Notice2025-07936
Mohan Kaza, M.D.; Default Decision and Order
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Published
May 7, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 87 (Wednesday, May 7, 2025)</title>
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[Federal Register Volume 90, Number 87 (Wednesday, May 7, 2025)]
[Notices]
[Pages 19317-19319]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07936]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mohan Kaza, M.D.; Default Decision and Order
I. Introduction
On July 26, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Mohan Kaza, M.D., of Troy, MI (Respondent).
Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The
OSC/ISO informed Respondent of the immediate suspension of his DEA
Certificate of Registration, Control No. FK8011063, pursuant to 21
U.S.C. 824(d), alleging that Respondent's continued registration
constitutes `` `an imminent danger to the public health or safety.' ''
Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the
revocation of Respondent's registration, alleging that Respondent's
continued registration is inconsistent with the public interest. Id.
(citing 21 U.S.C. 823(g)(1), 824(a)(4)).
The OSC/ISO alleged that from January 17, 2024, through April 17,
2024, Respondent improperly issued Schedule II controlled substance
prescriptions to two individuals who were acting in an undercover
capacity, in violation of the Controlled Substances Act's (CSA's)
implementing regulations and Michigan state law.\1\ Id. at 1-2.
Specifically, the OSC/ISO alleged that Respondent: (1) issued these
prescriptions without conducting any assessment or examination; (2)
issued these prescriptions without addressing signs of diversion; (3)
coached the undercover individuals to provide false medical histories;
and (4) charged increased fees for examination appointments when
prescribing stronger dosages of the controlled substances. Id. at 2.\2\
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\1\ The OSC/ISO cites to: (1) Mich. Comp. Laws sec. 333.7401(1)
(``a practitioner . . . shall not . . . prescribe . . . a controlled
substance for other than legitimate and professionally recognized
therapeutic or scientific purposes or outside the scope of practice
of the practitioner''); (2) Mich. Comp. Laws sec. 333.7333 (defines
good faith in prescribing a controlled substance as prescribing ``in
the regular course of professional treatment to or for an individual
who is under treatment by the practitioner for a pathology or
condition other than that individual's physical or psychological
dependence on or addition to a controlled substance''); and (3)
Mich. Comp. Laws sec. 333.7405(1)(a) (states that a licensed
practitioner shall not ``distribute, prescribe, or dispense a
controlled substance in violation of section 7333''). Id. at 2.
\2\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 597 U.S. 450
(2022) (decided in the context of criminal proceedings).
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The OSC/ISO notified Respondent of his right to file with DEA a
written request for hearing and an answer, 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. RFAAX 1, at 6 (citing 21 CFR 1301.43). On
August 26, 2024, Respondent filed a Request for Hearing and Request for
Extension of Time to File Answer; Respondent's request was granted
giving him until 2:00 p.m. on September 10, 2024, to file an Answer.
See RFAAX 3-4.\3\ On September 11, 2024, the Government filed a Motion
to Terminate Proceedings, and Respondent was given until September 18,
2024, to respond. See RFAAX 5-6. On September 18, 2024, Respondent
filed a Motion to Withdraw Request for Hearing and Request for
Extension of Time to File Answer. See RFAAX 7. On the same date,
following Respondent's motion, Administrative Law Judge Paul E.
Soeffing issued an Order Terminating Proceedings. See RFAAX 8.
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\3\ Based on the Government's submissions in its RFAA October
28, 2024, the Agency finds that service of the OSC/ISO on Registrant
was adequate. According to the included Declaration from a DEA
Diversion Investigator, Registrant was personally served with the
OSC/ISO on July 31, 2024. RFAAX 2, at 2.
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``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); see also
RFAAX 1, at 6 (providing notice to Respondent). 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]
1316.67.'' Id. Sec. 1301.43(f)(1). Here, the Government has requested
final agency action based on Respondent's default pursuant to 21 CFR
1301.43(c), (f), 1301.46. RFAA, at 1; see also 21 CFR 1316.67.
II. Applicable Law
A. The Alleged Statutory and Regulatory Violations
As discussed above, the OSC/ISO alleges that Respondent violated
provisions of the Controlled Substances Act (CSA) and its implementing
regulations. As the Supreme Court stated in Gonzales v. Raich, ``the
main objectives of the CSA were to conquer drug abuse and to control
the legitimate and illegitimate traffic in controlled substances. . . .
To effectuate these goals, Congress devised a closed regulatory system
making it unlawful to . . . dispense[ ] or possess any controlled
substance except in a manner authorized by the CSA.'' 545 U.S. 1, at
12-13 (2005). In maintaining this closed regulatory system, ``[t]he CSA
and its implementing regulations set forth strict requirements
regarding registration, . . . drug security, and recordkeeping.'' Id.
at 14.
Here, the OSC/ISO's allegations concern the CSA's ``strict
requirements regarding registration . . . drug security, and
recordkeeping'' and, therefore, go to the heart of the CSA's ``closed
regulatory system'' specifically designed
[[Page 19318]]
``to conquer drug abuse and to control the legitimate and illegitimate
traffic in controlled substances.'' Id.
B. Improper Prescribing (21 CFR 1306.04(a); Mich. Comp. Laws Secs.
333.7333, 333.7401(1), 333.7405(1)(a))
The OSC/ISO alleges that Respondent improperly issued controlled
substance prescriptions to two patients who were acting in an
undercover capacity. RFAAX 1, at 1. According to CSA regulations, a
prescription for a controlled substance is proper 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 Michigan state law, ``a practitioner . . . shall not . . .
prescribe . . . a controlled substance for other than legitimate and
professionally recognized therapeutic or scientific purposes or outside
the scope of practice of the practitioner.'' Mich. Comp. Laws sec.
333.7401(1). Further, Michigan state law defines good faith in
prescribing a controlled substance as prescribing ``in the regular
course of professional treatment to or for an individual who is under
treatment by the practitioner for a pathology or condition other than
that individual's physical or psychological dependence on or addition
to a controlled substance.'' Id. sec. 333.7333.\4\
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\4\ Michigan state law also states that a licensed practitioner
shall not ``distribute, prescribe, or dispense a controlled
substance in violation of section 7333.'' Id. sec. 333.7405(1)(a).
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III. Findings of Fact
The Agency finds that, in light of Respondent's default, the
factual allegations in the OSC/ISO are deemed to be admitted.
A. Undercover Patient 1 (UC1)
Respondent admits that on or about January 17, 2024, Respondent
prescribed 15 mg of amphetamine aspartate (a Schedule II stimulant) to
UC1 without conducting an adequate medical assessment or properly
addressing red flags of diversion. RFAAX 1, at 3. Specifically,
Respondent admits that Respondent issued the prescription to UC1 after
UC1 stated that he/she had been acquiring controlled substance
stimulants from acquaintances through illegitimate means. Id. Further,
Respondent admits that, for fear of being audited, Respondent provided
UC1 with answers to his/her medical history in order to reach a
diagnosis, rendering the diagnosis illegitimate. Id.
Respondent admitted that on or about February 13, 2024, Respondent
prescribed 20 mg of amphetamine dextroamphetamine (a Schedule II
stimulant) to UC1 outside of the usual course of professional practice
and not for a legitimate medical purpose. Id. at 4. On this same date,
Respondent dispensed to UC1 a 30 mg amphetamine tablet without a
prescription and with no medical justification. Id.
Respondent admits that on or about March 20, 2024, Respondent
increased the dosage of UC1's amphetamine aspartate prescription to 30
mg at UC1's request and without medical necessity. Id. On the same
date, Respondent told UC1 that the dosage increase would require UC1 to
pay a higher cash amount for the office visit. Id. Respondent further
admits that on or about April 17, 2024, Respondent issued UC1 a
prescription for amphetamine dextroamphetamine 30 mg without conducting
any assessment or examination. Id.
Accordingly, the Agency finds substantial record evidence that the
five controlled substances prescriptions that Respondent issued or
dispensed to UC1 were issued outside the usual course of professional
practice and not for a legitimate medical purpose. RFAAX 1, at 3-4.
B. Undercover Patient 2 (UC2)
Respondent admits that on or about March 20, 2024, Respondent
issued a prescription for 15 mg of amphetamine dextroamphetamine to UC2
without conducting an adequate medical assessment or establishing a
diagnosis to justify the use of controlled substances. RFAAX 1, at 4.
Respondent further admits that when UC2 appeared to struggle with
responses to his/her medical history, Respondent advised UC2 to look up
responses on the internet in order to give the illusion of a proper
examination and diagnosis, rendering the diagnosis illegitimate. Id.
Respondent also gave UC2 permission to change the responses to his/her
medical history based on what he/she found on the internet. Id. at 5.
Respondent admits that on or about April 17, 2024, at the request
of UC2, Respondent increased the quantity of the amphetamine
dextroamphetamine 15 mg tablets from 30 tablets to 60 tablets without
medical justification or necessity. Id. On this same date, Respondent
told UC2 that the dosage increase would require an increased cash
payment amount for the office visit. Id.
Accordingly, the Agency finds substantial record evidence that both
of the controlled substances prescriptions that Respondent issued to
UC2 were issued outside the usual course of professional practice and
not for a legitimate medical purpose. RFAAX 1, at 3-5.
IV. Discussion
A. The Controlled Substances Act's Public Interest Factors
Pursuant to the CSA, ``[a] registration . . . to . . . distribute[
] or 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 by such
section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
Congress directed the Attorney General to consider five factors in
making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).\5\
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\5\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(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.
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (``It is
well established that these factors are to be considered in the
disjunctive,'' citing In re Arora, 60 FR 4,447, 4,448 (1995)); Robert
A. Leslie, M.D., 68 FR 15,227, 15,230 (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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D., 58 FR
37507, 37508 (1993).
According to Agency decisions, the Agency ``may rely on any one or
a combination of factors and may give each factor the weight [it] deems
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't
Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U.S. Drug Enf't
Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin.,
419 F.3d 477, 482 (6th Cir. 2005).
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Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay,
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419
F.3d at 482. ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, findings under a single factor can support the revocation
of a registration. MacKay, 664 F.3d at 821.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case regarding
Respondent's violations of the CSA's implementing regulations is
confined to Factors B and D. RFAAX 1, at 3. Moreover, the Government
has the burden of proof in this proceeding. 5 U.S.C.A. 556(d); 21 CFR
1301.44.
B. Factors B and/or D--Applicant's Registration Is Inconsistent With
the Public Interest
Evidence is considered under Public Interest Factors B and D when
it reflects compliance or non-compliance with federal and local laws
related to controlled substances and experience dispensing controlled
substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). Here, as found above, Respondent
admits and the Agency finds substantial record evidence that Respondent
issued 7 controlled substance prescriptions to two undercover
individuals that were issued outside the usual course of professional
practice and not for a legitimate medical purpose. RFAAX 1, at 3-5.
Further, Respondent is deemed to admit that his ``conduct in issuing
prescriptions for cash to the undercover [individuals], completely
betrayed any semblance of legitimate medical treatment.'' Id. at 3
(internal citations omitted).
As such, the Agency finds substantial record evidence that the
Respondent violated 21 CFR 1306.04 and Mich. Comp. Laws secs.
333.7401(1) and 333.7405(1)(a). After weighing Factors B and D, the
Agency further finds that Respondent's continued registration is
outside the public interest. 21 U.S.C. 823(g)(1). Accordingly, the
Agency finds that the Government established a prima facie case, that
Applicant did not rebut that prima facie case, and that there is
substantial record evidence supporting the revocation of Respondent's
registration. 21 U.S.C. 823(g)(1).
V. Sanction
Here, the Government has met its prima facie burden of showing that
Respondent's continued registration is inconsistent with the public
interest due to his numerous violations pertaining to his controlled
substance prescribing. Accordingly, the burden shifts to Respondent to
show why he can be entrusted with a registration. Morall, 412 F.3d. at
174; Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR
18882, 18904 (2018); supra sections III and IV.
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that he will not engage in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, although Respondent initially requested a hearing, he
ultimately withdrew his hearing request, and did not otherwise avail
himself of the opportunity to refute the Government's case. As such,
there is no record evidence that Respondent takes responsibility, let
alone unequivocal responsibility, for the founded violations, meaning,
among other things, that it is not reasonable to believe that
Respondent's future controlled substance-related actions will comply
with legal requirements. Accordingly, Respondent did not convince the
Agency that he can be entrusted with a registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature of Respondent's
violations, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
In sum, Respondent has not offered any evidence on the record that
rebuts the Government's case for revocation of his registration, and
Respondent has not demonstrated that he can be entrusted with the
responsibility of registration. Accordingly, the Agency will order the
revocation of Respondent's registration.
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(g)(1), I hereby revoke DEA Certificate
of Registration No. FK8011063 issued to Mohan Kaza, M.D. Further,
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(g)(1), I hereby deny any pending applications
of Mohan Kaza, M.D., to renew or modify this registration, as well as
any other pending application of Mohan Kaza, M.D., for additional
registration in Michigan. This Order is effective June 6, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 24, 2025, by Acting Administrator Derek Maltz. 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. 2025-07936 Filed 5-6-25; 8:45 am]
BILLING CODE 4410-09-P
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