[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21156-21165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07702]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Kareem Hubbard, M.D.; Decision and Order

    On June 4, 2020, the former Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to Kareem 
Hubbard, M.D. (hereinafter, Applicant) of San Leandro, California. 
Request for Final Agency Action (hereinafter, RFAA) Exhibit 
(hereinafter RFAAX) 2 (OSC), at 1 and 12. The OSC proposed to deny 
Applicant's application for a DEA Certificate of Registration, as well 
as to deny any applications for any other registrations, pursuant to 21 
U.S.C. 824(a)(1) and (4) because Applicant ``materially falsified [his] 
application'' and because ``[Applicant's] registration is inconsistent 
with the public interest, as that term is defined in 21 U.S.C. 
823(f).'' Id. at 1.
    The OSC alleged that Applicant's application contained a materially 
false statement in which Applicant failed to disclose his previous 
surrender for cause of his DEA registration. Id. at 3. According to the 
OSC, Applicant had surrendered for cause his previous DEA registration 
``less than two months before submitting [his] application.'' Id. 
Further, the OSC alleged that Applicant ``violated federal and 
California law by issuing prescriptions for controlled substances to 
four patients outside the usual course of professional practice and not 
for a legitimate medical purpose.'' Id. at 4.
    The OSC notified Applicant of the right to request a hearing on the 
allegations or to submit a written statement, while waiving the right 
to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 11 (citing 21 
CFR 1301.43). The OSC also notified Applicant of the opportunity to 
submit a corrective action plan. Id. at 11-12 (citing 21 U.S.C. 
824(c)(2)(C)).
    By letter dated July 23, 2020, Applicant requested a hearing 
through counsel. RFAAX 3 (Request for Hearing), at 1. In his Request 
for Hearing, Applicant requested that his application for DEA 
registration be granted, because ``he applied for it in good faith and 
did not believe his surrender of [his] previous certificate was `for 
cause.' '' Id. Additionally, Applicant's Request for Hearing included 
an attachment addressing the Government's allegations in detail. Id. at 
3-5. On July 23, 2020, Applicant also submitted a Corrective Action 
Plan in which he offered a ``historical perspective, in addition to 
[his] interim practice activities and corrective action plan.'' RFAAX 
4, at 5. On August 14, 2020, Applicant submitted a Withdrawal of 
Hearing Request in which he ``with[drew] his request for a hearing in 
[the] matter'' and ``with[drew] his pending application for a new DEA 
Certificate of Registration'' \1\ without ``waiv[ing] his future right 
to reapply for [the] same.'' RFAAX 5, at 1; RFAAX 6 (Order Terminating 
Proceedings). On August 17, 2020, the Chief Administrative Law Judge 
John J. Mulrooney, II (hereinafter, the Chief ALJ) terminated the 
proceedings. RFAAX 6.
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    \1\ After an applicant has received an OSC regarding his or her 
application for DEA registration, the application may not be 
withdrawn without the permission of the Administrator. 21 CFR 
1309.36(a). Here, Applicant had already received the OSC before 
attempting to withdraw his application, and he has not demonstrated 
good cause why his application should be withdrawn, nor do I find 
that withdrawal would be in the public interest due to the nature 
and extent of the allegations in front of me and the Applicant's 
stated intention that he will reapply for a registration. 
Adjudicating this matter to finality will create an official record 
the Agency can use in any future interactions with Applicant. As 
additionally noted in Olsen, ``a final adjudication is a public 
record of the Agency's expectations for current and prospective 
members of that community,'' and adjudications inform stakeholders, 
such as legislators and the public, about the Agency's work and 
allow them to provide feedback to the Agency, thereby helping shape 
how the Agency carries out its responsibilities under the CSA. Id. 
Adjudicating this matter to finality will create a public record to 
educate current and prospective registrants about the Agency's 
expectations regarding the responsibilities of registrants under the 
CSA and allow stakeholders to provide feedback regarding the 
Agency's enforcement priorities and practices. I have not permitted 
Applicant's application to be withdrawn. Accordingly, Applicant's 
withdrawal is not effective.
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    On September 23, 2020, the Government forwarded its RFAA, along 
with the evidentiary record for this matter, to my office. The 
Government seeks a final order of denial of Applicant's application for 
DEA registration because Applicant ``materially falsified his 
application under 21 U.S.C. 824(a)(1), and committed acts which render 
his continued registration inconsistent with the public interest'' 
under 21 U.S.C. 824(a)(4) and 823(f). RFAA, at 1. I issue this Decision 
and Order after considering the entire record before me, 21 CFR 
1301.43(e); and I make the following findings of fact.

I. Findings of Fact

A. Application for DEA Registration

    On or about April 8, 2019, Applicant applied for a DEA Certificate 
of Registration as a practitioner in Schedules II through V with a 
proposed registered address of 15035 E 14th St., San Leandro, CA 94578. 
RFAAX 1 (Certification of Non Registration), at 1. Applicant's 
application was assigned Control No. W19032408C and is in a ``new 
pending'' status. Id. On Applicant's application, when presented with 
the question, ``Has the applicant ever surrendered (for cause) or had a 
federal controlled substance registration revoked, suspended, 
restricted or denied, or is any such action pending?'' Applicant 
answered, ``No.'' Id. Applicant previously held DEA Certificate of 
Registration Control No. FH4372859, which expired on October 31, 2016, 
and DEA Certificate of Registration Control No. FH4334037, which 
expired on October 31, 2019. Id. at 2. Both of Applicant's previous DEA

[[Page 21157]]

registrations are currently in a ``retired'' status. Id.

B. Investigation of Applicant

1. Declaration of Group Supervisor
    According to a DEA Group Supervisor (hereinafter, the GS 1) in the 
San Jose Resident Office of the San Francisco Field Division assigned 
to investigate Applicant, ``DEA began investigating [Applicant] in 2018 
after receiving information that he had prescribed large quantities of 
controlled substances.'' RFAAX 8 (GS's Declaration), at 1. GS stated 
that in early 2019, ``DEA reviewed [Applicant's] report from CURES, 
California's Prescription Data Monitoring Program'' and ``identified 
several red flags of abuse or diversion in [Applicant's] controlled 
substance prescribing, such as patients traveling long distances and 
receiving drug cocktails, among other red flags.'' Id. On February 21, 
2019, DEA served an administrative subpoena on Applicant's practice for 
Applicant's patient files. Id. at 2; see also id. at Appendix 
(hereinafter, App.) A (administrative subpoena). On the same day, DEA 
also ``interviewed [Applicant] regarding his care of some of the 
patients whose files were the subject of the administrative subpoena'' 
and ``informed [Applicant] about several red flags of abuse or 
diversion (such as long distances traveled by patients, high dosages, 
and opioid cocktails) that DEA identified in his controlled substance 
prescribing.'' Id. at 2. Accordingly, DEA asked Applicant to 
voluntarily surrender his DEA Certificate of Registration Control No. 
FH4334037, and he did. Id.; see also id. at App B (Applicant's signed 
surrender for cause).
2. Declaration of Diversion Investigator T.B.
    A DEA Diversion Investigator (hereinafter, the DI) assigned to 
investigate Applicant's application found that Applicant voluntarily 
surrendered for cause his previous DEA Certificate of Registration 
Control No. FH4334037 on February 21, 2019. RFAAX 7 (DI's Declaration), 
at 2. The DI also found that Applicant ``did not previously possess a 
DATA (Drug Addiction Treatment Act)[ ] Waiver number, which authorizes 
registrants to prescribe controlled substances for maintenance or 
detoxification treatment.'' Id.
    Additionally, the DI obtained Applicant's 2017-2019 report from the 
CURES database to review Applicant's controlled substance prescribing 
from 2017-2019. Id. at 3; see also id. at App. B (CURES Report for 
Applicant dated from May 1, 2017 to June 30, 2019). In response to 
administrative subpoenas served to various pharmacies, the DI obtained 
copies of the controlled substance prescriptions issued by Applicant to 
Patients L.C., P.B., S.N., and J.H. Id. at 3; see also id. at Apps. C-F 
(copies of patient prescription records). Further, the DI determined 
the respective distances between Applicant's previous registered 
address and the home addresses for Patients L.C., P.B., and S.N. by 
entering the addresses online into Bing Maps. Id. at 3; see also id. at 
App. G (printouts from Bing Maps). The DI found that the distance 
between Patient L.C.'s home address and Applicant's previous registered 
location was at least 30 miles; the distance between Patient P.B.'s 
home address and Applicant's previous registered location was nearly 80 
miles; and the distance between Patient S.N.'s home and Applicant's 
previous registered location was at least 35 miles. Id. at 4; see also 
id. at App. G (printouts from Bing Maps). Finally, in response to 
administrative subpoenas served to Applicant's practice, the DI 
obtained copies of the patient files for Patients L.C., P.B., S.N., and 
J.H. Id.; see also id. at Apps. H(i)-K (copies of patient files).

C. The Government Expert's Review of Applicant's Prescriptions

    The DEA hired Dr. Timothy Munzing, M.D. to opine on Applicant's 
controlled substance prescribing based on the CURES report and the 
patient files described above. Id. at 4. Dr. Munzing is a physician 
licensed in California who has been the Family Medicine Residency 
Program Director at Kaiser Permanente Orange County for three decades. 
RFAAX 9 (Dr. Munzing's Declaration), at 1; see also id. at App. A (Dr. 
Munzing's CV). Dr. Munzing has also held an appointment as a full 
Clinical Professor at the University of California, Irvine School of 
Medicine since 2005 and has served on the Board of Directors of the 
Orange Academy of Family Physicians for over twenty years as well as on 
the Board of Directors for the California Academy of Family Physicians 
for five years. Id. Dr. Munzing currently serves on several other 
national and state boards and committees overseeing quality of care and 
residency and medical student training and in his three decades of 
practice has formally taught and/or lectured to thousands of physicians 
and students the core principles and guidelines of appropriate opioid 
and controlled substance medication prescribing. Id. at 1-2; see also 
id. at App. A. I find that Dr. Munzing is an expert in the standard of 
care for prescribing controlled substances in California, and I give 
his report full credit.
    Dr. Munzing was retained as an expert to determine whether or not 
Applicant's prescribing was ``consistent with the usual course of 
professional practice, as required under 21 CFR 1306.04(a), and with 
California law.'' Id. at 2. Accordingly, Dr. Munzing's Declaration 
``explain[ed] [his] expert opinion on the standard of care in 
California for medical practice, particularly with respect to the 
prescribing of controlled substances, and [his] conclusions as to 
[Applicant's] prescribing outside of that standard of care with regard 
to specific prescriptions that [Applicant] issued to [the] four 
different patients'' described above. Id.
1. The Standard of Care in California
    Dr. Munzing attested that various state laws and regulations, as 
well as two guidelines published by the Medical Board of California, 
informed his opinion as to California's standard of care for the 
practice of medicine, particularly with respect to the prescribing of 
controlled substances for pain. Id. at 3-7. Dr. Munzing noted that 
California Health and Safety Code Sec.  11153(a) requires 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.' '' Id. at 3. 
Further, California Health and Safety Code Sec.  11154(a) states that 
`` `no person shall knowingly prescribe, administer, dispense, or 
furnish a controlled substance to or for any person . . . not under his 
or her treatment for a pathology or condition.' '' Id. Dr. Munzing also 
cited California Business and Professions Code Sec. Sec. Sec.  2242(a), 
2234, and 725(a), noting that unprofessional conduct subject to 
sanction includes `` `[p]rescribing, dispensing, or furnishing 
[controlled substances] without an appropriate prior examination and a 
medical indication' . . . `[g]ross negligence'; `[r]epeated negligent 
acts'; `[i]ncompetence'; or `[t]he commission of any act involving 
dishonesty or corruption that is substantially related to the 
qualifications, functions, or duties of a physician and surgeon' . . . 
and `[r]epeated acts of clearly excessive prescribing, furnishing, 
dispensing, or administering of drugs . . .' '' Id. at 3-4. Finally, 
the two Medical Board of California guidelines referenced by Dr. 
Munzing included the Guide to the Laws Governing the Practice of

[[Page 21158]]

Medicine by Physicians and Surgeons \2\ and the Guidelines for 
Prescribing Controlled Substances for Pain.\3\ Id. at 3.
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    \2\ Available at: http://web.archive.org/web/20210921192242/http://www.mbc.ca.gov/Download/Documents/laws-guide.pdf.
    \3\ Available at: https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf.
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    Dr. Munzing opined that, as informed by the above statutes and 
guidelines, the California standard of care requires that before 
prescribing controlled substances, at minimum, a practitioner must:

    (1) ``obtain a medical history and perform an appropriate 
physical examination'';
    (2) ``assess the patients' pain, physical and psychological 
functions, substance abuse history, and history of prior pain 
treatment (such as reviewing past medical records, laboratory 
studies, and imaging studies to establish a diagnosis and medical 
necessity)'';
    (3) ``assess any underlying or coexisting diseases or conditions 
and order and perform diagnostic testing if necessary'';
    (4) ``discuss the risks and benefits of using controlled 
substances and any other treatment modalities (such as non-opioid 
therapeutic options)'';
    (5) ``periodically review the course of pain treatment or gather 
any new information, if any, about the etiology of a patient's state 
of health'';
    (6) ``give special attention to patients who, by their own words 
and actions, pose a risk for medication misuse and/or diversion'';
    (7) ``maintain accurate and complete records''; and
    (8) ``document the presence of a recognized medical indication 
for the use of a controlled substance.''

Id. at 4. Additionally, Dr. Munzing opined that, as informed by 
guidelines from the Centers for Disease Control and Prevention 
(hereinafter, CDC) \4\ and from the Food and Drug Administration 
(hereinafter, FDA),\5\ the California standard of care imposes 
additional requirements and considerations for prescribing opioids as 
well as for prescribing benzodiazepines in combination with opioids. 
RFAAX 9, at 5-6. These additional requirements and considerations 
include that:
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    \4\ The CDC guidelines referenced by Dr. Munzing included the 
CDC publication, ``Calculating Total Daily Dose of Opioids for Safer 
Dosage'' and the CDC's ``Guideline for Prescribing Opioids for 
Chronic Pain'' published in 2016. Id. at 5; see https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf and https://www.cdc.gov/drugoverdose/prescribing/guideline.html.
    \5\ Dr. Munzing referenced the FDA publication, ``New Safety 
Measures Announced for Opioid Analgesics, Prescription Opioid Cough 
Products, and Benzodiazepines'' published in 2016. RFAAX 9, at 5-6; 
see https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm518110.htm.

    (1) ``[o]pioids prescribed at Morphine Milligram Equivalent 
(`MME') dosages above 90 mg per day significantly increase a 
patient's risk of overdose and death'';
    (2) practitioners must ``carefully adjust, as well as closely 
monitor, patients who are prescribed MME dosages above 90 MME a 
day--a dangerously high dosage of opioids'';
    (3) ``required monitoring when high-dosage opioids are 
prescribed include[s]: Periodic and close evaluations or 
examinations to determine the appropriateness of high-dosage opioids 
or [the consideration of] non-opioid alternatives; frequent and 
periodic review of a patient's report from [CURES]; and periodic 
urine drug screens'';
    (4) MME dosages above 90 mg per day should be avoided or 
carefully justified;
    (5) ``[t]he FDA requires `Black Box' warnings about combining 
benzodiazepines with opioids'' because ``taking benzodiazepines with 
opioids can cause profound sedation, respiratory depression, coma, 
and death'';
    (6) ``the combination of opioids and benzodiazepines should be 
avoided except in limited circumstances given the heightened risk of 
overdose and death when opioids and benzodiazepines are taken in 
combination'';
    (7) ``[t]he combination of oxycodone, a benzodiazepine, and the 
muscle relaxant carisoprodol, is a dangerous drug cocktail known as 
the `Holy Trinity' '';
    (8) ``[t]he `Holy Trinity' cocktail, as well as the combination 
of an opioid and a benzodiazepine, are both red flags of abuse or 
diversion''; and
    (9) ``[t]he `Holy Trinity' cocktail, in particular, is a 
combination of drugs that is popular among the drug-abusing 
community.''

Id. Finally, Dr. Munzing opined that the California standard of care 
requires ``practitioners prescribing controlled substances to monitor 
and address red flags of abuse or diversion, such as long distances 
traveled, inconsistent urine drug screen results, early refills, and 
drug cocktails'' and to ``document how they addressed or resolved red 
flags of abuse or diversion.'' Id. at 6. Specifically, Dr. Munzing 
noted that, per the California standard of care:

    (1) ``[p]atients willing to travel long distances to see a 
physician to obtain controlled substances is a red flag of abuse or 
diversion'' and physicians must address or resolve this red flag;
    (2) ``[p]eriodic urine drug screening is part of a physician's 
duty to perform ongoing monitoring of patients prescribed controlled 
substances'' and physicians prescribing controlled substances must 
``address or resolve inconsistent urine drug screen results, which 
are red flags of abuse or diversion'';
    (3) ``[i]nconsistent urine drug screen results that must be 
addressed or resolved are: (1) Positive results for non-prescribed 
controlled substances; and (2) negative results for prescribed 
controlled substances'';
    (4) ``[e]ven should a physician address or resolve an 
inconsistent urine drug screen result,'' the physician must 
``proceed to closely monitor the patient, which may include 
additional and more frequent urine drug screens''; and
    (5) ``[p]atients with a history or pattern of obtaining or 
requesting early refills is a red flag of abuse or diversion'' and 
physicians must address or resolve this red flag.

Id. at 6-7.
    Having read and analyzed all of the record evidence and law, I find 
that Dr. Munzing's declaration concerning a California physician's 
standard of care when prescribing controlled substances is supported by 
substantial evidence and is consistent with the explicit text of 
California law as well as state and federal guidelines. As such, I 
apply the standard of care of the state of California as described by 
Dr. Munzing.
2. The Subject Patients
i. Patient L.C.
    From May 1, 2017, to February 21, 2019, and on an approximately 
monthly basis, Applicant prescribed Patient L.C. various opioids 
including oxycodone, hydrocodone-acetaminophen, Nucynta, Belbuca 
(buprenorphine), and hydromorphone, which Dr. Munzing calculated to 
amount to at least 420 mg MME per day. RFAAX 9, at 8; see also RFAAX 7, 
App. B (Applicant's CURES Report), App. C (prescription records for 
Patient L.C.), and Apps. H(i)-(ii) (patient file for Patient L.C.). 
Based upon his review of Patient L.C.'s file, Dr. Munzing concluded 
that Applicant ``prescribed such high-dosage opioids without 
consistently performing detailed examinations or evaluations, 
dependably considering non-opioid alternatives, or reliably weaning 
Patient L.C. off such high dosages.'' RFAAX 9, at 8. In particular, 
``[Applicant's] frequent concurrent prescribing for Patient L.C. of 
oxycodone and hydrocodone-acetaminophen (both short-acting opioids) was 
therapeutically duplicative and therefore medically unnecessary.'' Id. 
Dr. Munzing also stated that, ``[t]here was no medical justification 
for [Applicant's] Belbuca (buprenorphine) prescriptions for Patient 
L.C.'' and noted that ``[Applicant] could not have prescribed Belbuca 
(a Schedule III opioid) for maintenance or detoxification treatment 
(for which Belbuca is usually prescribed) because [Applicant] did not 
possess a DATA-waiver at the time he issued these prescriptions.'' Id. 
Moreover, according to Dr. Munzing, ``given all the other high-dosage 
opioids Patient L.C. was prescribed, there was no legitimate medical 
purpose for additionally prescribing buprenorphine for pain 
management.'' Id.
    Additionally, Dr. Munzing concluded, based upon his review of 
Patient L.C.'s file, that ``[Applicant] frequently prescribed to 
Patient L.C. either (1) a combination of opioids and the

[[Page 21159]]

benzodiazepine, clonazepam . . . or (2) the `Holy Trinity' cocktail, 
which consists of an opioid; a benzodiazepine, such as clonazepam; and 
carisoprodol . . . without performing adequate evaluation or monitoring 
to medically justify these combinations.'' Id. at 8-9. Specifically, 
Dr. Munzing noted that by February 6, 2018, Patient L.C. reported 
experiencing ``side effects attributable to [Applicant's] controlled 
substance prescriptions and which [Applicant] did not adequately 
examine or evaluate.'' Id. at 9. Further, ``[Applicant] improperly 
continued to prescribe these dangerous drug cocktails after February 6, 
2018[,] without further examining or evaluating Patient L.C.'s reported 
side effects.'' Id.
    Finally, Dr. Munzing concluded, based upon his review of Patient 
L.C.'s file, that Applicant failed to address several red flags of 
abuse or diversion. Id. First, Dr. Munzing noted that there was no 
documentation that Applicant adequately addressed or resolved Patient 
L.C.'s inconsistent urine drug screen results, which included positive 
results for controlled substances that Applicant had not prescribed to 
Patient L.C. and that Patient L.C. had not filled the prescriptions 
anywhere in California according to CURES reports, some of which were 
dangerous in combination with the high-dosage opioids that Applicant 
had prescribed to Patient L.C. Id. at 9-10. Patient L.C.'s urine drug 
screen results also included negative results for controlled substances 
for which Applicant had issued prescriptions to Patient L.C. and which 
Patient L.C. had filled. Id. at 10. Second, Dr. Munzing noted that 
there was no documentation that Applicant adequately addressed or 
resolved evidence of Patient L.C.'s early refills of controlled 
substances on at least 34 occasions between 2017 and 2019.\6\ Id. at 
10-11. Finally, Dr. Munzing noted that there was no documentation that 
Applicant addressed or resolved evidence that Patient L.C. traveled a 
long distance (at least 60 miles roundtrip from Martinez, CA to 
Applicant's office in San Leandro, CA) to obtain controlled substances 
from Applicant on a nearly monthly basis. Id.; see also RFAAX 7, App. G 
(printouts from Bing Maps), at 3.
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    \6\ Dr. Munzing noted that ``[e]ven though [Applicant] 
documented on several occasions about providing early refills due to 
Patient L.C. claiming to have lost her tablets from vomiting, there 
was no legitimate medical purpose for consistently continuing to 
provide early refills for this reason without first treating Patient 
L.C.'s issues with vomiting.'' Id. at 11.
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ii. Patient P.B.
    On an approximately monthly basis, Applicant prescribed Patient 
P.B. various opioids including OxyContin, oxycodone, Nucynta, and 
levorphanol tartrate, which Dr. Munzing calculated to amount to at 
least 840 mg MME per day. RFAAX 9, at 11; see also RFAAX 7, App. B 
(Applicant's CURES Report), App. D (prescription records for Patient 
P.B.), and App. I (patient file for Patient P.B.). Based upon his 
review of Patient P.B.'s file, Dr. Munzing concluded that Applicant 
``prescribed such high-dosage opioids without consistently performing 
detailed examinations or evaluations, dependably considering non-opioid 
alternatives, or reliably weaning Patient P.B. off such high dosages.'' 
RFAAX 9, at 11-12. In particular, Dr. Munzing stated that, 
``[Applicant's] concurrent prescribing for Patient P.B. of oxycodone 
and Nucynta (both short-acting opioids) on at least one occasion was 
therapeutically duplicative and therefore medically unnecessary.'' Id. 
at 12. Additionally, Dr. Munzing concluded, based upon his review of 
Patient P.B.'s file, that ``[Applicant] frequently prescribed to 
Patient P.B. either (1) a combination of opioids and the 
benzodiazepine, clonazepam . . . or (2) the ``Holy Trinity'' cocktail, 
which consists of an opioid; a benzodiazepine, such as clonazepam; and 
carisoprodol . . . without performing adequate evaluation or monitoring 
to medically justify these combinations.'' Id.
    Finally, Dr. Munzing concluded, based upon his review of Patient 
P.B.'s file, that Applicant failed to address several red flags of 
abuse or diversion. Id. Specifically, Dr. Munzing noted that there was 
no documentation that Applicant adequately addressed or resolved 
Patient P.B.'s inconsistent urine drug screen results, which included 
positive results for controlled substances that Applicant had not 
prescribed to Patient P.B. and for which Patient P.B. had not filled 
the prescriptions anywhere in California according to CURES reports. 
Id. at 12-13. Patient P.B.'s inconsistent urine drug screen results 
also included a negative result for a controlled substance for which 
Applicant had issued prescriptions to Patient P.B. and which Patient 
P.B. had filled. Id. at 13. Dr. Munzing also noted that there was no 
documentation that Applicant addressed or resolved evidence that 
Patient P.B. traveled a long distance (at least 160 miles roundtrip 
from Newman, CA to Applicant's office in San Leandro, CA) to obtain 
controlled substances from Applicant on a nearly monthly basis. Id. at 
14; see also RFAAX 7, App. G (printouts from Bing Maps), at 4.
iii. Patient S.N.
    On an approximately monthly basis, Applicant prescribed Patient 
S.N. various opioids including OxyContin, oxycodone, and Xtampza, which 
Dr. Munzing calculated to amount to at least 405 mg and 885 mg MME per 
day. RFAAX 9, at 14; see also RFAAX 7, App. B (Applicant's CURES 
Report), App. E (prescription records for Patient S.N.), and App. J 
(patient file for Patient S.N.). Based upon his review of Patient 
S.N.'s file, Dr. Munzing concluded that Applicant ``prescribed such 
high-dosage opioids without consistently performing detailed 
examinations or evaluations, dependably considering non-opioid 
alternatives, or reliably weaning Patient S.N. off such high dosages.'' 
RFAAX 9, at 14.
    Additionally, Dr. Munzing concluded, based upon his review of 
Patient S.N.'s file, that Applicant failed to address several red flags 
of abuse or diversion. Id. First, Dr. Munzing noted that there was no 
documentation that Applicant adequately addressed or resolved Patient 
S.N.'s inconsistent urine drug screen results, which included a 
positive result for controlled substances that Applicant had not 
prescribed to Patient S.N. and for which Patient S.N. had not filled 
the prescriptions anywhere in California according to CURES reports. 
Id. Dr. Munzing also noted that ``[Applicant] failed to document any 
test results for Patient S.N.'s three subsequent urine drug screens 
performed in 2018.'' Id. at 14-15. Second, Dr. Munzing noted that there 
was no documentation that Applicant adequately addressed or resolved 
evidence of Patient S.N.'s early refills of controlled substances on at 
least three occasions between 2017 and 2019. Id. at 15. Finally, Dr. 
Munzing noted that there was no documentation that Applicant addressed 
or resolved evidence that Patient S.N. traveled a long distance (at 
least 70 miles roundtrip from Pittsburg, CA to Applicant's office in 
San Leandro, CA) to obtain controlled substances from Applicant on a 
nearly monthly basis. Id.; see also RFAAX 7, App. G (printouts from 
Bing Maps), at 1-2.
iv. Patient J.H.
    On an approximately monthly basis, Applicant prescribed Patient 
J.H. various opioids including oxycodone, oxycodone-acetaminophen, 
OxyContin, and fentanyl, which Dr. Munzing calculated to amount to at 
least 1,350 mg MME per day. RFAAX 9, at 15; see also RFAAX 7, App. B 
(Applicant's

[[Page 21160]]

CURES Report), App. F (prescription records for Patient J.H.), and App. 
K (patient file for Patient J.H.). Based upon his review of Patient 
J.H.'s file, Dr. Munzing concluded that Applicant ``prescribed such 
high-dosage opioids without consistently performing detailed 
examinations or evaluations, dependably considering non-opioid 
alternatives, or reliably weaning Patient J.H. off such high dosages.'' 
RFAAX 9, at 15. In particular, ``[Applicant's] frequent concurrent 
prescribing for Patient J.H. of oxycodone and oxycodone-acetaminophen 
(both short-acting opioids) was therapeutically duplicative and 
therefore medically unnecessary.'' Id.
    Dr. Munzing also concluded, based upon his review of Patient J.H.'s 
file, that ``[Applicant] frequently prescribed Patient J.H. the `Holy 
Trinity' cocktail, which consists of an opioid; a benzodiazepine, such 
as alprazolam . . . and carisoprodol . . . without performing adequate 
evaluation or monitoring to medically justify this combination.'' Id. 
at 15-16. Specifically, Dr. Munzing noted that by January 29, 2018, 
Patient J.H. reported having experienced ``side effects attributable to 
[Applicant's] controlled substance prescriptions and which [Applicant] 
did not adequately examine or evaluate.'' Id. at 16. Further, 
``[Applicant] improperly continued to prescribe the `Holy Trinity' 
after January 29, 2018[,] without further examining or evaluating 
Patient J.H.'s reported side effects.'' Id. Dr. Munzing also concluded, 
based upon his review of Patient J.H.'s file, that, ``[Applicant] 
frequently prescribed stimulants, either amphetamine salts . . . or 
modafinil . . . without any legitimate medical purpose.'' Id. Dr. 
Munzing noted that he did not find any apparent medical diagnosis or 
evaluation in Patient J.H.'s file for Attention-Deficit Hyperactivity 
Disorder (ADHD), ``for which amphetamine salts are normally used to 
treat.'' Id. Additionally, Dr. Munzing noted that ``while amphetamine 
salts and modafinil can be used to treat drowsiness or extreme 
sleepiness, the use of such stimulants for Patient J.H. was not 
medically appropriate as the patient's drowsiness or sleepiness were 
likely side effects of his prescribed high-dosage opioids.'' Id.
    Finally, Dr. Munzing concluded, based upon his review of Patient 
J.H.'s file, that Applicant failed to address or resolve several red 
flags of abuse or diversion. Id. Specifically, Dr. Munzing noted that 
there was no documentation that Applicant adequately addressed or 
resolved Patient J.H.'s inconsistent urine drug screen results, which 
included positive results for controlled substances that Applicant had 
not prescribed to Patient J.H. and for which Patient J.H. had not 
filled the prescriptions anywhere in California according to CURES 
reports, some of which were dangerous in combination with the high-
dosage opioids that Applicant had prescribed to Patient J.H. Id. at 16-
17. Applicant's inconsistent urine drug screen results also included 
positive results for alcohol, which Dr. Munzing noted can ``amplify the 
risk of overdose and death associated with the `Holy Trinity' cocktail 
[Applicant] prescribed Patient J.H.'' Id. at 17. Moreover, Applicant's 
inconsistent urine drug screen results included negative results for 
controlled substances for which Applicant had issued prescriptions to 
Patient J.H. and which Patient J.H. had filled. Id. at 17-18.
    Based on his expert medical opinion, Dr. Munzing concluded, and I 
agree, that ``the controlled substance[ ] prescriptions issued by 
[Applicant] for Patients L.C., P.B., S.N., and J.H. between May 1, 
2017, and February 21, 2019[,] were issued without a legitimate medical 
purpose and were issued beneath the standard of care for the practice 
of medicine in the State of California, and therefore outside of the 
usual course of professional practice.'' Id. at 7.

II. Discussion

A. Government's Position

    In its RFAA, the Government sought denial of Applicant's 
application for DEA registration because Applicant ``materially 
falsified his application under 21 U.S.C. 824(a)(1), and committed acts 
which render [granting his] registration inconsistent with the public 
interest.'' RFAA, at 1 (citing 21 U.S.C. 824(a)(1), (a)(4) and 823(f). 
Specifically, the Government argued that Applicant had materially 
falsified his application when he falsely provided a ``No'' response to 
the liability question asking him whether he had ever surrendered for 
cause a federal controlled substance registration and when he knew or 
should have known that his ``No'' response was false. Id. at 19. The 
Government also argued that Applicant had repeatedly violated state and 
federal law by issuing prescriptions for controlled substances to four 
patients outside of the standard of care in the State of California and 
outside of the usual course of professional practice. Id. at 21. The 
Government concluded its RFAA by requesting that Applicant's 
application for DEA registration be denied and that any applications by 
Applicant for any other registrations be denied. Id. at 25.

B. Applicant's Position

    Within his Request for Hearing and his Corrective Action Plan, both 
submitted in response to the OSC, Applicant offered explanation as to 
his misconduct, however, Applicant did not offer supporting evidence 
nor any ability for me to assess the credibility of his unsworn 
statements.\7\ See RFAAX 3 (Request for Hearing) and RFAAX 4 
(Corrective Action Plan). In his Request for Hearing, Applicant 
addressed the allegations of material falsification and stated that 
when, on February 21, 2019, DEA investigators visited Applicant's 
registered location to serve an administrative subpoena for patient 
files from his practice, the investigators ``explained that the DEA was 
concerned about certain red flags associated with [his] controlled 
substance prescribing, including but not limited to, long distances 
traveled by patients, high dosages, and drug cocktails.'' RFAAX 3, at 
3. Applicant stated that he ``believed that if [he] surrendered [his] 
DEA certificate that [he] would be demonstrating good faith that [he] 
had done nothing wrong.'' Id. Applicant also stated that he ``was 
unaware and did not understand that [he] was being asked to surrender 
[his] DEA certificate `for cause.' '' Id.
---------------------------------------------------------------------------

    \7\ Applicant specifically did not opt to submit a written 
statement in lieu of a hearing under 21 CFR 1316.49. In this case, I 
have considered these unsworn submissions minimally to represent 
Applicant's position because they address the underlying 
allegations. Even if I afforded these unsupported and unsworn 
statements the weight of a written statement, they would be 
insufficient to rebut the Government's case for denial of 
Applicant's application for the reasons stated herein.
---------------------------------------------------------------------------

    In both his Request for Hearing and his Corrective Action Plan, 
Applicant offered a ``historical perspective'' regarding the improper 
prescribing allegations. RFAAX 3, at 3-5; RFAAX 4, at 5. According to 
Applicant, in 2018, he ``acquired a medical practice from 
anesthesiologist/pain medicine specialist [M. J.], a frequent 
prescriber of schedule II and III medications.'' RFAAX 4, at 5. 
Applicant stated that prior to considering the purchase of M. J.'s 
practice, and before working with him, Applicant ``discussed with him 
his patient population'' and `` [a] contract was drawn up ensuring that 
all [M. J.] was doing was within state and deferral [sic] laws.'' RFAAX 
3, at 3. Applicant stated that he and M. J. agreed that M. J. would 
continue to work with Applicant for the first year and then turn the 
practice over to Applicant. Id. The contract was signed by both

[[Page 21161]]

Applicant and M. J. and witnessed by a third party. Id. According to 
Applicant, CDC guidelines were also discussed, and M.J. ``informed 
[Applicant] that [they] were recommendations, not mandates.'' Id. M.J. 
said that patients had been established with him for 20-30 years. Id. 
Further, M.J. discussed the ``tolerance displayed by long term chronic 
pain patients,'' their ``functionality'' (that patients could ``go to 
work, address activities of daily life, [and] enjoy the benefits of 
being sociable'') and ``an overall high level of productivity of 
patients.'' Id. M.J. further stated that ``if there had been any 
problems, he would not [have been] allowed to operate for all this 
time, incident free.'' Id.
    According to Applicant, upon his evaluation of the patients, he 
realized that ``many patients were not getting the proper workups, 
diagnostic studies[,] and referrals needed to improve their pain.'' Id. 
Further, ``[m]any of them were exhibiting chronic pain due to lack of 
early appropriate treatment'' and ``patients had been pushed toward 
interventional procedures that either were not indicated or ended up 
hurting them.'' Id. Applicant stated that ``[t]his was all done under 
the guise of performing a `trial' '' and that ``[m]edications had been 
escalated due to failed `trials' and recommended due to inability to 
control pain with interventions.'' Id. Applicant stated that ``[a]s 
medications were elevated and encouraged by [M.J.], patients had become 
dependent on their current regimens, and had been educated that their 
pain was so severe that high medication dosages were indicated.'' Id.
    According to Applicant, in April 2019, he was the victim of a cyber 
crime when ransomware was placed onto his servers and corrupted all of 
his electronic medical records. Id. at 4. Applicant stated that 
``[although] no HIPPA violation occurred and the charts were retrieved 
on an external hard drive, upon attempting to upload the data, the 
external hard drive became corrupted leading to loss of all charting 
information.'' Id. As a result of the data loss, Applicant was only 
able to provide management details for the four patients referenced in 
the OSC by memory and not by specific references to their patient 
records. Id. Applicant stated that ``[a]ll four patients cited in the 
[OSC] were patients managed or at one time managed by [M.J.].'' Id. 
Further, ``[n]one of them were na[iuml]ve to opioids and were elevated 
to the regimens in question by [M.J.].'' Id. Applicant concluded that 
``[a]ll of these patients, from the moment [he] inherited them, were 
already and for years [had been] above the current state, federal[,] 
and CDC guidelines.'' Id.
    Regarding Patient L.C., Applicant stated that her medications had 
been escalated prior to her becoming Applicant's patient. Id. According 
to Applicant, Patient L.C. had indicated that ``she had tried many 
procedures for her condition including [ ] a trial of a Spinal Cord 
Stimulator (SCS).'' Id. However, Patient L.C. said that during the SCS 
trial she had been hurt and she ``frequently had her mother [with her] 
at appointments to advocate that she would never have [an] SCS [again] 
due to the adverse experience during the trial.'' Id. Applicant stated 
that he and other physicians believed that Patient L.C. was getting too 
much medication and Applicant ``used [other] opinions to further 
bolster [his own],'' but Patient L.C. disagreed and ``cit[ed] [M.J.].'' 
Id. Applicant then started Patient L.C. on a ``slow wean'' of her 
medications. Id. According to Applicant, Patient L.C. was also 
undergoing a trial of Belbuca for her pain, and as he was weaning down 
her medications, Belbuca was used ``to continue to cover her chronic 
pain.'' Id. Applicant stated that Belbuca ``is indicated for the 
management of pain severe enough to require daily, around-the-clock, 
long-term opioid treatment and for which alternative treatment options 
are inadequate.'' Id. For Patient L.C., Belbuca was ``not being used 
for maintenance or detoxification treatment.'' Id.
    Regarding Patient P.B., Applicant stated that her medications had 
been escalated prior to her becoming Applicant's patient. Id. According 
to Applicant, there had been no diagnostic studies on file for Patient 
P.B. and weaning down of her medications occurred once diagnostic 
studies were performed. Id.
    Regarding Patient S.N., Applicant stated that his medications had 
also been escalated prior to him becoming Applicant's patient. Id. at 
5. According to Applicant, Patient S.N. ``cited tailbone pain that made 
sitting for long periods difficult'' and ``had a job where he often 
traveled by plane and was not able to stop and take breaks from 
sitting.'' Id. ``Refills made early usually represented a documented 
trip he had on behalf of his profession.'' Id. According to Applicant, 
Patient S.N. ``had never been worked up for his pain'' and ``[m]ultiple 
diagnostic studies were conducted in attempts to find a solution.'' Id. 
Applicant stated that he started Patient S.N. on a weaning down of his 
medication and ``[a]fter S.N. transferred care to obtain medication 
from another provider, he continued to work with [Applicant] in an 
attempt to solve his pain.'' Id. Applicant also stated that Patient 
S.N. ``attempted a nerve block to further investigate a solution to his 
pain, though no opioids were being prescribed by [Applicant] at the 
time.'' Id.
    Finally, regarding Patient J.H., Applicant stated that his 
medications too had been escalated prior to him becoming Applicant's 
patient. Id. According to Applicant, Patient J.H. had sustained an 
occupational injury and was being managed under a workers' compensation 
insurer. Id. Patient J.H. previously had a failed surgical procedure 
and was a candidate for a revision procedure. Id. Applicant stated that 
he had agreed with the revision procedure as an option, but that the 
procedure was denied by the insurer. Id. According to Applicant, 
``[o]ther non-opioid options were recommended to help decrease [Patient 
J.H.'s use of] opioids and [to] manage his pain.'' Id.
    Applicant concluded his Request for Hearing by asserting that his 
patients ``had been taught that issues that could have normally been 
mitigated by appropriate treatment were instead only able to be 
addressed with high levels of medication'' and that ``[t]he belief had 
been ingrained that medications were the only option.'' Id. Applicant 
asserted that his patients in turn became dependent on their 
medications and that ``[a]s a competent, caring doctor, [he] could not 
abandon them.'' Id. Applicant stated that he ``was working diligently 
to reduce their medication use, but found a number of patients who had 
been on long term opiate use'' and thus ``[had] to very slowly wean 
them.'' Id.
    In his Corrective Action Plan, Applicant stated, ``Given my 
training in physical medicine and rehabilitation, my focus was to taper 
his patients from high dose opioids and offer them an array of 
alternative treatment options.'' RFAAX 4, at 5. According to Applicant, 
``[o]n February 23, 2019, in the midst of this process, DEA officers 
presented to the clinic and requested that [he] surrender [his] DEA 
license'' to which Applicant ``voluntarily complied.'' Id. Applicant 
further stated that ``[a]t that time, patients who were on scheduled 
medications were provided the option of tapering off their medications 
or provided a list of alternative physicians for transfer of care, 
including an addiction medicine specialist.'' Id. Applicant asserted 
that ``[f]or those patients who decided to taper/discontinue their 
medications, [he] continued to provide them care in the framework of 
holistic treatment options such as physical and behavioral therapies, 
procedures, durable medical

[[Page 21162]]

equipment, self-directed exercise, and other non-medical pain 
management strategies.'' Id.
    Applicant stated that he ``proceeded to close the practice, and 
after full disclosure, [he has] been evaluating and treating patients 
at RehabOne Medical Group, Inc.'' Id. Applicant chose to work at 
RehabOne ``because of their positive reputation in the community [and] 
their focus on functional restoration.'' Id. Applicant also chose 
RehabOne for ``their attentiveness to documentation, record keeping, 
and compliance [as well as] medical provider supervision[,] oversight, 
and collaboration.'' Finally, Applicant chose RehabOne for their 
``adherence with evidence-based guideline recommendations for 
prescribing controlled substances.'' Id. Applicant stated that 
``[a]lthough [he has] not personally prescribed any scheduled 
medications, RehabOne has a strong risk management policy that utilizes 
opioid and addiction risk screening tools, long-term controlled 
substance agreements, routine CURES analysis, initial and random urine 
toxicology, and `5 As' monitoring.'' Id. Further, ``[w]hen opioid or 
non-opioid medications are considered appropriate as part of a 
treatment plan, all efforts are made to utilize the lowest dose and 
frequency possible to achieve optimal outcomes.'' Id. According to 
Applicant, ``[a]t RehabOne, medications are very carefully considered 
as part of an overall, comprehensive treatment strategy with the 
primary goal of functional restoration and quality of living.'' Id.
    Applicant concluded his Corrective Action Plan by stating that 
``[m]oving forward, [he plans] to strictly adhere to these practices 
and principles as [he strives] to help [his] patients lead full and 
meaningful lives.'' Id. Applicant stated that he ``will continue to 
review and implement the most current evidence-based guidelines for the 
treatment of chronic pain'' and requested that ``[DEA] reinstate [his] 
DEA license so that [he] can utilize appropriate medications as one 
tool in the toolbox to achieve these outcomes.'' Id.

C. Analysis

1. 21 U.S.C. 823(f): The Five Public Interest Factors
    Pursuant to section 303(f) of the Controlled Substances Act 
(hereinafter, CSA), ``[t]he Attorney General shall register 
practitioners . . . to dispense . . . controlled substances . . . if 
the applicant is authorized to dispense . . . controlled substances 
under the laws of the State in which he practices.'' 21 U.S.C. 823(f). 
Section 303(f) further provides that an application for a 
practitioner's registration may be denied upon a determination that 
``the issuance of such registration . . . would be inconsistent with 
the public interest.'' Id. In making the public interest determination, 
the CSA requires consideration of the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f).
    The 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). Thus, there is no need to enter findings on each of the 
factors. Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). 
Furthermore, there is no requirement to consider a factor in any given 
level of detail. Trawick v. Drug Enf't Admin., 861 F.2d 72, 76-77 (4th 
Cir. 1988). The balancing of the public interest factors ``is not a 
contest in which score is kept; 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 . . . .'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). When deciding whether 
registration is in the public interest, the DEA must consider the 
totality of the circumstances. See generally Joseph Gaudio, M.D., 74 FR 
10083, 10094-95 (2009) (basing sanction on all evidence on record).
    The Government does not dispute that Applicant holds a valid state 
medical license and is authorized to dispense controlled substances in 
the State of California where he practices. See RFAAX 2 (OSC), at 2. 
While I have considered all of the public interest factors \8\ in 21 
U.S.C. 823(f), the Government's evidence in support of its prima facie 
case for denial of Applicant's application is confined to Factors Two 
and Four. See RFAA, at 19-25. Moreover, the Government has the burden 
of proof in this proceeding. 21 CFR 1301.44. I find that the 
Government's evidence satisfies its prima facie burden of showing that 
Applicant's registration would be ``inconsistent with the public 
interest.'' 21 U.S.C. 824(f). I further find that Applicant failed to 
provide sufficient evidence to rebut the Government's prima facie case.
---------------------------------------------------------------------------

    \8\ As to Factor One, there is no record evidence of 
disciplinary action against Applicant's state medical license. 21 
U.S.C. 823(f)(1). State authority to practice medicine is ``a 
necessary, but not a sufficient condition for registration . . . .'' 
Robert A. Leslie, M.D., 68 FR at 15230. Therefore, ``[t]he fact that 
the record contains no evidence of a recommendation by a state 
licensing board does not weigh for or against a determination as to 
whether continuation of [or granting of a] DEA certification is 
consistent with the public interest.'' Roni Dreszer, M.D., 76 FR 
19434, 19444 (2011).
    As to Factor Three, there is no evidence in the record that 
Applicant 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(f)(3). However, as Agency 
cases have noted, there are a number of reasons why a person who has 
engaged in criminal misconduct may never have been convicted of an 
offense under this factor, let alone prosecuted for one. Dewey C. 
MacKay, M.D., 75 FR 49956, 49973 (2010). Agency cases have therefore 
found that ``the absence of such a conviction is of considerably 
less consequence in the public interest inquiry'' and is therefore 
not dispositive. Id.
    As to Factor Five, the Government's evidence fits squarely 
within the parameters of Factors Two and Four and does not raise 
``other conduct which may threaten the public health and safety.'' 
21 U.S.C. 823(f)(5). Accordingly, Factor Five does not weigh for or 
against Applicant.
---------------------------------------------------------------------------

i. Factors Two and Four
    Evidence is considered under Public Interest Factors Two and Four 
when it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
Established violations of the CSA, DEA regulations, or other laws 
regulating controlled substances at the state or local level are 
cognizable when considering whether granting a registration is 
consistent with the public interest.
    Here, the Government has alleged that from at least May 1, 2017, 
through at least February 21, 2019, Applicant unlawfully issued 
prescriptions for controlled substances in violation of the CSA. RFAAX 
2 (OSC), at 2 and 4-10. Specifically, the Government alleges that 
Applicant repeatedly violated 21 CFR 1306.4(a) by issuing prescriptions 
for controlled substances to Patients L.C., P.B., S.N., and J.H. 
beneath the standard of care and outside the usual course of 
professional practice in California--the state in which Applicant is 
applying for DEA registration. Id.

[[Page 21163]]

    According to the CSA's implementing regulations, a lawful 
controlled substance order or prescription is one that is ``issued for 
a legitimate medical purpose by an individual practitioner acting in 
the usual course of his professional practice.'' 21 CFR 1306.04(a). The 
Supreme Court has stated, in the context of the CSA's requirement that 
schedule II controlled substances may be dispensed only by written 
prescription, that ``the prescription requirement . . . ensures 
patients use controlled substances under the supervision of a doctor so 
as to prevent addiction and recreational abuse . . . [and] also bars 
doctors from peddling to patients who crave the drugs for those 
prohibited uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    I found above that the Government's expert credibly declared, as 
supported by California law and federal and state guidelines, that the 
standard of care in California requires physicians to, among other 
things, perform a sufficient physical exam and take a medical history, 
counsel patients on the risks and benefits of the use of particular 
controlled substances, periodically review the course of treatment and 
adjust as needed, give special attention to patients who pose a risk 
for medication misuse and diversion, and monitor and address any red 
flags of abuse or diversion. Further, the standard of care in 
California requires additional care and consideration for the 
prescribing of opioids, as well as for the prescribing of 
benzodiazepines in combination with opioids.
    Based on the credible and unrebutted opinion of the Government's 
expert, I found above that Applicant issued a high number of controlled 
substance prescriptions to at least four different patients, often for 
extremely high doses of opioids and in dangerous combinations of 
opioids and benzodiazepines, without performing detailed examinations 
or evaluations, dependably considering non-opioid alternatives, 
reliably weaning patients off such high dosages, or resolving or 
documenting resolution of red flags of abuse and/or diversion as 
required by the standard of care. See supra I.C.2.i-iv. My findings 
demonstrate that Applicant repeatedly violated the applicable standard 
of care when prescribing controlled substances and that his conduct was 
not an isolated occurrence, but occurred with multiple patients. See 
Kaniz Khan Jaffery, 85 FR 45667, 45685 (2020); Wesley Pope, M.D., 82 FR 
42961, 42986 (2017). As such, I find that the Government has presented 
substantial evidence that from May 1, 2017, to February 21, 2019, 
Applicant issued controlled substance prescriptions to the four subject 
patients beneath the applicable standard of care in California and 
outside the usual course of professional practice. Accordingly, I am 
sustaining the Government's allegation that Applicant violated 21 CFR 
1306.04(a).
    The Government has also alleged that Applicant's prescribing 
practices in regard to the subject patients violated California State 
law. RFAAX 2, at 2-3 and 4-10. Echoing the federal regulations, 
California law requires that a ``prescription for a controlled 
substance shall only be issued for a medical purpose by an individual 
practitioner acting in the usual course of his or her professional 
practice.'' Cal. Health & Safety Code Sec.  11153(a).\9\ Further, 
California Business and Professions Code Sec.  2242(a) states, 
``Prescribing, dispensing, or furnishing [controlled substances] 
without an appropriate prior examination and a medical indication[ ] 
constitutes unprofessional conduct.'' \10\ Accordingly, I find that, 
similarly to 21 CFR 1306.04(a), the record contains substantial 
evidence that Applicant violated these provisions with respect to the 
controlled substance prescriptions for Patients L.C., P.B., S.N., and 
J.H.
---------------------------------------------------------------------------

    \9\ The Government also alleged that Applicant violated 
California Health and Safety Code Sec.  11154(a), which states that 
``no person shall knowingly prescribe, administer, dispense, or 
furnish a controlled substance to or for any person . . . not under 
his or her treatment for a pathology or condition.'' Dr. Munzing's 
expert report did not address whether Applicant knowingly prescribed 
controlled substances to or for any person not under his treatment 
for a pathology or condition. Accordingly, I find that the 
Government has not met its burden to prove by substantial evidence 
that Applicant violated California Health and Safety Code Sec.  
11154(a).
    \10\ The Government also alleged that Applicant violated 
California Business and Professions Code Sec. Sec.  2234 and 725(a), 
which state that unprofessional conduct includes ``[g]ross 
negligence''; ``[r]epeated negligent acts''; ``[i]ncompetence''; or 
``[t]he commission of any act involving dishonesty or corruption 
that is substantially related to the qualifications, functions, or 
duties of a physician and surgeon'' as well as ``[r]epeated acts of 
clearly excessive prescribing, furnishing, dispensing, or 
administering of drugs.'' Dr. Munzing's expert report did not 
address whether Applicant engaged in these particular forms of 
unprofessional conduct. Accordingly, I find that the Government has 
not met its burden to prove by substantial evidence that Applicant 
violated California Business and Professions Code Sec. Sec.  2234 
and 725(a).
---------------------------------------------------------------------------

    In sum, I find that the record contains substantial evidence that 
Applicant issued a multitude of prescriptions for controlled 
substances, including high dosages of opioids, to multiple patients 
beneath the applicable standard of care, outside the usual course of 
professional practice, and in violation of federal and state law. I, 
therefore, find that Factors Two and Four weigh in favor of denial of 
Applicant's application and thus find Applicant's registration to be 
inconsistent with the public interest in balancing the factors of 21 
U.S.C. 823(f).
2. 21 U.S.C. 824(a)(1): Material Falsification
    In addition to the public interest allegations, as previously 
mentioned, the OSC in this matter also alleges that Applicant's 
application for registration should be denied, because Applicant's 
application contains a materially false response to a liability 
question. RFAAX 2, at 1 and 3-4; see supra I.A-B.1. The CSA, however, 
places the provision addressing the ramification of a material 
falsification with the bases for revocation or suspension of a 
registration. 21 U.S.C. 824(a). Prior Agency decisions have addressed 
whether it is appropriate to consider a material falsification and 
other provisions of 21 U.S.C. 824(a) when determining whether or not to 
grant a practitioner registration application. For over forty-five 
years, Agency decisions have concluded that it is. See, e.g., Lisa M. 
Jones, N.P., 86 FR 52196 (2021), Robert Wayne Locklear, 86 FR 33738 
(2021) (collecting Agency decisions). These decisions offer multiple 
bases and analyses for that conclusion. 86 FR at 33744-45.
    Having read and analyzed all of the record evidence, I find from 
clear, unequivocal, convincing, and unrebutted record evidence that 
Applicant surrendered (for cause) his previous DEA registration on 
February 21, 2019. See supra I.A-B.1. Having read and analyzed all of 
the record evidence, I find from clear, unequivocal, convincing, and 
unrebutted record evidence that when presented with the liability 
question, ``Has the applicant ever surrendered (for cause) or had a 
federal controlled substance registration revoked, suspended, 
restricted or denied, or is any such action pending?''--Applicant 
answered, ``No.'' Id. Applicant's false answer to this liability 
question in his application implicates two of the public interest 
factors that the CSA requires me to consider (see supra II.C.1): 
Applicant's experience in dispensing controlled substances and 
Applicant's compliance with applicable federal laws relating to 
controlled substances. 21 U.S.C. 823(f)(2) and (4); Frank Joseph 
Stirlacci, M.D., 85 FR 45229, 45234 (2020). As such, Applicant's false 
response to this liability question in his application was 
``predictably capable of affecting, i.e., had a natural tendency to 
affect'' my official decision on Applicant's application. Frank Joseph 
Stirlacci,

[[Page 21164]]

M.D., 85 FR at 45238. Accordingly, I find from clear, unequivocal, 
convincing, and unrebutted record evidence that Applicant's application 
for DEA registration contains a material falsification, which is an 
independent basis for the denial of Applicant's application.

III. Sanction

    The Government has established grounds to deny a registration; 
therefore, I will review any evidence and argument that Applicant 
submitted to determine whether or not Applicant has presented 
``sufficient mitigating evidence to assure the Administrator that [he] 
can be trusted with the responsibility carried by such a 
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). `` `Moreover, 
because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 
(7th Cir. 1995), [the Agency] has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for [the registrant's] 
actions and demonstrate that [registrant] will not engage in future 
misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting 
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Samuel S. Jackson, 
D.D.S., 72 FR at 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709 
(2006); Prince George Daniels, D.D.S., 60 FR 62884, 62887 (1995). The 
issue of trust is necessarily a fact-dependent determination based on 
the circumstances presented by the individual respondent; therefore, 
the Agency looks at factors, such as the acceptance of responsibility 
and the credibility of that acceptance as it relates to the probability 
of repeat violations or behavior and the nature of the misconduct that 
forms the basis for sanction, while also considering the Agency's 
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR 
8247, 8248 (2016).

A. Acceptance of Responsibility

    As previously discussed, although Applicant initially requested a 
hearing and submitted a Corrective Action Plan on July 23, 2020, 
Applicant later withdrew his hearing request on August 14, 2020, and 
the proceedings were terminated. See RFAAX 3 (Request for Hearing); 
RFAAX 4 (Corrective Action Plan); RFAAX 5 (Withdrawal of Hearing 
Request); RFAAX 6 (Order Terminating Proceedings). As such, there is no 
credible, sworn evidence on the record regarding acceptance of 
responsibility for me to consider. Further, even if I could consider 
the explanations that Applicant offered in his initial Request for 
Hearing and Corrective Action Plan, they do not demonstrate sufficient 
acceptance of responsibility or evidence of remedial measures that 
would aid me in entrusting Applicant with registration. See RFAAX 3 and 
RFAAX 4.
    As to the allegations of material falsification, Applicant claimed 
that, at the time he surrendered his DEA certificate for cause, he 
misunderstood that he was doing so and believed instead that he was 
``demonstrating good faith that [he] had done nothing wrong.'' \11\ 
RFAAX 3, at 3. Whether or not Applicant's claims are truthful, they do 
not demonstrate acceptance of responsibility for his (intentional or 
not) materially false response to a liability question. Rather, 
Applicant's claims demonstrate an attempt to either shift the blame to 
DEA investigators for failing to properly explain the situation to him 
or to simply use his ignorance as an excuse, neither of which inspire 
confidence that Applicant fully appreciates an applicant's obligation 
to provide truthful and accurate responses on an application for DEA 
registration.
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    \11\ It is noted that in spite of Applicant's claims that he did 
not know that he was surrendering his previous registration ``for 
cause,'' RFAAX 3, at 3, the DEA Form 104 that Applicant signed was 
clearly entitled, ``Surrender for Cause of DEA Certificate of 
Registration,'' RFAAX 8, App. B (emphasis added).
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    As to the allegations of improper prescribing, Applicant claimed 
that he had inherited the subject patients from his purchase of another 
physician's practice and that the physician he had purchased the 
practice from had assured him that all was proper regarding the 
practice and his patients. RFAAX 3, at 3; RFAAX 4, at 5. However, 
Applicant claimed that he only later realized that all was not proper 
regarding the practice and the patients that he had inherited and that 
he had done the best that he could to wean the four subject patients 
off of their high dosages of controlled substances. RFAAX 3, at 3-5; 
RFAAX 4, at 5. Again, Applicant's statements do not demonstrate 
acceptance of responsibility for his improper prescribing, but instead 
demonstrate an attempt to shift the blame to the physician whom he had 
inherited the subject patients from or, at the very least, a failure to 
acknowledge that, regardless of his intentions, his prescribing was 
beneath the applicable standard of care and outside the usual course of 
professional practice.
    As for remedial measures, I do not consider them when an Applicant 
has not unequivocally accepted responsibility, however, even if I were 
to consider Applicant's remedial measures here, I do not find them to 
be sufficient. Applicant discussed how since surrendering his DEA 
registration, he has closed his practice and has begun treating 
patients at another practice, one which he lauds for its adherence to 
best practices for prescribing controlled substances. RFAAX 4, at 5. 
Applicant also stated his own commitment to adhering to these best 
practices moving forward, however, Applicant did not specify in what 
ways he would ensure this adherence. Id. As such, Applicant has not 
sufficiently demonstrated that he is ready to be entrusted with the 
responsibility of registration.

B. Specific and General Deterrence

    In addition to acceptance of responsibility, the Agency considers 
both specific and general deterrence when determining an appropriate 
sanction. Daniel A. Glick, D.D.S., 80 FR 74,800, 74,810 (2015). 
Specific deterrence is the DEA's interest in ensuring that a registrant 
complies with the laws and regulations governing controlled substances 
in the future. Id. General deterrence concerns the DEA's responsibility 
to deter conduct similar to the proven allegations against the 
registrant for the protection of the public at large. Id. In this case, 
I believe that denial of Applicant's application for DEA registration 
would deter Applicant and the general registrant community from the 
improper prescribing of controlled substances as well as from ignoring 
their obligation to provide accurate and truthful responses on an 
application for DEA registration.

C. Egregiousness

    The Agency also looks to the egregiousness and the extent of the 
misconduct as significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR at 18,910 (collecting 
cases). Here, the record contains substantial evidence that Applicant 
issued a high number of prescriptions for controlled substances, 
including high dosages of opioids and dangerous combinations of opioids 
and benzodiazepines, to at least four different patients beneath the 
applicable standard of care and outside the usual course of 
professional practice. Further, Applicant gave a materially false 
response to a liability question on his application for DEA 
registration that directly concerned his improper prescribing practices 
and his negative history with DEA registration.
    As discussed above, to be granted a registration when grounds for 
denial

[[Page 21165]]

exist, an Applicant must convince the Administrator that his acceptance 
of responsibility is sufficiently credible to ensure that his 
misconduct will not reoccur and that he can be entrusted with 
registration. I find that Applicant has not met this burden. In sum, 
Applicant has not offered any credible evidence on the record to rebut 
the Government's case for denial of his application and Applicant has 
not demonstrated that he can be entrusted with the responsibility of 
registration. Accordingly, I will order the denial of Applicant's 
application below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f) and 21 U.S.C. 824(a), I hereby deny the pending 
application for a Certificate of Registration, Control Number 
W19032408C, submitted by Kareem Hubbard, M.D., as well as any other 
pending application of Kareem Hubbard, M.D. for additional registration 
in California. This Order is effective May 11, 2022.

Anne Milgram,
Administrator.
[FR Doc. 2022-07702 Filed 4-8-22; 8:45 am]
BILLING CODE 4410-09-P