Zizhuang Li, M.D.; Decision and Order, 71660-71665 [2013-28525]
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[FR Doc. 2013–28653 Filed 11–27–13; 8:45 am]
BILLING CODE 4410–A5–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Zizhuang Li, M.D.; Decision and Order
On June 10, 2013, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Zizhuang Li, M.D.
(Applicant), of Leawood, Kansas. GX 5.
The Show Cause Order proposed the
denial of Applicant’s application for a
DEA Certificate of Registration as a
practitioner, on the ground that his
‘‘registration would be inconsistent with
the public interest.’’ Id. at 1 (citing 21
U.S.C. 823(f)).
As basis for the denial, the Show
Cause Order alleged that ‘‘[o]n
September 27, 2012, the Mississippi
State Board of Medical Licensure
(Board) found that from April through
August 2010, [Applicant] prescribed
controlled substances, including
oxycodone, carisoprodol, and
alprazolam, outside the course of
professional practice to four patients.’’
Id. Next, the Show Cause Order alleged
that the Board found that Applicant
‘‘engaged in unprofessional conduct’’ by
failing ‘‘to conduct an appropriate risk/
benefit analysis for [his] patients,’’ and
that he also ‘‘failed to document proper
written treatment plans.’’ Id. (citing
Miss. Code Ann. §§ 73–25–29(8)(d) &
(13); 73–25–83(a)). The Order then
alleged that based on its findings, the
Board suspended Applicant’s medical
license for twelve months.1 Id.
On June 10, 2013, the Government
attempted to serve the Show Cause
Order by certified mail, return receipt
requested, addressed to Applicant at the
address he provided on his application
for receiving mail from the Agency. GX
1 The Show Cause Order also notified Applicant
of his right to request a hearing on the allegations
or to submit a written statement while waiving his
right to a hearing, the procedure for electing either
option, and the consequence of failing to elect
either option. GX 5, at 2–3 (citing 21 CFR 1301.43).
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6, at 1. However, on July 6, 2013, the
Government queried the Postal Service’s
Track and Confirm Web page and
determined that the mailing had not
been accepted.2 Accordingly, on July 9,
2013, the Government mailed the Show
Cause Order to Applicant at the same
address using first class mail. Id. That
same day, DEA also emailed an
electronic version of the Show Cause
Order to two email addresses
purportedly used by Applicant,
including the address which he had
provided on his application for
registration.3 Id. Neither email was
returned as undeliverable or resulted in
an error message. Id.
Based on the above, I find that the
Government has complied with its
obligation ‘‘to provide ‘notice,
reasonably calculated under all the
circumstances, to apprise [Applicant] of
the pendency of the action and afford
[him] an opportunity to present [his]
objections.’ ’’ Jones v. Flowers, 547 U.S.
220, 226 (2006) (quoting Mullane v.
Central Hanover Bank & Trust Co., 339
U.S. 306, 314 (1950)); see also Emilio
Luna, 77 FR 4829, 4830 n.2 (2012) (‘‘[I]t
seems relatively clear that when
certified mail is returned unclaimed, in
most cases, the Government can satisfy
its constitutional obligation by simply
re-mailing the Show Cause Order by
regular first class mail.’’) (citing Jones,
547 U.S. at 234–35).
On August 20, 2013, the Government
submitted its Request for Final Agency
Action, along with the Investigative
Record. Based on the Government’s
submission, I further find that more
than thirty days have now passed since
service of the Show Cause Order was
accomplished, and neither Applicant,
nor anyone purporting to represent him,
has either requested a hearing or
submitted a written statement in lieu of
a hearing. 21 CFR 1301.43(a) & (c).
Accordingly, I find that Applicant has
waived his right to a hearing or to
submit a written statement. 21 CFR
1301.43(d). I therefore issue this
Decision and Final Order based on
relevant material contained in the
Investigative Record submitted by the
Government. I make the following
findings of fact.
2 On July 12, 2013, the mailing was returned to
DEA and marked as ‘‘Return to sender, unclaimed,
unable to forward, returned to sender.’’ GX 6, at 1.
3 Regarding the two email addresses, the
Diversion Investigator (DI), who investigated the
application, ‘‘discovered that [Applicant] gave the
Board the email address of jacksonstone22@
hotmail.com . . . [and] [o]n a residential rental
application in San Diego . . . Applicant listed his
email address as zizhuangli@yahoo.com.’’ GX 4, at
2. The latter is the same email address Applicant
provided on his DEA application.
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Findings
Applicant’s Registration and Licensure
Status
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Applicant previously held three DEA
Certificates of Registration, pursuant to
which he was authorized to dispense
controlled substances in schedules II
through V. GX 2, at 2; GX 3, at 2. Two
of the registrations (at least one of which
was for a location in Mississippi) were
retired on September 28, 2012,
apparently after Applicant voluntarily
surrendered them. GX 2. As for the third
registration, it was retired on May 1,
2010. Id. However, there is no evidence
establishing why this registration was
retired.
On November 16, 2012, Applicant
applied for a new registration at the
proposed registered address of 20265
Valley Boulevard, Suite E, Walnut,
California. GX 1, at 1. Applicant sought
authority limited to dispensing
controlled substances in schedules IV
and V. GX 2, at 1. It is this application
which is at issue in this matter.
Applicant also holds a current
Physician’s and Surgeon’s Certificate
issued by the Medical Board of
California. GX 1, at 1. Applicant’s
California license is not due to expire
until December 31, 2013.4 Id.
Applicant was also licensed by the
Mississippi State Board of Medical
Licensure. However, as found below, on
June 8, 2012, the Board initiated a
proceeding against Applicant, alleging
twenty-four counts of violations of
Mississippi law. GX 3, at 1. Following
a hearing on September 27, 2012, at
which Applicant was represented by
counsel, the Board suspended his state
license for a period of twelve months,
which was effective immediately. Id. at
23–24. Moreover, ‘‘[n]otwithstanding
the twelve (12) month period’’ of
suspension, the Board ordered that
‘‘Licensee shall not practice medicine in
any manner or form, until such time as
he appears before this Board, [and]
submits proof of compliance with all
requirements set forth in [the] order, as
well as Miss. Code Ann. [§ ] 73–25–
32.’’ 5 Id. at 23. The Board also required
4 Pursuant to 5 U.S.C. 556(e) and 21 CFR 1316.59,
I take official notice that on December 28, 2012, the
California Board issued an Accusation/Petition to
Revoke Applicant’s state license based on the
results of the Mississippi Board’s action. That
matter is still pending.
I have also taken official notice of the fact that
Applicant voluntarily surrendered his Louisiana
medical license (MD.204358) on October 8, 2012.
5 This statute provides that ‘‘[a] person whose
license to practice medicine . . . has been revoked
or suspended may petition the [Board] to reinstate
this license after a period of not less than one (1)
year has elapsed from the date of the revocation or
suspension.’’ Miss. Code Ann. § 73–25–32(1). The
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that Applicant complete courses in
controlled substance prescribing,
recordkeeping, and medical ethics, and
that he pay ‘‘all costs incurred in
relation to the . . . matter . . . not to
exceed $10,000.’’ Id. at 23–24.
The Board’s Findings
Based on the evidence presented at
the hearing, the Board made extensive
findings regarding Applicant’s
prescribing of controlled substances to
four patients. GX 3, at 1–23. With
respect to Patient #1, a thirty-three year
old male, the Board found that
Applicant issued him twenty-one (21)
prescriptions for controlled substances
(totaling 2,415 dosage units) during the
period of April 26 through August 18,
2010. Id. at 4. The prescriptions
included one prescription for 60
Percocet 10/650mg, six prescriptions for
945 oxycodone 30mg, five prescriptions
for 450 Xanax 2mg, 600 Soma
(carisoprodol) 350mg, and four
prescriptions for 360 Neurontin
(gabapentin) 300mg.6 The Board further
found that Applicant repeatedly
prescribed multiple drugs to Patient #1
at a visit, including Xanax, Soma, and
oxycodone. Id. at 5–6.
The Board then identified multiple
failures by Applicant to follow its
regulations for the ‘‘Use of Controlled
Substances for Chronic (Non-Terminal)
Pain’’ in prescribing to Patient #1. These
included that:
(1) Applicant ‘‘allowed the patient to
dictate his care by continually
prescribing controlled substances for
pain notwithstanding [his]
recommendation that the patient should
have surgery’’;
statute further requires that the petition ‘‘be
accompanied by two (2) or more verified
recommendations from physicians . . . licensed by
the Board . . . and by two (2) or more
recommendations from citizens each having
personal knowledge of the activities of the
petitioner since the disciplinary penalty was
imposed and such facts as may be required by the
Board.’’ Id. § 73–25–32(2).
6 Carisoprodol did not become a federally
controlled substance until January 11, 2012, when
its placement into schedule IV of the Controlled
Substances Act became effective. See DEA,
Schedules of Controlled Substances: Placement of
Carisoprodol into Schedule IV, 76 FR 77330 (2011).
However, several DEA final orders had previously
discussed the abuse of carisoprodol in conjunction
with other controlled substances, including opiates
such as oxycodone and hydrocodone, and
benzodiazepines, such as alprazolam and diazepam.
See, e.g., Paul H. Volkman, 73 FR 30630, 30638
(2008) (noting expert’s testimony regarding
prescribing of drug cocktails of a narcotic,
benzodiazepine, and carisoprodol, and that the
cocktail, which ‘‘is very popular amongst those
individuals who go to doctors’ offices to take drugs
to abuse them,’’ also ‘‘increase[s] the likelihood of
sedation, respiratory depression and death.’’) (other
citations omitted).
Neurontin (gabapentin) is not a federally
controlled substance.
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(2) notwithstanding evidence in the
patient’s medical record that he ‘‘visited
multiple pharmacies and physicians in
the past,’’ the record ‘‘contained no
record of prior treatment and there [was]
no information . . . suggesting that
[Applicant] conducted an appropriate
risk/benefit analysis by reviewing his
own records . . . or records’’ of prior
treating physicians;
(3) there was no documentation that
Applicant discussed with Patient #1
‘‘taking medication as prescribed’’;
(4) there was no indication that
Applicant sought ‘‘outside consultation
to determine the origin of the patient’s
pain,’’ or recommended treatment
modalities (beyond prescribing
controlled substances) other than
‘‘warm baths and heating pads’’;
(5) there was ‘‘only one urine drug
screen’’ in Patient #1’s chart, which was
done at his initial visit and there were
‘‘[n]o subsequent drugs screens [in] the
record to document compliance with
treatment’’;
(6) Patient #1 ‘‘continued to come
early for each visit and [Applicant]
continued to write prescriptions on each
early visit’’;
(7) Patient #1’s file ‘‘contained . . .
‘red flags’ suggesting possible drug
abuse by Patient #1’’; and
(8) Applicant ‘‘issued Patient #1
prescriptions at times when [he] should
not have finished taking the same
medication from a previous prescription
had the . . . directions been properly
followed or the correct dosage . . .
taken.’’
GX 3, at 7–9.
As for Patient #2, the Board found
that from April 6 through August 9,
2010, Applicant ‘‘issued to [him] twenty
four (24) prescriptions totaling
approximately 2,178 dosage units of
controlled substances,’’ including six (6)
prescriptions for 352 Lortab 10/500mg
(hydrocodone/acetaminophen), six
prescriptions for 704 Soma
(carisoprodol) 350mg, six prescriptions
for 704 oxycodone 30mg, and six
prescriptions for 418 Xanax 2mg. GX 3,
at 9. Here again, the Board’s findings
show that Applicant repeatedly
dispensed prescriptions for all four of
these drugs to Patient #2 on a single
day.
The Board then identified multiple
failures on Applicant’s part in
complying with its regulations. These
included:
(1) Patient #2’s ‘‘chart shows very
little physical exam conclusions and
hardly any pathology . . . which would
indicate the therapeutic nature for
prescribing the particular controlled
substances in the quantities and
strengths so noted’’;
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(2) Applicant noted in the chart that
he recommended that Patient #2 see an
orthopedic specialist, yet there was ‘‘no
documentation or further mention of
whether a referral was made or if Patient
#2 saw an orthopedist’’;
(3) Applicant issued Patient #2 new
prescriptions on June 11, 2010, ‘‘only 18
days after [his] visit on May 24,’’ while
noting in the chart that the visit had
occurred on June 21, 2010, and there
was no explanation in the chart for
issuing the prescriptions early, nor ‘‘any
significant change in the verbal pain
scale’’ to support the ‘‘increased
consumption of the prior issued
medications’’;
(4) Applicant ‘‘continued to prescribe
controlled substances for pain without
any analysis regarding the effectiveness
of the medications’’ and there was ‘‘no
documentation of other treatment
modalities (other than recommending
warms baths and heating pads)’’;
(5) Applicant ‘‘allowed Patient #2 to
dictate his care by simply continuing
previous prescriptions for controlled
substances, failing to follow up on his
own recommendations regarding
referral to an orthopedist, and, at a
minimum, failing to recognize noncompliance by the patient’’; and
(6) Patient #2’s chart ‘‘contained
indicators or ‘red flags’ suggesting
possible drug abuse,’’ including: (a)
Documentation suggesting that Patient
#2 had previously been terminated for
noncompliance with a treatment plan by
a prior pain management physician; (b)
a printout from a pharmacy showing
that Patient #2 was obtaining controlled
substances from multiple doctors; and
(c) Applicant ‘‘continued to write new
prescriptions for controlled substances
at a time when the previous
prescriptions for the same medications
would not have been completed had the
patient followed’’ the dosing
instructions.
Id. at 11–13.
With respect to Patient #3, the Board
found that from April 7 through August
2, 2010, Applicant issued twenty-three
controlled prescriptions to her ‘‘totaling
approximately 2,515 dosage units.’’ Id.
These included five prescriptions for
880 Norco (hydrocodone/apap) 10/
325mg, five prescriptions for 600 Soma
350mg, one prescription for 10
oxycodone 15mg, two prescriptions for
35 oxycodone 30mg, five prescriptions
for 540 Xanax 2mg, and five
prescriptions for 450 Fiorinal with
codeine. Id. Here again, Applicant
issued the patient up to four controlled
substance prescriptions at a single visit.
Id. at 14.
The Board then identified multiple
failures on Applicant’s part in
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complying with its regulations. These
included:
(1) That the most recent MRI was five
years old, and while it showed that
Patient #3 had ‘‘degenerative disc and
hypertrophy issues along with prolapse
of L5–S1,’’ there was ‘‘no mention of
consultation or referral to a specialist to
attempt other modalities of treatment’’;
(2) Applicant ‘‘determined that the
best course of treatment was to continue
the prescriptions previously issued to
[her] by prior physicians, along with
warm baths and use of heating pads’’;
however, ‘‘[t]here [was] no . . .
justification as to why the patient
needed this particular combination of
medications in these particular
quantities and strengths’’;
(3) Patient #3’s medical record
‘‘contained no psychiatric analysis to
determine the necessity for the use of
Xanax. If the Xanax was prescribed for
the purpose of muscle relaxation, then
there [was] no indication to include
Soma in the medication regime’’;
(4) Patient #3’s file ‘‘contained
indicators or ‘red flags’ suggesting
possible drug abuse by’’ her, including
that she was driving from Kenner,
Louisiana to Picayune, Mississippi; that
she claimed to have gone to the
emergency room (ER) for pain related
reasons, but Applicant did not attempt
to verify her claim; and that after Patient
#3 claimed to have gone to the ER,
Applicant added oxycodone 15mg to
her medications, and then increased the
dosage to 30mg on a subsequent visit,
even though Patient #3 reported a
‘‘significant pain reduction and
improvement’’ during that period; and
(5) Applicant issued Patient #3 new
prescriptions ‘‘at times when [she]
should not have finished taking the
same medication from a previous
prescription had the prescription
directions been properly followed.’’
Id. at 15–17.
As for Patient #4, the Board found
that from May 19 through August 10,
2010, Applicant issued her twelve (12)
controlled substance prescriptions for a
total of approximately 1,290 dosage
units. Id. at 17. These included four (4)
prescriptions for 570 Lorcet
(hydrocodone/acetaminophen) 10/
650mg, four prescriptions for 480 Soma
350mg, and four prescriptions for 240
Xanax 2mg. Id. Here again, Applicant
issued prescriptions for all drugs at each
of her four visits. Id. at 17–18.
The Board then identified multiple
failures on Applicant’s part in
complying with its regulations. These
included:
(1) That while Patient #4 reported a
very high pain level throughout
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treatment, ‘‘there was no real analgesic
response to the medication or
improvement in general; and the
continued prescribing of opiates and
other controlled medications for pain
was not supported’’;
(2) Patient #4’s MRI ‘‘show[ed] some
mild degenerative changes,’’ but was
otherwise ‘‘unremarkable’’ and did not
support ‘‘the amount of pain the patient
was reporting’’; however, ‘‘there [was]
no outside consultation to determine the
etiology of the patient’s severe pain’’;
(3) there was ‘‘no psychiatric
evaluation’’ to support the prescribing
of Xanax, and if ‘‘Xanax was being
prescribed for muscle relaxation, then
there [was] no justification for the
additional prescribing of Soma’’;
(4) Applicant subjected Patient #4 to
a single urine drug screen, which
occurred at her initial visit; however,
given her history, ‘‘it was not
appropriate to test [her] once at the
beginning of treatment and not . . .
during the treatment’’;
(5) Applicant ‘‘continued the
prescriptions previously issued to [her]
by previous physicians and there [was]
no indication or justification as to why
[she] need[ed] this particular
combination of medications in these
particular quantities and strengths’’;
Applicant also recommended no
treatment modalities ‘‘[o]ther than
controlled substances, warm baths and
heating pads’’;
(6) Patient #4’s file contained various
red flags suggesting drug abuse,
including that she had been discharged
by a Louisiana pain clinic for testing
positive on multiple occasions for drugs
she had not been prescribed. The red
flags included: (a) An incident, four
months earlier, when she tested positive
for oxycodone, which had not been
prescribed to her and she admitted that
she used her husband’s Percocet; and (b)
two incidents, which had occurred only
two and three months before Applicant
began prescribing to her, in which she
attempted to use another person’s urine
during a urine drug screen. While
Applicant obtained these records the
day before he first prescribed controlled
substances to Patient #4, he did not
document having discussed these
incidents with her; and
(7) Applicant issued new
prescriptions to Patient #4 ‘‘at times
when [she] should not have finished
taking the same medication from a
previous prescription had the
prescription directions been properly
followed or the correct dosage taken.’’
Id. at 18–20.
Based on these findings, the Board
found Applicant guilty of four counts of
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‘‘administering, dispensing, or
prescribing . . . narcotic drugs, or other
drugs having addiction-forming or
addiction-sustaining liability otherwise
than in the course of legitimate
professional practice.’’ Id. at 21 (citing
Miss. Code Ann. § 73–25–29(3)). It also
found Applicant guilty of four counts of
‘‘prescribing controlled substances or
other drugs having addiction-forming or
addiction-sustaining liability for chronic
pain in a non-therapeutic manner.’’ Id.
at 22 (citing id. § 73–25–29(13)). The
Board further found Applicant guilty of
four counts of ‘‘prescribing controlled
substances for the treatment of chronic
pain to a patient who has consumed or
disposed of controlled substances and
other drugs having addiction forming or
addiction sustaining liability other than
in strict compliance with [his]
directions.’’ Id. (citing Miss. Code Ann.
§ 73–25–29(13)).’’ 7
The Board also found that during his
testimony, Applicant ‘‘expressed very
little understanding of the disease of
addiction and possible drug abuse,’’ and
that this, when, combined ‘‘with [the]
clear evidence’’ that he ‘‘failed to
comply with the Board’s rules . . .
increased the risk of harm to the
public.’’ Id. The Board further found
that Applicant ‘‘either failed to identify
or chose to ignore clear evidence of drug
seeking behavior by the very patients he
has an obligation to treat, heal and
protect.’’ Id. Finally, the Board found
that Applicant ‘‘willingly participated
in a medical clinic . . . [which] had
[the] primary purpose [of] hand[ing]-out
controlled substances.’’ Id. at 22–23.
Discussion
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Section 303(f) of the Controlled
Substances Act (CSA) provides that an
application for a practitioner’s
registration may be denied ‘‘if the
Attorney General determines that the
issuance of such registration . . . would
be inconsistent with the public
interest.’’ 21 U.S.C. 823(f). In making
this determination, Congress directed
that the following factors be considered:
7 In addition, the Board found Applicant guilty of
four counts of ‘‘failing to conduct an appropriate
risk/benefit analysis by review of previous medical
history which was provided by another treating
physician, which indicates there is a need for longterm controlled substances therapy,’’ as well as
‘‘fail[ing] to clearly enter into the record the
analysis and a consultation/referral report which
determines the underlying pathology or cause of the
chronic pain.’’ GX 3, at 21 (citing Miss. Code Ann.
§ 73–25–29(13)). Finally, the Board found Applicant
guilty of four counts of ‘‘failing to document a
written treatment plan which contains stated
objectives as a measure of successful treatment and
planned diagnostic evaluations, e.g., psychiatric
evaluation or other treatments.’’ Id. at 21–22 (citing
Miss. Code Ann. § 73–25–29(13)).
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(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.
71663
meet the CSA’s threshold requirement
that he be ‘‘authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Rather, he seeks
registration in California, where, while
he is the subject of an Accusation filed
by the Medical Board of California
(MBC) (which is based on the
Mississippi Board’s Order), he
nonetheless holds a current Physician’s
and Surgeon’s Certificate. Because
Applicant seeks registration in
Id. ‘‘These factors are . . . considered in California, the MBC, and not the
the disjunctive.’’ Robert A. Leslie, M.D.,
Mississippi Board is the ‘‘appropriate
68 FR 15227, 15230 (2003). I ‘‘may rely
[s]tate licensing board’’ for the purpose
on any one or a combination of factors
of factor one.
and may give each factor the weight
Here, the MBC has not made a formal
. . . [I] deem[ ] appropriate in
recommendation to the Agency as to
determining whether . . . an
what action should be taken in this
application for registration [should be]
matter. Moreover, Applicant currently
denied.’’ Id.; see also Kevin Dennis,
holds an active California medical
M.D., 78 FR 52787, 52794 (2013);
license.
MacKay v. DEA, 664 F.3d 808, 816 (10th
That being said, ‘‘the Agency has long
Cir. 2010).
held that possession of state authority is
The Government has the burden of
not dispositive of the public interest
proving, by substantial evidence, that
inquiry.’’ George Mathew, 75 FR 66138,
the requirements for the denial of an
66145 (2010), pet. for rev. denied,
application, pursuant to 21 U.S.C.
Mathew v. DEA, No. 10–73480, slip. op.
823(f), are met. 21 CFR 1301.44(e). This
at 5 (9th Cir. Mar. 16, 2012). Instead,
is so even in a non-contested case.
‘‘the Controlled Substances Act requires
Gabriel Sanchez, M.D., 78 FR 59060,
that the Administrator . . . make an
59063 (2013). Having considered all of
independent determination [from that
made by state officials] as to whether
the factors,8 I conclude that the
the granting of controlled substance
Government’s evidence with respect to
privileges would be in the public
factors two and four establishes, prima
interest.’’ Mortimer Levin, 57 FR 8680,
facie, that the issuance of a new
8681 (1992). Thus, the fact that
registration to Applicant ‘‘would be
Applicant currently has an active
inconsistent with the public interest.’’
California license neither weighs in
21 U.S.C. 823(f).
favor of, or against a finding that issuing
Factor One: The Recommendation of the a new registration ‘‘would be
Appropriate State Licensing Board
inconsistent with the public interest.’’
Noting the various findings of the
21 U.S.C. 823(f).
Mississippi Board, the Government
Factors Two and Four: The Applicant’s
argues that ‘‘[i]n light of the Board’s
Experience in Dispensing Controlled
Order, factor one weighs heavily in
Substances and Compliance With
favor of a finding that granting
Applicable State or Federal Laws
Applicant’s . . . registration would be
To effectuate the dual goals of
inconsistent with the public interest.’’
conquering drug abuse and controlling
Request for Final Agency Action, at 4.
both the legitimate and illegitimate
While the Government is undoubtedly
traffic in controlled substances,
correct that the Board’s findings
‘‘Congress devised a closed regulatory
strongly support the denial of
system making it unlawful to
Applicant’s application—indeed, for
manufacture, distribute, dispense, or
reasons explained later, they are
possess any controlled substance except
conclusive—its contention that factor
in a manner authorized by the CSA.’’
one supports the denial of the
Gonzales v. Raich, 545 U.S. 1, 13 (2005).
application is misplaced.
With respect to the dispensing of
Here, Applicant does not seek a new
controlled substances, the closed system
registration in Mississippi, where,
is maintained by a longstanding Agency
because he has not been reinstated to
regulation, which provides that ‘‘[a]
practice medicine, he does not even
prescription for a controlled substance
8 Having considered all of the factors, I conclude
[is not] effective [unless it is] issued for
that it is not necessary to make findings with
a legitimate medical purpose by an
respect to factors three (the applicant’s conviction
individual practitioner acting in the
record) and five (such other conduct which may
usual course of [his] professional
threaten public health and safety). See Jose G.
Zavaleta, M.D., 76 FR 49506, 49507 (2011).
practice.’’ 21 CFR 1306.04(a). The
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regulation further provides that ‘‘an
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 recently
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, 143 (1975)); see also
United States v. Alerre, 430 F.3d 681,
691 (4th Cir. 2005), cert. denied, 547
U.S. 1113 (2006) (prescription
requirement stands as a proscription
against doctors acting not ‘‘as a healer[,]
but as a seller of wares’’).
As found above, following a hearing
before the Mississippi Board, at which
Applicant was represented by counsel,
the Board made extensive factual
findings regarding his treatment of four
patients. Most significantly, the Board
found Applicant guilty of four counts of
‘‘administering, dispensing, or
prescribing . . . narcotic drugs, or other
drugs having addiction-forming or
addiction-sustaining liability otherwise
than in the course of legitimate
professional practice.’’ GX 3, at 21
(citing Miss. Code Ann. § 73–25–29(3))
(emphasis added). It also found
Applicant guilty of four counts of
‘‘prescribing controlled substances or
other drugs having addiction-forming or
addiction-sustaining liability for chronic
pain in a non-therapeutic manner.’’ Id.
at 22 (citing id. § 73–25–29(13))
(emphasis added). The Board further
found Applicant guilty of four counts of
‘‘prescribing controlled substances for
the treatment of chronic pain to a
patient who has consumed or disposed
of controlled substances and other drugs
having addiction forming or addiction
sustaining liability other than in strict
compliance with [his] directions.’’ Id.
(citing Miss. Code Ann. § 73–25–29(13)).
Because Applicant had a full and fair
opportunity to litigate the issues raised
in the Mississippi Board proceeding—
and in fact, was represented by counsel
and did apparently litigate the issues—
the Board’s findings are entitled to
preclusive effect in this proceeding. See
Robert L. Dougherty, M.D., 76 FR 16823,
16830 (2011) (citing cases); see also
Univ. of Tenn. v. Elliot, 478 U.S. 788,
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17:56 Nov 27, 2013
Jkt 232001
797–98 (1986) (‘‘When an
administrative agency is acting in a
judicial capacity and resolves disputed
issues of fact properly before it which
the parties have had an adequate
opportunity to litigate, the courts have
not hesitated to apply res judicata[.]’’)
(internal quotations and citations
omitted); David A. Ruben, M.D., 78 FR
38363, 38365–67 (2013) (collateral
estoppel precludes a party from relitigating issues of fact or law that were
previously decided against him in a
state board proceeding); cf. Jose G.
Zavaleta, M.D., 78 FR 27431, 27431–34
(2013) (‘‘[a]llowing an applicant to
relitigate issues which he/she had a full
and fair opportunity to litigate in a prior
proceeding but chose not to’’ will likely
result in unnecessary waste of agency
resources).
Moreover, the Board’s findings that
Applicant prescribed controlled
substances ‘‘otherwise than in the
course of legitimate professional
practice’’ and ‘‘in a non-therapeutic
manner,’’ in violation of State law, also
establish that he acted outside of ‘‘the
usual course of professional practice’’
and without a ‘‘legitimate medical
purpose’’ in prescribing to the four
patients identified in the Board’s Order,
and thus also violated the CSA.9 21 CFR
1306.04(a); Cf. Kenneth Harold Bull, 78
FR 62666, 62674–75 n. 9 (2013)
(rejecting ALJ’s conclusion that state
board’s finding established violations of
21 CFR 1306.04(a), noting that state
board’s ‘‘injudicious prescribing’’
standard was ‘‘not equivalent to the
standard imposed under 21 CFR
1306.04(a)’’). As the Board further
found, Applicant ‘‘willingly
participated in a medical clinic . . .
[which] had [the] primary purpose [of]
hand[ing]-out controlled substances.’’
GX 3, at 22–23. Thus, I conclude that
the State Board’s findings support a
9 In addition, the Board found Applicant guilty of
four counts of ‘‘failing to conduct an appropriate
risk/benefit analysis by review of previous medical
history which was provided by another treating
physician, which indicates there is a need for longterm controlled substances therapy’’ and by
‘‘fail[ing] to clearly enter into the record the
analysis and a consultation/referral report which
determines the underlying pathology or cause of the
chronic pain.’’ GX 3, at 21 (citing Miss. Code Ann.
§ 73–25–29(13)). Finally, the Board found Applicant
guilty of four counts of ‘‘failing to document a
written treatment plan which contains stated
objectives as a measure of successful treatment and
planned diagnostic evaluations, e.g., psychiatric
evaluation or other treatments.’’ Id. at 21–22 (citing
Miss. Code Ann. § 73–25–29(13)). Not that it is
needed given the Board’s findings which are
discussed above, these findings provide additional
support for the conclusion that Applicant acted
outside the usual course of professional practice
and lacked a legitimate medical purpose in
prescribing controlled substances to the four
patients. 21 CFR 1306.04(a).
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Frm 00104
Fmt 4703
Sfmt 4703
finding that Applicant knowingly and
intentionally diverted controlled
substances. See 21 U.S.C. 841(a)(1). I
therefore hold that the Government has
met its prima facie burden of showing
why issuing a new registration to
Applicant ‘‘would be inconsistent with
the public interest.’’ Id. § 823(f).10
It is acknowledged that Applicant
does not seek authority to dispense
controlled substances in schedules II
and III, but rather only those in
schedule IV and V. GX 2, at 1. Be that
as it may, the findings of the State Board
conclusively establish that his
misconduct is egregious and that he
cannot be entrusted with authority to
dispense controlled substances in any
schedule, a conclusion which stands
unrefuted given that Applicant waived
his right to a hearing or to submit a
written statement. Accordingly, because
there is no evidence that Applicant
acknowledges his misconduct and has
undertaken any remedial measures,11 I
conclude that denial of his application
is necessary to protect the public
interest. See, e.g., Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(‘‘where a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[his] actions and demonstrate that [he]
will not engage in future misconduct’’);
see also Jose G. Zavaleta, M.D., 76 FR
49506, 49507 (2011) (denying
10 The Board also found that Applicant ignored
multiple red flags that the four patients were
abusing controlled substances. These included that
the patients sought early refills and did not comply
with his dosing instructions, two patients had been
terminated by prior physicians for non-compliance
(one of whom was obtaining controlled substances
from multiple doctors), another patient was driving
a long distance to see him, and another patient had
not only tested positive for a controlled substance
which had not been prescribed to her, but twice
attempted to use another person’s urine when
subjected to a urine drug screen.
These findings provide further support for the
conclusion that issuing a new registration to
Applicant ‘‘would be inconsistent with the public
interest.’’ 21 U.S.C. 823(f). As the Administrator has
held, ‘‘[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
naive.’’ Jayam Krishna-Iyer, M.D., 74 FR 459, 460
n.3 (2009); see also Bienvenido Tan, M.D., 76 FR
17673, 17689 (2011) (quoting Paul J. Caragine, Jr.,
63 FR 51592, 51601 (1998)) (‘‘Just because
misconduct is unintentional, innocent or devoid of
improper motivation, [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.).
11 As found above, the Mississippi Board required
Applicant, as a condition of reinstatement, to take
courses in controlled substance prescribing,
recordkeeping, and medical ethics. There is,
however, no evidence that he has taken any of these
courses.
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application for DEA registration in
schedules IV and V where doctor
violated federal law by, inter alia,
issuing prescriptions outside the usual
course of professional practice).
Accordingly, I will order that his
application be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I order that the
application of Zizhuang Li, M.D., for a
DEA Certificate of Registration as a
practitioner be, and it hereby is, denied.
This order is effective immediately.
Dated: November 21, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013–28525 Filed 11–27–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Office of Justice Programs
[OMB Number 1121–0224]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; National Youth
Gang Survey
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
60-Day Notice.
The U.S. Department of Justice, Office
of Justice Programs, Office of Juvenile
Justice and Delinquency Prevention,
will be submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The proposed
information collection is published to
obtain comments from the public and
affected agencies. Comments are
encouraged and will be accepted for ‘‘60
days’’ until January 28, 2014. This
process is conducted in accordance with
5 CFR 1320.10.
If you have additional comments,
especially on the estimated public
burden or associated reponse time, or
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Mr. Dennis Mondoro, (202) 514–3913,
Office of Juvenile Justice and
Delinquency Prevention, Office of
Justice Programs, U.S. Department of
Justice, 810 Seventh Street NW.,
Washington, DC 20531.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
VerDate Mar<15>2010
17:56 Nov 27, 2013
Jkt 232001
comments should address one or more
of the following four points:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility.
• 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.
• Enhance the quality, utility, and
clarity of the information to be
collected.
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology;
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection:
Extension of a currently approved
collection.
2. Title of the Form/Collection:
National Youth Gang Survey.
3. Agency form number, if any, and
the applicable component of the U.S.
Department of Justice sponsoring the
collection: Office of Juvenile Justice and
Delinquency Prevention, Office of
Justice Programs, United States
Department of Justice.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Local, state, or tribal law
enforcement agencies.
Other: None.
Abstract: This collection will gather
information related to youth and their
activities for research and assessment
purposes.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that 2,100
respondents will take ten minutes each
to complete the survey.
6. An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 424
total annual burden hours associated
with this collection.
If additional information is required,
contact Jerri Murray, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE., Suite 3W–
1407B, Washington, DC 20530.
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71665
Dated: November 25, 2013.
Jerri Murray,
Department Clearance Officer for PRA,
United States Department of Justice.
[FR Doc. 2013–28606 Filed 11–27–13; 8:45 am]
BILLING CODE 4410–18–P
DEPARTMENT OF LABOR
Office of the Assistant Secretary for
Administration and Management;
Agency Information Collection
Activities; Comment Request;
Application for Use of Public Space by
Non-DOL Agencies in the Frances
Perkins Building
ACTION:
Notice.
The Department of Labor
(DOL) is soliciting comments
concerning an Information Collection
Request (ICR) proposing to extend
Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501 et seq., authority
to conduct the information collection
titled, ‘‘Application for Use of Public
Space by Non-DOL Agencies in the
Frances Perkins Building.’’ This
comment request is part of continuing
Departmental efforts to reduce
paperwork and respondent burden.
DATES: Submit written comments on or
before January 28, 2014.
ADDRESSES: Contact Michel Smyth by
telephone at 202–693–4129 (this is not
a toll-free number) to request a free copy
of this ICR that includes applicable
supporting documentation providing a
description of the likely respondents,
proposed frequency of response, and
estimated total burden. Submit written
comments about, or requests for a copy
of, this ICR by mail or courier to the
U.S. Department of Labor-OASAM,
Office of the Chief Information Officer,
Attn: Information Policy and
Assessment Program, Room N1301, 200
Constitution Avenue NW., Washington,
DC 20210; or by email: DOL_PRA_
PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Contact Michel Smyth by telephone at
202–693–4129 (this is not a toll-free
number) or by email at DOL_PRA_
PUBLIC@dol.gov.
SUMMARY:
Authority: 44 U.S.C. 3506(c)(2)(A).
The DOL
headquarters building, the Frances
Perkins Building (FPB), has conference
and meeting capabilities located in its
public space areas that non-DOL entities
may request to use. The Administrator
of the General Services Administration
set forth terms and conditions
delegating FPB operation to the DOL,
Office of the Assistant Secretary for
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71660-71665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28525]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Zizhuang Li, M.D.; Decision and Order
On June 10, 2013, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Zizhuang Li, M.D. (Applicant), of Leawood, Kansas. GX 5.
The Show Cause Order proposed the denial of Applicant's application for
a DEA Certificate of Registration as a practitioner, on the ground that
his ``registration would be inconsistent with the public interest.''
Id. at 1 (citing 21 U.S.C. 823(f)).
As basis for the denial, the Show Cause Order alleged that ``[o]n
September 27, 2012, the Mississippi State Board of Medical Licensure
(Board) found that from April through August 2010, [Applicant]
prescribed controlled substances, including oxycodone, carisoprodol,
and alprazolam, outside the course of professional practice to four
patients.'' Id. Next, the Show Cause Order alleged that the Board found
that Applicant ``engaged in unprofessional conduct'' by failing ``to
conduct an appropriate risk/benefit analysis for [his] patients,'' and
that he also ``failed to document proper written treatment plans.'' Id.
(citing Miss. Code Ann. Sec. Sec. 73-25-29(8)(d) & (13); 73-25-83(a)).
The Order then alleged that based on its findings, the Board suspended
Applicant's medical license for twelve months.\1\ Id.
---------------------------------------------------------------------------
\1\ The Show Cause Order also notified Applicant of his right to
request a hearing on the allegations or to submit a written
statement while waiving his right to a hearing, the procedure for
electing either option, and the consequence of failing to elect
either option. GX 5, at 2-3 (citing 21 CFR 1301.43).
---------------------------------------------------------------------------
On June 10, 2013, the Government attempted to serve the Show Cause
Order by certified mail, return receipt requested, addressed to
Applicant at the address he provided on his application for receiving
mail from the Agency. GX 6, at 1. However, on July 6, 2013, the
Government queried the Postal Service's Track and Confirm Web page and
determined that the mailing had not been accepted.\2\ Accordingly, on
July 9, 2013, the Government mailed the Show Cause Order to Applicant
at the same address using first class mail. Id. That same day, DEA also
emailed an electronic version of the Show Cause Order to two email
addresses purportedly used by Applicant, including the address which he
had provided on his application for registration.\3\ Id. Neither email
was returned as undeliverable or resulted in an error message. Id.
---------------------------------------------------------------------------
\2\ On July 12, 2013, the mailing was returned to DEA and marked
as ``Return to sender, unclaimed, unable to forward, returned to
sender.'' GX 6, at 1.
\3\ Regarding the two email addresses, the Diversion
Investigator (DI), who investigated the application, ``discovered
that [Applicant] gave the Board the email address of
jacksonstone22@hotmail.com . . . [and] [o]n a residential rental
application in San Diego . . . Applicant listed his email address as
zizhuangli@yahoo.com.'' GX 4, at 2. The latter is the same email
address Applicant provided on his DEA application.
---------------------------------------------------------------------------
Based on the above, I find that the Government has complied with
its obligation ``to provide `notice, reasonably calculated under all
the circumstances, to apprise [Applicant] of the pendency of the action
and afford [him] an opportunity to present [his] objections.' '' Jones
v. Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)); see also Emilio
Luna, 77 FR 4829, 4830 n.2 (2012) (``[I]t seems relatively clear that
when certified mail is returned unclaimed, in most cases, the
Government can satisfy its constitutional obligation by simply re-
mailing the Show Cause Order by regular first class mail.'') (citing
Jones, 547 U.S. at 234-35).
On August 20, 2013, the Government submitted its Request for Final
Agency Action, along with the Investigative Record. Based on the
Government's submission, I further find that more than thirty days have
now passed since service of the Show Cause Order was accomplished, and
neither Applicant, nor anyone purporting to represent him, has either
requested a hearing or submitted a written statement in lieu of a
hearing. 21 CFR 1301.43(a) & (c). Accordingly, I find that Applicant
has waived his right to a hearing or to submit a written statement. 21
CFR 1301.43(d). I therefore issue this Decision and Final Order based
on relevant material contained in the Investigative Record submitted by
the Government. I make the following findings of fact.
[[Page 71661]]
Findings
Applicant's Registration and Licensure Status
Applicant previously held three DEA Certificates of Registration,
pursuant to which he was authorized to dispense controlled substances
in schedules II through V. GX 2, at 2; GX 3, at 2. Two of the
registrations (at least one of which was for a location in Mississippi)
were retired on September 28, 2012, apparently after Applicant
voluntarily surrendered them. GX 2. As for the third registration, it
was retired on May 1, 2010. Id. However, there is no evidence
establishing why this registration was retired.
On November 16, 2012, Applicant applied for a new registration at
the proposed registered address of 20265 Valley Boulevard, Suite E,
Walnut, California. GX 1, at 1. Applicant sought authority limited to
dispensing controlled substances in schedules IV and V. GX 2, at 1. It
is this application which is at issue in this matter.
Applicant also holds a current Physician's and Surgeon's
Certificate issued by the Medical Board of California. GX 1, at 1.
Applicant's California license is not due to expire until December 31,
2013.\4\ Id.
---------------------------------------------------------------------------
\4\ Pursuant to 5 U.S.C. 556(e) and 21 CFR 1316.59, I take
official notice that on December 28, 2012, the California Board
issued an Accusation/Petition to Revoke Applicant's state license
based on the results of the Mississippi Board's action. That matter
is still pending.
I have also taken official notice of the fact that Applicant
voluntarily surrendered his Louisiana medical license (MD.204358) on
October 8, 2012.
---------------------------------------------------------------------------
Applicant was also licensed by the Mississippi State Board of
Medical Licensure. However, as found below, on June 8, 2012, the Board
initiated a proceeding against Applicant, alleging twenty-four counts
of violations of Mississippi law. GX 3, at 1. Following a hearing on
September 27, 2012, at which Applicant was represented by counsel, the
Board suspended his state license for a period of twelve months, which
was effective immediately. Id. at 23-24. Moreover, ``[n]otwithstanding
the twelve (12) month period'' of suspension, the Board ordered that
``Licensee shall not practice medicine in any manner or form, until
such time as he appears before this Board, [and] submits proof of
compliance with all requirements set forth in [the] order, as well as
Miss. Code Ann. [Sec. ] 73-25-32.'' \5\ Id. at 23. The Board also
required that Applicant complete courses in controlled substance
prescribing, recordkeeping, and medical ethics, and that he pay ``all
costs incurred in relation to the . . . matter . . . not to exceed
$10,000.'' Id. at 23-24.
---------------------------------------------------------------------------
\5\ This statute provides that ``[a] person whose license to
practice medicine . . . has been revoked or suspended may petition
the [Board] to reinstate this license after a period of not less
than one (1) year has elapsed from the date of the revocation or
suspension.'' Miss. Code Ann. Sec. 73-25-32(1). The statute further
requires that the petition ``be accompanied by two (2) or more
verified recommendations from physicians . . . licensed by the Board
. . . and by two (2) or more recommendations from citizens each
having personal knowledge of the activities of the petitioner since
the disciplinary penalty was imposed and such facts as may be
required by the Board.'' Id. Sec. 73-25-32(2).
---------------------------------------------------------------------------
The Board's Findings
Based on the evidence presented at the hearing, the Board made
extensive findings regarding Applicant's prescribing of controlled
substances to four patients. GX 3, at 1-23. With respect to Patient
1, a thirty-three year old male, the Board found that
Applicant issued him twenty-one (21) prescriptions for controlled
substances (totaling 2,415 dosage units) during the period of April 26
through August 18, 2010. Id. at 4. The prescriptions included one
prescription for 60 Percocet 10/650mg, six prescriptions for 945
oxycodone 30mg, five prescriptions for 450 Xanax 2mg, 600 Soma
(carisoprodol) 350mg, and four prescriptions for 360 Neurontin
(gabapentin) 300mg.\6\ The Board further found that Applicant
repeatedly prescribed multiple drugs to Patient 1 at a visit,
including Xanax, Soma, and oxycodone. Id. at 5-6.
---------------------------------------------------------------------------
\6\ Carisoprodol did not become a federally controlled substance
until January 11, 2012, when its placement into schedule IV of the
Controlled Substances Act became effective. See DEA, Schedules of
Controlled Substances: Placement of Carisoprodol into Schedule IV,
76 FR 77330 (2011). However, several DEA final orders had previously
discussed the abuse of carisoprodol in conjunction with other
controlled substances, including opiates such as oxycodone and
hydrocodone, and benzodiazepines, such as alprazolam and diazepam.
See, e.g., Paul H. Volkman, 73 FR 30630, 30638 (2008) (noting
expert's testimony regarding prescribing of drug cocktails of a
narcotic, benzodiazepine, and carisoprodol, and that the cocktail,
which ``is very popular amongst those individuals who go to doctors'
offices to take drugs to abuse them,'' also ``increase[s] the
likelihood of sedation, respiratory depression and death.'') (other
citations omitted).
Neurontin (gabapentin) is not a federally controlled substance.
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The Board then identified multiple failures by Applicant to follow
its regulations for the ``Use of Controlled Substances for Chronic
(Non-Terminal) Pain'' in prescribing to Patient 1. These
included that:
(1) Applicant ``allowed the patient to dictate his care by
continually prescribing controlled substances for pain notwithstanding
[his] recommendation that the patient should have surgery'';
(2) notwithstanding evidence in the patient's medical record that
he ``visited multiple pharmacies and physicians in the past,'' the
record ``contained no record of prior treatment and there [was] no
information . . . suggesting that [Applicant] conducted an appropriate
risk/benefit analysis by reviewing his own records . . . or records''
of prior treating physicians;
(3) there was no documentation that Applicant discussed with
Patient 1 ``taking medication as prescribed'';
(4) there was no indication that Applicant sought ``outside
consultation to determine the origin of the patient's pain,'' or
recommended treatment modalities (beyond prescribing controlled
substances) other than ``warm baths and heating pads'';
(5) there was ``only one urine drug screen'' in Patient
1's chart, which was done at his initial visit and there were
``[n]o subsequent drugs screens [in] the record to document compliance
with treatment'';
(6) Patient 1 ``continued to come early for each visit and
[Applicant] continued to write prescriptions on each early visit'';
(7) Patient 1's file ``contained . . . `red flags'
suggesting possible drug abuse by Patient 1''; and
(8) Applicant ``issued Patient 1 prescriptions at times
when [he] should not have finished taking the same medication from a
previous prescription had the . . . directions been properly followed
or the correct dosage . . . taken.''
GX 3, at 7-9.
As for Patient 2, the Board found that from April 6
through August 9, 2010, Applicant ``issued to [him] twenty four (24)
prescriptions totaling approximately 2,178 dosage units of controlled
substances,'' including six (6) prescriptions for 352 Lortab 10/500mg
(hydrocodone/acetaminophen), six prescriptions for 704 Soma
(carisoprodol) 350mg, six prescriptions for 704 oxycodone 30mg, and six
prescriptions for 418 Xanax 2mg. GX 3, at 9. Here again, the Board's
findings show that Applicant repeatedly dispensed prescriptions for all
four of these drugs to Patient 2 on a single day.
The Board then identified multiple failures on Applicant's part in
complying with its regulations. These included:
(1) Patient 2's ``chart shows very little physical exam
conclusions and hardly any pathology . . . which would indicate the
therapeutic nature for prescribing the particular controlled substances
in the quantities and strengths so noted'';
[[Page 71662]]
(2) Applicant noted in the chart that he recommended that Patient
2 see an orthopedic specialist, yet there was ``no
documentation or further mention of whether a referral was made or if
Patient 2 saw an orthopedist'';
(3) Applicant issued Patient 2 new prescriptions on June
11, 2010, ``only 18 days after [his] visit on May 24,'' while noting in
the chart that the visit had occurred on June 21, 2010, and there was
no explanation in the chart for issuing the prescriptions early, nor
``any significant change in the verbal pain scale'' to support the
``increased consumption of the prior issued medications'';
(4) Applicant ``continued to prescribe controlled substances for
pain without any analysis regarding the effectiveness of the
medications'' and there was ``no documentation of other treatment
modalities (other than recommending warms baths and heating pads)'';
(5) Applicant ``allowed Patient 2 to dictate his care by
simply continuing previous prescriptions for controlled substances,
failing to follow up on his own recommendations regarding referral to
an orthopedist, and, at a minimum, failing to recognize non-compliance
by the patient''; and
(6) Patient 2's chart ``contained indicators or `red
flags' suggesting possible drug abuse,'' including: (a) Documentation
suggesting that Patient 2 had previously been terminated for
noncompliance with a treatment plan by a prior pain management
physician; (b) a printout from a pharmacy showing that Patient
2 was obtaining controlled substances from multiple doctors;
and (c) Applicant ``continued to write new prescriptions for controlled
substances at a time when the previous prescriptions for the same
medications would not have been completed had the patient followed''
the dosing instructions.
Id. at 11-13.
With respect to Patient 3, the Board found that from April
7 through August 2, 2010, Applicant issued twenty-three controlled
prescriptions to her ``totaling approximately 2,515 dosage units.'' Id.
These included five prescriptions for 880 Norco (hydrocodone/apap) 10/
325mg, five prescriptions for 600 Soma 350mg, one prescription for 10
oxycodone 15mg, two prescriptions for 35 oxycodone 30mg, five
prescriptions for 540 Xanax 2mg, and five prescriptions for 450
Fiorinal with codeine. Id. Here again, Applicant issued the patient up
to four controlled substance prescriptions at a single visit. Id. at
14.
The Board then identified multiple failures on Applicant's part in
complying with its regulations. These included:
(1) That the most recent MRI was five years old, and while it
showed that Patient 3 had ``degenerative disc and hypertrophy
issues along with prolapse of L5-S1,'' there was ``no mention of
consultation or referral to a specialist to attempt other modalities of
treatment'';
(2) Applicant ``determined that the best course of treatment was to
continue the prescriptions previously issued to [her] by prior
physicians, along with warm baths and use of heating pads''; however,
``[t]here [was] no . . . justification as to why the patient needed
this particular combination of medications in these particular
quantities and strengths'';
(3) Patient 3's medical record ``contained no psychiatric
analysis to determine the necessity for the use of Xanax. If the Xanax
was prescribed for the purpose of muscle relaxation, then there [was]
no indication to include Soma in the medication regime'';
(4) Patient 3's file ``contained indicators or `red flags'
suggesting possible drug abuse by'' her, including that she was driving
from Kenner, Louisiana to Picayune, Mississippi; that she claimed to
have gone to the emergency room (ER) for pain related reasons, but
Applicant did not attempt to verify her claim; and that after Patient
3 claimed to have gone to the ER, Applicant added oxycodone
15mg to her medications, and then increased the dosage to 30mg on a
subsequent visit, even though Patient 3 reported a
``significant pain reduction and improvement'' during that period; and
(5) Applicant issued Patient 3 new prescriptions ``at
times when [she] should not have finished taking the same medication
from a previous prescription had the prescription directions been
properly followed.''
Id. at 15-17.
As for Patient 4, the Board found that from May 19 through
August 10, 2010, Applicant issued her twelve (12) controlled substance
prescriptions for a total of approximately 1,290 dosage units. Id. at
17. These included four (4) prescriptions for 570 Lorcet (hydrocodone/
acetaminophen) 10/650mg, four prescriptions for 480 Soma 350mg, and
four prescriptions for 240 Xanax 2mg. Id. Here again, Applicant issued
prescriptions for all drugs at each of her four visits. Id. at 17-18.
The Board then identified multiple failures on Applicant's part in
complying with its regulations. These included:
(1) That while Patient 4 reported a very high pain level
throughout treatment, ``there was no real analgesic response to the
medication or improvement in general; and the continued prescribing of
opiates and other controlled medications for pain was not supported'';
(2) Patient 4's MRI ``show[ed] some mild degenerative
changes,'' but was otherwise ``unremarkable'' and did not support ``the
amount of pain the patient was reporting''; however, ``there [was] no
outside consultation to determine the etiology of the patient's severe
pain'';
(3) there was ``no psychiatric evaluation'' to support the
prescribing of Xanax, and if ``Xanax was being prescribed for muscle
relaxation, then there [was] no justification for the additional
prescribing of Soma'';
(4) Applicant subjected Patient 4 to a single urine drug
screen, which occurred at her initial visit; however, given her
history, ``it was not appropriate to test [her] once at the beginning
of treatment and not . . . during the treatment'';
(5) Applicant ``continued the prescriptions previously issued to
[her] by previous physicians and there [was] no indication or
justification as to why [she] need[ed] this particular combination of
medications in these particular quantities and strengths''; Applicant
also recommended no treatment modalities ``[o]ther than controlled
substances, warm baths and heating pads'';
(6) Patient 4's file contained various red flags
suggesting drug abuse, including that she had been discharged by a
Louisiana pain clinic for testing positive on multiple occasions for
drugs she had not been prescribed. The red flags included: (a) An
incident, four months earlier, when she tested positive for oxycodone,
which had not been prescribed to her and she admitted that she used her
husband's Percocet; and (b) two incidents, which had occurred only two
and three months before Applicant began prescribing to her, in which
she attempted to use another person's urine during a urine drug screen.
While Applicant obtained these records the day before he first
prescribed controlled substances to Patient 4, he did not
document having discussed these incidents with her; and
(7) Applicant issued new prescriptions to Patient 4 ``at
times when [she] should not have finished taking the same medication
from a previous prescription had the prescription directions been
properly followed or the correct dosage taken.''
Id. at 18-20.
Based on these findings, the Board found Applicant guilty of four
counts of
[[Page 71663]]
``administering, dispensing, or prescribing . . . narcotic drugs, or
other drugs having addiction-forming or addiction-sustaining liability
otherwise than in the course of legitimate professional practice.'' Id.
at 21 (citing Miss. Code Ann. Sec. 73-25-29(3)). It also found
Applicant guilty of four counts of ``prescribing controlled substances
or other drugs having addiction-forming or addiction-sustaining
liability for chronic pain in a non-therapeutic manner.'' Id. at 22
(citing id. Sec. 73-25-29(13)). The Board further found Applicant
guilty of four counts of ``prescribing controlled substances for the
treatment of chronic pain to a patient who has consumed or disposed of
controlled substances and other drugs having addiction forming or
addiction sustaining liability other than in strict compliance with
[his] directions.'' Id. (citing Miss. Code Ann. Sec. 73-25-29(13)).''
\7\
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\7\ In addition, the Board found Applicant guilty of four counts
of ``failing to conduct an appropriate risk/benefit analysis by
review of previous medical history which was provided by another
treating physician, which indicates there is a need for long-term
controlled substances therapy,'' as well as ``fail[ing] to clearly
enter into the record the analysis and a consultation/referral
report which determines the underlying pathology or cause of the
chronic pain.'' GX 3, at 21 (citing Miss. Code Ann. Sec. 73-25-
29(13)). Finally, the Board found Applicant guilty of four counts of
``failing to document a written treatment plan which contains stated
objectives as a measure of successful treatment and planned
diagnostic evaluations, e.g., psychiatric evaluation or other
treatments.'' Id. at 21-22 (citing Miss. Code Ann. Sec. 73-25-
29(13)).
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The Board also found that during his testimony, Applicant
``expressed very little understanding of the disease of addiction and
possible drug abuse,'' and that this, when, combined ``with [the] clear
evidence'' that he ``failed to comply with the Board's rules . . .
increased the risk of harm to the public.'' Id. The Board further found
that Applicant ``either failed to identify or chose to ignore clear
evidence of drug seeking behavior by the very patients he has an
obligation to treat, heal and protect.'' Id. Finally, the Board found
that Applicant ``willingly participated in a medical clinic . . .
[which] had [the] primary purpose [of] hand[ing]-out controlled
substances.'' Id. at 22-23.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied ``if the
Attorney General determines that the issuance of such registration . .
. would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
In making this determination, 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.
Id. ``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 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 . . . an application for
registration [should be] denied.'' Id.; see also Kevin Dennis, M.D., 78
FR 52787, 52794 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2010).
The Government has the burden of proving, by substantial evidence,
that the requirements for the denial of an application, pursuant to 21
U.S.C. 823(f), are met. 21 CFR 1301.44(e). This is so even in a non-
contested case. Gabriel Sanchez, M.D., 78 FR 59060, 59063 (2013).
Having considered all of the factors,\8\ I conclude that the
Government's evidence with respect to factors two and four establishes,
prima facie, that the issuance of a new registration to Applicant
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
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\8\ Having considered all of the factors, I conclude that it is
not necessary to make findings with respect to factors three (the
applicant's conviction record) and five (such other conduct which
may threaten public health and safety). See Jose G. Zavaleta, M.D.,
76 FR 49506, 49507 (2011).
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Factor One: The Recommendation of the Appropriate State Licensing Board
Noting the various findings of the Mississippi Board, the
Government argues that ``[i]n light of the Board's Order, factor one
weighs heavily in favor of a finding that granting Applicant's . . .
registration would be inconsistent with the public interest.'' Request
for Final Agency Action, at 4. While the Government is undoubtedly
correct that the Board's findings strongly support the denial of
Applicant's application--indeed, for reasons explained later, they are
conclusive--its contention that factor one supports the denial of the
application is misplaced.
Here, Applicant does not seek a new registration in Mississippi,
where, because he has not been reinstated to practice medicine, he does
not even meet the CSA's threshold requirement that he be ``authorized
to dispense . . . controlled substances under the laws of the State in
which he practices.'' 21 U.S.C. 823(f). Rather, he seeks registration
in California, where, while he is the subject of an Accusation filed by
the Medical Board of California (MBC) (which is based on the
Mississippi Board's Order), he nonetheless holds a current Physician's
and Surgeon's Certificate. Because Applicant seeks registration in
California, the MBC, and not the Mississippi Board is the ``appropriate
[s]tate licensing board'' for the purpose of factor one.
Here, the MBC has not made a formal recommendation to the Agency as
to what action should be taken in this matter. Moreover, Applicant
currently holds an active California medical license.
That being said, ``the Agency has long held that possession of
state authority is not dispositive of the public interest inquiry.''
George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied, Mathew
v. DEA, No. 10-73480, slip. op. at 5 (9th Cir. Mar. 16, 2012). Instead,
``the Controlled Substances Act requires that the Administrator . . .
make an independent determination [from that made by state officials]
as to whether the granting of controlled substance privileges would be
in the public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992).
Thus, the fact that Applicant currently has an active California
license neither weighs in favor of, or against a finding that issuing a
new registration ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f).
Factors Two and Four: The Applicant's Experience in Dispensing
Controlled Substances and Compliance With Applicable State or Federal
Laws
To effectuate the dual goals of conquering drug abuse and
controlling both the legitimate and illegitimate traffic in controlled
substances, ``Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). With respect to the
dispensing of controlled substances, the closed system is maintained by
a longstanding Agency regulation, which provides that ``[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). The
[[Page 71664]]
regulation further provides that ``an 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 recently 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, 143 (1975)); see also United States v. Alerre, 430 F.3d 681, 691
(4th Cir. 2005), cert. denied, 547 U.S. 1113 (2006) (prescription
requirement stands as a proscription against doctors acting not ``as a
healer[,] but as a seller of wares'').
As found above, following a hearing before the Mississippi Board,
at which Applicant was represented by counsel, the Board made extensive
factual findings regarding his treatment of four patients. Most
significantly, the Board found Applicant guilty of four counts of
``administering, dispensing, or prescribing . . . narcotic drugs, or
other drugs having addiction-forming or addiction-sustaining liability
otherwise than in the course of legitimate professional practice.'' GX
3, at 21 (citing Miss. Code Ann. Sec. 73-25-29(3)) (emphasis added).
It also found Applicant guilty of four counts of ``prescribing
controlled substances or other drugs having addiction-forming or
addiction-sustaining liability for chronic pain in a non-therapeutic
manner.'' Id. at 22 (citing id. Sec. 73-25-29(13)) (emphasis added).
The Board further found Applicant guilty of four counts of
``prescribing controlled substances for the treatment of chronic pain
to a patient who has consumed or disposed of controlled substances and
other drugs having addiction forming or addiction sustaining liability
other than in strict compliance with [his] directions.'' Id. (citing
Miss. Code Ann. Sec. 73-25-29(13)).
Because Applicant had a full and fair opportunity to litigate the
issues raised in the Mississippi Board proceeding--and in fact, was
represented by counsel and did apparently litigate the issues--the
Board's findings are entitled to preclusive effect in this proceeding.
See Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011) (citing
cases); see also Univ. of Tenn. v. Elliot, 478 U.S. 788, 797-98 (1986)
(``When an administrative agency is acting in a judicial capacity and
resolves disputed issues of fact properly before it which the parties
have had an adequate opportunity to litigate, the courts have not
hesitated to apply res judicata[.]'') (internal quotations and
citations omitted); David A. Ruben, M.D., 78 FR 38363, 38365-67 (2013)
(collateral estoppel precludes a party from re-litigating issues of
fact or law that were previously decided against him in a state board
proceeding); cf. Jose G. Zavaleta, M.D., 78 FR 27431, 27431-34 (2013)
(``[a]llowing an applicant to relitigate issues which he/she had a full
and fair opportunity to litigate in a prior proceeding but chose not
to'' will likely result in unnecessary waste of agency resources).
Moreover, the Board's findings that Applicant prescribed controlled
substances ``otherwise than in the course of legitimate professional
practice'' and ``in a non-therapeutic manner,'' in violation of State
law, also establish that he acted outside of ``the usual course of
professional practice'' and without a ``legitimate medical purpose'' in
prescribing to the four patients identified in the Board's Order, and
thus also violated the CSA.\9\ 21 CFR 1306.04(a); Cf. Kenneth Harold
Bull, 78 FR 62666, 62674-75 n. 9 (2013) (rejecting ALJ's conclusion
that state board's finding established violations of 21 CFR 1306.04(a),
noting that state board's ``injudicious prescribing'' standard was
``not equivalent to the standard imposed under 21 CFR 1306.04(a)''). As
the Board further found, Applicant ``willingly participated in a
medical clinic . . . [which] had [the] primary purpose [of] hand[ing]-
out controlled substances.'' GX 3, at 22-23. Thus, I conclude that the
State Board's findings support a finding that Applicant knowingly and
intentionally diverted controlled substances. See 21 U.S.C. 841(a)(1).
I therefore hold that the Government has met its prima facie burden of
showing why issuing a new registration to Applicant ``would be
inconsistent with the public interest.'' Id. Sec. 823(f).\10\
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\9\ In addition, the Board found Applicant guilty of four counts
of ``failing to conduct an appropriate risk/benefit analysis by
review of previous medical history which was provided by another
treating physician, which indicates there is a need for long-term
controlled substances therapy'' and by ``fail[ing] to clearly enter
into the record the analysis and a consultation/referral report
which determines the underlying pathology or cause of the chronic
pain.'' GX 3, at 21 (citing Miss. Code Ann. Sec. 73-25-29(13)).
Finally, the Board found Applicant guilty of four counts of
``failing to document a written treatment plan which contains stated
objectives as a measure of successful treatment and planned
diagnostic evaluations, e.g., psychiatric evaluation or other
treatments.'' Id. at 21-22 (citing Miss. Code Ann. Sec. 73-25-
29(13)). Not that it is needed given the Board's findings which are
discussed above, these findings provide additional support for the
conclusion that Applicant acted outside the usual course of
professional practice and lacked a legitimate medical purpose in
prescribing controlled substances to the four patients. 21 CFR
1306.04(a).
\10\ The Board also found that Applicant ignored multiple red
flags that the four patients were abusing controlled substances.
These included that the patients sought early refills and did not
comply with his dosing instructions, two patients had been
terminated by prior physicians for non-compliance (one of whom was
obtaining controlled substances from multiple doctors), another
patient was driving a long distance to see him, and another patient
had not only tested positive for a controlled substance which had
not been prescribed to her, but twice attempted to use another
person's urine when subjected to a urine drug screen.
These findings provide further support for the conclusion that
issuing a new registration to Applicant ``would be inconsistent with
the public interest.'' 21 U.S.C. 823(f). As the Administrator has
held, ``[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 naive.'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 460 n.3 (2009); see also Bienvenido
Tan, M.D., 76 FR 17673, 17689 (2011) (quoting Paul J. Caragine, Jr.,
63 FR 51592, 51601 (1998)) (``Just because misconduct is
unintentional, innocent or devoid of improper motivation, [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.).
---------------------------------------------------------------------------
It is acknowledged that Applicant does not seek authority to
dispense controlled substances in schedules II and III, but rather only
those in schedule IV and V. GX 2, at 1. Be that as it may, the findings
of the State Board conclusively establish that his misconduct is
egregious and that he cannot be entrusted with authority to dispense
controlled substances in any schedule, a conclusion which stands
unrefuted given that Applicant waived his right to a hearing or to
submit a written statement. Accordingly, because there is no evidence
that Applicant acknowledges his misconduct and has undertaken any
remedial measures,\11\ I conclude that denial of his application is
necessary to protect the public interest. See, e.g., Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (``where a registrant has committed
acts inconsistent with the public interest, the registrant must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct''); see also Jose G. Zavaleta, M.D., 76 FR
49506, 49507 (2011) (denying
[[Page 71665]]
application for DEA registration in schedules IV and V where doctor
violated federal law by, inter alia, issuing prescriptions outside the
usual course of professional practice). Accordingly, I will order that
his application be denied.
---------------------------------------------------------------------------
\11\ As found above, the Mississippi Board required Applicant,
as a condition of reinstatement, to take courses in controlled
substance prescribing, recordkeeping, and medical ethics. There is,
however, no evidence that he has taken any of these courses.
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) and 0.104, I order that the application of Zizhuang
Li, M.D., for a DEA Certificate of Registration as a practitioner be,
and it hereby is, denied. This order is effective immediately.
Dated: November 21, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-28525 Filed 11-27-13; 8:45 am]
BILLING CODE 4410-09-P
