Notice2021-23263
Nicholas P. Roussis, M.D.; Decision and Order
Primary source
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Published
October 26, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 204 (Tuesday, October 26, 2021)</title>
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[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59190-59196]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23263]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-22]
Nicholas P. Roussis, M.D.; Decision and Order
On May 27, 2020, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause to Nicholas P. Roussis, M.D.
(hereinafter, Respondent), of Staten Island, New York. Order to Show
Cause (hereinafter, OSC), at 1. The OSC proposed the denial of
Respondent's application for DEA Certificate of Registration, Control
No. W19115227C, because Respondent was mandatorily excluded from
```participation in Medicare, Medicaid, and all federal health care
programs for a minimum period of 10 years' pursuant to 42 U.S.C. 1320a-
7(a)'' and such exclusion ``warrants denial of [Respondent's]
application for a [registration] pursuant to 21 U.S.C. 824(a)(5).'' Id.
at 1-2 (citing Richard Hauser, M.D., 83 FR 26308 (2018)).
Specifically, the OSC alleged that, on October 16, 2017, the United
States District Court for the District of New Jersey issued a judgment
against Respondent ``based on [Respondent's] plea of 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, a felony.''
Id. at 2 (citing U.S. v. Nicholas P. Roussis, No. 2:17-cr-00231-SRC
(D.N.J.)). 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''), by letter dated April 30, 2018,
mandatorily excluded [Respondent] from `participation in Medicare,
Medicaid, and all federal health care programs for a minimum period of
10 years' pursuant to 42 U.S.C. 1320a-7(a), effective May 20, 2018.''
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. at 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)).
By letter dated June 30, 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 Mark M. Dowd
(hereinafter, the ALJ). On July 1, 2020, the ALJ issued an Order for
Prehearing Statements. ALJX 3. The Government timely filed its
prehearing statement (hereinafter, Govt Prehearing) on July 13, 2020.
ALJX 4. Respondent timely filed his prehearing statement (hereinafter,
Resp Prehearing) on July 22, 2020. ALJX 5. On July 28, 2020, the 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 1-11).
On September 8, 2020, the Government filed ``Objections Pursuant to
21 CFR 1316.59'' (hereinafter, Govt Objections), which objected to the
admission of certain evidence submitted by Respondent on the grounds of
authenticity. ALJX 8 (Govt Objections), at 2. The evidence in question
consisted of ``Respondent's Exhibit 1, a 38-page document containing
approximately 18 letters'' that Respondent had submitted on August 3,
2020. Govt Objections, at 1. According to the Govt Objections, ``[m]ost
of the letters [appeared] to have been drafted . . . nearly three years
before the Government served its [OSC].'' Id. Further, the Government
alleged that, ``[a]ll but two of the letters [were] unsigned and four
[were] undated.'' Id. Finally, the Government claimed that,
``[although] all but one of the letters [appeared] to be directed
toward a Federal District Court Judge in connection with U.S. v.
Nicholas P. Roussis . . . the letters [did] not seem to be available
for inspection as part of the publically [sic] assessable electronic
court file.'' Id. at 2. The Government concluded that because ``all but
two of the letters [were] unsworn and no witness [was] disclosed to
authenticate and/or lay a foundation for the documents' admissibility''
the letters should not be admitted. Id. On September 9, 2020,
Respondent filed a Reply to Government's Objections (hereinafter, Reply
to Objections). In the Reply to Objections, Respondent attached an
affirmation from one of the attorneys who represented him in his
criminal case. Reply to Objections, at 1. The affirmation stated that
all 18 letters had been submitted as exhibits to the District of New
Jersey as part of Respondent's sentencing submission during his
criminal case. Reply to Objections, Attachment (Affirmation of Angela
D. Lipsman), at 1-3. In the Reply to Objections, Respondent stated,
``[p]lease consider that affirmation as a response to the Government's
objections.'' Reply to Objections, at 1. At the hearing in this matter,
which took place on September 14, 2020, the Government further objected
to the admission of the letters on the grounds of relevance. Tr. 41.
The Government argued that in context, the letters related only to the
sentencing of the Respondent in his criminal case and not to
Respondent's prescribing practices or whether he could be entrusted
with a DEA registration. Tr. 41-42. The ALJ ultimately overruled the
Government's objections on both grounds of authenticity and relevance
and admitted the letters into the record. Tr. 42-43.
The hearing in this matter took place via video teleconference on
September 14, 2020. Following the hearing, both the Government and the
Respondent filed their post-hearing briefs on October 21, 2020. On
November 5, 2020, the 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 ALJ during the
administration of the hearing.
Having considered the record in its entirety, I agree with the ALJ
and find that that the record established by substantial evidence a
prima facie case supporting the denial of Respondent's application. RD,
at 37. I also agree with the ALJ that the Respondent failed to fully
accept responsibility for his misconduct, failed to demonstrate that
the Agency can entrust him to maintain his registration, and therefore,
that denial of his application is the appropriate sanction. Id. I make
the following findings of fact.
[[Page 59191]]
I. Findings of Fact
A. Respondent's Application for DEA Registration
Respondent previously held DEA registration No. BR8697940 as a
practitioner authorized to handle controlled substances in Schedules
II-V at the registered location of 2627B Hylan Blvd., Staten Island, NY
10306. RD, at 11 (Stipulation 1). Respondent's previous DEA
registration expired by its terms on April 30, 2019. Id. On October 4,
2019, Respondent applied for a DEA registration, which was assigned
Control No. W19115227C, in Schedules II-V at 4735 Hylan Blvd., Staten
Island, New York 10312. GX 1, at 1; see also RD, at 12-13 (Stipulation
8).\1\
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\1\ The parties stipulated that the application was submitted on
October 7, 2019, based on the Government's prehearing statement, but
it appears that the application submission date was a scrivener's
error.
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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; RD, at 13. 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, 4-5; see
also RD, at 12 (Stipulations 3-4). The Information charged that BLS
used the patient blood specimens from Respondent to submit claims to
Medicare, Tricare, and private insurers to collect approximately
$250,000. Id. at 5. Further, the Information charged that between
October 2010 and April 2013, ``in addition to cash payments'' 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].'' Id.; see
also RD, at 12 (Stipulation 4). 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 4, at 3. Respondent was found guilty on October 16, 2017. GX 4,
at 3; see also RD, at 12 (Stipulation 2). Respondent was sentenced to
serve 24 months in prison, pay a fine of $5,000, and forfeit $175,000.
GX 3, at 7; GX 4, at 4, 8, and 9; see also RD, at 12 (Stipulation 5).
C. Respondent's Exclusion
Based on Respondent's conviction, on April 30, 2018, HHS/OIG
excluded Respondent from participation in Medicare, Medicaid, and all
federal health care programs for a minimum period of 10 years pursuant
to 42 U.S.C. 1320a-7(a). GX 2, at 1; see also RD, at 12 (Stipulation
6).
D. Respondent's State Medical License
Respondent was authorized to practice medicine in the State of New
York by issuance of license number 231555. GX 7, at 1. Following
Respondent's guilty plea and conviction, Respondent's New York medical
license was suspended during the period of his incarceration after a
charge of professional misconduct was sustained. Id. Respondent's state
medical license was to be reinstated on August 16, 2019, subject to
probation for five years and other conditions. Id. According to the
State of New York's online records, the status of Respondent's state
medical license is currently listed as ``Registered.'' <a href="http://www.op.nysed.gov/opsearches.htm">http://www.op.nysed.gov/opsearches.htm</a> (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 August
30, 2017. GX 5; see also RD, at 12 (Stipulation 7).
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; Govt
Prehearing. The Government alleges that Respondent's exclusion was
based on his guilty plea 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. Id. The Government further alleges that
Respondent's exclusion from Medicare, Medicaid, and all federal health
care programs warrants denial of his application notwithstanding the
fact that the underlying conduct that led to his exclusion did not have
a nexus to controlled substances. Id.
The Government's documentary evidence includes a copy of
Respondent's application for DEA registration No. W19115227C as well as
a copy of Respondent's exclusion letter from HHS/OIG. 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 and the Terms of Probation and Order
of Judgment following Respondent's conviction. See GX 3 and 4. Finally,
the Government's documentary evidence includes various New York State
documents pertaining to Respondent's exclusion from the New York State
Medicaid program, the status of Respondent's New York State medical
license, and Respondent's disciplinary proceedings with the New York
State Department of Health following his conviction. See GX 5-7.
The Government called one witness to testify at the hearing, a
Group Supervisor (hereinafter, GS) who works for the DEA New York Field
Division. The GS 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. 16-30; see also RD, at 5-6. The GS
also authenticated the Government's documentary evidence through her
testimony. Id.
Having read and analyzed all of the record evidence, I agree with
the RD that the GS was ``consistent, genuine and credible,'' in her
testimony and that the GS ``effectively explained how the investigation
of the Respondent began and how she verified the Respondent's exclusion
from federal [health care] programs.'' RD, at 22. I also agree with the
RD that although she was the Government's witness, there was ``no
indication from her testimony that any partiality interfered with her
reliable testimony.'' Id.
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 a collection of
support letters from patients, colleagues, family, and friends that had
been previously submitted to the District of New Jersey as part of
Respondent's sentencing submission during his criminal case. See RX 1.
Respondent was the sole witness to testify for his case.
Respondent testified that he has a wife, three children, and an
elderly mother with medical problems who lives with him and his family.
Tr. 31-32. Respondent became involved with
[[Page 59192]]
BLS when a friend, who was a pharmaceutical representative for another
company, started working for BLS as a salesman. Id. at 53. Respondent's
friend asked him if he would ``send business his way'' just as he was
sending it to other laboratories. Id. at 54. Respondent was ``very
financially pressed'' at the time and when his friend and BLS offered
to help him with some of his bills, ``at that point, [he] accepted.''
Id. Respondent and his co-defendant, his brother, received a combined
$175,000 from BLS. Id. at 60-61. The bribes were periodic monthly
payments of approximately $2,000 to $3,000 and not based on specific
referrals. Id. at 69-70. BLS also paid for Respondent and his brother
to go to strip clubs and to receive lap dances. Id. at 61-62.
Respondent received payments from approximately October or November
2010 until January or February 2013. Id. at 70-71.
Respondent testified that he never prescribed any medication that
was not necessary, never performed any unnecessary tests, and was never
charged with performing any unnecessary tests. Id. at 32-33. Further,
he claimed that the Government did not lose any money because
Respondent used BLS and the payments made to BLS were the same as would
be made to any other laboratory. Id. at 33-34. Additionally, Respondent
testified that BLS was a ``credible laboratory'' \2\ that provided
legitimate, accurate, and verified \3\ results and never did any
improper testing. Id. at 33. He stated that BLS results were
consistent, BLS was faster than other laboratories, and BLS never
charged the patients any copay. Id. at 54-55; see also id. at 33
(``their turnaround time was quicker than the other laboratories, which
was also another reason why I used them, as well.''). Respondent
testified that ``from a testing aspect and a laboratory aspect'' he was
satisfied with BLS. Id. at 55. Respondent testified that ``no patients
were harmed in any way'' and that his actions did not cost the patients
any money. Id. at 59. Nonetheless, Respondent testified that his
actions were not a victimless crime and that his patients were the
victims. Id. at 60. Respondent admitted to pleading guilty to the
charges against him and when prompted for an explanation, said he did
not have an explanation for it. Id. at 32. Respondent stated, ``It was
the wrong thing to do, it was a wrong decision on my part, and I regret
it every day, to this day.'' Id.
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\2\ When prompted later during cross examination, Respondent
clarified that he had meant that BLS was a ``credible'' laboratory
in terms of their work, not in terms of their behavior. Id. at 53-
55.
\3\ Respondent initially testified that he had verified all of
the results from all of the patients that he sent to BLS,
approximately 500 patients. Id. at 55-56. When prompted for
clarification, however, Respondent admitted that he did not actually
verify every single patient that he had sent to BLS. Id. at 56-57.
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Respondent was incarcerated and his medical license was suspended
while he was incarcerated. Id. at 34. Respondent's medical license has
since been restored subject to probation with a practice monitor for
two years. Id. at 32. Respondent testified that even though his medical
license was restored, without a DEA license, he cannot effectively
practice. Id. at 48. Respondent testified that he was ``totally
guilty'' and ``totally [took] responsibility for what [he] did.'' Id.
Respondent testified that he made a very bad decision that negatively
affected his life as well as his family and patients. Id. at 48-49.
There was a hearing regarding Respondent's medical license and the
hearing committee determined that Respondent's medical license should
be suspended, not revoked. Id. at 34-37. The hearing committee made
their recommendation based on Respondent's acknowledgement of his poor
judgment, Respondent's personal statement expressing remorse, the
testimony of other doctors, letters from patients, and Respondent's
remedial efforts in lecturing about his misconduct. Id. at 37-38.
Respondent also wrote a letter to the Department of Health and Human
Services ``trying to find out, and to speak with the judge . . . as to
why [he] would have a ten year exclusion being the fact that [his
actions were] nothing having to do with [billing].'' Id. at 51.
Respondent testified that he ``had no part of the billing at all with
Medicare and Medicaid, or the TRICARE federal services'' and ``[a]ll
[he] did was [he] accepted the bribes.'' Id. Respondent also requested
if he could have a decrease in his mandatory restriction, but the ten-
year restriction was upheld. Id. at 51-52.
Respondent testified that he suffered in prison because he was away
from his family. Id. at 49. While he was in prison, he ``tried to stay
proactive'' and read medical journals. Id. Since his release from
prison, he has taken over 200 hours \4\ in continuing medical education
courses (CME), multiple courses and certifications in his field,
medical ethics courses, and courses such as the DEA's opioid training
program. Id. at 38-39. Respondent also mentioned that he had become a
CPR instructor and performed CPR classes. Id. at 39. Respondent also
spoke to the Medical Society of Staten Island and to the residents at
Richmond University Medical Center to explain what he had done and to
deter them from making the same mistake. Id. at 47. Respondent
testified that he had destroyed his life, embarrassed himself and his
family, and become an embarrassment to his patients, community and
church. Id. He explained that he ``just became very proactive because
[he] wanted [his] medical license.'' Id. Respondent testified that he
paid back all his debts to society from his forfeiture, fines, prison,
and supervised release. Id. at 50. Respondent testified that medicine
is ``the only thing [he knows] how to do'' and ``the only thing [he
wants] to do.'' Id. at 49. Respondent testified that he wants to get
back to practicing medicine and become a good member of society again.
Id. at 49-50.
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\4\ Respondent initially testified that he had taken over 200
``courses'' but later clarified that he had meant 200 hours of
courses. Id. at 38, 64.
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Respondent stated that while previously working in obstetrics and
gynecology, he did not prescribe oxycodone or opioids to patients and
the most he ever prescribed was Tylenol with Codeine after delivery or
a caesarian section.\5\ Id. at 64. Respondent testified that he ``never
really prescribed any controlled substances unless [he] had to.'' Id.
Respondent currently has an aesthetics practice where ``[he] will be
doing injectables, fillers, hormone therapy, and weight loss
treatment'' and that it is the type of practice he intends to maintain.
Id. at 52. Respondent testified that he would need Schedules II-V for
his practice. Id. at 53. Finally, Respondent testified that the
majority of the support letters that had been submitted during his
criminal case had been sent directly to his attorney. Id. at 58-59.
Respondent had spoken to patients and asked them if they would write
character letters for him as well as provided his attorney's email for
them to send the letters directly. Id. at 59.
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\5\ This was the only testimony Respondent gave pertaining to
his work in obstetrics and gynecology.
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Having read and analyzed all of the record evidence, I agree with
the RD that Respondent was candid in discussing the details of his
misconduct as well as the remedial efforts that he made following his
conviction. RD, at 22-23. However, I also agree with the RD that
Respondent's conflicting statements, particularly those regarding his
characterization of BLS as a ``credible'' laboratory and his initial
claim that he had verified all of the results from BLS, as well as the
defensive bend to much of his testimony, reduce his credibility and the
[[Page 59193]]
weight the decision gives to his testimony. Id. at 23-24; Tr. 33 and
53-57.
II. Discussion
A. Government's Position
In its Proposed Findings of Fact and Conclusions of Law
(hereinafter, Government's Post-Hearing Brief), the Government argues
that ``[m]andatory exclusion pursuant to 42 U.S.C. 1320a-7(a) is a
basis to revoke a DEA registration under 21 U.S.C. 824(a)(5)'' and that
``notwithstanding the fact that the underlying conduct for which
Respondent was convicted had no nexus to controlled substances,
Respondent's mandatory exclusion from Medicare, Medicaid and all
Federal health care programs by HHS/OIG warrants revocation of his
registration pursuant to 21 U.S.C. 824(a)(5).'' Government's Post-
Hearing Brief, at 9. Additionally, the Government argues that
Respondent's continued registration would be contrary to the public
interest, specifically under factor five of 21 U.S.C. 823(f), ``such
other conduct which may threaten the public health and safety.'' Id. at
10-11. Further, the Government argues that ``[Respondent's] crimes were
not wholly unrelated to his practice as a practitioner'' and that
``[his] behavior [evinced] a severe lack of ethical judgment that, had
it occurred in a clinical context, could have resulted in diversion or
an adverse impact on patient care.'' Id. Finally, the Government
expresses doubts as to Respondent's acceptance of responsibility for
his actions and emphasizes the deterrent effects of revoking
Respondent's registration. Id. at 12-13.
B. Respondent's Position
In Respondent's Post-Hearing Brief, Respondent highlighted the
Determination and Order of the Hearing Committee on [New York State]
Department of Health, State Board for Professional Medical Conduct
(hereinafter, Hearing Board) that rejected revocation of Respondent's
medical license and instead suspended Respondent's license.
Respondent's Post-Hearing Brief, at 3. Respondent alleged that the
Hearing Board based its judgment on ``Respondent's acknowledgement of
his poor judgment in accepting bribes, his remorse for his criminal
conduct, and the testimony of two doctors and patients' letters.'' Id.
Respondent also highlighted how he had ``lectured to physician
residents . . . about his misdeeds'' and that ``since [his] release
from prison, [he had] taken over 200 hours of CME courses'' including
DEA's opioid training program. Id. Further, Respondent argued that he
was ``a true follower of the Hippocratic Oath'' and provided letters
from patients, colleagues, family, and friends to ``[demonstrate] the
type of care [he] provided to his patients and how they reflect his
following the Hippocratic Oath.'' Id. at 3-4. In concluding his Post-
Hearing Brief, Respondent emphasized that he had broken the law, made a
mistake, and ``paid dearly for it.'' Id. at 6. Respondent also
reiterated that without a DEA license, he would no longer be able to
practice medicine and earn a living as a doctor. Id.
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)(2). OSC, at 1-2. The Government did not allege that
Respondent's applications should be denied because his 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 prehearing statement. See
generally Govt Prehearing; OSC. The Government raised the public
interest factors in its Post-hearing Brief; however, I find that they
are unavailable as a basis of sanction due to the late stage at which
they were raised. See Robert Wayne Locklear, M.D., 85 FR 33738, 33745
(2021). Accordingly, the OSC's specific substantive basis for proposing
the denial of Registrant's registration application is his mandatory
exclusion under 21 U.S.C. 824(a)(5).
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 33744-45 (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 33745. 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 15972, 15973-74 (1996).
1. 21 U.S.C. 823(f): The Five Public Interest Factors
Under Section 304 of the Controlled Substances Act, ``[a]
registration . . . to . . . dispense a controlled substance . . . may
be suspended or revoked by the Attorney General upon a finding that the
registrant . . . has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined by such section.'' 21 U.S.C. 824(a)(4).
In the case of a ``practitioner,'' defined in 21 U.S.C. 802(21) to
include a ``physician,'' Congress directed the Attorney General to
consider the following factors in making the public interest
determination:
(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. RD, at 13; see also GX 1.
Because the Government has not timely 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 a ground for
revocation
[[Page 59194]]
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 Registrant 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 2, at 1; GX 4, at 3; Respondent's Post-Hearing
Brief, at 2. 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).\6\ 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 15973 (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).
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\6\ 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 46968, 46971-72 (2019); see
also Narciso Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK Pharmacy,
64 FR 49507, 49510 (1999) (collecting cases); Melvin N. Seglin,
M.D., 63 FR 70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61 FR
60727, 60728 (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 46968, 46972 (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 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 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).
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 29569, 29572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49704,
49728). Here, Respondent has not alleged that he committed the
misconduct in question unknowingly or unintentionally. I will,
therefore, look for a clear acceptance of responsibility from
Respondent.
Respondent is clearly remorseful for his conduct, testifying that
it was ``the wrong thing to do'' and that he ``regret[s] it every day,
to this day.'' Tr. 32. However, remorse and acceptance of
responsibility are not the same thing, and I agree with the ALJ's
conclusion that Respondent's consistent focus on his own suffering does
not suggest an unequivocal acceptance of responsibility, but rather,
suggests regret for the negative consequences that he has personally
faced. RD, at 34. As the ALJ found, ``Respondent was more remorseful of
the impact that his decisions had on his own life, rather than the
effects his actions posed to his patients.'' Id. Additionally, I, too,
am ``not convinced that [Respondent] would not take part in such a
scheme in the future, if the monetary need were to arise.'' Id. at 36.
Throughout his testimony, Respondent highlighted his own suffering
above all else, emphasizing that he had ``destroyed [his] whole life''
and lamenting how he had ``embarrassed [himself], [his] family, [and]
became an embarrassment to [his] patients, to [his] community, [and] to
[his] church . . . .'' Tr. 47. Though Respondent did acknowledge that
his actions had affected his patients, his testimony quickly shifted
focus to what he had personally suffered, particularly that he had gone
to prison ``away from [his] family, [and] [his] young children, for two
years.'' Id. at 49. Even when Respondent stated that his actions were
not ``a victimless crime'' and that ``[his] patients were the victims''
his explanation for why his patients were victims was that ``[t]hey
lost [him], [he] lost them.'' \7\ Id. at 60. Further, according to
Respondent's testimony, when Respondent spoke to
[[Page 59195]]
the Medical Society of Staten Island and to the resident physicians at
the Richmond University Medical Center, he ``tried to deter them from
it, not to make [the same] mistake because . . . [he] destroyed his
whole life.'' Id. at 47.
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\7\ I also find it troubling that Respondent has clearly not
attempted to fully understand the impact of his actions on others.
His na[iuml]ve belief that his patients were only victims because
they lost him demonstrates that he has failed to even question
whether there were greater impacts on his patients, potentially
related to insurance claims or increases in pricing, or impacts on
the laboratories that were legitimately conducting their business. I
weigh Respondent's inability to perceive the full impact of his
wrongdoing against a finding that Respondent has accepted
responsibility. See Robert Wayne Locklear, M.D., 86 FR 33738, 33747
(2021) (finding it ``significant in evaluating [the applicant's]
acceptance of responsibility that he did not seem to be aware of the
full extent of the harm that he caused.'').
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Additionally, there are points of Respondent's testimony and
actions in the record that suggest attempts to downplay his mistakes,
further demonstrating a lack of clear acceptance of responsibility and
a lack of full appreciation for the severity of his misconduct. As the
ALJ found, I too find it particularly alarming that despite everything
that has happened, Respondent testified at the hearing that BLS was a
``credible laboratory, actually'' and did not clarify his
characterization until later prompted to do so. Id. at 33, 53-55. I am
also troubled by the letter that Respondent wrote to the Department of
Health and Human Services in which, according to his testimony, he had
questioned his ten-year exclusion and requested a decrease (which was
ultimately rejected) because his misconduct had nothing to do with
billing and ``all [he] did was [he] accepted the bribes.'' Id. at 51-
52. On direct examination, Respondent defended his characterization of
BLS as a ``credible laboratory'' and claimed ``[t]hey never had any
issues with performing the laboratory tests or [for] obtaining results.
They were legitimate results, they were accurate results, and they were
verified,\8\ as well. They never did any improper testing. Their
turnaround time was quicker than the other laboratories, which was also
another reason why [he] used them, as well.'' Id. at 33. As the ALJ
noted, ``[Respondent's] consistent bolstering of [BLS's] credentials
tends to serve as a validation of his behavior.'' RD, at 36. Regarding
himself, Respondent emphasized that he never prescribed unnecessary
medication, never performed any unnecessary tests, was never charged
with performing any unnecessary tests, that the government did not lose
any money because of him, and that the payments made to BLS were not
any higher than they would be to another laboratory. Id. at 32-34.
Overall, Respondent's focus on himself and his minimization of his
wrongdoings suggests that he has not unequivocally accepted
responsibility for his actions and the harm that he caused. See Stein,
84 FR 46972 (finding that a registrant's attempts to minimize his
misconduct weigh against a finding of unequivocal acceptance of
responsibility).
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\8\ As the ALJ noted, Respondent initially claimed that he
verified all of the BLS lab results, but then conceded that he had
not actually verified the results of every single patient he sent to
BLS. Id. at 55-58.
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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 33748, 33773 (2021). While in prison, he
kept up with medical journals, has taken a wide variety of courses--
including over 200 hours in continuing medical educations courses (CME)
\9\--has become a CPR instructor, has taken certifications in ``areas
of medicine that [he wants] to practice,'' and after his release, he
spoke to the Medical Society of Staten Island and to the residents at
Richmond University Medical Center about his crime.\10\ Id. at 38-39,
49, and 64. In concluding his testimony regarding his remediation
efforts, Respondent said, ``[medicine is] the only thing I know how to
do, it's the only thing I want to do, and it's my passion . . . I just
want to get back to practicing medicine, and get back to society.'' Id.
at 49. From Respondent's testimony, it seems that the purpose of his
remediation efforts was not as much about righting his wrongs and
deterring others from similar acts as it was about saving Respondent's
career. In fact, he even admitted to as much when he stated that after
his release from prison, he ``just became very proactive because [he]
wanted [his] medical license.'' Id. at 47. Accordingly, I find that,
again, Respondent's consistent focus on how his own life has been
impacted by his misconduct does not suggest that he can be entrusted
with a DEA registration.
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\9\ Though Respondent testified to completing CME courses, he
did not provide evidence to the record confirming the completion of
the courses.
\10\ 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 24012, 24019 (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.
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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 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 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 10354, 10357 (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 18910 (collecting cases).
In this case, Respondent knew that his arrangement with BLS was wrong
but accepted the arrangement anyway and kept it going for a long period
of time because, ``at that time, he was financially pressed.'' Tr. at
54. The arrangement was a blatant kick back scheme involving
substantial monetary payments.\11\ In addition, the
[[Page 59196]]
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. After receiving 2 to 3 thousand dollars per month, Id.
at 70, there must have been a point at which he was no longer
``financially pressed,'' and yet he continued.
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\11\ 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 and his brother's],'' Tr. 53,
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.
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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 2, at 2. The
exclusion letter explains that HHS/OIG excluded Respondent for ten
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 20728, 20732 (2021) (considering the length of the HHS
exclusion in assessing egregiousness).
D. Letters of Support
My final item of consideration is the collection of eighteen
letters that Respondent submitted from patients, colleagues, friends,
and family to demonstrate his high level of care as a physician and his
commitment to the Hippocratic Oath. Respondent's Post-Hearing Brief, at
3-4;RX 1. 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 45867, 45873 (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 40636, 40641 (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 1;Tr. 41. Additionally, almost
all of the letters are unsigned, four are undated, and none of the
letters are addressed to anyone at DEA. RX 1. Finally, because
Respondent has not demonstrated an unequivocal acceptance of
responsibility, any value that the letters may have offered in
evaluating my ability to trust Respondent with a DEA registration is
nullified by the fact that he, himself, has not shown that he can be so
entrusted. Kinkaid, M.D., 86 FR 40641.
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 consistent focus on his own suffering
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, though genuine, suggest to me that
Respondent views the negative consequences he has faced as obstacles to
overcome in restoring his career rather than the result of a serious
lapse in ethics that calls for self-reflection. 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, if he found himself in difficult financial times, or if
he was persuaded by a friend or family member. 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 order that the pending application for a
Certificate of Registration, Control Number W19115227C, submitted by
Nicholas P. Roussis, M.D., is denied. This Order is effective November
26, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021-23263 Filed 10-25-21; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 26, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.