Notice2023-24151
Osmin A. Morales, M.D.; Decision and Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 2, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 211 (Thursday, November 2, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75309-75312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24151]
=======================================================================
-----------------------------------------------------------------------
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\).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\7\ Respondent also issued four controlled substance
prescriptions to Patient K.L. when Respondent was not in the
country. See supra, Patient K.L.
---------------------------------------------------------------------------
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]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on November 2, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.