[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82635-82637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23513]


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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).
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    \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.
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    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.
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    \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).
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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.
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    \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.
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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.
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    \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.
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    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.
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    \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.
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    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]
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