 
Applicant's ``conviction record under Federal . . . laws relating to 
the manufacture, distribution, or dispensing of controlled 
substances.'' \24\ 21 U.S.C. 823(f)(3). Accordingly, the CSA, under 
Factor Three, requires me to consider these six felony convictions in 
my determination of whether the issuance of a registration to Applicant 
would be ``inconsistent with the public interest.'' Id.
---------------------------------------------------------------------------

    \24\ Just as a felony conviction relating to controlled 
substances provides a basis for revoking an existing registration 
without proof of any other misconduct, see 21 U.S.C. 824(a)(2), it 
also provides an independent and adequate ground for denying an 
application. Mark P. Koch, D.O., 79 FR at 18734-35; Alvin Darby, 
M.D., 75 FR 26993 n.30 (2010); Brady Kortland Fleming, D.O., 46 FR 
45841, 45842 (1981).
---------------------------------------------------------------------------

C. Factor One--Recommendation of the Appropriate State Licensing Board

    Factor One calls for consideration of the ``recommendation of the 
appropriate state licensing board or professional disciplinary 
authority'' in the public interest determination. 21 U.S.C. 823(f)(1). 
Neither the VBD Order nor any other record evidence constitutes a 
direct recommendation to the Agency from the VBD about Applicant's 
registration application.
    As already discussed, after suspending Applicant's dental license 
about ten days after entry of Judgment in the Eight Felony Conviction 
Trial, the VBD reinstated Applicant's dental license, placed it on 
indefinite suspension, and stayed that suspension ``contingent upon 
continued compliance'' with various terms and conditions. GX 3, at 10-
11. One such term and condition was that Applicant was not to 
``prescribe or dispense Schedule II, III, and IV controlled substances 
for a period of two (2) years from the date of this Order,'' September 
22, 2016. GX 3, at 11-12. Both parties implicitly interpret this VBD 
term as authorizing Applicant to prescribe and dispense Schedule V 
controlled substances in Virginia. See, e.g., OSC, at 2.
    The record does not include a comparison of the evidence presented 
in the Eight Felony Conviction Trial and in the VBD hearing. Clearly, 
though, the Fourth Circuit Conviction Affirmance and the VBD Order do 
not discuss all of the same incidents or evidence.

[[Page 45698]]

    My predecessor recently addressed Factor One and its application in 
a matter when the state board granted a doctor limited controlled 
substance authority based on less evidence of misconduct than the 
Government had presented during the OSC proceeding. John O. Dimowo, 
M.D., 85 FR 15800, 15810 (2020).\25\ In that case, my predecessor 
concluded that the state board's input was not a ``direct 
recommendation'' for purposes of Factor One. Id. at 15810. Viewing the 
state's action as ``indicating a recommendation,'' though, and stating 
that the CSA clearly places on him the responsibility to conduct the 
public interest inquiry and analysis, he noted that the state board had 
``severely limited'' the doctor's medical license, ``which does not 
indicate a substantial amount of trust'' in the doctor. Id. Pointing 
out that he had more evidence of misconduct before him than the state 
board had, he stated that he considered the state board's action in the 
doctor's favor even though it was based on a subset of the evidence 
before him. Id.
---------------------------------------------------------------------------

    \25\ The John O. Dimowo, M.D. Agency decision stands for the 
proposition that ``[a]lthough statutory analysis [of the CSA] may 
not definitively settle . . . [the breadth of the cognizable state 
`recommendation' referenced in Factor One], the most impartial and 
reasonable course of action is to continue to take into 
consideration all actions indicating a recommendation from an 
appropriate state.'' 85 FR at 15810.
---------------------------------------------------------------------------

    I apply the same analysis and reach the same conclusion here given 
the differences between the evidence set out in the VBD Order and the 
evidence before me, including the evidence addressed in the Fourth 
Circuit Conviction Affirmance. In sum, while the terms of the VBD Order 
are not dispositive of the public interest inquiry in this case and are 
minimized due to the differences in the evidence in the VBD Order and 
the uncontroverted record evidence in this matter, I consider the VBD's 
grant of Schedule V authority in Applicant's favor.

D. Factors Two and Four--Applicant's Experience Dispensing Controlled 
Substances and Compliance With Applicable Laws Related to Controlled 
Substances

    Factors Two and Four call for consideration of Applicant's 
``experience in dispensing . . . controlled substances'' and his 
``[c]ompliance with applicable State, Federal, or local laws relating 
to controlled substances.'' 21 U.S.C. 823(f)(2) and (4), respectively. 
I reviewed all of the record evidence concerning Applicant's controlled 
substance dispensing experience and compliance with applicable laws 
relating to controlled substances, including the testimony received 
during the adjudication of this OSC, and Applicant's position on it. I 
evaluated the evidence using the credibility assessments already 
discussed. Supra section II.E.
    Relevant, uncontroverted record evidence concerning Factors Two and 
Four is in the VBD Order documenting Applicant's unlawful 2,711 dosage 
unit dispensing of controlled substances in Schedule II (1,740 dosage 
units), Schedule III (290 dosage units), and Schedule IV (681 dosage 
units). GX 2, at 2-10; see also supra section II.D. The VBD Order also 
documents the multiple provisions of Virginia law about controlled 
substances that Applicant violated.\26\ GX 3, at 2-10. Other relevant, 
uncontroverted record evidence concerning Factors Two and Four is in 
the Judgment of the Eight Felony Conviction Trial and in the Fourth 
Circuit Conviction Affirmance already discussed.\27\ Supra section 
II.D. GX 2, at 1; 576 F. App'x at 254-64 (GX 5, at 3-11).
---------------------------------------------------------------------------

    \26\ Va. Code Ann. sec. 54.1-3303 (West, current through End of 
the 2016 Reg. Sess.) (amended 2017, 2018, 2019); Va. Code Ann. sec. 
54.1-3408 (West, current through End of the 2016 Reg. Sess.) 
(amended 2017, 2018, 2019). The seriousness and extent of these 
violations are sufficient bases for my decision in this matter and, 
therefore, I need not address the other VBD founded violations of 
Virginia law alleged in the OSC.
    \27\ 21 U.S.C. 841(a)(1) and 846.
---------------------------------------------------------------------------

    Other record evidence concerning Applicant's controlled substance 
experience and dispensing is Applicant's testimony and written 
communications. During the hearing, for example, Applicant admitted 
that he wrote prescriptions that he ``shouldn't have written and that 
was a mistake and that would never, ever happen again.'' Tr. 130. By 
way of further example, Applicant also admitted that he ``wrote 
prescriptions, a few prescriptions that were not medically necessary. . 
. . I made a mistake, stupidity, naivet[eacute], not being 
responsible.'' Id. at 131. He also admitted that he ``authorized a 
prescription or called a prescription or wrote a prescription that . . 
. [he did not] really know if it was a legitimate dental purpose, 
because they didn't come in.'' Id. at 129; see also id. at 128. Going 
back to 2006 and 2007, and ``quite a long time ago,'' Applicant 
testified, he ``made mistakes as far as what I prescribed to certain 
people.'' Id. at 129.
    While admitting he wrote controlled substance prescriptions that 
were not legitimate, Applicant also testified that ``as far as . . . 
[his] trying to get any kind of favors or money or anything like that, 
that is not the case.'' Id. at 130. Material in the Fourth Circuit 
Conviction Affirmance conflicts with this testimony. 576 F. App'x, at 
256 (GX 5, at 4) (describing a total of several hundred pills that were 
``devoid of any clinical notes to support this treatment'' that 
Applicant prescribed between 2007 and 2008 to a woman with whom he was 
romantically involved). By way of further example, in written 
communications with DI, Applicant stated that ``I have never abused, 
sold drugs or anything like that.'' GX 6, at 1. This is not true 
according to the Fourth Circuit Conviction Affirmance. 576 F. App'x, at 
256-57 (GX 5, at 4-5) (finding it a ``reasonable determination'' for 
the jury to have credited other witnesses' testimony over Applicant's 
when Applicant corroborated the testimony of his former office manager 
that Applicant wrote a prescription for several boxes of fentanyl 
patches in her name and applied a patch to his body in her presence 
because he was ``hoping this was something . . . [he] could use as a 
treatment modality . . . for any oral pain . . . [and wanted] to see if 
it helps . . . [his] back,'' even though, according to Dr. Singer, a 
fentanyl patch is ``outside the scope of dentistry or oral surgery and 
`is only appropriate for a chronic pain patient who has cancer pain or 
. . . something extremely debilitating and may be chronically ill''').
    In sum, I carefully considered all of the record evidence relevant 
to Factors One, Two, Three, and Four and Applicant's arguments about 
that evidence. I applied my and the Chief ALJ's credibility assessments 
to that evidence. I conclude that the Government met its prima facie 
burden of showing that it would be ``inconsistent with the public 
interest'' for me to grant Applicant's registration application for 
Schedule V authority. 21 U.S.C. 823(f). I further find that Applicant 
did not rebut the Government's prima facie case.

IV. Sanction

    Where, as here, the Government presented a prima facie case that it 
would be ``inconsistent with the public interest'' to grant Applicant's 
request for a Schedule V registration, and Applicant did not rebut the 
Government's prima facie case, Applicant must then ``present[ ] 
sufficient mitigating evidence'' to show why he can be entrusted with a 
registration. Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018). 
Further, as past performance is the best predictor of future 
performance, Agency

[[Page 45699]]

decisions require Applicant's unequivocal acceptance of responsibility 
for his actions and a demonstration that he will not engage in future 
misconduct. ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th 
Cir. 1995); Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (collecting 
cases); Jeffrey Stein, M.D., 84 FR 46968, 46972-73 (2019). The Agency 
has decided that the egregiousness and extent of the misconduct are 
significant factors in determining the appropriate sanction. Garrett 
Howard Smith, M.D., 83 FR at 18910 (collecting cases). The Agency has 
also considered the need to deter similar acts by Applicant and by the 
community of registrants. Id.
    The extent of Applicant's misconduct proven by the record evidence 
is eight felonies, six of which relate to controlled substances and all 
of which were affirmed on appeal, and the unlawful dispensing of over 
2,700 dosage units of controlled substances in Schedules II, III, and 
IV. In addition, as already discussed, Applicant's testimony was not 
always marked by candor. Supra sections II.E. and III.D; see also GX 3, 
at 3 (``Individual I stated that in or about 2011, . . . [Applicant] 
instructed her to tell investigators that he had written prescriptions 
for pain medications for her, although this was not true.'').
    While Applicant took responsibility for some of his wrongdoing, he 
did not take unequivocal responsibility for all of it. First, despite 
the Fourth Circuit Conviction Affirmance, Applicant testified that he 
did not conspire to distribute and dispense controlled substances in 
violation of 21 U.S.C. 846. Tr. 115 (denying that he ever unlawfully 
directed employees to go to pharmacies to pick up prescriptions and 
return them to him); see also id. at 133-34. Instead, he blamed his 
conspiracy conviction on false testimony of his former office manager. 
Id. at 116-17. Second, concerning his convictions for unlawfully 
dispensing controlled substances, Applicant denied writing 
prescriptions that did not have a legitimate dental purpose. Id. at 
116. Instead, he testified that the prescriptions were legitimate. He 
explained that his ``problem'' was that the prescriptions lacked proof 
of their legitimacy in the form of proper documentation. Id. at 117. 
Third, he testified that it ``would be wrong'' for someone to say that 
he intentionally wrote or gave people prescriptions ``for other than a 
legitimate medical purpose.'' Id. at 121. Instead, he attributed what 
courts and the VBD determined were unlawful prescriptions to his not 
being careful enough, his making a mistake, his stupidity, and his 
being lax. Id. at 127-31.
    As the Chief ALJ stated, ``It would be illogical for the Agency to 
entrust . . . [Applicant] with the weighty responsibilities of a DEA 
registrant where he is unable to even accept the proposition that he 
has engaged in the misconduct that he was convicted of and which was 
sustained by the . . . [VBD].'' RD, at 42. ``[S]o long as . . . 
Applicant adheres to his (almost bizarre) state of denial regarding the 
actual facts subsumed in his convictions (and Board findings),'' the 
Chief ALJ continued, ``it would be unreasonable to believe that he will 
alter his conduct.'' Id. Thus, as past Agency decisions make clear that 
unequivocal acceptance of responsibility is a prerequisite for the 
forbearance of a sanction, Applicant's failure unequivocally to accept 
responsibility means that he is not eligible to avoid an unfavorable 
disposition of his application under the record facts in this case.\28\
---------------------------------------------------------------------------

    \28\ Applicant testified about the changes he made to his dental 
practice after his felony convictions and the VBD Order. Those so-
called ``remedial measures,'' however, ``bear no logical nexus to 
his established misconduct'' of misusing his controlled substance 
privileges, as the Chief ALJ observed. RD, at 41. While Applicant 
testified about the expensive educational courses he took and the 
``measures calculated to protect his scripts and prescribing 
software from potential malfeasance of staff members and burglars,'' 
he introduced no remedial measure ``that might bear the capacity to 
protect these powerful tools from his own future malfeasance.'' Id.
---------------------------------------------------------------------------

    Applicant testified that he is not currently prescribing controlled 
substances in his dental practice and that he does not expect the 
income he realizes from his practice to increase if he had that 
authority. Tr. 46-48,113-14. Instead, he stated, he would like 
authority to prescribe Schedule V controlled substances for the sake of 
his patients' comfort. Id. at 46-48; cf. supra n.17 (summarizing 
Applicant's testimony that his not having authorization to dispense 
controlled substances has not dissuaded patients from using his 
practice). Applicant does not cite, and I am unaware of, any past 
Agency decision that grants a registration for the sake of patient 
comfort when the applicant was convicted of eight felonies and the 
unlawful dispensing of over 2,700 controlled substance dosage units. I 
decline to suggest, let alone establish, such a path.
    I agree with the Chief ALJ that ``consideration of the 
egregiousness of . . . [Applicant's] transgressions likewise does not 
support a sanction less than an outright denial of . . . [Applicant's] 
application.'' RD, at 43.

    The record in this case paints a picture of a registrant out of 
control. He distributed and dispensed drugs to himself and others 
with no justifiable reason, tasked his employees with taking 
controlled substance scrips to pharmacies and filling them so that 
he could dole them out to himself, friends, and other non-patients, 
slapped a fentanyl patch on himself in front of his staff, handed 
out powerful controlled drugs to his love interests, and prescribed 
scores of controlled substances to multiple patients without a 
legitimate medical purpose.

    Id. In this context, specific and general deterrence weigh in favor 
of denying the application. I agree with the Chief ALJ that ``[t]o 
issue a registration to this . . . [Applicant] would send a message to 
the regulated community that misconduct (even repeated serious, 
intentional misconduct) will bear no meaningful consequence, even after 
state board findings and convictions,'' if the Applicant ``deflects 
blame onto others.'' Id.
    Given my decision that Applicant's application is not in the public 
interest, I conclude that Applicant's proposed Corrective Action Plan 
provides no basis for me to discontinue or defer this proceeding.
    Accordingly, I shall order the denial of Applicant's application.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f), I hereby deny the application submitted by Hamada 
Makarita, D.D.S., Control No. W16093263C, seeking registration in 
Virginia as a practitioner in Schedule V, and any other pending 
application submitted by Hamada Makarita, D.D.S. for a DEA registration 
in the Commonwealth of Virginia. This Order is effective August 28, 
2020

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-16355 Filed 7-28-20; 8:45 am]
BILLING CODE 4410-09-P