[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68474-68489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27096]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Jeffrey D. Olsen, M.D.; Decision and Order

    On August 2, 2016, a former Acting Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause (OSC) and Immediate Suspension of Registration 
(ISO) to Jeffrey D. Olsen, M.D. (hereinafter, Registrant), of Newport 
Beach, CA. Order to Show Cause and Immediate Suspension of Registration 
(hereinafter collectively, OSC 2)), at 1; see also Government Exhibit 
(hereinafter, GX) 26, at 1-6. OSC 2 informed Registrant of the 
immediate suspension of his DEA Certificate of Registration 
(hereinafter, COR) FO6043638 pursuant to 21 U.S.C. 824(d) ``because . . 
. [his] continued registration constitute[d] an imminent danger to the 
public health and safety.'' Id.
    The substantive ground for the proceeding, as alleged in OSC 2, was 
that Registrant's ``continued registration is inconsistent with the 
public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. 
(citing 21 U.S.C. 824(a)(4)). Specifically, the OSC alleged that 
Registrant issued numerous prescriptions outside the usual course of 
the professional practice of medicine in violation of 21 U.S.C. 
841(a)(1) and 21 CFR 1306.04(a) and in violation of California law and 
the minimum standards of medical practice in California. Id. at 2-4. 
The OSC stated that ``[Registrant's] conduct, viewed as a whole, 
`completely betrayed any semblance of legitimate medical treatment.''' 
Id. at 4 (citing Jack A. Danton, D.O., 76 FR 60900, 60904

[[Page 68475]]

(2011)). Further, OSC 2 alleged that, on March 15, 2016, DEA had served 
Registrant with an initial Order to Show Cause and Immediate Suspension 
Order (hereinafter, collectively OSC 1), which immediately suspended 
Registrant's previous COR B02524204. Id. at 1-2; see also GX 26, at 7-
12 (OSC 1). After receiving OSC 1, Registrant surrendered his DEA COR 
BO2524204 for cause on March 18, 2016. GX 17 (Voluntary Surrender of 
Controlled Substances Privileges). However, OSC 2 alleged that on May 
20, 2016, Registrant filed an application for a new COR, and he 
materially falsified his application by providing an answer in the 
negative to the question of whether he had ever surrendered his federal 
COR. OSC 2, at 2. OSC 2 further alleged that pursuant to 21 U.S.C. 824, 
this action ``constitute[d] independent grounds for revocation.'' Id. 
OSC 2 also enclosed a copy of, and incorporated by reference, OSC 1, 
which detailed numerous other issuances of prescriptions outside the 
usual course of the professional practice of medicine in violation of 
21 U.S.C. 841(a)(1) and 21 CFR Sec.  1306.04(a) and in violation of 
California law and the minimum standards of medical practice in 
California. OSC 2, at 2; see also GX 26, at 7-12 (OSC 1).
    OSC 2 notified Registrant of his right to request a hearing on the 
allegations, or to submit a written statement while waiving his right 
to a hearing, the procedures for electing either option, and the 
consequence of failing to elect either option. OSC 2, at 5-6 (citing 21 
CFR 1301.43).

Adequacy of Service and Timeliness of Hearing Request

    In a Declaration dated December 22, 2017, a Diversion Investigator 
(hereinafter, DI) assigned to the Los Angeles Field Division declared 
under penalty of perjury that, in the presence of a DEA Special Agent 
and a DEA Task Force Officer, she personally served OSC 2 on Registrant 
at his registered address on August 3, 2016. GX 31, at 7 (Second Sworn 
DI Declaration, dated Dec. 22, 2017). According to the DI, Registrant 
acknowledged receipt of OSC 2 by signing a DEA-12, Receipt for Cash or 
Other Items, on August 3, 2016. GX 27 (DEA-12 signed by Registrant).
    Based on the DI's Declaration, the Government's written 
representations, and my review of the record, I find that the 
Government accomplished service of OSC 2 on Registrant on August 3, 
2016.
    On October 18, 2016, the Office of Administrative Law Judges 
(hereinafter, OALJ) received ``what appeared to be a hearing request 
and a request for an extension of time to respond to the OSC.'' RFAA, 
at 2; see also GX 29 (Registrant's Request for Reasonable Time 
Extension). The request was signed by Registrant, referenced an 
attorney, and requested additional time ``due to recent medical 
problems, deterioration of his health and due to the time consuming, 
expensive, medical care required on his behalf.'' GX 29, at 1 
(capitalization omitted). The request described multiple medical 
complaints and stated, ``This long list of simultaneous, major medical 
problems have converged upon and legitimately burdened [Registrant], 
who has struggled with the symptoms, signs and consequences of all of 
these.'' Id. at 1.
    The matter was assigned to the Chief Administrative Law Judge 
(hereinafter, ALJ), who denied Registrant's request for an extension of 
time, found that Registrant waived his opportunity for a hearing, and 
terminated the proceeding. GX 30 (Order Denying the Registrant's 
Request for Additional Time to Respond to the Order to Show Cause/
Immediate Suspension of Registration and Terminating Proceedings, dated 
October 28, 2016), at 4. The Chief ALJ found that the Registrant's 
letter ``arrived 76 days after service--46 days after the deadline to 
respond to the OSC/ISO.'' Id. at 1. The Chief ALJ cited 21 CFR 
1301.43(d), which states in relevant part that a registrant who fails 
to request a timely hearing, ``shall be deemed to have waived the 
opportunity for a hearing or to participate in the hearing, unless such 
person shows good cause for such failure.'' See GX 30, at 2.
    I concur with the Chief ALJ that, in this case, ``[i]t is not 
necessary to accept the Government's broad and uncompromising 
suggestion that preoccupation with other matters cannot constitute good 
cause for an untimely filing, under any circumstances, to decide the 
[Registrant's] Enlargement Motion.'' Id. at 3.
    I further agree with the Chief ALJ's reasoning in denying 
Registrant's request for an extension of time:

    Even accepting, arguendo, that . . . [Registrant's] medical 
conditions are serious and impactful, as described, they do not 
present a scenario where the [Registrant] was precluded from 
answering for 76 days. While certainly true that responding and 
seeking out counsel would have required some commitment of time, 
sending a response to the OCS/ISO was hardly rendered `impossible,' 
by his ailments as he described them and by his other distractions. 
The [Registrant] does not allege that he was hospitalized or 
otherwise unable (physically or mentally) to prepare and submit a 
response or seek out representation.

Id.
    I therefore find that, because Registrant did not provide good 
cause for his failure to meet the deadline for requesting a hearing, he 
waived his right to a hearing.
    On January 2, 2018, the Government forwarded its Request for Final 
Agency Action (RFAA), along with the evidentiary record in this matter, 
to my office. The Government argued that Registrant offered no evidence 
that he accepted responsibility for [his] actions and would not engage 
in future misconduct, and his COR should be revoked, because it is 
contrary to the public interest. RFAA, at 21. I issue this Decision and 
Order after considering the entire record before me. 21 CFR 1301.43(e).

Question of Mootness

    On January 7, 2019, I issued an Order taking notice of the Agency's 
registration records, which showed that on December 31, 2018, 
Registrant's COR was due to expire, and requested that the parties 
address whether the case was moot. January Order, at 1.
    On January 15, 2019, the Government timely responded to my Order 
with a two-page filing arguing that ``[w]here, as here, the DEA 
registrations that are the subject of a pending litigation expire or 
otherwise terminate prior to the issuance of a final order, DEA 
precedent (with one recent exception) makes clear that the matter 
should be dismissed as moot, at least absent collateral consequences 
not present here.'' Government's Response to Order and Suggestion of 
Mootness (hereinafter, GR), at 1 (citations omitted). The Government 
requested, ``consistent with the significant majority of agency 
precedent on point'' that this case be dismissed as moot 
``notwithstanding'' a DEA decision to the contrary. Id. at 2. Beyond 
citation of the cases, the Government did not elaborate on, or offer 
the legal analysis behind, its assertions regarding ``controlling 
agency precedent'' and the ``significant majority of agency precedent 
on point.'' Id. at 1, 2.
    Registrant did not submit a filing or otherwise respond to my 
Order.\1\
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    \1\ As a courtesy, my office gave Registrant an opportunity to 
respond to my Order. Although my office mailed the Order to the most 
recent address he provided in these proceedings, the address on 
Registrant's Request, the certified envelope was returned 
``unclaimed.'' When my office re-mailed the Order by first-class 
mail, it was not returned as undeliverable. Thus, it appears that 
Registrant received a copy of my Order.
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    My analysis of the constitutional origins of administrative 
agencies and of federal and Agency decisions addressing mootness sets 
me on a

[[Page 68476]]

different course from many, but not all, previous Agency decisions in 
which the registrant allowed the registration at issue in an Immediate 
Suspension Order and/or in an Order to Show Cause (hereinafter, ISO/
OSC) to expire before final adjudication of that ISO/OSC.\2\ As an 
initial matter, therefore, I note that Agency decisions from 1977 to 
the present do not exhibit uniformity regarding mootness or the 
ramifications of a registration's expiration before issuance of a final 
decision. Instead, almost since the Agency's inception, my predecessors 
have grappled with this matter.\3\
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    \2\ In F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502 
(2009), the Supreme Court acknowledged that administrative agency 
adjudications change course and addressed how an agency may do so 
and continue to pass muster on appellate review under the 
Administrative Procedure Act (hereinafter, APA). First, the Supreme 
Court pointed out that the APA does not mention a heightened 
standard of review for agency adjudication course adjustments. Id. 
at 514. Instead, it stated that the narrow and deferential standard 
of review of agency adjudications set out in 5 U.S.C. 706 continues 
to apply. Id. at 513-14 (concluding that ``our opinion in State Farm 
neither held nor implied that every agency action representing a 
policy change must be justified by reasons more substantial than 
those required to adopt a policy in the first instance.'').
     Second, according to the Supreme Court, an agency would 
``ordinarily display awareness that it is changing position'' and it 
may not ``depart from a prior policy sub silentio or simply 
disregard rules that are still on the books.'' Id. at 515. Further, 
an agency must ``show that there are good reasons for the new 
policy'' but need not ``demonstrate to a court's satisfaction that 
the reasons for the new policy are better than the reasons for the 
old one; it suffices that the new policy is permissible under the 
statute, that there are good reasons for it, and that the agency 
believes it to be better.'' Id. (emphases in original). Finally, the 
Supreme Court had warned in an earlier decision that an ``irrational 
departure'' from agency policy, ``as opposed to an avowed alteration 
of it,'' could be overturned as arbitrary and capricious, or an 
abuse of discretion. I.N.S. v. Yueh-Shaio Yang, 519 U.S. 26, 32 
(1996).
     Given the lack of uniformity over time in the body of Agency 
decisions concerning adjudications when the registration at issue is 
allowed to expire before issuance of a final decision, my current 
mootness-related analysis may not be the ``agency change'' the 
Supreme Court contemplated in Fox Television. Nevertheless, I am 
following the parameters the Court announced to support my CSA-
related responsibilities and out of respect for, and to facilitate, 
any appellate review.
    \3\ Mootness, as described in federal case law, differs from the 
mootness that results from action such as an appellate court's 
reversal of the criminal convictions on which an OSC charge under 21 
U.S.C. 824(a)(2) is based. See, e.g., William Russell Greenfield, 
Jr., M.D., 42 FR 34386, 34386 (1977) (finding no lawful basis for 
revocation after the underlying criminal convictions were 
overturned). I agree with the mootness finding in William Russell 
Greenfield, Jr., M.D., because the criminal convictions, which were 
the factual premise and essential bases of the OSC, were overturned.
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    Park and King Pharmacy, 52 FR 13136 (1987), involved an OSC 
alleging that the registrant dispensed controlled substances other than 
pursuant to the lawful order of a practitioner, and that the president 
and registered pharmacist of registrant pled nolo contendere to the 
felony possession of a controlled substance with intent to deliver or 
sell. 52 FR at 13136. Park and King Pharmacy is among the earliest 
decisions addressing the expiration of a registration before issuance 
of a final decision. In it, my predecessor rejected the suggestion that 
the matter was moot, adjudicated the matter, and revoked the 
registration. Id. at 13,137. According to the decision, both DEA and 
its predecessor agency, since implementation of the Controlled 
Substances Act (hereinafter, CSA), ``maintain[ed] registrations on a 
day-to-day basis pending resolution of administrative proceedings 
seeking to revoke such registrations.'' Id. Also according to the 
decision, this ``administrative `hold''' prevented both the 
registration from expiring and Respondent from renewing the 
registration. Id. at 13,138. Based on this understanding, my 
predecessor concluded that, ``[N]either the nominal expiration date on 
the face of Respondent's registration nor . . . [Respondent's] 
inability to file a renewal application have any effect upon the matter 
pending before the Administrator.'' \4\ Id.
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    \4\ The decision notes four points that DEA counsel made in 
support of adjudication to a final decision and revocation. First, 
DEA counsel argued that, had respondent been a medical practitioner, 
``there is no question but that the DEA would not permit him to 
surrender his registration . . . during the 23rd hour of a 
proceeding.'' 52 FR at 13137. Second, Respondent's ability to 
``direct the destiny of his registration'' terminated with the 
issuance of the OSC. Id. Third, permitting an individual or entity 
under an OSC to ``duck the issue'' at the ``last minute'' would 
enable him/it to ``put the agency to the expense of a hearing, with 
a commitment of public resources which is not insubstantial.'' Id. 
The individual/entity could thereby ``avoid any or all of the 
collateral sanctions which accompany the revocation of a 
registration[,] . . . reopen at a later time or in a different 
location, submitting a new application for registration and 
truthfully answering on such application that he had never had a 
registration revoked . . . . This would diminish the chances that 
the application would be noticed for further administrative 
proceedings.'' Id. Fourth, if Respondent's ``last minute 
withdrawal'' meant that no final order would issue, ``another full 
hearing on the new application might be required . . . prevent[ing] 
the administrative processes of DEA from operating effectively.'' 
Id.
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    Park and King Pharmacy was reconsidered in late 1998. In Ronald J. 
Riegel, D.V.M., 63 FR 67132 (1998), the then-Acting Deputy 
Administrator stated that he was ``troubled'' by Park and King 
Pharmacy, because ``no authority was cited . . . for the position that 
an expired registration can still be revoked if no renewal application 
has been filed.'' \5\ Id. at 67,133. He agreed with DEA counsel who 
argued that ``there is no viable registration to revoke.'' Id. The 
then-Acting Deputy Administrator determined, however, that ``it would 
be unfair to now terminate the proceedings without resolution . . . 
`mid-case, without notice [to Respondent] and opportunity to comply 
with the changed procedure.' '' Id. He revoked the veterinarian's 
registration after stating that he was ``deeply troubled by 
Respondent's conduct.'' Id. at 67,134. Agency decisions from then until 
the end of 2006 concerning similar facts cited mootness and dismissed 
the OSCs when the registration at issue had been allowed to expire 
during OSC proceedings.\6\
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    \5\ In Ronald J. Riegel, D.V.M., the OSC was based on 21 U.S.C. 
824(a)(2) (controlled substance-related felony conviction) and 
(a)(4) (contrary to the public interest). The veterinarian's 
registration expired about three months after the OSC was issued and 
the doctor did not submit a renewal application. 63 FR at 67132.
    \6\ Daniel Koller, D.V.M., 71 FR 66975, 66981 (2006) (concluding 
that the revocation portion of the OSC was moot because the 
registration expired and ``Respondent did not file a renewal 
application, let alone a timely one, for this registration''); 
William Franklin Prior, Jr., M.D., 64 FR 15806, 15807 (1999) (citing 
mootness to terminate proceedings initiated pursuant to 21 U.S.C. 
823(f), 824(a)(1) (materially falsified application), and 824(a)(4) 
(against the public interest) because Respondent's criminal plea 
agreement required him to surrender his registration and withdraw 
his pending application).
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    At the end of 2006, the then-Deputy Administrator (later, 
Administrator) repudiated Ronald J. Riegel, D.V.M. and suggested 
multiple reasons, legal and practical, for not finding mootness. 
William R. Lockridge, M.D., 71 FR 77,791 (2006). In that case, the ISO/
OSC charged respondent with issuing prescriptions for persons he never 
physically examined and, thus, without a legitimate medical purpose. 
Many of the reasons cited in William R. Lockridge, M.D. had been 
discussed in Park and King Pharmacy as arguments raised by DEA counsel.
    First, William R. Lockridge, M.D. stated that Article III's ``case 
or controversy'' limitation does not apply to federal administrative 
agency adjudications.

    Having carefully considered . . . [Ronald J. Riegel, D.V.M.], as 
well as authorities discussing the mootness doctrine in both the 
judicial and administrative settings, I conclude that Riegel is not 
controlling. ``[A]n administrative agency is not bound by the 
constitutional requirement of a ``case or controversy'' that limits 
the authority of [A]rticle III courts to rule on moot issues.' ''

Id. at 77796.
    Second, William R. Lockridge, M.D. stated that its repudiation of 
mootness ``finds ample support'' in ``long settled principles . . . 
applied by the courts.'' Id. at 77797. Citing the Supreme Court, 
William R. Lockridge, M.D. stated, ``[A]

[[Page 68477]]

defendant's voluntary cessation of a challenged practice does not 
deprive a federal court of its power to determine the legality of the 
practice' because `if it did, the courts would be compelled to leave 
``[t]he defendant . . . free to return to his old ways.'' ' '' Id. 
(citing Friends of the Earth, Inc. v. Laidlaw Env. Servs., Inc., 528 
U.S. 167, 189 (2000)). William R. Lockridge, M.D. pointed out that the 
standard for determining whether a defendant's voluntary conduct moots 
a case is stringent--``if subsequent events made it absolutely clear 
that the allegedly wrongful behavior could not reasonably be expected 
to recur.'' 71 FR at 77797 (citing Friends of the Earth, 528 U.S. at 
189). Because Respondent had not submitted any ``evidence (such as a 
declaration) establishing that he intends to permanently cease the 
practice of medicine, . . . Respondent can apply for a new registration 
at any time and could re-engage in the practice at issue here.'' 71 FR 
at 77797 (citing 21 CFR 1301.52(a)). William R. Lockridge, M.D. 
concluded that ``[i]t is thus not ```absolutely clear that 
[Respondent's] allegedly wrongful behavior could not reasonably be 
expected to recur.'' ' '' 71 FR at 77797 (citing Friends of the Earth, 
528 U.S. at 189).
    Third, William R. Lockridge, M.D. determined that the collateral 
consequences of an OSC militate against finding mootness. Citing 
``several courts . . . in cases involving sanctions against licensed 
professionals such as attorneys,'' William R. Lockridge, M.D. found 
that ``even a temporary suspension followed by a reinstatement does not 
moot a challenge to the initial suspension because the action `is 
harmful to a [professional's] reputation' '' and this possibility is 
sufficient to preclude a finding of mootness. 71 FR at 77,797 (citing 
In re Surrick, 338 F.3d 224, 230 (3d Cir. 2003)). Likewise, according 
to William R. Lockridge, M.D., the issuance of an ISO along with an OSC 
is an ``extraordinary step to protect public health and safety'' that 
has potentially harmed Respondent's reputation. 71 FR at 77 797. 
Finally, William R. Lockridge, M.D. noted that an additional collateral 
consequence to an ISO is being required to report the ISO when renewing 
a state medical license and when applying for a DEA registration. Id.
    Fourth, William R. Lockridge, M.D. further noted that both parties 
had ``expended substantial resources in litigating this case,'' and 
that the ALJ ``committed an extensive amount of time to preparing her 
decision.'' Id. As such, it reasoned, ``[t]o dismiss this proceeding 
without making the findings which the evidence in this case compels 
would prejudice the public interest.'' Id. Thus, William R. Lockridge, 
M.D. concluded, ``Respondent's failure to submit a renewal application 
does not preclude the entry of a final order in this matter.'' \7\ Id. 
Agency decisions into the middle of 2007 cited William R. Lockridge, 
M.D.\8\
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    \7\ William R. Lockridge, M.D. affirmed the ISO and cancelled 
Respondent's DEA number. It did not dismiss the OSC.
    \8\ See Trinity Health Care Corp., D/B/A Oviedo Discount 
Pharmacy, 72 FR 30849, n.14 (2007) (concluding that the case is not 
moot, declining to adopt the ALJ's recommendation to revoke the 
registration, affirming the ISO, and stating that ``there is neither 
an existing registration to revoke nor a pending application to 
deny''); Rose Mary Jacinta Lewis, M.D., 72 FR 4035, 4042 (2007) 
(affirming the ISO, cancelling the registration number, but not 
dismissing the OSC).
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    Starting in the middle of 2007, adjudications during which 
registrations were allowed to expire before the issuance of a final 
decision were resolved in particularly fact-specific ways. Ronald J. 
Riegel, D.V.M. and its progeny, despite the more recent and substantive 
William R. Lockridge, M.D. decision, controlled adjudications and were 
cited to moot proceedings.\9\ Further, the Administrator initiated 
dismissals due to mootness after taking official notice of the status 
of the registration at issue in DEA's database.\10\ Meanwhile, William 
R. Lockridge, M.D. was explicitly limited to ISOs, but not uniformly 
applied to them.\11\ Indeed, over time, the analysis actually applied 
to ISO cases that cited William R. Lockridge, M.D. was reduced to 
invoking William R. Lockridge, M.D. and describing it as a ``limited 
exception to the mootness rule'' due to the ``collateral consequences'' 
associated with an ISO.\12\ The full scope of the ``collateral 
consequences'' addressed in William R. Lockridge, M.D., in turn, 
focused on the forfeiture ramifications,

[[Page 68478]]

if any, of seized controlled substances.\13\ Thus, the reach of William 
R. Lockridge, M.D. was virtually narrowed to ISOs, and only ISOs for 
which the status of seized controlled substances had not been 
sufficiently resolved. In sum, the decisions in this period continued 
to exhibit a lack of uniformity.
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    \9\ See Amy S. Benjamin, N.P., 77 FR 72408, 72409 (2012) (citing 
Ronald J. Riegel, D.V.M. and dismissing the OSC as moot); Louisiana 
All Snax, Inc., 76 FR 20034 (2011) (dismissing as moot an OSC 
alleging lack of state authority after the ALJ anticipated mootness 
based on the registration's expiration date and the 25-day mandated 
period for the filing of exceptions); Thomas E. Mitchell, M.D., 76 
FR 20032 (2011) (dismissing as moot an OSC alleging lack of state 
authority and specifically noting that Respondent must again be 
authorized to dispense controlled substances under the laws of the 
state in which he practices before he would be entitled to a 
registration); John G. Costino, D.O., 76 FR 4940 (2011) (dismissing 
as moot an OSC alleging lack of state authority); Kermit B. Gosnell, 
M.D., 76 FR 4938, 4938-39 (2011) (rejecting the ALJ's recommended 
decision, concluding the case is moot, and dismissing the OSC); 
Sylvester A. Nathan, 74 FR 17516 (2009) (dismissing as moot an OSC 
alleging lack of state authority); William W. Nucklos, M.D., 73 FR 
34330 (2008) (dismissing as moot the OSC based on ten felony 
convictions, and noting that dismissal on mootness grounds does not 
have collateral estoppel effect if Respondent were to apply for a 
registration in the future); Benjamin Levine, M.D., 73 FR 34329 
(2008) (dismissing as moot the OSC based on material falsification, 
loss of state authority, and acts inconsistent with the public 
interest, and noting that dismissal on mootness grounds does not 
have collateral estoppel effect if Respondent were to apply for a 
registration in the future); David L. Wood, M.D., 72 FR 54936 (2007) 
(dismissing as moot the OSC after citing Ronald J. Riegel, D.V.M. 
and limiting William R. Lockridge, M.D.'s application to ISOs).
    \10\ See Donald Kenneth Shreves, D.V.M., 83 FR 22518, 22518 
(2018) (dismissing as moot ``effective immediately'' an OSC alleging 
lack of state authority after taking official notice of Registrant's 
registration record); Keith F. Ostrosky, D.D.S., 83 FR 12406 (2018) 
(same); Mohammed S. Aljanaby, M.D., 82 FR 34552 (2017) (taking 
official notice of Registrant's registration record in DEA's files 
and dismissing the OSC because Registrant's registration expired 
without a pending renewal application); David M. Lewis, D.M.D., 78 
FR 36591 (2013) (same); Donald Brooks Reece II, M.D., 77 FR 35054, 
35054 (2012) (taking official notice of Respondent's registration 
record in DEA's files and dismissing the OSC after Respondent's 
registration expired while the case was pending with the 
Administrator and after the ALJ recommended revocation because 
``Respondent's continued registration would be fully inconsistent 
with the public interest''); James Edgar Lundeen, Sr., M.D., 77 FR 
29696 (2012) (dismissing the OSC after taking official notice of 
Respondent's registration record in DEA's files, determining that 
Respondent's registration expired, and finding that Respondent did 
not file a renewal application).
    \11\ See Meetinghouse Community Pharmacy, Inc., 74 FR 10073, 
n.10 (2009) (noting that Respondent was still in business and that 
controlled substances were seized, relied on William R. Lockridge, 
M.D. to affirm the ISO and ``make clear'' that the registration 
would have been revoked if it had not expired); Nirmal and Nisha 
Saran, M.D./D.O., 73 FR 78827 (2008) (adjudicating the ISO/OSC as 
the best way to serve principles of judicial economy given 
Respondents' desire to remain registered); Elmer P. Manalo, M.D., 73 
FR 50353 (2008) (citing William R. Lockridge, M.D. as authority, but 
finding the ISO to be moot and dismissing the OSC because Respondent 
stopped participating in the proceeding and had not provided 
evidence of his intent to remain in professional practice or of any 
collateral consequence of the ISO); Paul H. Volkman, 73 FR 30630 
(2008), correction, 73 FR 32629 (2008) (adjudicating the renewal 
application and modification, but not following William R. 
Lockridge, M.D.); RX Direct Pharmacy, Inc., 72 FR 54070 (2007) 
(dismissing the OSC as moot after the state license expired, the 
business closed, and no plan to re-enter the pharmacy business at 
some future date was evident, and stating that controlled substances 
seized pursuant to the ISO may be forfeited in any number of ways); 
CRJ Pharmacy, Inc. and YPM Total Care Pharmacy, Inc., 72 FR 30846 
2007) (not adjudicating the ISO; revoking the registrations for lack 
of state authority).
    \12\ In Robert Charles Ley, D.O., 76 FR 20033 (2011), for 
example, the ISO/OSC charged that Respondent had issued to 
undercover police officers numerous prescriptions for controlled 
substances lacking a legitimate medical purpose. Respondent allowed 
his registration to expire and DEA counsel moved to terminate the 
proceeding on the ground that the case was moot. Respondent's 
response to the termination motion stated that the summary 
suspension of his registration was ``improper and unjustified'' and 
that he did not object to the termination of the proceeding. The 
then-Administrator dismissed the ISO/OSC based on Ronald J. Riegel, 
D.V.M. while citing William R. Lockridge, M.D. as a ``limited 
exception to the mootness rule.'' 76 FR at 20033.
    \13\ See Martin L. Korn, M.D., 79 FR 66406 (2014) (elaborating 
on, and agreeing with, Quigley that it is appropriate to dismiss an 
ISO/OSC when the Registrant does not respond and when he allows his 
registration to expire, acknowledging some of the collateral 
consequences originally identified in William R. Lockridge, M.D., 
and explicitly noting that there is no issue to resolve concerning 
seized controlled substances); Richard C. Quigley, D.O., 79 FR 50945 
(2014) (dismissing the ISO/OSC as moot because Registrant did not 
answer the ISO/OSC, noting that no controlled substances had been 
seized, and finding that Registrant's fleeing the country meant he 
did not intend to remain in professional practice, thus mitigating 
the concerns implicit in William R. Lockridge, M.D.'s original 
collateral consequences); Tin T. Win, M.D., 78 FR 52802 (2013) 
(dismissing the ISO/OSC after the Registrant allowed her 
registration to expire and finding no collateral consequence because 
no controlled substances had been seized pursuant to the ISO); but 
see Patricia A. Newton, M.D., 82 FR 26516, 26516 (2017) (dismissing 
the OSC after finding that there was ``no showing of any collateral 
consequence which precludes a finding of mootness'').
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    In 2012 and thereafter, decisions ``affirm'' ISOs based on an 
analysis of the merits while indicating that there is no registration 
to revoke because the registration at issue had been allowed to 
expire.\14\ Ronald J. Riegel, D.V.M., 63 FR at 67,133. In 2015, an ALJ 
cited a regulatory provision, 21 CFR 1301.36(h), as a legal basis for 
not dismissing ISOs.\15\ Odette L. Campbell, M.D., 80 FR 41,062 
(2015).\16\ Citing this regulation, William R. Lockridge, M.D., and 
Meetinghouse Community Pharmacy, Inc., the ALJ concluded that 
``application of the mootness doctrine . . . is unwarranted and would 
deny both Parties an opportunity to resolve the evidentiary issues, as 
well as prejudice the public interest. Additionally, there is no 
indication that Respondent intends to suspend her medical practice or 
not seek restoration of her registration.'' Id. at 41,068.
---------------------------------------------------------------------------

    \14\ See ChipRX, L.L.C., d/b/a City Center Pharmacy, 82 FR 51433 
(2017) (``affirming'' the ISO after stating that there is neither a 
registration to revoke nor an application to act upon, addressing 
the merits, and ordering the forfeiture of all seized controlled 
substances); S&S Pharmacy, Inc., d/b/a Platinum Pharmacy & 
Compounding, 78 FR 57656 (2013) (``affirming'' the ISO after 
addressing the merits, noting the existence of a federal court order 
that the registration be forfeited, stating that there is neither a 
registration to revoke nor an application to act upon, and ordering 
forfeiture of all seized controlled substances); Darryl J. Mohr, 
M.D., 77 FR 34998, 34999 (2012) (``affirming'' the ISO when 
Respondent allowed his registration to expire after the ALJ issued 
his recommendation that it be revoked, and finding the allegations 
``off the table'' despite Respondent's and DEA counsel's arguments 
against mootness).
    \15\ ``Any suspension shall continue in effect until the 
conclusion of all proceedings upon the revocation or suspension, 
including any judicial review thereof, unless sooner withdrawn by 
the Administrator or dissolved by a court of competent 
jurisdiction.''
    \16\ There is no indication that the Administrator adopted any 
part of the ALJ's recommended decision even though it is attached in 
its entirety.
---------------------------------------------------------------------------

    Less than a week after publication of Odette L. Campbell, the then-
Administrator again ``affirmed'' an ISO and ordered the immediate 
forfeiture of all seized controlled substances.\17\ The practices of 
dismissing OSCs when the registration at issue was allowed to expire, 
and ``affirming'' ISOs when controlled substances had been seized and 
required a final disposition, continued.\18\
---------------------------------------------------------------------------

    \17\ Syed Jawed Akhtar-Zaidi, M.D., 80 FR 42,962 (2015).
    \18\ Perry County Food & Drug, 80 FR 70084 (2015) (affirming the 
ISO after taking official notice of a late-filed renewal application 
and vesting all right to forfeited controlled substances in the 
United States); Victor B. Williams, M.D., 80 FR 50029 (2015) 
(dismissing the OSC as moot); AIM Pharmacy & Surgical S. Corp., 80 
FR 46326 (2015) (dismissing the OSC as moot).
---------------------------------------------------------------------------

    While I may find a proceeding moot in appropriate situations, the 
Government has cited no legal authority requiring me to do so when a 
registrant/respondent has allowed the registration at issue in an ISO/
OSC to expire before issuance of a final decision. It is imperative to 
handle such expired registrations in a manner that is consistent with 
the Constitution, applicable legal authority, and sound law enforcement 
policy.
    The U.S. Constitution does not mandate that I find mootness when a 
registrant/respondent allows the registration subject to an ISO/OSC to 
expire before issuance of my final decision. According to the case law, 
mootness is a product of Article III of the Constitution and the 
judicially-created prudential rules for federal courts. As the D.C. 
Circuit stated concerning Article III courts and mootness, the history 
of federal courts' refusal to hear moot cases traces back to the common 
law notion that courts lack power to decide abstract questions when no 
dispute exists. Tennessee Gas Pipeline v. Federal Power Comm'n, 606 
F.2d 1373, 1379 (D.C. Cir. 1979). More recently, also according to the 
D.C. Circuit, this ``prudential rule has been raised to constitutional 
proportion, based specifically on the case or controversy requirement 
of Article III.'' Id.
    The D.C. Circuit cited the need for a ``present, live controversy'' 
to ensure avoidance of ``advisory opinions on abstract propositions of 
law.'' Id. It noted that the ``case or controversy requirement 
preserves the separation of powers by `assur(ing) that the federal 
courts will not intrude into areas committed to the other branches of 
government.''' Id. Finally, it noted that the mootness doctrine's 
purpose also includes ``limit[ing] the business of federal courts to 
questions presented in an adversary context and in a form historically 
viewed as capable of resolution through the judicial process.'' Id.
    Administrative agencies, such as DEA, however, do not exist by 
virtue of Article III. According to the D.C. Circuit, the different 
constitutional origins of Article III courts and administrative 
agencies mean that mootness does not play the same role in 
administrative agency adjudications as it plays in Article III court 
proceedings.

    The subject matter of agencies' jurisdiction naturally is not 
confined to cases or controversies inasmuch as agencies are 
creatures of [A]rticle I. Though agencies must act without 
arbitrariness, . . . still agencies are generally free to act in 
advisory or legislative capacities. While this is obvious in the 
case of rulemaking, it is also true where an agency proceeds via 
traditional adjudicatory forms of decision. Thus the Commission 
correctly observes that an agency may, if authorized by statute, 
issue an advisory opinion or abstract declaration without regard to 
the existence of an actual controversy. The . . . [APA] expressly 
permits such practices: The agency, with like effect as in the case 
of other orders, and in its sound discretion, may issue a 
declaratory order to terminate a controversy or remove uncertainty.

Id. at 1380 (citing 5 U.S.C. 554(e)); see also Climax Molybdenum Co. v. 
Sec'y of Labor, Mine Safety and Health Admin., 703 F.2d 447, 451 (10th 
Cir. 1983) (``At the outset, we note that an administrative agency is 
not bound by the constitutional requirement of a `case or controversy' 
that limits the authority of [A]rticle III courts to rule on moot 
issues.'').\19\
---------------------------------------------------------------------------

    \19\ Federal courts' recognition that Article III and judicially 
created gateway prudential rules are not binding on administrative 
agency adjudications not only applies to mootness, but also applies 
to advisory opinions and declaratory orders. Americans for Safe 
Access v. Drug Enf't Admin., 706 F.3d 438, 443 (D.C. Cir. 2013) 
(``An administrative agency, which is not subject to Article III of 
the Constitution . . . and related prudential limitations, may issue 
a declaratory order in mere anticipation of a controversy or simply 
to resolve an uncertainty.'' (citing Pfizer Inc. v. Shalala, 182 
F.3d 975, 980 (D.C. Cir. 1999))); Metropolitan Council of NAACP 
Branches v. FCC, 46 F.3d 1154, 1161 (D.C. Cir. 1995) (``[A]n agency 
may issue a declaratory order to terminate a controversy or remove 
uncertainty.'').
---------------------------------------------------------------------------

    More recently, the Tenth Circuit, citing the D.C. Circuit, 
reaffirmed that administrative agencies are not bound by the 
constitutional requirement of a

[[Page 68479]]

``case or controversy'' that limits the authority of Article III courts 
to rule on moot issues. RT Communications, Inc. v. FCC, 201 F.3d 1264, 
1267 (10th Cir. 2000). Further, according to the Tenth Circuit, an 
agency has ``substantial discretion'' to decide moot issues. Id. In 
exercising this discretion, according to that Court, the agency should 
be guided by two factors: ``(1) whether resolution of the issue is the 
proper role of the agency as an adjudicatory body; and (2) whether 
concerns for judicial economy weigh in favor of present resolution.'' 
Id. (citing Climax Molybdenum Co., 703 F.2d at 451.
    Even as to Article III courts, however, the Supreme Court rejected 
the strict application of mootness in a law enforcement context. In 
United States v. W.T. Grant Co., 345 U.S. 629, 632 (1953), the parties 
agreed that ``voluntary cessation of allegedly illegal conduct does not 
deprive the tribunal of power to hear and determine the case, i.e., 
does not make the case moot.'' 345 U.S. at 632. According to the Court, 
the controversy that may remain to be settled, even after cessation of 
the allegedly illegal conduct, is the ``dispute over . . . [the 
challenged practices'] legality.'' Id. The Court explained that a 
mootness determination could be appropriate, but only if the defendant 
met the ``heavy'' burden of demonstrating that ``there is no reasonable 
expectation that the wrong will be repeated.'' Id. at 633. Otherwise, 
because ``say[ing] that the case has become moot means that the 
defendant is entitled to a dismissal as a matter of right, . . . [t]he 
courts have rightly refused to grant defendants such a powerful weapon 
against public law enforcement.'' Id. at 632. The application of 
mootness, therefore, even by Article III courts, is not always 
appropriate.
    I consider robust law enforcement and public safety to be paramount 
as I enforce the CSA, lead those who serve this Agency's mission every 
day, and guide the registrant community's compliance with the law.\20\ 
As a corollary, it is inconsistent with robust law enforcement and 
public safety to allow a registrant/respondent ``such a powerful weapon 
against public law enforcement'' by allowing the registration at issue 
to expire and thereby bringing about the termination of ISO/OSC 
proceedings without a final decision. Id. Adjudicating OSCs/ISOs to 
finality allows DEA personnel to focus on conducting the most effective 
and efficient law enforcement work possible without the distraction of 
having to maneuver around the possibility of a mootness dismissal 
simply because they detected possible registrant wrongdoing too close 
to the expiration date of the registrant's registration.
---------------------------------------------------------------------------

    \20\ In Gonzales v. Oregon, the Supreme Court addressed the 
scope of the CSA. 546 U.S. 243, 248-49 (2006). The case was filed 
after the U.S. Attorney General issued an Interpretive Rule stating 
that using controlled substances to assist suicide is not a 
legitimate medical purpose and, therefore, unlawful under the CSA. 
Id.
     In ruling for Oregon, the Supreme Court stated that the main 
objectives of the CSA are to combat drug abuse and to control the 
legitimate and illegitimate traffic in controlled substances. Id. at 
250. To accomplish these objectives, the Supreme Court stated, the 
CSA ``creates a comprehensive, closed regulatory regime 
criminalizing the unauthorized manufacture, distribution, 
dispensing, and possession'' of controlled substances. Id. (citing 
Gonzales v. Raich, 545 U.S. 1, 12-13 (2005)). The Court noted that 
part of this regime requires a physician, who wishes to prescribe 
controlled substances, to obtain a registration from the Attorney 
General, a function the Attorney General delegated to the DEA 
Administrator. Oregon, 546 U.S. at 251. The decision whether to 
issue, deny, suspend, or revoke a registration involves an 
evaluation of whether the physician's having, or continuing to have, 
a registration is consistent with the public interest or is 
appropriate under other circumstances that the CSA articulates. Id.; 
see also 21 U.S.C. 823 and 824.
---------------------------------------------------------------------------

    Further, final adjudications are particularly helpful in supporting 
the purposes of the CSA and my responsibilities to enforce the CSA 
because nothing in the CSA prohibits an individual or an entity from 
applying for a registration even when there is a history of being 
denied a registration, or a history of having a registration suspended 
or revoked. As such, having a final, official record of allegations, 
evidence, and the Administrator's decisions regarding those allegations 
and evidence, assists and supports future interactions between the 
Agency and the registrant or applicant. Thus, these records and final 
decisions also support and facilitate my responsibilities under the 
CSA.
    Next, concerning the regulated community as a whole, a final 
adjudication is a public record of the Agency's expectations for 
current and prospective members of that community. Such a record helps 
all current and prospective registrants comply with the CSA and avoid 
ISOs/OSCs. Further, similar to what has already been suggested, a final 
reviewable, or reviewed, decision provides the Agency, the registrant, 
and current and prospective members of the registrant community the 
additional benefit of circuit court correction and imprimatur. Circuit 
court review, and the lapsed possibility of circuit court review, 
enhance the authoritativeness of Agency decisions for all concerned.
    Further, final adjudications inform the Executive Branch, the 
Legislative Branch, and the public about the Agency's work, the CSA's 
provisions, and the Agency's CSA-related law enforcement activities. 
Final adjudications supply information to support those stakeholders' 
duties and responsibilities concerning drug law enforcement. The 
stakeholders may then provide feedback to the Agency based on this 
information, thereby helping shape how the Agency carries out its 
responsibilities.
    Lastly, final adjudications provide continuing education for all 
DEA personnel and help coordinate law enforcement efforts. They support 
efficient communications among law enforcement personnel because they 
contain information critical to how DEA personnel and their law 
enforcement partners are expected to meet law enforcement challenges 
and implement solutions.
    In this matter, both an ISO and an OSC are at issue. Registrant's 
Request makes clear that he has a ``genuine over-riding desire [to] be 
able to practice medicine once again.'' Registrant's Request, at 6. His 
decision to let his registration expire, therefore, does not reflect a 
commitment to leave the medical profession. After being served with OSC 
1 and voluntarily surrendering it, Registrant applied for another 
registration. There is nothing to stop Registrant from doing the same 
in the future. Thus, I shall adjudicate OSC 2 to finality.\21\ I reject 
the Government's suggestion that this proceeding be dismissed as 
moot.\22\
---------------------------------------------------------------------------

    \21\ The input that Registrant provided about his situation in 
Registrant's Request does not control my analysis. Nevertheless, 
inasmuch as it indicates Registrant's desire to practice medicine 
again, it certainly supports my decision to adjudicate OSC 2 to 
finality.
    \22\ At this time, I see no reason why my analysis of the 
constitutional origins of administrative agencies and of federal and 
Agency decisions addressing mootness would set me on a different 
course if, in the matter before me, only an OSC were at issue.
---------------------------------------------------------------------------

    I make the following findings of fact.

Findings of Fact

Registrant's DEA Registrations

    Registrant was previously registered with the DEA as a practitioner 
in schedules II through V under DEA COR BO2524204 at 901 Dover Drive, 
Suite 123, Newport Beach, California, 92660. GX 31 (Sworn DI 
Declaration dated October 21, 2016), at 2.
    This COR was suspended pursuant to an Immediate Suspension Order, 
dated March 15, 2016 (OSC 1). Id. On March 18, 2016, after the 
Government served Registrant with OSC 1, he surrendered that COR. GX 
17.

[[Page 68480]]

    On May 20, 2016, Registrant submitted an application for a new COR. 
GX 18. Registrant answered in the negative to Question Two on the 
application, which reads ``[h]as the applicant ever surrendered (for 
cause) or had a federal [COR] revoked, suspended, restricted or denied, 
or is any such action pending?'' Id. Subsequently, on June 8, 2016, 
Registrant was issued a new COR, FO6043638, as a practitioner in 
schedules II through V at the registered address of 901 Dover Drive, 
Suite 123, Newport Beach, California, 92660. GX 25 (Registrant's COR), 
at 1.\23\
---------------------------------------------------------------------------

    \23\ As noted previously, this COR expired on December 31, 2018. 
See GX 25.
---------------------------------------------------------------------------

    On August 2, 2016, DEA issued OSC 2 concerning COR FO6043638. OSC 
2, at 1. OSC 2 incorporated and attached OSC 1, and therefore, the 
facts included herein are derived from both OSC 1 and 2. See OSC 2, at 
2; see also GX 26, at 7-12 (OSC 1).

The Investigation of Registrant

Undercover S.M.
    On August 27, 2013,\24\ an Irvine, California Police Department law 
enforcement officer acting in an undercover capacity (hereinafter, 
S.M.) visited the Registrant at his office and asked for an 
appointment, but was told that none was available. GX 31, at 2. 
Registrant asked S.M. whether he had ``documentation to validate his 
injury,'' and S.M. responded in the negative. Id. The Registrant then 
told S.M. that ``the fee for an appointment would be $400 if [S.M.] 
required a Schedule II medication.'' Id. On August 29, 2013, S.M. 
returned to the office, where Registrant gave him a short physical 
examination for his ``arm pain and numbness.'' Id. They discussed 
S.M.'s lack of health insurance and lack of medical documentation and 
x-rays or MRIs, and Registrant urged S.M. to get an x-ray, but 
``[e]ventually, [Registrant] agreed to prescribe hydrocodone, stating 
that it `would still be crazy for me to do, but just cause I feel bad 
that you were here and I asked you to come back.''' Id. Registrant 
wrote a prescription for 30-ten milligram tablets of hydrocodone with 
one refill, which S.M. filled the next day, and refilled on September 
10, 2013. Id.
---------------------------------------------------------------------------

    \24\ Although there is no supporting documentation demonstrating 
this encounter or the resulting prescription, nor any basis in the 
declaration for the DI's knowledge of the encounter, I have no 
reason to doubt the veracity of the DI's sworn Declaration, nothing 
in the record contradicts the DI's Declaration, and further, the 
encounter the DI Declaration describes is consistent with the audio 
recording and transcript of the September 24, 2013 encounter in GX 1 
and 2; therefore, I find the events as described by the DI to be 
facts.
---------------------------------------------------------------------------

    On September 24, 2013, S.M. visited Registrant at his office and 
audio recorded the interaction, which the Government provided along 
with a transcription certified by the DI. GX 2 (Transcription of 
Undercover Visit); GX 31, at 2; see also GX 1, at audio Enclosure 14 
olson uc buy walk 9-24-13. S.M. told Registrant that he had ``been 
taking the Roxys,\25\ '' and when Registrant asked him who prescribed 
them, S.M. told him ``I've been taking them but not prescribed.'' GX 2, 
at 2. Registrant then referred S.M. to a radiologist to obtain x-rays, 
and S.M. asked, ``Am I able to get another set of Norcos in the 
meantime until I can get in?'' Id. Registrant responded, ``Uhhhh, yeah, 
yeah, yeah I'll do that.'' Id. However, when S.M. asked Registrant for 
``Roxys,'' in addition to the ``Norcos,'' because the Roxys might show 
up on his drug test for a job interview, Registrant refused stating, 
``[I]t's pretty liberal of me to even prescribe the pain medication 
without any real strong diagnosis,'' and then described the scrutiny 
that he was under for controlled substances prescriptions. Id. at 4-5. 
When writing the prescription for the Norco, Registrant asked, ``[H]ow 
many did I give you last time?'' Id. at 7. S.M. replied, ``I think you 
gave me 30 and a refill.'' Id. S.M. received the prescription from 
Registrant for Norco, which he filled on September 25, 2013, and 
refilled on November 6, 2013. GX 31, at 3; see also GX 3 (prescription 
from Registrant to S.M. for a quantity of 30 ``Norco tabs'' 10 
milligrams with one refill).
---------------------------------------------------------------------------

    \25\ The DI's Declaration asserts that ``Roxys'' refers to 
``Roxycodone, a brand name for the generic Schedule II controlled 
substances, oxycodone.'' GX 31, at 2.
---------------------------------------------------------------------------

    In sum, regarding S.M., I find that Registrant prescribed 
hydrocodone, or Norco, to S.M. on two different occasions with two 
refills, based on a minimal physical exam, without x-rays or pain 
assessments and knowing that S.M. was taking controlled substances that 
had not been prescribed.
Confidential Source K.B.
    On February 13, 2015, a confidential source, K.B., audio/video 
recorded a visit with Registrant, a copy of which the government 
provided along with a transcription certified by the DI. GX 5 
(Transcription of recorded interaction with K.B.); see also GX 1, at 
02-13-uc-video.001 and 002. Registrant stated that he was ``selective 
of taking new patients,'' because ``there's a lot at stake . . . 
particularly for the doctor,'' so he had ``to be really confident in 
who [he] take[s] . . . because [his] future is in their hands as 
well.'' GX 5, at 2. K.B. told Registrant that she had ``previously 
obtained prescriptions for controlled substances from a physician whose 
prescriptions had been declined by her pharmacy.'' GX 31, at 3; GX 5, 
at 3. When K.B. told Registrant that she was on oxycodone and Xanax, he 
said, ``See, it's just, the more patients that I have that are on 
oxycodone, just the more attention I get from the DEA.'' GX 5, at 5. 
K.B. identified the source of pain as being in her neck and shoulder, 
but the medical records she produced were for her lower back. Id. at 6-
7. In response to Registrant's questions about whether the pain was in 
her neck or her back, K.B. stated ``[d]epends'' and ``[i]t's up and 
down.'' Id. at 10. Registrant stated that ``sometimes people will come 
in and they think that the more painful things that they have, the more 
likely it would be that the [doctor] \26\ would continue them on 
medications--that's really not the case.'' \27\ Id. When K.B. repeated 
that her pain was in her shoulder and lower back, Registrant replied, 
``That's my--that's the point--you've got to be careful when you--
doctors just kind of shut you out if you talk about too many spots.'' 
Id. K.B. then said, ``My shoulder more than my back,'' but admitted 
that she did not have an MRI on her shoulder. Id. at 11, 13. Registrant 
asked K.B. to perform some basic movements and describe whether they 
hurt and stated, ``See your range of motion is pretty good.'' Id. at 
11-12. The video recording demonstrated that Registrant remained behind 
his desk for his brief requests to K.B. to demonstrate movement of her 
arms and neck. GX 1, 02-13-uc video.001, at 29:52-30.45. Registrant 
told her that she needed an MRI on her shoulder despite her difficulty 
with insurance, because ``[t]hey hold me to a standard of medical care 
. . . and so--I'm just exposed that way . . . unless people can find 
ways to at least get the minimum.'' GX 5, at 14. Registrant continued 
stating, ``Well . . . that's the thing . . . you have a legitimate 
reason, but according to what you say . . . this MRI is kind of soft 
for . . . being on oxycodone--for long term.'' Id. at 15.

[[Page 68481]]

Registrant asked her if she had taken any other ``meds'' for ``anxiety 
or depression,'' and she responded that she was currently taking 2 
milligrams of Xanax. Id. at 18. Later in the appointment, Registrant 
determined the dosage and quantity of the drugs he prescribed based 
solely on what K.B. requested. GX 5, at 22, 29; see also GX 31, at 3. 
Registrant also advised K.B. to not fill her prescription at a big 
chain pharmacy, because they ``will just give you a big problem.'' GX 
5, at 29. While appearing to fill out her prescriptions, Registrant 
asked K.B. if she had ever been seen by a psychiatrist for [her] 
anxiety; she responded, ``Yeah--I don't think I have.'' Id. at 29-30. 
As a result of this visit, Registrant prescribed K.B. 120 thirty-
milligram tablets of oxycodone and 60 two-milligram tablets of 
alprazolam. GX 31, at 3; see also, GX 4, at 1 (copy of oxycodone and 
alprazolam prescriptions).
---------------------------------------------------------------------------

    \26\ Based on my review of the audio recording, I find that the 
transcription occasionally contains a scrivener's error in using 
``Olsen'' instead of ``doctor.'' See, e.g., GX 1, 2015-02-
13_uc_video.001, at 28.27.
    \27\ Throughout the transcripts, the DI used ellipses to depict 
pauses in the conversation. I have removed these and replaced them 
with dashes to prevent confusion between pauses and omissions of 
words from the quotations.
---------------------------------------------------------------------------

    On March 9, 2015, K.B. returned to Registrant, and during an audio/
video recorded conversation, she requested an increased dosage of 
oxycodone. GX 7, at 2. This visit was audio/video recorded, which the 
Government provided along with a transcription certified by the DI. GX 
7, at 2 (transcript); see also GX 1, 17 UC 3.9.15 Olsen 3-9, 3-9(2). 
Registrant discussed surgery, which K.B. said she would consider after 
she could get insurance. GX 7, at 3. When asked, she told Registrant 
that she normally took 120 oxycodone, presumably, each month, and when 
he asked why she wanted ``to go up,'' she told him that she ``need[ed] 
it.'' Id. at 2. Registrant stated, ``Well, I've been giv[ing] you 120 
so I could give you 180,'' to which K.B. replied, ``Perfect. And then I 
don't know if you do, do you do ADD?'' Id. at 4. They discussed whether 
K.B. had taken Adderall before, and she said that she had, and that she 
wanted to try it because the oxycodone made her tired. Id. Registrant 
replied, ``[I]t's just kinda hard on the body being on an opiate and 
then a stimulant as well,'' but he acquiesced. Id. K.B. reminded 
Registrant when writing the prescription to ``put the Xanax on the one 
too'' and ``any chance you could go up to 90 on that?'' referring to 
the prescriptions he was writing. Id. at 6; see also GX 1, 17 UC 3.9.15 
3-9(2). Registrant told her that he ``sure hate[d] to prescribe a lot 
of Xanax,'' and she replied that she usually took it before bed to calm 
herself down. GX 7, at 6. Registrant told her ``Xanax with oxycodone 
has been red flagged as associated with overdoses.'' Id. Later, 
Registrant was determining how much Adderall to prescribe and he said, 
``Since I'm just starting you, I'll give you--uh--I think there's 10, 
20, and 30. . .'' K.B. replied, ``I was doing 30's once a day.'' Id. at 
10. Although Registrant expressed some concern about the potency, he 
prescribed K.B. thirty 30-milligram tablets of Adderall, one hundred 
and eighty 30-milligram tablets of oxycodone; and sixty 2-milligram 
tablets of alprazolam. GX 6 (copy of Adderall, oxycodone, and 
alprazolam prescriptions dated March 9, 2015).
    In sum, regarding K.B., I find that Registrant repeatedly 
prescribed to K.B. multiple controlled substances, with limited 
physical examination, without assessing her pain or verifying the 
injuries, and in spite of drug seeking behavior.
Confidential Sources K.B. and J.W.
    On April 9, 2015, K.B. returned to see Registrant, along with J.W., 
another confidential source. GX 10, at 1. This visit was audio/video 
recorded, which the Government provided along with a transcription 
certified by the DI. GX 1, at 2015-4-09_uc_video.001 and 002 (video); 
GX 10 (Transcription of recorded interaction with K.B. and J.W.). After 
introductions, Registrant reviewed K.B.'s prescriptions stating, ``[W]e 
have oxycodone, Xanax, and Adderall.'' Id. at 1-3. K.B. asked him, 
``[C]an we go . . . up to 200?'' Id. at 4. Registrant answered, ``No--I 
don't want to go up.'' Id. He told K.B., ``[Y]ou have to set out the 
number you are going to allow yourself to have that day . . . and do it 
that way--otherwise you will always take more.'' Id. K.B. told 
Registrant, ``It just kind of helps me sleep,'' and he responded, 
``Now--I get that, but . . . you're taking the Adderall, so that's 
going to work against that . . . and then you have the alprazolam 
should help you sleep.'' Id. She then asked for something she could 
take ``for sleeping.'' Id. at 5. He responded, ``[S]ee the thing is--
you're on three very big time drugs . . . [n]ow just to throw in 
another one.'' Id. at 6.
    K.B. then told Registrant she was taking the Adderall twice a day, 
and he noted ``I'm only giving you thirty--`[o]ne a day,''' and she 
admitted that she had been running out. Id. at 7. She replied, ``I feel 
like when I was taking two it was good.'' Id. Registrant advised her to 
break the Adderall in half, taking one-half in the morning and half at 
noon, and ``shift [the Xanax] later.'' Id. at 7-8.
    Registrant then asked when she was taking the Xanax and she told 
him ``first thing in the morning.'' Id. at 8. He questioned why, and 
she said it made her ``mellow.'' Id. Finally, he told her, ``I don't 
really want to add another drug . . . to this.'' Id. at 10. K.B. agreed 
to ``just do what we're doing--[k]eep it simple.'' Id.
    Registrant told her that because she was ``a new patient'' she had 
to ``stay in--the directions,'' because it was ``too dangerous'' to 
have ``people run out early--and having you--calling.'' Id. He then 
counseled K.B. that one of the pitfalls of ``medications is--um--you 
kind of start living like you should be in the mood to do everything--
that you do,'' and that ``this kind of a ``regimen[] kind of speaks to 
that--that--you also have to just kind of make yourself do stuff . . . 
[c]onsistently--or you don't--mature really.'' Id.
    Registrant then asked K.B., ``How's your shoulder?'' to which she 
responded, ``Better.'' Id. at 11. He then apologized for ``lecturing'' 
her. Id. at 11.
    At this point, J.W. told Registrant that she went to school with 
K.B., and that K.B. ``has failed to mention too is like--there has been 
a couple times where she has allowed me--cause I deal with anxiety, 
too--as well.'' Id. at 11. Registrant then broke in and said, ``She's 
sharing her medicine.'' Id. J.W. affirmed and told Registrant that the 
Xanax was helping her too and she didn't want K.B. ``to take all the 
heat for it.'' Id. at 11, 12. J.W. also said, ``So she's been sharing 
some of the meds and like I'm an ex dancer as well--so like--I have 
some injuries, so it's not just like--[K.B.] has been burning through 
everything.'' Id. at 12. Registrant replied, ``I guess I should have 
expected that . . . sometimes I'm a little na[iuml]ve.'' Id. J.W. then 
told Registrant she had injuries and asked if Registrant would consider 
``taking [her] on separately . . . since [she was] already here . . . 
.'' Id.
    Registrant stated, ``[I]t is a good way to do it, I have to admit--
is have somebody who I've seen bring in someone else and sort of 
endorse them--but no I just kind of met you.'' Id. K.B. protested that 
they were ``going on three months now,'' and J.W. and K.B. then joked 
about relationships and told him they had brought ``extra money, so we 
can pay you a little bit more--we'll give you $800.'' Id. at 12-13. 
Registrant answered, ``No I don't want--I don't want to get into doing 
that,'' but then asked J.W. if her issues were ``primarily anxiety? Or 
[p]ain?'' Id. at 13. J.W. answered, ``Both,'' and agreed that they were 
similar problems to K.B. Id. J.W. told Registrant the Xanax was ``good 
for [her]'' at night, because she waitressed so she got ``tense'' 
(Registrant's interrupted with the word), and then she discussed her 
ankle pain, which she claimed was caused by a fractured ankle in a 
skydiving accident several years before. Id. at 13-17.

[[Page 68482]]

Registrant asked if she was ``taking medication?'' Id. at 17. J.W. said 
she was taking ``like probably 1 or 2,'' and when Registrant asked if 
she was dependent on it she said, ``No.'' Id. K.B. told him, ``She just 
doesn't want to get it off the street,'' and Registrant warned them 
that ``strong pain medication like oxycodone is a way that you get kind 
of lured in.'' Id. J.W. told Registrant that she could ``have a bottle 
of prescription and not even touch it,'' but since living with K.B., 
she ``would just like dip into hers.'' Id. at 18.
    Registrant told K.B., ``I know you kind of run out--but we found 
it's another reason too,'' and warned ``it's never a good thing when 
early and people are taking more than they should--or they run out.'' 
Id. He then told them he had to focus while writing up the 
prescriptions. Id. at 19. After prompting from K.B., Registrant asked 
J.W. to fill out an initial visit form and one that ``looks like a 
little contract.'' Id.
    Registrant asked K.B., ``I've just been giving you one month at a 
time, right?'' Id. at 23. She affirmed and asked, ``Now if I wanted 
[two] refills or something like that, do I pay you more--or?'' Id. at 
24. Registrant responded, ``This is what I do--I will do two months at 
a time and you just pay me a second $100 for the second month.'' Id. He 
explained that he would give a second prescription ``to save people 
time and hassle coming in to see me,'' but then added that ``it's not 
like I'll do it for free--I still ask that they pay for the $100 
coverage for that month . . . because I still have to do everything 
that goes into covering these scripts--like they will call and verify 
and it's . . . [i]t's a big deal.'' Id. Then he added, ``[A]lthough to 
tell you the truth, that's where I sometimes have problems. People do 
as they should, submit the second prescription when it's time to submit 
it . . . Because pharmacies are on the lookout as well--they don't want 
people getting their medication early.'' Id. at 25.
    Registrant also said, ``[O]nce I get to know you, I'll give a 
person more leeway. I'll even go a third month as long as everything 
has been ok and you know I feel like I can trust you . . . then you 
know I'll just work with you so that you get--you[`re] covered.'' Id. 
at 26.
    Registrant asked J.W., ``[W]hich ankle is it?'' and ``that's by far 
the worst pain?'' Id. at 31. J.W. told him she had a neck injury, too, 
from a back handspring accident, and that she had had an MRI that was 
``probably'' in her files at home. Id. at 31-32. Registrant told her he 
would ``love to see that'' and it would be very helpful to see ``x-rays 
of [her] ankle--just some of the background of [her] injuries.'' Id. at 
32. He added, ``In fact it'd be essential.'' Id. He asked when the 
injuries occurred, and about the symptoms of her neck injury, and if 
she had any other medical problems. Id. at 32-35. When Registrant 
repeated that J.W. had ``been using some of [K.B.]'s oxycodone,'' J.W. 
responded, ``Yeah, oxycodone, her Xanax and I'm taking Adderall for 
studying too.'' Id. at 35.
    Registrant told J.W. he had to ``decide where to start [her] in 
terms of medication . . . you want to take as little as you can get by 
with--first of all--that's just important.'' Id. at 36. He added he was 
going to start her off at 15mg strength oxycodone, because the 30 mg 
was ``the strongest pain pill you can take'' and ``for [him] to just 
start [J.W.] off on that would be bad medicine.'' Id.
    K.B. suggested ``15 and then 60?'' and Registrant stated, ``So I 
give you the 15 and I'll give you like 60 of them, so you can have 
the--you know--one to two as needed . . . and we'll just see how it 
goes with that.'' Id. at 37. While writing J.W.'s prescription, 
Registrant told her he was ``going to put your neck injury here--it's 
just--it's more of a potentially serious injury.'' Id. at 39. J.W. 
replied, ``Ok--whatever you think is best--I trust you--whatever you 
tell me to do.'' Id. He added that he chose ``the 15mg, cause most 
pharmacies will have that--oh, if they have oxycodone, they'll have 
this one.'' Id. He then decided to give her 90 [tablets] to start 
instead of 60, because it ``gives you a little bit more value for your 
money.'' Id.
    K.B. asked if Registrant could mail a prescription for a second 
month (presumably of oxycodone), and they agreed K.B. could pay for the 
prescription at this visit and Registrant would mail the prescription 
to her. Id. at 41.
    Registrant then turned to the Adderall prescription for J.W., and 
she said, ``It helps with school--it really does.'' Id. He told J.W. 
that he would ``give [her] 30 of those and just take \1/2\ to 1 tab.'' 
Id.
    J.W. then left the office to use the bathroom, and after chatting a 
bit, Registrant asked K.B. (presumably referring to J.W.) ``[S]he takes 
the alprazolam, right?'' Id. at 43. K.B. answered, ``Yeah--I'd do like 
60,'' and Registrant replied, ``Yeah--thanks.'' When J.W. returned, he 
told her he was giving her ``the one milligram Xanax--rather than the 
2,'' because he was starting her off. Id. at 43-44. Registrant finished 
writing prescriptions for both women, which he gave to J.W. and told 
her ``just be really careful with the medication--just really respect 
it.'' Id. at 47.
    Registrant issued to J.W. a prescription dated April 9, 2015, for 
90 oxycodone 15mg, listing the diagnosis as ``Dx Cervical Disk.'' GX 8, 
at 1. He also issued her a prescription for 30 Adderall tabs 30mg, 
listing ADHD as the diagnosis, and a third prescription for 60 
alprazolam 1 mg, listing the diagnosis as ``Anxiety/Insomnia'' and 
authorizing 1 refill. GX 8, at 2-3.\28\
---------------------------------------------------------------------------

    \28\ Registrant did not include an address on any of the 
prescriptions to K.B. or J.W., which would constitute a violation of 
21 CFR 1306.05(a), but neither OSC alleged this violation, so I am 
not basing my findings on these violations. See e.g., GX 8, GX 11, 
GX 13.
---------------------------------------------------------------------------

    At the same visit, Registrant issued a prescription to K.B. for 30 
Adderall tabs 30mg with a diagnosis of ``Rotator Cuff/ADHD.'' GX 9, at 
1. He also issued a single prescription, with the diagnosis of 
``Rotator Cuff Tear [L] Shoulder,'' which included 180 oxycodone 30 mg, 
and 60 alprazolam 2mg for ``Severe Anxiety/Insomnia.'' Id. at 2. On the 
same date, April 9, 2015, Registrant issued to K.B. another 
prescription for 30 Adderall 30mg for ``Attention Deficit Dys,'' which 
includes a note ``Release date April 30, 2015.'' GX 11, at 1. 
Registrant wrote another prescription, also dated April 9, 2015, and 
noting ``Release April 30, 2015,'' for 180 oxycodone 30mg for ``severe 
pain,'' 60 alprazolam 2mg ``PRN Anxiety,'' and 60 Naproxen 550 ``PRN 
Inflammation/Pain'' with a diagnosis ``C/S Disk [ ] Rot Cuff Tear [ 
].'' Id. at 2. The Government's evidence also includes a copy of an 
envelope bearing a postmark of April 17, 2015, Registrant's name and 
return office address at 901 Dover Drive, Suite #123, Newport Beach, 
California, and addressed to K.B in Las Vegas, NV 89101. GX 12. 
Although the DI does not state the origin of the envelope, at the 
undercover meeting, K.B. discussed Registrant mailing her second 
prescriptions. See GX 10, at 45.
    On April 28, 2015, J.W. returned to Registrant's office alone. This 
visit was audio/video recorded, which the Government provided along 
with a transcription certified by the DI. GX 14 (Transcription of 
recorded interaction with J.W.); see also GX 1, 24 UC 4.28.15, 
0431.001-003. Registrant greeted her and asked, ``How'd it go with the 
medication the past few weeks?'' GX 14, at 1. J.W. replied that it 
``went well'' but then told him that K.B. had left town, and J.W. 
``gave [K.B.] some of [J.W.'s] because she ran out before she left and 
she didn't know if she'd be able to get the script from [Registrant] . 
. . That's why [J.W.] came in so much earlier for a refill.'' Id. 
Registrant said, ``Right . . . I owed her one.'' Id.

[[Page 68483]]

    She told him she was taking the ``smaller Oxys'' and was taking 
them more often, and asked, ``[I]s there any way just so I won't have 
to take them as frequently?'' Id. at 3. Registrant replied that it was 
``bad form to start with the highest dose'' in the initial 
prescription, but he could ``bump it up now.'' Id. Registrant then 
stated he had given her ``90 last time so I'll give you 90 of the 30 
milligram.'' Id. at 5. J.W. repeated that she had given K.B. ``half of 
them before she left town.'' Id. Registrant said, ``I see,'' but added 
he had already written ``the 90'' and that he ``still owe[d] her,'' but 
that he thought the prescriptions were sent out. Id. He added, ``And um 
you guys can just settle up.'' Id.
    Registrant then inquired, ``[s]o the [o]xycodone and then the 
Adderall and the alprazolam, right?'' to which J.W. agreed. Id. at 6. 
He told her he was giving her 30 tablets of 30-milligram Adderall, 
which ``is the max dose'' and 1 milligram of Xanax. Id. at 7. J.W. said 
she thought [K.B.] got ``the 2's'' and began to ask if Registrant 
``fe[lt] comfortable with, sorry, I hope you don't mind . . .'' Id. 
Registrant interrupted, ``No, it's okay I don't mind. It's just when 
you first write a prescription for somebody it just looks bad to like 
hit them with the highest dosage.'' Id. at 8. Finally, Registrant told 
her she owed ``just 100'' and that the $400 was just the initial fee. 
Id. at 11. He also told her that he didn't ``put a refill on the 
[a]lprazolam,'' because he would need to see her the following month. 
Id. He took a picture of the prescriptions using his cellphone, which 
he said he forwarded to his daughter, ``so she can validate them with 
the pharmacist.'' Id. at 11-12.
    J.W. then asked for a receipt, and if she could ``come back a 
little earlier than the month,'' if she needed to. Id. at 12-13. 
Registrant agreed that J.W. had ``a little bit of [a] situation,'' 
likely referring to the uncertainty of K.B.'s return, and added, ``I'll 
take care of you.'' Id. at 13. Registrant told her, ``100--uh--charge 
we're gonna go with cash so . . .'' Id. at 14. J.W. handed $100 cash to 
Registrant, who then obtained her email address to email her receipt, 
and the visit concluded. Id.
    The Government's evidence included copies of three prescriptions 
issued to J.W. by Registrant on April 28, 2015; one for 90 oxycodone 
30mg for a diagnosis of Cervical Disk w/[],'' another for ``Anxiety'' 
for 60 alprazolam 2mg tab \29\ and the third for ``DX-ADHD'' for 30 
Adderall 30mg. GX 13, at 1-3.
---------------------------------------------------------------------------

    \29\ There is no date on this prescription, but the Government 
did not allege violations of the CSA regulations, so I will not 
include it in my findings of fact.
---------------------------------------------------------------------------

    On January 20, 2016, J.W. returned to Registrant's office to obtain 
refills of her prescriptions. GX 31, at 4; GX 16, at 1-5. This visit 
was audio/video recorded, which the Government provided along with a 
transcription certified by the DI.\30\ GX 16, at 5 (Transcription of 
recorded interaction with J.W.); GX 24 (CD containing audio/video 
recording (Olsen_Buy_Walk_1-20-16.005), transcript and DEA 6--Report of 
Investigation).
---------------------------------------------------------------------------

    \30\ The oath states that the visit occurred on 4/28/15, but the 
DI signed and dated the transcription on January 22, 2016, thus I 
find the date April 28, 2015 to be a scrivener's error.
---------------------------------------------------------------------------

    According to the recording and the transcript, Registrant noted 
that he had not seen J.W. ``in a while,'' and she told Registrant that 
she had been living in Monterey and ``just came back in town again'' 
and she ``usually come[s] back for like 6 months at a time . . . so 
[she]'ll probably see [Registrant] more regularly now.'' GX 16, at 1. 
Registrant said, ``I was giving you before, I guess, oxycodone . . . 
and alprazolam and Adderall,'' and later asked ``do you just make these 
last longer or . . . [d]id you see other doctors?'' Id. J.W. replied, 
``Up in Monterey? Yeah, I don't have any of his stuff on me right 
now.'' Id. at 2. Registrant then told her that the other doctor would 
appear on her CURES (Controlled Substance Utilization Review and 
Evaluation System) report, and explained that report to her. Id. He 
told her to ``be a little careful with that,'' but that ``it's fine,'' 
because ``[she] didn't know probably if [she was] going to come back.'' 
Id.
    Registrant then asked her, ``[S]o . . . exactly what I did before--
oxycodone 30 mg #90 . . . Alprazolam 2mg #60/. . . Adderall 30mg[?]'' 
Id. J.W. asked, ``If you can you give me something that will last me a 
little longer and then I'll come back in February--I mean end of 
February.'' Id. at 3. Registrant told her he could ``give [her] 120 
oxycodone'' and warned ``you just have to be careful.'' Id. According 
to the video, while J.W. and Registrant talked, he remained seated 
behind his desk writing and referring to paperwork. GX 24, at 
Olsen_Buy_Walk_1-20-16.005 at 26--37. He asked, ``Your main pain 
problem--was it your lower back?'' GX 16, at 4. J.W. told him it was an 
``ankle issue and then a neck as well,'' and he responded, ``[o]h, 
cervical is what I put.'' Id. at 4. He then asked ``Does this control 
your pain pretty well?'' and she replied ``[y]eah--it's good for 
sleeping.'' Id. He then told her, ``It's $150,'' which she paid and he 
texted her a receipt. Id. at 4-5; see also GX 24, Olsen_Buy_Walk_1-20-
16.005, at 36:26-37:11.
    The Government's evidence includes copies of three prescriptions 
issued by Registrant to J.W. on January 20, 2016: ``Adderall tabs 30mg 
#30;'' ``Alprazolam tabs 2.0mg 60 1 tab . . . severe anxiety;'' 
``Oxycodone tabs 30mg 120 . . . Severe pain (Max 4/day).'' GX 15, at 1-
3.
    In sum, regarding K.B. and J.W., I find that Registrant issued both 
of them multiple prescriptions for several controlled substances, 
conducted no physical examinations or pain assessments, changed J.W.'s 
primary injury to justify controlled substance prescription, and 
ignored drug seeking behavior for both J.W. and K.B., including that 
K.B. was sharing her medication and that J.W. had been prescribed 
unknown quantities of medication by another doctor.
B.H. Records
    OSC 2 also alleged prescribing below the standard of care for B.H. 
and M.C., whose medical records were seized as a result of the 
execution of a criminal search warrant at Registrant's registered 
address. \31\ GX 31, at 5. From the evidence seized, the DI identified 
B.H., to whom Registrant had issued prescriptions for controlled 
substances, including ``oxymorphone, carisoprodol, oxycodone, 
alprazolam, on at least 29 different occasions. For example, 
[Registrant] issued a prescription for 120-forty milligram tablets of 
oxymorphone, 180-thirty milligram tablets of oxycodone'' and 30 two-
milligram tablets of alprazolam on the same day.\32\ Id. at 6; see also 
GX 20, at

[[Page 68484]]

16, 18, 14. Additionally, Registrant issued a new prescription for 120 
forty-milligram tablets of oxymorphone to B.H. on July 6, 2016, after 
Registrant surrendered his previous COR following the issuance of OSC 1 
and obtained a new COR. Id.; see also GX 20, at 19.
---------------------------------------------------------------------------

    \31\ OSC 2 lists the date of the search warrant as March 16, 
2016, but the rest of the evidence, including the Declaration and 
the Registrant's Voluntary Surrender points to the date as being 
March 18, 2016. See GX 17; GX 31, at 5. I otherwise find the DI 
Declaration credible that the search warrant was conducted and that 
it resulted in the seizure of these records, so I am not including 
the date, but am relying on the submitted evidence.
    \32\ OSC 2 and the DI Declaration also allege that in addition 
to these medications, Registrant prescribed ``two different 
prescriptions for 30 two-milligram tablets of alprazolam.'' GX 31, 
at 6; see also OSC 2, at 2. OSC 2 states that this transaction 
occurred on March 16, 2016; however, the Government's evidence 
includes only one prescription for alprazolam on that date. GX 31, 
at 6; see also OSC 2, at 2; but see GX 20, at 12, 14 (showing one 
prescription for 60 tablets of 2-milligram alprazolam on February 
23, 2016, and one prescription for 30 tablets of 2-milligram 
alprazolam on March 16, 2016). It appears that the mistake may have 
been made using the Dr. Munzing's list of B.H.'s prescriptions, 
where he includes the correct prescription amounts, but mistook the 
date for the first 60 tablet prescription. GX 32, at 10. Dr. Munzing 
makes no further findings related to the double prescription, so I 
am deeming the error to be nonessential to the Government's case. 
Had it been included in the OSC, it appears that B.H. could not have 
possibly exhausted his supply of 60 tablets by taking 2 per day for 
22 days (B.H. could have been diverting them), but I make my 
findings based on the other evidence presented on B.H.
    It does appear from the records submitted that Registrant issued 
two prescriptions on the same day for varying amounts of 40 
milligram oxymorphone tablets with no release date, but neither the 
OSC, nor Dr. Munzing included allegations regarding the double 
prescribing of oxymorphone, so I will not include it in my findings 
of fact. GX 20, at 1&2.
---------------------------------------------------------------------------

    The DI also declared that the search warrant did not reveal any 
record of the ``patient's chief complaint or vital signs,'' or ``of any 
medical history or examination,'' or ``progress notes or treatment 
plan.'' GX 31, at 5. The DI stated that ``[e]lectronic records 
indicated that B.H. was a `new patient' on January 15, 2015, and had 
been referred by another physician who `was working on a plan to get 
[B.H.] off of meds slowly.''' Id. Further, the DI stated that the 
electronic files included a note about a ``dirt bike injury L5 S1'' and 
``previous shoulder surgeries.'' Id. According to the DI, the only 
paper records that were found were prescriptions and a pain agreement. 
Id. GX 22 (seized prescription paper records). The Government's 
evidence includes prescriptions issued to B.H.\33\ for multiple 
controlled substances on six different dates. See GX 20, at 1, 2 
(Prescription for oxycodone, two for oxymorphone, and one for 
carisoprodol issued August 11, 2015); at 3 (oxycodone November 24, 
2015); at 5, 6 (oxymorphone, oxycodone and alprazolam issued December 
22, 2015); at 7, 8 (oxycodone, oxymorphone and alprazolam issued 
January 25, 2016); at 9, 11, 12 (oxycodone and two different 
prescriptions for oxymorphone and alprazolam issued on February 23, 
2016); at 14, 16, 18 (alprazolam, oxycodone, oxymorphone issued March 
16, 2016); at 22 (oxycodone issued on July 6, 2016).
---------------------------------------------------------------------------

    \33\ In the vast majority of the prescriptions to B.H., the 
Registrant did not include an address, which would also constitute a 
violation of 21 CFR 1306.05(a). It also appears that as a result of 
this empty address, B.H. was able to fill prescriptions from 
multiple different pharmacies, using different addresses, 
potentially in an attempt to avoid detection by law enforcement. See 
e.g., GX 20, at 5&6 (demonstrating that B.H. used two different 
addresses and two different pharmacies to fill Registrant's 
prescriptions dated December 22, 2015). Because the regulatory 
violation was not charged in either OSC, I am not including that 
charge in my findings, but OSC 2 does note that B.H.'s utilization 
of multiple pharmacies to fill his prescriptions was a red flag 
indicating drug abuse and/or diversion, so I believe that Registrant 
had adequate notice that the Government was charging him with B.H's 
indications of drug abuse/diversion, one of which is using multiple 
addresses, and so I include that fact herein.
---------------------------------------------------------------------------

    In sum, regarding B.H., I find that Registrant issued multiple 
prescriptions for several controlled substances to B.H., and it appears 
from Registrant's records that Registrant did not conduct physical 
examinations, pain assessments, did not obtain documentation of B.H's 
injuries and ignored red flags for diversion/abuse.
M.C. Records
    OSC 2 also includes allegations related to prescribing below the 
standard of care related to M.C. based on the records obtained from the 
search warrant. OSC 2, at 3. The DI reviewed the prescriptions for M.C. 
and determined that Registrant had issued prescriptions for controlled 
substances, including oxycodone, hydrocodone and alprazolam, on 14 
different occasions from June 2015 to July 2016. GX 31, at 6. ``For 
example, on February 18, 2016, [Registrant] issued prescriptions to 
M.C. for 240 thirty-milligram tablets of oxycodone and 180 ten-
milligram tablets of hydrocodone'' and 90 two-milligram tablets of 
alprazolam.\34\ Id.; see also GX 19, at 20, 18, 15. (M.C. 
prescriptions). Additionally, Registrant issued prescriptions to M.C. 
for hydrocodone and oxycodone on July 1, 2016, after Registrant had 
surrendered his first COR and obtained his new COR. GX 31, at 6; see 
also GX 19, at 22 (prescription). The Government included prescriptions 
for multiple controlled substances issued to M.C. on six different 
dates in its exhibits. See GX 19, at 1 (Prescription for hydrocodone 
and alprazolam issued February 25, 2015); at 2, 4 (oxycodone and 
hydrocodone June 16, 2015); at 6, 8 (oxycodone and hydrocodone issued 
August 26, 2015); 10 (testosterone September 21, 2015); at 11, 13 
(oxycodone and hydrocodone issued December 16, 2015); at 15, 18, 20 
(alprazolam, hydrocodone, and oxycodone issued February 18, 2016); at 
22 (oxycodone and hydrocodone issued July 1, 2016 (after he had 
surrendered his first COR and obtained a new COR)).
---------------------------------------------------------------------------

    \34\ Again, it appears from the evidence that the DI made a 
mistake about the existence of two prescriptions for alprazolam. See 
OSC 2, at 3; see also GX 31, at 6. The evidence demonstrates that 
there was one refill, which might have been the source of the 
confusion. GX 19, at 17. Once again, there is no finding related to 
this, nor is there any indication in Dr. Munzing's declaration, so I 
am not sustaining any allegation on the double prescription and I am 
basing my findings on the other uncontroverted evidence.
---------------------------------------------------------------------------

    The DI declared that the electronic records for M.C. stated that he 
was diagnosed with ``chronic pain syndrome,'' but there were no records 
of the chief complaint, vital signs, medical history, physical 
examination, progress notes or treatment plan. GX 31, at 5. The DI 
included the only three paper records seized related to M.C., which 
consisted of two prescriptions and a note documenting ``chest pain.'' 
Id.; see also GX 21 (three paper records on M.C.).
    In sum, regarding M.C., I find that Registrant issued multiple 
prescriptions for several controlled substances to M.C. and it appears 
from Registrant's records that Registrant did not conduct physical 
examinations, pain assessments, did not obtain documentation of M.C.'s 
injuries and ignored red flags for diversion/abuse.
The Government Expert's Review of Registrant's Prescribing to S.M., 
K.B. and J.W.
    Dr. Munzing, the Government's Expert, is a physician licensed and 
practicing in the State of California, who has more than three decades 
of clinical work and who has served as a Medical Expert Reviewer for 
the Medical Board of California.\35\ GX 32, at 1 (Declaration of Dr. 
Munzing); see also, GX 23 (Dr. Munzing's Curriculum Vitae). I find that 
Dr. Munzing is an expert in standard of care for prescribing controlled 
substances in California and I give his report full credit.
---------------------------------------------------------------------------

    \35\ Currently named California Department of Consumer Affairs, 
Division of Investigation, and Health Quality Investigation Unit 
(``HQIU''). GX 32, at 1.
---------------------------------------------------------------------------

    Dr. Munzing concluded, and I agree, that with regard to the 
controlled substances prescribed to S.M., K.B., and J.W., and M.C. and 
B.H., Registrant's actions ``were both dangerous and reckless and fell 
far below the acceptable standard of care in the State of California.'' 
Id. at 7 (S.M., K.B., and J.W.); see also 10 (related to M.C. and 
B.H.). He relied in part on the standard of care in California, as 
described in the Guidelines for Prescribing Controlled Substances for 
Pain (Medical Board of

[[Page 68485]]

California November 2014\36\)\37\ (hereinafter, ``the Guidelines''). 
Id. He declared that the Guidelines state that ``at a minimum, a 
physician must complete a medical history and physical examination.'' 
Id. (citing Guidelines, at 9). Dr. Munzing attested that the Guidelines 
also set the standard that a physician ``should perform a psychological 
evaluation that includes the risk of addictive disorders''; ``should 
establish a diagnosis and medical necessity based on reviewing past 
medical records, laboratory [studies], and imaging studies''; ``should 
also order new studies if necessary''; should ``employ screening tools 
such as scales that measure pain intensity and interference''; ``should 
also explore non-opioid therapeutic options''; ``should evaluate the 
potential risks and benefits of opioid therapy, remain cognizant of 
aberrant or drug seeking behaviors, and review CURES data to monitor 
such behavior.'' GX 32, at 7 (citing the Guidelines, at 9-10).
---------------------------------------------------------------------------

    \36\ It is noted that these guidelines were published in 
November of 2014 and Registrant saw S.M. in 2013; however, Dr. 
Munzing also based his opinion on the Guide to the Laws Governing 
the Practice of Medicine by Physicians and Surgeon's 2013, which he 
identified as the 7th Edition. GX 32, at 8. Upon review of the 
guide, it does not state a particular date of publication, but the 
portions of the guide on which he relies are statutory and 
preexisted 2013. See https://www.mbc.ca.gov/Download/Documents/laws-guide.pdf. Because the California laws on which Dr. Munzing relied 
for his assessment of the standard of care, were in existence at the 
time of S.M.'s visit to Registrant, I find that the fact that Dr. 
Munzing relied in part on guidelines that were issued after S.M.'s 
visit does not affect his overall assessment that Registrant's 
prescribing to S.M. was below the standard of care in California. I 
have not considered Dr. Munzing's bases that appeared to rely on the 
2014 Guide, but I believe that his underlying finding that the 
prescription was not issued for a legitimate medical purpose and 
that there was no physical examination as required by California law 
demonstrates that Registrant's prescribing to S.M. fell below the 
standard of care in California. See GX 32, at 5.
    \37\ Although the Government's evidence did not include the 
Guidelines, they are publically available at: http://www.mbc.ca.gov/Licensees/Prescribing/Pain_Guidelines.pdf.
---------------------------------------------------------------------------

    Dr. Munzing also based his conclusions on California law, 
specifically California Health and Safety Code Sec.  11153(a),\38\ 
which ``states that a prescription for [a] controlled substance shall 
only be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his or her professional 
practice[ ].'' Id. at 7 (citing Cal. Health & Safety Code Sec.  
11153(a) (West 2019)). He also referenced California Health and Safety 
Code Section 11154(a), which ``states that no person shall knowingly 
prescribe or furnish a controlled substance to any person not under his 
treatment for a pathology or condition.'' Id. (citing Cal. Health & 
Safety Code Sec.  11154(a) (West 2019)). He concluded, and I agree, 
that Registrant ``failed to adequately identify a pathology or 
condition that would justify the prescribing of controlled 
substances.'' Id. Additionally, Dr. Munzing ``considered California 
Business and Profession[s] Code Sec. Sec.  2242 (prescribing without an 
appropriate prior examination and medication indication); 2241 
(prescribing to a person presenting him/herself as an addict); 2234 
(defining `unprofessional conduct' as an act of gross negligence, 
repeated negligent acts, or incompetence); and 725 (repeated acts of 
clearly excessive prescribing).'' Id. at 7.
---------------------------------------------------------------------------

    \38\ In citing the California code sections, Dr. Munzing cited 
to 1153(a) and 1154(a) instead of 11153(a) and 11154(a); however, I 
find that this merely to be a scrivener's error. See G.X. 32, at 7.
---------------------------------------------------------------------------

    Dr. Munzing also based his conclusions on the ``Guide to the Laws 
Governing the Practice of Medicine by Physicians and Surgeons'' 
published by the Medical Board of California, 7th Edition 2013 
(hereinafter, ``the Physician's Guide''), which, in his opinion, 
further sets out the applicable standard of care in California. Id. at 
8. According to him, the Physician's Guide explains that when 
prescribing controlled substances for the treatment of pain, a 
practitioner must perform a sufficient physical examination and take a 
medical history. Id. at 8. (citing Cal. Health & Safety Code Sec. Sec.  
11150, 11154 (West 2019)). ``The practitioner must make an assessment 
of the patients' pain, their physical and psychological function, and 
their history of prior pain treatment.'' Id.

    The practitioner must also make an assessment of any underlying 
or coexisting diseases or conditions and order and perform 
diagnostic testing if necessary. [Citing the Guide at 57]. Finally, 
the practitioner must adequately discuss the risks and benefits of 
the use of controlled substances and any other treatment modalities; 
periodically review the course of pain treatment or gather any new 
information about the etiology of the patient or the patients' state 
of health, and give special attention to patients, who, by their own 
words and actions, pose a risk for medication misuse and/or 
diversion.

    Id. Finally, Dr. Munzing continued, the Physician's Guide mandates 
that a physician should ``keep accurate and complete records which 
document the items listed . . . including the medical history and 
physical examination, other evaluations and consultations, treatment 
plan objectives, informed consent, treatments, medication, rationale 
for changes in the treatment plan or medications, agreements with the 
patient, and periodic reviews of the treatment plan.'' Id. at 8 (citing 
the Physician's Guide, at 59). ``The [Physician's] Guide also states, 
``[p]ain levels, levels of function, and quality of life should be 
documented.'' Id. (citing the Physician's Guide, at 59).
    According to his sworn Declaration, Dr. Munzing reviewed the audio 
recording of S.M.'s undercover visit on September 24, 2013, and a copy 
of the prescription issued at that visit. GX 32, at 1-2. He concluded, 
and I agree, that S.M. presented ``numerous red flags'' for diversion, 
including that on September 24th, he had specifically asked for 
``Roxys'' and ``further indicated he had been taking oxycodone 
illegally and was afraid it would show up in a drug screen.'' Id. at 4-
5. He also found that Registrant failed to take an appropriate current 
medical history, review S.M.'s past medical history, and take S.M.'s 
vital signs. Id. at 5. He also opined, and I agree, that Registrant 
``performed a minimal, substandard physical examination'' during the 
first visit only, that ``he failed to determine the patient's current 
or past alcohol and/or drug use and/or abuse,'' and that ``he failed to 
note the patient's pain level or functional level.'' Id. He also noted 
that no imaging was ordered on the first visit and no prior images were 
provided to Registrant by the patient, and that ``there was no 
indication that [Registrant] ordered any other tests, made any 
referrals, explored any alternatives to controlled substances, or 
checked to see [S.M.'s] prescription history on the state prescription 
monitoring program CURES.'' Id. Finally, Dr. Munzing opined, and I 
agree, that Registrant ``prescribed hydrocodone based on feeling sorry 
for the patient and not for any legitimate medical reason.'' Id.
    Regarding K.B.'s February 13, 2015, and March 9, 2015, 
appointments, Dr. Munzing concluded, and I agree, that K.M. had 
demonstrated numerous indicia of diversion, which were ignored by 
Registrant. Id. According to Dr. Munzing these red flags included that: 
She admitted she had obtained prescriptions that were declined by a 
pharmacy; she complained of neck and shoulder pain, but the MRI she 
presented was of her lower back; and, she requested Adderall, a third 
controlled substance and an increase in oxycodone, without offering any 
legitimate medical reason on her second visit. Id. For both visits, Dr. 
Munzing determined that Registrant took a minimal, but inadequate 
current medical history, as well as past medical history; failed to 
take vital signs; ``performed only a minimal, but

[[Page 68486]]

inadequate, physical examination'' on the first visit (and none on the 
second visit); failed to determine past alcohol and/or drug use and/or 
abuse; and failed to note the pain level or functional level. Id. No 
controlled substance agreement was signed, urine drug tests ordered, 
and there was only ``minimal but inadequate discussion about the risks 
and benefits of controlled substance use.'' Id. Further, Dr. Munzing 
concluded that Registrant had not ``ordered any other tests, made any 
referrals, or checked to see the patient's prescription history on 
CURES.'' The diagnosis of anxiety justifying the prescription for 
alprazolam, ``was not based on any evidence gathered during the 
visit.'' Id. Dr. Munzing concluded, and I agree, that the controlled 
substances prescribed to K.B. on March 9, 2015, ``were not prescribed 
for a medically legitimate purpose.'' Id. at 6.
    Dr. Munzing concluded, and I agree, that on April 9, 2015, J.W. and 
K.B. demonstrated further indicia of diversion. Id. Specifically, K.B. 
requested an increase in oxycodone and admitted that she had abused the 
oxycodone that had been prescribed by increasing her dosage. Id. J.W. 
admitted that ``she had obtained alprazolam and oxycodone from K.B.'' 
Id.; see also, GX 10, at 11-12. K.B. mentioned that J.W. obtained 
controlled substances ``off the street'' and J.W. discussed filling her 
prescriptions at out-of-state pharmacies. GX 32, at 6; see also GX 10, 
at 17. Additionally, Dr. Munzing concluded, and I agree, that on April 
28, 2015, J.W. admitted diverting controlled substances when she stated 
that she was sharing medication with K.B., and exhibited other drug 
seeking activity by requesting a higher dose of oxycodone without 
providing a medical justification, and without providing any 
documentation of her injuries. GX 32, at 6. Dr. Munzing concluded that 
J.W. demonstrated further indicia of abuse or diversion that Registrant 
ignored, including, obtaining controlled substances from multiple 
providers; asking for an increased quantity of oxycodone; and telling 
Registrant that oxycodone was ``good for sleeping.'' Id. For all of the 
visits with J.W., including the joint visit with K.B., Dr. Munzing 
found that Registrant took no current or past medical history, failed 
to take vital signs, ``performed no physical examination,'' failed to 
determine past alcohol and/or drug use and/or abuse, and failed to note 
the patient's pain level or functional level. Id. According to Dr. 
Munzing, no urine drug tests were ordered, and no imaging was provided 
or ordered. Id. Further, Dr. Munzing determined, ``There is no 
indication that [Registrant] ordered any other tests, made any 
referrals, or checked to see the patient's prescription histories on 
CURES.'' Id. at 6-7.
    Dr. Munzing also reviewed the prescriptions and medical records for 
M.C. and B.H. that were included in the Government's evidence and 
reviewed the CURES reports for these individuals. Id. at 8-10. In 
reviewing the medical records for M.C. and B.H., Dr. Munzing opined 
that there was no record of any medical history or examination, pain 
history, progress notes, or treatment plan for either patient. Id. at 
9, 10. He also found that there was no legitimate diagnosis on which to 
base the prescriptions. Id. at 9 (finding that M.C.'s ``chronic pain 
syndrome'' is not a legitimate medical diagnosis); see also id. at 10. 
Furthermore, he identified numerous indicia of abuse and/or diversion, 
such as, B.H. and M.C. utilized multiple pharmacies, received dangerous 
prescription cocktails (both received opioids along with 
benzodiazepines), received high doses of opioid medications. 
Additionally, B.H. drove long distances, and M.C. did not fill 
prescriptions until several weeks after they were written. Id. at 11.
    Dr. Munzing further concluded, and I agree, that Registrant 
``failed to adhere to the above-described California requirements for 
prescribing controlled substances for pain,'' and that ``to the extent 
that [Registrant] attempted to comply with some of the requirements, 
his attempts fell far below the acceptable standard of care.'' Id. at 8 
(related to S.M., K.B., and J.W.). He further concluded that 
Registrant's ``treatment of M.C. and B.H. was both dangerous and 
reckless and fell far below the standard of care for prescribing 
controlled substances in the State of California.'' Id. at 10. He 
concluded, and I agree, in summary, that it was his ``professional 
opinion that the prescriptions issued to S.M., K.B., J.W., M.C. and 
B.H. lacked a legitimate medical purpose and were issued outside the 
usual course of professional practice.'' Id. at 11.

Allegation That Registrant Issued Prescriptions for Controlled 
Substances Outside the Usual Course of the Professional Practice

    Having read and analyzed all of the record evidence, I agree with 
and incorporate the conclusions of Dr. Munzing and find that the record 
contains substantial evidence that Registrant prescribed controlled 
substances outside of the usual course of the professional practice in 
California. See GX 32, at 11. In particular, Dr. Munzing stated that 
the Guide requires that a practitioner prescribing controlled 
substances must perform a ``sufficient physical examination and take a 
medical history.'' GX 32, at 8 (citing The Guide, at 57). With respect 
to S.M. and K.B., Registrant conducted minimal physical evaluations on 
the first visit and no physical evaluation on subsequent visits. See GX 
31, at 2 (brief physical examination for S.M); see also GX 5, at 11-12 
(minimal physical evaluation of K.B.). Moreover, Registrant never 
conducted a physical examination on J.W. See GX 10, 14, 16. The video 
evidence demonstrates that Registrant spent most of the time during the 
appointments sitting behind his desk and writing prescriptions. See GX 
1, GX 24. To the extent that Registrant conducted any physical 
evaluation on patients B.H. and M.C., it was not documented. See GX 21 
and 22; see also GX 31, at 5. Dr. Munzing stated that the ``Guide 
mandates that a physician should keep accurate and complete records.'' 
GX 31, at 5 (citing to the Guide, at 59). Registrant also failed to 
complete any documented medical history, treatment plans other 
evaluations or consultations. See GX 31, at 5. Registrant failed to 
make any progress notes or treatment plans or even assessments of the 
patients' pain. Id. He only maintained records of pain agreements for 
two out of the five individuals. Id. I find that Registrant failed to 
meet the standards for prescribing controlled substances in California 
as to B.H. and M.C.
    Further, I find that Registrant ignored signs of abuse and/or 
diversion. I find that Registrant noticed drug-seeking behavior and 
failed to address that behavior as the applicable standard of care 
requires. Dr. Munzing credibly declared that: The 2014 Guidelines 
require that a physician prescribing controlled substances must 
``remain cognizant of aberrant or drug seeking behaviors''; the 
Physician's Guide mandates that special attention be paid to patients 
who ``pose a risk for medication misuse and/or diversion''; and, with 
limited exceptions, California state law forbids prescribing to an 
addict. GX 32, at 7, 8. S.M. asked for specific controlled substances 
and indicated that he was taking medication without a prescription. GX 
31, at 2; GX 32, at 4. K.B. repeatedly requested increases in dosages, 
new medications, admitted to sharing her medication without a 
prescription and did very little to justify her need for the 
prescription. GX 7, at 4; GX 10, at 4, 17; GX 32, at 5, 6. J.W. 
admitted to

[[Page 68487]]

``dip[ping] into'' her roommate's controlled substances, and getting 
medication ``off the street.'' GX 10, at 17, 18. She asked for 
increased dosages and admitted to seeing another doctor for opioid 
prescriptions. GX 16, at 2, 3. B.H. and M.C. used multiple pharmacies, 
received high doses of dangerous prescription cocktails, and B.H. also 
used multiple addresses, and drove long distances. GX 32, at 11; See 
e.g., GX 20, at 5, 6.
    In sum, based on all of the evidence in the record, I find 
substantial evidence that Registrant prescribed controlled substances 
outside of the usual course of the professional practice in California 
and without a legitimate medical purpose.

Allegations of Violations of State Law

    I also find that there is substantial evidence that Registrant 
violated state law. California law 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) (Westlaw, current with urgency legislation through Ch 706 of 
the 2019 Regular Session). Further, a prescription is unlawful if it is 
issued to ``an addict or habitual user'' outside of a narcotic 
treatment program or professional practice. Id. Additionally, 
practitioners prescribing to addicts are required to comply with the 
regular practice of their profession and a patient receiving controlled 
substances must be under their ``treatment for a pathology or 
condition.'' Id. at 11154(a). With inapplicable exceptions to this 
situation, the state law again makes clear that ``no person shall 
prescribe . . . a controlled substance . . . [for] an addict, or to any 
person representing himself or herself as such.'' Id. at 11156(a). The 
California Business and Professions Code states that ``prescribing . . 
. dangerous drugs . . . without an appropriate prior examination and a 
medical indication constitutes unprofessional conduct.'' Cal. Bus. & 
Prof. Code Sec.  2242(a) (Westlaw, current with urgency legislation 
through Ch 706 of the 2019 Regular Session). 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) (Westlaw, current with urgency legislation through Ch 706 of the 
2019 Regular Session).
    I find that none of the controlled substances prescriptions issued 
to S.M., K.B., J.W. M.C., or B.H. were issued for a legitimate medical 
purpose. GX 32, at 11. Dr. Munzing opined, and I agree, that physical 
exams on S.M., K.B. and J.W. were either not conducted or were ``wholly 
inadequate,'' and that the three presented themselves as ``drug seeking 
individuals and the amounts prescribed to them were both excessive and 
unjustified.'' Id. at 8-10 (no evidence of a physical examination on 
M.C. or B.H.) Registrant ignored obvious signs of addiction to 
controlled substances and prescribed strong doses of controlled 
substances despite those signs. Id. at 11. Registrant's failure to 
document or perform medical exams, and his repeated prescriptions below 
the standard of care constituted unprofessional conduct in California. 
Id. at 7.

Allegation That Registrant Materially Falsified His Application for a 
COR

    The record evidence demonstrates that Registrant's initial COR was 
suspended pursuant to an Order to Show Cause and Immediate Suspension 
Order, dated March 16, 2016, and that he surrendered this COR on March 
18, 2016. GX 26, at 7; GX 17. The record also demonstrates that on May 
20, 2016, Registrant completed an application for a new DEA COR. GX 18. 
Registrant answered in the negative to Question Number Two on the 
application, which reads ``[h]as the applicant ever surrendered (for 
cause) or had a federal controlled substance registration revoked, 
suspended, restricted or denied, or is any such action pending?'' Id. 
at 1. Subsequently, on June 8, 2016, Registrant was issued a new 
registration. GX 25, at 1. When asked by the DI about the false 
statements on his application, Registrant stated that ``he was trying 
to do what he thought was right for his patients.'' GX 31, at 7. I find 
that the substantial evidence on the record shows that Registrant 
materially falsified his application for a COR.

Discussion

Allegation That Registrant's COR Is Inconsistent With the Public 
Interest

    Under Section 304 of the Controlled Substances Act (hereinafter, 
CSA), ``[a] registration . . . to . . . distribute[ ] or 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,'' which is 
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 COR. 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 COR. 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

[[Page 68488]]

Four. I find that the Government's evidence with respect to Factors Two 
and Four satisfies its prima facie burden of showing that Registrant's 
continued registration would be ``inconsistent with the public 
interest.'' 21 U.S.C. 823(f). However, Registrant's request for a 
hearing was untimely. I find that he had not rebutted the Government's 
prima facie showing. I find Registrant's misconduct to be egregious and 
I will order that Registrant's COR be revoked.

Factors Two and/or Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

    Under Factor Two, I evaluate the registrant's ``experience in 
dispensing . . . with respect to controlled substances.'' 21 U.S.C. 
823(f)(2). There is no evidence in the record as to the Registrant's 
positive dispensing experience; however, the Government has clearly 
established the Registrant's significant history of unlawful and 
dangerous dispensing practices through the undercover officer, 
confidential sources and the seized medical records.
    Factor Four is demonstrated by evidence that a registrant has not 
complied with laws related to controlled substances, including 
violations of the CSA, DEA regulations, or other state or local laws 
regulating the dispensing of controlled substances. 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, supra, 546 U.S. at 274.
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a legitimate doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Ralph J. Chambers, 
79 FR 4962 at 4970 (2014) (citing Paul H. Volkman, 73 FR 30629, 30642 
(2008), pet. for rev. denied Volkman v. Drug Enf't Admin., 567 F.3d 
215, 223-24 (6th Cir. 2009)); see also U.S. v. Moore, 423 U.S. 122, 
142-43 (1975) (noting that evidence established that the physician 
exceeded the bounds of professional practice, when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against . . . misuse and 
diversion''). The CSA, however, generally looks to state law to 
determine whether a doctor and patient have established a legitimate 
doctor-patient relationship. Volkman, 73 FR 30642.
Allegations that Registrant Prescribed Below the California Standard of 
Care
    In this case, as found above, Dr. Munzing has credibly opined that 
none of the prescriptions in evidence were issued for a legitimate 
medical purpose under the standard of care in California. GX 32, at 11. 
Registrant conducted little-to-no physical examination during all of 
the visits in violation of California law and below of the California 
standard of care. See Moore, 423 U.S. at 142-43 (noting that evidence 
established that physician ``exceeded the bounds of professional 
practice,'' when, inter alia, ``he gave inadequate physical 
examinations or none at all'' and ignored signs of diversion); see also 
Cal. Bus. & Prof. Code section 2242(a) (requiring a ``prior 
examination'' before prescribing medication, such as controlled 
substances); see also Gabriel Sanchez, M.D., 78 FR 59060, 59063-64 
(2013) (finding that a doctor acted outside the usual course of 
professional practice by not conducting an adequate physical 
examination before prescribing controlled substances).
    Additionally, as already discussed the evidence demonstrates that 
S.M., K.B. and J.W. were not seeking the drugs for a legitimate medical 
condition, but rather for the purpose of abusing or diverting them. See 
e.g., GX 16, at 4 (When Registrant asked if the oxycodone controlled 
her pain, she said ``it's good for sleeping.''); see also GX 7, at 2 
(K.B. wanted to try Adderall because the oxycodone made her tired); see 
also GX 10, at 35 (J.W. asked for Adderall ``for studying''). These 
prescriptions amounted to ``outright drug deals.'' James Clopton, M.D., 
79 FR 2475, 2478 (2014) (holding that a California physician who 
prescribed controlled substances to an undercover with no physical exam 
after the undercover disclosed that he borrowed pills from a friend and 
that the medication's purpose was ``it helps [me] unwind'' to be a 
clear violation of the law amounting to a drug deal). I also find that 
Registrant, by his own repeated admissions, demonstrated that the 
purpose of any constraint he was exercising in his prescribing 
practices was to avoid detection. See e.g., GX 8, at 14 (Registrant 
told J.W. that when first prescribing it looked ``bad to like hit them 
with the highest dosage,'' and then increased the dosage on the second 
visit when requested). I further find that Registrant blatantly altered 
his rationale for his prescribing pain medication for J.W. from her 
ankle to her neck on the prescription stating that her ``neck injury 
here--it's just--it's more of a potentially serious injury.'' GX 10, at 
39. Based on this and all of the other evidence herein, I find that 
Registrant prescribed below the standard of care in California and 
issued prescriptions without a legitimate medical purpose.
Allegations of Violations of State and Federal Law
    OSCs 1 and 2 alleged multiple violations of state law and 
unprofessional conduct in violation of California Health and Safety 
Code Sec. Sec.  11153(a), 11154(a), 11156 and California Business 
Professional Code Sec. Sec.  725, 2242(a).\39\ In addition, the OSCs 
alleged the Registrant's issuance of prescriptions for controlled 
substances without a medical purpose violated 21 U.S.C. 841(a)(1) 
(unlawful distribution of a controlled substance) and 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''). I find that 
the Government has established that the controlled substances were 
prescribed without a legitimate medical purpose and below the standard 
of care in California, and in violation of state law, as detailed 
above, and therefore that Registrant's prescribing practices violated 
federal law.
---------------------------------------------------------------------------

    \39\ I am excluding Cal. Bus. & Prof. Code section 2234 from my 
finding regarding violations of state law, because neither the 
Government's Expert, nor the Government fully explained its 
application to this proceeding.
---------------------------------------------------------------------------

Summary of Factors Two and Four and Imminent Danger

    As found above, the Government's case establishes by substantial 
evidence that Registrant issued controlled substance prescriptions 
outside the usual course of the professional practice. I conclude that 
Registrant engaged in egregious misconduct, which supports the 
revocation of his COR. See Wesley Pope, 82 FR 14944, 14985 (2017).
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Registrant has ``fail[ed] . . . to maintain 
effective controls

[[Page 68489]]

against diversion or otherwise comply with the obligations of a 
registrant'' under the CSA. 21 U.S.C. 824(d)(2). Dr. Munzing credibly 
opined that Registrant's ``treatment of M.C. and B.H was both dangerous 
and reckless and fell far below the standard of care for prescribing 
controlled substances in the State of California,'' and stated that he 
was ``particularly concerned that [Registrant] was continuing to 
prescribe excessive amounts of opioid medication and prescription 
cocktails to both M.C. and B.H., even after he had surrendered one DEA 
registration . . . and obtained another. . . .'' GX 32, at 10. The 
substantial evidence that Registrant issued controlled substance 
prescriptions outside the usual course of the professional practice 
establishes that there was ``a substantial likelihood of an immediate 
threat that death, serious bodily harm, or abuse of a controlled 
substance . . . [would] occur in the absence of the immediate 
suspension'' of Registrant's registration. Id. Therefore, I affirm the 
ISO \40\ issued on Registrant's COR.
---------------------------------------------------------------------------

    \40\ As explained herein, OSC/ISO 2 incorporated by reference 
OSC/ISO 1, and therefore, I am issuing this revocation on the bases 
of both OSC/ISOs issued on Registrant's COR, and in affirming OSC/
ISO 2, I am also affirming OSC/ISO 1. See OSC 2, at 2.
---------------------------------------------------------------------------

Allegation That Registrant Materially Falsified His Application for a 
COR
    Based on the facts of this case, it is abundantly clear that 
Registrant falsified his application in answering in the negative to 
the question about surrendering his COR. GX 18, at 1. The Government 
argues that Registrant's negative answer meets the test of 
``misrepresentation or concealment . . . predictably capable of 
affecting the official decision'' and thus ``meets the definition of 
materiality.'' RFAA, at 21, citing Scott C. Bickman, M.D., 76 FR 17694, 
17701 (2011), quoting Kungys v. United States, 485 U.S. 759, 770, 
(1988). The Government contends that Registrant's ``subsequent DEA 
registration would not have been granted'' had Registrant disclosed OSC 
1 at the time of the application. RFAA, at 21.
    I find that Registrant's answer of ``N'' [symbolizing ``no''] to 
the question of whether he had surrendered his COR was materially 
false.
    Registrant's false answer clearly affected the decision of whether 
to grant his application. See Jose G. Zavaleta, M.D. 78 FR 27431 (2013) 
(physician's failure to disclose prior voluntary surrender of DEA COR 
following investigation into prescribing to undercover officers was 
clearly capable of influencing the decision of the Agency and thus 
material); see also Arthur H. Bell, D.O., 80 FR 50033, at 50038 (2015).
    I therefore find substantial evidence that Registrant materially 
falsified his May 20, 2016, application for registration when he failed 
to disclose that he had surrendered his DEA registration ``for cause.'' 
I further conclude that this finding alone constitutes an independent 
basis for revocation of Registrant's COR. See Murphy v. Drug Enf't 
Admin. 111 F.3d 140 (10th Cir. 1997) (finding that ``material 
falsification of his application is itself sufficient grounds for 
revocation of his COR.'')
    In sum, I find that there is substantial evidence on the record 
that Registrant repeatedly issued prescriptions for controlled 
substances without a legitimate medical purpose and dangerously below 
the standard of care in California, committed multiple violations of 
state law, and engaged in numerous acts of unprofessional conduct in 
violation of state law. Further, I find that Registrant materially 
falsified his application for a DEA COR after having been served with 
OSC 1 and surrendering his previous COR, which constitutes an 
independent basis for revocation of Registrant's COR.

Sanction

    Where, as here, the Government has met its prima facie burden of 
showing by two independent bases that Registrant's COR should be 
revoked because he materially falsified his application and his 
continued registration is inconsistent with the public interest, the 
burden shifts to the Registrant to show why he can be entrusted with a 
registration. Garrett Howard Smith, M.D., 83 FR 18882, 18910 (2018) 
(collecting cases).
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales, 546 U.S. at 259. 
``Because `past performance is the best predictor of future 
performance, ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 
(7th Cir. 1995), [the Agency] has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for [the registrant's] 
actions and demonstrate that [registrant] will not engage in future 
misconduct.''' Jayam Krishna-Iyer, 74 FR at 463 (quoting Medicine 
Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72 FR at 23853; John 
H. Kennnedy, M.D., 71 FR 35705, 35709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62884, 62887 (1995). The issue of trust is necessarily a 
fact-dependent determination based on the circumstances presented by 
the individual registrant; therefore, the Agency looks at factors, such 
as the acceptance of responsibility, and the credibility of that 
acceptance as it relates to the probability of repeat violations or 
behavior, and the nature of the misconduct that forms the basis for 
sanction, while also considering the Agency's interest in deterring 
similar acts. See Arvinder Singh, M.D., 81 FR 8247, 8248 (2016).
    Here, Registrant failed to timely respond to the Government's 
second Order to Show Cause and Immediate Suspension Order and did not 
avail himself of the opportunity to refute the Government's case. As 
such, Registrant has made no representations as to his future 
compliance with the CSA or to demonstrate that he can be entrusted with 
a COR. All evidence of Registrant's egregious conduct constituting two 
independent bases for revocation indicates clearly that he cannot be so 
entrusted.
    Accordingly, I shall order the sanctions the Government requested, 
as contained in the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f) and 824(a), I hereby revoke DEA Certificate of 
Registration FO6043638 issued to Jeffrey Olsen, M.D. I further hereby 
deny any pending application of Jeffrey D. Olsen, M.D., to renew or 
modify this COR, as well as any other applications of Jeffrey D. Olsen, 
M.D. for an additional COR in California. Pursuant to 28 CFR 0.100(b) 
and the authority vested in me by 21 U.S.C. 824(a) and (d), I hereby 
affirm the Order of Immediate Suspension of Registration issued to 
Jeffrey Olsen, M.D. This Order is effective January 15, 2020.

    Dated: December 6, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-27096 Filed 12-13-19; 8:45 am]
 BILLING CODE 4410-09-P