[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]
-----------------------------------------------------------------------
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)).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ I reviewed, and agree with, the Chief ALJ's pre-hearing,
hearing, and post-hearing rulings and orders.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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].
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\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
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\8\ The parties agreed to the authenticity of four of the
Government's Exhibits. ALJX 10; see also supra n.2.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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