Robert Wayne Locklear, M.D.; Decision and Order
| Published date | 25 June 2021 |
| Citation | 86 FR 33738 |
| Record Number | 2021-13525 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 86 Issue 120 (Friday, June 25, 2021)
[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33738-33748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13525]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-18]
Robert Wayne Locklear, M.D.; Decision and Order
I. Procedural History
On March 26, 2019, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Robert
Wayne Locklear, M.D., (hereinafter, Respondent) of Johnson City,
Tennessee. Administrative Law Judge (hereinafter, ALJ) Exhibit
(hereinafter, ALJX) 1 (OSC), at 1. The OSC proposed the denial of
Respondent's application for a DEA Certificate of Registration,
Application Control No. W18124612C, ``pursuant to 21 U.S.C. 824(a)(2) &
(a)(5), because [Respondent has] been convicted of a felony related to
controlled substances and because [he has] been excluded from
participation in a program pursuant to section 1320a-7(a) of Title
42.'' Id.
Specifically, the OSC alleged that, on October 8, 2014, Judgment
was entered against Respondent in the United States District Court for
the Eastern District of Tennessee (hereinafter, E.D. Tenn.) ``after
[Respondent] pled guilty to: one count of `Conspiracy to Distribute a
Quantity of Cocaine Base,' in violation of 21 U.S.C. 846 &
841(b)(1)(C); and one count of `Conspiracy to Defraud a Health Care
Benefit Program,' in violation of 18 U.S.C. 1347 & 1349.'' Id. at 2
(citing U.S. v. Robert Wayne Locklear, No. 2:14-CR-38 (E.D. Tenn. Oct.
8, 2014)). The OSC alleged that Respondent's conviction of a felony
related to controlled substances warrants the denial of Respondent's
application pursuant to 21 U.S.C. 824(a)(2).
The OSC further alleged that ``based on [such] conviction, the U.S.
Department of Health and Human Services, Office of Inspector General
(`HHS/OIG') mandatorily excluded [Respondent] from participation in
Medicare, Medicaid, and all Federal health care programs pursuant to 42
U.S.C. 1320a-7(a).'' Id. The OSC stated that this exclusion took effect
on June 18, 2015, and ``runs for a period of ten years,'' and that such
exclusion ``warrants denial of [Respondent's] application for DEA
registration pursuant to 21 U.S.C. 824(a)(5).'' Id.
The Order to Show Cause notified Respondent of the right to request
a hearing on the allegations or to submit
[[Page 33739]]
a written statement, while waiving the right to a hearing, the
procedures for electing each option, and the consequences for failing
to elect either option. Id. at 2-3 (citing 21 CFR 1301.43). The OSC
also notified Respondent of the opportunity to submit a corrective
action plan. Id. at 3-4 (citing 21 U.S.C. 824(c)(2)(C)).
On April 8, 2019, Respondent timely filed a request for a hearing,
in which he affirmed his conviction and stated that he ``developed a
severe addiction to cocaine and alcohol'' and that he had been ``clean
and sober and active in Recovery since June 27th, 2013.'' ALJX 2
(Request for a Hearing, at 2).
The matter was placed on the docket of the Office of Administrative
Law Judges and assigned to Chief Administrative Law Judge John J.
Mulrooney II (hereinafter, the Chief ALJ). On April 10, 2019, the ALJ
established a schedule for the filing of prehearing statements. ALJX 3
(Amended Order for Prehearing Statements), at 1-2. The Government filed
a Motion for Summary Disposition on April 16, 2019, alleging that there
was no genuine issue of material fact and separately filed a Prehearing
Statement on the same date. ALJX 4 (hereinafter, Govt MSD) and ALJX 5
(hereinafter, Govt Prehearing). Respondent pro se filed a Motion for
Continuance requesting a delay in the prehearing while he awaited a
response on his Corrective Action Plan.\1\ ALJX 7 (Motion for
Continuance). The Chief ALJ denied the Motion for Continuance, because
``the filing and pendency of a corrective action plan, standing alone,
presents no impediment to proceeding as scheduled or any cognizable
justification for a continuance . . . .'' ALJX 8 (Order Denying
Respondent's Motion for Continuance). On May 3, 2019, Respondent pro se
filed his Prehearing Statement. ALJX 9 (hereinafter, Resp Prehearing).
The Chief ALJ issued a Prehearing Ruling on May 10, 2019, which, among
other things, set out six stipulations \2\ already agreed upon and
established schedules for the filing of additional joint stipulations
and supplemental prehearing statements. ALJX 10 (Prehearing Ruling). On
May 17, 2019, Respondent filed a Notice of Appearance of counsel and
filed requests for continuance and extension of time as a result of
obtaining counsel, which the Chief ALJ considered in amending his
prehearing deadlines. ALJX 11-15.
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\1\ Respondent did not introduce the Corrective Action Plan into
the record.
\2\ The Stipulations included the fact that Respondent
voluntarily surrendered for cause his previous DEA registration on
July 8, 2013; the fact that Respondent was excluded from
participation in Medicare, Medicaid, and all Federal health care
programs pursuant to 42 U.S.C. 1320a-7(a) effective June 18, 2015;
the fact that on October 8, 2014, Respondent was convicted in E.D.
Tenn. Of one count of ``Conspiracy to Distribute a Quantity Cocaine
Base'' and one count of ``Conspiracy to Defraud a Health Care
Benefit Program;'' and the fact that Respondent received a
conditional medical license in the State of Tennessee on November
16, 2018. ALJX 10, at 2.
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On June 13, 2019, Respondent filed a Response to Government's
Statement of Undisputed Material Facts and Statement of Additional
Undisputed Material Fact of Respondent Robert Wayne Locklear, M.D., in
which he confirmed the previous stipulations, but clarified that ``on
the day he was arrested by the Drug Task Force that, although he never
sold any, he shared some illegal substances with others that same
day.'' ALJX 16, at 2. On that same date, Respondent also filed a
Response to Motion for Summary Disposition of Respondent Robert Wayne
Locklear, M.D., in which he argued that material facts exist related to
why Respondent can be entrusted with his DEA registration, and that
Respondent ``is no longer a threat to the public . . . .'' ALJX 17
(Respondent's Response to MSD), at 6-7. Further on that same date,
Respondent filed a Second Prehearing Statement of Respondent Robert
Wayne Locklear, M.D. (hereinafter, Resp Supp Prehearing). ALJX 18. On
June 18, 2019, the Chief ALJ denied the Government's Motion for Summary
Disposition, finding that ``the Agency has established that where the
Government has met its burden by making a prima facie case for
sanction, the burden of production then shifts to a respondent to show
that, given the totality of the facts and circumstances in the record,
denial or revocation [of] the registrant's registration would not be
appropriate.'' ALJX 20, at 8 (citations omitted). I have reviewed and
agree with the procedural rulings of the Chief ALJ during the
administration of the hearing.
The hearing in this matter spanned one day.\3\ On August 29, 2019,
the Government filed its Proposed Findings of Fact and Conclusions of
Law and Respondent filed his Proposed Findings of Fact and Conclusions
of Law of Respondent Robert Wayne Locklear, M.D. ALJX 26 (hereinafter,
Govt Posthearing); ALJX 25 (hereinafter, Resp Posthearing). The
Recommended Rulings, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge (hereinafter, RD) is dated September
11, 2019. On October 8, 2019, the Chief ALJ transmitted his RD, along
with the certified record, to me, and certified that no exceptions were
filed by either party. ALJ Transmittal Letter, at 1.\4\
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\3\ Hearings were held in Knoxville, Tennessee on July 30, 2019.
\4\ Respondent filed a Motion to Reopen the Record on January
21, 2021 (hereinafter, Resp Mot to Reopen), which the Chief ALJ
denied on January 25, 2021. The Respondent noted in this filing that
Respondent should be allowed to reopen the record for the submission
of new ``material evidence,'' because the Respondent believed that
the Chief ALJ ``took issue with Dr. Locklear's intention to
imminently petition the Board for removal of the practice monitoring
requirement'' and asserts that despite such removal, Respondent
maintains the advocacy of the Tennessee Medical Foundation. Resp Mot
to Reopen, at 2. I found evidence in the record transmitted to me on
October 8, 2019, that supported the finding that Respondent would be
required to maintain the Tennessee Medical Foundation's advocacy in
order to maintain his medical license. See infra n.12. Specifically,
in addition to Respondent's testimony that he would continue to have
the Tennessee Medical Foundation's advocacy for life, Tr. 129, the
conditions on Respondent's medical license required the maintenance
of the ``advocacy of the Tennessee Medical Foundation for the
duration of time that [he is] licensed in Tennessee.'' RX 17, at 1.
Therefore, although Respondent's proposed evidence may be more
current, that finding has already been included in the record.
Further, I do not find the continuance of this advocacy or the
removal of the practice monitor to ultimately affect my final
decision in the matter. As explained in infra IV, Respondent has
repeatedly evaded accountability measures in the past, and I cannot
entrust him with the responsibility of a controlled substances
registration.
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Having considered this matter in the entirety, I find that
Respondent has been convicted of a felony related to controlled
substances and has been excluded from participation in a program
pursuant to section 1320a-7(a) of Title 42, and that therefore, there
is a basis to deny Respondent's application. See infra III. I further
find that, given the facts on the record, Respondent has not
established sufficient mitigating evidence to assure me that he can be
entrusted with a controlled substances registration.
I issue this Decision and Order based on the entire record before
me. 21 CFR 1301.43(e). I make the following findings of fact.
II. Findings of Fact
A. Stipulations
1. Respondent's DEA Registration
On November 21, 2018, Respondent filed an application (Application
Control No. W18124612C) for a DEA Certificate of Registration as a
practitioner in schedules II-V, with a proposed registered location at
Recovery Associates Inc., 401 E Main St., Ste 3, Johnson City,
Tennessee 37601-4891. Government Exhibit (hereinafter, GX) (Certificate
of Non-Registration) 1, at 1; see also RD, at 3 (Stipulation
(hereinafter, Stip) 1).
[[Page 33740]]
On July 8, 2013, Respondent submitted a Form DEA-104, Voluntary
Surrender of Controlled Substances Privileges, surrendering his
previous DEA Registration Control No. BL7274107. GX 2 (DEA-104); see
also RD, at 3 (Stip 2).
2. Respondent's Conviction
On October 8, 2014, judgment was entered against Respondent in the
United States District Court for the Eastern District of Tennessee
(hereinafter, E.D. Tenn.) after the Respondent pled guilty to one count
of ``Conspiracy to Distribute a Quantity of Cocaine Base,'' in
violation of 21 U.S.C. 841(b)(1)(C) & 846, and one count of
``Conspiracy to Defraud a Health Care Benefit Program,'' in violation
of 18 U.S.C. 1347 & 1349.'' U.S. v. Robert Wayne Locklear, No. 2:14-CR-
38 (E.D. Tenn. Oct. 8, 2014)). RD, at 3 (Stip 3); see also GX 3 (Plea
Agreement) and GX 4 (Judgment in a Criminal Case).
3. Respondent's Exclusion
Based on the Respondent's conviction, HHS/OIG mandatorily excluded
the Respondent from participation in Medicare, Medicaid, and all
federal health care programs under 42 U.S.C. 1320a-7(a). RD, at 4 (Stip
4). The exclusion was effective on June 18, 2015, and runs for a
minimum period of ten years. Id.; see also GX 5 (Exclusion Letter), at
1.
4. Respondent's State License
The Respondent received a conditional medical license in the State
of Tennessee on November 16, 2018. RD, at 4 (Stip. 6); see also RX 17
(Letter from the Board of Medical Examiners); RX 18 (Conditional
Medical License).
B. The Government's Case
The Government's documentary evidence consists primarily of records
supporting the stipulated facts. GX 1-6. The Government called one
witness, a Diversion Investigator (hereinafter, the DI). RD, at 4; Tr.
17-33. The DI testified that she has been employed by DEA for
approximately eleven years and as a DI for over three and a half years.
Tr. 18. The DI testified that she became familiar with Respondent due
to his answers to the liability questions on the DEA application and
she testified as to the basis of the Government Exhibits 2-6. Id. at
18-30. The Chief ALJ found, and I agree that the DI's testimony ``was
primarily focused on the non-controversial introduction of documentary
evidence and her contact with this case'' and ``merits full credibility
in these proceedings.'' RD, at 6.
The Government's evidence includes the Plea Agreement in
Respondent's criminal case, the stipulated facts of which describe
Respondent's conspiracy to defraud a health care benefit program and
his interactions with law enforcement regarding his crack/cocaine use,
including his conspiracy to distribute. Regarding Respondent's drug
charges, the plea agreement stated:
Between the approximate month of January 2013 and continuing
through the month of July 2013, in the Eastern District of Tennessee
and elsewhere, conservatively, the defendant did knowingly,
intentionally, and without authority, conspire with at least one
other person to distribute approximately at least 5.6 but less than
11.2 grams of a mixture and substance containing a detectable amount
of cocaine base (``crack''), a Schedule II controlled substance.
GX 3, at 3.
The plea agreement further detailed that Respondent had smoked
crack cocaine prior to seeing patients on May 13, 2013. Id. at 5. On
June 5, 2013, police seized crack cocaine from Respondent, and he
admitted that ``he had a drug problem'' and that ``he had been smoking
crack a few times a day (before, during and after work).'' Id. On June
11, 2013, Respondent was arrested and crack cocaine was seized from his
person. Id. He admitted that ``a total of $2,000 worth of crack cocaine
was purchased that morning and that he and several others smoked some
of it'' and that ``he gave the dealer from Knoxville and her friends
approximately $200 to $300 worth of crack cocaine to help them out.''
Id. at 6-7.
In addition to his drug use, the plea agreement provided details as
to Respondent's unlawful actions regarding his conspiracy to defraud a
health care benefit program. Id. ``The [Respondent] operated two
businesses in the Eastern District of Tennessee: Trinity Internal
Medicine and Sleep (`TIMS') and Trinity Recover Clinic (`TRC'). TIMS
was a primary care medical practice . . . TRC was operated as an office
based substance abuse treatment program . . . .'' Id. at 3. The Plea
Agreement stated that, ``[d]ue primarily to his usage of crack cocaine
and alcohol, the defendant was frequently physically absent from the
medical practices TIMS and TRC during periods when the medical
practices were open for business and providing medical services to
patients who were enrolled in health care benefit programs.'' Id. at 8.
According to the plea agreement, while Respondent was absent, he ``told
office staff to see patients and prescribe medications, including
Suboxone in his absence,'' even though he ``knew that no employee/
medical assistant at his practice was properly licensed or trained to
provide these requisite medical services.'' Id. Further, the plea
agreement states that Respondent ``often did not examine, interview or
treat the patients on return visits, was often absent from the practice
when the patients returned and thus did not attend to or assess the
patients' medical conditions.'' Id. at 9.
The plea agreement concluded that Respondent's absence from the
office ``caused the pharmacies to submit claims to health benefits
programs and receive reimbursement for prescriptions that had been
issued outside of the usual course of professional practice and without
a finding of medical necessity.'' Id. Additionally, ``laboratory
service providers [ ] submitted claims to health care benefits programs
. . . when in fact, the testing had not been reviewed or directed by
[Respondent] for the purpose of diagnosing or treating a medical
condition.'' Id. Furthermore, ``[o]n numerous occasions, drug screens
came back positive for the presence of other scheduled drugs such as
marijuana or heroin, but the patients continued to have their Suboxone
prescriptions called in anyway.'' Id. at 9. The plea agreement provided
numerous examples of the claims filed to health care benefits programs
and found: ``an approximate total of 150 dates of service where a
prescription was issued and [Respondent] was not present to examine the
patient;'' ``the total amount of loss to be applied in this case,
conservatively, is more than $120,000 but less than $200,000;'' and
that ``this offense involved 10 or more victims (health care benefit
companies).'' Id. at 13.
C. The Respondent's Case
Respondent submitted documentary evidence including records related
to his conviction, sentencing, probation, treatment for substance
abuse, and medical license. See Respondent's Exhibits (hereinafter,
RX). Respondent also testified on his own behalf and submitted an
affidavit signed by himself \5\ and testimony of character witnesses,
coworkers, and family members. Tr. 33-167; RX 7.
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\5\ The Chief ALJ noted, and I agree that this affidavit was
allowed into the record with the caveat that it would be subject to
cross-examination at the hearing. RD, at 15-16 n.43.
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Respondent testified that he attended Duke Medical School. Tr. 50-
51. He admitted that ``second year of medical school, [he] began
experimenting with
[[Page 33741]]
crack, and it took [him] down very fast, very quickly.'' Id. at 149.
After medical school, Respondent testified that he practiced at
Takoma Medical Center from 2002 to 2012 in ``internal medicine.'' Id.
at 51. Respondent stated, ``I had moved out of my home [in]
approximately 2005 because I wanted to--I wanted to drink, drug \6\ and
womanize. And in 2008, my [wife]--she had had enough . . . and we
divorced in 2008. And then my drinking continued to get worse. At this
point, I hadn't started back drugging. I had done some drugs back when
I was in college, in medical school, but I hadn't started back.'' Id.
at 52. In 2012, he testified that his employer at Takoma Medical Center
``asked [him] to leave because of [his] erratic behavior with [his]
drinking. So [he] went and opened up [his] own practice in 2012, and it
wasn't a month after [he] was in private practice that [he] started
using drugs again.'' Id. Respondent stated that ``a big part of it was
at that point [he] had no accountability.'' \7\ Id.
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\6\ It is noted that this is inconsistent with what Respondent
said a few sentences later, that he ``hadn't started back
drugging.'' Tr. 52.
\7\ It is unclear what Respondent meant by this statement. The
record demonstrates that as a result of this behavior, he lost his
practice, medical license and was arrested and went to jail.
Additionally, he had previously almost been removed from medical
school, been divorced and been required to leave his job at Takoma
Medical Center due to his addiction. I disagree with the statement
that he had no accountability--it instead appears that he did not
regard these consequences as important at the time.
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Respondent further testified that he and his wife reconciled in
2012, when he was ``at the height of [his] drug addiction,'' before he
was arrested and that he ``tormented her and put her through H-E double
L.'' Id. at 55. Since the arrest, he stated that he turned his life
around. He said, ``I was completely broken and I wanted to do whatever
was recommended so that I could get better. I had a baby on the way,
and grown kids, and a--and a woman at this time who was not my wife
again, but who loved me, and so I did--I followed the suggestions, went
to church, went to meetings, did whatever was recommended I do.'' Id.
at 56.
Respondent introduced a letter from Talbott Recovery Campus in
Atlanta, Georgia (hereinafter, Talbott), which stated that he had
``successfully completed all phases of his treatment program.'' RX 8.
He testified that he competed a 90-day inpatient program there, because
``the judge allowed me--offered me to go to rehab if--to get out of
jail.'' Tr. 65-66. When asked if there was bail, Respondent stated, ``I
was initially given bail and initially released, but I ran the first
time.'' Id. at 67. He explained that after his arrest, he went to rehab
in Alabama at Bradford Health Services (hereinafter, Bradford), where
he was for about ``six days,'' but he ``wanted to use drugs,'' and so
he escaped and was later ``picked up by a bounty hunter'' after he had
been living with other drug addicts for a few days. Id. at 69-70. Then
Respondent testified that he then went to jail \8\ for eleven days and
``unbelievably, the judge allowed me to go--to leave again and go to
rehab within 11 days.'' Id. at 71. When asked why he went to Talbott
instead of Bradford, Respondent stated, ``[w]e didn't want to go back
to Bradford, and we told the judge that Bradford wasn't good for me,
when it really wasn't Bradford, it was me. But we--it was an angle to
go somewhere else.'' Id. at 73. Respondent further explained that it
was ``an excuse to maybe try something different'' and he did not
``know that Bradford would have even taken [him] back.'' Id. at 74.
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\8\ Respondent testified that he lost his bail, and he could not
remember how much it was, but his wife could probably remember. Tr.
70-71. Later, when asked about whether there was bail after his time
at Talbott, he stated, ``It's fuzzy. I think there might have been,
Judge. Honestly, I don't know.'' Id. at 78.
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Respondent submitted his first agreement with the Tennessee Medical
Foundation, which memorialized his sobriety date as June 27, 2013, and
was signed prior to his admission to Talbott's rehabilitation program
on January 26, 2013. Id. at 85; RX 12, at 7. After he was released from
Talbott on October 6, 2013, Respondent testified that he ``went home,
and it was about a year and a half before [he] got sentenced to
prison.'' Id. at 78; RX 7, at 2; RX 8, at 1. After his year in prison,
Respondent was released early and signed up for a halfway house through
which he completed another rehabilitation program. Id. at 82-84; RX 13.
Respondent testified that he pled guilty in federal court,
``because he was guilty'' and that he was ``[v]ery. Very sorry.'' Id.
at 34. He testified that he was sentenced to two years in a
penitentiary, ``but served only one because [he] completed a drug
program in prison.'' Id. He stated that after prison, he held various
jobs making pizza dough, working as a secretary and a personal trainer,
and then in 2016, he ``got a job as a peer counselor in a drug
treatment program,'' because he ``felt like it was [his] purpose.'' Id.
at 35. Respondent stated that he worked at East Tennessee Recovery and
for the past two years, he has been working at Recovery Associates. Id.
at 36.
Respondent stated that he wanted to get his medical license back
because he ``was in recovery and wanted to help people.'' Id. at 58. To
regain his medical license, he had to ``do a competency evaluation,''
which he passed. Id. Respondent testified that he is ``closely
monitored'' through the Tennessee Medical Foundation and that
monitoring includes: Random drug screens that began an average of
``once a week to once every two weeks'' and are now ``about once a
month;'' checking in every morning seven days a week to see if
Respondent requires a screen that day, and ``on occasion, they ask
[him] to do a nail sample;'' going to ``a Caduceus \9\ meeting once a
week;'' and, ``[he has] \10\ to go to three--at least three other 12-
step recovery meetings a week outside of that, so at least four
meetings a week.'' Id. at 38. Further, Respondent testified that he
``meet[s] with a supervisor every three months who reports to the
Tennessee Medical Foundation. We have to participate in a retreat once
a year.'' Respondent added that he has to meet with a counselor and
``licensed addictionologist once a quarter to be evaluated,'' and the
addictionologist is a psychiatrist and also monitors his depression.
Id. at 60. He stated that if he did not meet the requirements of the
Tennessee Medical Foundation, ``they would report me--report me
immediately to the board and my license would be revoked.'' Id. at 60-
61. Respondent introduced into evidence his second agreement \11\ with
the Tennessee Medical Foundation, which was executed on January 11,
2016, and expires 5 years after its date of execution. RX 16, at 2.
Respondent further submitted a letter, dated October 12, 2018, from the
Tennessee Board of Medical Examiners, which granted him a conditional
medical license, and among other things, required a practice monitor
for six months and the maintenance of the ``advocacy of the Tennessee
Medical Foundation for the duration of time that [he is] licensed in
Tennessee.'' \12\ RX 17, at 1.
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\9\ A Caduceus meeting is ``a meeting for physicians and other
health care professionals in recovery, a peer support group.'' Tr.
38.
\10\ The Chief ALJ asked Respondent if it was ``mandated to go
to Caduceus plus the three other 12-step recovery'' every week, and
Respondent answered affirmatively. Tr. 40
\11\ This agreement, as well as the first agreement, included a
provision to which Respondent agreed stating, ``I will not seek
employment or work in pain medicine, addiction medicine, or any
medication assisted treatment (MAT) center for a minimum of the
first 2 (two) years under the [ ] contract.'' RX 16, at 6; RX 12, at
6.
\12\ Respondent testified that when his five years expired with
the Tennessee Medical Foundation, he would enter a new contract and
that he and the foundation ``both agreed that [he] need[s] to be on
a lifetime contract.'' Tr. 129. Although the Chief ALJ had noted
that Respondent's agreement was expiring shortly, RD, at 36, I find
that the record supports that even if certain restrictions, such as
the practice monitoring were lifted, Respondent would likely
continue to have some sort of accountability monitored through the
Tennessee Medical Foundation for the duration of his medical
license. The language in his conditional license was clear that this
would be a requirement for ``the duration of time that [he is]
licensed in Tennessee.'' RX 17, at 1. Therefore, I find that the
record support that Respondent will maintain the Tennessee Medical
Foundation's advocacy for the duration of his practice of medicine.
I also have found below that even with the full accountability
measures in place, Respondent has not demonstrated that he can be
entrusted with a controlled substances registration. See supra IV.
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[[Page 33742]]
Respondent also submitted a letter from the Tennessee Medical
Foundation, which was written at the request of his malpractice
insurance that states that Respondent is ``in compliance with all of
the requirements of his monitoring contract.'' RX 15, at 1; Tr. 97-101.
The purpose of Respondent's controlled substances registration,
Respondent testified, would be to work in addiction medicine at
Recovery Associates, and also to open up a practice with his wife,
based on direct primary care ``where patients pay a certain fee a month
to get unlimited access to the physician,'' because Respondent is
excluded from federal health care programs. Tr. 103-05.
Respondent testified that his supervisor at Recovery Associates Dr.
H.\13\ ``has a terminal illness and that's why he's not able to be here
today. And he's been very supportive and encouraging for me.'' Id. at
47. Respondent stated that Dr. H. was scheduled to testify, but he has
``end stage myeloma, and he is bedridden at the moment.'' Id. at 138.
When asked on cross examination how Dr. H. is ``effectively
monitoring'' his practice if he is ill, Respondent stated that ``he has
been monitoring me up to this point, but there's other doctors there
that are also involved'' and that Dr. H. was onsite ``about a week and
a half ago.'' Id. at 140. Respondent responded affirmatively to the
follow up of whether the Tennessee Medical Board knows that Dr. H. is
too ill to be on site monitoring his practice. Id. Then he said,
``Well, let me--let me rephrase that. I don't--I haven't said anything
to the Tennessee Medical Board, and at this point I don't practice.''
Id. at 141. Respondent admitted that he is required to have a practice
monitor by the medical board and Dr. H. is that practice monitor.\14\
Id. He then shifted his position and stated that when Dr. H. is not
there, ``then what I do--I occasionally see patients individually, and
then I give the patient charts to the doctor, but then they see the
patient themselves individually.'' Id. at 142. The Chief ALJ asked
whether Dr. H. was ``not there 50 percent of the time now, and he's not
going to be there 50 percent of the time if he has end stage multiple
myeloma, right?'' Id. at 145. Respondent answered, ``He has been--he's
been around for a while. He's had--he's had it for 10 years, 11 years.
He's just not there to--right now.'' Id.
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\13\ Respondent also testified that his conditional medical
license ``means that I can only practice for a certain physician
[Dr. H].'' Tr. 121.
\14\ Respondent's conditional medical license required reporting
from his practice monitor every month for six months, which started
on the effective date of November 14, 2018; therefore, six months
had likely passed before Dr. H. became bedridden before this hearing
on July 30, 2019; however, the letter from the Board states that
Respondent must ``petition for an Order of Compliance to have the
monitoring requirements lifted.'' RX 17, at 1. Respondent testified
that he was going to ask for the conditions on his license to be
removed, ``as soon as [he] can get the paperwork in'' and
``imminently.'' Tr. 133. Therefore, although the period of six
months had elapsed, the conditions on his medical license leave open
the question of whether Respondent might have been required to have
a practice monitor at the time that Dr. H. became ill. This raises a
concern, because Respondent testified that he had not notified the
Board or the Tennessee Medical Foundation about Dr. H.'s inability
to monitor him. Id. at 141. Ultimately, as explained below,
Respondent's other egregious behavior is more compelling in deciding
a sanction in this case, but both Respondent's change in answers
regarding this topic and his lack of communication with the Board or
the Tennessee Medical Foundation certainly raise concerns about my
ability to trust him.
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Regarding Respondent's plans for his controlled substances
registration, Respondent stated that his ``training is internal
medicine, so what [he'd] be doing . . . [he'd] be treating adults for
medical issues, anything from diabetes, to COPD, to congestive heart
failure to hypertension.'' Id. at 48. When asked how he plans to work
with drug addicts, he stated that he ``feel[s] confident that [he has]
a strong support system in place.'' Tr. 128-29.
Respondent testified that he accepts responsibility and is
remorseful for both the felony and the exclusion. Tr. 134-35. When
asked why he believes he can be a responsible DEA registrant,
Respondent answered, ``I think that the same--it's the same reasons I
can be--I'm responsible with the--with the things that I've been given
so far. The last thing I want to do--I--I'm not the same person I was.
I've been rehabilitated. The last thing I want to do is hurt someone.''
Id. at 136. When asked whether ``working with patients who are being
treated for substance abuse puts [him] at increased risk for relapse
[him]self,'' he admitted that ``[t]here are times it can be a trigger,
yes.'' Id. at 137. He testified, ``I work in an environment--I make
sure I work in an environment that's recovery-oriented, that most \15\
of the people there are in active recovery, so they not only--I'm not
only accountable to my support system outside of work, I'm accountable
at work.'' Id.
---------------------------------------------------------------------------
\15\ Respondent noted that 100 percent of the patients are being
treated with buprenorphine and that the typical course of treatment
time is ``at least two years'' and that when someone gets off
buprenorphine, ``[t]hey usually just don't show back up.'' Tr. 125-
26. Later, he stated, ``They don't come back, so they're discharged,
but we don't know why they're not coming back, oftentimes.'' Id.
---------------------------------------------------------------------------
The Chief ALJ asked Respondent about his previous rehabilitation
efforts and Respondent admitted that ``second year of medical school,
[he] began experimenting with crack, and it took [him] down very fast,
very quickly.'' Id. at 149. When asked by the Chief ALJ, he admitted
that at the time, he had started the clinical portion and was ``in and
out of a support role in patient care,'' while he was experimenting
with crack. Id. at 149-50. Respondent admitted that he was ``directed
to rehab by the faculty at Duke'' after he ``went to the emergency
room'' and he had to go to inpatient rehab for 30 days and then was
sober for five years. Id. at 151. Respondent testified
I was being monitored by the medical school and the residency
program, so as soon as that monitoring was lifted--but all along, I
had it in the back of my head that I could drink. I still thought I
could drink. I knew I couldn't do drugs, but I thought I could drink
successfully. But I couldn't drink while I was being monitored, so
as soon as the five years was up and I no longer had any
supervision, I had it in my head I was going to drink, and I did.''
Id. at 152.
He then stated that he had to leave Takoma Hospital because of a
``culmination of events related to [his] drinking,'' including ``not
showing up for work, being erratic, outbursts'' and he was sent to the
Tennessee Medical Foundation for an evaluation, during which he ``lied,
and Tennessee Medical Foundation recommended some inpatient programs or
some retreats for [his] depression and trauma issues, but [he] never
followed through.'' Id. at 154. He stated that he was asked to leave
Takoma because of the refusal to complete rehabilitation and
``inappropriate behavior'' and he sometimes showed up to work in an
``incapacitated status.'' Id. at 155. But then he retracted and
clarified that he was not under the influence at Takoma and that it was
really the inappropriate behavior in texting a colleague that
[[Page 33743]]
precipitated his departure from Takoma. Id. at 156.
Respondent admitted that during the time leading up to his arrest,
he was not showing up to work, and that as a result, ``there were other
people making decisions about controlled substances who weren't
qualified to do that'' and doing so was ``extremely'' dangerous and
``[he] put them at risk, as well as the patient.'' Id. at 160. He said
that he believed that he was successful at Talbott's rehabilitation
program because he ``was in jail long enough'' and ``because [he] had
the right mindset by that point.'' Id. at 164.
Regarding Respondent's credibility, the Chief ALJ found that:
As the witness with the most at stake at the hearing, the
Respondent is certainly imbued with the largest motive to embellish
and fabricate. Additionally, it cannot escape notice that the
Respondent has a lengthy history of convincing responsible,
experienced professionals of his sincerity. He has convinced medical
school administrators, rehabilitation professionals, physicians, a
judge and family members that he has periodically been
rehabilitated.
RD, at 18. The Chief ALJ further noted ``internal inconsistencies in
the Respondent's testimony. . . .'' For example, he found that
Respondent testified at first that his TMF monitor was unavailable to
testify because he was bedridden, and when asked whether he had
notified the TMF that his monitor was unable to monitor him, Respondent
stated that he had not, ``then said (contrary to prior testimony) that
monitoring was unnecessary because he was not practicing.'' Id. The
Chief ALJ also noted that Respondent admitted to lying to Takoma
Hospital and TMF, id. (citing Tr. 154), and lying so that a District
Court Judge would send him to a different rehabilitation facility, id.
The Chief ALJ concluded that ``there were biographical elements and
other areas where the Respondent's testimony could be credited.
However, where the Respondent's testimony conflicts with objective,
established facts of record, other evidence and testimony in the
record, and common sense, that testimony must be viewed with robust
skepticism.'' Id. at 18-19. I agree with the Chief ALJ, and although I
appreciate Respondent's honesty about his previous incidents of lying
to a Judge to get what he wanted, it makes it very difficult for me to
be able to trust that he is not being honest now as an angle to
manipulate my decision. See RD, at 18. I also find that there were
additional moments of inconsistency, such as when he discussed the
reasons for his dismissal from Takoma--at first he stated that he had
erratic behavior, such as outbursts and not showing up to work, Tr.
154, but then he insisted that he was never impaired at Takoma and that
he was really dismissed because of his inappropriate texting, id. at
156. I find it unlikely given the ``erratic'' behavior and tardiness
that he was never impaired at work.
Respondent's wife, S.L., testified on his behalf. Tr. 170-190. She
testified that she has known Respondent since middle school. Tr. 170-
71. S.L. testified that she is an addiction counselor and that she and
Respondent were divorced in 2008 and remarried in 2018. Id. S.L.
believes Respondent that he has not used drugs or alcohol in the last
six years, because she has ``been there, and also because there's a lot
of things in place to ensure that he doesn't.'' Id. at 172-73. When
asked why she trusts Respondent, she said, ``I didn't start out, you
know, trusting him, you know, when he first came out of recovery. But
you know, over the years, I've definitely come to trust him. I wouldn't
have remarried him if I--if I didn't.'' Id. at 173. She testified about
his previous rehabilitation efforts in medical school and stated, that
``I think it was a situation where he came out and he did really well
when he had some--you know, he was going to meetings. He was doing
everything that he needed to do. From that standpoint--stayed sober. I
can't remember how many years.'' Id. at 184. But then she stated,
``When he stopped going to meetings, when he stopped doing the things
that were the basis of recovery, I was a little wary, you know.'' Id.
However, she followed, ``[a]nd that's why I'm hoping like this time,
for me--you know, there's a lot of things that are put in place that--
to hold him accountable, and that's been good for me in knowing--you
know, it's not on me to keep an eye and try to predict, you know, our
behavior, because we can't. We can't.'' Id. When the Chief ALJ asked
her if the difference is that there are safeguards in place now, she
agreed, but also added that ``his general well-being is better. His
mental health is better.'' Id. at 186.
The Chief ALJ found, and I agree, that ``[n]otwithstanding the
obvious reality that [S.L.] has a vested interest in the issuance of a
COR to her husband so that they can bring their joint practice plans to
fruition, she presented as a generally candid witness whose testimony
bore sufficient detail, internal consistency, and plausibility to be
afforded credibility in these proceedings.'' RD, at 20.
Respondent next presented the testimony of Dr. G., who is an
``addiction medicine specialist'' \16\ and who has known Respondent
``nine years, probably since 2010.'' Tr. 191-211. Dr. G. testified that
he knew Respondent before and after his recovery, and that before, they
were ``colleagues in the sense that [Respondent] saw some patients that
had some substance use disorders, and it's a small-knit group of people
in recovery. . . .'' Id. at 192. Dr. G. testified that he took over the
care of some of Respondent's patients during his addiction. Id. at 193.
Now, Dr. G. sees Respondent ``once a week, every week, for the past six
years'' as part of a recovery meeting for medical professionals, where
they are peers. Id. at 194. Dr. G. testified that Respondent has never
been impaired at one of those meetings. Id. at 201, 206. Dr. G. also
described that impression of the difference between Respondent now and
his previous acquaintance with Respondent in 2012 as ``day and night.''
Id. at 206. He further testified that Respondent has been doing all of
the things that are important for recovery. Id. at 206-07. He further
stated that ``[t]he wonderful thing about [the Tennessee Medical
foundation contract] is I know [Respondent] every day has to pick up a
phone, and he's got to punch in a number and he's got to see if he's
being drug screened, seven days a week.'' Id. at 208. He further
stated, ``It made me think about that when you said would I be able to
tell if [Respondent] was doing something. Well, there's not only me,
there is the Tennessee Medical Foundation that has advocated for
[Respondent], that--he is under their monitoring.'' Id. Dr. G. also
testified that he feels Respondent has been rehabilitated and when
asked if he would trust his judgment in taking care of patients, he
said, ``Absolutely.'' Id. at 210.
---------------------------------------------------------------------------
\16\ Respondent's attorney moved to qualify Dr. G. as an expert
witness, but the Chief ALJ found, and I agree, that there had not
been adequate notice that Respondent would call upon Dr. G. as an
expert. Tr. 202-04.
---------------------------------------------------------------------------
The Chief ALJ found, and I agree, that some of Dr. G.'s testimony
was ``likely more broad and optimistic than his objective bases for
those positions would justify. . . . [it] was sufficiently detailed,
plausible, and internally consistent to be deemed credible in these
proceedings.'' RD, at 24.
The next witness to testify on behalf of Respondent was M.C., who
is a licensed clinical social worker and a peer \17\ colleague of
Respondent for
[[Page 33744]]
about six years and sees him ``anywhere from two to four times a week
in person'' at work. Tr. 212-13. M.C. testified that he would be able
to tell if Respondent ever had come into work impaired, because he is
``a recovering drug addict [himself], so [he] know[s] what it looks
like, what it smells like, what it tastes like, what it acts like,''
and he has never seen Respondent impaired. Id. at 214-15. M.C.
described Respondent as ``transparent,'' because as he stated, ``in
recovery, if a person's going to get clean, stay clean, they have to
get honest.'' Id. at 215. He further stated that he would trust his
clinical judgment, although he has never observed him with patients,
because he is ``behind closed doors.'' Id. at 225-26. The Chief ALJ
found, and I agree, that ``[w]hile the depth of his knowledge of the
Respondent's suitability to discharge the duties of a DEA registrant is
extremely limited, M.C. presented testimony that was sufficiently
cogent, detailed, plausible, and internally consistent to be considered
generally credible.'' RD, at 25.
---------------------------------------------------------------------------
\17\ Respondent testified initially that M.C. is charged with
monitoring him as he is ``the head counselor at the program, which
is part of [Respondent's] job role.'' Tr. 145. However, later he
clarified that the ``person who does the direct monitoring is Dr.
H.'' Id. at 146. It was clear from M.C.'s testimony that he does not
monitor Respondent's patient care or ``supervise [him] in any way.''
Id. at 226.
---------------------------------------------------------------------------
Another of Respondent's co-workers, W.J., who is a certified peer
specialist and has known Respondent for three and a half years
testified on his behalf. Tr. 228-30. He testified that Respondent
became his first sponsor, but they became such close friends that he is
no longer his sponsor. Id. at 233. He said he has never seen Respondent
impaired and that he trusts Respondent ``with [his] life.'' Id. at 230,
233. The Chief ALJ found, and I agree, that although Respondent's
assistance to W.J. is ``undoubtedly commendable,'' ``there was very
little presented through [W.J.] that can be objectively considered as
helpful in determining whether the Agency can have confidence that
Respondent can/will discharge his duties as a DEA registrant.'' RD, at
26.
Respondent's son, C.L., also testified on his father's behalf. He
stated that he is studying experimental biological psychology to
conduct ``addiction and pharmacological research.'' Tr. 237. He
testified that he was interested in the subject because of his parents'
work and ``the things that we've experienced as a family . . .'' Id. at
238. When asked about his relationship with his father, he stated,
``Today, it's fantastic.'' He further stated that he believes his
father is sober, because ``he was just an entirely different person,
but you know, it's--hasn't been anything like that in a very long time.
. . .'' Id. at 239. He also testified that he and his father had built
trust and that he trusted his father now, but there was a time when he
did not, ``because there was no--there was no sort of stability.'' Id.
at 243.
Respondent's oldest son, R.L., also testified on his father's
behalf. Id. at 244-55. He testified that he is a youth minister in
North Carolina and working on a master's degree in cultural studies.
Id. at 247. When asked if he trusts his father, he stated, ``I trust
that he is--he is moving in--you know, moving in the right direction,
and so it's just been, you know exciting and just encouraging for me to
see, so yeah. Yes, I do, I trust him.'' Id. at 248-49. He testified
that he has seen his father mature, and control his anger. Id. at 249-
50. When asked if he believes his father has been sober for six years,
he said, ``I've never seen any evidence of it, never heard any--of
anything from my parents, or sisters, or anybody, and continuing to see
him grow, so yeah, I believe him.'' Id. at 250.
With respect to both of Respondent's sons, the Chief ALJ found, and
I agree, that C.L. and R.L. presented as ``loving'' sons, ``seeking to
support [their] father and family.'' RD, at 21. He found that their
testimony was ``internally consistent, plausible, and based on the
questions [they were] asked, adequately detailed.'' However, he
ultimately found, and I agree, that ``there was very little practical
value added'' by these witnesses as ``to a determination of whether the
issuance of a [registration] would be in the public interest.'' Id. at
21-22.
Respondent also presented the testimony of the Reverend at his
church, where Respondent teaches Sunday school and has ``a significant
role.'' Tr. 258. He testified that he has known Respondent for about
three years and that he trusts Respondent and described him as
reliable--``if he says something, he's going to do that.'' Id. at 260.
The Chief ALJ concluded, and I agree, that in part due to the
limitations on the time and context that the Reverend has known the
Respondent, the Reverend ``presented as a responsible dedicated pastor
whose testimony however believable, added only minimally to an
objective determination of whether the Respondent should be entrusted
with a DEA COR.'' RD, at 27.
III. Discussion
In this matter, as already discussed, the OSC calls for my
adjudication of the application for registration based on the charge
that Respondent has been convicted of a felony related to controlled
substances and that he was excluded from participation in a program
pursuant to section 1320a-7(a) of Title 42. OSC, at 1-4; supra sections
II.A and II.D. Both of these are bases for revocation or suspension or
a controlled substances registration under 21 U.S.C. 824(a)(2) &
(a)(5). The OSC does not allege that granting Respondent's application
would be inconsistent with the public interest based on consideration
of the factors in 21 U.S.C. 823(f)(1) through (5) (hereinafter, the
public interest factors). The Government raised the public interest
factors in its Posthearing Brief; however, the Chief ALJ found that
they were ``unavailable as a basis for sanction in these proceedings,''
due to the late stage in which they were raised. See RD, at 28 n.65.
Accordingly, the OSC's specific substantive bases for proposing the
denial of Registrant's registration application are his felony
conviction and his mandatory exclusion under 21 U.S.C. 824(a)(2) &
(a)(5). OSC, at 1-4.
Prior Agency decisions have addressed whether it is appropriate to
consider a provision of 21 U.S.C. 824(a) when determining whether or
not to grant a practitioner registration application. For over forty-
five years, Agency decisions have concluded that it is.
In John R. Amato, M.D., 40 FR 22852 (1975), the Agency issued an
Order to Show Cause regarding Dr. Amato's application on November 6,
1974. Id. The Order to Show Cause referenced a medical license
revocation issued by the New Jersey Board of Medical Examiners. Id. The
Agency's analysis began by citing, and agreeing with, Administrative
Law Judge Parker's conclusion, ``as a matter of law,'' that the state
dispensing authority requirement of section 823(f) ``must logically
give the Administrator the authority to deny a registration if the
practitioner is not authorized by the State to dispense controlled
substances.'' \18\ Id. The Administrator agreed, stating ``[t]o hold
otherwise would mean that all applications would have to be granted
only to be revoked the next day under 21 U.S.C. 824(a)(3).'' Id. The
Administrator also stated that ``[t]his agency has consistently held
that where a registration can be revoked under section 824, it can, a
fortiori, be denied under section 823.'' Id. The Administrator stated
that he accepted Judge Parker's recommendation that the application be
denied because Dr. Amato lacked authority in New Jersey
[[Page 33745]]
``to administer, dispense or prescribe controlled substances.'' Id.
---------------------------------------------------------------------------
\18\ Section 303(f) states that the Attorney General shall
register practitioners if they have authority to ``dispense . . .
controlled substances under the laws of the State in which . . .
[they] practice[ ].'' 21 U.S.C. 823(f).
---------------------------------------------------------------------------
Other Agency decisions from the 1970s and 1980s similarly concluded
that a provision of section 824 may be the basis for the denial of a
practitioner registration application. See, e.g., Arthur R. Black,
D.O., 49 FR 33183, 33183 (1984) (denying practitioner registration
application for ``two lawful grounds'': A federal felony conviction and
material falsification of the application); Brady Kortland Fleming,
D.O., 46 FR 45841, 45842 (1981) (denying practitioner registration
application due to past controlled substance-related federal felony
conviction); Thomas W. Moore, Jr., M.D., 45 FR 40743, 40743-44 (1980)
(denying practitioner registration application due to past controlled
substance-related federal felony convictions); Raphael C. Ciliento,
M.D., 44 FR 30466, 30466 (1979) (denying practitioner registration
application due to past controlled substance-related state felony
conviction and applicant's decision not to attend the hearing he
requested and show why denial is not appropriate).
I agree with the results of all of these Agency decisions.
An Agency decision from the 1990s, when the practitioner portions
of sections 823 and 824 looked more like they do today than when the
Agency decided the above-cited decision, likewise concluded that a
practitioner registration application may be denied based on a
provision of section 824. Dinorah Drug Store, Inc., 61 FR 15972 (1996).
Dinorah is the adjudication of a practitioner registration application
by a retail pharmacy. Id. at 15972. The Order to Show Cause referenced
21 U.S.C. 823(f) as well as 21 U.S.C. 824(a)(5) (mandatory exclusion
from federal health care programs). Id.
The parties disagreed on whether a provision of section 824 could
be the basis for the denial of a pharmacy's registration application.
Id. at 15973. The Government's position was that section 824(a)(5) ``is
to be construed as not only grounds for the suspension or revocation of
a DEA registration, but also as a basis for the denial of an
application for a DEA registration.'' Id. The pharmacy's position was
that section 824(a)(5) is ``limited to the revocation or suspension of
already existing registrations.'' Id.
According to the Agency's decision in Dinorah:
To reject 21 U.S.C. 824(a)(5) as a basis for the denial of DEA
registration makes little sense. The result would be to grant the
application for registration, only to possibly turn around and
propose to revoke or suspend that registration based on registrant's
exclusion from a Medicare program. A statutory construction which
would impute a useless act to Congress will be viewed as unsound and
rejected. South Corp. v. United States, 690 F.2d [1369], 1374 (Fed.
Cir. 1982).
Id. In other words, the basis for the decision's conclusion is
statutory construction as articulated by the Federal Circuit. Id. The
decision thus concluded that ``21 U.S.C. 824(a)(5) may serve as a basis
for the denial of a DEA registration.'' Id.
Dinorah is also instructive for its analysis of the application and
its conclusion to grant the application despite the mandatory
exclusion. Id. at 15973-74. The decision, citing the ALJ, agreed that
``[s]ince denial of registration under Section 824(a)(5) is
discretionary, the factors listed in Section 823(f) may be considered
in determining whether the granting of [the] Respondent's application
is inconsistent with the public interest.'' Id. at 15973. The decision
analyzed each of the public interest factors, finding each of them
relevant. Id. at 15973-74; 21 U.S.C. 823(f). The Deputy Administrator's
analysis of the public interest factors was favorable to the pharmacy,
while he explicitly stated that he did not ``condone'' the fraudulent
activity in which the pharmacy and its owner had engaged. 61 FR at
15974. Accordingly, the Deputy Administrator approved the pharmacy's
registration application. Id. I agree with my predecessor's conclusion
that a provision of section 824 may be the basis for the denial of a
practitioner registration application and that allegations related to
section 823 remain relevant to the adjudication of a practitioner
registration application when a provision of section 824 is involved.
Accordingly, when considering an application for a registration, I
will consider any allegations related to the grounds for denial of an
application under 823 and will also consider any allegations that the
applicant meets one of the five grounds for revocation or suspension of
a registration under section 824. See id. at 15973-74.
i. 21 U.S.C. 823(f): The Five 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, or conducting
research with respect to 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. 21 U.S.C. 823(f).
In this case, it is undisputed that Respondent holds a valid state
medical license and is authorized to dispense controlled substances in
the State of Tennessee where he practices. RX 17, 18. The Government
did not allege that Respondent's registration would be inconsistent
with the public interest pursuant to section 823 in the OSC and did not
advance any arguments or present any evidence under the public interest
factors in its case at hearing. See OSC; Govt Prehearing. Instead, the
Government based its initial case in section 824 alleging that
Respondent's conviction of a felony related to controlled substances
and his mandatory exclusion from federal health programs merit the
denial of his registration under 21 U.S.C. 824(a)(2) & (a)(5). See OSC;
Govt Prehearing. Because the Government has not alleged that
Respondent's registration is inconsistent with the public interest
under section 823, I will not deny Respondent's application based on
section 823, and although I have considered 823, I will not analyze
Respondent's application under the public interest factors. Therefore,
in accordance with prior agency decisions, I will move to assess
whether the Government has proven by substantial evidence that one or
more grounds for revocation exist under 21 U.S.C. 824(a).
ii. 21 U.S.C. 824(a)(2) & (a)(5)
Each subsection of section 824(a) provides an independent ground to
impose a sanction on a registrant. Arnold E. Feldman, M.D., 82 FR
39614, 39617 (2017); see also Gilbert L. Franklin, D.D.S., 57 FR 3441
(1992) (``[M]andatory exclusion from participation in the Medicare
program constitutes an independent ground for revocation pursuant to 21
U.S.C. [Sec. ]
[[Page 33746]]
824(a)(5).''). Pursuant to 824(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). The ground in 21 U.S.C. 824(a)(5) requires that the
registrant ``has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title
42.'' 42 U.S.C. 1320a-7(a) provides a list of four predicate offenses
for which exclusion from Medicare, Medicaid, and other federal health
care programs is mandatory and sets out mandatory timeframes for such
exclusion. Id.
Here, there is no dispute in the record that Respondent is
mandatorily excluded pursuant to Section 1320a-7(a) of Title 42 and,
therefore, that a ground for the revocation or suspension of
Registrant's registration exists. 21 U.S.C. 824(a)(5). There is also no
dispute in the record that Respondent has been convicted one count of
``Conspiracy to Distribute a Quantity of Cocaine Base,'' in violation
of 21 U.S.C. 841(b)(1)(C) & 846, which constitutes a felony conviction
``relating to'' controlled substances as those terms are defined in 21
U.S.C. 824(a)(2). William J. O'Brien, III, D.O., 82 FR 46527, 46529
(2017).
Where, as here, the Government has met its prima facie burden of
showing that two grounds for revocation exists, the burden shifts to
the Registrant to show why he can be entrusted with a registration. See
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019).
IV. Sanction
Where, as in the instant case, the Government has established
grounds to deny a registration, I will review any evidence and argument
the respondent submitted to determine whether or not the respondent has
presented ``sufficient mitigating evidence to assure the Administrator
that [he] can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). `` `Moreover,
because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452
(7th Cir. 1995), [the Agency] has repeatedly held that where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for [the registrant's]
actions and demonstrate that [registrant] will not engage in future
misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Samuel S. Jackson,
D.D.S., 72 FR at 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709
(2006); Prince George Daniels, D.D.S., 60 FR 62884, 62887 (1995). The
issue of trust is necessarily a fact-dependent determination based on
the circumstances presented by the individual respondent; therefore,
the Agency looks at factors, such as the acceptance of responsibility
and the credibility of that acceptance as it relates to the probability
of repeat violations or behavior and the nature of the misconduct that
forms the basis for sanction, while also considering the Agency's
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
In evaluating the degree required of a respondent's acceptance of
responsibility to entrust him with a registration, in Mohammed Asgar,
M.D., the Agency looked for ``unequivocal acceptance of responsibility
when a respondent has committed knowing or intentional misconduct.'' 83
FR 29569, 29572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49704,
49728). Here, Respondent pled guilty to one count of ``Conspiracy to
Distribute a Quantity of Cocaine Base,'' in violation of 21 U.S.C.
841(b)(1)(C) & 846, and one count of ``Conspiracy to Defraud a Health
Care Benefit Program,'' in violation of 18 U.S.C. 1347 & 1349. U.S. v.
Robert Wayne Locklear, No. 2:14-CR-38 (E.D. Tenn. Oct. 8, 2014)). I
will, therefore, look for a clear acceptance of responsibility from
Respondent.
Respondent took concrete actions to accept responsibility for his
misconduct while his criminal case was ongoing. He did so by pleading
guilty to the charges in Federal Court. Respondent testified that he
pled guilty in federal court ``because he was guilty'' and that he was
``[v]ery. Very sorry.'' Tr. at 34. However, after his arrest, he was
given the option of entering an inpatient rehabilitation program in
lieu of incarceration, and after only six days, he escaped, because he
``wanted to use drugs.'' Id. at 67-68. By his own admission, it was not
until he had been ``in jail long enough,'' that he was fully ready to
accept rehabilitation. Id. at 167. It is difficult to credit
Respondent's guilty pleas as full acceptance of responsibility given
his behavior after his arrest.
Regarding Respondent's acceptance of responsibility for the health
care benefit fraud, the Chief ALJ found, and I agree that:
During his testimony, the Respondent complacently agreed that
allowing unqualified administrative staff personnel to hand out
controlled substance prescriptions while he was absent from his
office due to his drug and alcohol abuse was ``[e]xtremely
dangerous.'' Tr. 160. He even allowed that he ``put [his staff] at
risk, as well as the patient,'' but his demeanor conveyed no
indication that he regretted his actions or even recognized the
monetary and safety ramifications of those actions. The message his
nonchalant testimonial demeanor conveyed was that it happened, he
got caught, and his actions merited no further reflection.
RD, at 32. I defer to the Chief ALJ's assessment of Respondent's
demeanor. Because the Administrative Law Judge has had the opportunity
to observe the demeanor and conduct of hearing witnesses, the factual
findings regarding demeanor set forth in his recommended decision are
entitled to significant deference. Universal Camera Corp. v. NLRB, 340
U.S. 474, 496 (1951); Jeffery J. Becker, D.D.S., and Jeffery J. Becker,
D.D.S., Affordable Care, 77 FR 72387, 72403 (2012). I find the Chief
ALJ's characterization of Respondent's reaction in making these
statements to be important in this case, particularly because the
illegal conduct involved the prescribing of controlled substances--the
very responsibility with which Respondent now seeks to be entrusted.
Furthermore, the magnitude of the offense is staggering--the plea
agreement included 150 dates of service where a prescription was issued
and Respondent was not present to examine the patient. GX 3, at 13. The
offense therefore, warranted much more attention and focus from
Respondent in accepting responsibility. This crime did not just affect
federal health care programs, but also the patients, who were not
receiving adequate medical care, and Respondent's staff, who as
Respondent noted, he put at risk for malpractice and even potential
criminal liability. The plea agreement also noted that ``[o]n numerous
occasions, drug screens came back positive for the presence of other
scheduled drugs such as marijuana or heroin, but the patients continued
to have their Suboxone prescriptions called in anyway.'' GX 3, at 9.
Additionally, Respondent admitted that he saw patients after smoking
crack cocaine. Id. at 5. This behavior is directly related to his
controlled substance registration--and I find that the magnitude of the
harm that he caused and could have caused merited more than a
``nonchalant'' admission.\19\
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\19\ There is no mention at all of the conduct related to
prescribing in the affidavit Respondent submitted, see RX 7, and he
submitted no testimony on his own about this specific matter. The
Chief ALJ had to ask him about the controlled substances
prescriptions in the plea agreement. Tr. 160.
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[[Page 33747]]
Regarding Respondent's acceptance of responsibility for his felony
conviction for Conspiracy to Distribute a Quantity of Cocaine Base, he
testified that he accepts responsibility and is remorseful. Tr. 134-35.
Although he made these overall statements, in the affidavit he
submitted, he stated that he ``admitted on the day [he] was arrested by
the Drug Task Force that, although [he] never sold any illegal
substances, [he] shared some crack cocaine with others that same day.''
RX 7. Respondent seems to assume that the act of sharing somehow would
improve my view of his actions, when in truth the fact that he
distributed an illegal substance to others is serious misconduct in
considering whether he can be entrusted with a controlled substance
registration, irrespective of whether he did so as a gift or for
payment. In sharing crack cocaine, he endangered the lives of these
individuals and brought them further into the same spiral of addiction
in which he was swirling. This statement, which qualifies what he did
not do, appears to be aimed at minimizing the egregiousness of his
conduct, which the Agency has previously weighed against a finding of
acceptance of full responsibility. See Ronald Lynch, M.D., 75 FR 78745,
78754 (2010) (Respondent did not accept responsibility noting that he
``repeatedly attempted to minimize his [egregious] misconduct''; see
also Michael White, M.D., 79 FR 62957, 62967 (2014) (finding that
Respondent's ``acceptance of responsibility was tenuous at best'' and
that he ``minimized the severity of his misconduct by suggesting that
he thinks the requirements for prescribing Phentermine are too
strict.'').
As to his demeanor in his acceptance of responsibility for the
felony charge, the Chief ALJ remarked that Respondent ``cooly related''
the events leading up to his arrest. RD, at 33. He further stated that:
If the Respondent understands that doling out crack cocaine in a
hotel room, particularly when committed by one who had been
entrusted with a DEA registration, was reprehensible, that
understanding was reflected in neither his language nor his tone
during the hearing. In his testimony, he described his actions with
no more emotion than if he were recounting an uneventful shopping
trip to a local mall.
RD, at 34.
I also find it of significance in evaluating Respondent's
acceptance of responsibility that he did not seem to be aware of the
full extent of the harm that he caused. For example, when the Chief ALJ
asked him what happened to his bail when he escaped from Bradford,
Respondent testified that it was ``lost,'' and he could not remember
how much it was, but his ``wife could probably tell you for sure.'' Tr.
70-71; supra n.8. And, again, when asked about whether he posted bail
after Talbott, he answered that it was ``fuzzy,'' and ``I think there
might have been.'' Id. at 78. The fact that he did not fully understand
the financial impact on his family and left the responsibility of that
knowledge to his wife, does not demonstrate full acceptance of
responsibility for his misconduct.
Further, the Chief ALJ noted, and I agree, that Respondent ``was
repeatedly successful in convincing persons in authority to afford him
the benefit of rehabilitation.'' Id. at 35; see Tr. 152-53 (Duke
Medical School); Tr. 153-59 (Takoma Medical Center); Tr. 162 (District
Court Judge who sent him to Bradford); Tr. 168-69 (District Court Judge
sent him to Talbott after he escaped from Bradford); Tr. 78-79
(released after Talbott). Like the Chief ALJ, I find Respondent's
admission that he described his statements to a District Court Judge
that he could not go back to Bradford Rehabilitation as ``an angle to
go somewhere else,'' id. at 73, to be of particular concern, see RD, at
36. Although I credit his retrospective honesty, in deciding whether I
can trust him, I cannot ignore the fact that he has successfully angled
to obtain trust repeatedly, and repeatedly abused that trust.
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 a respondent and by the community of registrants. Id. In this case,
there is no doubt that the Respondent's felonies and past behavior are
egregious. His acts related to his controlled substances registration--
instructing unqualified staff to issue controlled substances
prescriptions on his behalf and without properly considering contrary
urine drug screens, I find to be particularly egregious. Further, as
the Chief ALJ stated, ``intentionally and volitionally distributing
crack cocaine is a grave departure from even the most minimal standard
of responsibility to guard against diversion that is expected of a DEA
registrant. It is not that he just came up short in preventing drug
diversion, he intentionally diverted crack cocaine.'' RD, at 39.
As the Chief ALJ noted, although the Agency has permitted
registrants to maintain or obtain registrations based on demonstrated
unequivocal acceptance of responsibility and ``concrete, sincere
efforts at rehabilitation,'' many of these cases involved no harm to
anyone beyond the respondent and no grounds for revocation under
Section 824; whereas, in this case, the ``record reflects the
distribution of crack to others, the placement of his patients in
extreme danger, professional (even criminal) exposure inflicted on his
office staff, and monetary damages to various health care providers who
submitted reimbursement claims.'' RD, at 38 (citing Ronald F. Lambert,
D.D.S., 78 FR 62662, 62664 (2013); Kimberly Maloney, N.P., 76 FR 60922,
60927-28 (2011); John J. Cienki, M.D. 63 FR 52293, 52296 (1998)
(parentheticals omitted)).
Generally, I find Respondent's recovery to be commendable given his
lengthy and difficult battle with addiction. Respondent cited the
support of his friends and family numerous times as being essential to
his recovery. Tr. 128-29, 136, 137. Although the testimony of his
network of family and friends who support him is important to
understanding their opinions about the status of his recovery, I find
that overall, their opinions are not the best evidence for me to use to
determine my ability to be entrust Respondent with a controlled
substances registration. See Raymond A. Carlson, 53 FR 7425 (1988)
(finding that none of the character ``witnesses was in a position to
make an adequate assessment of [r]espondent's ability to properly
handle controlled substances.''). Further, I find that the record
evidence of Respondent's egregious controlled substance dispensing-
related violations is relevant to my evaluation and outweighs all of
the record evidence from his family, friend, colleague, and minister
that he has been generally trustworthy and reliable since his recovery.
See George Pursley, M.D. 85 FR 80162, 80180 (2020).
In addition to acceptance of responsibility, the Agency also gives
consideration to both specific and general deterrence when determining
an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810
(2015). Specific deterrence is the DEA's interest in ensuring that a
registrant complies with the laws and regulations governing controlled
substances in the future. Id. General deterrence concerns the DEA's
responsibility to deter conduct similar to the proven allegations
against the
[[Page 33748]]
respondent for the protection of the public at large. Id. In this case,
I agree with the Chief ALJ that ``the absence of a sanction where a DEA
registrant has been convicted of actually intentionally distributing
crack cocaine would send a powerful message to the regulated community
that even the most blatant intentional diversion will carry no
consequences.'' RD, at 40.
In Respondent's favor, Respondent has been held accountable for his
criminal behavior--having been sentenced to prison and temporarily
losing his medical license. He has met the requirements for
rehabilitation and for obtaining a conditional medical license.
However, based on the facts of this case, I find it difficult to find
that this accountability will have a deterrent effect on the potential
for Respondent's relapse, because he has faced serious consequences
many times in his life--losing his wife and family, getting expelled
from medical school, losing his job, getting arrested, going to jail,
etc.--and none of those things seemed to deter him from repeating his
behavior until now.
Although Respondent testified extensively about the accountability
to which he is held pursuant to his agreement with the Tennessee
Medical Foundation, and many of his character witnesses testified about
how much that accountability comforted them, I cannot find that
accountability necessarily to be a sufficient deterrent from abuse of
his controlled substances registration due to his history of repeatedly
ignoring accountability measures,\20\ even at the risk of
incarceration. Therefore, in spite of his commendable sobriety thus
far, I have reason to doubt his claim that he would always be a
compliant registrant. See George R. Smith, M.D., 78 FR 44972, 44980
(2013). Particularly, I remain concerned that if he relapsed, which the
record has demonstrated previously occurred on several occasions, while
entrusted with a controlled substances registration, he could harm
himself and others too quickly for detection by this Agency or his
monitoring. Ensuring that a registrant is trustworthy to comply with
all relevant aspects of the CSA without constant oversight is crucial
to the Agency's ability to complete its mission of preventing diversion
within such a large regulated population. Jeffrey Stein, M.D., 84 FR at
46974.
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\20\ There is also evidence on the record that at the time of
the hearing that Respondent might not have been in compliance with
his monitoring requirements due to his monitor's illness and that he
did not inform the state board or the Tennessee Medical Foundation
of the lapse in monitoring. See supra n.14. I find that this lapse
is mitigated by its circumstances, but that it is further evidence
that Respondent has repeatedly demonstrated disregard for
accountability measures.
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As discussed above, to receive a registration when grounds for
denial exist, a respondent must convince the Administrator that his
acceptance of responsibility and remorse are sufficiently credible to
demonstrate that the misconduct will not reoccur and that he can be
entrusted with a registration. Having reviewed the record in its
entirety, I find that Respondent has not met this burden. Accordingly,
I will order the denial of Respondent's application for a certificate
of registration.
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 pending application for a Certificate
of Registration, Control Number W18124612C, submitted by Robert Wayne
Locklear, M.D., as well as any other pending application of Robert
Wayne Locklear, M.D. for additional registration in Tennessee. This
Order is effective July 26, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-13525 Filed 6-24-21; 8:45 am]
BILLING CODE 4410-09-P
