[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75309-75312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24151]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-36]


Osmin A. Morales, M.D.; Decision and Order

    On May 25, 2022, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Osmin A. Morales, 
M.D., (Respondent) of Florida seeking to deny his application for a DEA 
Certificate of Registration, Control No. W20125906C, and alleging that 
his registration ``would be inconsistent with the public interest.'' 
OSC, at 1 (citing 21 U.S.C. 823(g)(1) \1\).
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    \1\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Pub. L. 117-215, 136 Stat. 2257 
(2022) (Marijuana Research Amendments or MRA), amended the 
Controlled Substances Act (CSA) and other statutes. Relevant to this 
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
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    A hearing was held before DEA Chief Administrative Law Judge John 
J. Mulrooney, II (the Chief ALJ). On February 8, 2023, the Chief ALJ 
issued his Recommended Rulings, Findings of Fact, Conclusions of Law, 
and Decision (RD), which recommended that the Agency deny Respondent's 
application. RD, at 22. Respondent did not file exceptions to the RD. 
Having reviewed the entire record, the Agency adopts and hereby 
incorporates by reference the entirety \2\ of the Chief ALJ's rulings, 
credibility findings,\3\ findings of fact,

[[Page 75310]]

conclusions of law, and recommended sanction in the RD and summarizes 
and expands upon portions thereof herein.
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    \2\ See footnotes 4 and 6, infra.
    \3\ The Agency adopts the Chief ALJ's summary of each of the 
witnesses' testimonies as well as the Chief ALJ's assessment of each 
of the witnesses' credibility. See RD, at 3-10. The Agency agrees 
with the Chief ALJ that the Diversion Investigator's (DI) testimony, 
which focused on the investigative steps completed in the case and 
establishing the foundations for exhibits received into the record, 
was sufficiently detailed, plausible, and internally consistent to 
be afforded full credibility. See id. at 3-4. The Agency also agrees 
with the Chief ALJ's assessment of the testimony provided by a Task 
Force Agent (TFA) on investigative assistance provided to DEA and 
non-controversial introduction of documentary evidence. See id. at 
4. The testimony was sufficiently detailed, plausible, and 
internally consistent to be afforded full credibility. Id. M.L., 
mother of Patient K.L, primarily testified about her observations of 
K.L. during the time period in which Respondent issued K.L. 
controlled substance prescriptions, as well as an interaction with 
Respondent at his medical office. Id. at 5-6. Despite M.L.'s 
apparent anger toward Respondent for the role that she believed he 
played in her daughter's addiction to pain medication, the Agency 
agrees with the Chief ALJ that M.L.'s testimony was sufficiently 
consistent, plausible, and detailed to be afforded credibility. See 
id. at 6. Further, the Agency agrees with the Chief ALJ that Dr. 
Mark Rubenstein, M.D., the Government's expert witness, provided 
opinions on Florida's standard of care and Respondent's prescribing 
history that ``gave every appearance of being comprehensive and 
well-reasoned,'' were unrefuted and uncontroverted, and merited 
controlling weight. Id. at 10. Respondent did not present a case. 
Id. at 3; Tr. 1,124-25.
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I. Findings of Fact

    The Agency finds from clear, unequivocal, convincing, and 
unrebutted evidence that Respondent committed numerous failures in his 
prescribing conduct that fell below the standard of care in Florida. 
Overall, the Agency finds that Respondent issued at least 252 
prescriptions \4\ to patients from September 27, 2017, through November 
25, 2020, without a legitimate medical purpose, outside the usual 
course of professional practice, and beneath the standard of care in 
Florida. See RD, at 18-19.
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    \4\ In addition to the misconduct discussed in this Decision, 
the Chief ALJ found misconduct related to 23 prescriptions 
Respondent issued to patients on November 18, 2020, that the 
Government alleged were either (a) signed and dated prior to their 
issuance date, (b) fraudulently written by Respondent's staff, and/
or (c) issued after Respondent surrendered his prior DEA 
registration. RD, at 4, 18-19. Based on the overwhelming nature of 
the evidence establishing Respondent's other misconduct in his 
prescribing of controlled substances, the Agency need not reach a 
factual finding with regard to these 23 prescriptions.
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Florida Standard of Care

    Dr. Rubenstein provided expert testimony on the applicable standard 
of care for prescribing controlled substances in Florida.\5\ RD, at 7-
8; Tr. 637. According to Dr. Rubenstein, a physician is required to 
conduct ``an appropriate history and physical examination to establish 
an appropriate medical diagnosis, [and] review appropriate medical 
records,'' prior to prescribing a controlled substance. RD, at 7 
(quoting Tr. 638). Dr. Rubenstein further explained that while the 
nature and depth of the physical examination may vary depending on the 
location of the pain, it should include an assessment tailored to the 
patient's particular complaints. RD, at 7; Tr. 639-40. He clarified 
that while the physical examination at the initial visit is usually the 
most thorough, physicians must still conduct additional physical 
examinations at subsequent visits. RD, at 7; Tr. 641. Dr. Rubenstein 
emphasized that ``[t]o prescribe controlled substances, you must 
establish an appropriate and valid medical diagnosis.'' RD, at 7 
(quoting Tr. 646).
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    \5\ The Agency adopts and incorporates by reference the entirety 
of the Chief ALJ's findings regarding the standard of care in 
Florida and the related summary of Dr. Rubenstein's expert 
testimony.
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    Dr. Rubenstein also testified that prior to issuing a controlled 
substance prescription, a physician should query the state prescription 
monitoring program (PMP), which, in Florida, is the Electronic-Florida 
Online Reporting of Controlled Substance Evaluation Program (E-FORCSE). 
RD, at 7-8; Tr. 638, 650, 835-36. The physician should also assess and 
document signs of misuse or noncompliance. RD, at 8; Tr. 647, 651-52. 
Notably, Dr. Rubenstein stressed the importance of maintaining ``full 
and appropriate records'' that include patient history, physical 
examinations, medical records, diagnostic studies, and controlled 
substance prescriptions. RD, at 8 (quoting Tr. 646); Tr. 650, 813.

The Patients

Patient K.L.
    Regarding Patient K.L., the Agency finds that Respondent issued at 
least 110 controlled substance prescriptions from July 9, 2018, through 
November 25, 2020, without a legitimate medical purpose, outside the 
usual course of professional practice, and beneath the applicable 
standard of care.\6\ See RD, at 18-19; GX 7, 12; Tr. 670-71, 852-54. 
Based on Dr. Rubenstein's testimony and the record as a whole, these 
prescriptions were issued without a legitimate medical purpose, outside 
the usual course of professional practice, and beneath the standard of 
care because Respondent failed to appropriately establish or document a 
medical indication (RD, at 8; GX 11; Tr. 689-90, 705, 708-10, 714, 719, 
722, 725, 736-37, 853), altered prescriptions without any documented 
justification (RD, at 8; GX 11; Tr. 825-34), maintained Patient K.L. on 
high doses and high-risk combinations of controlled substances without 
any established or documented medical indication (RD, at 8-9; GX 11; 
Tr. 671, 687, 706, 710, 712-13, 717-19, 725-26, 729, 737, 853), issued 
prescriptions on dates prior to correlating patient visits (RD, at 9; 
GX 11-12; Tr. 758-61, 801-810), failed to resolve or adequately address 
signs of potential diversion prior to issuing prescriptions (RD, at 9; 
GX 11; Tr. 825-27, 839, 841, 843-48, 853-54), failed to document and 
maintain copies of certain prescriptions (RD, at 9; GX 11-12; Tr. 814-
19) created patient records with inconsistent information (RD, at 9; GX 
11-12; Tr. 745-50, 756-58, 851-52, 957-58), and/or failed to conduct 
in-person examinations of the patient, including a purported office 
visit noted in Patient K.L.'s file when evidence indicated that 
Respondent was not in the country (RD, at 9; GX 11-12, 20; Tr. 542, 
745-50, 756-58, 851-52, 957-58).
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    \6\ Based on the overwhelming evidence of misconduct related to 
Respondent's prescribing to K.L., the Agency need not issue findings 
regarding prescriptions issued to K.L. on July 5, 2016, and July 15, 
2016.
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Patient R.J.
    Regarding Patient R.J., the Agency finds that Respondent issued at 
least 83 controlled substance prescriptions from August 2, 2018, to 
October 26, 2020, without a legitimate medical purpose, outside the 
usual course of professional practice, and beneath the standard of care 
in Florida. See RD, at 18-19; GX 14; 857, 925-26. Based on Dr. 
Rubenstein's testimony and the record as a whole, these prescriptions 
were issued beneath the standard of care and outside the usual course 
of professional practice because Respondent failed to appropriately 
establish or document a medical indication (RD, at 8; GX 13; Tr. 863, 
868-69, 885, 896-97, 904-06), maintained Patient R.J. on high doses and 
high-risk combinations of controlled substances without any established 
or documented medical indication (RD, at 8-9; GX 13; Tr. 866-67, 898, 
905-06, 925), issued prescriptions on dates prior to correlating 
patient visits (RD, at 9; GX 13-14; Tr. 914-17), failed to resolve or 
adequately address signs of potential diversion prior to issuing 
prescriptions (RD, at 9; GX 13; Tr. 920-23, 925), failed to document 
and maintain copies of certain prescriptions (RD, at 9; GX 13-14; Tr. 
917-20), and/or created patient records with inconsistent information 
(RD, at 9; GX 13-14; Tr. 882, 911, 914).
Patient A.H.
    Regarding Patient A.H., the Agency finds that Respondent issued at 
least 19 controlled substance prescriptions from June 26, 2019, through 
November 11, 2020, without a legitimate medical purpose, outside the 
usual course of professional practice, and beneath the standard of care 
in Florida. See RD, at 18-19; GX 16; Tr. 927-28, 931. Based on Dr. 
Rubenstein's testimony and the record as a whole, these prescriptions 
were issued beneath the standard of care and outside the usual course 
of professional practice because Respondent failed to appropriately 
establish or document a medical indication (RD, at 8; GX 15; Tr. 927-
29), maintained Patient A.H. on high doses and high-risk combinations 
of controlled substances without any established or documented medical 
indication (RD, at 8-9; GX 15; Tr. 927-

[[Page 75311]]

29), and/or failed to conduct and document a physical examination, 
obtain and document a medical history, monitor and document compliance, 
and/or create and document a treatment plan (RD, at 9-10; GX 15; Tr. 
928-31).
Patient R.H.
    Regarding Patient R.H., the Agency finds that Respondent issued at 
least 37 controlled substance prescriptions from September 27, 2017, 
through November 4, 2020, without a legitimate medical purpose, outside 
the usual course of professional practice, and beneath the standard of 
care in Florida. See RD, at 18-19; GX 18; Tr. 934, 941. Based on Dr. 
Rubenstein's testimony and the record as a whole, these prescriptions 
were issued beneath the standard of care and outside the usual course 
of professional practice because Respondent failed to appropriately 
establish or document a medical indication (RD, at 8; GX 17; Tr. 939), 
maintained Patient R.H. on high doses and high-risk combinations of 
controlled substances without any established or documented medical 
indication (RD, at 8-9; GX 17; Tr. 712, 933-34), and/or failed to 
conduct and document a physical examination, obtain and document a 
medical history, monitor and document compliance, and/or create and 
document a treatment plan (RD, at 9-10; GX 17; Tr. 934-35, 939-41).
Patients M.P., C.C., and C.A.
    The Agency finds that Respondent issued one controlled substance 
prescription each to Patients M.P., C.C., and C.A.--on January 3, 2019, 
January 2, 2019, and December 26, 2018, respectively--without a 
legitimate medical purpose, outside the usual course of professional 
practice, and beneath the standard of care in Florida.\7\ See RD, at 
18-19; Tr. 945-46, 949-50, 956, 959-60. Although office visit notes 
indicated that Respondent had conducted in-person examinations of these 
patients, testimony by the DI and TFA, as well as U.S. Customs and 
Border Protection records, established that Respondent was not in the 
United States when he issued these controlled substance prescriptions. 
RD, at 5; GX 20, 22-27; Tr. 141-48, 608-25. Based on this evidence and 
related testimony by Dr. Rubenstein, these controlled substance 
prescriptions were issued to M.P., C.C., and C.A. without a legitimate 
medical purpose, outside the usual course of professional practice, and 
beneath the standard of care in Florida. RD, at 9; Tr. 941-56, 960.
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    \7\ Respondent also issued four controlled substance 
prescriptions to Patient K.L. when Respondent was not in the 
country. See supra, Patient K.L.
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II. Discussion

    According to the CSA, a practitioner's application for a DEA 
registration may be denied upon a determination that ``the issuance of 
such registration . . . would be inconsistent with the public 
interest.'' 21 U.S.C. 823(g)(1). In the case of a practitioner, the CSA 
requires that the Agency consider the following factors in determining 
whether an applicant's registration would be inconsistent with the 
public interest:
    (A) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (B) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(g)(1).

    DEA considers these public interest factors in the disjunctive. 
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 proof in this proceeding. 21 CFR 
1301.44. While the Agency has considered all of the public interest 
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of 
its prima facie case for denying Respondent's application is confined 
to Factors B and D. See RD, at 13, n.24 (finding that Factors A, C, and 
E do not weigh for or against the sanction sought by the Government).

Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21156, 21162 (2022). DEA regulations require that for a 
prescription for a controlled substance to be effective, it must be 
issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of professional practice. 21 CFR 1306.04(a); 
see also 21 U.S.C. 829.
    Based on Dr. Rubenstein's uncontroverted expert opinion, the Agency 
finds that Respondent issued more than 250 prescriptions outside of the 
usual course of professional practice and beneath the Florida standard 
of care in violation of Federal law. See supra I. Additionally, the 
Agency finds that Respondent violated Fla. Stat. section 456.44(3) with 
regard to patients K.L., R.J., A.H., and R.H., by failing to obtain 
and/or document a medical history, establish and/or document a medical 
indication for prescribing, conduct and/or document a physical 
examination, create and/or document a treatment plan, monitor and 
document compliance, and/or maintain accurate and complete medical 
records.
    The Agency finds that for each of the seven patients at issue, 
Respondent failed to maintain sufficiently detailed medical records 
that were accurate and complete and, among other things, justified the 
course of medical treatment, thereby violating Fla. Stat. section 
456.44(3), Fla. Stat. section 458.331(1)(m), and Fla. Admin. Code r. 
64B8-9.003. Lastly, the Agency finds that Respondent violated Fla. 
Stat. section 458.331(1)(k) by preparing office visit notes stating 
that he had conducted in-person examinations of patients K.L., M.P., 
C.C., and C.A., when in fact he was not in the United States. This 
conduct violated Florida law and further rendered Respondent's 
dispensing outside the usual course of professional practice.
    In sum, and in agreement with the RD, the Agency finds that the 
record contains substantial evidence that Respondent prescribed and 
dispensed controlled substances in violation of both Federal and State 
law. RD, at 18; see 21 U.S.C. 829; 21 CFR 1306.04(a); Fla. Stat. 
sections 456.44(3), 458.331(1)(k), 458.331(1)(m); Fla. Admin. Code r. 
64B8-9.003. In weighing Factors B and D, the Agency finds that the 
Government has established a prima facie case that Respondent committed 
acts that render his registration inconsistent with the public interest 
and support denial of his registration application. See 21 U.S.C. 
823(g)(1).

III. Sanction

    Where, as here, the Government has established grounds to deny 
Respondent's application, 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 18882, 18910 (2018). 
When a respondent has committed acts inconsistent with the public 
interest, he must both accept responsibility and

[[Page 75312]]

demonstrate that he has undertaken corrective measures. Holiday CVS, 
L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (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, the 
credibility of that acceptance as it relates to the probability of 
repeat violations or behavior, the nature of the misconduct that forms 
the basis for sanction, and the Agency's interest in deterring similar 
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR 33738, 33746 
(2021).
    When a respondent declines to testify and ``neither [takes] 
responsibility for his misconduct nor provid[es] any assurances that he 
has implemented remedial measures to ensure such conduct is not 
repeated,'' the respondent's silence weighs against registration. Zvi 
H. Perper, M.D., 77 FR 64131, 64142 (2012) (citing Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008)); see also Jeanne E. Germeil, M.D., 
85 FR 73786, 73803 (2020). Such silence also warrants an adverse 
inference against the respondent. MacKay v. Drug Enf't Admin, 664 F.3d 
808, 820 (10th Cir. 2011) (upholding the Agency's finding that a 
respondent's failure to testify warranted an adverse inference because 
there was ``no evidence that [respondent] recognized the extent of his 
misconduct and was prepared to remedy his prescribing practices''); 
T.J. McNichol, M.D., 77 FR 57133, 57153-54 (2012) (stating that ``it is 
appropriate to draw an adverse inference from Respondent's failure to 
testify'').
    Here, Respondent has failed to accept responsibility or offer any 
basis for the Agency to trust him, despite his past misconduct, with 
the responsibility of a registration. RD, at 21. In light of 
Respondent's silence, he has not sufficiently demonstrated that he can 
be entrusted with a DEA registration. See id.; MacKay, 664 F.3d at 820; 
Jeanne E. Germeil, M.D., 85 FR at 73803; Zvi H. Perper, M.D., 77 FR at 
64142.
    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 considers both specific 
and general deterrence when determining an appropriate sanction. Daniel 
A. Glick, D.D.S., 80 FR 74800, 74810 (2015). Here, Respondent's blatant 
and repeated disregard for the laws relating to controlled substances 
warrants a sanction. Respondent's inappropriate and unlawful 
prescribing of controlled substances placed multiple patients, and the 
public, at risk of harm. In this case, the Agency believes that denial 
of Respondent's application would deter Respondent and the general 
registrant community from disregarding controlled substance laws and 
engaging in the pattern of misconduct that permeated Respondent's 
actions as a registrant. See RD, at 22. As the Chief ALJ noted, ``[t]he 
misconduct established was sufficiently egregious that a denial is 
strongly supported.'' RD, at 22. Further, there is no evidence that 
Respondent's behavior is unlikely to recur in the future such that the 
Agency can entrust him with a registration.
    In sum, the public interest factors weigh in favor of denial as a 
sanction; accordingly, the Agency shall order the sanctions the 
Government requested, as contained in the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(g)(1), I hereby deny the DEA registration application of 
Osmin A. Morales, M.D. (Control No. W20125906C) and any other pending 
application of Osmin A. Morales, M.D., for a DEA registration in 
Florida. This Order is effective December 4, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 25, 2023, 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.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-24151 Filed 11-1-23; 8:45 am]
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