[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