[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61316-61323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24205]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-29]


George Roussis, M.D.; Decision and Order

    On August 10, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to George Roussis, M.D. 
(hereinafter, Respondent), of Staten Island, New York. Order to Show 
Cause (hereinafter, OSC), at 1 and 3. The OSC proposed the denial of 
Respondent's application for DEA Certificate of Registration, Control 
No. W20041078C, because Respondent was excluded from ``participation in 
Medicare, Medicaid, and all Federal health care programs pursuant to 
section 1320a-7(a) of Title 42'' and such exclusion ``warrants denial 
of [Respondent's] application for a DEA registration pursuant to 21 
U.S.C. 824(a)(5).'' Id. at 1-2 (citing Narciso A. Reyes, M.D., 83 FR 
61,678 (2018)).
    Specifically, the OSC alleged that, on or about October 16, 2017, a 
judgment was entered against Respondent based on his conviction on one 
count of ``Racketeering-Transporting In Aid of Travel Act-Acceptance of 
Bribes'' in violation of 18 U.S.C. 1952(a)(3) and 2. Id. at 1 (citing 
U.S. v. George Roussis, No. 2:17-CR-00232-SRC-1 (D.N.J. Oct. 16, 
2017)). The OSC further alleged that ``[b]ased on [Respondent's] 
conviction, the U.S. Department of Health and Human Services, Office of 
[the] Inspector General (``HHS/OIG''), mandatorily excluded 
[Respondent] from participation in Medicare, Medicaid, and all Federal 
health care programs pursuant to 42 U.S.C. Sec.  1320a-7(a).'' Id. at 
2. According to the OSC, the exclusion was effective on April 19, 2018, 
and runs for 13 years. Id.
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit 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. (citing 21 CFR 
1301.43). The OSC also notified Respondent of the opportunity to submit 
a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated September 2, 2020, Respondent timely requested a 
hearing. Administrative Law Judge Exhibit (hereinafter, ALJX) 2. The 
matter was placed on the docket of the Office of Administrative Law 
Judges and was assigned to Administrative Law Judge John J. Mulrooney, 
II (hereinafter, the Chief ALJ). On September 11, 2020, the Chief ALJ 
issued an Order for Prehearing Statements. ALJX 3. The Government 
timely filed its prehearing statement on September 25, 2020. ALJX 4. 
Respondent timely filed his prehearing statement on October 1, 2020. 
ALJX 5. On October 19, 2020, the Chief ALJ issued a prehearing ruling 
that, among other things, established the schedules and procedures for 
the remaining prehearing activities and for the hearing. ALJX 6 
(Prehearing Ruling, at 1-7).

[[Page 61317]]

    The hearing in this matter took place via video teleconference on 
December 16, 2020. Following the hearing, both the Government and 
Respondent filed their post-hearing briefs on January 22, 2021. On 
January 26, 2021, the Chief ALJ issued the Recommended Rulings, 
Findings of Fact, Conclusions of Law, and Decision (hereinafter, RD). 
Neither party filed exceptions to the RD. See generally Transmittal 
Letter. I have reviewed and agree with the procedural rulings of the 
Chief ALJ during the administration of the hearing.
    Having considered the record in its entirety, I agree with the 
Chief ALJ and find that the record established by substantial evidence 
a prima facie case supporting the denial of Respondent's application. 
RD, at 12. I also agree with the Chief ALJ that Respondent failed to 
fully accept responsibility for his misconduct, failed to demonstrate 
that the Agency can entrust him to maintain his registration, and that 
denial of his application is appropriate. Id. at 12-15. I make the 
following findings of fact.

I. Findings of Fact

A. Respondent's Application for DEA Registration

    Agency records show that on April 30, 2020, Respondent applied for 
DEA registration No. W20041078C as a practitioner authorized to handle 
controlled substances in Schedules II-V at the proposed registered 
location of 4735 Hylan Blvd., Staten Island, New York 10312. GX 1, at 
1; see also RD, at 3 (Stipulation 1). Respondent previously held DEA 
registration No. BR7710999. GX 2, at 2. Respondent's previous DEA 
registration was the subject of an OSC issued on February 19, 2019, 
based on the sole allegation that Respondent was without authority to 
handle controlled substances in New York, the state in which he was 
registered with the DEA, because his New York medical license had been 
suspended. Id. at 1-2. The OSC was dismissed when the suspension of 
Respondent's New York medical license was lifted subject to probation 
and other conditions on August 16, 2019. Id. at 2. The expiration date 
of Respondent's previous DEA registration was April 30, 2020, and it is 
in retired status. Id.

B. Respondent's Criminal Conviction

    The evidence in the record demonstrates that on June 21, 2017, an 
Information was filed in the United States District Court for the 
District of New Jersey against Respondent. GX 3. The Information 
charged that from October 2010 through April 2013, Respondent engaged 
in commercial bribery in violation of N.J.S.A. Sec.  2C:21-10, 18 
U.S.C. 1952(a)(3). Id. at 4. The Information charged that from October 
2010 through April 2013, Biodiagnostic Laboratory Services, LLC 
(hereinafter, BLS), a clinical blood laboratory, paid Respondent and 
his brother bribes of approximately $175,000 in the aggregate to refer 
patient blood specimens to BLS. Id. at 1 and 4. The Information charged 
that BLS used the patient blood specimens from Respondent to submit 
claims to Medicare and private insurers to collect approximately 
$1,450,000. Id. at 4. Further, the Information charged that between 
October 2010 and April 2013, ``in addition to cash payments'' and ``at 
the request of [Respondent], on multiple occasions,'' BLS paid bribes 
to Respondent and his brother in the form of trips to strip clubs where 
``BLS paid for women to perform lap dances on, and engage in sex acts 
with, [Respondent] and [Respondent's brother], in order to induce 
[Respondent] to refer the blood specimens of [Respondent's] patients to 
BLS for testing and related services.'' Id. On June 21, 2017, 
Respondent pled guilty to the charge of Racketeering-Transporting in 
Aid of Travel Act-Acceptance of Bribes in violation of 18 U.S.C. 
1952(a)(3) & 18 U.S.C. 2. GX 5, at 1. Judgment was entered on October 
16, 2017, and as a result of his guilty plea, Respondent was sentenced 
to serve 37 months in prison, pay a fine of $7,500, and forfeit 
$175,000 ``jointly and severally with [his brother].'' GX 3, at 6; GX 
4, at 4; GX 5, at 1-2, 7, and 8; see also RD, at 3 (Stipulation 2).

C. Respondent's Exclusion

    Based on Respondent's guilty plea and conviction, on March 30, 
2018, HHS/OIG excluded Respondent from participation in Medicare, 
Medicaid, and all federal health care programs for a minimum period of 
13 years pursuant to 42 U.S.C Sec.  1320a-7(a). GX 7, at 1; see also 
RD, at 3 (Stipulation 4).

D. Respondent's State Medical License

    Respondent was authorized to practice medicine in the State of New 
York by issuance of license number 224106. GX 2, at 2. Following 
Respondent's guilty plea and conviction, Respondent's New York medical 
license was suspended for 15 months starting from May 16, 2018. Id. On 
August 16, 2019, Respondent's state medical license was reinstated 
subject to probation for five years. Id. According to the State of New 
York's online records, the status of Respondent's state medical license 
is currently listed as ``Registered.'' http://www.op.nysed.gov/opsearches.htm (last visited date of signature of this Order). 
Following his conviction, Respondent was also excluded from 
participation in the New York State Medicaid program, effective 
November 5, 2017. GX 6, at 1-2.

E. The Parties' Positions

1. Government's Position
    The OSC's sole allegation is that Respondent's exclusion from 
federal health care programs pursuant to 42 U.S.C. 1320a-7(a) warrants 
denying his application under 21 U.S.C. 824(a)(5). OSC, at 2. The 
Government alleges that Respondent's exclusion was based on his 
conviction on one count of Racketeering-Transporting In Aid of Travel 
Act-Acceptance of Bribes, in violation of 18 U.S.C. 1952(a)(3) & 18 
U.S.C. 2. Id. at 1-2.
    The Government's documentary evidence includes a copy of 
Respondent's application for DEA registration No. W20041078C as well as 
a copy of the Certification of Non Registration for DEA registration 
No. W20041078C. See GX 1 and 2. The Government's documentary evidence 
also includes a copy of the Information filed in the United States 
District Court for the District of New Jersey against Respondent as 
well as Respondent's Plea Agreement and the Judgment following 
Respondent's conviction. See GX 3-5. Additionally, the Government's 
documentary evidence includes a copy of Respondent's exclusion letter 
from HHS/OIG as well as a website screen print from the HHS/OIG 
exclusions database showing that Respondent is excluded. See GX 7 and 
8. Finally, the Government's documentary evidence includes a copy of 
Respondent's exclusion letter from the New York State Medicaid program. 
See GX 6.
    The Government called one witness to testify at the hearing, a 
Group Supervisor (GS) who works for the DEA New York Field Division. 
The GS testified about her career experience, including her previous 
encounter with Respondent when Respondent's prior DEA registration was 
the subject of an OSC because Respondent's New York medical license had 
been suspended. Tr. 15-21; see also RD, at 3; GX 2, at 1-2. The GS also 
authenticated the Government's documentary evidence and testified about 
her investigation-related actions, including obtaining the Government's 
documentary evidence and confirming that Respondent's exclusion from 
federal health care programs was still in effect. Tr. 15-37; see also 
RD, at 3-4.
    Having read and analyzed all of the record evidence, I agree with 
the Chief ALJ that the testimony from the GS was

[[Page 61318]]

``sufficiently detailed, plausible, and internally consistent,'' and 
that the GS ``presented as an objective regulator and investigator with 
no discernable motive to fabricate or exaggerate.'' RD, at 4.
2. Respondent's Position
    Respondent requested a hearing in response to the Government's OSC, 
asserting that although his medical license had been restored, without 
a DEA registration, he was not able to effectively practice. Request 
for a Hearing (hereinafter, Hearing Request).
    The Respondent's documentary evidence includes various orders from 
the New York State Department of Health regarding the status of 
Respondent's medical license following his conviction. See RX 1-3. The 
Respondent's documentary evidence also includes a collection of support 
letters from patients, colleagues, and friends that had been previously 
submitted to the District of New Jersey as part of Respondent's 
criminal case. See RX 4. Respondent was the sole witness to testify for 
his case.
    Respondent explained his educational background, including both his 
undergraduate and medical education. Tr. 71-73. Respondent also 
described his career in pediatrics. Id. at 75-78. Respondent testified 
that he is currently married with two eleven-year-old children and that 
they are a ``very loving family.'' Id. at 48. Respondent also confirmed 
that he committed the crime to which he pled guilty. Id. Respondent 
testified that he had been having financial difficulties as a solo 
practitioner at the time but that it was not an excuse for what he did. 
Id. at 97. Respondent testified that a friend who worked for BLS as a 
representative introduced him to BLS and initiated Respondent's 
arrangement with BLS. Id. at 64. Respondent stated that he referred his 
laboratory specimens to BLS and in exchange he would receive $2,000-
$4,000 \1\ in cash on a monthly basis and trips to a strip club with 
his brother a few times a year.\2\ Id. at 48-49, 60-61, 63, and 65. 
Regarding his non-monetary remuneration, he testified, ``So what I 
received was of course we would eat there. I mean they had typical--it 
was a restaurant in there. And alongside that, it would be a lap 
dance.'' Id. at 60. Respondent's friend who introduced him to BLS was 
the one who brought Respondent the monthly payments at Respondent's 
office. Id. at 64-66. The monthly payments varied but did not depend on 
anything in particular like how much lab work Respondent sent to BLS. 
Id. at 65. Respondent testified that his wife did not know about his 
arrangement with BLS, however, his wife knew that he was going out with 
the owners of BLS to a strip club and Respondent and his wife have 
nonetheless maintained a good and trusting relationship. Id. at 62-63 
and 66. Respondent also testified that he was ``not exclusive to BLS.'' 
Id. at 49. Respondent sent approximately 40% of his lab work to BLS and 
Respondent and his brother received a combined total of $175,000, of 
which Respondent received half. Id. at 49 and 99. Respondent stated 
that he knew that referring the blood samples to BLS was wrong at the 
time that he was doing it. Id. As far as his protocol for deciding 
whether to send blood samples to BLS or other laboratories, Respondent 
testified that he rotated laboratories to compare the blood results 
amongst the different laboratories. Id. at 49-50. On cross examination, 
Respondent testified that the arrangement with BLS ended when BLS was 
arrested by the federal government and that he did not know the 
approximate number of patients that he had referred to BLS throughout 
the duration of the arrangement. Id. at 95.
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    \1\ The RD noted that Respondent's testimony in which Respondent 
first stated that the cash payments were ``always the same amount'' 
but then went on to state that the cash payments ranged from $2,000-
$4,000 as an example of Respondent's lack of candor. RD, at 5; Tr. 
65. It is difficult to tell from the record whether Respondent was 
just clarifying that the payments were not based on a particular 
factor when he stated that they were ``always the same amount,'' but 
the Chief ALJ then asked him on what the range depended and he 
stated, ``There was nothing--it would vary. That's all I would 
say.'' Tr. 65. I agree with the Chief ALJ that these statements do 
not appear to be fully forthcoming and should be considered as 
relevant to Respondent's acceptance of responsibility.
    \2\ On cross examination, Respondent was questioned regarding 
the specific services he and his brother were given during the trips 
to strip clubs provided by BLS because while in his testimony he had 
indicated that they were only given lap dances, in the plea 
agreement that he had signed, it was indicated that they had 
received lap dances and sexual acts. Id. 110-114. During this line 
of questioning, Respondent testified that they had only received lap 
dances, that ``sex acts'' referred only to lap dances, and that 
regarding the ambiguity of the wording involved with the plea 
agreement, he had simply signed what he was told to sign by his 
attorney. Id.
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    Respondent testified that he was never charged with doing any 
unnecessary testing and that there was no additional expense to the 
patients, insurance companies, or the government. Id. at 50 and 80. 
Respondent also testified that although BLS was not a reputable company 
and what they did was ``terrible'' their blood testing was normal and 
comparable with other laboratories. Id. at 95-96. Other than the 
present case, Respondent has never been in trouble with the law. Id. at 
50. Additionally, Respondent has made all of the payments required as 
part of his plea agreement. Id. at 82. During cross examination, 
Respondent confirmed that he appealed his exclusion ``with regards to 
[his] extent of the blame for the exclusion'' and described his attempt 
to lessen the time period of the exclusion. Id. at 84 and 87. 
Respondent also confirmed that he was aware of the aggravating factors 
that contributed to his long exclusion period, including the financial 
loss to government agencies of $50,000 or more, his conviction lasting 
more than two years, and his sentence including a period of 
incarceration. Id. at 88. Respondent stated that he didn't believe it 
was unreasonable to receive an exclusion, but that he thought it was an 
``excessive'' exclusion. Id. at 88-89.
    Respondent is currently licensed without restriction but is subject 
to probation for five years and has to have a practice monitor for 24 
months. Id. The practice monitor is board-certified in internal 
medicine. Id. at 75. Before he was convicted and excluded from federal 
health care programs, Respondent had a pediatric practice. Id. at 51. 
Respondent stated that he wants to return to pediatrics but that 
because of his exclusion from federal health care programs, he is 
having issues being credentialed by private insurance companies, which 
insure the majority of his patients. Id. at 66-68. Respondent has also 
lost his previous hospital admitting privileges. Id. at 77. 
Additionally, Respondent was previously certified by the American Board 
of Pediatrics but because of his felony conviction, was suspended. Id. 
at 73-74. Respondent stated that he petitioned to be reinstated but 
because of the condition on his license that he has to have a practice 
monitor, he was unsuccessful. Id. at 74. Respondent confirmed that his 
petition was unsuccessful only because of the practice monitor 
requirement and not because of any issues with his level of practice. 
Id. Respondent also mentioned that he receives ``many phone calls'' 
asking him to return to pediatric practice. Id. at 79.
    In the time since his medical license was reinstated in August 
2019, Respondent has only been actively practicing medicine as of 
October 2020. Id. at 92. Respondent currently has an aesthetics 
wellness practice with his brother that offers aesthetic services, 
hormone replacement, and medical weight loss and Respondent has 
``trained in many courses'' regarding aesthetics wellness. Id. at 51-
53. Respondent testified that he would need a DEA registration to keep 
the practice running because he needs to prescribe

[[Page 61319]]

testosterone for hormone replacement and because it's ``very difficult 
to earn a living without [the] DEA license.'' Id. at 53-55. On cross 
examination, Respondent testified that he has not partnered with any 
other medical professionals in situations where his patients need 
controlled substances, so if a patient needs a controlled substance, 
Respondent will deny them service. Id. at 92-93. Respondent also 
confirmed that he would not have a need to prescribe opioid drugs or 
benzodiazepine drugs. Id. at 94. When questioned by the Chief ALJ if he 
would need the DEA registration for other reasons like malpractice 
insurance or credentialing, Respondent said he would not and that he 
did not have any issues with malpractice insurance. Id. at 54.
    Prior to his sentencing, Respondent spoke to the Richmond County 
Medical Society, which, although he was embarrassed, he felt was 
``absolutely necessary'' to express how sorry he was to have ``betrayed 
them and . . . the profession.'' Id. at 69-70. Respondent stated that 
they all knew about his situation because it was all public and that 
they accepted and understood that he was trying to ``educate them not 
to fall into the same trap.'' Id. Respondent also stated that if he 
could ``do anything to take it back [he] would.'' Id. at 70. Respondent 
testified that while he was in prison for 18 months, his wife would 
send him weekly journals regarding ``pretty much all disciplines of 
medicine which [he] would actually keep up with.'' Id. at 55-56 and 98. 
Respondent also testified that there were other physicians with him in 
prison and that they formed a club and had discussions regarding 
medicine on a weekly basis. Id. at 56. Since his release from prison, 
Respondent has taken about 60 CME credits, received his opiate 
certificate, and taken a 12-week ethics course, the latter two of which 
were required by the Office of Professional Medical Conduct (OPMC). Id. 
at 56-59. Respondent stated that he brought shame to his family, 
friends, and patients and that ``there wasn't anybody that wasn't the 
victim both directly [and] indirectly.'' Id. at 81. Respondent said 
that he was ``not looking to go back in prison'' and that ``[o]ne day 
in prison is enough to teach anybody a lesson.'' Id. Respondent's 
father passed away while he was in prison and Respondent described the 
remorse he feels for not being able to tell his father how sorry he was 
for what he did. Id. Respondent stated that it's been very difficult 
for him to start his practice and that he's ``tried everything [he] can 
to feed [his] family.'' Id. Respondent stated that he will ``never 
compromise [his] position as long as [he has] been given this last 
chance to do the right thing'' and that ``[he] will do the right 
thing.'' Id. at 82. On cross examination, Respondent testified that 
even if he had financial difficulties in the future, ``[a]fter being in 
prison for [so] long'' he would not take another ``opportunity for 
financial enrichment.'' Id. at 98.
    Respondent's testimony also included the authentication of 
Respondent's exhibits. Id. at 40-44. Regarding a determination order 
from the New York State Department of Health State Board for 
Professional Medical Conduct, Respondent testified that the Board 
referred to Respondent's ``special remorse for which [he] suffered 
financially.'' Id. at 70-71. Regarding Respondent's collection of 
support letters, Respondent testified that he had not solicited 
patients for the letters but that because his case was in the news and 
everyone found out about it, patients had come in and asked what they 
could do to help him. Id. at 44-45. Respondent also testified that, in 
regard to glaring similarities between the letters, he had only told 
his patients to ``speak the truth and how [they] [felt] about [him]'' 
and ``what [their] [experiences were] with [Respondent] treating [them] 
as patients.'' Id. at 45-46. Finally, Respondent testified that he had 
received ``many more character letters'' than those included in the 
collection submitted for this case. Id. at 47-48. On cross examination, 
Respondent confirmed that all of the letters were written in 2017 in 
response to his criminal conviction and that none of the letters were 
addressed to the court of the current matter. Id. at 106-107.
    Having read and analyzed all of the record evidence, I agree with 
the RD that while Respondent was candid and credible in discussing his 
background and his personal remorse, Respondent's testimony in other 
areas raises concerns regarding Respondent's candor and thus reduces 
his credibility and the weight this decision gives to his testimony. 
RD, at 8. In particular, I find that Respondent's testimony regarding 
his reasons for seeking a DEA registration was confusing and ambiguous 
as to whether he intends to return to pediatrics or to continue with 
the aesthetics practice that he currently operates with his brother. 
Tr. 51-55 and 66-68; see also RD, at 7.\3\ I also agree with the Chief 
ALJ that ``[Respondent's] own admission that he signed his plea 
agreement, not because it was all true, but because his attorney told 
him to, raises significant doubts as to the credibility of his 
testimony.'' \4\ RD, at 8; see also Tr. 110-114. Finally, and as will 
be discussed in more detail below, the stark similarities between 
Respondent's patient support letters combined with Respondent's 
testimony that there was no coaching or even solicitation involved in 
their acquisition further raises concerns regarding Respondent's candor 
and thus further damages Respondent's credibility. RX 4; RD, at 6-7; 
Tr. 44-46.
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    \3\ I am not considering the purpose of his application for a 
DEA registration for any other reason than his inconsistent 
statements.
    \4\ In the recent decision Keith A Jenkins, N.P., which found in 
favor of the Respondent, a similar issue regarding the Respondent 
signing something because his attorney advised it was raised. Keith 
A Jenkins, N.P., 86 FR 35,339 (2021). However, the present case can 
be distinguished from Jenkins in that in the present case, the issue 
pertains to a major fact of the underlying crime, while in Jenkins, 
the Respondent entered an Alford plea of guilty as a strategic 
decision at the advice of his attorney regarding a particular legal 
element of his offense. Id. at 35,344.
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II. Discussion

A. The Government's Position

    In its Post-Hearing Brief, the Government argues that ``[a] 
respondent's mandatory exclusion from federal health care programs 
under 42 U.S.C. 1320a-7(a) provides grounds for denial under 21 U.S.C. 
Sec.  824(a)(5)'' and notes that ``[i]t is undisputed that Respondent 
has been excluded from participation in Medicare, Medicaid, and all 
[f]ederal health programs pursuant to 42 U.S.C. 1320a-7(a) for a period 
of 13 years.'' Government's Post-Hearing Brief, at 6. Additionally, the 
Government argues that the denial of Respondent's application is the 
appropriate sanction and that even if Respondent's application were 
granted, it should be restricted because ``Respondent has not 
unequivocally accepted responsibility, but has instead attempted to 
downplay his misconduct'' and ``Respondent's misconduct is so 
egregious, that denial of his application is warranted notwithstanding 
any purported acceptance of responsibility.'' Id. at 6-7. Specifically, 
the Government alleges that Respondent failed to acknowledge a portion 
of the bribes he received (namely, that he received both lap dances and 
additional sex acts) and that Respondent downplayed his role in the 
bribery scheme by characterizing it as ``nothing more than an informal 
arrangement between old friends.'' Id. at 7-9. Moreover, the Government 
contends that ``[a]lthough Respondent's crimes are not related to the 
controlled substances act, his crimes are of a nature that should 
concern the Agency'' because ``[w]ere Respondent to accept

[[Page 61320]]

cash payments to prescribe unlawful prescriptions, it would be 
challenging for DEA to detect.'' Id. at 9-10. Finally, the Government 
concludes that for the protection of the public, even if granted, 
Respondent's registration should be limited to only what he claims that 
he needs it for, namely testosterone prescriptions. Id. at 10.

B. Respondent's Position

    In Respondent's Post-Hearing Brief, Respondent highlighted a 
Determination and Order of the New York State Department of Health 
which, after a hearing was held to determine if Respondent's New York 
medical license should be revoked following his conviction, denied the 
Department's request to revoke Respondent's license and instead, opted 
to suspend Respondent's license until he was released from 
incarceration, followed by five years of probation, the first two years 
including a practice monitor. Respondent's Post-Hearing Brief, at 3-4. 
Respondent's Post-Hearing Brief included a quote from the Determination 
and Order stating that ``[t]he Committee based [its] determination on 
the Respondent's personal statement accepting full responsibility.'' 
Id. at 4. The included quote also noted that ``Respondent also offered 
in mitigation letters from colleagues and patients and the testimony of 
[colleagues] to show his commitment to his pediatric practice.'' Id. 
Finally, the quote concluded, ``[t]he Hearing Committee credited the 
Respondent's expressions of remorse for enriching himself financially 
while participating in such a scheme and his remedial efforts in 
appearing before the Richmond County Medical Society to candidly 
discuss his unlawful acts.'' Id.
    Respondent's Post-Hearing Brief went on to argue that Respondent 
was truly remorseful, as evidenced in part by his lecturing to other 
doctors about the mistake he made and how they should avoid it. Id. at 
4-5. Respondent's Post-Hearing Brief also noted that no patient's care 
was ever compromised, that Respondent never performed any unnecessary 
tests, that the payments made by Medicare and other insurance entities 
were exactly the same as they would have been from any other lab, and 
that BLS never provided anything but ``top quality work.'' Id. at 5. 
Respondent's Post-Hearing Brief emphasized that Respondent has never 
had any trouble with the law and described Respondent as ``an old-
fashioned doctor who besides providing excellent medical care to his 
patients, listened to his patients and never rushed them out of his 
office.'' Id. Moreover, Respondent's Post-Hearing Brief included 
excerpts from some of the patient letters that Respondent submitted as 
Exhibit 4 in this case to demonstrate ``the type of care Respondent 
provided to his patients and how they reflect his following the 
Hippocratic Oath.'' Id. at 5-8.
    Respondent's Post-Hearing Brief then went on to describe 
Respondent's remedial efforts, including keeping up with medical 
journals while incarcerated, forming a club with other physicians while 
incarcerated, and, since his release from prison, taking CME courses, 
an Opiate course, and an ethics course. Id. at 8-9. Respondent's Post-
Hearing Brief concluded by emphasizing Respondent's remorse once again, 
describing how Respondent has suffered from being incarcerated, from 
paying fines and forfeiture, and from embarrassing and hurting his 
family, community, and patients. Id. at 9. Respondent's Post-Hearing 
Brief highlighted that Respondent ``is now trying to turn his life 
around and become a productive member of society'' and that to do this, 
he needs a DEA license for his aesthetics practice, because he is no 
longer able to practice pediatrics because he cannot get insurance. Id. 
Finally, Respondent's Post-Hearing Brief included an excerpt of 
Respondent's testimony in which Respondent reiterated his remorse, 
stated that he needed the DEA license to continue practicing medicine, 
and testified that even if he faced financial difficulties in the 
future, he would never again take similar actions because of the 
disgrace he brought to his family, friends, and patients and because he 
had learned his lesson by going to prison. Id. at 9-10.

C. Analysis of Respondent's Application for Registration

    In this matter, the OSC calls for my adjudication of the 
application for registration based on the charge that Respondent was 
excluded from participation in a program pursuant to section 1320a-7(a) 
of Title 42, which is a basis for revocation or suspension under 21 
U.S.C. 824(a)(5). OSC, at 1-2.
    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. Robert Wayne 
Locklear, M.D., 86 FR at 33,744-45 (collecting cases); see also, 
William Ralph Kincaid. In the recent decision Robert Wayne Locklear, 
M.D., the former Acting Administrator stated his agreement with the 
results of these past decisions and reaffirmed that a provision of 
section 824 may be the basis for the denial of a practitioner 
registration application. 86 FR at 33,745. He also clarified that 
allegations related to section 823 remain relevant to the adjudication 
of a practitioner registration application when a provision of section 
824 is involved. Id.
    Accordingly, when considering an application for a registration, I 
will consider any actionable 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. Id. See 
also Dinorah Drug Store, Inc., 61 FR 15,972, 15,973-74 (1996).
1. 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 New York where he practices. See GX 2.
    Because the Government has not alleged that Respondent's 
registration is inconsistent with the public interest under 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,

[[Page 61321]]

I will move to assess whether the Government has proven by substantial 
evidence that a ground for revocation exists under 21 U.S.C. 824(a). 
Supra II.C.

2. 21 U.S.C. 824(a)(5): Mandatory Exclusion From Federal Health Care 
Programs Pursuant to 42 U.S.C. 1320a-7(a)

    Under Section 824(a) of the Controlled Substances Act (hereinafter, 
CSA), a registration ``may be suspended or revoked'' upon a finding of 
one or more of five grounds. 21 U.S.C. 824. 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.'' Id. Here, there is no dispute in the record 
that Respondent is mandatorily excluded from federal health care 
programs under 42 U.S.C. 1320a-7(a). The Government has presented 
substantial evidence of Respondent's exclusion and the underlying 
criminal conviction that led to that exclusion, and Respondent has 
admitted to the same. GX 5; GX 7-8; Respondent's Post-Hearing Brief, at 
2-3. Accordingly, I will sustain the Government's allegation that 
Respondent has been excluded from participation in a program pursuant 
to section 1320a-7(a) of Title 42 and find that the Government has 
established that a ground exists upon which a registration could be 
revoked pursuant to 21 U.S.C. 824(a)(5).\5\ Although the language of 21 
U.S.C. 824(a)(5) discusses suspension and revocation of a registration, 
for the reasons discussed above, it may also serve as the basis for the 
denial of a DEA registration application. Dinorah Drug Store, Inc., 61 
FR at 15,973 (interpreting 21 U.S.C. 824(a)(5) to serve as a basis for 
the denial of a registration because it ``makes little sense . . . to 
grant the application for registration, only to possibly turn around 
and propose to revoke or suspend that registration based on the 
registrant's exclusion from a Medicare program''). Respondent's 
exclusion from participation in a program under 42 U.S.C. 1320a-7(a), 
therefore, serves as an independent basis for denying his application 
for DEA registration. 21 U.S.C. 824(a)(5).
---------------------------------------------------------------------------

    \5\ The Government correctly argues, and Respondent did not 
rebut, that the underlying conviction forming the basis for a 
registrant's mandatory exclusion from participation in federal 
health care programs need not involve controlled substances to 
provide the grounds for revocation or denial pursuant to section 
824(a)(5). Jeffrey Stein, M.D., 84 FR 46,968, 46,971-72 (2019); see 
also Narciso Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK Pharmacy, 
64 FR 49,507, 49,510 (1999) (collecting cases); Melvin N. Seglin, 
M.D., 63 FR 70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61 FR 
60,727, 60,728 (1996).
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    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).
    Where, as here, the Government has met its prima facie burden of 
showing that a ground for revocation exists, the burden shifts to the 
Respondent to show why he can be entrusted with a registration. See 
Jeffrey Stein, M.D., 84 FR 46,968, 46,972 (2019).

III. Sanction

    The Government has established grounds to deny a registration; 
therefore, 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 23,848, 23,853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (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 23,853; John H. Kennnedy, M.D., 71 FR 35,705, 35,709 
(2006); Prince George Daniels, D.D.S., 60 FR 62,884, 62,887 (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).

A. Acceptance of Responsibility

    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 29,569, 29,572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49,704, 
49,728). Here, the Respondent stated that he knew at the time that he 
did it that it was wrong. Tr. 49. I will, therefore, look for a clear 
acceptance of responsibility from Respondent.
    Respondent is clearly remorseful for his conduct, with Respondent 
emphasizing how he had brought shame to his family, friends, and 
patients and that ``there wasn't anybody that wasn't the victim both 
directly [and] indirectly.'' Tr. 81. He does seem to acknowledge that 
there are many victims, although his statements do not show any 
particular understanding of his crime or its impact. However, remorse 
and acceptance of responsibility are not the same thing, and although 
Respondent acknowledged that his patients had suffered, Respondent's 
focus on his own suffering does not suggest an unequivocal acceptance 
of responsibility, but rather, suggests that what he regrets most are 
the negative consequences that he has personally faced. As the Chief 
ALJ noted, Respondent ``freely admits that the ramifications of getting 
caught and punished has visited an extreme level of inconvenience and 
misfortune.'' RD, at 13. In particular, much of Respondent's testimony 
focused on how much of an impact his incarceration had had on him, with 
Respondent testifying that ``[o]ne day in prison is enough to teach 
anybody a lesson'' and describing the remorse he had felt about not 
being able to tell his father how sorry he was for what he did because 
his father had passed away while he was incarcerated. Tr. 81. 
Respondent also mentioned how difficult it has been for him to start a 
new practice following his incarceration. Id. Regarding whether, if 
faced with financial difficulties in the future, he would take another 
``opportunity for financial enrichment'', Respondent testified that 
``[a]fter being in prison for [so] long'' he would not, suggesting that 
the fear of incarceration, rather than genuine regret for the harm he 
has caused, is what would deter him from similar misconduct in the 
future. Id. at 98.
    Additionally, there are points of Respondent's testimony and 
actions in the record that suggest attempts to downplay his mistakes. 
As the Chief ALJ pointed out, ``[t]he Respondent here essentially 
admitted to those things which he dared not deny. He admitted he was 
convicted and excluded from Medicare, but presented testimony that

[[Page 61322]]

was equivocal and confusing regarding the details.'' RD, at 13. 
Respondent testified that he was never charged with doing any 
unnecessary testing, that there was no additional expense to the 
patients, insurance companies, or the government, and that, although 
BLS was not a reputable company and what they did was ``terrible,'' 
their blood testing was normal and comparable with other 
laboratories.\6\ Id. at 50, 80, 95-96. Respondent repeatedly minimized 
his characterization of the non-monetary remunerations he received and 
even when confronted with the plain language of his plea agreement. See 
supra n.2; Tr. 60, 62; RD, at 13. Also, Respondent confirmed that he 
had appealed his exclusion from federal healthcare programs because, 
although he had understood the aggravating factors, he had also thought 
his long exclusion period was ``excessive,'' but he did not explain 
further the rationale for this belief or why the exclusion period was 
so long initially. Id. at 84 and 87-89. I do credit Respondent for 
stating, ``I just did it. I mean, I have no excuse.'' Id. at 97. 
However, ``the degree of acceptance of responsibility that is required 
does not hinge on the respondent uttering `magic words' of repentance, 
but rather on whether the respondent has credibly and candidly 
demonstrated that he will not repeat the same behavior and endanger the 
public in a manner that instills confidence in the Administrator.'' 
Stein, 84 FR at 46,973.
---------------------------------------------------------------------------

    \6\ It is also noted that Respondent provided no support for the 
statement that the testing was normal and comparable in the record.
---------------------------------------------------------------------------

    Overall, Respondent's focus on himself and his minimization of his 
wrongdoings and the issues with his credibility suggest that he has not 
credibly and unequivocally accepted responsibility for his actions and 
the harm that he caused. See id. at 46,972 (finding that a registrant's 
attempts to minimize his misconduct weigh against a finding of 
unequivocal acceptance of responsibility).
    Even if Respondent's acceptance of responsibility for his 
wrongdoing had been sufficient such that I would reach the matter of 
remedial measures, Respondent has not offered adequate remedial 
measures to assure me that I can entrust him with a registration. See 
Carol Hippenmeyer, M.D., 86 FR 33,748, 33,773 (2021). Prior to his 
sentencing, Respondent spoke to the Richmond County Medical Society 
about his crime. \7\ Tr. 69-70. While in prison, Respondent kept up 
with medical journals and formed a club with other physicians to 
discuss medicine. Tr. 55-56. Since his release, Respondent has taken 
about 60 hours in continuing medical educations courses (CME),\8\ 
gotten his opiate certificate, and taken a 12-week ethics course.\9\ 
Id. at 56-59. Given the circumstances and in comparison to the similar 
case in Martinho, I find that Respondent's remedial efforts have been 
minimal and thus insufficient to ensure that Respondent can be trusted 
with registration.
---------------------------------------------------------------------------

    \7\ I commend Respondent on his attempts to have a deterrent 
effect on his colleagues and community. In Martinho, the former 
Acting Administrator considered this type of engagement in 
determining that a respondent who had been excluded from federal 
healthcare programs for accepting similar kickbacks for laboratory 
referrals could be entrusted with a registration; however, the facts 
of Martinho are very distinct from the facts on the present record. 
Michele L. Martinho, M.D., 86 FR 24,012, 24,019 (2021). The 
respondent in that case had dedicated herself to self-described 
``restorative justice'' well beyond what was required by her 
probation--engaging in sixty-nine speaking engagements, which were 
featured in major news outlets. Id. Although her misconduct occurred 
for a similar amount of time and money, HHS penalized her with the 
minimum timeframe for exclusion, she engaged in a methodological 
survey to verify for her own conscience that she did not increase 
her blood draws and did not overstate that survey's value, she 
admitted that the lab had created insurance problems for her 
patients and tried to correct it, and importantly, she also fully, 
sincerely and credibly accepted responsibility for her actions, such 
that the prosecutor at her criminal sentencing stated that she `` 
`had demonstrated a level of contrition that has been unique among 
the many, many doctors that we've dealt with in this case.' '' Id.
    \8\ Though Respondent testified to completing CME courses, he 
did not provide evidence to the record confirming the completion of 
the courses.
    \9\ As previously mentioned, the latter two were required by the 
Office of Professional Medical Conduct (OPMC). Id.
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B. Specific and General Deterrence

    In addition to acceptance of responsibility, the Agency gives 
consideration to both specific and general deterrence when determining 
an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74,800, 74,810 
(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 respondent for the protection of the public at large. Id. 
Where a respondent has committed a crime with no nexus to controlled 
substances, it is sometimes difficult to demonstrate that a sanction 
will have a useful deterrent effect. In this case, I believe a sanction 
of denial of the application would deter Respondent and the general 
registrant community from unethical behavior and deceit, particularly 
involving the acceptance of money for unlawful and unethical acts. It 
is not difficult to imagine, as the Agency has repeatedly encountered, 
this situation repeating itself in the context of receiving money for 
controlled substance prescriptions. ``Deterring such deceit and knowing 
criminal behavior both in Respondent and the general registrant 
community is relevant to ensuring compliance with the CSA.'' Ibrahim 
Al-Qawaqneh, D.D.S., 86 FR 10,354, 10,357 (2021).

C. Egregiousness

    The Agency also looks to the egregiousness and the extent of the 
misconduct as significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR at 18,910 (collecting 
cases). In this case, Respondent knew that his arrangement with BLS was 
wrong but accepted the arrangement anyway and kept it going from 
October 2010 to March of 2013, because he had been having financial 
difficulties as a solo practitioner. Tr. 95. The arrangement was a 
blatant kickback scheme involving substantial monetary payments.\10\ In 
addition, the arrangement was both periodic and ongoing for multiple 
years, giving Respondent plenty of opportunity to correct course, but 
there is nothing in the record to indicate that he had any intention of 
ending the arrangement. See also RD, at 14. After receiving 2 to 4 
thousand dollars per month, Id. at 65, there must have been a point at 
which he was no longer facing financial difficulties, and yet he 
continued until ``the laboratory got arrested by the federal 
government.'' Tr. 95. Furthermore, the exclusion letter notes that HHS/
OIG deemed Respondent's criminal misconduct egregious enough to warrant 
an exclusion period in excess of the statutory minimum. GX 7, at 2. The 
exclusion letter explains that HHS/OIG excluded Respondent for thirteen 
years instead of the statutory minimum of five years because (1) 
Respondent's misconduct caused or was intended to cause financial loss 
of more than $50,000 to a government agency or program; (2) Respondent 
committed the misconduct over a period of at least a year; and (3) 
Respondent's sentence included incarceration. Id. See Michael Jones, 
M.D., 86 FR 20,728, 20,732 (2021) (considering the length of the HHS

[[Page 61323]]

exclusion in assessing egregiousness). As the Chief ALJ noted, ``on the 
record, the interests of general deterrence, like the egregiousness of 
the established conduct, support the imposition of the application 
denial sought by the Government.'' RD, at 15.
---------------------------------------------------------------------------

    \10\ Also, I am concerned about repeat behavior in this case 
because the wrongdoing appears to be influenced by social 
interactions. The fact that Respondent was first approached about 
the bribes by a ``friend of [his],'' Tr. 64, participated in the 
arrangement with his brother, and they all engaged in social 
activities together during which payments were received, does not 
inspire confidence that Respondent will take his responsibility to 
his patients and his ethical obligations seriously in the future.
---------------------------------------------------------------------------

D. Letters of Support

    My final item of consideration is the collection of nineteen 
letters that Respondent submitted from patients, colleagues, and 
friends to demonstrate his high level of care as a physician and his 
commitment to the Hippocratic Oath. Respondent's Post-Hearing Brief, at 
5-8; RX 4. Although I find the letters to be sincere, they can only be 
of limited weight in this proceeding because of the limited ability to 
assess the credibility of the letters given their written form. See 
Michael S. Moore, M.D., 76 FR 45,867, 45,873 (2011) (evaluating the 
weight to be attached to letters provided by the respondent's hospital 
administrators and peers in light of the fact that the authors were not 
subjected to the rigors of cross examination). Furthermore, these 
letters were not written for the purposes of recommending that 
Respondent be granted a controlled substances registration and 
therefore offer little value in assessing the Respondent's suitability 
to discharge the duties of a DEA registrant. William Ralph Kinkaid, 
M.D., 86 FR 40,636, 40,641 (2021). Instead, Respondent's letters were 
used by his criminal defense counsel prior to his sentencing, with most 
of the letters dated back to 2017. RX 4; Tr. 106-107. Additionally, as 
the Chief ALJ noted, the ``recognizable pattern'' of the patient 
letters, in combination with Respondent's insistence that there was no 
suggested format and Respondent's testimony that he had not solicited 
patients for the letters, does raise questions as to whether there was 
any ``coaching or importuning'' involved in their collection and thus 
damages their credibility. RD, at 6-7; RX 4Tr. 44-46. The Chief ALJ did 
note that ``it would be difficult (and unjust) to ignore the volume of 
support/correspondence from his patients, or the often poignant 
accounts enshrined within those letters.'' RD, at 14. I agree and I 
note that the letters say many positive things about Respondent, 
however, I find that because Respondent has not demonstrated credible 
and unequivocal acceptance of responsibility, I cannot place weight on 
letters written in a different context in demonstrating that Respondent 
can be entrusted with a DEA registration, when he, himself, has not 
credibly done so. See Kinkaid, M.D., 86 FR at 40,641.
    As discussed above, to receive a registration when grounds for 
denial exist, a respondent must convince the Administrator that his 
acceptance of responsibility is sufficiently credible to demonstrate 
that the misconduct will not occur 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. Although Respondent expressed 
remorse and took some responsibility for his actions through his guilty 
plea and his efforts at remediation, his acceptance of responsibility 
was not unequivocal. Respondent's focus on his own consequences and his 
minimization of his wrongdoings both raise concerns that he does not 
truly understand the severity of his misconduct. Further, Respondent's 
remediation efforts have been minimal and unpersuasive. As such, I am 
not convinced that Respondent would not commit similar misconduct again 
in the future if he believed that it would not result in negative 
consequences. 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, I hereby deny the pending application for a Certificate of 
Registration, Control Number W20041078C, submitted by George Roussis, 
M.D., as well as any other pending application of George Roussis, M.D., 
for additional registration in New York. This Order is effective 
December 6, 2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-24205 Filed 11-4-21; 8:45 am]
BILLING CODE 4410-09-P