Patrick K. Chau, M.D.; Decision and Order, 36003-36008 [2012-14653]
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• County of sentencing
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In addition, BJS is requesting OMB
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the NCRP collection, all of which are
likely available from the same databases
as existing data elements, and should
therefore pose minimal additional
burden to the respondents, while greatly
enhancing BJS’ ability to better
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• Date and type of parole admission
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documenting or explaining the data for
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Starting with report year 2013, this
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(6) An estimate of the total public
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If additional information is required
contact: Jerri Murray, Department
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Jerri Murray,
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Department of Justice.
[FR Doc. 2012–14612 Filed 6–14–12; 8:45 am]
BILLING CODE 4410–18–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Consent Decree
Under the Clean Water Act
Notice is hereby given that on June
11, 2012, a proposed Consent Decree in
United States v. Siemens Industry, Inc.,
et al., Civil Action No. 1:12-cv-00729
was lodged with the United States
District Court for the District of
Delaware.
The complaint in this matter alleges
that defendants violated Section 311 of
the Clean Water Act at an oil recycling,
storage and distribution facility in
Wilmington, Delaware through their
failure to prepare and implement an
adequate Facility Response Plan, failing
to provide an adequate secondary
containment system, and failing to
prepare and implement an adequate
Spill Prevention, Control, and
Countermeasure Plan.
The proposed Consent Decree
requires defendants to take appropriate
actions to comply with Section 311 of
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36003
the CWA and implementing regulations
at 40 CFR part 112, particularly to
insure compliance with secondary
containment requirements and Spill
Prevention, Control and
Countermeasure Plan requirements.
Defendants will also pay a $300,000
civil penalty.
The Department of Justice will receive
for a period of thirty (30) days from the
date of this publication comments
relating to the proposed Decree.
Comments should be addressed to the
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pubcomment-ees.enrd@USDOJ.gov or
mailed to P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611, and should refer to United
States v. Siemens Industry, Inc., D.J. Ref.
90–5–1–1–09287.
During the public comment period,
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on the following Department of Justice
Web site: https://www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
proposed Decree may also be obtained
by mail from the Consent Decree
Library, P.O. Box 7611, U.S. Department
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or by faxing or emailing a request to
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Robert Brook,
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[FR Doc. 2012–14664 Filed 6–14–12; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Patrick K. Chau, M.D.; Decision and
Order
On August 8, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Patrick K. Chau, M.D.
(Registrant), of Vancouver, Washington.
The Show Cause Order proposed the
revocation of Registrant’s DEA
Certificate of Registration BC1983659,
which authorizes him to dispense
controlled substances as a practitioner,
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and the denial of any pending
application to renew or modify his
registration, on the ground that his
‘‘continued registration is inconsistent
with the public interest.’’ GX 3, at 1
(citing 21 U.S.C. 823(f) & 824(a)(4)).
More specifically, the Show Cause
Order alleged that between February 20
and March 27, 2009, Registrant had
issued prescriptions for alprazolam, a
schedule IV controlled substance, to two
undercover officers, without a legitimate
medical purpose and outside the usual
course of professional practice, in
violation of 21 CFR 1306.04(a) and
Wash. Rev. Code § 18.130.180(4). Id. at
1–2. The Show Cause Order further
alleged that on October 15, 2009, the
State of Washington’s Medical Quality
Assurance Commission issued an order
prohibiting Registrant from prescribing
controlled substances and that
Registrant is therefore without authority
to prescribe controlled substances in the
State in which he is registered with
DEA. Id. at 2. Finally, the Show Cause
Order notified Registrant of his right to
request a hearing on the allegations or
to submit a written statement regarding
the matters of fact and law raised in the
Order in lieu of a hearing, the
procedures for doing either, and the
consequences for failing to do either. Id.
(citing 21 CFR 1301.43(a), (c), (d), & (e)).
As evidenced by the signed return
receipt card, the Government
accomplished service on or about
August 11, 2011. GX 4. Since the date
of service of the Show Cause Order,
more than thirty days have now passed
and neither Registrant, nor anyone
purporting to represent him, has either
filed a request for a hearing or submitted
a written statement in lieu thereof.
Accordingly, I find that Registrant has
waived both his right to a hearing and
his right to submit a written statement
in lieu of a hearing. 21 CFR 1301.43(e).
I therefore issue this Decision and Order
based on relevant evidence contained in
the Investigative Record submitted by
the Government. I make the following
findings.
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Findings
Registrant is the holder of DEA
Certificate of Registration BC1983659,
which authorizes him to dispense
controlled substances in schedules II
through V as a practitioner at the
registered location of 6816 NE Highway
99, Suite 108, Vancouver, Washington.
GX 1. While this registration was due to
expire on August 31, 2010, on August
30, 2010, Registrant submitted a renewal
application. GX 2. Accordingly, I find
that Registrant’s registration has
remained in effect pending the issuance
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of the Final Order in this matter. 5
U.S.C. 558(c).
Registrant, who is a board-certified
psychiatrist, is also the holder of a
license to practice as a physician and
surgeon issued by the State of
Washington. GX 6, at 2. On October 1,
2009, Registrant entered into a
Stipulated Findings of Fact,
Conclusions of Law and Agreed Order
with the State’s Medical Quality
Assurance Commission (hereinafter,
MQAC or Commission); the MQAC
accepted the Order on October 15, 2009.
Id. at 24.
The MQAC’s Order contained
extensive findings regarding Registrant’s
prescribing of controlled substances to
numerous patients. See id. at 3–17. For
example, the MQAC found that
Registrant had ‘‘violated the standard of
care in the following ways’’ in treating
Patient B, noting that:
Patient B was on addicting doses of
benzodiazepines and opioids when he started
seeing [Registrant]. At that point, [Registrant]
should have had Patient B detoxified rather
than continue to support his treatment, and
over time, increased the prescribed amounts
of addictive medications.
[Registrant] increased Patient B’s already
addictive and dangerous doses of opioids and
benzodiazepines. In addition, there is no
evidence of much, if any, resulting
improvement to the patient’s condition.
[Registrant’s] prescriptions of large
amounts of opioids likely caused Patient B to
become addicted to narcotics. [Registrant]
failed to consider and try Patient B on nonaddictive alternatives to treat his headaches.
Id. at 5–6. The MQAC thus found that
‘‘[a]s a result, [Registrant] harmed, or
created an unreasonable risk of harm, to
Patient B.’’ Id. at 6.
The MQAC further found that
Registrant ‘‘has engaged in a pattern of
prescribing high doses and large
amounts of addicting medication,
particularly benzodiazepines, to new
patients who claimed to need ongoing
treatment at such doses, but who also
provided rationales for transferring their
care to [Registrant], such as that they
recently moved from another state or
part of this state, or that they changed
or lost their insurance.’’ Id. at 7. The
Commission then found that in
numerous instances Registrant ‘‘did not
obtain any records or otherwise verify [a
patient’s] treatment history.’’ See id. at
7–13 (Patients D, E, F, G, H, I, J, K, L,
M, N, O, P, Q, & R). Moreover, with
respect to Patients D through R, the
MQAC found that Registration violated
the standard of care by:
Failing to recognize that the patients were
on addicting doses of medication and refer
them to an appropriate detoxification facility.
Repeatedly providing new patients with
three-month supplies of high doses of
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addictive medications without planning to
see the patients for three months.
Ignoring possible drug-seeking and
diversion behaviors, and not requesting
medical records from other providers or
otherwise substantiating the patients’
reported treatment and prescription histories.
As a result, [Registrant] placed these patients
at an unreasonable risk of harm.
Id. at 13.
The MQAC catalogued additional
violations by Registrant of the standard
of care with respect to several of the
patients. With respect to Patient K, the
MQAC found that Registrant ‘‘violated
the standard of care * * * by
prescribing two benzodiazepines, both
at addicting doses.’’ Id. Next, the MQAC
found that Registrant ‘‘violated the
standard of care in prescribing
OxyContin to Patient M and Norco to
Patient N because he did not document
that they suffered from current pain
complaints.’’ Id. at 14.
With respect to Patient S, the MQAC
found that he had told Registrant ‘‘that
his symptoms improved when he tried
two milligrams of Xanax supplied by
‘other people.’’’ Id. Registrant
‘‘prescribed a daily regimen of eight
milligrams of Xanax, wrote for a threemonth supply, and asked the patient to
return in three months. The patient
returned one month early * * * at
which time [Registrant] increased the
prescription to ten milligrams per day
and again wrote for a three-month
supply.’’ Id. The Commission also found
that approximately two months later,
‘‘Patient S told [Registrant] that he was
leaving the area for a summer job in
Alaska and that he needed a 90-day
supply of Xanax to last him for that
period. [Registrant] provided the
requested prescription.’’ Id.
Regarding his prescribing to Patient S,
the MQAC found that Registrant
violated the standard of care, explaining
that:
He started the patient on an unduly high
and addictive dose of Xanax instead of
starting at a safer, lower dose and titrating up
if warranted. He also disregarded signs that
the patient was drug-seeking and possibly
diverting. In accepting the patient’s claim
that he needed a 90-day supply of Xanax
because he was going to work in Alaska for
the summer, [Registrant] accepted at face
value a brief note to that effect that the
patient provided. The note was purportedly
written by another of [Registrant’s] patients.
Id.
Based on these and other findings, the
MQAC concluded that Registrant had
‘‘committed unprofessional conduct’’ in
violation of RCW 18.130.180(4), (8)(a),
and (9). Id. at 18. The Commission
placed Registrant’s medical license on
probation and prohibited him from
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prescribing controlled substances,
explaining that it ‘‘will not lift this
restriction unless the Center for
Personalized Education for Physicians
in Denver, Colorado * * * determined
that [Registrant] can prescribe safely and
with reasonable skill and without
posing an unreasonable risk of harm to
the public.’’ Id.
On February 20, 2009, a DEA Special
Agent (S/A) made an undercover visit to
Registrant. During the visit, which was
recorded, Registrant explained that he is
a psychiatrist and asked the S/A if he
was looking for psychiatric services and
that his fee was $140, which the S/A
paid in cash. GXs 8 & 9. The S/A told
Registrant that he had a friend in Seattle
who was giving him Xanax and that his
girlfriend had also given him some of
the drug. GX 9. Registrant asked the S/
A to tell him about his symptoms; the
SA replied that he had a friend who
gave him a couple of pills, stated that he
was really relaxed and ‘‘just more
relaxed after’’ taking the drug, that ‘‘I
feel better after I take the pill,’’ and ‘‘I
definitely feel better after than before.’’
Id. Registrant than asked the S/A
whether anyone in his family had
anxiety; the S/A denied that anyone in
his family had ‘‘an anxiety problem.’’ Id.
Registrant then reviewed some type of
agreement with the S/A, and after
completing this, Registrant stated that
‘‘my diagnosis for you is some sort of
general anxiety problem.’’ Id.
However, at no point during the visit,
did the S/A state that he felt anxious.
Registrant nonetheless gave the S/A a
prescription for 90 tablets of Xanax 1mg.
GX 10.
The Government also submitted a
recording of a second undercover visit,
which was conducted on March 27,
2009 by a different S/A. In his affidavit,
the S/A stated that he had paid $140
cash; that he told Registrant that he had
been referred by the S/A, who had
performed the previous visit; and that
Registrant gave him a prescription for 73
tablets of Xanax 1mg. GX 11, at 1–2; see
also GX 13 (copy of Rx).
During the visit, the S/A told
Registrant that he had not seen a doctor
in a long time, and after confirming that
he lived in Seattle, the S/A denied
having a doctor in Seattle, stating that
he was ‘‘actually pretty healthy to be
honest with you.’’ After discussing the
S/A’s purported job, Registrant asked
the S/A to ‘‘tell me about what kind of
symptoms you would like me to help
you with?’’ The S/A answered: ‘‘Well
actually * * * I’m not doing bad, I’m
doing very good.’’ Registrant replied:
‘‘OK,’’ and asked the S/A why he
wanted to see him. The S/A explained
he wanted to get some Xanax and when
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asked to explain why, stated that ‘‘the
only reason I can think of is it makes me
feel good when I take it. Can’t think of
anything else to be honest with you.’’
Registrant then asked the SA if he had
previously taken Xanax; the S/A replied
that he had taken it about two years ago.
Registrant asked the S/A why he had
then taken Xanax; the S/A stated: ‘‘the
same reason really.’’ After Registrant
asked: ‘‘You feel relaxed’’?; the S/A
said: ‘‘It makes me feel good,’’ and that
he had bought it on the street then, but
that it was too expensive. After
discussing the price the S/A had paid
on the street, Registrant asked: ‘‘Can you
tell me the benefit when you taking it?
Like when you’re on it compared to
when you’re not on it? And the
difference to justify the benefit, the
reason you pay money to take it?’’ The
S/A answered: ‘‘It just makes me feel
good. I mean in general.’’
Registrant then asked if a doctor had
‘‘ever formally prescribe[d]’’ the drug;
the S/A stated ‘‘No, No, I’ll be honest
with you.’’ Next, Registrant asked if the
Xanax helped him sleep; the S/A denied
having any problem sleeping. Registrant
then asked: ‘‘And in the way you feel
good that means you’re relaxed? Able to
do your job better? Is that right?’’ The
SA responded: ‘‘I don’t know if I could
say that. I’m trying to be honest with
you. I’m not trying to lie to you.’’
Registrant then told the SA to ‘‘try to
justify the reason you come to visit me
and to get the medication and so there’s
a reason. It just feels good. If you don’t
take it, if you feel good also, that might
not be really reasonable right?’’ The
S/A replied ‘‘right,’’ and Registrant
continued, stating: ‘‘So in order for you
to pay that much money and to come all
the way to see me you must have some
reason you want to do so.’’ The S/A
stated: ‘‘right, right, right. It just makes
me feel better in general.’’ Registrant
remarked: ‘‘General well-being. So I
suppose it takes away some kind of a
tense, some kind of anxiety feeling.’’
The S/A replied: ‘‘well if we’ve * * *
if that. If we’ve gotta say that, yes we
can say that if we’ve gotta say that, yes.’’
Registrant responded that ‘‘anxiety is
not like a panic that comes and goes and
for some kind of anxiety that is
pervasive always there, and that if the
anxiety is being resolved and the people
feel liberated from those feelings, that’s
how you feel better or general sense of
well-being.’’ The S/A replied: ‘‘I mean if
we have to say that, general well-being
then you know, let’s say that. I thank
God I’m doing very good in everything,
really, you know.’’ Registrant then
stated:
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So what I would do since there’s not a very
severe degree of symptom and may not be as
drastic as other people I’ve had and there’s
also a considerable benefit like that you tell
me that makes you come all the way. So what
I would call a middle of the road approach,
ok? Of course I believe you are not selling
drugs either and not trying to take the
medicine from me to go to the streets sell
eighty bucks a pill. So I have to trust the best
of you. You go to a lawyer, the lawyer have
to trust you instead of think that you’re bad.
Otherwise, won’t be a client relationship.
Continuing, Registrant said that in ‘‘this
good willing or good faith, I would give
you a try, ok, a preliminary trial of
medication,’’ but that it wouldn’t be
‘‘what you get from the street but
according to our standard of trial I will
start you on a very preliminary dose.’’
Registrant then explained his dosing
regimen and that he would not give the
S/A more than a one-month prescription
for a patient that had not been receiving
the medication on an ongoing basis from
another doctor.
Registrant further said that he was
‘‘fighting the State of Washington over
the controversial [sic] of prescribing
Xanax and Klonopin because some
people doesn’t want to, some people
says it’s excess, but for me its justified
for the patient’s presentation. Except in
your case, we are ambiguous, ambiguity.
So I want the patient to use only one
pharmacy.’’ Registrant then told the
S/A that he would have to use a local
WalMart pharmacy and required him to
sign an agreement for their ‘‘mutual
protection,’’ which required that he use
only one pharmacy, that he was not on
methadone or heroin, that he would not
divert or sell the controlled substance to
others, and that he would not have more
than one doctor prescribe the same class
of controlled substances.
Subsequently, in between small talk,
Registrant asked the S/A whether he
had ‘‘any other physical illness’’ and
whether family members ‘‘have any
anxiety problem’’; the S/A answered:
‘‘No, they’re doing great.’’ Registrant
then calculated the number of tablets he
was prescribing per his dosing regimen
and wrote out the prescription, which
he then gave to the S/A.
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that ‘‘[a]
registration pursuant to section 823 of
this title to * * * dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
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section.’’ 21 U.S.C. 824(a)(4). In making
the public interest determination in the
case of a practitioner, Congress directed
that the following factors be considered:
(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
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
21 U.S.C. 823(f).
‘‘[T]hese factors are considered in the
disjunctive.’’ Robert A. Leslie, 68 FR
15227, 15230 (2003). 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 an existing registration or to
deny an application. Id. Moreover,
while I ‘‘must consider each of these
factors, [I] ‘need not make explicit
findings as to each one.’’’ MacKay v.
DEA, 664 F.3d 808, 816 (10th Cir. 2011)
(quoting Volkman v. DEA, 567 F.3d 215,
222 (6th Cir. 2009)); see also Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005)
(citing Morall v. DEA, 412 F.3d 165,
173–74 (DC Cir. 2005)).
With respect to a practitioner’s
registration, the Government bears the
burden of proving by substantial
evidence that the continuation of a
registration would be inconsistent with
the public interest. Cf. 21 CFR
1301.44(d).1 In this matter, I have
considered all of the factors and
conclude that the evidence with respect
to factors one, two, and four supports a
finding that Registrant’s continued
registration would be inconsistent with
the public interest.
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Factor One—The Recommendation of
the State Licensing Board
As found above, on October 15, 2009,
the MQAC adopted the Agreed Order
which Registrant has previously entered
into, pursuant to which Registrant is
prohibited from prescribing controlled
substances under Washington law. See
Rev. Code Wash. § 18.130.160(3)
1 As found above, Registrant neither requested a
hearing nor submitted a written statement
explaining his position on the matters of fact and
law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as
for example, by showing that a registrant has
committed acts which are inconsistent with the
public interest, the burden then shifts to the
registrant to demonstrate why he can be entrusted
with a registration. Medicine Shoppe-Jonesborough,
73 FR 363, 380 (2008).
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(authorizing a ‘‘[r]estriction or limitation
of [license’s holder’s] practice’’); id.
§ 18.130.180(9) (providing that ‘‘[f]ailure
to comply with an order issued by the
disciplining authority or a stipulation
for informal disposition entered into
with the disciplining authority’’ is
unprofessional conduct).
The CSA defines ‘‘the term
‘practitioner’ [to] mean [] a * * *
physician * * * or other person
licensed, registered or otherwise
permitted, by * * * the jurisdiction in
which he practices * * * to distribute,
dispense, [or] administer * * * a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Consistent with this definition,
Congress, in setting the requirements for
obtaining a practitioner’s registration,
provided that ‘‘[t]he Attorney General
shall register practitioners * * * if the
applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which he practices.’’
21 U.S.C. 823(f).
Accordingly, because one cannot
obtain a practitioner’s registration
unless one holds authority under state
law to dispense controlled substances,
and because where a registered
practitioner’s state authority has been
revoked or suspended, the practitioner
no longer meets the statutory definition
of a practitioner, DEA has repeatedly
held that the possession of authority to
dispense controlled substances under
the laws of the State in which a
practitioner engages in professional
practice is a fundamental condition for
both obtaining and maintaining a
practitioner’s registration.2 See, e.g.,
Calvin Ramsey, 76 FR 20034, 20036
(2011); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988). Because the CSA
expressly conditions the holding of a
practitioner’s registration on the
practitioner’s being ‘‘authorized to
dispense controlled substances under
the laws of the State in which he
practices,’’ id., and also limits the
definition of the term ‘‘practitioner’’ to
a physician who is licensed, registered
or otherwise permitted to dispense a
controlled substance in the course of
professional practice, id. § 802(21), and
Registrant, by virtue of the Agreed
Order, is no longer authorized under his
license to dispense a controlled
2 To effectuate this requirement, in 21 U.S.C.
843(a)(3), Congress also granted the Attorney
General authority to revoke a registration ‘‘upon a
finding’’ that a registrant ‘‘has had his State license
or registration suspended, revoked, or denied by
competent State authority and is no longer
authorized by State law to engage in the * * *
dispensing of controlled substances.’’
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substance, this factor provides reason
alone to revoke his registration.
Factors Two and Four—Registrant’s
Experience in Dispensing Controlled
Substances and Record of Compliance
With Applicable Laws Related to
Controlled Substances
The MQAC Findings
As found above, the MQAC found that
Registrant had repeatedly violated the
standard of care and committed
unprofessional conduct in prescribing
controlled substances to numerous
patients. More specifically, the MQAC
found that Registrant had committed
‘‘[i]ncompetence, negligence, or
malpractice which results in injury to a
patient or which creates an
unreasonable risk that a patient may be
harmed.’’ GX 6, at 18 (citing Rev. Code
Wash. § 18.130.180(4)). The MQAC also
found that Registrant committed
unprofessional conduct by ‘‘[f]ail[ing] to
cooperate with the disciplinary
authority,’’ as well as by ‘‘[f]ail[ing] to
comply with an order issued by the
disciplinary authority,’’ id. (citing Rev.
Code Wash. § 18.130.180(8) & (9)).
However, the MQAC did not find that
Registrant had prescribed controlled
substances ‘‘other than for legitimate or
therapeutic purpose’’ or that he diverted
controlled substances, in violation of
Rev. Code Wash. § 18.130.180(6)).3 Id.
As I have previously acknowledged,4
numerous federal courts of appeal have
held ‘‘the offense of unlawful
3 Under a longstanding DEA regulation, a
prescription for a controlled substance is not
‘‘effective’’ unless it 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). This regulation
further provides that ‘‘[a]n order purporting to be
a prescription issued not in the usual course of
professional treatment * * * is not a prescription
within the meaning and intent of [21 U.S.C. 829]
and * * * the person issuing it, shall be subject to
the penalties provided for violations of the
provisions of law relating to controlled substances.’’
Id.
As the Supreme Court has explained, ‘‘the
prescription requirement * * * ensures patients
use controlled substances under the supervision of
a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those
prohibited uses.’’ Gonzales v. Oregon, 546 U.S. 243,
274 (2006) (citing United States v. Moore, 423 U.S.
122, 135 (1975)).
4 I also assume, without deciding, that the facts
as found by the MQAC in the Agreed Order do not
establish a violation of 21 CFR 1306.04(a). But see
George Mathew, M.D., 75 FR 66138, 66146 (2010)
(rejecting MQAC’s finding that physician had not
diverted controlled substances when ‘‘[s]everal
Federal courts of appeals have held that conduct
similar to what the MQAC found [the physician] to
have engaged in by prescribing over the Internet
violates the prescription requirement of Federal law
and constitutes an unlawful distribution under 21
U.S.C. 841(a)’’), pet. for rev. denied, Mathew v.
DEA, No. 10–73480, slip op. at 5 (9th Cir. Mar. 16,
2012).
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distribution requires proof that the
practitioner’s conduct went ‘beyond the
bounds of any legitimate medical
practice, including that which would
constitute civil negligence.’’’ Laurence
T. McKinney, 73 FR 43260, 43266
(quoting United States v. McIver, 470
F.3d 550, 559 (4th Cir. 2006)). See also
United States v. Feingold, 454 F.3d
1001, 1010 (9th Cir. 2006) (The Supreme
Court in United States v. Moore, 423
U.S. 122 (1975), ‘‘based its decision not
merely on the fact that the doctor had
committed malpractice, or even
intentional malpractice, but rather on
the fact that his actions completely
betrayed any semblance of legitimate
medical treatment.’’).
However, as the Agency has
explained in multiple cases, ‘‘the
Agency’s authority to deny an
application [and] to revoke an existing
registration * * * is not limited to those
instances in which a practitioner
intentionally diverts a controlled
substance.’’ Bienvenido Tan, 76 FR
17673, 17689 (2011) (citing Paul J.
Caragine, Jr., 63 FR 51592, 51601
(1998)); see also Dewey C. MacKay, 75
FR 49956, 49974 (2010), pet. for rev.
denied 664 F.3d 808 (10th Cir. 2011). As
Caragine explained: ‘‘[j]ust because
misconduct is unintentional, innocent,
or devoid of improper motive, [it] does
not preclude revocation or denial.
Careless or negligent handling of
controlled substances creates the
opportunity for diversion and [can]
justify’’ the revocation of an existing
registration or the denial of an
application for a registration. 63 FR at
51601.
‘‘Accordingly, under the public
interest standard, DEA has authority to
consider those prescribing practices of a
physician, which, while not rising to the
level of intentional or knowing
misconduct, nonetheless create a
substantial risk of diversion.’’ MacKay,
75 FR at 49974. Likewise, ‘‘[a]
practitioner who ignores the warning
signs that [his] patients are either
personally abusing or diverting
controlled substances commits ‘acts
inconsistent with the public interest,’ 21
U.S.C. 824(a)(4), even if [he] is merely
¨
gullible or naıve.’’ Jayam Krishna-Iyer,
74 FR 459, 460 n.3 (2009).
Here, even if the MQAC’s findings do
not establish that Registrant engaged in
intentional or knowing misconduct,
they nonetheless establish numerous
instances in which he recklessly
prescribed controlled substances and
that his prescribing practices created a
substantial risk of diversion and abuse.
More specifically, the MQAC found that
Patient B was already on addictive
doses of benzodiazepines and opioids
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when he/she started seeing Registrant
and that he should have referred B to
detoxification. Yet Registrant increased
B’s doses, failed to try non-addictive
alternatives, and as a result, B likely
became addicted. GX 6, at 5–6.
The MQAC further identified
numerous other practices by Registrant
which created a substantial risk of
diversion and abuse. For example, the
MQAC found that he ‘‘engaged in a
pattern of prescribing high doses and
large amounts of addicting medication,
particularly benzodiazepines, to new
patients who claimed to need ongoing
treatment at such doses,’’ and who
represented that they had either moved
or changed/lost their insurance, and yet
Registrant ‘‘did not obtain any records
or otherwise verify [the patient’s]
treatment history.’’ Id. at 7. Indeed, the
MQAC identified fifteen patients who
obtained controlled substances from
Registrant in this manner. Id. at 7–13.
With respect to each of these patients,
the MQAC found that: (1) Registrant
failed to recognize that they were on
addictive doses and refer them for
detoxification; (2) he repeatedly
prescribed three-month supplies of high
doses of controlled substances ‘‘without
planning to see the patients for three
months’’; (3) he ignored ‘‘drug-seeking
and diversion behaviors’’; and (4) he did
not request the patient’s medical records
from other providers and otherwise
failed to ‘‘substantiat[e] the patients’
reported treatment and prescription
histories.’’ Id.
With respect to still another patient
(K), the MQAC found that he ‘‘violated
the standard of care * * * by
prescribing two benzodiazepines, both
at addicting doses.’’ Id. at 13. In
addition, the MQAC found that
Registrant prescribed OxyContin (a
schedule II controlled substance) to
Patient M and Norco (hydrocodone, a
schedule III controlled substances) to
Patient N but ‘‘did not document that
they suffered from current pain
complaints.’’ 5 Id. at 14.
Finally, the MQAC found that Patient
S had told Registrant that he had
obtained Xanax from non-medical
sources and yet started him at ‘‘an
unduly high and addictive dose’’ of
eight milligrams a day and wrote him a
prescription for a three-month supply.
Id. Yet, Patient S returned one month
early and at this visit, Registrant wrote
him another prescription for a threemonth supply and increased his daily
dose to ten milligrams. Id. Moreover,
two months later, Patient S returned and
5 No explanation was provided by the MQAC as
to why these two instances do not constitute
violations of Rev. Code Wash. § 18.130.180(6).
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36007
said that he was going to take a summer
job in Alaska and needed a 90-day
supply, and presented a note to this
effect. Id. Registrant issued the
requested prescription to Patient S. The
MQAC found that Registrant had
accepted at face value Patient S’s
representation and that Registrant
‘‘disregarded signs that [Patient S] was
drug-seeking and possibly diverting.’’
Id. at 14.
As the forgoing demonstrates, even if
Respondent did not intentionally divert
controlled substances to any of the
patients identified in the MQAC’s
Order, the Order identified numerous
instances in which Respondent
recklessly prescribed controlled
substances to persons who were likely
engaged in either self-abuse or
diversion. Respondent’s repeated failure
to obtain the medical records for his
patients, as well as to otherwise verify
their treatment histories and other
claims, created a substantial risk of
diversion and abuse. MacKay, 75 FR at
49974.
So too, Respondent’s practice of
‘‘[r]epeatedly providing new patients
with three-month supplies of high doses
of addictive medications without
planning to see the patients for three
months,’’ id. at 13, created a substantial
risk that the patients were either
diverting the drugs or abusing them. As
the Supreme Court explained in
Gonzales, one of the core purposes of
the CSA’s ‘‘prescription requirement [is
to] ensure[] [that] patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse.’’ 546
U.S. at 274 (other citation omitted). The
MQAC’s Order makes clear that
Respondent failed to properly monitor
numerous patients to ensure that they
were not abusing or diverting the drugs
he prescribed to them.
Accordingly, I hold that the MQAC’s
findings alone support findings under
factors two and four that Registrant has
committed acts which render his
registration ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4). See
also Tan 76 FR at 17689; Krishna-Iyer,
74 FR at 460 n.3; Caragine, 63 FR at
51601. I further hold that this finding
supports the revocation of Registrant’s
registration.
The DEA Undercover Visits
As found above, in February and
March 2009, two S/As made undercover
visits to Registrant and at each visit,
obtained Xanax prescriptions. At the
first visit, the S/A told Registrant that he
had gotten Xanax from both a friend and
his girlfriend, and when Registrant
asked him to describe his symptoms, the
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S/A reiterated that a friend had given
him a couple of pills and that he was
just more relaxed after taking the drug,
and that he felt better after taking the
drug. Significantly, at no point during
the meeting did the S/A relate that he
had anxiety, and denied that anyone in
his family had anxiety.
Registrant then stated that he was
diagnosing the S/A with some sort of
general anxiety problem. However,
given that the S/A stated that he was
getting the pills from non-medical
sources, and that when asked to relate
his symptoms, simply stated that the
pills just made him relax and that he felt
better after taking the drug, I conclude
that substantial evidence supports a
finding that Registrant lacked a
legitimate medical purpose and violated
21 CFR 1306.04(a) when he prescribed
Xanax to the first S/A.6
Likewise, when asked to relate what
symptoms he wanted Registrant to help
him with, the second S/A stated that he
wasn’t doing badly but was doing ‘‘very
good’’ and that he actually wanted to get
some Xanax. When asked to explain
why, the S/A explained that the drug
made him feel good when he took it.
Subsequently, the second S/A made
clear that he had gotten Xanax off the
street and that the drug had never been
prescribed to him. Upon further
questioning by Registrant, the second S/
A again said that the drug made him feel
good and denied that he had any
problem sleeping. Moreover, when
asked whether taking Xanax helped him
relax and do his job better, the S/A said
that he did not know that he ‘‘could say
that’’ and later added that the drug just
made him ‘‘feel better in general.’’
Finally, after Registrant explained that
the S/A’s statement suggested that
taking the drug took ‘‘away some kind
of a tense, some kind of anxiety
feeling,’’ the S/A replied that ‘‘if we
have to say that, yes we can say that,’’
but that he was ‘‘doing very good in
everything.’’ Subsequently, Registrant
stated that the S/A’s presentation of his
reason for taking Xanax was ambiguous.
However, I conclude that there was
nothing ambiguous in the S/A’s
presentation because he never once
acknowledged being anxious, and
repeatedly denied having symptoms or
problems that would provide a medical
justification for prescribing the drug.
Indeed, whenever Registrant questioned
him, the S/A response was that he took
Xanax because it just made him feel
better. Accordingly, I conclude that
substantial evidence supports a finding
6 While I have considered the audio recordings
submitted in this matter, in future cases such
evidence must be accompanied by a transcript.
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that Registrant lacked a legitimate
medical purpose and violated 21 CFR
1306.04(a) when he prescribed Xanax to
the second S/A.
Registrant’s prescribing of Xanax to
the two S/As thus provides additional
support for my conclusion that he has
committed acts which render his
registration ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4).
However, as explained above, the
findings of the MQAC are, by
themselves, more than adequate to reach
this conclusion and to support the
revocation of his registration.7
Sanction
Having found that Registrant lacks
state authority to dispense controlled
substances, and that he has committed
numerous acts which render his
registration inconsistent with the public
interest, I conclude that the Government
has made out a prima facie case for
revocation. Because Registrant failed to
request a hearing or to submit a written
statement in lieu of a hearing, and has
thus offered no evidence to rebut the
Government’s prima facie case, I will
order that his registration be revoked
and that any pending application be
denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a)(4), as
well as 28 CFR 0.100(b), I order that
DEA Certificate of Registration
BC1983659, issued to Patrick K. Chau,
M.D., be, and it hereby is, revoked. I
further order that any pending
application of Patrick K. Chau, M.D., to
renew or modify his registration, be, and
it hereby is, denied. This Order is
effective July 16, 2012.
Dated: June 5, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–14653 Filed 6–14–12; 8:45 am]
BILLING CODE 4410–09–P
7 It is acknowledged that there is no evidence that
Registrant has been convicted of an offense falling
within factor three. However, this is not dispositive
of the public interest inquiry. See MacKay, 664 F.3d
at 817–18 (quoting Dewey C. MacKay, 75 FR 49956,
49973 (2010)). I also deem it unnecessary to make
any findings under factor five.
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DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
[OMB Number 1110–0048]
Agency Information Collection
Activities; Proposed Collection: Cargo
Theft Incident Report, Revision of a
Currently Approved Collection,
Comments Requested
30-Day notice of information
collection under review.
ACTION:
The Department of Justice, Federal
Bureau of Investigation, Criminal Justice
Information Services Division (CJIS)
will be submitting the following
Information Collection Request to the
Office of Management and Budget
(OMB) for review and clearance in
accordance with the established review
procedures of the Paperwork Reduction
Act of 1995. The proposed information
collection is published to obtain
comments from the public and affected
agencies. This proposed information
collection was previously published in
the Federal Register Number 72,
Volume 77, on page 22348, on April 12,
2012, allowing for a 60 day comment
period.
The purpose of this notice is to allow
for an additional 30 days for public
comment until July 16, 2012. This
process is conducted in accordance with
5 CFR 1320.10.
Written comments and/or suggestions
regarding the items contained in this
notice, especially the estimated public
burden and associated response time,
should be directed to Mr. Gregory E.
Scarbro, Unit Chief, Federal Bureau of
Investigation, CJIS Division, Module E–
3, 1000 Custer Hollow Road, Clarksburg,
West Virginia 26306; facsimile (304)
625–3566.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Comments
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
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Agencies
[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Pages 36003-36008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14653]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Patrick K. Chau, M.D.; Decision and Order
On August 8, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Patrick K. Chau, M.D. (Registrant), of Vancouver,
Washington. The Show Cause Order proposed the revocation of
Registrant's DEA Certificate of Registration BC1983659, which
authorizes him to dispense controlled substances as a practitioner,
[[Page 36004]]
and the denial of any pending application to renew or modify his
registration, on the ground that his ``continued registration is
inconsistent with the public interest.'' GX 3, at 1 (citing 21 U.S.C.
823(f) & 824(a)(4)).
More specifically, the Show Cause Order alleged that between
February 20 and March 27, 2009, Registrant had issued prescriptions for
alprazolam, a schedule IV controlled substance, to two undercover
officers, without a legitimate medical purpose and outside the usual
course of professional practice, in violation of 21 CFR 1306.04(a) and
Wash. Rev. Code Sec. 18.130.180(4). Id. at 1-2. The Show Cause Order
further alleged that on October 15, 2009, the State of Washington's
Medical Quality Assurance Commission issued an order prohibiting
Registrant from prescribing controlled substances and that Registrant
is therefore without authority to prescribe controlled substances in
the State in which he is registered with DEA. Id. at 2. Finally, the
Show Cause Order notified Registrant of his right to request a hearing
on the allegations or to submit a written statement regarding the
matters of fact and law raised in the Order in lieu of a hearing, the
procedures for doing either, and the consequences for failing to do
either. Id. (citing 21 CFR 1301.43(a), (c), (d), & (e)).
As evidenced by the signed return receipt card, the Government
accomplished service on or about August 11, 2011. GX 4. Since the date
of service of the Show Cause Order, more than thirty days have now
passed and neither Registrant, nor anyone purporting to represent him,
has either filed a request for a hearing or submitted a written
statement in lieu thereof. Accordingly, I find that Registrant has
waived both his right to a hearing and his right to submit a written
statement in lieu of a hearing. 21 CFR 1301.43(e). I therefore issue
this Decision and Order based on relevant evidence contained in the
Investigative Record submitted by the Government. I make the following
findings.
Findings
Registrant is the holder of DEA Certificate of Registration
BC1983659, which authorizes him to dispense controlled substances in
schedules II through V as a practitioner at the registered location of
6816 NE Highway 99, Suite 108, Vancouver, Washington. GX 1. While this
registration was due to expire on August 31, 2010, on August 30, 2010,
Registrant submitted a renewal application. GX 2. Accordingly, I find
that Registrant's registration has remained in effect pending the
issuance of the Final Order in this matter. 5 U.S.C. 558(c).
Registrant, who is a board-certified psychiatrist, is also the
holder of a license to practice as a physician and surgeon issued by
the State of Washington. GX 6, at 2. On October 1, 2009, Registrant
entered into a Stipulated Findings of Fact, Conclusions of Law and
Agreed Order with the State's Medical Quality Assurance Commission
(hereinafter, MQAC or Commission); the MQAC accepted the Order on
October 15, 2009. Id. at 24.
The MQAC's Order contained extensive findings regarding
Registrant's prescribing of controlled substances to numerous patients.
See id. at 3-17. For example, the MQAC found that Registrant had
``violated the standard of care in the following ways'' in treating
Patient B, noting that:
Patient B was on addicting doses of benzodiazepines and opioids
when he started seeing [Registrant]. At that point, [Registrant]
should have had Patient B detoxified rather than continue to support
his treatment, and over time, increased the prescribed amounts of
addictive medications.
[Registrant] increased Patient B's already addictive and
dangerous doses of opioids and benzodiazepines. In addition, there
is no evidence of much, if any, resulting improvement to the
patient's condition.
[Registrant's] prescriptions of large amounts of opioids likely
caused Patient B to become addicted to narcotics. [Registrant]
failed to consider and try Patient B on non-addictive alternatives
to treat his headaches.
Id. at 5-6. The MQAC thus found that ``[a]s a result, [Registrant]
harmed, or created an unreasonable risk of harm, to Patient B.'' Id. at
6.
The MQAC further found that Registrant ``has engaged in a pattern
of prescribing high doses and large amounts of addicting medication,
particularly benzodiazepines, to new patients who claimed to need
ongoing treatment at such doses, but who also provided rationales for
transferring their care to [Registrant], such as that they recently
moved from another state or part of this state, or that they changed or
lost their insurance.'' Id. at 7. The Commission then found that in
numerous instances Registrant ``did not obtain any records or otherwise
verify [a patient's] treatment history.'' See id. at 7-13 (Patients D,
E, F, G, H, I, J, K, L, M, N, O, P, Q, & R). Moreover, with respect to
Patients D through R, the MQAC found that Registration violated the
standard of care by:
Failing to recognize that the patients were on addicting doses
of medication and refer them to an appropriate detoxification
facility.
Repeatedly providing new patients with three-month supplies of
high doses of addictive medications without planning to see the
patients for three months.
Ignoring possible drug-seeking and diversion behaviors, and not
requesting medical records from other providers or otherwise
substantiating the patients' reported treatment and prescription
histories. As a result, [Registrant] placed these patients at an
unreasonable risk of harm.
Id. at 13.
The MQAC catalogued additional violations by Registrant of the
standard of care with respect to several of the patients. With respect
to Patient K, the MQAC found that Registrant ``violated the standard of
care * * * by prescribing two benzodiazepines, both at addicting
doses.'' Id. Next, the MQAC found that Registrant ``violated the
standard of care in prescribing OxyContin to Patient M and Norco to
Patient N because he did not document that they suffered from current
pain complaints.'' Id. at 14.
With respect to Patient S, the MQAC found that he had told
Registrant ``that his symptoms improved when he tried two milligrams of
Xanax supplied by `other people.''' Id. Registrant ``prescribed a daily
regimen of eight milligrams of Xanax, wrote for a three-month supply,
and asked the patient to return in three months. The patient returned
one month early * * * at which time [Registrant] increased the
prescription to ten milligrams per day and again wrote for a three-
month supply.'' Id. The Commission also found that approximately two
months later, ``Patient S told [Registrant] that he was leaving the
area for a summer job in Alaska and that he needed a 90-day supply of
Xanax to last him for that period. [Registrant] provided the requested
prescription.'' Id.
Regarding his prescribing to Patient S, the MQAC found that
Registrant violated the standard of care, explaining that:
He started the patient on an unduly high and addictive dose of
Xanax instead of starting at a safer, lower dose and titrating up if
warranted. He also disregarded signs that the patient was drug-
seeking and possibly diverting. In accepting the patient's claim
that he needed a 90-day supply of Xanax because he was going to work
in Alaska for the summer, [Registrant] accepted at face value a
brief note to that effect that the patient provided. The note was
purportedly written by another of [Registrant's] patients.
Id.
Based on these and other findings, the MQAC concluded that
Registrant had ``committed unprofessional conduct'' in violation of RCW
18.130.180(4), (8)(a), and (9). Id. at 18. The Commission placed
Registrant's medical license on probation and prohibited him from
[[Page 36005]]
prescribing controlled substances, explaining that it ``will not lift
this restriction unless the Center for Personalized Education for
Physicians in Denver, Colorado * * * determined that [Registrant] can
prescribe safely and with reasonable skill and without posing an
unreasonable risk of harm to the public.'' Id.
On February 20, 2009, a DEA Special Agent (S/A) made an undercover
visit to Registrant. During the visit, which was recorded, Registrant
explained that he is a psychiatrist and asked the S/A if he was looking
for psychiatric services and that his fee was $140, which the S/A paid
in cash. GXs 8 & 9. The S/A told Registrant that he had a friend in
Seattle who was giving him Xanax and that his girlfriend had also given
him some of the drug. GX 9. Registrant asked the S/A to tell him about
his symptoms; the SA replied that he had a friend who gave him a couple
of pills, stated that he was really relaxed and ``just more relaxed
after'' taking the drug, that ``I feel better after I take the pill,''
and ``I definitely feel better after than before.'' Id. Registrant than
asked the S/A whether anyone in his family had anxiety; the S/A denied
that anyone in his family had ``an anxiety problem.'' Id. Registrant
then reviewed some type of agreement with the S/A, and after completing
this, Registrant stated that ``my diagnosis for you is some sort of
general anxiety problem.'' Id.
However, at no point during the visit, did the S/A state that he
felt anxious. Registrant nonetheless gave the S/A a prescription for 90
tablets of Xanax 1mg. GX 10.
The Government also submitted a recording of a second undercover
visit, which was conducted on March 27, 2009 by a different S/A. In his
affidavit, the S/A stated that he had paid $140 cash; that he told
Registrant that he had been referred by the S/A, who had performed the
previous visit; and that Registrant gave him a prescription for 73
tablets of Xanax 1mg. GX 11, at 1-2; see also GX 13 (copy of Rx).
During the visit, the S/A told Registrant that he had not seen a
doctor in a long time, and after confirming that he lived in Seattle,
the S/A denied having a doctor in Seattle, stating that he was
``actually pretty healthy to be honest with you.'' After discussing the
S/A's purported job, Registrant asked the S/A to ``tell me about what
kind of symptoms you would like me to help you with?'' The S/A
answered: ``Well actually * * * I'm not doing bad, I'm doing very
good.'' Registrant replied: ``OK,'' and asked the S/A why he wanted to
see him. The S/A explained he wanted to get some Xanax and when asked
to explain why, stated that ``the only reason I can think of is it
makes me feel good when I take it. Can't think of anything else to be
honest with you.''
Registrant then asked the SA if he had previously taken Xanax; the
S/A replied that he had taken it about two years ago. Registrant asked
the S/A why he had then taken Xanax; the S/A stated: ``the same reason
really.'' After Registrant asked: ``You feel relaxed''?; the S/A said:
``It makes me feel good,'' and that he had bought it on the street
then, but that it was too expensive. After discussing the price the S/A
had paid on the street, Registrant asked: ``Can you tell me the benefit
when you taking it? Like when you're on it compared to when you're not
on it? And the difference to justify the benefit, the reason you pay
money to take it?'' The S/A answered: ``It just makes me feel good. I
mean in general.''
Registrant then asked if a doctor had ``ever formally
prescribe[d]'' the drug; the S/A stated ``No, No, I'll be honest with
you.'' Next, Registrant asked if the Xanax helped him sleep; the S/A
denied having any problem sleeping. Registrant then asked: ``And in the
way you feel good that means you're relaxed? Able to do your job
better? Is that right?'' The SA responded: ``I don't know if I could
say that. I'm trying to be honest with you. I'm not trying to lie to
you.'' Registrant then told the SA to ``try to justify the reason you
come to visit me and to get the medication and so there's a reason. It
just feels good. If you don't take it, if you feel good also, that
might not be really reasonable right?'' The S/A replied ``right,'' and
Registrant continued, stating: ``So in order for you to pay that much
money and to come all the way to see me you must have some reason you
want to do so.'' The S/A stated: ``right, right, right. It just makes
me feel better in general.'' Registrant remarked: ``General well-being.
So I suppose it takes away some kind of a tense, some kind of anxiety
feeling.'' The S/A replied: ``well if we've * * * if that. If we've
gotta say that, yes we can say that if we've gotta say that, yes.''
Registrant responded that ``anxiety is not like a panic that comes
and goes and for some kind of anxiety that is pervasive always there,
and that if the anxiety is being resolved and the people feel liberated
from those feelings, that's how you feel better or general sense of
well-being.'' The S/A replied: ``I mean if we have to say that, general
well-being then you know, let's say that. I thank God I'm doing very
good in everything, really, you know.'' Registrant then stated:
So what I would do since there's not a very severe degree of
symptom and may not be as drastic as other people I've had and
there's also a considerable benefit like that you tell me that makes
you come all the way. So what I would call a middle of the road
approach, ok? Of course I believe you are not selling drugs either
and not trying to take the medicine from me to go to the streets
sell eighty bucks a pill. So I have to trust the best of you. You go
to a lawyer, the lawyer have to trust you instead of think that
you're bad. Otherwise, won't be a client relationship.
Continuing, Registrant said that in ``this good willing or good faith,
I would give you a try, ok, a preliminary trial of medication,'' but
that it wouldn't be ``what you get from the street but according to our
standard of trial I will start you on a very preliminary dose.''
Registrant then explained his dosing regimen and that he would not give
the S/A more than a one-month prescription for a patient that had not
been receiving the medication on an ongoing basis from another doctor.
Registrant further said that he was ``fighting the State of
Washington over the controversial [sic] of prescribing Xanax and
Klonopin because some people doesn't want to, some people says it's
excess, but for me its justified for the patient's presentation. Except
in your case, we are ambiguous, ambiguity. So I want the patient to use
only one pharmacy.'' Registrant then told the S/A that he would have to
use a local WalMart pharmacy and required him to sign an agreement for
their ``mutual protection,'' which required that he use only one
pharmacy, that he was not on methadone or heroin, that he would not
divert or sell the controlled substance to others, and that he would
not have more than one doctor prescribe the same class of controlled
substances.
Subsequently, in between small talk, Registrant asked the S/A
whether he had ``any other physical illness'' and whether family
members ``have any anxiety problem''; the S/A answered: ``No, they're
doing great.'' Registrant then calculated the number of tablets he was
prescribing per his dosing regimen and wrote out the prescription,
which he then gave to the S/A.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
``[a] registration pursuant to section 823 of this title to * * *
dispense a controlled substance * * * may be suspended or revoked by
the Attorney General upon a finding that the registrant * * * has
committed such acts as would render his registration under section 823
of this title inconsistent with the public interest as determined under
such
[[Page 36006]]
section.'' 21 U.S.C. 824(a)(4). In making the public interest
determination in the case of a practitioner, Congress directed that the
following factors be considered:
(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 manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, 68 FR 15227, 15230 (2003). 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 an existing registration
or to deny an application. Id. Moreover, while I ``must consider each
of these factors, [I] `need not make explicit findings as to each
one.''' MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009)); see also Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall v. DEA, 412 F.3d
165, 173-74 (DC Cir. 2005)).
With respect to a practitioner's registration, the Government bears
the burden of proving by substantial evidence that the continuation of
a registration would be inconsistent with the public interest. Cf. 21
CFR 1301.44(d).\1\ In this matter, I have considered all of the factors
and conclude that the evidence with respect to factors one, two, and
four supports a finding that Registrant's continued registration would
be inconsistent with the public interest.
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\1\ As found above, Registrant neither requested a hearing nor
submitted a written statement explaining his position on the matters
of fact and law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as for example, by
showing that a registrant has committed acts which are inconsistent
with the public interest, the burden then shifts to the registrant
to demonstrate why he can be entrusted with a registration. Medicine
Shoppe-Jonesborough, 73 FR 363, 380 (2008).
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Factor One--The Recommendation of the State Licensing Board
As found above, on October 15, 2009, the MQAC adopted the Agreed
Order which Registrant has previously entered into, pursuant to which
Registrant is prohibited from prescribing controlled substances under
Washington law. See Rev. Code Wash. Sec. 18.130.160(3) (authorizing a
``[r]estriction or limitation of [license's holder's] practice''); id.
Sec. 18.130.180(9) (providing that ``[f]ailure to comply with an order
issued by the disciplining authority or a stipulation for informal
disposition entered into with the disciplining authority'' is
unprofessional conduct).
The CSA defines ``the term `practitioner' [to] mean [] a * * *
physician * * * or other person licensed, registered or otherwise
permitted, by * * * the jurisdiction in which he practices * * * to
distribute, dispense, [or] administer * * * a controlled substance in
the course of professional practice.'' 21 U.S.C. 802(21). Consistent
with this definition, Congress, in setting the requirements for
obtaining a practitioner's registration, provided that ``[t]he Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices.'' 21 U.S.C. 823(f).
Accordingly, because one cannot obtain a practitioner's
registration unless one holds authority under state law to dispense
controlled substances, and because where a registered practitioner's
state authority has been revoked or suspended, the practitioner no
longer meets the statutory definition of a practitioner, DEA has
repeatedly held that the possession of authority to dispense controlled
substances under the laws of the State in which a practitioner engages
in professional practice is a fundamental condition for both obtaining
and maintaining a practitioner's registration.\2\ See, e.g., Calvin
Ramsey, 76 FR 20034, 20036 (2011); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988). Because the CSA
expressly conditions the holding of a practitioner's registration on
the practitioner's being ``authorized to dispense controlled substances
under the laws of the State in which he practices,'' id., and also
limits the definition of the term ``practitioner'' to a physician who
is licensed, registered or otherwise permitted to dispense a controlled
substance in the course of professional practice, id. Sec. 802(21),
and Registrant, by virtue of the Agreed Order, is no longer authorized
under his license to dispense a controlled substance, this factor
provides reason alone to revoke his registration.
---------------------------------------------------------------------------
\2\ To effectuate this requirement, in 21 U.S.C. 843(a)(3),
Congress also granted the Attorney General authority to revoke a
registration ``upon a finding'' that a registrant ``has had his
State license or registration suspended, revoked, or denied by
competent State authority and is no longer authorized by State law
to engage in the * * * dispensing of controlled substances.''
---------------------------------------------------------------------------
Factors Two and Four--Registrant's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws Related to
Controlled Substances
The MQAC Findings
As found above, the MQAC found that Registrant had repeatedly
violated the standard of care and committed unprofessional conduct in
prescribing controlled substances to numerous patients. More
specifically, the MQAC found that Registrant had committed
``[i]ncompetence, negligence, or malpractice which results in injury to
a patient or which creates an unreasonable risk that a patient may be
harmed.'' GX 6, at 18 (citing Rev. Code Wash. Sec. 18.130.180(4)). The
MQAC also found that Registrant committed unprofessional conduct by
``[f]ail[ing] to cooperate with the disciplinary authority,'' as well
as by ``[f]ail[ing] to comply with an order issued by the disciplinary
authority,'' id. (citing Rev. Code Wash. Sec. 18.130.180(8) & (9)).
However, the MQAC did not find that Registrant had prescribed
controlled substances ``other than for legitimate or therapeutic
purpose'' or that he diverted controlled substances, in violation of
Rev. Code Wash. Sec. 18.130.180(6)).\3\ Id.
---------------------------------------------------------------------------
\3\ Under a longstanding DEA regulation, a prescription for a
controlled substance is not ``effective'' unless it 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).
This regulation further provides that ``[a]n order purporting to be
a prescription issued not in the usual course of professional
treatment * * * is not a prescription within the meaning and intent
of [21 U.S.C. 829] and * * * the person issuing it, shall be subject
to the penalties provided for violations of the provisions of law
relating to controlled substances.'' Id.
As the Supreme Court has explained, ``the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135 (1975)).
---------------------------------------------------------------------------
As I have previously acknowledged,\4\ numerous federal courts of
appeal have held ``the offense of unlawful
[[Page 36007]]
distribution requires proof that the practitioner's conduct went
`beyond the bounds of any legitimate medical practice, including that
which would constitute civil negligence.''' Laurence T. McKinney, 73 FR
43260, 43266 (quoting United States v. McIver, 470 F.3d 550, 559 (4th
Cir. 2006)). See also United States v. Feingold, 454 F.3d 1001, 1010
(9th Cir. 2006) (The Supreme Court in United States v. Moore, 423 U.S.
122 (1975), ``based its decision not merely on the fact that the doctor
had committed malpractice, or even intentional malpractice, but rather
on the fact that his actions completely betrayed any semblance of
legitimate medical treatment.'').
---------------------------------------------------------------------------
\4\ I also assume, without deciding, that the facts as found by
the MQAC in the Agreed Order do not establish a violation of 21 CFR
1306.04(a). But see George Mathew, M.D., 75 FR 66138, 66146 (2010)
(rejecting MQAC's finding that physician had not diverted controlled
substances when ``[s]everal Federal courts of appeals have held that
conduct similar to what the MQAC found [the physician] to have
engaged in by prescribing over the Internet violates the
prescription requirement of Federal law and constitutes an unlawful
distribution under 21 U.S.C. 841(a)''), pet. for rev. denied, Mathew
v. DEA, No. 10-73480, slip op. at 5 (9th Cir. Mar. 16, 2012).
---------------------------------------------------------------------------
However, as the Agency has explained in multiple cases, ``the
Agency's authority to deny an application [and] to revoke an existing
registration * * * is not limited to those instances in which a
practitioner intentionally diverts a controlled substance.'' Bienvenido
Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR
51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR 49956, 49974
(2010), pet. for rev. denied 664 F.3d 808 (10th Cir. 2011). As Caragine
explained: ``[j]ust because misconduct is unintentional, innocent, or
devoid of improper motive, [it] does not preclude revocation or denial.
Careless or negligent handling of controlled substances creates the
opportunity for diversion and [can] justify'' the revocation of an
existing registration or the denial of an application for a
registration. 63 FR at 51601.
``Accordingly, under the public interest standard, DEA has
authority to consider those prescribing practices of a physician,
which, while not rising to the level of intentional or knowing
misconduct, nonetheless create a substantial risk of diversion.''
MacKay, 75 FR at 49974. Likewise, ``[a] practitioner who ignores the
warning signs that [his] patients are either personally abusing or
diverting controlled substances commits `acts inconsistent with the
public interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible
or na[iuml]ve.'' Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009).
Here, even if the MQAC's findings do not establish that Registrant
engaged in intentional or knowing misconduct, they nonetheless
establish numerous instances in which he recklessly prescribed
controlled substances and that his prescribing practices created a
substantial risk of diversion and abuse. More specifically, the MQAC
found that Patient B was already on addictive doses of benzodiazepines
and opioids when he/she started seeing Registrant and that he should
have referred B to detoxification. Yet Registrant increased B's doses,
failed to try non-addictive alternatives, and as a result, B likely
became addicted. GX 6, at 5-6.
The MQAC further identified numerous other practices by Registrant
which created a substantial risk of diversion and abuse. For example,
the MQAC found that he ``engaged in a pattern of prescribing high doses
and large amounts of addicting medication, particularly
benzodiazepines, to new patients who claimed to need ongoing treatment
at such doses,'' and who represented that they had either moved or
changed/lost their insurance, and yet Registrant ``did not obtain any
records or otherwise verify [the patient's] treatment history.'' Id. at
7. Indeed, the MQAC identified fifteen patients who obtained controlled
substances from Registrant in this manner. Id. at 7-13. With respect to
each of these patients, the MQAC found that: (1) Registrant failed to
recognize that they were on addictive doses and refer them for
detoxification; (2) he repeatedly prescribed three-month supplies of
high doses of controlled substances ``without planning to see the
patients for three months''; (3) he ignored ``drug-seeking and
diversion behaviors''; and (4) he did not request the patient's medical
records from other providers and otherwise failed to ``substantiat[e]
the patients' reported treatment and prescription histories.'' Id.
With respect to still another patient (K), the MQAC found that he
``violated the standard of care * * * by prescribing two
benzodiazepines, both at addicting doses.'' Id. at 13. In addition, the
MQAC found that Registrant prescribed OxyContin (a schedule II
controlled substance) to Patient M and Norco (hydrocodone, a schedule
III controlled substances) to Patient N but ``did not document that
they suffered from current pain complaints.'' \5\ Id. at 14.
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\5\ No explanation was provided by the MQAC as to why these two
instances do not constitute violations of Rev. Code Wash. Sec.
18.130.180(6).
---------------------------------------------------------------------------
Finally, the MQAC found that Patient S had told Registrant that he
had obtained Xanax from non-medical sources and yet started him at ``an
unduly high and addictive dose'' of eight milligrams a day and wrote
him a prescription for a three-month supply. Id. Yet, Patient S
returned one month early and at this visit, Registrant wrote him
another prescription for a three-month supply and increased his daily
dose to ten milligrams. Id. Moreover, two months later, Patient S
returned and said that he was going to take a summer job in Alaska and
needed a 90-day supply, and presented a note to this effect. Id.
Registrant issued the requested prescription to Patient S. The MQAC
found that Registrant had accepted at face value Patient S's
representation and that Registrant ``disregarded signs that [Patient S]
was drug-seeking and possibly diverting.'' Id. at 14.
As the forgoing demonstrates, even if Respondent did not
intentionally divert controlled substances to any of the patients
identified in the MQAC's Order, the Order identified numerous instances
in which Respondent recklessly prescribed controlled substances to
persons who were likely engaged in either self-abuse or diversion.
Respondent's repeated failure to obtain the medical records for his
patients, as well as to otherwise verify their treatment histories and
other claims, created a substantial risk of diversion and abuse.
MacKay, 75 FR at 49974.
So too, Respondent's practice of ``[r]epeatedly providing new
patients with three-month supplies of high doses of addictive
medications without planning to see the patients for three months,''
id. at 13, created a substantial risk that the patients were either
diverting the drugs or abusing them. As the Supreme Court explained in
Gonzales, one of the core purposes of the CSA's ``prescription
requirement [is to] ensure[] [that] patients use controlled substances
under the supervision of a doctor so as to prevent addiction and
recreational abuse.'' 546 U.S. at 274 (other citation omitted). The
MQAC's Order makes clear that Respondent failed to properly monitor
numerous patients to ensure that they were not abusing or diverting the
drugs he prescribed to them.
Accordingly, I hold that the MQAC's findings alone support findings
under factors two and four that Registrant has committed acts which
render his registration ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). See also Tan 76 FR at 17689; Krishna-Iyer, 74 FR at
460 n.3; Caragine, 63 FR at 51601. I further hold that this finding
supports the revocation of Registrant's registration.
The DEA Undercover Visits
As found above, in February and March 2009, two S/As made
undercover visits to Registrant and at each visit, obtained Xanax
prescriptions. At the first visit, the S/A told Registrant that he had
gotten Xanax from both a friend and his girlfriend, and when Registrant
asked him to describe his symptoms, the
[[Page 36008]]
S/A reiterated that a friend had given him a couple of pills and that
he was just more relaxed after taking the drug, and that he felt better
after taking the drug. Significantly, at no point during the meeting
did the S/A relate that he had anxiety, and denied that anyone in his
family had anxiety.
Registrant then stated that he was diagnosing the S/A with some
sort of general anxiety problem. However, given that the S/A stated
that he was getting the pills from non-medical sources, and that when
asked to relate his symptoms, simply stated that the pills just made
him relax and that he felt better after taking the drug, I conclude
that substantial evidence supports a finding that Registrant lacked a
legitimate medical purpose and violated 21 CFR 1306.04(a) when he
prescribed Xanax to the first S/A.\6\
---------------------------------------------------------------------------
\6\ While I have considered the audio recordings submitted in
this matter, in future cases such evidence must be accompanied by a
transcript.
---------------------------------------------------------------------------
Likewise, when asked to relate what symptoms he wanted Registrant
to help him with, the second S/A stated that he wasn't doing badly but
was doing ``very good'' and that he actually wanted to get some Xanax.
When asked to explain why, the S/A explained that the drug made him
feel good when he took it. Subsequently, the second S/A made clear that
he had gotten Xanax off the street and that the drug had never been
prescribed to him. Upon further questioning by Registrant, the second
S/A again said that the drug made him feel good and denied that he had
any problem sleeping. Moreover, when asked whether taking Xanax helped
him relax and do his job better, the S/A said that he did not know that
he ``could say that'' and later added that the drug just made him
``feel better in general.'' Finally, after Registrant explained that
the S/A's statement suggested that taking the drug took ``away some
kind of a tense, some kind of anxiety feeling,'' the S/A replied that
``if we have to say that, yes we can say that,'' but that he was
``doing very good in everything.'' Subsequently, Registrant stated that
the S/A's presentation of his reason for taking Xanax was ambiguous.
However, I conclude that there was nothing ambiguous in the S/A's
presentation because he never once acknowledged being anxious, and
repeatedly denied having symptoms or problems that would provide a
medical justification for prescribing the drug. Indeed, whenever
Registrant questioned him, the S/A response was that he took Xanax
because it just made him feel better. Accordingly, I conclude that
substantial evidence supports a finding that Registrant lacked a
legitimate medical purpose and violated 21 CFR 1306.04(a) when he
prescribed Xanax to the second S/A.
Registrant's prescribing of Xanax to the two S/As thus provides
additional support for my conclusion that he has committed acts which
render his registration ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). However, as explained above, the findings of the MQAC
are, by themselves, more than adequate to reach this conclusion and to
support the revocation of his registration.\7\
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\7\ It is acknowledged that there is no evidence that Registrant
has been convicted of an offense falling within factor three.
However, this is not dispositive of the public interest inquiry. See
MacKay, 664 F.3d at 817-18 (quoting Dewey C. MacKay, 75 FR 49956,
49973 (2010)). I also deem it unnecessary to make any findings under
factor five.
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Sanction
Having found that Registrant lacks state authority to dispense
controlled substances, and that he has committed numerous acts which
render his registration inconsistent with the public interest, I
conclude that the Government has made out a prima facie case for
revocation. Because Registrant failed to request a hearing or to submit
a written statement in lieu of a hearing, and has thus offered no
evidence to rebut the Government's prima facie case, I will order that
his registration be revoked and that any pending application be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration BC1983659, issued to Patrick K. Chau, M.D., be, and it
hereby is, revoked. I further order that any pending application of
Patrick K. Chau, M.D., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective July 16, 2012.
Dated: June 5, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14653 Filed 6-14-12; 8:45 am]
BILLING CODE 4410-09-P