Notice2022-07685
David H. Betat, M.D.; Decision and Order
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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 21175-21181]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07685]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
David H. Betat, M.D.; Decision and Order
On August 21, 2019, a former Assistant Administrator of the
Diversion Control Division of the Drug Enforcement Administration
(hereinafter, Government) issued an
[[Page 21176]]
Order to Show Cause (hereinafter, OSC) seeking to revoke the DEA
Certificate of Registration, number BB0500365, of David H. Betat, M.D.
(hereinafter, Registrant). Government Request for Final Agency Action
(hereinafter, RFAA) Exhibit (hereinafter, RFAAX) 1 (OSC). The OSC
sought to revoke Registrant's registration pursuant to 21 U.S.C.
824(a)(4) on the ground that it is inconsistent with the public
interest, as that term is defined in 21 U.S.C. 823(f), and to deny any
pending applications for renewal or modification of such registration
pursuant to 21 U.S.C. 823(f). Id. at 1.
Specifically, the OSC alleged that Registrant, from at least 2012
through at least 2017, prescribed controlled substances to various
patients that were not issued for a legitimate medical purpose, that
were beneath the standard of care for the practice of medicine in the
State of California, and that were not issued in the usual course of
professional practice. Id. at 2-4. The OSC further alleged that
Registrant's controlled substance prescribing practices violated both
federal and state law. Id. at 4.
In response to the OSC, Registrant submitted a timely request for a
hearing. RFAAX 3 (Request for Hearing for the OSC). The case was
subsequently assigned to Administrative Law Judge (hereinafter, ALJ)
Mark M. Dowd, who ordered that the Government file its prehearing
statement by October 16, 2019, and that Registrant file his prehearing
statement by November 1, 2019. RFAAX 4 (Order for Prehearing
Statements). Registrant failed to file a prehearing statement by
November 1, 2019. ALJ Dowd subsequently issued an order to show cause
on November 8, 2019, providing Registrant until November 20, 2019, to
file both a prehearing statement and a statement demonstrating good
cause for failure to meet the original deadline. See RFAAX 5 (ALJ Dowd
Order to Show Cause). Registrant did not respond to the ALJ's order to
show cause. Consequently, ALJ Dowd issued an order finding that
Registrant had waived his right to a hearing and terminating the
proceedings. RFAAX 6 (Order Terminating Proceedings).
On August 17, 2020, the Government forwarded its RFAA, along with
the evidentiary record in this matter, to my office. The Government
seeks a final order of revocation because Registrant has ``committed
acts that render his continued registration inconsistent with the
public interest under 21 U.S.C. 824(a) and 823(f).'' RFAA, at 3. 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. Registrant's DEA Registration
Registrant is registered with DEA as a practitioner authorized to
handle controlled substances in schedules II through V under DEA
Certificate of Registration number BB0500365 at the registered address
of 925 Bevins Court, Lakeport, California 95453. RFAAX 7 (Certificate
of Registration). Registrant's registration expires by its terms on
July 31, 2022. Id.
b. Investigation of Registrant
On May 10, 2018, a DEA Diversion Investigator (hereinafter, the DI)
served an administrative subpoena on Registrant for patient files
reflecting Registrant's treatment of various patients. RFAAX 8
(Declaration of Diversion Investigator), App. A. Registrant provided
copies of various patient files in response to DEA's subpoena,
including patient files for Patients K.K., G.K., T.L., J.P., and Y.P.
RFAAX 8, at 2 and Apps. B-F (Copies of patient files).
In furtherance of the DEA investigation of Registrant, the DI
obtained information from the California Controlled Substance
Utilization Review Evaluation System (CURES) database regarding
Registrant's prescriptions to Patients K.K., G.K., T.L., J.P., and Y.P.
for the period of 2012 through 2017. Id. at ] 13 and App. G (Copy of
CURES database report). The DI also issued administrative subpoenas to
various pharmacies to obtain copies of Registrant's prescriptions to
Patients K.K., G.K., T.L., J.P., and Y.P. Id. at ] 16. The pharmacies
responded with copies of prescriptions for the requested patients. Id.
at Apps. I-M (Copies of prescriptions from CVS Pharmacy), O-P (Copies
of prescriptions from Kmart Pharmacy), R-T, V-X (Copies of
prescriptions from North Lake Medical Pharmacies), Z-AA (Copies of
prescriptions from Safeway Pharmacy), AC (Copies of prescriptions from
Omnicare, Inc.), AE (Copies of prescriptions from Pharmacy Care
Concepts), AG-AH (Copies of prescriptions from Lucerne Pharmacy), AJ
(Copies of prescriptions from Moran's Pharmacy), AL (Copies of
prescriptions from Walmart Pharmacy). In addition to producing copies
of Registrant's prescriptions to Patients K.K., G.K, T.L, J.P, and
Y.P., two pharmacies informed the DI that there were certain
prescriptions they failed to produce because they were unable to locate
them or the records had been lost. Id. at ]] 48-49, App. AM-AN.
c. The Government Expert's Review of Registrant's Prescriptions
The DEA hired Dr. Timothy A. Munzing to review Registrant's patient
files for the patients under review and the CURES report showing
Registrant's prescriptions to those patients for the period from 2012-
2017. Id. at ] 15. Dr. Munzing is a physician licensed and practicing
in the State of California, who has more than three decades of clinical
work and has served as a Medical Expert Reviewer for the Medical Board
of California.\1\ RFAAX 9, at ]] 1-3 (Declaration of Dr. Munzing); see
also id. at App. A (Dr. Munzing CV). 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.
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\1\ Currently named California Department of Consumer Affairs,
Division of Investigation, and Health Quality Investigation Unit
(``HQIU''). RFAAX 9, at ] 3.
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Dr. Munzing's expert report ``review[ed] the management of the five
patients [K.K., G.K., T.L., J.P, and Y.P.] and opine[d] on the
controlled substance prescriptions, specifically whether they were
medically legitimate and in the usual course of professional
practice.'' RFAAX 9, App. B, at 4 (Munzing Report) (emphasis omitted).
Dr. Munzing concluded, and I agree, that with regard to patients K.K.,
G.K., T.L., J.P., and Y.P., Registrant repeatedly issued controlled
substance prescriptions without a legitimate medical purpose, outside
the usual course of professional practice in the State of California,
and ``in violation of the minimum standard of care that governs
California physicians with respect to the use of controlled substances
in pain management.'' Id. at ] 15.
i. Standard of Care in California
Dr. Munzing attested that several statutes inform the standard of
care in California for the use of controlled substances in pain
management. RFAAX 9, at ] 10. Among them, California Health and Safety
Code 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.'' California Business and Professional Code
2241.5 permits California physicians to treat patients under their care
for pain, including intractable pain, by prescribing controlled
substances, but requires them to ``exercise reasonable
[[Page 21177]]
care in determining whether a particular patient or condition, or the
complexity of a patient's treatment, . . . requires consultation with,
or referral to, a more qualified specialist.'' Finally, California
Business and Professional Code 2242 provides that ``[p]rescribing,
dispensing, or furnishing'' controlled substances to a patient
``without an appropriate prior examination and a medical indication''
is ``unprofessional conduct'' by the prescribing physician. RFAAX 9, at
] 10. Dr. Munzing further noted that California's applicable standard
for the use of controlled substances in pain management is also
informed by the ``Guide to the Laws Governing the Practice of Medicine
by Physicians and Surgeons,'' Medical Board of California, 7th ed. 2013
(hereinafter, the Guide). Id. at ] 11.
Dr. Munzing opined that, as informed by the above statutes and the
Guide, the California standard of care for the use of controlled
substances in pain management requires, among other things, that a
physician prescribing controlled substances:
``(1) perform a sufficient physical examination and take a medical
history;
(2) make an assessment of the patient's pain, their physical and
psychological function, and their history of prior pain treatment;
(3) make an assessment of any underlying or coexisting diseases or
conditions and order and perform diagnostic testing if necessary;
(4) discuss with the patient the risks and benefits of the use of
controlled substances or any other treatment modules;
(5) review periodically the course of pain treatment and gather any
new information, if any, about the etiology of a patient's state of
health; and
(6) give special attention to patients who, by their own words and
actions, pose a risk for medication misuse and/or diversion.''
Id. at ] 12. Dr. Munzing also opined that the California standard of
care imposes additional requirements for certain specific controlled
substance prescriptions that Registrant prescribed to the subject
patients. First, a physician must closely monitor patients prescribed
opioid doses equivalent to or greater than 100 mg of morphine per day
due to the substantially increased risks of overdose and death.\2\ Id.
at ] 13; see also id. at App. B, at 62 and 66 (referencing Centers for
Disease Control guideline \3\ that encourages keeping opioid dosing
less than 50 mg per day MED if possible). In particular, Dr. Munzing
attested that a California physician must specifically counsel the
patient on the risks posed by such prescriptions and document that
counseling; conduct urine drug screens of the patient and review the
patient's profile in the CURES database at least every 3-4 months;
refer the patient for co-management by a specialist in pain management
where appropriate; and attempt to lower the medication dosage
prescribed as much as possible. Id. at ] 13.
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\2\ Dr. Munzing explained that a patient's daily dosage of
opioids is evaluated using morphine milligram equivalency (``MME''),
also known as the daily morphine equivalent dosage (``MED''), under
which each different opioid is assigned a value to represent its
potency relative to morphine sulfate. RFAAX 9, at n. 1.
\3\ Although the Government's evidence did not include the
Centers for Disease Control and Prevention (CDC), Guideline for
Prescribing Opioids for Chronic Pain, 2016, it is publically
available at: <a href="https://www.cdc.gov/drugoverdose/prescribing/guideline.html">https://www.cdc.gov/drugoverdose/prescribing/guideline.html</a>.
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Second, a physician prescribing both opioids and benzodiazepines to
a patient must exercise extra caution because both groups of drugs are
respiratory depressants and simultaneous prescriptions can increase the
patient's risk of overdose and death. Id.; see also id. at App. B, at
63 (referencing Food and Drug Administration 2016 ``Black Box Warning''
on the serious risks associated with the combined use of certain opioid
medications and benzodiazepines and the Centers for Disease Control
2016 Guideline for Prescribing Opioids for Chronic Pain). Dr. Munzing
attested that a physician who simultaneously prescribes both an opioid
and a benzodiazepine should document the medical necessity for
prescribing both, discuss the risks of prescribing with the patient,
and document that conversation. Id.
Third, a physician prescribing opioids for pain management must
avoid issuing overlapping prescriptions with the same therapeutic
effect, commonly referred to as therapeutic duplication. Id. at ] 13.
Fourth, a physician prescribing methadone to a patient for an extended
term must exercise special care because methadone increases the risk of
cardiac arrhythmia in certain patients. Id.; see also id. at App. B, at
64-66 (citing Food and Drug Administration November 2006 ``Black Box
Warning'' regarding methadone hydrochloride). In particular, Dr.
Munzing attested that a physician should conduct a baseline EKG test
and conduct follow-up EKGs at least annually. Id.
Finally, Dr. Munzing opined that the California standard of care
for the use of controlled substances in pain management requires
physicians to be vigilant for the ``red flags'' of drug abuse or
diversion of controlled substances. Id. at ] 14. A physician who
encounters a red flag of abuse or diversion must address it, including
through documented discussions with the patient, closer monitoring,
adjusting the prescribed medication, or discontinuing treatment. Id.
Dr. Munzing attested that the following are examples of well-known red
flags of abuse and diversion of controlled substances: Extended gaps
between patient visits or prescription refills; early requests for
refills of controlled substances; filling prescriptions at multiple
pharmacies, which could indicate the patient is attempting to avoid
oversight by the pharmacist; and prescribing a ``Trinity cocktail'' of
a narcotic painkiller, a benzodiazepine, and a muscle relaxer, which is
combination widely known to be abused and/or diverted and which is
dangerous because each component causes respiratory depression. Id.
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--in particular that it is consistent with the
explicit text of California law, the Guide, and the Medical Board of
California's 2014 Guidelines for Prescribing Controlled Substances for
Pain.\4\ As such, I apply the standard of care of the state of
California as described by Dr. Munzing and California law.
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\4\ Dr. Munzing referenced the 2007 and 2014 Medical Board of
California Guidelines for Prescribing Controlled Substances for Pain
in his expert report. RFAAX 9, App. B, at 66. Although the
Government's evidence did not include the Guidelines, the 2014
update is publically available at: <a href="http://www.mbc.ca.gov/Licensees/Prescribing/Pain_Guidelines.pdf">http://www.mbc.ca.gov/Licensees/Prescribing/Pain_Guidelines.pdf</a>.
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ii. The Subject Patients
Patient K.K.
Registrant issued at least 244 controlled substance prescriptions
to Patient K.K. between January 2012 and November 2016, including
prescriptions for methadone, morphine sulfate, oxycodone, oxycodone-
acetaminophen, hydromorphone, and zolpidem tartrate. RFAAX 9, at ] 17;
see also RFAAX 8, App. G (CURES data); RFAAX 8, Apps. I, O, R, V, Z,
AG, and AJ (copies of prescriptions from the filling pharmacies).
Registrant's prescriptions to K.K. also included various strengths and
quantities across different prescriptions for the same controlled
substances. For example, at different times, Registrant prescribed
morphine sulfate to K.K. in 30mg, 60mg, and 100mg strengths. See RFAAX
8, App. G.
[[Page 21178]]
After reviewing the prescriptions and Registrant's patient file for
Patient K.K., Dr. Munzing noted several deficiencies and departures
from the standard of care and usual course of professional practice
with respect to Registrant's controlled substance prescriptions for
K.K. RFAAX 9, at ] 17. First, Registrant repeatedly issued ``dangerous
levels of opioids'' to Patient K.K., including daily morphine
equivalent doses ranging from over 1,600 mg per day to as high as 3,780
mg per day, without monitoring the patient through checks of the CURES
database or co-management by a specialist in pain management.\5\ Id.
Registrant also issued prescriptions to K.K. for opioids with
duplicated therapeutic effects, including overlapping prescriptions for
oxycodone and oxycodone-acetaminophen and overlapping prescriptions for
hydromorphone and oxycodone. Id. Furthermore, in Dr. Munzing's expert
opinion, Registrant failed to conduct and document an evaluation of
Patient K.K., including an adequate physical examination and medical
history, sufficient to justify the controlled substance prescriptions
that he issued to K.K. Id.
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\5\ Dr. Munzing's declaration also states that Registrant's
prescriptions to K.K., G.K., T.L., and J.P. fell below the standard
of care in part because he prescribed high levels of opioids without
monitoring the patients through urine drug screens. RFAAX 9, at ]]
17, 19, 21, and 23. All of the patients' files, however, contain
results for at least one urine drug screen during the relevant five
year time period. See, e.g., RFAAX 8, at App. B at 122, App. C at
93, App. D at 113, and App. E at 384. Dr. Munzing's declaration and
report focused on the absence of urine drug screens, and did not
provide an opinion regarding the frequency with which a physician
prescribing the levels of opioids that Registrant was prescribing
should conduct drug testing to meet the applicable standard of care.
Accordingly, I cannot find substantial evidence that Registrant's
urine drug screening fell below the standard of care in California
based on the record evidence, and therefore, I am not sustaining the
Government's allegations related to urine drug testing for any of
these patients.
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Finally, Patient K.K. presented red flags of drug abuse and
diversion that Registrant failed to address or document. Id. The red
flags included early refill requests for controlled substances, the use
of multiple pharmacies to fill controlled substance prescriptions, and
an extended gap in care during 2013, without an adequate explanation.
Id.
Based on the above deficiencies, particularly the lack of an
appropriate physical exam and medical history prior to Registrant's
issuance of controlled substance prescriptions, Dr. Munzing found, and
I agree, that the controlled substance prescriptions that Registrant
issued to Patient K.K represent ``an extreme departure'' from the
standard of care in California and were issued outside the usual course
of professional practice. Id. at ] 18.
Patient G.K.
Registrant issued at least 269 controlled substance prescriptions
to Patient G.K. between January 2012 and July 2017, including
prescriptions for hydrocodone-acetaminophen, hydromorphone, methadone,
oxycodone, oxycodone-acetaminophen, temazepam, and tramadol. RFAAX 9,
at ] 19; see also RFAAX 8, App. G (CURES data); RFAAX 8, Apps. J and P
(copies of prescriptions from the filling pharmacies).
After reviewing the prescriptions and Registrant's patient file for
Patient G.K., Dr. Munzing noted several deficiencies and departures
from the standard of care and usual course of professional practice
with respect to Registrant's controlled substance prescriptions for
G.K. RFAAX 9, at ] 19. Registrant repeatedly issued ``dangerous levels
of opioids'' to Patient G.K., including daily morphine equivalent doses
ranging from 600 mg per day to as high as 1,820 mg per day, without
monitoring the patient through checks of the CURES database, co-
management by a specialist in pain management, or discussing and
documenting the discussion of the risks posed by the high levels of
opioids prescribed. Id. There is also no record that Registrant ever
conducted EKG testing to detect abnormalities caused by long-term
methadone use despite prescribing methadone to Patient G.K. from 2012
through at least 2017. Id. Registrant additionally issued prescriptions
to G.K. for opioids with duplicated therapeutic effects, including
overlapping prescriptions for hydromorphone and oxycodone, and
concurrently prescribed G.K. with opioids and benzodiazepines without
documenting the medical necessity for prescribing those controlled
substances together or document any discussion with G.K. regarding the
risks of doing so. Id. Furthermore, in Dr. Munzing's expert opinion,
Registrant failed to conduct and document an evaluation of Patient
G.K., including an adequate physical examination and medical history,
sufficient to justify the controlled substance prescriptions that he
issued to G.K. Id.
Finally, Patient G.K. presented red flags of drug abuse and
diversion that Registrant failed to address or document. Id. The red
flags included early refill requests for controlled substances and the
use of multiple pharmacies to fill controlled substance prescriptions.
Id.
Based on the above deficiencies, particularly the lack of an
appropriate physical exam and medical history prior to Registrant's
issuance of controlled substance prescriptions, Dr. Munzing found, and
I agree, that the controlled substance prescriptions that Registrant
issued to Patient G.K represent ``an extreme departure'' from the
standard of care in California and were issued outside the usual course
of professional practice. Id. at ] 20.
Patient T.L.
Registrant issued at least 120 controlled substance prescriptions
to Patient T.L. between January 2012 and July 2017, including
prescriptions for hydromorphone, methadone, and oxycodone. RFAAX 9 at ]
21; see also RFAAX 8, App. G (CURES data); RFAAX 8, Apps. K, W (copies
of prescriptions from the filling pharmacies).
After reviewing the prescriptions and Registrant's patient file for
Patient T.L, Dr. Munzing noted several deficiencies and departures from
the standard of care and usual course of professional practice with
respect to Registrant's controlled substance prescriptions for T.L.
RFAAX 9, at ] 21. First, Registrant repeatedly issued ``dangerous
levels of opioids'' to Patient T.L., including daily morphine
equivalent doses ranging from over 1,100 mg per day to as high as 2,380
mg per day. Id. Registrant also issued prescriptions to T.L. for
opioids with duplicated therapeutic effects, including overlapping
prescriptions for hydromorphone and oxycodone. Id. Furthermore, in Dr.
Munzing's expert opinion, Registrant failed to conduct and document an
evaluation of Patient T.L., including an adequate physical examination
and medical history, sufficient to justify the controlled substance
prescriptions that he issued to T.L. Id.
Based on the above deficiencies, particularly the lack of an
appropriate physical exam and medical history prior to Registrant's
issuance of controlled substance prescriptions, Dr. Munzing found, and
I agree, that the controlled substance prescriptions that Registrant
issued to Patient T.L represent a departure from the standard of care
in California and were issued outside the usual course of professional
practice. Id. at ] 22.
Patient J.P.
Registrant issued at least 409 controlled substance prescriptions
to Patient J.P. between January 2012 and July 2017, including
prescriptions for clonazepam, diazepam, fentanyl, hydrocodone-
acetaminophen,
[[Page 21179]]
hydromorphone, methadone, morphine sulfate, oxycodone, temazepam, and
tapentadol. RFAAX 9, at ] 23; see also RFAAX 8, App. G (CURES data);
RFAAX 8, Apps. L, T, AA, AC, AE, and AH (copies of prescriptions from
the filling pharmacies). Registrant's prescriptions to J.P. also
included various strengths and quantities across different
prescriptions for the same controlled substances. For example, at
different times, Registrant prescribed clonazepam to J.P. in .5 mg, 1
mg, and 2 mg strengths. See RFAAX 8, App. G.
After reviewing the prescriptions and Registrant's patient file for
Patient J.P., Dr. Munzing noted several deficiencies and departures
from the standard of care and usual course of professional practice
with respect to Registrant's controlled substance prescriptions for
J.P. RFAAX 9, at ] 23. Registrant repeatedly issued ``dangerous levels
of opioids'' to Patient J.P., including daily morphine equivalent doses
ranging from 150 mg per day to as high as 2,460 mg per day, without
monitoring the patient through checks of the CURES database or co-
management by a specialist in pain management. Id. The prescribed
opioids included prescriptions for methadone ``beginning in 2012 and
continuing through at least 2016 even though EKG testing in October
2014 revealed that patient J.P. had developed a prolonged QT
interval,'' meaning that, in Dr. Munzing's opinion, ``continued use of
methadone put J.P. at increased risk of death.'' Id. Registrant also
concurrently prescribed J.P. opioids and benzodiazepines without
documenting the medical necessity for prescribing those controlled
substances together or documenting any discussion with J.P. regarding
the risks of doing so. Id. Furthermore, in Dr. Munzing's expert
opinion, Registrant failed to conduct and document an evaluation of
Patient J.P., including an adequate physical examination and medical
history, sufficient to justify the controlled substance prescriptions
that he issued to J.P. Id.
Finally, Patient J.P. presented red flags of drug abuse and
diversion that Registrant failed to address or document. Id. The red
flags included early refill requests for controlled substances and the
use of multiple pharmacies to fill controlled substance prescriptions.
Id.
Based on the above deficiencies, particularly the lack of an
appropriate physical exam and medical history prior to Registrant's
issuance of controlled substance prescriptions, Dr. Munzing found, and
I agree, that the controlled substance prescriptions that Registrant
issued to Patient J.P represent ``an extreme departure'' from the
standard of care in California and were issued outside the usual course
of professional practice. Id. at ] 24.
Patient Y.P.
Registrant issued at least 122 controlled substance prescriptions
to Patient Y.P. between January 2012 and July 2017, including
prescriptions for carisoprodol, diazepam, hydrocodone-acetaminophen,
and oxycodone-acetaminophen. RFAAX 9, at ] 25; see also RFAAX 8, App. G
(CURES data); RFAAX 8, Apps. M, X, and AL (copies of prescriptions from
the filling pharmacies).
After reviewing the prescriptions and Registrant's patient file for
Patient Y.P., Dr. Munzing noted several deficiencies and departures
from the standard of care and usual course of professional practice
with respect to Registrant's controlled substance prescriptions for
Y.P. RFAAX 9, at ] 25. Registrant concurrently prescribed Y.P. opioids
and benzodiazepines without documenting the medical necessity for
prescribing those controlled substances together or documenting any
discussion with Y.P. regarding the risks of doing so. Id. Registrant
also repeatedly prescribed the ``Trinity cocktail'' to Patient Y.P.,
which as noted above, Dr. Munzing opined to be a dangerous combination
of controlled substances widely known to be abused and/or diverted.
Furthermore, in Dr. Munzing's expert opinion, Registrant failed to
conduct and document an evaluation of Patient Y.P., including an
adequate physical examination and medical history, sufficient to
justify the controlled substance prescriptions that he issued to Y.P.
Id.
Finally, Patient Y.P. presented red flags of drug abuse and
diversion that Registrant failed to address or document. Id. The red
flags included early refill requests for controlled substances, the use
of multiple pharmacies to fill controlled substance prescriptions, and
multiple extended gaps in care including from October 2012 to December
2013, from December 2013 to March 2014, from June 2014 to October 2014,
and from December 2015 to March 2016. Id.
Based on the above deficiencies, particularly the lack of an
appropriate physical exam and medical history prior to Registrant's
issuance of controlled substance prescriptions and the prescriptions
for the ``Trinity cocktail,'' Dr. Munzing found, and I agree, that the
controlled substance prescriptions that Registrant issued to Patient
Y.P represent ``an extreme departure'' from the standard of care in
California and were issued outside the usual course of professional
practice. Id. at ] 26.
II. Discussion
Under Section 304 of the Controlled Substances Act (hereinafter,
CSA), ``[a] registration . . . to . . . dispense a controlled substance
. . . may be suspended or revoked by the Attorney General upon a
finding that the registrant . . . has committed such acts as would
render his registration under section 823 of this title inconsistent
with the public interest as determined by such section.'' 21 U.S.C.
824(a)(4). In the case of a ``practitioner,'' defined in 21 U.S.C.
802(21) to include a ``physician,'' Congress directed the Attorney
General to consider the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the . . . 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). These factors are considered in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
According to Agency decisions, I ``may rely on any one or a
combination of factors and may give each factor the weight [I] deem[ ]
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin.,
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't Admin.,
567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d
477, 482 (6th Cir. 2005). Moreover, while I am required to consider
each of the factors, I ``need not make explicit findings as to each
one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see
also Hoxie, 419 F.3d at 482. ``In short, . . . the Agency is not
required to mechanically count up the factors and determine how many
favor the Government and how many favor the registrant. Rather, it is
an inquiry which focuses on protecting the public interest; what
matters is the seriousness of the registrant's misconduct.'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth
[[Page 21180]]
Circuit has recognized, findings under a single factor can support the
revocation of a registration. MacKay, 664 F.3d at 821.
DEA regulations state, ``[a]t any hearing for the revocation . . .
of a registration, the . . . [Government] shall have the burden of
proving that the requirements for such revocation . . . pursuant to . .
. 21 U.S.C. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR 1301.44(e).
In this matter, while I have considered all of the factors, the
Government's evidence in support of its prima facie case is confined to
Factors Two and Four.\6\ I find that the evidence satisfies the
Government's prima facie burden of showing that Registrant's continued
registration would be ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). I further find that Registrant has not produced any
evidence to rebut the Government's prima facie case. Registrant filed a
request for a hearing upon receipt of the OSC but did not make any
subsequent filings and failed to respond to an order issued by the ALJ.
The ALJ, therefore, properly determined that Registrant had waived his
right to a hearing and terminated the proceedings.
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\6\ As to Factor One, there is no record evidence of
disciplinary action against Registrant'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 Registrant's 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
Registrant has a ``conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(f). However, as prior Agency
decisions 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. Dewey C. MacKay, M.D., 75 FR at 49973.
Those Agency decisions have therefore concluded that ``the absence
of such a conviction is of considerably less consequence in the
public interest inquiry'' and is therefore not dispositive. Id.
The Government's case includes no allegation under Factor Five.
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a. Factors Two and/or Four--The Registrant's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
Evidence is considered under Public Interest Factors Two and Four
when it reflects a registrant's compliance (or non-compliance) with
laws related to controlled substances and experience dispensing
controlled substances. Established violations of the Controlled
Substances Act, DEA regulations, or other laws regulating controlled
substances at the state or local level are cognizable when considering
if a registration is consistent with the public interest.
i. Allegations of Violations of Federal Law
The Government has alleged that from at least January 2012 through
at least December 2017, Registrant unlawfully issued prescriptions for
controlled substances in violation of the CSA. OSC, at 4. Specifically,
the Government alleges that Registrant repeatedly violated 21 CFR
1306.04 by issuing prescriptions for controlled substances to Patients
K.K., G.K., T.L., J.P., and Y.P. beneath the standard of care in
California, the state in which Registrant holds DEA registration,
outside the usual course of professional practice, and without a
legitimate medical purpose. Id.
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 the California Guide to the Laws
Governing the Practice of Medicine by Physicians and Surgeons, 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 and document the discussions, and give special
attention to patients who pose a risk for medication misuse and
diversion. Based on the credible and unrebutted opinion of the
Government's expert, I also found above that Registrant issued at least
1,164 controlled substance prescriptions, often for extremely high
doses of opioids and in dangerous combinations of opioids and
benzodiazepines, without performing or documenting physical
examinations or conducting medical histories adequate to justify the
prescribed medications, and often without counseling the patients on
the risks posed by their medications; proper ongoing monitoring; or
resolving or documenting resolution of red flags of abuse and/or
diversion as required by the standard of care. See supra I.c.ii.
My findings demonstrate that Registrant 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). For example, I found,
based on Dr. Munzing's credible and unrebutted expert opinion, that
Registrant did not perform adequate physical exams or take appropriate
medical histories before issuing controlled substances to the five
subject patients.
I also found that Registrant repeatedly ignored signs of abuse and/
or diversion. Dr. Munzing credibly opined that a California physician
who prescribes controlled substances for pain management within the
standard of care and in the usual course of professional practice must
be vigilant for red flags of abuse or diversion of controlled
substances and must address any such red flags he encounters, including
through ``documented discussions with the patient, closer monitoring,
adjusting the medication or quantity of medication prescribed, or
discontinuing treatment.'' RFAAX 9, at ] 14. As discussed supra, I
found four of the subject patients presented red flags of abuse and
diversion of controlled substances, including early requests for
refills of controlled substances. Registrant, however, did not document
discussions with the patients regarding the majority of the red flags,
and there is no evidence in the patient files that Registrant otherwise
addressed the red flags of abuse and diversion presented by Patients
K.K., G.K., J.P., and Y.P. Registrant's failure to document and address
the red flags was a violation of the standard of care in accordance
with the credible and unrebutted opinion of the Government's expert.
For these reasons, in addition to the reasons I detailed supra
I.c.ii, I find that the Government has presented substantial evidence
that between 2012 and 2017 Registrant issued controlled substance
prescriptions to the five subject patients that were issued outside the
usual course of professional practice and beneath the applicable
standard of care in California. Accordingly, I am
[[Page 21181]]
sustaining the Government's allegation that Registrant violated 21 CFR
1306.04.
ii. Allegations of Violations of California Law
The Government has also alleged that Registrant's prescribing
practices in regards to the subject patients violated state law. OSC,
at 4-7. 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
11153(a). Therefore, I find that, similarly to 21 CFR 1306.04(a), the
record contains substantial evidence that Registrant violated this
provision with respect to the controlled substance prescriptions for
Patients K.K., G.K., T.L., J.P., and Y.P. I also find based on the
uncontroverted evidence that Registrant issued these same controlled
substance prescriptions without ``an appropriate prior examination and
a medical indication,'' which is a violation of Cal. Bus. & Prof. Code
2242(a).\7\
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\7\ The Government has also alleged that Registrant violated
Cal. Bus. & Prof. Code Sec. 2241.5. Section 2241.5 permits
California physicians to treat pain, including intractable pain, but
requires them, among other requirements, to ``exercise reasonable
care in determining whether a particular patient or condition, or
the complexity of a patient's treatment, . . . requires consultation
with, or referral to, a more qualified specialist.'' Dr. Munzing's
expert report did not address whether Registrant failed to exercise
reasonable care in determining whether the subject patients'
treatment required consultation with, or referral to, a more
qualified specialist. Accordingly, I find that the Government has
not met its burden to prove by substantial evidence that Registrant
violated Cal. Bus. & Prof. Code Sec. 2241.5.
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In sum, I find that the record contains substantial evidence that
Registrant 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
the professional practice, and in violation of federal and state law.
I, therefore, find that Factors Two and Four weigh in favor of
revocation. See Mark A. Wimbley, M.D., 86 FR 20713, 20726 (2021).
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Registrant's registration should be revoked because his
continued registration is inconsistent with the public interest, the
burden shifts to the Registrant to show why he can be entrusted with a
registration. Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018)
(collecting cases).
The CSA authorizes the Attorney General to ``promulgate and enforce
any rules, regulations, and procedures which he may deem necessary and
appropriate for the efficient execution of his functions under this
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates
``to `registration' and `control,' and `for the efficient execution of
his functions' under the statute.'' Gonzales, 546 U.S. at 259.
``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 at 463 (quoting Medicine
Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 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 registrant; 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).
In this matter, Registrant did not avail himself of the opportunity
to refute the Government's case. As such, Registrant has made no
representations as to his future compliance with the CSA or made any
demonstration that he can be trusted with a registration. The evidence
presented by the Government of Registrant's conduct clearly indicates
that he cannot be so entrusted.
Accordingly, I shall order the sanctions the Government requested,
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and Sec. 823(f), I hereby revoke DEA Certificate of
Registration No. BB0500365. Further, pursuant to 28 CFR 0.100(b) and
the authority vested in me by 21 U.S.C. 823(f), I hereby deny any
pending application of David H. Betat, M.D. to renew or modify this
registration, as well as any other pending application of David H.
Betat, M.D. for registration in California. This Order is effective May
11, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022-07685 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.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.