Notice2024-23513
Michael Berman, D.O.; 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
October 11, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 198 (Friday, October 11, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82635-82637]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-23513]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Michael Berman, D.O.; Decision and Order
On July 6, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Michael Berman,
D.O., of Rancho Mirage, California (Registrant). Request for Final
Agency Action (RFAA), Exhibit (RFAAX) 1, Attachment A, at 1, 10. The
OSC proposed the revocation of Registrant's DEA Certificate of
Registration (registration) No. BB3337905, alleging that Registrant has
committed such acts as would render his registration inconsistent with
the public interest. Id. at 2-3 (citing 21 U.S.C. 823(g)(1),
824(a)(4)).
The OSC notified Registrant of his right to file with DEA a written
request for hearing, and that if he failed to file such a request, he
would be deemed to have waived his right to a hearing and be in
default. Id. at 8-9 (citing 21 CFR 1301.43). Here, Registrant did not
request a hearing. RFAA, at 2.\1\ ``A default, unless excused, shall be
deemed to constitute a waiver of the registrant's/applicant's right to
a hearing and an admission of the factual allegations of the [OSC].''
21 CFR 1301.43(e).
---------------------------------------------------------------------------
\1\ Based on the Government's submissions in its RFAA dated
October 16, 2023, the Agency finds that service of the OSC on
Registrant was adequate. Specifically, the Declaration from a DEA
Diversion Investigator (DI) indicates that on July 12, 2023, the DI
personally left a copy of the OSC along with her business card at
Registrant's registered address. RFAAX 1, at 1-2. The DI also stated
in her Declaration that on August 22, 2023, Registrant's attorney
contacted her and noted that Registrant received the OSC and
business card. Id. at 2. Additionally, the Declaration from a DEA
Group Supervisor (GS) indicates that on July 14, 2023, the GS sent a
copy of the OSC via certified mail to Registrant's registered
address and emailed a copy of the OSC to Registrant's registered
email address. RFAAX 2, at 2; see also id., at Attachment A.
---------------------------------------------------------------------------
Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 1; see
also 21 CFR 1316.67.
I. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are admitted.\2\ Registrant is deemed to
have admitted, and the Agency finds, that from at least January 12,
2021, through at least August 26, 2021, Registrant issued numerous
controlled substance prescriptions to undercover DEA Task Force
Officers without first conducting an appropriate evaluation, performing
a physical examination, taking a patient history, establishing a proper
medical justification, or obtaining informed consent. RFAAX 1,
Attachment A, at 2-8. Registrant further admits, and the Agency finds,
that after prescribing, Registrant failed to properly monitor the
undercovers by appropriately addressing red flags of abuse and
diversion. Id.
---------------------------------------------------------------------------
\2\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2,370
(2022) (decided in the context of criminal proceedings).
---------------------------------------------------------------------------
A. Prescribing to UC1
Between January 12, 2021, and August 26, 2021, Registrant issued
prescriptions for mixed amphetamine salts 30 mg, a Schedule II
stimulant, and hydrocodone/acetaminophen 10/325 mg, a Schedule II
opioid, to an undercover DEA Task Force Officer (UC1). RFAAX 1,
Attachment A, at 3.
On January 12, 2021, February 18, 2021, April 2, 2021, and June 24,
2021, Registrant prescribed UC1 mixed amphetamine salts 30 mg to treat
Attention Deficit Hyperactivity Disorder (ADHD), but repeatedly did so
without conducting an appropriate evaluation. Id. at 3-5. Specifically,
Registrant: (1) failed, during the initial visit, to address UC1's ADHD
questionnaire, despite UC1 reporting minimal symptoms of ADHD; (2)
repeatedly failed to perform adequate physical examinations of UC1; and
(3) repeatedly failed to take a patient history. Id. Accordingly,
Registrant repeatedly failed to establish a proper medical
justification for prescribing mixed amphetamine salts to UC1. Id.
Registrant also repeatedly failed to obtain UC1's informed consent by
informing UC1 of the benefits, risks, and reasons for prescribing mixed
amphetamine salts. Id.
On July 23, 2021, and August 26, 2021, Registrant prescribed UC1
mixed amphetamine salts 30 mg and hydrocodone/acetaminophen 10/325 mg,
but in both instances did so without conducting an appropriate
evaluation. Id. at 5-6. In both instances, Registrant again failed to
perform an adequate physical examination of UC1 and failed to take a
patient history. Id. Accordingly, Registrant failed in both instances
to establish a proper medical justification for prescribing mixed
amphetamine salts and hydrocodone/acetaminophen to UC1. Id. Registrant
also failed in both instances to obtain UC1's informed consent by
informing UC1 of the benefits, risks, and reasons for prescribing mixed
amphetamine salts and hydrocodone/acetaminophen. Id.
Throughout Registrant's treatment of UC1, Registrant failed to
properly monitor UC1's medication compliance and failed to
appropriately address red flags of abuse and/or diversion. Id. at 3-6.
Specifically, when UC1 tested negative for all drugs on a urine drug
test, despite reporting that he/she was taking mixed amphetamine salts
and hydrocodone/acetaminophen, Registrant failed to discuss the test
results with UC1. Id. at 3. Further, Registrant repeatedly failed to
address UC1's regular receipt of the highest dosages of oxycodone,
hydrocodone/, alprazolam, carisoprodol, and mixed amphetamine salts
from different physicians, as indicated on the California Controlled
Substance Utilization, Review and Evaluation System (CURES). Id. at 3-
6.\3\ Finally, when provided with UC1's prior medical file, Registrant
failed to address the diversion red flag that UC1 tried hydrocodone/
acetaminophen and carisoprodol (``Soma'') that he/she had obtained from
a friend. Id. at 5.
---------------------------------------------------------------------------
\3\ Registrant also failed to address that: (1) UC1 received
hydrocodone/acetaminophen from a different physician between the
January 12, 2021, and February 18, 2021 visits; (2) UC1 received
alprazolam, hydrocodone/acetaminophen, and mixed amphetamine salts
from different physicians between the February 18, 2021, and April
2, 2021 visits; and (3) UC1 received alprazolam, hydrocodone/
acetaminophen, and mixed amphetamine salts from different physicians
between the April 2, 2021, and June 24, 2021 visits. Id. at 4-5.
---------------------------------------------------------------------------
B. Prescribing to UC2
Between February 9, 2021, and April 20, 2021, Registrant issued
prescriptions for mixed amphetamine salts 30 mg to an undercover DEA
Special Agent (UC2). Id. at 6.
On February 9, 2021, March 10, 2021, and April 20, 2021, Registrant
prescribed UC2 mixed amphetamine
[[Page 82636]]
salts 30 mg to treat ADHD. Id. at 6-8.\4\ As with UC1, Registrant
repeatedly issued the mixed amphetamine salts prescriptions without
conducting an appropriate evaluation. Id. Specifically, Registrant: (1)
failed, during the initial visit, to address UC2's ADHD questionnaire,
despite UC2 reporting minimal symptoms of ADHD; (2) repeatedly failed
to perform adequate physical examinations of UC2; and (3) repeatedly
failed to take a patient history. Id. Accordingly, Registrant
repeatedly failed to establish a proper medical justification for
prescribing mixed amphetamine salts to UC2. Id. Registrant also
repeatedly failed to obtain UC2's informed consent by informing UC2 of
the benefits, risks, and reasons for prescribing mixed amphetamine
salts. Id.
---------------------------------------------------------------------------
\4\ The OSC notes that on March 10, 2021, Registrant prescribed
UC2 60 tablets of Adderall 30 mg. Id. at 7. Adderall is a brand name
for amphetamine-dextroamphetamine, a Schedule II controlled
substance.
---------------------------------------------------------------------------
Throughout Registrant's treatment of UC2, Registrant failed to
properly monitor UC2's medication compliance and failed to
appropriately address red flags of abuse and/or diversion. Id. at 6-8.
For example, Registrant failed to appropriately address UC2's negative
urine drug screen, UC2's admission that he/she diverted drugs to his/
her boyfriend, and UC2's CURES report, which showed that UC2 filled
controlled substance prescriptions at multiple pharmacies and regularly
received the highest dosages of hydrocodone/acetaminophen, alprazolam,
mixed amphetamine salts, oxycodone, and diazepam. Id. at 7.
DEA consulted with an independent medical expert who reviewed
recordings of the undercover visits with Registrant described above.
Id. at 8. The medical expert concluded that Registrant's prescribing
``violated the minimum medical standards applicable to the practice of
medicine in California.'' Id. Registrant is deemed to have admitted,
and the Agency finds, that the controlled substance prescriptions
described above were not issued for a legitimate medical purpose or in
the usual course of professional practice. Id.
II. Discussion
A. The Five Public Interest Factors
Under the Controlled Substances Act (CSA), ``[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 his registration under [21
U.S.C. 823] inconsistent with the public interest as determined under
such section.'' 21 U.S.C. 824(a). In making the public interest
determination, the CSA requires consideration of the following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant]'s experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant]'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).
The Agency 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).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\5\ the Government's evidence in support of its
prima facie case for revocation of Registrant's registration is
confined to Factors B and D. See RFAAX 1, Attachment A, at 2-3.
Moreover, the Government has the burden of proof in this proceeding. 21
CFR 1301.44.
---------------------------------------------------------------------------
\5\ As to Factor A, the record contains no evidence of a
recommendation from any state licensing board or professional
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an
absence of such evidence ``does not weigh for or against a
determination as to whether continuation of the [registrant's] DEA
certification is consistent with the public interest.'' Roni
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is
no evidence in the record that Registrant has been convicted of an
offense under either federal or state law ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). However, Agency cases have found that ``the
absence of such a conviction is of considerably less consequence in
the public interest inquiry'' and is therefore not dispositive.
Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). Finally, as to
Factor E, the Government's evidence fits squarely within the
parameters of Factors B and D and does not raise ``other conduct
which may threaten the public health and safety.'' 21 U.S.C.
823(g)(1)(E). Accordingly, Factor E does not weigh for or against
Registrant.
---------------------------------------------------------------------------
Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Registrant's continued registration
would be ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4).
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). In the current matter, the Government has
alleged that Registrant violated both federal and state law regulating
controlled substances. RFAAX 1, Attachment A, at 1-2. Specifically,
under federal regulations, a prescription for a controlled substance is
valid only if ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'' 21 CFR 1306.04(a). As for state law, California regulations
also require that ``[a] prescription for a controlled substance shall
only be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his or her professional
practice.'' Cal. Health & Safety Code sec. 11153(a). Additionally,
California regulations define unprofessional conduct to include, as
relevant here: violating or attempting to violate any provision of the
Medical Practice Act; gross negligence; repeated negligent acts;
incompetence; and ``[p]rescribing, dispensing, or furnishing
[controlled substances] without an appropriate prior examination and a
medical indication.'' Cal. Bus. & Prof. Code secs. 2234, 2242(a).
Here, Registrant has admitted, and the Agency finds, that
Registrant repeatedly issued prescriptions for controlled substances
without conducting appropriate evaluations, establishing a medical
justification for the controlled substances prescribed, or obtaining
informed consent. RFAAX 1, Attachment A, at 3-8. Further, Registrant
has admitted, and the Agency finds, that Registrant repeatedly failed
to properly monitor the two undercovers' medication compliance and
failed to appropriately address red flags of abuse and/or diversion.
Id. DEA's medical expert concluded, and thus the Agency finds, that
Registrant's prescribing ``violated the minimum medical standards
applicable to the practice of medicine in California.'' Id. at 8.
Registrant has further admitted, and the Agency finds, that none of the
above-referenced controlled substance prescriptions were issued for a
legitimate medical purpose in the usual course of professional
practice. As such, the Agency finds that Registrant violated 21 CFR
1306.04(a); California
[[Page 82637]]
Health & Safety Code sec. 11153(a); and California Business &
Professions Code secs. 2234, 2242(a).
Accordingly, the Agency finds that Factors B and D weigh in favor
of revocation of Registrant's registration and thus finds Registrant's
continued registration to be inconsistent with the public interest in
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds
that Registrant failed to provide any evidence to rebut the
Government's prima facie case.
III. Sanction
Where, as here, the Government has established grounds for
revocation, the burden shifts to the registrant to show why he can be
entrusted with the responsibility carried by a registration. Garret
Howard Smith, M.D., 83 FR 18882, 18910 (2018). To establish that he can
be entrusted with registration, a registrant must both accept
responsibility and 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).
Here, Registrant failed to answer the allegations contained in the
OSC and did not otherwise avail himself of the opportunity to refute
the Government's case. As such, Registrant has made no representations
as to his future compliance with the CSA nor made any demonstration
that he can be entrusted with registration. Moreover, the evidence
presented by the Government shows that Registrant violated the CSA,
further indicating that Registrant cannot be entrusted.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BB3337905 issued to Michael Berman, D.O. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Michael Berman, D.O., to renew
or modify this registration, as well as any other pending application
of Michael Berman, D.O., for additional registration in California.
This Order is effective November 12, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 2, 2024, 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. 2024-23513 Filed 10-10-24; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 11, 2024.
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.