[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30276-30279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10598]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-19]
Michael T. Harris, M.D.; Decision and Order
On May 20, 2021, a former Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government) issued an Order to Show Cause (hereinafter, OSC), seeking
to revoke the DEA Certificate of Registration, Control No. FH1510709,
of Michael T. Harris, M.D. (hereinafter, Respondent) and deny any
pending applications for renewal or modification of such registration,
or for additional registrations, pursuant to 21 U.S.C. 824(a)(4). OSC,
at 1. The Government alleges that Respondent's continued registration
is inconsistent with the public interest, as defined in 21 U.S.C.
823(f). Id.
A hearing was held before an Administrative Law Judge (hereinafter,
ALJ) on October 12, 2021. The ALJ issued Recommended Rulings, Findings
of Fact, Conclusions of Law, and Decision of the Administrative Law
Judge (hereinafter, Recommended Decision or RD), which recommended that
I revoke Respondent's registration and deny his pending application for
renewal. RD, at 39. Respondent filed Exceptions to the RD on January 7,
2021, and the Government filed its Response on January 28, 2022.
I. Findings of Fact
A. Witness Credibility
The Government presented its case through the testimony of two
witnesses, a DEA Diversion Investigator (hereinafter, DI), Tr. 16-58,
200-01, and Dr. L, a former colleague of Respondent, Tr. 60-80. The ALJ
gave the DI and Dr. L's testimonies full weight and credit. RD, at 7,
9. I adopt her summary of their testimonies and credibility
determinations. Id. at 5-9.
Respondent presented his case through two witnesses, Dr. R., who
medically monitored Respondent's drug rehabilitation, Tr. 80-144, and
Respondent, Tr. 144-190. The ALJ gave little weight to Dr. R's
testimony--finding that Dr. R was a ``combative and, at times,
condescending witness,'' who had a vested interest in Respondent
retaining his DEA registration. RD, at 13-14. I agree with the ALJ's
findings and adopt her credibility determination for Dr. R's testimony.
Id.
I also agree with the ALJ's credibility findings regarding
Respondent's
[[Page 30277]]
testimony. The ALJ found that Respondent presented as generally
credible to the extent he recounted his efforts at rehabilitation from
his substance abuse disorder. RD, at 18. But, as the ALJ pointed out,
Respondent's testimony was noteworthy for what it lacked--there was
virtually no acknowledgement of the fraud Respondent committed or the
numerous people he manipulated and harmed during the fraud. Id. at 18-
19. The ALJ found, as a result, that ``Respondent's testimony sounded
rehearsed and his demeanor and body language in testifying was
nonchalant. His testimony and demeanor sent the message that, while he
had a substance abuse problem, he had successfully engaged in a
rehabilitation program and that should be an end to the inquiry.'' Id.
at 19.
B. Respondent's Fraudulent Prescriptions and Criminal Indictment
Respondent is a Florida physician who holds a DEA registration to
handle controlled substances in Schedules II-V. Stip. 6. From November
2015 through July 2016, Respondent issued twenty-four prescriptions for
controlled substances using the DEA registration number of Dr. L. Tr.
27, GX 2. Respondent admitted that he did not have authorization or
permission from Dr. L to issue the prescriptions using Dr. L's DEA
registration number. Tr. 27, 65-72, 149. Respondent obtained the
prescriptions, some signed and some unsigned, from a lockbox at their
joint practice. Tr. 26, 149, 153-54. Respondent used the prescriptions,
forging Dr. L's signature when necessary, to issue controlled substance
prescriptions to himself and three family members. Id. Respondent
filled the prescriptions for his personal use. Tr. 30, 191-92.
Respondent deliberately filled prescriptions 30 days apart, rotated the
names he used on the prescriptions, and rotated which pharmacy he would
use in an effort to avoid detection. Tr. 88.
Dr. L first learned of Respondent's misuse of his prescription pad
in August 2016. Tr. 74. Dr. L sent a letter to the Florida Board of
Medicine stating that prescriptions were written under his name without
his consent and confronted Respondent. Tr. 74-75.
On October 15, 2019, Respondent was indicted in the Northern
District of Florida on one count of fraudulent acquisition of
controlled substances in violation of 21 U.S.C. 843(a)(3) and (d)(1)
and one count of unlawful use of another's DEA registration in
violation of 18 U.S.C. 1028(a)(7) and (b)(3)(A). Stip. 12. As of the
date of the hearing for this matter, Respondent was participating in a
pretrial diversion program scheduled to end December 25, 2021. Tr. 178.
The DI twice asked Respondent to voluntarily surrender his DEA
registration, once after an interview with Respondent in April of 2017
and once after Respondent's criminal indictment. Respondent declined
both times. Tr. 31, 56-7.
C. Respondent's Rehabilitation
After Respondent was confronted by Dr. L about the fraudulent
prescriptions, Respondent's wife, in conjunction with Dr. L, called the
Florida Department of Health who referred them directly to the
Professional Resources Network (hereinafter, PRN), which has a contract
with the Florida Department of Health to ``monitor physicians and
nurses and other licensed practitioners in different fields for
impairment issues.'' Tr. 83, 100, 157, 159, 186. Respondent began a
rehabilitation program on August 27, 2016, which he reports included
inpatient detoxification, inpatient therapy, and constant monitoring.
Tr. 157-58, 162-64. According to Respondent, he was discharged pursuant
to a PRN monitoring contract, under which he had a PRN social worker or
``case manager'' to whom he reported regularly; weekly PRN meetings for
impaired professionals; a licensed psychologist to ensure compliance;
mandatory Alcoholics Anonymous (AA) meetings; meetings with an
addictionologist (Dr. R); marriage counseling; and random, but regular,
drug testing. Tr. 169. He must also regularly check in with his case
manager and his practice manager (another physician who reviews his
prescriptions and submits quarterly reports to PRN). Tr. 172, 195.
Respondent's PRN contract was scheduled to terminate on December
19, 2021. Tr. 168, 197. Once the contract ended, Respondent would no
longer be required to participate in therapy or be subject to drug
testing and practice monitoring. Tr. 197-98. When asked if he was
planning on stopping all counseling and treatment at the expiration of
the contract, Respondent replied that ``there are several options that
we considered, and that's something I would discuss with my wife'' but
did definitively testify that he would return to AA meetings. Tr. 183-
84
II. Discussion
Section 304(a) of the Controlled Substances Act (hereinafter, CSA)
provides that ``[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 [its] registration under section 823 of this title
inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a). In the case of a practitioner, the CSA
requires the Agency consider the following factors in determining
whether Respondent's registration would be inconsistent with the public
interest:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant'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). The DEA considers these public interest factors
separately. Robert A. Leslie, M.D., 68 FR 15227, 15230 (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 37507, 37508
(1993).
The Government has the burden of proving that the requirements for
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21
CFR 1301.44(e). When the Government has met its prima facie case, the
burden then shifts to the Respondent to show that revoking the
registration would not be appropriate, given the totality of the facts
and circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364,
387 (2008). Having reviewed the record and the ALJ's Recommended
Decision, I agree with the ALJ that the Government has proven by
substantial evidence that Respondent committed acts which render his
continued registration inconsistent with the public interest.
While I have considered all of the public interest factors, the
Government's case seeks the revocation of Respondent's registration
based primarily on conduct most aptly considered under Public Interest
Factors 2 and 4.1 2 Factors 2 and 4 are often
[[Page 30278]]
analyzed together. See, e.g., Fred Samimi, M.D., 79 FR 18698, 18709
(2014). Under Factor 2, the DEA analyzes a registrant's ``experience in
dispensing . . . controlled substances.'' 21 U.S.C. 823(f)(2). Factor 2
analysis focuses on a registrant's acts that are inconsistent with the
public interest, rather than on a registrant's neutral or positive acts
and experience. Randall L. Wolff, M.D., 77 FR 5106, 5121 n.25 (2012)
(explaining that ``every registrant can undoubtedly point to an
extensive body of legitimate prescribing over the course of [the
registrant's] professional career''). Similarly, under Factor 4, the
DEA analyzes a registrant's compliance with federal and state
controlled substance laws. 21 U.S.C. 823(f)(4). Factor 4 analysis
focuses on violations of state and federal laws and regulations.
Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009).
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\1\ Neither the Government nor Respondent introduced evidence of
any action by the appropriate state entity. There is also no
evidence on the record that Respondent has a criminal conviction
related to controlled substances. Accordingly, I find that Factors 1
and 3 do not weigh for or against revocation. See, e.g., Ajay S.
Ahuja, M.D., 84 FR 5479, 5490 (2019); Dewey C. MacKay, M.D., 75 FR
49956, 49973 (2010), pet. for rev. denied, MacKay v. Drug Enf't
Admin., 664 F.3d 808, 822 (10th Cir. 2011).
\2\ Respondent filed an exception to the ALJ's finding that
Factor 5 weighed neither for nor against Respondent. Exceptions, at
12-13. He argues the ALJ should have found that Factor 5 weighed in
Respondent's favor because ``Respondent voluntarily accepted
treatment [for his substance abuse disorder] and has remained
steadfast in his commitment to completing his rehabilitation.'' Id.
Factor 5 analysis focuses on a registrant's conduct that may
threaten the public health and safety and that was not considered
under the other public interest factors. 21 U.S.C. 823(f)(5).
Respondent does not cite to any precedent for his argument that
Factor 5 should weigh in favor of a registrant with a substance
abuse disorder if that registrant has completed rehabilitation. I,
therefore, reject Respondent's exception. I will further consider
Respondent's rehabilitation in the Sanction section, as the ALJ did,
as part of my determination of whether Respondent can be entrusted
with a registration.
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Respondent clearly violated both federal and state law when he
issued fraudulent prescriptions using Dr. L's DEA registration number
and, in some instances, with Dr. L's forged signature. First,
Respondent issued prescriptions for his own personal use to feed his
addiction, not for a legitimate medical use. This violates 21 U.S.C.
844(a), which provides that: ``[i]t shall be unlawful for any person
knowingly or intentionally to possess a controlled substance unless
such substance was obtained directly, or pursuant to a valid
prescription or order, from a practitioner, while acting in the course
of his professional practice.'' Respondent's actions also violate
Florida law, which provides, consistent with the federal law, that
[a] person may not be in actual or constructive possession of a
controlled substance unless such controlled substance was lawfully
obtained from a practitioner or pursuant to a valid prescription or
order of a practitioner while acting in the course of his or her
professional practice or to be in actual or constructive possession
of a controlled substance except as otherwise authorized by this
chapter.
Fla. Stat. Ann. Sec. 893.13(6)(a).
Second, Respondent violated federal and state law when he used Dr.
L's DEA registration number to issue fraudulent prescriptions. It
``shall be unlawful for any person knowingly or intentionally . . . to
use for the purpose of acquiring or obtaining a controlled substance, a
registration number which is . . . issued to another person.'' 21
U.S.C. 843(a)(2). Moreover, it ``shall be unlawful for any person
knowingly or intentionally . . . to acquire or obtain possession of a
controlled substance by misrepresentation, fraud, forgery, deception,
or subterfuge.'' Id. at (a)(3). Again, Florida law has a similar
provision. Fla. Stat. Ann. Sec. 893.13(7)(a)(9) (making it unlawful to
``acquire or obtain, or attempt to acquire or obtain, possession of a
controlled substance by misrepresentation, fraud, forgery, deception,
or subterfuge.''). Accordingly, Factors 2 and 4 weigh in favor of
revocation.
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that a respondent's continued registration is inconsistent with
the public interest due to his violations pertaining to controlled
substances, the burden shifts to the respondent to show why he can be
entrusted with the responsibility carried by his registration. Garret
Howard Smith, M.D., 83 FR 18882, 18910 (2018) (citing Samuel S.
Jackson, 72 FR 23848, 23853 (2007)). DEA cases have repeatedly found
that when a registrant has committed acts inconsistent with the public
interest, ``the Respondent is required not only to accept
responsibility for [the established] misconduct, but also to
demonstrate what corrective measures [have been] undertaken to prevent
the reoccurrence of similar acts.'' Holiday CVS LLC dba CVS Pharmacy
Nos 219 and 5195, 77 FR 62316, 62339 (2012) (internal quotations
omitted). 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).
I find, as the ALJ did, that Respondent has not unequivocally
accepted responsibility for his misconduct. To begin, Respondent's
testimony and overarching case strategy makes clear that he believes
entering a rehabilitation program constitutes acceptance of
responsibility. Tr. 175 (Q: ``Did you take responsibility for your
actions,'' A: ``Yes, I thought I had already showed that by going to
rehab at that time.''). While rehabilitation is an essential pre-
requisite for trusting a person with a substance use disorder with a
registration, it does not address all of the misconduct here--the
calculated fraud which involved a coherent strategy of deception
achieved through the manipulation of multiple people and ended only
because Respondent was caught. Cf. Noah David, P.A., 87 FR 21665,
21173-74 (2022) (Registrant manipulated relationships and engaged in
intentional deceit to unlawfully obtain controlled substances).
Respondent was conspicuously silent on this aspect of the case,
providing minimal details about the fraud, minimizing the scope of his
misconduct by characterizing the fraud as ``improper prescribing,'' and
primarily ignoring that he manipulated a series of people, stole pre-
signed prescriptions, and forged Dr. L's signature. RD, at 30.
Respondent also violated his entrusted position as a DEA registrant by
using his knowledge of the regulatory system to avoid detection, e.g.,
rotating the names on the prescriptions, rotating the pharmacies where
he filled the prescriptions, and waiting thirty days before refilling a
prescription. Id. at 30, 36.
Second, Respondent's decision to seek rehabilitation was not
entirely voluntary; he did so only after he knew Dr. L had reported him
to authorities. Respondent's attempt to characterize his rehabilitation
efforts as voluntary further suggest that he has not truly accepted
responsibility for his conduct, but is merely seeking to portray
himself in the most favorable light in these proceedings. Id. at 30.
When a registrant fails to make the threshold showing of acceptance
of responsibility, the Agency need not address the registrant's
remedial measures. Ahuja, 84 FR at 5498 n.33; Daniel A. Glick, D.D.S.,
80 FR 74800, 74801, 74810 (2015); see also Jones Total Health Care
Pharmacy, LLC, SND Healthcare, LLC, 881 F.3d 823, 833 (11th Cir. 2018)
(upholding DEA's refusal to consider pharmacy's remedial measures given
lack of acceptance). But
[[Page 30279]]
even if I were to consider Respondent's remedial measures, they would
not affect my ultimate decision in this matter. While I give Respondent
credit for the rehabilitation he has pursued so far, it is significant
that Respondent has never sustained his sobriety outside the context of
a regulated drug program and has provided no documentary evidence
corroborating his sobriety and remedial measures. I find it troubling
that as of the date of the administrative hearing, he had no set plans
for further treatment or other remedial measures once his PRN contract
expired. Respondent's remedial measures also dealt only with his drug
addiction, and he provided no evidence of remedial measures with
respect to his fraudulent scheme aside from taking general, required
courses on proper prescribing. Tr. 193-94. Thus, Respondent's remedial
measures are inadequate given his lack of corroborating evidence of the
measures he has already undertaken, his nonexistent plan for the
future, and his failure to show any remedial measures related to his
fraud.\3\
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\3\ Respondent argues the ALJ did not give proper weight to his
handling of controlled substances during the five years between the
fraudulent prescriptions and the OSC. Exceptions, at 20-21. I agree
with the ALJ that, while the record does not contain any evidence
that Respondent has issued fraudulent prescriptions or tested
positive for drugs since 2016 (an assertion for which he has
provided no documentary support), I cannot conclude Respondent has
learned from his mistakes and can be entrusted with a new
registration because of his failure to acknowledge his fraud and the
impact it had on those he manipulated and placed in legal jeopardy.
RD, at 34.
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In addition to acceptance of responsibility, the Agency looks to
the egregiousness and extent of the misconduct, Garrett Howard Smith,
M.D., 83 FR at 18910 (collecting cases), and gives consideration to
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (2015). Here,
Respondent's fraud was egregious--he perpetrated a calculated,
sophisticated scheme, manipulating those who trusted him, and using his
knowledge as a DEA registrant to evade detection. See Jana Marjenhoff,
D.O., 80 FR 29067, 29095 (2015). As for general deterrence, failing to
impose a significant sanction against Respondent would send the wrong
message to other registrants that the Agency does not take fraud
seriously--especially a fraudulent scheme in which a registrant uses
his knowledge of the controlled system of distribution to defeat it.
Such a message would be inconsistent with past Agency precedent and the
goals of the CSA. Id.
As for specific deterrence, the ``Agency also looks to the nature
of the crime in determining the likelihood of recidivism and the need
for deterrence.'' Jeffrey Stein, M.D., 84 FR 46968, 49973 (2019). The
Agency has previously found that criminal convictions and sanctions by
state licensing authorities can sufficiently deter physicians from
engaging in misconduct, making the revocation of a registration
unnecessary to achieve specific deterrence. Kansky J. Delisma, M.D., 85
FR 23845, 23854 (2020). Here, Respondent has not been criminally
convicted and there is no evidence in the record that he has faced any
sanctions by the state licensing authority. As a result, the interest
of specific deterrence clearly favors the sanction of revocation.
As discussed above, to avoid sanction when grounds for revocation
exist, a respondent must convince the Administrator that he can be
entrusted with a registration. I find that Respondent has not met this
burden.\4\ Accordingly, I shall order the sanctions the Government
requested, as contained in the Order below.
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\4\ In his Exceptions, Respondent re-raises nine DEA cases he
previously cited in his posthearing brief and cites to three
additional cases, which, he argues, demonstrate revocation in this
matter is improper. Exceptions, at 24-27. I disagree. As noted in
the RD, clear Agency precedent requires full acceptance of
responsibility, and Respondent has failed to demonstrate such
acceptance. See RD, at 38-39 (collecting cases). Imposing a sanction
of revocation in this matter is consistent with recent agency
decisions that have revoked registrations in matters where a
registrant unlawfully obtained controlled substances for personal
use and failed to accept full responsibility. See, e.g. David Mwebe,
M.D., 85 FR 51065, 51068 (2020) (revoking registration based on
fraudulent issuance of prescriptions for personal use); David W.
Bailey, M.D., 81 FR 6045, 6047 (2016) (revoking registration of
physician who issued controlled prescriptions in his wife's name for
personal use). For example, in Erica Grant, M.D., the Agency revoked
the registration of a registrant with a substance abuse disorder
because, while she had accepted responsibility for her unlawful use
of controlled substances, her acceptance of responsibility did not
cover all of the Agency's charges against her. 86 FR 40641, 40650
(2021); see also, Robert Wayne Locklear, M.D., 86 FR 33738, 33747-48
(2021).
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of
Registration No. FH1510709 issued to Michael T. Harris, M.D. Pursuant
to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f),
I further hereby deny any pending application to renew or modify this
registration, as well as any other pending applications of Michael T.
Harris, M.D. This Order is effective June 17, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-10598 Filed 5-17-22; 8:45 am]
BILLING CODE 4410-09-P