[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 20713-20728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08171]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-11]


Mark A. Wimbley, M.D.; Decision and Order

I. Procedural History

    On October 20, 2016, a former Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to Mark 
A. Wimbley, M.D. (hereinafter, Respondent), of Costa Mesa, California. 
Administrative Law Judge (hereinafter, ALJ) Exhibit (hereinafter, ALJX) 
1, (OSC) at 1. The OSC proposed the revocation of and denial of any 
pending application to modify or renew Respondent's Certificate of 
Registration No. BW5359004 pursuant to 21 U.S.C. 823(f) and 824(a)(4) 
for the reason that ``[his] continued registration is inconsistent with 
the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id.
    The OSC alleged that Respondent issued prescriptions for controlled 
substances to four \1\ individuals outside the usual course of the 
professional practice in violation of 21 CFR 1306.04(a) and in 
violation of California law and the minimum standards of medical 
practice in California. Id. at 2-8. Specifically, the OSC alleged that 
Respondent ``issued these orders for controlled substances without 
meeting the minimal medical standards required under California law, 
including those listed in the `Guide to the Laws Governing the Practice 
of Medicine by Physicians and Surgeons,' Medical Board of California, 
7th Ed. 2013.'' Id. at 7. Additionally, the OSC alleged that for the 
four listed patients, Respondent failed to do one or more of the 
following:
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    \1\ The Government withdrew allegations related to one of the 
patients in its Supplemental Prehearing Statement, so this matter is 
limited to three patients. ALJX 7, 7-8.

perform a physical examination; take appropriate medical history; 
assess pain, physical and psychological function; make an assessment 
of any underlying or coexisting diseases or conditions; confirm the 
patient was taking previously prescribed

[[Page 20714]]

controlled substance medications by checking California's Controlled 
Substance Utilization and Review System (``CURES'') or performing a 
urine drug test; order or perform any diagnostic testing; adequately 
discuss the risks and benefits of the use of controlled substances 
and other treatment modalities; periodically review the course of 
pain treatment or gather new information, if any, about the etiology 
of these patients or their state of health; or refer the patients to 
seek medical care to treat underlying conditions, such as pain 
management, orthopedics, behavioral therapy, physical therapy, and 
the like . . . . in violat[ion] of CA HLTH & S Sec. Sec.  11150,\2\ 
11153(a), and 11154(a).
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    \2\ Although the OSC alleged Cal. Health & Safety Code Sec.  
11150, I did not see any further mention of this provision in this 
proceeding, so I am not evaluating it. Further, I agree with the RD 
that this statute is inapplicable as an independent violation. See 
RD, at 69-70 n.165.

Id. at 7-8.
    The OSC further alleged that Respondent ``continued the unlawful 
practices . . . even after [he] was arrested on December 15, 2015, and 
charged by the State of California with 12 felony counts of prescribing 
controlled substances without a legitimate medical purpose.'' Id. at 8. 
Finally, the OSC alleged other violations of California State law, 
including Cal. Bus. & Prof. Code Sec. Sec.  2242(a), 2234, 725(a) and 
Cal. Health & Safety Code Sec.  11190(a). Id.
    The OSC notified Respondent 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 9-10 (citing 21 
CFR 1301.43).
    By letter dated November 11, 2016, Respondent timely requested a 
hearing. ALJX 2 (Request for Hearing), at 1. The matter was placed on 
the docket of the Office of Administrative Law Judges and assigned to 
Chief Administrative Law Judge John J. Mulrooney II (hereinafter, the 
Chief ALJ). On November 15, 2016, the ALJ established a schedule for 
the filing of prehearing statements. ALJX 3 (Order for Prehearing 
Statements), at 1-2. After requesting and being granted an extension of 
time, the Government filed its Prehearing Statement on December 7, 
2016, and Respondent filed its Prehearing Statement on December 28, 
2016. ALJX 6 (hereinafter, Govt Prehearing) and ALJX 8 (hereinafter, 
Resp Prehearing). On January 4, 2017, the Chief ALJ issued his 
Prehearing Ruling that, among other things, set out eight Stipulations 
already agreed upon and established schedules for the filing of 
additional joint stipulations and supplemental prehearing statements, 
which were filed by both the Respondent and the Government on December 
28, 2016, and January 25, 2017, respectively. ALJX 11 (Prehearing 
Ruling), at 1-6; ALJX 9 (hereinafter, Resp Supp Prehearing); ALJX 7 
(hereinafter, Govt Supp Prehearing). On January 27, 2017, the 
Government filed a Motion In Limine to limit the testimony of 
Respondent's proposed expert witness to which Respondent filed an 
Opposition to Complainant's Motion In Limine and Request for Additional 
Time on January 27, 2017. ALJX 13 (hereinafter, Gov Mot In Limine); 
ALJX 14 (hereinafter, Resp Opposition). The Chief ALJ granted 
Respondent's request for more time to supplement his prehearing 
disclosures and denied the Government's Motion to exclude testimony and 
denied Respondent's motion for ``an indefinite amount of `more time' to 
bring motions relating to issues raised in Government's supplemental 
prehearing statement.'' ALJX 16, at 7-8 (Order Regarding the Parties' 
Motions). Respondent filed a Second Supplemental Prehearing Statement 
on February 1, 2017. ALJX 10 (hereinafter, Resp Second Supp 
Prehearing). The parties filed additional Joint Stipulations \3\ of 
Facts on February 6, 2017, and February 7, 2017. ALJX 17a and 17b; RD, 
at 3-4. I have reviewed and agree with the procedural rulings of the 
ALJ during the administration of the hearing.
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    \3\ In particular, the Government and Respondent stipulated as 
to the Respondent's criminal charges, the Respondent's agreement 
with the District Attorney's Office regarding prescribing and 
Respondent's state medical license suspension. They further 
stipulated that the combination hydrocodone products Lortab, Vicodin 
and Norco, oxycodone (brand names ``Oxycontin'' and ``Roxicodone'') 
were Schedule II controlled substances; carisoprodol (brand name 
``Soma''), diazepam (brand name ``Valium), and alprazolam (brand 
name ``Xanax'') were Schedule IV controlled substances.'' RD, at 4. 
I incorporate the stipulated facts herein.
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    The hearing in this matter spanned four days.\4\ On May 22, 2017, 
the Government filed its Proposed Findings of Fact and Conclusions of 
Law and Respondent filed his Closing Brief. ALJX 30 (hereinafter, Govt 
Posthearing); ALJX 31 (hereinafter, Resp Posthearing). The Recommended 
Rulings, Findings of Fact, Conclusions of Law and Decision of the 
Administrative Law Judge (hereafter, RD) is dated June 1, 2017. The 
Government filed exceptions to the RD (hereinafter, Govt Exceptions) on 
June 21, 2017. ALJ Transmittal Letter, at 1. On June 27, 2017, the 
Chief ALJ transmitted his RD, along with the certified record, to me. 
Id.
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    \4\ Hearings were held in Los Angeles, California on March 28-
31, 2017.
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    Having considered this matter in the entirety, I find that 
Respondent issued prescriptions beneath the applicable standard of care 
and outside of the usual course of the professional practice in 
California, in violation of federal law, and that Respondent also 
committed violations of state law.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

II. Findings of Fact

A. Respondent's DEA Registration

    Respondent is registered with the DEA as a practitioner-DW/30 in 
schedules II, IIN, III, IIIN, IV, and V under DEA Certificate of 
Registration No. BW5359004 at the registered address of 2900 Bristol, A 
106, Costa Mesa, CA 92626. Government Exhibit (hereinafter, GX) 1 
(Respondent's Certificate of Registration). This registration expired 
on May 31, 2018.Id.\5\
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    \5\ The fact that a registrant allows his registration to expire 
during the pendency of an OSC does not impact my jurisdiction or 
prerogative under the Controlled Substances Act (hereinafter, CSA) 
to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 
68474 (2019).
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B. The Government's Case

    The Government's documentary evidence consisted primarily of 
medical records and pharmacy records and CURES reports related to three 
individuals treated by Respondent between October 2014 and July 2016. 
The Government called three witnesses: A DEA Diversion Investigator 
(hereinafter, the DI), who participated in the investigation of 
Respondent; a California State Investigator (hereinafter, the SI); and 
an expert witness, Dr. Timothy Munzing. RD, at 5-35.
    The Government first presented the testimony of the DI, Tr. 15-140, 
who testified that she took over as the lead diversion investigator on 
the case during the execution of a search warrant on the Respondent's 
house in November 2015 on Respondent's residence, office and vehicles. 
Id. at 21-22. She testified that DEA seized some of the medical records 
in the Respondent's garage, two or three computers, and from one of the 
cars, ``a few vials of controlled drugs in the center console which 
were later identified to be hydrocodone'' and another controlled 
substance that was not labeled. Id. at 24-25. The DI testified that 
Respondent's clinic ``was somewhat in disarray. The boxes of documents 
were just like random patient documents that were in no order at all.'' 
Id. at 25. The DI stated that ``the

[[Page 20715]]

records were boxed up and brought back to the office. [She] then 
organized them according to patient, scanned them into the computer, 
and then placed them into evidence.'' Id. at 27.
    The DI also testified to her presence at a second state warrant on 
Respondent's Clinic and vehicles, which was executed on August 30, 
2016. Tr. 33, 45; RD, at 9; GX 19 (State Search Warrant and Receipts). 
She stated that the office was ``less organized'' and there was ``less 
stuff'' than during the first warrant, and the medical records seized 
were ``brought back to the DEA office.'' Tr. 46. The DI further 
testified that the investigators ``went through all the boxes page by 
page to identify the patients that we were searching for.'' Tr. 58; RD, 
at 9. She stated that the J.M. and C.B. files in the Government 
Exhibits include records obtained from both warrants and the R.D. file 
contains records only obtained as a result of the second warrant, and 
further that Respondent did not notify her until recently that there 
were any additional documents for these patients. Tr. 50-56, 58; RD, at 
10. The Government's evidence includes three patient files obtained 
through those search warrants. GX 4, 6, 10-12. The DI also testified to 
the accuracy of the prescription records that she obtained from 
pharmacies. Tr. 61-86; GX 3, 5, 7-9, 11, 13. Finally, the DI testified 
to the methodology she undertook in obtaining the CURES report of the 
patients and Respondent. Tr. 89-90; GX 20-23.\6\
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    \6\ I agree with the reasoning of the Chief ALJ in admitting the 
CURES data in GX 20-22 over the Respondent's objection as to its 
authenticity. Tr. 93-96.
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    I agree with the Chief ALJ that the DI's testimony was ``plausible, 
detailed, consistent, and without any obvious motive to fabricate.'' 
RD, at 11. Therefore, I agree with the Chief ALJ that her ``testimony 
is accorded full credibility.'' Id.
    The Government also presented the testimony of the SI, who is an 
investigator with the Department of Healthcare Services in California. 
Tr. 142-185; RD, at 5-8. The SI testified that she was the lead 
investigator for the State of California and began an investigation 
when, ``in November 2015, [her] department received a complaint from a 
Medi-Cal Beneficiary stating that his information was being used to 
fill prescription drugs, and on those prescriptions the prescriber was 
[Respondent].'' Tr. 146. The SI stated that she went to the location on 
the prescriptions and found it empty and had obtained a state search 
warrant for a new office address, which was executed on August 30, 
2016. Id. at 149-151. During the search warrant, the SI stated that she 
had interviewed Respondent in the parking lot and he had stated that 
the three patients, J.M., R.D. and C.B., were his patients but had been 
discharged. Id. at 162-64; RD, at 6. She also stated that she asked 
Respondent specifically where all of his ``medical charts'' were and he 
stated that ``all of them are at this location.'' Tr. 165. The SI 
further stated that she indicated that the investigators searching 
Respondent's office ``stated that everything was thoroughly checked 
twice.'' Id. at 158; RD, at 6.
    I agree with the Chief ALJ and find that the SI ``had no obvious 
motivation to be anything but objective, and presented testimony that 
was sufficiently plausible, detailed, and internally consistent to be 
accorded full credibility in this recommended decision.'' RD, at 7-8.
    The Government's expert witness, Dr. Timothy Munzing, has been 
employed by Kaiser-Permanente for over thirty-one years, twenty-eight 
of which he has served as the family medicine program director. GX 16 
(Curriculum Vitae of Dr. Munzing); see also RD, at 11; Tr. 186-563. The 
Chief ALJ accepted Dr. Munzing without objection as ``an expert in 
family medicine, pain management, and the prescribing of controlled 
substances in California.'' Tr. 211-12. The matters about which Dr. 
Munzing testified included the general standard of care in California 
and his review and standard-of-care analysis of the medical records in 
the Government's Exhibits belonging to three of Respondent's patients.
    The Chief ALJ found, and I agree, that Dr. Munzing ``presented 
testimony that was generally authoritative, consistent, well-supported, 
objective, and persuasive.'' RD, at 35.

C. The Respondent's Case

    Respondent presented the testimony of two witnesses at the hearing, 
including his own. He also presented \7\ supplemental medical records 
(hereinafter, Respondent's Supplemental Records) that were not included 
in the Government's Exhibits for the three patients at issue in the 
case and written reports from his expert. Respondent Exhibit 
(hereinafter, RX) 3-5, 10, 17. The first witness, Dr. Umer Malik, was 
offered by Respondent and accepted (without objection) as an expert on 
the prescribing of controlled substances in the state of California, 
including required documentation for such prescribing. RD, at 38; Tr. 
579-608; 735-851. Dr. Malik graduated from medical school in Pakistan 
in 2005 and became a board certified physician in internal medicine in 
the United States in 2010. RD, at 38-39; Tr. 579-80. Dr. Malik has 
practiced in in-patient and out-patient settings and he ``estimated 
that he has seen 40 to 50 patients over an extended period of time who 
were on chronic opioid medications'' and that he has treated 600 to 800 
patients in California who were on opiates for chronic pain. RD, at 39 
(citing Tr. 583). Dr. Malik also was an ``internal expert reviewer'' 
for the quality control department when he was at Stanford University 
and continues to provide external expert review there and also for the 
Medical Board of California. Tr. 583-84; RD, at 39; see also RX 11 
(Curriculum Vitae of Dr. Malik).
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    \7\ Respondent included a declaration from Dr. Elliot Felman, 
who monitored Respondent's compliance with his California Ex Parte 
Interim Suspension Order. See RX 8. I agree with the Chief ALJ that 
``because the records that Dr. Felman reviewed post-dated the 
conduct charged in the [OSC] and does not concern the patients at 
issue in this matter, any factual representations or opinions 
expressed in his declaration should be deemed irrelevant.'' RD, at 
21 n.3.
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    Dr. Malik testified as to his familiarity with the term 
``prescription drug cocktail'' and that he has prescribed opioid 
medications to over 500 patients. Tr. 588; see also infra II.E. He 
testified regarding the standard of care in California and in the end 
opined that the prescriptions that he reviewed in Respondent's 
Supplemental Records were issued within the applicable standard of care 
in California. Tr. at 743-44. He stated that in preparing his export 
report, he reviewed RX 3-5. Id. at 764-65; Tr. 806. Although he did 
receive the Government's Exhibits, he did not include them in his 
reports. Id. at 799.

    I agree with the Chief ALJ that ``[a]lthough Dr. Malik presented 
as generally knowledgeable, certain aspects of his testimony 
undermined the confidence that could otherwise be afforded his 
opinions.'' RD, at 54. For example, the Chief ALJ noted that Dr. 
Malik testified that he had no idea that a pharmacy could refuse to 
fill a prescription presented by a patient, which is ``basic 
knowledge related to the regulation of controlled substance.'' Id. 
at 54-55 (citing Tr. 798). He further noted that Dr. Malik testified 
contrary to the DEA regulatory requirement regarding Schedule II 
controlled substances in 21 CFR 1306.12(a), that `` `there are 
physicians who call in for the refills of the benzodiazepines and 
for the refills of opiates if they have a chronic relationship with 
the patients.' '' Id. at 55 (quoting Tr. 843). Further, the Chief 
ALJ pointed out that there were inconsistencies with Dr. Malik's 
written report, including referenced pictures and blank progress 
notes that did not exist in Respondent's Supplemental Records and 
inconsistencies regarding how long

[[Page 20716]]

Respondent had been seeing a patient. RD, at 55-56 (citing RX 17, at 
1; RX 5; Tr. 801-02, 809; RX 10). Ultimately, the Chief ALJ found, 
and I agree, that with regard to Dr. Malik's testimony, RD, at 56-
57.
    His knowledge deficits in rudimentary aspects of the CSA and its 
regulations, his lack of specificity regarding where he located the 
key aspects of the Supplemental Files upon which he based his 
opinions and his willingness to reach into the future to essentially 
bootstrap prescribing decisions made in the past, were all factors 
that eroded the weight that can be afforded to his expert onions 
here, and make those opinions less persuasive than the opinions by 
the Government's expert, Dr. Munzing.

    Respondent testified on his own behalf. Tr. 610-734; 860-912. He 
testified that he attended medical school at the University of 
California at Los Angeles and trained to become a surgeon, but was in a 
car accident and ``couldn't really operate.'' Tr. 864; RX 1, at 1-2 
(Respondent's Curriculum Vitae). Respondent testified about the courses 
that he had taken ``primarily on pain management'' and future courses 
he planned on taking. Tr. 864-65; RX 1, at 3-18; RD, at 35. He also 
testified about a Medical Board of California disciplinary action, 
after which he was allowed to prescribe only Schedule V controlled 
substances. Tr. 871-72; RX 16 (Interim Suspension Order).\8\ He 
testified that he has treated ``more than 500 [patients] probably I 
think in 10 years'' as a pain management practitioner. Tr. 873-74.
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    \8\ As discussed further under supra III.A.1, the California 
Office of Administrative Hearings entered an Interim Suspension 
Order on December 17, 2016, stating that ``Respondent shall not 
prescribe any Schedule II, III, or IV controlled substances.'' RX 
16, at 7.
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    Regarding his medical records, Respondent testified that he ``tried 
to be extremely well documented,'' but that he ``didn't have a specific 
system for them. I had the patients, their packets and notes, and they 
weren't necessarily all together. They might have been. Some might have 
been somewhere together.'' Tr. 632, 683.
    Respondent testified as to the legitimacy of the files for C.B., 
J.M. and R.D. in RX 3, 4, and 5 (Respondent's Supplemental Records). 
Id. at 610. Respondent testified that on August 30, 2016, a state 
investigator came to his residence. Id. The SI showed Respondent a list 
of patients and he told her that several of the patients ``and then 
several other individuals on that list that are not my patients.'' Id. 
at 613. He also stated that the SI told him that ``she [was] 
investigating Medi-Cal fraud'' and he does not ``treat Medi-Cal 
patients now.'' Id. at 616-17. Respondent explained that he drove to 
the office to open it for the investigators to execute the search 
warrant and ``they searched the vehicle several times.'' Id. at 619-20. 
Respondent confirmed that the patient records were not in a file 
cabinet and that ``there were some by desk'' and he ``had different 
stacks of paper, different--[he] was trying to organize things for 
[his] attorney, some things have been taken to the attorney for 
different parts of this case or another case,'' and the other files 
``were in different stacks in different locations in [his] office.'' 
Id. at 621-23. He stated that ``[s]ome of the files like for R.D. were 
in the car.'' \9\ Id. at 622. When asked if the SI asked him where the 
records were for the patients, he answered that ``the main focus of the 
conversations that I recall was Medi-Cal fraud, a list of people that 
were not my patients.'' Id. at 626. When asked if the files were with 
his criminal attorneys, he stated, ``I had some things being reviewed 
because I was changing counsel.'' Id. Respondent stated that he found 
the RX 3, 4, and 5 ``rapidly'' and that ``they came on August 30th'' to 
conduct the search warrant and ``either that day or in a couple days 
they were in [his attorney's] office, probably before the 3rd or 4th of 
September.'' Id. at 631.\10\
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    \9\ Respondent stated that the R.D. records were ``like in a 
container for files'' in his vehicle ``in the back seat area'' and 
that the DI did not take those records. Id. at 659. Respondent's 
counsel had stated that the R.D. files were in the ``trunk'' of his 
car. Tr. 625.
    \10\ Respondent testified that in 2016, at his Newport Beach 
office, a toilet had overflowed and some of his records ``got wet,'' 
but he did not know whether they contained records for these 
patients. Id. at 641. However, Respondent's counsel objected to 
questioning about Respondent's Supplemental Records, because they 
were dated ``all after these water incidences'' from November 2015 
to April 2016. Id. at 645. After the objection, Respondent stated, 
``I'm not sure that I made a mistake. What I said is it happened 
before I moved. It was in 2015.'' He further stated that his house 
flooded in 2012 and his rental property in 2014 and that he may have 
lost documents in those floods, but he did not know whether they 
involved the patients at issue. Tr. 649-52. The SI testified that 
she saw no evidence of flood damage at his Newport Beach office and 
she stated that the property manager said he ``was evicted based on 
complaints and late rent.'' Tr. 172. Ultimately, I do not find any 
reliable evidence on the record, even from Respondent's own 
testimony, that Respondent possessed relevant records that were 
destroyed in these alleged water incidents, and therefore, I do not 
find these alleged water incidents relevant to these proceedings.
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    When asked about whether Respondent had told the DI that all of the 
medical records should be in his office, Respondent first answered, ``I 
may have.'' Id. at 656. Then when asked again, he stated, ``I mean, 
it's kind of obvious, isn't it?'' Id. Finally, he stated, ``The only 
particular request she made was the Patient M.C., and I told her 
exactly where to find the chart.'' Id. at 658.
    Respondent agreed that medical records should contain exam notes, 
progress notes, referrals, diagnostic testing, and medications 
prescribed, red flags, diversion review, and steps to resolve red 
flags, and that in California Schedule II prescriptions require certain 
information. Id. at 636-37. However, Respondent maintained that the 
prescriptions at issue in this case were issued within the applicable 
standard of care in the State of California. Id. at 878-86.
    During the hearing, in evaluating whether to admit Respondent's 
Supplemental Records, the Chief ALJ stated that Respondent's 
credibility is a ``mixed bag. I think he was frequently lacking in 
detail. He lost patience then answered questions that were not asked of 
him. Frequently, he would be responsive to his own counsel but almost 
intentionally unresponsive to Government's counsel.'' Tr. 731-32. 
Further, in the RD, the Chief ALJ stated that, ``he presented as a 
defensive, frequently non-responsive, vague \11\ witness.'' RD, at 38. 
Therefore, the Chief ALJ found, and I agree, that ``where the 
Respondent's testimony conflicts with other credible testimony and 
evidence, it cannot be afforded full credibility.'' Id.
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    \11\ In particular, I found Respondent's testimony regarding the 
presence of two separate records for the same patient on the same 
date to be vague and not credible. GX 10, at 67 is a form filled out 
at the top by R.D. and filled out on the bottom portion by 
Respondent, dated April 13, 2016. RX 5, at 25 is dated from the same 
visit; however, it provides a much more detailed account of the 
visit and is filled out entirely by Respondent. First, Respondent 
testified that the Respondent's Exhibit notes were written while the 
patient was sitting there and that the Government Exhibit notes were 
written ``probably right after he--right after he left.'' Tr. 694. 
When confronted with the notion that it does not make logical sense 
that he wrote the detailed notes while the patient was sitting there 
and then wrote more cursory notes on the form that the Respondent 
filled out after the patient left, he changed his testimony and 
stated that he ``wrote the more detailed one [the Respondent's 
Exhibit] later . . . after the patient left.'' Id. He stated, ``I'm 
writing on another piece of paper. At the same time later, I might 
finish whatever I need to do in another packet, or I might not. It's 
not that different.'' Id. at 693.
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D. Admission of Supplemental Patient Records

    During the hearing, over the Government's objections,\12\ the Chief 
ALJ admitted Respondent's Exhibits 3, 4, and 5 (Respondent's 
Supplemental Records), which consisted of patient records offered by 
the Respondent that supplemented the patient records found by the 
Government during the two

[[Page 20717]]

search warrants. In admitting the records, the Chief ALJ stated that 
``the proponent of any exhibit bears the burden of proof to establish 
that the document is what it purports to be.'' Tr. 731. He further 
stated, ``Because all of the documents weren't seized, and some of them 
bore things that I cannot fathom where they came from or how they would 
be generated later. Because that is true, what I'm going to do is admit 
the documents and allow you to use them to procure the expert 
opinion.'' Id. at 731-32. The Chief ALJ caveated that he did not ``have 
a high level of confidence in them'' and that he did not know ``why 
[Respondent] didn't comply with the [warrant.]'' Id. at 732.
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    \12\ The Government objected to the admission of these records 
into evidence based on authenticity during and prior to the hearing. 
See ALJX 24 (Notice of Objection on the Basis of Authenticity (March 
21, 2017)); Tr. 601.
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    In the RD, the Chief ALJ explained that:

    While true that in administrative enforcement proceedings the 
subsequent discovery of additional medical files can (and often 
does) raise the potential specter of evidence manufactured to 
support deficient records, the records offered by the Respondent 
contained some pages that would have been difficult to manufacture 
after-the-fact, including test results originating from other 
offices stamped with facsimile transmittal information and forms 
that were apparently completed by the patients themselves which are 
dated before the last search took place.

RD, at 37-38.
    I agree with the RD that Respondent's exhibits contained records 
that could not have been easily manufactured and appear to be 
legitimate.\13\ Furthermore, as the Chief ALJ noted, multiple witnesses 
testified during the hearing that Respondent's paperwork was in 
``complete disarray'' with patient records in piles all over his 
office, exam rooms and even inside his vehicle. RD, at 36 (citing Tr. 
715, 718-19); see also Tr. 622-23; Tr. 169. The RD summarized that 
``[Respondent] had no filing system, kept no payment or billing 
receipts, and was paid in cash on those occasions when his patients 
brought money to him.'' RD, at 36 (citing Tr. 683, 717-19). On the 
whole the evidence demonstrates that records were a mess and that some 
of the Respondent's Supplemental Records appeared legitimate. See RD, 
at 38 n.104.\14\ Therefore, in spite of the dubious authenticity and 
origin \15\ of some of Respondent's records, I ultimately will agree 
with the Chief ALJ's decision to admit them into evidence.
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    \13\ RX 5, at 4 is a laboratory report for R.D. that was faxed 
on May 30, 2016. Tr. 721. RX 3, at 45 is a fax cover sheet for an 
Operative Report from Dr. Lee's office for C.B. Id. at 721-22. 
Respondent testified that RX 3, at 1 and RX 4, at 1, are filled out 
by the patient and RX 4, at 2 included the patient's signature. Id. 
at 706-08. RX 5, at 8 includes a ``fax form'' that ``was sent from 
Perris Family Care Center, and it's--where it refers to the lab 
results that are back here.'' Id. at 709. Respondent testified that 
he found and provided the records to his attorney ``probably before 
the 3rd or 4th of September.'' Id. at 631. Government counsel noted 
that RX 3, at 45 also includes a fax time stamp of December 20, 
2016, which was after the September timeframe that Respondent 
claimed he gave the documents to his lawyer. Id. at 723.
    \14\ The DI testified that during the second search in August 
2016, investigators found very few documents dated before the date 
of the first search in November 2015, which may not even be related 
to the patients in this case. Tr. 137-38. The Chief ALJ found that 
this strengthened Respondent's position that the Supplemental 
Records were legitimate. RD, at 38 n.104. However, it is unclear 
from the record where Respondent's records were at any given time. 
Respondent stated that he ``was trying to organize things for [his] 
attorney, some things have been taken to the attorney for different 
parts of this case or another case.'' Tr. 622. I credit the 
testimony of the DI and SI regarding their thorough search of 
Respondent's records. The fact that some of Respondent's 
Supplemental Records could not be fabricated, indicates that they 
may have been elsewhere during the searches. It is ultimately 
unimportant to the resolution of the case, because Respondent only 
produced Supplemental Records for a portion of the controlled 
substance prescriptions in this case.
    \15\ The Government asserts that there are multiple reasons why 
the records should be discredited. For example, the ``character of 
Respondent's versions of records removed by law enforcement'' was 
``at best cursory, and in most cases blank,'' whereas Respondent's 
records were ``multipage and extensive,'' and this gave the 
appearance that they had been ``tailored to address many of the 
deficiencies alleged in the [OSC].'' Govt Posthearing, at 41 
(comparing, e.g., GX 4, at 17-20 with RX 4, at 21-27). ``Moreover, 
there is complete disparity between the two versions; there are no 
exam notes in records recovered by law enforcement that are in any 
way as extensive and complete as those in Respondent's versions, and 
similarly there are none in Respondent's that are as cursory or 
vacant as those recovered by law enforcement.'' Id. I agree with the 
Government regarding all of the suspicious circumstances surrounding 
these records; however, considering the breadth of evidence that the 
Government has submitted, which the Respondent has not rebutted, I 
find it unnecessary to make a finding that these records were not 
legitimate. As explained herein, the Government has more than met 
its burden in demonstrating that Respondent's registration is 
inconsistent the public interest, even if I take Respondent's 
records to be what they claim to be.
---------------------------------------------------------------------------

E. The Applicable Standard of Care in California

    Regarding the applicable standard of care in California, Dr. 
Munzing testified that on the first visit ``one must determine 
essentially whether or not this patient actually has a legitimate need 
for whatever treatment you're going to do.'' Tr. 213. ``[F]or 
controlled substances the first thing you need to do is take a 
history.'' Id. The history you need to assess includes: ``how long has 
one had the pain; specifically the area of pain,'' ``did it start 
gradually'' or ``was there an inciting incident'' and ``the pain level 
or how severe the pain is, but more importantly, is the--actually, the 
function.'' Id. Dr. Munzing stated that ``function's really more 
important because function is a little more objective than a number.'' 
Id. at 214. Further, as part of the medical history, ``[o]ne wants to 
know have you had imaging before, what kind of treatments have you had 
before, are you been on medicines before.'' Id. Also, Dr. Munzing 
testified that ``I want to know today or in the last couple of weeks, I 
want to know where things are: pain level, functional level'' and about 
``mental health history.'' Id. at 214-15. ``Once you've taken a 
thorough history, then you want to do a thorough exam.'' Id. at 216. 
Dr. Munzing said the exam should be a ``general exam on heart, and 
lungs, and kidney'' and ``[t]hen hone in on the area of pain.'' Id. He 
stated that ``you want to actually observe it, palpate it, touch it. Is 
it tender? Look for range of motion.'' Id. Additionally, for chronic 
pain, he stated that you want ``relatively recent imaging.'' Id. at 
217. Next, he stated that a practitioner would need ``to first of all 
look for red flags in [the patients'] story.'' Id. Dr. Munzing 
testified that he orders urine drug screens and checks CURES and the 
Prescription Drug Monitoring Program database (hereinafter, PDMP) ``to 
make sure that if they say that this is what I'm taking, I ensure that 
that's consistent.'' Id. at 218-19. Finally, Dr. Munzing stated, ``All 
this needs to be documented.'' In the documentation, he testified that 
there must be ``both pertinent positives, pertinent negatives, exams, 
documenting the information.'' Id. at 220.
    The Government included in its evidence the Medical Board of 
California, Guide to the Laws Governing the Practice of Medicine (7th 
Ed. 2013) (hereinafter, the Guide) and the Medical Board of California, 
Guidelines for Prescribing Controlled Substances for Pain (November 
2014). GX 17, 18. Dr. Munzing testified that the guidelines for 
prescribing controlled substances are meant to ``kind of say here's the 
things you need to do if you're actually going to prescribe controlled 
substances.'' Tr. 235. Dr. Munzing further stated that ``[y]ou don't 
have to do every single one of those, but if you're substantially 
complying with the standard of care--with the guidelines that would be 
the standard of care.'' Tr. 228. Regarding documentation, he testified 
that ``really, the medical record documentation, not only is it a law, 
is it a requirement, but I think it is that because it really is about 
patient safety . . . . it's for my own recollection of on this date and 
time this is what was going on.'' Id. 239. He also stated that ``if 
someone else is going to see the patient that way it's an accurate 
reflection of what's happening at this

[[Page 20718]]

date and time. My thought process behind it . . . .'' Id. Dr. Munzing 
testified that the standard of care required documentation ``[i]n the 
progress note it's vital to see a diagnosis that has something to do 
with pain in it.'' Id. at 241.
    The California Guide to the Practice of Medicine sets forth 
guidelines in managing pain patients, which Dr. Munzing described 
provides ``almost a outline of what I described a little bit ago. You 
need to do a history and a physical exam . . . then you come up with a 
treatment plan.'' Tr. 247 (citing to GX 17, at 59-61). He also stated 
that the Guide requires that the practitioner ``go over and discuss 
informed consent with the patient'' and ``periodic review.'' Id. at 
248. Regarding the Guide's requirements for documentation, Dr. Munzing 
stated, ``I guess I can't emphasize enough they're incredibly 
important, again for patient safety and for knowing what happened at 
any particular time. They're also important, again, for any kind of 
transfer of care, whether it's temporary or, you know, permanent.'' Id. 
at 249 (citing GX 17, at 65). He further stated that ``you want very 
thorough documentation for any kind of chronic pain, controlled 
substance medications, and some of the other areas because they're just 
higher risk areas.'' Id. Dr. Munzing stated that the record retention 
requirement for Schedule II controlled substances is three years, but 
``in reality, everyone I know keeps them indefinitely.'' Id. at 250. 
When asked to summarize what information should be kept in medical 
records under the standard of care in California, Dr. Munzing said, 
``the history, which includes past medical history, the medications; 
the other medical problems; the vital signs . . . the exam; any 
additional imaging results, lab results . . . and then the assessment . 
. . and then what your management plan is going forward.'' Tr. 253-54.
    Regarding ``red flags,'' Dr. Munzing testified that they are 
``things that kind of are just potential factors for abuse, diversion, 
misuse'' and include ``doctor shopping, seeing multiple doctors getting 
controlled substance medications, pharmacy shopping, going to multiple 
pharmacies.'' Tr. 256-57. When a practitioner is presented with a red 
flag, he has to ``delve a little deeper'' and ``it depends on what the 
red flag is.'' Id. at 259. For example, if he sees on CURES, that a 
patient is ``getting what--the combination called the trinity or holy 
trinity, which is an Oxycodone with a Benzodiazepine with Carisprodol--
Soma is the brand name--you put that together, that's a huge red flag 
because that's a popular combination in the drug culture.'' Id. at 260. 
Finally, he testified that the standard of care requires that ``one 
needs to document significant red flags.'' Id. at 261.
    Dr. Munzing also testified that ``when an individual is either 
taking an opioid or a physician is prescribing it, it's vitally 
important to calculate the Morphine equivalent dosing (MME). What that 
does is it translates an opioid, whether it be Oxycodone, or Methadone, 
or whatever to a base number, which they use Morphine as the base 
number.'' Id. at 288. He further stated that ``[t]he reason it's 
important is that if you go above 50 milligrams per day of Morphine-
equivalent dosing, the amount of overdose risk and death increases. 
Once you get to 100 milligrams per day--and the CDC is now recommending 
keep it under 90. If you go over 100, then you have an eightfold risk 
of overdose in a--per year . . . .'' Id. at 288-89.
    Regarding the applicable standard of care in California for 
prescribing controlled substances, Respondent's expert, Dr. Malik, 
testified, ``If there is no physical examination documented, if there 
is no history documented, if the doctor's not making a diagnosis, just 
giving the pain medications, that is breaching the standard of care.'' 
Id. at 787. He further stated that even for minimal risk of opiate 
abuse patients, ``the recommendations are to do a CURES test, to do a 
urine toxicology, and to make quick follow up visits. So, yes, it is 
within the standard of care for a physician to do at least these three 
things even if the patient comes under the mild opiate risk tool.'' Id. 
at 787-88.
    In general, Dr. Malik's and Dr. Munzing's expert opinions regarding 
the standard of care for prescribing opioids in California were often 
similar. They both used the Medical Board of California guidelines to 
formulate their opinions about whether Respondent had met the standard 
of care. Id. at 768; 235. Dr. Malik testified that a physician needed 
to be in compliance with most of the guidelines to be within the 
standard of care, whereas, Dr. Munzing described the guidelines as an 
``outline'' of what a physician needs to do to meet the standard. 
Compare id. at 744 with id. at 247.
    In a few areas, the experts diverged. Dr. Malik testified that it 
is not a breach of the standard of care to prescribe a trinity 
cocktail,\16\ and that there are times when ``the patient has an 
intractable pain.'' Id. at 735-36. He affirmed Dr. Munzing's testimony 
that physicians do calculate the morphine equivalent of controlled 
substances and stated that the morphine equivalent ``was designed to 
have a new medical standard on the basis of which different opiates can 
be compared based on their potential efficacy in a human's body.'' Id. 
at 736. Dr. Malik testified that it is not a deviation in the standard 
of care to provide more than 100 milligrams of morphine equivalent dose 
and per day;'' however, ``a physician has to be more careful, obviously 
have to be keep [sic] an eye on all these side effects, which can 
happen on a higher dose of MME.'' Id. at 737-38. Dr. Malik opined that 
based on Respondent's exhibits, Respondent was complying with the 
standard of care in terms of having his patients return to his office 
on a frequent basis. Id. at 738.
---------------------------------------------------------------------------

    \16\ Dr. Malik testified that he had never heard of the trinity 
cocktail until two months before he reviewed the records for this 
case. Tr. 792; RD, at 41.
---------------------------------------------------------------------------

    Overall, Dr. Malik testified that ``[Respondent is] a very poor 
documenter'' and that ``[i]t really takes a lot of effort to gather all 
that information, and think that the documentation is poor on his side, 
but I also believe that he has followed if not all, most of the 
recommendations from the guidelines of the Medical Board of 
California.'' Id. at 743. He further stated that ``following a 
substantial number of those guidelines can bring you to the standard of 
care.'' Id. at 744.
    As the Chief ALJ found, issues with Dr. Malik's credibility made 
his ``opinions less persuasive than the opinions by the Government's 
expert, Dr. Munzing.'' RD, at 57; see also supra II.C. Therefore, I 
generally apply the standard of care as testified to by Dr. Munzing to 
the prescriptions \17\ at issue in this case.
---------------------------------------------------------------------------

    \17\ However, as further explained herein, Dr. Munzing did not 
opine about whether Respondent's Supplemental Records met the 
standard of care for prescribing controlled substances. See infra F.
---------------------------------------------------------------------------

F. Allegations of Issuing Prescriptions Outside of the Usual Course of 
the Professional Practice and Prescribing Below the Applicable Standard 
of Care in California and Violations of State Law

    Having read and analyzed all of the record evidence, I agree with 
the RD's conclusion and find substantial record evidence that 
Respondent prescribed controlled substances outside of the usual course 
of the professional practice and below the applicable standard of care 
in California. RD, at 93-94 (listing sustained allegations). Overall, I 
find that the record contains substantial evidence that Respondent 
issued

[[Page 20719]]

numerous controlled substance prescriptions to J.M. and R.D. outside 
the usual course of the professional practice and beneath the 
applicable standard of care and in violation of several California laws 
and that Respondent issued controlled substance prescriptions to C.B. 
without complying with California law. The Chief ALJ found, and I agree 
that the record contains substantial evidence that Respondent issued 
sixteen controlled substance prescriptions to J.M., and eight 
controlled substance prescriptions to R.D. outside the usual course of 
the professional practice in violation of 21 CFR 1306.04 and Cal. 
Health & Safety Code Sec.  11153(a) (Westlaw, Current with urgency 
legislation through Ch. 2 of 2021 Regular Session),\18\ and without a 
medical examination or legitimate medical indication in violation of 
Cal. Bus. & Prof. Code Sec.  2242(a) (West, 2016). \19\ Id. Further, 
the Chief ALJ found, and I agree, that Respondent issued twelve 
Schedule II controlled substance prescriptions to J.M., eleven 
controlled substance prescriptions to R.D. and three controlled 
substance prescriptions to C.B. without making a record that comports 
with the requirements of Cal. Health & Safety Code Sec.  11190(a) 
(Westlaw, Current with urgency legislation through Ch. 2 of 2021 
Regular Session).\20\ Additionally, the Chief ALJ found, and I agree 
that Respondent's prescribing on eight dates constituted ``excessive 
prescribing'' in violation of Cal. Bus. & Prof. Code Sec.  725(a) 
(Westlaw, Current with urgency legislation through Ch. 2 of 2021 
Regular Session).\21\ I agree with the Chief ALJ's findings regarding 
these prescriptions and I further find, as explained below, an 
additional fourteen controlled substance prescriptions that Respondent 
issued to R.D. outside the usual course of the professional practice 
and beneath the applicable standard of care in violation of 21 CFR 
1306.04 and Cal. Health & Safety Code Sec.  11153(a).
---------------------------------------------------------------------------

    \18\ The relevant portions of Cal. Health & Safety Code Sec.  
11153(a) have not been amended during the relevant time period in 
this matter.
    \19\ Cal. Bus. & Prof. Code Sec.  2242(a) was amended in 2019. 
This Decision cites to the law that was in effect during the time of 
the alleged misconduct and when the OSC was issued. See Stats. 2019, 
c. 741 (A.B.1264), Sec.  1, eff. Oct. 11, 2019.
    \20\ The relevant portions of Cal. Health & Safety Code Sec.  
11190(a) have not been amended during the relevant time period in 
this matter.
    \21\ The relevant portions of Cal. Bus. & Prof. Code Sec.  
725(a) have not been amended during the relevant time period in this 
matter.
---------------------------------------------------------------------------

1. J.M.
(a) J.M.'s Medical Records in Government Exhibits
    Dr. Munzing testified in detail as to the contents of each record 
in the Government's Exhibits for J.M. He stated that the records 
included documentation of ``Past medical problems'' filled out by the 
patient, but with no date. Tr. 264-65 (citing GX 4, at 1-2). The 
records contained an opioid risk tool, which was never added up. Id. at 
270 (citing GX 4, at 8). The patient filled out ``a depression scale.'' 
Id. at 270-71 (citing GX 4, at 10-11). The records reflected questions 
about whether an individual is receiving controlled substances or 
opioids, but ``it's not filled out.'' \22\ Id. at 272 (citing GX 4, at 
12). J.M.'s records included a ``patient assessment questionnaire,'' 
which ``would typically be a form presumably filled out by the patient 
when they came in prior to seeing [Respondent].'' Id. at 272-73 (citing 
GX 4, at 13). Dr. Munzing identified GX 4, at 14 as ``essentially the 
progress note form that would be completed by the physician or provider 
when they were seeing the patient,'' but that ``there are 10 words 
here,'' ``there is no information as far as the assessment'' of the 
tumor listed, ``there should be a management plan there, and that's 
completely blank.'' Id. at 273-74. Dr. Munzing testified that ``[t]his 
isn't even in the universe of what an appropriate documentation, and 
exam, and evaluation should be.'' Id. at 274. He concluded that if this 
chart supported a decision to prescribe a controlled substance it would 
be ``very far below'' the standard of care in California. Id. at 274-
75. He stated that the documents ``[a]s I went through the standard of 
care earlier, [the documents] meet, actually, practically none of 
those.'' Id. at 280. On March 31, 2014, the Government's Exhibits 
include a pain assessment questionnaire and then a corresponding 
progress note with no writing, but ``a circle on the figure in the 
general area of the neck and one the general, or the low back,'' which 
``transmits no useful information and so it still falls far below the 
standard of care as we talked before.'' Id. 282 (citing GX 4, at 23). 
On November 4, 2013, the note includes ``complains of right knee 
pain,'' but [t]here's no assessment and no treatment plan.'' Tr. 286 
(citing GX 4, at 34). As such, Dr. Munzing testified that ``it falls 
completely short of the standard of care.'' Id. at 286.
---------------------------------------------------------------------------

    \22\ Respondent's attorney noted during the hearing that many of 
the forms, see e.g., GX 4, at 5-7, were samples contained in the 
Guide to Laws Governing the Practice of Medicine in Exhibit 14. Tr. 
459-60. However, Dr. Munzing testified, that ``I have no problem 
with this form. My concern is that if that's all you have and you 
don't specifically on a specific patient, a specific date, say 
exactly what your management plan is.'' Id. at 460. I find that Dr. 
Munzing credibly testified that the information on the forms in the 
Government's Exhibits did not meet the applicable standard of care 
in California.
---------------------------------------------------------------------------

    Dr. Munzing also testified that if a patient is on ``Norco \23\'' 
on a regular basis, the medical files should contain blood work ``most 
likely at least every year, year and a half, two years'' to check for 
kidney \24\ and liver function, which would not usually have clinical 
symptoms. Tr. 453-55, 458.\25\
---------------------------------------------------------------------------

    \23\ Norco is hyrdrocodone/APAP. Tr. 886.
    \24\ It is noted that Respondent's Exhibits for R.D. included a 
laboratory report, and Dr. Malik testified that ``the labs basically 
are complimentary to your history and physical examination.'' Tr. 
755 (citing RX 5, at 4). Respondent's Supplemental Record for J.M. 
did not include lab reports and I find Dr. Munzing's testimony 
regarding the need for blood work to meet the standard of care to be 
more credible than Dr. Malik's.
    \25\ Additionally, Dr. Munzing testified that none of the 
patient records for J.M., R.D., or C.B. included blood work or any 
urine drug testing, which he said ``is important because one wants 
to (a) confirm that they're actually taking what you're prescribing. 
And equally as important is they're not taking something that you're 
not prescribing, legal or illegal.'' Id. at 456-57. However, when 
asked on cross examination whether urine screens were required under 
the standard of care, Dr. Munzing stated that monitoring was 
required and urine screens were ``increasingly encouraged but not 
required.'' Id. at 458. I am not finding the lack of urine screens 
to be evidence of a violation of the standard of care; however, it 
is noted that the Government's Exhibits do not appear to include 
monitoring of any kind.
---------------------------------------------------------------------------

(b) J.M.'s Prescriptions
    The Government alleged that Respondent issued a total of thirty-two 
controlled substance prescriptions on seven dates to J.M. outside the 
usual course of professional practice and in violation of California 
law, on October 30, 2014, November 10, 2014, November 20, 2014, 
November 9, 19 and 29, 2015, April 9, 2016, and April 19, 2016. OSC, at 
2-3; RD, at 68-70.
    On October 30, 2014, J.M. received a prescription for: 30 milligram 
tablets of Roxicodone at 55 tablets to be taken one four times a day; 
80 milligram tablets of Oxycontin at 46 tablets to be taken one four 
times a day; 350 milligram tablets of Soma at 40 tablets to be taken 
one three times a day; and 10 milligram tablets of Valium at 90 tablets 
to be take one four times a day. Tr. 291-92 (citing GX 3, at 1). Dr. 
Munzing testified that the closest medical record that corresponded 
with this visit was on October 10, 2014, which was a pain assessment 
questionnaire. Tr. 292-93 (citing GX 4, at 19). He further testified 
that the controlled substance prescriptions were not issued within the 
California standard of care, because there was no documented ``medical

[[Page 20720]]

justification.'' Tr. 294. Further, Dr. Munzing testified that, ``I see 
some very alarming things, such as the very high Morphine-equivalent 
\26\ dosing, which when you calculate this out, puts you about 660'' 
and further that the prescriptions ``qualif[y] for the trinity, or the 
holy trinity, that we talked about earlier as the oxycodone, 
carisoprodol or Soma, and benzodiazepine. So not only is there not 
justification, but I see some very alarming things from that 
prescription.'' Id. at 295. He also noted that the oxycodone was 
prescribed at the highest dosage available.\27\ Id. at 298.
---------------------------------------------------------------------------

    \26\ As discussed in supra II.C., Dr. Munzing explained that 
calculating the morphine equivalent dosing or MME is ``vitally 
important'' to determine the amount of opioids to prescribe to a 
patient, and that the Centers for Disease Control and Prevention 
(CDC) recommends that doctors prescribe less than 90 MME per day and 
that the risks are high when 50 MME is exceeded. Tr. 288-89; RD, at 
73.
    \27\ Dr. Munzing testified that even if the patient had a tumor 
on his nerve and Respondent was treating the pain while the patient 
was ``going through the process of having an ENT review this mass,'' 
he did ``have concerns with the incredibly high dosage.'' Tr. 523. 
He further testified on cross examination that a patient's ability 
to pay to see a specialist is irrelevant to the standard of care. 
Id. at 526. If a patient could not afford a specialist, a 
responsible physician ``would need to document that I've advise x, 
x, x, x, and they're not doing it.'' Id. He also noted that the 
prescriptions themselves were ``very expensive'' and that would be 
something that would be required to be discussed and documented with 
the patient. Id.
---------------------------------------------------------------------------

    On November 10, 2014, Respondent prescribed J.M. 40 tablets of Soma 
at 350 milligrams per tablet; 40 tablets Valium at 10 milligrams per 
tablet; 46 tablets of Oxycontin at 80 milligrams per tablet, and 60 
tablets of Roxicodone at 30 milligrams per tablet. GX 3, at 3-4. Dr. 
Munzing testified that there were no corresponding records to 
demonstrate that Respondent had comported with the standard of care in 
issuing these prescriptions to J.M. He further testified that the note 
from the pharmacist on the prescriptions indicated that the pharmacist 
had spoken to Respondent and ``he says patient's pain is not well 
controlled,'' but that there was no indication in the patient records 
that J.M.'s pain was not controlled. Tr. 303 (citing GX 3, at 4). Dr. 
Munzing testified that these prescriptions also were concerning for 
being a trinity cocktail and having a morphine equivalent dosage of 
495, which was ``still way over the 100 milligram threshold.'' Tr. 310-
11. He stated that J.M. is ``at extremely high risk for overdose and 
death with the dosage, not just the trinity, but the morphine-
equivalent dosing that's you know, exceedingly high.'' Id. at 487. He 
concluded that the controlled substance prescriptions were issued 
outside of the standard of care in California. Id. at 310.
    On November 20, 2014, Respondent prescribed J.M. 40 tablets of Soma 
at 350 milligrams per tablet; 40 tablets Valium at 10 milligrams per 
tablet; 46 tablets of Oxycontin at 80 milligrams per tablet, and 60 
tablets of Roxicodone at 30 milligrams per tablet. GX 3, 5-6. Dr. 
Munzing testified that nothing in the J.M.'s patient file in the 
Government's Exhibits justify the prescriptions. Tr. 312-13 (citing GX 
4, at 17-20). He concluded that the controlled substance prescriptions 
were issued outside the standard of care in California for ``the same 
reasons [he] mentioned for the previous two prescriptions,'' including 
``the trinity cocktail, the morphine equivalent doing, as well as the 
fact that the progress notes--there's nothing there to medically 
justify the appropriateness of these medications.'' Tr. 313.
    On November 9, 2015, Respondent prescribed J.M. 40 tablets of Soma 
at 350 milligrams per tablet; 40 tablets Valium at 10 milligrams per 
tablet; 40 tablets of Oxycontin at 80 milligrams per tablet, and 55 
tablets of Roxicodone at 30 milligrams per tablet. GX 3, 7-6. Dr. 
Munzing testified that the Government's evidence contained no patient 
records dated after June 24, 2015 for J.M. Tr. 313-14. On November 19, 
2015, Respondent prescribed the same medications at the same dosages 
and amounts, except that the quantity of oxycodone was 40 tablets. GX 
3, at 9-10; Tr. 315. On November 29, 2015, Respondent issued a 
prescription for the same medications at the same dosages and amounts 
as the previous prescription to J.M. GX 3, at 11-12. On April 9, 2016, 
and April 19, 2016, Respondent issued a prescription for the same 
medications at the same dosages at smaller amounts with the addition of 
Motrin 600 milligrams at 60 tablets. Id. at 13-16.\28\ Dr. Munzing 
testified that the prescriptions ``all fell outside the medically 
legitimate prescribing for controlled substances'' and for all of the 
reasons previously stated including the morphine equivalent dosages and 
the trinity cocktail. Tr. 318-19. He testified that nothing in the 
medical records would justify prescribing to J.M. that level of opioids 
and that the state of J.M.'s patient files were ``not even close'' to 
the standard of care in California. Id. at 321. Dr. Munzing testified 
that to meet the standard of care, Respondent would have needed to 
include a ``new or updated history,'' ``side effects from the 
medications,'' ``is it helping you,'' ``an exam'' and a ``treatment 
plan.'' Id. at 322. He further testified that J.M.'s first visit 
appeared to be November 9, 2012, and the records for J.M.'s first visit 
were not the type of record that the standard of care required for a 
first visit. Id. at 325-26 (citing GX 4, at 37).
---------------------------------------------------------------------------

    \28\ On cross-examination, Dr. Munzing testified that it was 
``possible'' that the reduction of the oxycodone from 40 to 28 
tablets was tapering, but that there was ``no ability to be able to 
come to that conclusion in light of the sparse progress notes that 
were available.'' Tr. 474-75. Further, Dr. Munzing testified that 
``the prescriptions are not reflecting an active effort on 
[Respondent] to taper those medicines because one would usually go 
from three to four times a day, back to three times a day, back to 
twice a day.'' Id. at 487. He additionally testified that for 
tapering, you ``would actually see not only verbally to the patient 
documented in the records, but also on the scripts, you would see 
that there's a progression in tapering over time.'' Id. at 544. Dr. 
Munzing did testify that the reduction of the pills from 46 down to 
26 ``could be'' a taper, even though the daily instructions remained 
the same. Tr. 555. However, he testified that J.M. was still 
receiving the trinity over the course of prescriptions in the 
Government's records. Tr. 562. Further, he clearly testified that 
the standard of care required that tapering would have required 
documentation as such on both the patient's records and on the 
prescriptions. It is noted that Respondent's Supplemental Records 
did include notations regarding tapering for these prescriptions. 
See RX 4, at 23 (``taper off at all medications gradually''). I do 
not find that the April 2016 prescriptions were issued outside the 
standard of care due to the additional documentation in the 
Respondent's Supplemental Records, which was not examined by 
Government's expert; therefore, whether this reduction was tapering 
is irrelevant to the violations I am finding.
---------------------------------------------------------------------------

    In contrast to Dr. Munzing, Dr. Malik testified based on his review 
of Respondent's Exhibit 4 for J.M. in Respondent's Supplemental 
Records. Tr. 747. He stated that ``if you gather all the information 
from all the progress notes, the documentation was giving me enough 
information to say it was within the standard of care.'' \29\ Id.
---------------------------------------------------------------------------

    \29\ The Government argued that Dr. Malik's standard of care 
analysis was flawed, because he created a derivative product of all 
of Respondent's treatment notes to determine that Respondent had met 
the standard of care. Govt Posthearing, at 44-45; Govt Exceptions, 
at 45-46. The Government further argued that this method of 
justifying a prescription was not consistent with California law. 
Govt Exceptions, at 19. I agree with the Government and I found this 
method of Dr. Malik's standard of care analysis to be dubious; 
however, because I have no expert testimony to refute whether or not 
this is an appropriate manner to evaluate Respondent's care and no 
expert review of the Respondent's Exhibits opining that they do not 
demonstrate that Respondent met the standard of care, I have agreed 
with the Chief ALJ that Dr. Malik's testimony is unrefuted on the 
prescriptions that he reviewed as part of Respondent's Exhibits. See 
e.g., RD, at 70. This issue is not central to the resolution of this 
case, because I find herein that the Government has established a 
prima facie case that Respondent's registration is inconsistent with 
the public interest based on the prescriptions that were not 
included in Respondent's Supplemental Exhibits.
---------------------------------------------------------------------------

    On cross examination, Dr. Malik stated that he reviewed RX 4 in 
preparing his expert report contained in RX 10, and that the records 
for J.M. in this exhibit ranged from November 19,

[[Page 20721]]

2015, to April 19, 2016. Id. at 811. As such, the Government's counsel 
at the hearing noted that the records in GX 3, included prescriptions 
for J.M. dated October 30, 2014, November 10, 2014, November 20, 2014, 
and November 9, 2015, all of which predate the records that Dr. Malik 
reviewed in preparing his expert report. Tr. 812-13. Dr. Malik was 
asked to look at GX 4, at 17-20, and was then asked whether the records 
provided information needed to determine whether the controlled 
substance is being prescribed for a legitimate medical purpose. Id. at 
821. He responded that ``there's no physical examination documented 
here, so only talking about the pain doesn't say anything about 
anything else. I wouldn't say this is good enough for me to start the 
patient on the trinity cocktail,'' and he concluded the same regarding 
the decision to prescribe the high dose of opiates. Id. Dr. Malik later 
stated that if he were basing his evaluation as to whether Respondent 
met the standard of care in California for controlled substance 
prescribing based on GX 4, ``[h]e does not meet the standard of care 
based on only the records provided by the Government.'' Id. at 850.
    Based on the uncontroverted evidence presented by the Government, I 
find that the controlled substance prescriptions issued on October 30, 
2014, November 10, November 20, 2014, and November 9, 2015,\30\ were 
issued outside the usual course of professional practice and beneath 
the applicable standard of care in California. See also RD, at 69. 
Furthermore, I agree with the RD, and find that based on the 
uncontroverted testimony of Dr. Munzing that the record is required to 
include the patient's name, the date, the character and the quantity of 
the Schedule II controlled substance \31\ prescribed on the records 
from the visit where the controlled substance was prescribed and the 
patient's address in the file, Tr. 241-42, the record contains 
substantial evidence that Respondent did not comply with recordkeeping 
requirements under Cal. Health & Safety Code Sec.  11190(a) for the 
same Schedule II prescriptions. RD, at 71. The RD further found, and I 
agree, that the evidence in neither the Government's Exhibits nor 
Respondent's Exhibits include a patient's address until after the 
November 19 and 29, 2015 prescription dates and reflect an incorrect 
amount of oxycodone than what was prescribed. Id. at 72 & n.171 (citing 
RX 4, at 61-62; RX 4, at 1 (demonstrating the first patient's address 
recorded on December 9, 2015); compare RX 4, at 61 with GX 3, at 11-12 
(oxycodone quantity of forty on patient record, while prescription was 
for sixty). Finally, I agree with the RD that Dr. Munzing's testimony 
regarding Respondent's ``excessive prescribing'' in violation of Cal. 
Bus. & Prof. Code Sec.  725(a), was ``more persuasive'' than Dr. 
Malik's. RD, at 74. ``J.M. continuously received OxyContin 80mg and 
Roxicodone 30mg at either three or four times daily, resulting in a 660 
MME daily dose (if each taken four times per day) or a 495 MME daily 
dose (if each taken three times per day). At a minimum, that is about 
five times the daily CDC-advised limit that Dr. Munzing explained 
arises out of the increase in risk to the patient once exceeded.'' Id. 
(citing GX 3). The Chief ALJ found, and I agree, that the Government 
has established that Respondent's prescribing to J.M. was 
excessive.\32\
---------------------------------------------------------------------------

    \30\ The Chief ALJ found that the Government had not provided 
enough evidence to sustain a violation for the remaining 
prescriptions for which Respondent had provided additional 
documentation and which Dr. Malik had testified were issued within 
the standard of care in California, because ``the Government 
declined to elicit an opinion from its expert Dr. Munzing, regarding 
the J.M. supplemental file, including whether the Respondent's 
supplemental paperwork contained in that file brought his 
prescribing to within the standard of care . . .'' for those 
prescriptions. RD, at 70. Although I agreed with the Chief ALJ in 
finding credibility issues with Dr. Malik, supra II.C., and I agree 
with the Government that the origin of the Respondent's Supplemental 
Records was suspicious, supra II.D., I also agree with the Chief ALJ 
that the Government's failure to rebut the testimony of Respondent's 
expert regarding the additional files leaves the question of whether 
the prescriptions in the supplemental files were issued within the 
standard of care unresolved. I also find that the record contains 
more than enough uncontroverted evidence to demonstrate that it is 
against the public interest for Respondent to maintain his 
registration, and therefore, I have not violations of the DEA 
regulations for the supplemental file records.
    \31\ Roxicodone and OxyContin are Schedule II controlled 
substances. Stip. 5.
    \32\ Although the RD noted that Dr. Munzing did not 
``specifically testify as to what constitutes excessive prescribing 
in the Respondent's local community,'' his testimony as to the CDC 
recommendations, which were so extremely exceeded in this case, was 
sufficient to establish the excessive prescribing. RD, at 73. I 
agree. I further find that Dr. Malik's testimony on the issue of 
MMEs was less persuasive than Dr. Munzing's.
---------------------------------------------------------------------------

2. R.D.
    The Government alleged that Respondent issued a total of thirty 
controlled substance prescriptions on fifteen dates to R.D. outside the 
usual course of professional practice and without a legitimate medical 
purpose and in violation of California law, on July 8, 15, 22, and 29 
of 2015; November 4, 11, 18 and 25 of 2015; June 2, 11, 20 and 28 of 
2016; and July 6, 14, and 22, 2016. OSC, at 5; RD, at 77-79.
(a) R.D.'s Medical Records in Government Exhibits
    The Government's evidence related to R.D. demonstrated a patient 
questionnaire, dated March 11, 2009. GX 10, at 3. There is a progress 
note form that ``actually has more information on it,'' but is undated. 
Tr. 328-29 (citing GX 10, at 4). The patient file also included an 
opioid risk tool, an undated, unnamed pain scale, a depression 
checklist, which shows ``kind of on the border of mild depression,'' 
and a patient agreement. Id. at 332 (citing GX 10, at 8-12). The Family 
and Personal Health History form in the R.D. file stated that the last 
physical examination date was November 15, 2014, which was ``just over 
six months before.'' Id. at 333; (citing GX 10, at 13). Dr. Munzing 
testified that the progress note dated May 26, 2015, was deficient 
under the standard in California for many reasons to include there 
being no ``assessment, and the treatment plan, all it says is pain 
management.'' Id. at 334 (citing GX 10, at 14). He further testified 
that the other records for R.D. on May 26, 2015, did not meet the 
standard of care in California, stating that, ``[t]here's practically 
no information on them'' and further that the records related to 
Schedule II controlled substances were inadequate under to California 
Health and Safety Code 11190. Tr. 344-45 (citing GX 10, at 21-24). Dr. 
Munzing testified that the records related to R.D. on December 9, 2015, 
taken together as a whole do not meet the California standard of care. 
Tr. 354 (citing GX 10, at 43-46). Dr. Munzing further testified that 
the patient record, dated April 13, 2016, did not fulfill the 
requirements for listing controlled substances under California law, 
because there was ``no strength, no amount, no directions . . .'' and 
that although ``the exam portion for the musculoskeletal is consistent. 
There are no vital signs listed. There's no heart and lung exam 
listed,'' and therefore the documentation is not consistent with the 
standard of care for a controlled substance prescriber in California 
``in entirety.'' Tr. 361-63, 365 (citing GX 10, at 67).
(b) R.D.'s Prescriptions
    On July 8, July 15, July 22, July 28, 2015, Respondent prescribed 
R.D. 60 tablets of Norco at 10/350 milligrams per tablet. GX 7, 1-2, 3-
4, 5-6, 7-8; Tr. 369-70. Further, the Government presented a dispensing 
report from White Front Pharmacy that also indicated that on each of 
these dates, Respondent prescribed R.D. 2 milligrams of alprazolam. GX 
8, at 3; Tr.

[[Page 20722]]

370-71. Dr. Munzing testified that the closest date to these 
prescriptions in Respondent's records for R.D. was May 26, 2015, and 
that the prescriptions for alprazolam and Norco were issued ``far below 
the standard of care,'' and the records ``practically have no 
information written on them.'' Tr. 372, 374-75. Dr. Munzing further 
testified that the number of Norco pills ``is a pretty hefty amount of 
Norco'' and that the large number of pills raises the potential for 
additional risk of diversion or abuse. Id. at 377.
    On November 4, November 11, November 18, and November 25, 2015, 
Respondent prescribed R.D. 60 tablets of Norco at 10/350 milligrams per 
tablet GX 7, 9-10, 11-12, 13-14, 15-16; Tr. 379-85. On November 11, 
Respondent prescribed an additional 10 pills of 2 milligrams per pill 
of Xanax. GX 7, at 11. The Government presented a dispensing report 
from White Front Pharmacy that also indicated that on each of these 
dates, Respondent prescribed R.D. 10 tablets of alprazolam at 2 
milligrams. GX 8, at 4; Tr. 382-83. Dr. Munzing testified that these 
prescriptions were ``an extreme departure from the standard of care'' 
based on the records and the amounts. Tr. 384.
    On June 2, June 11, June 20, June 28, July 6, July 14, July 22, 
2016, Respondent prescribed R.D. 55 tablets of Norco at 10/325 
milligrams per tablet. GX 7, at 17-18, 19-20, 21-22, 23-24, 25-26, 27-
28, 29-30; Tr. 386. Additionally, on June 2, and July 22, 2016, 
Respondent prescribed 9 pills of 2 milligrams per pill of Xanax. GX 7, 
at 17-18, 29-30. The Government presented a dispensing report from 
White Front Pharmacy that also indicated that on June 11, 20, July 6 
and July 14, 2016, Respondent prescribed 9 tablets of alprazolam at 2 
milligrams to R.D. GX 8, at 7; Tr. 387-88. Dr. Munzing testified that 
the closest records to the prescriptions for R.D. were dated April 13, 
2016. Tr. 389. He further testified that all of these prescriptions 
were ``prescribed outside the standard of care'' due to the lack of 
documentation of the history, imaging, evaluation, and that the amount, 
although slightly lower than the previous amounts, were still ``a 
pretty hefty amount'' and raised concerns about diversion and abuse. 
Id. at 389-91. Further, he testified that the combination of the 
alprazolam and the Norco was a concern, because ``[i]t's been well 
known for quite some time both in literature and in practice the 
combination increases the risk of overdoes and potential death.'' Id. 
at 392.
    Dr. Munzing also testified that R.D.'s file included a ``huge red 
flag'' \33\ due to his acknowledgement that he had been arrested for 
drunk driving, and that the standard of care would require a doctor to 
``[t]ake a history and document a history and resolve that that's not 
an issue if you're going--if and when you're going to prescribe 
controlled substances.'' Id. at 393-95; GX 10, at 59; see also GX 10, 
at 68 (acknowledgement of drunk driving). Dr. Munzing explained that 
R.D. had another unresolved red flag stating that R.D. ran out of 
medications early, because ``it would indicate that presumably the 
patient's taking more than--more medications than they have 
prescribed'' or that ``they were selling, giving--they were diverting 
the medication.'' Tr. 396-97; GX 10, at 71. He stated that to resolve 
this red flag under the California standard of care, the physician 
would need to ``resolve that issue as far as is it a reasonable, 
appropriate reason for running out early or not,'' and that he saw no 
resolution of the red flag in the patient file. Tr. 397. Finally, Dr. 
Munzing testified that R.D.'s file contained a red flag of distance 
traveled from Perris, California to Costa Mesa, which is approximately 
63-65 miles, which is a red flag and would require a practitioner to 
document the rationale for traveling the distance. Id. at 399-401; see 
RD, at 30.\34\ Again, he explained that the standard of care in 
California is that a practitioner must resolve the red flags, ``and 
document because others are going to be reviewing these charts, and one 
needs to determine here is a red flag. How is this okay or not okay.'' 
Id. at 402.
---------------------------------------------------------------------------

    \33\ It is noted that although Dr. Malik testified that he saw 
no red flags in Respondent's exhibits, the forms indicating this red 
flag were not included in the records that Dr. Malik reviewed. Tr. 
763-64. Dr. Malik did testify that a physician ``has to'' evaluate 
the risk of a patient abusing controlled substance under the 
California standard of care and document the conversations regarding 
the red flags in the record. Id. at 762; 796. He also testified that 
driving under the influence would be a red flag. Id. at 794.
    \34\ On cross-examination, Dr. Munzing testified that if R.D. 
had lived closer at one point to Respondent's office and then moved, 
``it certainly could be a resolution of the red flag.'' Tr. 463. Dr. 
Munzing had testified that he would expect to see ``[a] small 
notation in the chart,'' but he did not elaborate on whether it 
would be required under the standard of care if the red flag had 
already been resolved. Id. at 462. I find that the record was 
ultimately unclear about whether the distance red flag could have 
been resolved, but there were several other red flags regarding R.D. 
that were unresolved in the Government's Exhibits. See also RD, at 
78 n.177 (not sustaining the distance red flag on other grounds).
---------------------------------------------------------------------------

    Dr. Malik testified based on his review of Respondent's Exhibit 5 
for R.D. Id. at 751. He stated that in order to determine that 
Respondent's documentation was within the standard of care, he had to 
``go[ ] through a different progress note to compile everything, and in 
the very end, one particular which [he] had pretty much had everything 
which the recommendations, our guidelines say.'' Id. He further 
testified that, based on the records that he had reviewed, Respondent 
had complied with the standard of care in California in prescribing 
controlled substances to R.D. Tr. 752-53.
    On cross examination, Dr. Malik stated that he reviewed RX 5 in 
preparing his expert report contained in RX 17, and that the records 
for R.D. in RX 5 ranged from August 26, 2015,\35\ to July 6, 2016. Id. 
at 826-30 (citing RX 5, at 82 and 1). As such, the Government's counsel 
at the hearing noted that the records in GX 7, included prescriptions 
for Norco dated July 8, 2015, July 15, 2015, July 26, 2015, July 29, 
2015, July 14, 2016, July 22, 2016 (Xanax and Norco), which either 
predated or postdated the records that Dr. Malik reviewed in preparing 
his expert report. Tr. 831-32 (citing GX 7, at 1-8, 27-30). Further, GX 
8 was a dispensing report from a pharmacy demonstrating prescriptions 
for alprazolam on July 8, 2015, July 15, 22, 29, 2015, July 14, 2016, 
which either predated or postdated the records that Dr. Malik reviewed 
in preparing his expert report. Tr. 833-35 (citing GX 8, at 3, 7). Dr. 
Malik testified that the prescriptions for Xanax and Norco that 
postdated the Respondent's Supplemental Records would still be within 
the standard of care because the progress note that he reviewed on July 
6, 2016 ``tells about the patient's condition or the overall scenario 
of the patient for over a period of time.'' Tr. 841-42 (citing GX 7, at 
27 and 29).
---------------------------------------------------------------------------

    \35\ Although RX 5 included a cholesterol report from June 2, 
2014, Dr. Malik testified that it would ``not affect [Respondent's] 
decision to continue or not continue or change the dose of the pain 
medications.'' Tr. 830 (citing RX 5, at 4).
---------------------------------------------------------------------------

    Based on the uncontroverted evidence presented by the Government, I 
find that the controlled substance prescriptions issued on July 8, 15, 
22, and 29, 2015,\36\

[[Page 20723]]

were issued outside the usual course of professional practice and 
beneath the applicable standard of care in California. See also RD, at 
77-78.\37\ Furthermore, I agree with the RD, and find, based on the 
uncontroverted testimony of Dr. Munzing, that the records for Schedule 
II \38\ controlled substances are required to include the patient's 
name, the date, the character and the quantity of the controlled 
substance prescribed on the records from the visit during which the 
controlled substance was prescribed and the patient's address must be 
in the file prior to prescribing, Tr. 241-42, the record contains 
substantial evidence that Respondent did not comply with recordkeeping 
requirements under CA Hlth & S Sec.  11190(a) for the same 
prescriptions. RD, at 84. The RD further found, and I agree, that 
Respondent's Exhibits for November 4, 11, 25, 2015, and June 20, 28, 
July 14, and 22, 2016,\39\ did not include all of the information that 
Dr. Munzing testified was necessary for Schedule II controlled 
substances under California law. Id. at 84 (citing RX 5, at 72-73, 66-
67, 61-62).\40\
---------------------------------------------------------------------------

    \36\ The Chief ALJ noted that, as with J.M., the Government's 
expert and Respondent's expert had testified solely to the 
legitimacy of the R.D. prescriptions as documented in their 
respective exhibits. RD, at 76-77. He also noted that the Government 
had not provided enough evidence to sustain a violation for the 
prescriptions in Respondent's Supplemental records and which Dr. 
Malik had testified were issued within the standard of care in 
California, because Dr. Munzing had not reviewed or testified as to 
whether Respondent's Supplemental Records were within the standard 
of care. RD, at 79. As explained in supra n.24, I will follow the 
Chief ALJ's rationale in not including these prescriptions in my 
consideration of Public Interest Factors Two and Four.
    \37\ For R.D., there were additional prescriptions that were 
issued after the majority of the records in Respondent's Exhibits, 
which the Chief ALJ designated ``Patient R.D. Group 3 Prescribing 
Events.'' The Chief ALJ concluded that Respondent had ``produced 
significant additional documentation that was not considered by Dr. 
Munzing,'' when he opined that R.D.'s file contained red flags that 
were not resolved in the documentation. RD, at 82. I agree with the 
Chief ALJ regarding the limitations of the Government's case based 
on red flags in the Respondent's Supplemental Records, except for 
the red flag of the DUI as explained below.
    \38\ Norco has been a Schedule II controlled substance since 
October 6, 2014. Stip. 4.
    \39\ Respondent's Exhibits did not contain any additional 
records for these particular June and July visits.
    \40\ I agree with the RD that the Government has demonstrated 
substantial evidence that Respondent was excessively prescribing to 
R.D., because Dr. Munzing never testified that the ``hefty amount'' 
of Norco amounted to excessive prescribing. RD, at 84-85 (citing Tr. 
377).
---------------------------------------------------------------------------

    I generally agree with the Chief ALJ that the Government did not 
adequately demonstrate that the red flags that Dr. Munzing identified 
with respect to R.D. were unresolved in the prescriptions that 
coincided with and postdated Respondent's Supplemental Records, because 
Dr. Munzing never reviewed or opined on the Respondent's files to 
determine whether the red flags had been resolved. RD, at 82. However, 
Dr. Munzing identified what he described as a ``huge red flag'' 
regarding R.D.'s arrest for a DUI, GX 10, at 59, 68, which was 
documented by R.D. in the April 13, 2016 R.D. records in the 
Government's Exhibits, and which Dr. Munzing stated ``needs a lot of 
explanation.'' Tr. 397. Respondent's records for R.D. include dates 
from April 13, 2016, to July 6, 2016, RX 5, at 1-25, and yet, nowhere 
in these records, nor in the Government's Exhibits, are any notes that 
could possibly resolve the red flag of the DUI. There is no mention of 
alcohol or a DUI on any of the Respondent's exhibits after this date. 
Dr. Malik testified that a DUI would be a potential red flag, and that 
``after fair warning, the physician should stop prescribing these pain 
medications with the patient anymore, but there have to be significant 
red flags for that to happen'' and also that these conversations with 
the patient need to be documented by the doctor. Tr. 794-96. It is 
apparent that both experts agreed that a DUI is a red flag and must be 
documented. My reading of the records in evidence shows no mention of 
the red flag of the DUI and I believe that both experts testified that 
the DUI must be addressed in some manner, which it is clear from the 
record that it was not. Therefore, I also find that the controlled 
substance prescriptions issued to R.D. after the admission that raised 
the red flag on April 13, 2016, were issued outside of the usual course 
of the professional practice and beneath the applicable standard of 
care.\41\
---------------------------------------------------------------------------

    \41\ Although I am finding that these additional fourteen 
prescriptions, in what the Chief ALJ has entitled the Patient R.D. 
Group 3 prescribing events, RD, at 80-81, were issued outside the 
usual course of the professional practice and beneath the applicable 
standard of care in California, even without the finding of these 
additional violations, there is more than enough evidence on the 
record to indicate that Respondent's registration is inconsistent 
with the public interest.
---------------------------------------------------------------------------

3. C.B.
    The Government alleged that Respondent issued a total of eight 
controlled substance prescriptions on four dates to C.B. outside the 
usual course of professional practice and without a legitimate medical 
purpose and in violation of California law. OSC, at 7; RD, at 86.
(a) C.B.'s Medical Records in Government Exhibits
    Dr. Munzing testified that C.B.'s medical complaints seemed to be 
that she had a skiing accident, but that ``[t]he timing of the accident 
seems to move through the records, whether it be in the late 1990s or 
early 2000s.'' \42\ Tr. 404. The Government's evidence related to 
patient C.B.'s file consisted of many of the same forms as the files 
for R.D. and J.M., including Pain Assessment Questionnaires filled out 
by the patient, see e.g., GX 12, at 22, Pain medication agreements, id. 
at 17, and exam notes that are either blank or have some information 
filled out, id. at 36, 44; Tr. 410-45. The evidence also contains 
several Controlled Substance Utilization Review and Evaluation System 
(hereinafter, CURES) reports for C.B. Dr. Munzing testified that the 
CURES reports ending on April 23, 2015, indicated several red flags, in 
that there is a ``combination of two different opioids'' prescribed by 
two different doctors, and ``[t]here is also Suboxone prescribed by Dr. 
T[ ], and the majority of the time that Suboxone is used, it's used for 
substance use disorder or addiction . . . '' and ``pharmacy shopping.'' 
Tr. 416 (citing GX 12, at 40-41). Dr. Munzing testified that the CURES 
report in April showed similar red flags, including multiple doctors 
and pharmacies and also the ``trinity'' of controlled substances. Tr. 
418 (citing GX 12, at 9-10). Dr. Munzing testified that there is a 
handwritten note in C.B.'s file stating that patient should not have 
multiple doctors and that she signed a renewed pain agreement; however, 
he testified that the note alone does not resolve all of the red flags 
in the file, such as the combination of medicines, the Suboxone \43\ 
and multiple pharmacies. Tr. 418-21 (citing GX 12, at 10). According to 
Dr. Munzing, the records in C.B.'s file closer to the time of the 
Government's allegations, had ``significant missing information,'' such 
as ``no vital signs,'' ``limited historical information,'' no dosages 
of the controlled substance, ``no comment as far as whether the 
patient's getting better, worse, etc.'' Tr. 431 (citing GX 12, at 316-
19). Although some of the records were ``the best that [Dr. Munzing 
had] seen'' in Respondent's records, they were still missing ``aspects 
of vital signs, of medications prescribed.'' Tr. 436 (citing GX 12, at 
322-24).
---------------------------------------------------------------------------

    \42\ Compare GX 12, at 278 (09/08/2004 Questionnaire indicating 
immediate pain onset in January 2008), with id. at 288 (05/12/2004 
PAQ indicating pain onset in 1996 from snow skiing accident). See 
RD, at 31 n.74 (full assessment of various dates claimed for pain 
onset for C.B. file).
    \43\ The Government's records do include a note regarding 
``Cures problems,'' which mentions the Suboxone prescription and 
that the note states that it was discontinued, but it was unclear 
whether the psychiatrist was the one who had discontinued the 
prescription. GX 12, at 22; Tr. 549. Dr. Munzing testified that this 
note does not resolve the red flag that the patient was ``taking the 
trinity based on the prescriptions that she was obtaining from two 
doctors,'' Dr. Munzing testified that there was nothing in the 
record to demonstrate that the red flag was resolved regardless of 
the timing being near the surgery. Tr. 550; 562. However, Dr. 
Munzing did not testify as to whether the Respondent's Supplemental 
Records included any resolution of the red flag.

---------------------------------------------------------------------------

[[Page 20724]]

(b) C.B.'s Prescriptions
    On January 6, January 25, Respondent prescribed C.B. 60 tablets of 
Vicodin at 7.5/300 milligrams per tablet and 30 tablets of Soma at 350 
milligrams per tablet. GX 11, at 1-2, 3-4; Tr. 443-45. Dr. Munzing 
testified that these prescriptions do not meet the standard of care in 
California, because ``there's no progress note or evidence that 
supports the medical justification.'' Tr. 446. On February 11, 2016, 
Respondent prescribed C.B. 55 tablets of Vicodin at 7.5/300 milligrams 
per tablet and 55 tablets of Soma at 350 milligrams per tablet. GX 11, 
at 5-6. Dr. Munzing again testified that this prescription did not meet 
the standard of care in California, due to the lack of documentation. 
Tr. 447-48 (citing GX 12, at 325 (Patient records for C.B. dated 
January 27, 2016)). On March 3, 2016, Respondent prescribed C.B. 50 
tablets of Vicodin at 7.5/300 milligrams per tablet and 30 tablets of 
Soma at 350 milligrams per tablet. GX 11, at 7-8. Dr. Munzing testified 
that this visit ``does not fall within the standard of care, though in 
re-review in preparation for this hearing, I think that for this one 
visit, I would call this a simple departure . . . .'' Tr. 449 (citing 
GX 12, at 322-24 (Patient records for C.B. dated March 3, 2016)).
    Dr. Malik testified that C.B. was prescribed the ``trinity 
cocktail'' for brief period of time, but that ``for that particular 
patient, these three medications for a certain period of time after the 
breast surgery in a patient whose body is already used to a high dose 
of opiates I think brought enough comfort to her pain.'' Tr. 745. He 
testified that ``[Respondent's] documentation was probably very down 
there, pretty bad, but . . . if I can gather all the information from 
all the records . . . I will say it was all within the standard of 
care.'' Id. at 745-46.
    The Chief ALJ found that Respondent's Supplemental Records 
contained notes that correspond with all of the prescriptions and dates 
included in the OSC for C.B. RD, at 86 (citing GX 12 and RX 3). I agree 
with the Chief ALJ that because Dr. Munzing did not consider the 
detailed records in the Respondent's Supplemental Records and the 
Government did not present expert testimony regarding whether the 
Supplemental Records resolved the standard of care issues that Dr. 
Munzing had identified in the Government's Exhibits, ``Dr. Malik's 
testimony that the prescribing to C.B. on those dates was within the 
standard of care based upon a review of that documentation stands 
unrefuted.'' RD, at 88.
    However, the Chief ALJ found, and I agree, that based on the 
uncontroverted testimony of Dr. Munzing, that the records for Schedule 
II \44\ controlled substances are required to include the patient's 
name, the date, the character and the quantity of the controlled 
substance prescribed on the records from the visit during which the 
controlled substance was prescribed and the patient's address must be 
in the file prior to prescribing, Tr. 241-42, the record contains 
substantial evidence that Respondent did not comply with recordkeeping 
requirements under Cal. Health & Safety Code Sec.  11190(a) for the 
prescriptions on January 6, February 11, and March 3,\45\ 2016 because 
the records do not include the quantity prescribed. RD, at 89-90 
(citing RX 3, at 25, 28, 38, and 42).
---------------------------------------------------------------------------

    \44\ Vicodin is and has been a Schedule II controlled substance 
since October 6, 2014. Stip. 4.
    \45\ The Chief ALJ noted that the record on this date appeared 
to reflect what might be considered to be a quantity, but it was 
inconsistent with the actual prescription. RD, at 90 n.208 (citing 
RX 3, at 22-27, GX 12, at 322-24).
---------------------------------------------------------------------------

    Overall, I find that the record contains substantial evidence to 
support the finding that Respondent issued numerous controlled 
substance prescriptions to J.M. and R.D. outside the usual course of 
the professional practice and beneath the applicable standard of care 
and in violation of several California laws and that Respondent issued 
controlled substance prescriptions to C.B. without complying with 
California law.

III. Discussion

A. Allegation That Respondent's Registration Is Inconsistent With the 
Public Interest

    Under Section 304 of the 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 
Circuit has recognized, findings under a single factor can support the 
revocation of a registration. MacKay, 664 F.3d at 821.
    Under DEA's regulation, ``[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.\46\ I address Factor One briefly

[[Page 20725]]

because Respondent introduced evidence into the record that is 
potentially relevant to Factor One as explained below. Overall, I find 
that the Government's evidence with respect to Two and Four satisfies 
its prima facie burden of showing that Respondent's continued 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4). I further find that Respondent failed to produce 
sufficient evidence to rebut the Government's prima facie case.
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    \46\ I agree with the Chief ALJ with regard to Factor Three that 
``although the record contains evidence of a pending criminal matter 
(Stips. 3, 9), there is no evidence in the record that the 
Respondent has been convicted of a crime related to controlled 
substances.'' RD, 60 n.146. Therefore, I find that Factor Three does 
not weigh for or against revocation in this case. Although this 
hearing was completed several years ago and the criminal case may 
have come to a conclusion in the interim, I am not taking notice of 
any additional facts on the record, as I find that doing so is 
unnecessary based on the completeness of the record that is before 
me.
---------------------------------------------------------------------------

1. Factor One--the Recommendation of the Appropriate State Licensing 
Board or Professional Disciplinary Authority
    In determining the public interest, the ``recommendation of the 
appropriate State licensing board or professional disciplinary 
authority . . . shall be considered.'' 21 U.S.C. 823(f)(1). Two forms 
of recommendations appear in Agency decisions: (1) A recommendation to 
DEA directly from a state licensing board or professional disciplinary 
authority (hereinafter, appropriate state entity), which explicitly 
addresses the granting or retention of a DEA COR; and (2) the 
appropriate state entity's action regarding the licensure under its 
jurisdiction on the same matter that is the basis for the DEA OSC. John 
O. Dimowo, M.D., 85 FR 15800, 15810 (2020); see also Vincent J. 
Scolaro, D.O., 67 FR 42060, 42065 (2002).
    In this case, neither the Medical Board of California (hereinafter, 
the State Board) nor any other state entity has made a direct 
recommendation to the Agency regarding whether the Respondent's 
registration should be suspended or revoked. However, during the 
hearing, Respondent introduced an ``Interim Suspension Order'' 
(hereinafter, Suspension Order) issued by the State of California 
Office of Administrative Hearings on December 7, 2016. RD, at 95 
(citing RX 16). The Suspension Order stated that ``Respondent shall not 
prescribe any Schedule II, III, or IV controlled substances.'' RX 16, 
at 7. Respondent argued that ``a petition for Interim Suspension Order 
to stop [Respondent] from practicing altogether was denied by the 
California Medical Board after they found he was not a danger to public 
safety, and [Respondent] is permitted to continue practicing 
medicine.'' Resp Posthearing, at 7.
    The fact that the State Board did not choose to immediately suspend 
Respondent's state medical license carries minimal-to-no weight under 
Factor One, because there is no evidence that the State Board would 
have made the same decision after a full hearing on the merits was 
completed, and additionally, the State Board did significantly restrict 
Respondent's prescribing authority pending a full determination on the 
allegations.\47\ Accordingly, the terms of the State Board Order have 
been considered, but I find that they have no impact on the public 
interest inquiry in this case. See John O. Dimowo, M.D., 85 FR at 
15810.
---------------------------------------------------------------------------

    \47\ In Dimowo, the Acting Administrator found that ``[a]lthough 
statutory analysis [of the CSA] may not definitively settle . . . 
[the breadth of the cognizable state `recommendation' referenced in 
Factor One], the most impartial and reasonable course of action is 
to continue to take into consideration all actions indicating a 
recommendation from an appropriate state;'' however, Dimowo also 
limited the ``recommendations'' DEA would consider to the ``actions 
of an appropriate state entity on the same matters, particularly 
where it rendered an opinion regarding the practitioner's medical 
practice in the state due to the same facts alleged in the DEA 
OSC.'' John O. Dimowo, 85 FR at 15810. In this case, I have no 
indication that the State Board would make a similar decision after 
a full adjudication, and even in the interim, the State Board did 
significantly restrict Respondent's ability to prescribe controlled 
substances.
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2. Factors Two and/or Four--The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
(a) Allegation That Respondent Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice
    According to the CSA's implementing regulations, a lawful 
prescription for controlled substances 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).
    In defense of Respondent's continued registration, he has submitted 
supplemental records, which are far more detailed than the records in 
the Government's Exhibits. RX 3-5. However, Respondent's Supplemental 
Records only address a subset of the prescriptions at issue in this 
case, and the Government has established through unrefuted expert 
testimony that the records that Respondent did not supplement 
constituted ``an extreme departure from'' the standard of care in 
California. Tr. 384. Even Respondent's own expert testified that the 
records in the Government's Exhibits alone did not justify the 
prescriptions to J.M. Id. at 850.
    The end result remains that Respondent issued numerous controlled 
substance prescriptions beneath the applicable standard of care and 
outside of the usual course of the professional practice in California. 
DEA decisions have found that ``just because misconduct is 
unintentional, innocent, or devoid of improper motive, [it] does not 
preclude revocation or denial. Careless or negligent handling of 
controlled substances creates the opportunity for diversion and [can] 
justify the revocation of an existing registration . . .'' Bobby D. 
Reynolds, N.P., Tina L. Killebrew, N.P., & David R. Stout, N.P., 80 FR 
28643, 28662 (2015) (quoting Paul J. Caragine, Jr. 63 FR 51592, 51601 
(1998).
    The violations I have found demonstrate that Respondent repeatedly 
violated the applicable standard of care and state law and that his 
conduct was not an isolated occurrence, but occurred with multiple 
patients. See Wesley Pope, M.D., 82 FR 42961, 42986 (2017).
    The Respondent asserted that ``[t]he fact is that [Respondent's] 
biggest failure was over documenting not under documenting.'' Resp 
Posthearing, at 6. This is simply not true based on the facts on the 
record. If Respondent's Supplemental Records are legitimate, an 
assumption to which I have applied a large degree of latitude in this 
case, he has not presented supplemental records to support many of the 
controlled substances prescriptions in the Government's prima facie 
case. Therefore, I cannot assume that this so-called ``over 
documentating'' exists. Furthermore, Respondent's own expert testified 
with regard to Respondent's Supplemental Records that ``[Respondent is] 
a very poor documenter,'' which directly contradicts Respondent's 
assertion. Id. at 743.
    ``Diversion occurs whenever controlled substances leave `the closed 
system of distribution established by the CSA . . . .' '' Id. (citing 
Roy S. Schwartz, 79 FR 34360, 34363 (2014)). In this case, I have found 
that Respondent issued controlled substance prescriptions without 
complying with his obligations under the CSA and California law. See 
George Mathew, M.D., 75 FR 66138, 66148 (2010)).
    Furthermore, Agency decisions highlight the Agency's interpretation 
that ``[c]onscientious documentation is

[[Page 20726]]

repeatedly emphasized as not just a ministerial act, but a key 
treatment tool and vital indicator to evaluate whether the physician's 
prescribing practices are `within the usual course of professional 
practice.' '' Cynthia M. Cadet, M.D., 76 FR 19450, 19464 (2011). DEA's 
ability to assess whether controlled substances registrations are 
consistent with the public interest is predicated upon the ability to 
consider the evidence and rationale of the practitioner at the time 
that he prescribed a controlled substance--adequate documentation is 
critical to that assessment. Here, Respondent's sparse documentation, 
and even his organization of such documentation, made it impossible to 
evaluate his prescribing practices in any meaningful way. Further, as 
Dr. Munzing stated regarding maintaining accurate and complete records, 
``I guess I can't emphasize enough they're incredibly important, again 
for patient safety and for knowing what happened at any particular 
time. They're also important, again, for any kind of transfer of care, 
whether it's temporary or, you know, permanent.'' Id. at 249. 
Therefore, recordkeeping is not only important for compliance, but also 
for the safety of the patients.
    I find that in issuing prescriptions to J.M. and R.D. beneath the 
applicable standard of care and outside the usual course of the 
professional practice in California, Respondent violated 21 CFR 
1306.04(a) (``A prescription for a controlled substance to be effective 
must be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice'').
(b) Allegations of Violations of California \48\ Law
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    \48\ The OSC alleged a violation of Cal. Health & Safety Code 
Sec.  11154(a) (prescribing to persons not under practitioner's 
treatment) and OSC, at 8. Although listed in the Government's 
briefings, I did not find any explanation on the record regarding 
the legal theory supported by evidence on the record specifically 
related to this citation; therefore, I am not evaluating it in the 
final decision. See, e.g., Govt Posthearing, at 32.
---------------------------------------------------------------------------

    California law also 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.'' Cal. Health & Safety Code Sec.  11153(a). 
Therefore, I find that, similarly to 21 CFR 1306.04(a), the record 
contains substantial evidence that Respondent violated this provision 
with respect to some of the prescriptions for J.M. and R.D. in supra 
II.F.1.b. I also find based on the uncontroverted evidence that 
Respondent issued these same controlled substance prescriptions without 
documenting a medical examination or legitimate medical indication in 
violation of Cal. Bus. & Prof. Code Sec.  2242(a).
    Additionally, California law states that ``repeated acts of clearly 
excessive prescribing, furnishing, dispensing, or administering of 
drugs or treatment . . . as determined by the standard of the community 
of licensees is unprofessional conduct for a physician.'' Cal. Bus. & 
Prof. Code Sec.  725(a). The Chief ALJ opined, and I agreed, that the 
record contains substantial evidence that Respondent's prescribing to 
J.M. was excessive in violation of this California provision of law. 
Supra II.F.1.b.
    California Health & Safety Code Sec.  11190(a) requires that 
practitioners who prescribe Schedule II controlled substances must keep 
certain specific records, to include, ``[t]he character, including the 
name and strength, and quantity of controlled substances involved.'' 
Cal. Health & Safety Code Sec.  11190(a)(3) (Westlaw, current with all 
laws through Ch. 372 of 2020 Regular Session). I found above that 
Respondent's recordkeeping for all three patients--J.M., R.D. and 
C.B.--were missing elements of the required specific records, and 
therefore, I find that the record contains substantial evidence that 
Respondent was in violation of this provision of state law and this is 
evidence that Respondent's registration is not in the public interest 
under Factors 2 and 4. Supra II.F.1.b, F.2, & F.3.
    Ultimately I find that the record contains substantial evidence 
that Respondent issued multiple prescriptions of high dosages of 
controlled substances to multiple patients beneath the applicable 
standard of care and outside the usual course of the professional 
practice and in violation of state law. I therefore find that Factors 
Two and Four weigh in favor of revocation. See Wesley Pope, 82 FR 
14944, 14985 (2017).
3. Factor Five
    Under Factor Five, the Administrator considers ``[s]uch other 
conduct which may threaten the public health and safety.'' 5 U.S.C. 
823(f)(5). Although Factor Five is broad, DEA decisions have qualified 
its breadth by limiting the considerations made under that factor to 
those where there is ``a substantial relationship between the conduct 
and the CSA's purpose of preventing drug abuse and diversion.'' Zvi H. 
Perper, M.D., 77 FR 64131, 64141 (2012) (citing Tony T. Bui, 75 FR 
49979, 49988 (2010)).
    The Government alleged that ``[d]espite being arrested and charged 
for unlawfully prescribing, Respondent continued to prescribe to J.M., 
R.D., and C.B. in violation of state and federal law.'' Govt 
Posthearing, at 39. Therefore, the Government argued that ``it is thus 
clear that being arrested and later arraigned for allegedly unlawfully 
prescribing was not enough of a deterrent for Respondent to stop such 
conduct. That he would continue to do so highlights the egregious 
nature of his actions and heightens the probability that Respondent is 
`a probable or possible threat . . . to the public health and safety.' 
'' Id. (citing Drezer, 76 FR at 19386 n.2). Respondent argued that his 
``prescribing after his arrest was not unlawful because there was a 
legitimate medical purpose.'' Resp Posthearing, at 6.
    Until Respondent had entered into an agreement with the Orange 
County District Attorney's Office on August 30, 2016, whereby he 
``agreed to not prescribe Schedule II-IV controlled substances,'' it 
was not per se a violation of this agreement for him to prescribe 
controlled substances in these schedules to these patients; however, 
the fact that I have found that in some instances, he continued to 
violate federal and California law after his arrest on December 15, 
2015, certainly demonstrates both the egregious nature of his actions 
and the improbability of his ability to meaningfully prevent the 
reoccurrence of similar acts. See Stips. 3&10. In this case, I agree 
with the Chief ALJ that this particular misconduct has already been 
considered under Factors Two and Four, and I believe that, in this 
case, the Government's arguments regarding the deterrent effect of his 
arraignment and the issues of trust that this misconduct necessarily 
implicates are more appropriately considered in my assessment of the 
correct sanction for Respondent as set forth below. See RD, at 92-93.
    Overall, I conclude that the Government has met its prima facie 
burden of showing that Respondent's continued registration is 
``inconsistent with the public interest.'' I further find that 
Respondent did not rebut the Government's prima facie case.

IV. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration is inconsistent with 
the public interest due to his violations pertaining to controlled 
substance prescribing and non-compliance with federal and state

[[Page 20727]]

law, the burden shifts to the Respondent to show why he can be 
entrusted with a new 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 v. Oregon, 546 U.S. at 
259. A clear purpose of this authority is to ``bar[ ] doctors from 
using their prescription-writing powers as a means to engage in illicit 
drug dealing and trafficking.'' Id. at 270. In efficiently executing 
the revocation and suspension authority delegated to me under the CSA 
for the aforementioned purposes, I review the evidence and argument 
Respondent submitted to determine whether or not he has presented 
``sufficient mitigating evidence to assure the Administrator that [she] 
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. DEA, 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 
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).
    In evaluating the degree of a respondent's acceptance of 
responsibility required to entrust him with a registration, in Mohammed 
Asgar, M.D., 83 FR 29569, 29572 (2018), the Agency looked for 
``unequivocal acceptance of responsibility when a respondent has 
committed knowing or intentional misconduct.'' Id. (citing Lon F. 
Alexander, M.D., 82 FR 49704, 49728 (2017)). The Chief ALJ found, and I 
agree, that ``[t]he record is devoid of any inclination on the part of 
the Respondent to accept any level of responsibility for his 
prescribing, unequivocal or otherwise. He remains doggedly committed to 
the proposition that he did nothing wrong.'' RD, at 97 (citing Tr. 
882). Respondent's assertion that ``[t]he fact is that [Respondent's] 
biggest failure was over documenting not under documenting'' is 
unsupported by the record evidence and demonstrates no acknowledgment 
of fault or wrongdoing. Resp Posthearing, at 6. See Hoxie v. Drug Enf't 
Admin., 419 F.3d at 483 (``The DEA properly considers the candor of the 
physician'' and ``admitting fault'' is an ``important factor[] in 
determining whether the physician's registration should be revoked'').
    Respondent's mitigating evidence has reduced the number of 
violations found in this case; however, I see no evidence from 
Respondent that demonstrates that he will ``prevent the re-occurrence 
of similar acts.'' Jeri Hassman, M.D. 75 FR 8194, 8236 (2010). 
Acceptance of responsibility is an important part of that 
demonstration. Id. In fact, as noted herein, the evidence indicates 
that Respondent will do nothing to prevent the reoccurrence of similar 
acts, because after being arrested under allegations of the same state 
law violations at issue in this case, the record contains substantial 
evidence that in some instances, Respondent continued the unlawful 
prescribing activity and continued to violate state recordkeeping law. 
See supra II.F.2&3.
    The Agency also looks to the egregiousness and extent of the 
misconduct which are significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR at 18910 (collecting 
cases). I agree with the Chief ALJ that ``the record evidence here 
establishes that [Respondent] doled out a steady stream of powerful 
controlled drugs without applying and documenting even the most 
rudimentary of applicable standards of care and treatment, which is 
sufficiently egregious to militate in favor of revocation.'' RD, at 99-
100. In addition, Respondent's lack of recordkeeping in the 
prescriptions in the Government's Exhibits was not simply inadequate. 
Dr. Munzing described Respondent's records for J.M. and R.D. 
respectively as ``not even close'' to and ``an extreme departure from'' 
the standard of care in California; therefore, I would characterize 
Respondent's misconduct as egregious. Tr. 321, 384.
    In sanction determinations, the Agency has historically considered 
its interest in deterring similar acts, both with respect to the 
respondent in a particular case and the community of registrants. See 
Joseph Gaudio, M.D., 74 FR 10083, 10095 (2009); Singh, 81 FR at 8248. 
With regard to general deterrence, I agree with the Chief ALJ that 
``[t]o continue the Respondent's registration privileges on the present 
record would send a message to the regulated community that no 
meaningful consequences will likely result from repeatedly and 
unabashedly prescribing controlled substances while maintaining sparse, 
unintelligible, incomplete documentation and storing it in random piles 
in a manner that makes it virtually unavailable (to the prescriber, to 
his patients or their future caretakers, or to anyone else) in the 
absence of a scavenger hunt by any federal or state regulators seeking 
to evaluate compliance.'' RD, at 99. Furthermore, as previously 
discussed, I have no confidence that any measure short of revocation 
would specifically deter Respondent from future misconduct, given that 
he continued his woefully inadequate medical recordkeeping and 
prescribing practices after he was arrested for similar behavior. See 
Singh, M.D., 81 FR at 8248 (``until . . . [a] Respondent can 
convincingly show he [or she] accepts the authority of the law and 
those bodies charged with enforcing it and regulating his [or her] 
activities, granting [ ] a DEA registration will gravely endanger the 
public.'').
    Here, there is insufficient evidence in the record to demonstrate 
that Respondent can be entrusted with a registration. See Leo R. 
Miller, M.D., 53 FR at 21932 (describing revocation as a remedial 
measure ``based upon the public interest and the necessity to protect 
the public from individuals who have misused controlled substances or 
their DEA Certificate of Registration and who have not presented 
sufficient mitigating evidence to assure the Administrator that they 
can be trusted with the responsibility carried by such a 
registration.'').
    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), I hereby revoke DEA Certificate of Registration 
BW5359004 issued to Mark A. Wimbley, M.D. Further,

[[Page 20728]]

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 Mark A. Wimbley, M.D., 
to renew or modify this registration, as well as any other applications 
of Mark A. Wimbley, M.D. for additional registration in California. 
This Order is effective May 21, 2021.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-08171 Filed 4-20-21; 8:45 am]
BILLING CODE 4410-09-P