[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21175-21181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.cdc.gov/drugoverdose/prescribing/guideline.html.
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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: http://www.mbc.ca.gov/Licensees/Prescribing/Pain_Guidelines.pdf.
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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