[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

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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

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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

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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