[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35795-35797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12612]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-24]
Gary A. Matusow, D.O.; Decision and Order
An official of the Drug Enforcement Administration (``Government'')
issued an Order to Show Cause (OSC) seeking to deny the pending
application for a Drug Enforcement Administration (DEA) Certificate of
Registration of Gary Matusow, D.O. (``Respondent'').\1\ After a
hearing, the Administrative Law Judge (ALJ) recommended that
Respondent's application be denied.\2\ The Agency agrees with the ALJ's
conclusion, and, for the reasons explained below, denies Respondent's
application as inconsistent with the public interest under 21 U.S.C.
823(f).
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\1\ Administrative Law Judge Exhibit (ALJX) 1 (OSC).
\2\ See Recommended Rulings, Findings of Fact, Conclusions of
Law, and Decision of the Administrative Law Judge (``Recommended
Decision'' or ``RD''). Respondent filed Exceptions, but later asked
to withdraw them. Resp Notice to Dismiss, at 2-3. The Agency is
granting Respondent's request to withdraw his Exceptions, but
declining Respondent's request to adopt the Recommended Decision and
instead issuing a Final Order based on consideration of the record
in its entirety.
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I. Findings of Fact
On November 14, 2018, Respondent submitted an application for a DEA
Certificate of Registration. GX 1. Respondent was previously registered
with DEA to handle controlled substances but voluntarily surrendered
this registration for cause. GX 9.
The Government and Respondent have agreed to fifty-eight
stipulations, which are hereby incorporated into the record. See RD, at
41-47.
Respondent was previously employed as an osteopathic physician
partner at a practice in New Jersey that he shared with a partner, Dr.
M.\3\ Between August 9, 2015, and January 8, 2017, Respondent filled
(or refilled) prescriptions for controlled substances that were issued
with Dr. M's DEA registration. Stip. 17-18. Respondent issued each of
the prescriptions to himself by calling them into a pharmacy with Dr.
M's name. Stip. 19. Respondent picked up each of the prescriptions from
the pharmacy. Stip. 20. Respondent is not a patient of Dr. M and was
not a patient of his when the prescriptions were issued. Stip. 21.
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\3\ Stip. 14. Respondent's partner's name has been replaced with
his initial.
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A. Allegations
The Government argues that Respondent's application for a new DEA
registration should be denied because he displayed dishonesty in a
number of ways and violated the law.\4\ The Government has shown that
Respondent obtained controlled substances for his personal use in
violation of state law, but the Government's other allegations are not
sustained.
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\4\ Govt Posthearing, at 3. In its Posthearing Brief, the
Government also alleged that Respondent issued a prescription for
phentermine, a controlled substance, in violation of N.J. Admin.
Code Sec. 13.35-7.5A(b) and 21 CFR 1306.04. This allegation is not
sustained because its legal grounds were not properly noticed.
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1. Respondent Obtained Controlled Substances Without a Valid
Prescription in Violation of State Law
The Government has alleged that Respondent violated N.J. Stat. Ann.
Sec. 2C:35-10 when he filled the controlled substance prescriptions
issued under Dr. M's name and DEA registration number. Under N.J. Stat.
Ann. Sec. 2C:35-10, it is ``unlawful for any person, knowingly or
purposely, to obtain . . . a controlled dangerous substance . . .
unless the substance was obtained directly, or pursuant to a valid
prescription or order form from a practitioner, while acting in the
course of his professional practice . . . .''
Respondent admits that he obtained controlled substances pursuant
to prescriptions authorized by Dr. M and under Dr. M's DEA registration
despite not being a patient of Dr. M. See Stip. 21. Respondent
testified that when he asked Dr. M for authorization to call in the
prescriptions under Dr. M's name, Respondent knew he should have been a
patient of the practice and that the discussion between Respondent and
Dr. M about his health issues should have been documented in a patient
chart. Tr. 358-59; see N.J. Admin. Code Sec. 13:35-7.1A (``[A]
practitioner shall not dispense drugs or issue a prescriptions to an
individual . . . without first having conducted an examination, which
shall be properly documented in the patient record.''). Respondent also
admitted that he knew the prescriptions did not comply with state and
federal regulations. See Tr. 456-59. When asked if he believed Dr. M
had taken ``those steps that you have to take before you prescribe
controlled substances,'' Respondent responded that he did not and that
he thought that he and Dr. M were both negligent. Id. at 456. He also
testified that he knew the Dr. M prescriptions were ``off the books''
and that they exposed Dr. M to professional and potential criminal
liability. Id. at 456-57.
Based on Respondent's admissions during the administrative hearing,
the Agency finds that he knew the subject prescriptions were not valid
prescriptions issued in the usual course of Dr. M's professional
practice. Accordingly, the Agency finds that Respondent violated N.J.
Stat. Ann. Sec. 2C:35-10.
2. Allegation That Respondent Used Dr. M's DEA Registration To
Fraudulently Obtain Controlled Substances
The Government has alleged that Respondent fraudulently obtained
controlled substances by using Dr. M's DEA registration number without
Dr. M's authorization in violation of federal law (21 U.S.C. 843(a)(3))
and state law (N.J. Stat. Ann. Sec. 2C:35-10). Dr. M and Respondent
gave conflicting testimony as to whether Dr. M authorized Respondent's
use of Dr. M's registration to obtain these controlled substances. The
ALJ was in the best position to observe the demeanor of the witnesses,
and having considered his credibility determinations in light of the
``consistency and inherent probability of the testimony,'' the Agency
adopts the ALJ's findings regarding Dr. M's and Respondent's testimony
on this issue. See Universal Camera Corp. v. NLRB, 340 U.S. 474, 496
(1951); see also Tr. 242-43; RD, at 77-78, 85-88. Accordingly, the
Agency finds no violation of these laws.\5\
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\5\ The Government has also alleged that Respondent's conduct
violated 21 U.S.C. 843(a)(2). Govt Posthearing, at 27. This
provision was not fully briefed until after the RD. See Resp
Exceptions, at 13-15; Govt Response to Resp Exceptions, at 11-15.
The Agency declines to make a finding on this criminal violation
because the factual record in this case has not been developed
sufficiently to determine how section 843(a)(2) applies.
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[[Page 35796]]
3. Allegation That Respondent Prescribed Controlled Substances After
Agreeing To Cease Medical Practice
Respondent entered into a Consent Order with the New Jersey State
Board of Medical Examiners (BME). See Stip. 32; GX 5. The Government
alleges that Respondent prescribed in violation of this Consent Order,
illustrating a lack of candor. Govt Posthearing, at 34; OSC, at 4-5.
The Agency is not sustaining this allegation: the Government has not
proven that Respondent had reached an agreement to cease the practice
of medicine when he issued the prescriptions or that Respondent was
less than candid with the BME regarding the prescriptions. GX 5, at 2;
see also RD, at 95-96, 99-100.
4. Allegation That Respondent's Answers to Questions in his Application
for Registration Displayed a Lack of Candor
The Government alleges that, on his application to DEA for a new
registration, Respondent failed to fully explain the circumstances
behind his voluntary surrender for cause of his previous registration,
demonstrating an alleged lack of candor. OSC, at 4. After a review of
Respondent's written statements in his application, the Agency agrees
with the ALJ that the information Respondent disclosed was truthful.
See RD, at 112-114. The lack of the omitted information does not make
his response deceptively incomplete, and the Government's allegation
thus is not sustained.\6\
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\6\ The Government also alleged that Respondent's answers on his
registration application displayed a failure to accept
responsibility for fraudulent use of Dr. M's registration, but, as
explained, the record does not support a finding that Respondent
fraudulently used Dr. M's registration to obtain controlled
substances.
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II. Discussion
``The 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). An application for
a practitioner's registration may be denied if ``the issuance of such
registration . . . would be inconsistent with the public interest.''
Id. In making this determination, the following factors are considered:
(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.
Id. These factors are considered separately. Robert A. Leslie,
M.D., 68 FR 15,227, 15,230 (2003). Each factor is weighed on a case-by-
case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C.
Cir. 2005). Any one factor, or combination of factors, may be decisive.
David H. Gillis, M.D., 58 FR 37,507, 37,508 (1993).
A. Factor 1
Respondent entered into a Consent Order with the BME. Supra I.A.3;
GX 5. While this is not a direct recommendation for purposes of Factor
1, it indicates a recommendation by the appropriate state entity on
many of the allegations and evidence at issue here. John O. Dimowo, 85
FR 15,800, 15,810 (2020). It makes clear that the Board knew Respondent
had called in prescriptions for controlled substance for himself using
Dr. M's name.\7\ It is not clear, however, what details regarding
Respondent's self-prescribing were before the Board or the basis for
the Board's disciplinary action in the Consent Order--although the
multi-year requirement that Respondent be monitored by third parties
does not indicate substantial trust in Respondent. For these reasons,
the Consent Order is not dispositive of the public interest inquiry in
this case, and although the Agency has considered the Order slightly in
favor of Respondent, it is also minimized by the circumstances
described above. See John O. Dimowo, 85 FR at 15,810-11.\8\
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\7\ Additionally, an investigator for the Board was present
during the interview the DI had with Respondent and his attorney
regarding the DEA's investigation in May 2017. Tr. 97.
\8\ There is no evidence on the record that Respondent has a
criminal conviction related to controlled substances. Accordingly,
Factor 3 does not weigh for or against a finding that his
application for registration is in the public interest. See, e.g.,
Dewey C. MacKay, M.D., 75 FR 49,956, 49,973 (2010).
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B. Factors 2 and 4
Evidence is considered under Public Interest Factors 2 and 4 when
it reflects an applicant's compliance (or non-compliance) with laws
related to controlled substances and experience dispensing them.
Established violations of the Controlled Substances Act (CSA), DEA
regulations, or other laws regulating controlled substances at the
state or local level are cognizable when considering if a registration
is consistent with the public interest. Here, Respondent violated N.J.
Stat. Ann. Sec. 2C:35-10. Supra I.A.1. This violation is most
appropriately considered under Factor 4 and weighs against a finding
that Respondent's application for a DEA registration is in the public
interest, because the Government has proven that Respondent failed to
comply with a state law related to controlled substances.\9\
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\9\ Respondent has demonstrated substantial experience as a
gastroenterologist since 1988. The Agency assumes that Respondent
has prescribed legally because the Agency has not sustained
allegations related to Respondent's dispensing of controlled
substances. Accordingly, the Agency finds that Factor 2 does not
weigh against Respondent's application.
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C. Factor 5
Respondent has admitted to conduct that may threaten the public
health and safety and is properly considered under Factor 5. Respondent
believed it to be illegal to prescribe controlled substances to
himself, Tr. 355, so instead he obtained casual, non-specific
permission from his partner to prescribe himself controlled substances
under his partner's registration. He did this with the knowledge that
he and his partner had not established a legitimate doctor-patient
relationship under state law. Respondent's conduct clearly circumvented
the closed regulatory system established by the CSA and ``makes
questionable [the Respondent's] commitment to the DEA statutory and
regulatory requirements designed to protect the public from diversion .
. . .'' Net Wholesale, 70 FR 24,626, 24,627 (2005). Respondent's
admitted conduct is inconsistent with the public interest under Factor
Five. 21 U.S.C. 823(f)(5).
D. Balancing of the Public Interest Factors
Respondent violated a state law related to controlled substances
and committed other conduct that may threaten the public health and
safety, weighing against finding that his registration would be in the
public interest under Factors 4 and 5. The other public interest
factors are inapplicable or do not weigh significantly for or against
finding that Respondent's registration would be in the public interest.
Thus, the Government established a prima facie case that Respondent's
registration ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f).
III. Sanction
Where, as here, the Government has established grounds to deny an
[[Page 35797]]
application for a registration, the burden shifts to the respondent to
show why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 (2018).
When a registrant has committed acts inconsistent with the public
interest, they must both accept responsibility and demonstrate they
have undertaken corrective measures. Holiday CVS LLC dba CVS Pharmacy
Nos 219 and 5195, 77 FR 62,316, 62,339 (2012) (internal quotations
omitted). Trust is necessarily a fact-dependent determination based on
individual circumstances; 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, e.g., Robert Wayne Locklear, M.D., 86 FR 33,738,
33,746 (2021). When a registrant fails to make the threshold showing of
acceptance of responsibility, the Agency need not address the
registrant's remedial measures.\10\ Daniel A. Glick, D.D.S., 80 FR
74,800, 74,810 (2015).
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\10\ Here, although Respondent's Continuing Medical Education
efforts were in excess of what New Jersey required, RD, at 38
(citing Tr. 414-15; RX 1), Respondent has not sufficiently convinced
the Agency that he has accepted responsibility and can be entrusted
with a registration.
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The Agency adopts the ALJ's finding, that while Respondent
testified that what he did was inappropriate and that he ``wouldn't do
it again,'' Tr. 458, he has not accepted full responsibility for his
misconduct. RD, at 116. When asked about Dr. M's responsibility,
Respondent answered, ``I think we were both negligent'' and ``it was
carelessness on my part to even ask him.'' Tr. 456, 459.\11\ The
Respondent's characterizations of his misconduct minimized the
seriousness of his actions. See Jeffrey Stein, M.D., 84 FR 46,968,
46,972.\12\
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\11\ Respondent is credited for declining to pass blame to his
former partner, given the animosity between the two.
\12\ Respondent's actions were not ``negligent,'' nor were they
mere ``carelessness''--they constitute criminal misconduct under New
Jersey law.
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Respondent was not ignorant to his misdeeds. He knew self-
prescribing using his own DEA registration would raise suspicion at the
pharmacy, Tr. 355, so he decided, based on his knowledge as a DEA
registrant, to self-prescribe using Dr. M's registration, presumably to
evade detection. Respondent's actions also do not reflect a momentary
lapse in judgment. He used Dr. M's registration to self-prescribe for
over a year and a half. See Noah David, P.A., 87 FR 21,165, 21,174
(2022); see also Garrett Howard Smith, M.D., 83 FR 18,882, 18,910
(2018) (collecting cases) (``The egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction.'') Therefore, as the ALJ stated, ``Respondent has lost a
significant amount of trust and has failed to overcome that loss and
demonstrate to the Agency that he can now be entrusted to maintain his
[registration] in a lawful fashion.'' RD, at 118.\13\
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\13\ Respondent submitted letters and character testimony. RX 5-
18. The letters are of limited weight because the Agency has limited
ability to assess their actual credibility. See Michael S. Moore,
M.D., 76 FR 45,867, 45,873 (2011). They also do not appear to be
written to recommend that Respondent be granted a registration and
offer little value in assessing his suitability to discharge those
duties. The character testimony is more relevant to the former
partners' relationship and is viewed with caution given the ALJ's
credibility findings. See RD, at 68-70. These references very
minimally support Respondent's potential for rehabilitation.
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Furthermore, specific and general deterrence weigh in favor of
denial of Respondent's application. Daniel A. Glick, D.D.S., 80 FR at
74,810. Given the egregious nature of Respondent's violations, a
sanction less than denial would send a message to the current and
prospective registrant community that compliance with core controlled-
substance legal principles is not a condition precedent to receiving
and maintaining a DEA registration.
As discussed above, to receive a registration when grounds for
denial exist, a respondent must convince the Agency that his acceptance
of responsibility and remorse are sufficiently credible to demonstrate
that the misconduct will not reoccur and that he can be entrusted with
a registration. Having reviewed the record in its entirety, the Agency
finds that Respondent has not met this burden and orders the denial of
the application for the certificate of registration at issue in this
case, as contained in the Order below.
However, in light of the passage of time since the surrender of his
previous registration, if Respondent can demonstrate that he will
reliably treat his controlled substances registration with the respect
that such a responsibility deserves and requires under the law, the
Agency is instructing the Government to consider such facts in
assessing any new application.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby deny DEA registration application No.
W18122357C submitted by Gary Matusow, D.O. This Order is effective July
13, 2022.
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 6, 2022, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-12612 Filed 6-10-22; 8:45 am]
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