Notice2022-07702
Kareem Hubbard, M.D.; Decision and Order
Primary source
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Published
April 11, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 87 Issue 69 (Monday, April 11, 2022)</title>
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[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21156-21165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://web.archive.org/web/20210921192242/http://www.mbc.ca.gov/Download/Documents/laws-guide.pdf">http://web.archive.org/web/20210921192242/http://www.mbc.ca.gov/Download/Documents/laws-guide.pdf</a>.
\3\ Available at: <a href="https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf">https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf</a>.
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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 <a href="https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf">https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf</a> and <a href="https://www.cdc.gov/drugoverdose/prescribing/guideline.html">https://www.cdc.gov/drugoverdose/prescribing/guideline.html</a>.
\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 <a href="https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm518110.htm">https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm518110.htm</a>.
(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.
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\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.
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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.
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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.
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\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).
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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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
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</html>Indexed from Federal Register on April 11, 2022.
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