90 FR 87 pgs. 19317-19319 - Mohan Kaza, M.D.; Default Decision and Order
Type: NOTICEVolume: 90Number: 87Pages: 19317 - 19319
Pages: 19317, 19318, 19319FR document: [FR Doc. 2025-07936 Filed 5-6-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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
Footnotes:
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).
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.
Footnotes:
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.
"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. §?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.
[top] 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
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
Footnotes:
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).
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
Footnotes:
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.
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).
[top] 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).
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]
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