Thomas Neuschatz, M.D.; Decision and Order, 76322-76327 [2013-29956]
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3. Ratification List
4. Vote in Inv. Nos. 701–TA–405, 406,
and 408 and 731–TA–899–901 and
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By order of the Commission.
Issued: December 13, 2013.
William R. Bishop,
Supervisory Hearings and Information
Officer.
[FR Doc. 2013–30058 Filed 12–13–13; 11:15 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms
and Explosives
[OMB Number 1140–0036]
Agency Information Collection
Activities: Proposed Collection;
Comments Requested: FFL Out-ofBusiness Records Request
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ACTION:
60-Day notice.
The Department of Justice (DOJ),
Bureau of Alcohol, Tobacco, Firearms
and Explosives (ATF), will submit 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
‘‘sixty days’’ until February 18, 2014
This process is conducted in accordance
with 5 CFR 1320.10.
If you have comments especially on
the estimated public burden or
associated response time, suggestions,
or need a copy of the proposed
information collection instrument with
instructions or additional information,
please contact Tracey Robertson,
Tracey.Robertson@atf.gov or (304) 616–
4647, Chief, Federal Firearms Licensing
Center, 244 Needy Road, Martinsburg,
WV 25405. Written comments and
suggestions from the public and affected
agencies concerning the proposed
collection of information are
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encouraged. Your 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
functions 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; and
—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.
Summary of Information Collection
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) Title of the Form/Collection: FFL
Out-of-Business Records Request.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: Form Number: ATF F
5300.3A. Bureau of Alcohol, Tobacco,
Firearms and Explosives.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Business or other forprofit. Other: None.
Need for Collection: Firearms
licensees are required to keep records of
acquisition and disposition. These
records remain with the licensee as long
as they are in business. The ATF F
5300.3A, FFL Out-of-Business Records
Request is used by ATF to notify
licensees who go out of business. When
discontinuance of the business is
absolute, such records shall be delivered
within thirty days following the
business discontinuance to the ATF
Out-of-Business Records Center.
(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 1,924
respondents will take approximately 5
minutes to complete the form.
(6) An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 160.3
annual total burden hours associated
with this collection.
If additional information is required
contact: Jerri Murray, Department
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Clearance Officer, Policy and Planning
Staff, Justice Management Division,
Department of Justice, Two Constitution
Square, 145 N Street NE., Room 3W–
1407B, Washington, DC 20530.
Dated: December 11, 2013.
Jerri Murray,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2013–29885 Filed 12–16–13; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Thomas Neuschatz, M.D.; Decision and
Order
On July 2, 2013, the Deputy Assistant
Administrator, Office of Diversion
Control, issued an Order to Show Cause
to Thomas Neuschatz, M.D. (hereinafter,
Applicant), of Marysville, California. GX
9. 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. (citing 21 U.S.C.
823(f)).
The Show Cause Order specifically
alleged that on April 29, 2011,
Applicant had surrendered his DEA
registration, and that on May 30, 2011,
Applicant applied for a new registration
as a practitioner. Id. Next, the Order
alleged that a DEA investigation had
found that Applicant ‘‘prescribed and
dispensed inordinate amounts of
controlled substances . . . under
circumstances where [he] knew or
should have known the prescriptions
were not for legitimate medical
purposes.’’ Id.
Next, the Show Cause Order alleged
that a medical Expert had reviewed the
medical records of three of Applicant’s
patients (E.G., R.E., and J.G.) and
concluded that he ‘‘prescribed
controlled substances to those patients
without a legitimate medical purpose
and/or outside the usual course of
professional practice.’’ Id. at 1–2. More
specifically, with respect to E.G., the
Order alleged that over the course of
E.G’s first five visits, Applicant
escalated the daily dose of medication
from 22.5 mg of hydrocodone to 80 mg
of hydrocodone and 320 mg of
oxycodone. Id. at 2. The Order further
alleged that ‘‘[f]rom approximately
January 4, 2011 through April 16, 2011,
[Applicant] prescribed Dilaudid to E.G.
without conducting an in-person
physical examination’’ and during this
period, E.G. made a single office visit.
Id. The Order then alleged that based on
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Applicant’s ‘‘prescribing of high dosages
of opioid medications and failing to
perform a diagnostic evaluation of E.G.’s
pain complaints,’’ the Expert concluded
that Applicant’s ‘‘treatment of E.G. fell
outside the usual course of professional
practice.’’ Id. at 2.
After alleging that R.E. died of ‘‘acute
poisoning by multiple pharmaceuticals
and illegal substances,’’ the Show Cause
Order alleged that Applicant had failed
to inquire into the patient’s history of
drug abuse, notwithstanding that R.E.’s
intake forms had suggested that such
history existed, and that R.E. ‘‘provided
no medical records and was unable to
list previous physicians or pharmacies.’’
Id. The Order further alleged that
Applicant ‘‘performed limited physical
examinations of R.E. over the course of
approximately 11 office visits.’’ Id.
Based on Applicant’s alleged ‘‘failure to
confirm R.E.’s medical history, [his]
failure to determine R.E.’s source of
pain, and’’ that he ‘‘escalated dosages of
highly addictive pain medications
despite an unconfirmed . . . diagnosis,’’
the Order further alleged that the Expert
had concluded that Applicant acted
‘‘outside the usual course of
professional practice’’ in prescribing
controlled substances to R.E. Id.
With respect to J.G., the Show Cause
Order alleged that Applicant violated
federal law by prescribing methadone to
treat J.G.’s ‘‘opioid dependence’’
because he was ‘‘not authorized to
prescribe [s]chedule II controlled
substances to treat narcotic dependent
patients.’’ Id. (citing 21 U.S.C. 823(g)(1);
21 CFR 1306.07(a)). The Order further
alleged that ‘‘J.G. died of an apparent
overdose of prescription medications’’
after his last visit with Applicant. Id.
The Show Cause Order, which also
notified Applicant of his right to request
a hearing on the allegations or to submit
a written a statement regarding the
allegations while waiving his right to a
hearing, the procedure for electing
either option, and the consequences for
failing to elect either option, id. at 3,
was served on Applicant by certified
mail addressed to him at the address of
his proposed registered location. GX 10,
at 1. As evidenced by the signed return
receipt card, service was accomplished
on July 10, 2013. Id. at 2.
On August 13, 2013, the Government
submitted a Request for Final Agency
Action. Therein, the Government noted
that since the date of service of the
Show Cause Order, Applicant had not
requested a hearing. Request for Final
Agency Action, at 4. The Government
thus contends that Applicant has
waived his right to a hearing and
requests the issuance of a final order
denying the application. Id. at 4, 7.
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Subsequently, on August 22, 2013, the
Government filed an addendum to its
Request for Final Agency Action.
Therein, the Government noted that on
July 23, 2013, the Medical Board of
California (MBC) adopted a Stipulated
Surrender of License and Order
(hereinafter, Stipulated Surrender),
pursuant to which Applicant
surrendered his California Physician’s
and Surgeon’s Certificate, and that the
MBC’s Order ‘‘became effective on
August 22, 2013.’’ Addendum to
Request for Final Agency Action, at 1–
2. The Government attached a copy of
the MBC’s Decision, the Stipulated
Surrender of License and Order, and the
Accusation, which alleged forty-nine
(49) causes for discipline. The
Government also served a copy of the
addendum on Applicant.
Based on the Government’s
submission, I find that since the date of
service of the Order to Show Cause,
neither Applicant, nor anyone
purporting to represent him, has either
requested a hearing on the allegations or
submitted a written statement in lieu of
a hearing. See 21 CFR 1301.43(a) & (c).
Accordingly, I find that Applicant has
waived his right to a hearing or to
submit a written statement. Id.
§ 1301.43(c) & (d). I therefore issue this
Decision and Final Order based on the
Investigative Record submitted by the
Government. Id. § 1301.43(e). I make the
following findings of fact.
Findings
Applicant previously held DEA
Certificate of Registration BN5628194,
which authorized him to dispense
controlled substances, as a practitioner,
in schedules II–V. GX 2, at 1. However,
on April 29, 2011, Applicant voluntarily
surrendered this registration. Id. On
May 30, 2011, Applicant submitted an
application for a new registration. GX 1,
at 1.
Applicant also previously held a
Physician’s and Surgeon’s Certificate
which was issued by the MBC.
However, on May 23, 2012, the MBC’s
Executive Director issued a forty-nine
(49) count administrative complaint,
which sought the revocation of
Applicant’s state license. See
Accusation, In re Thomas Neuschatz,
M.D., (M.B.C. 2012) (No. 02–2009–
199792). On June 25, 2013, Applicant
voluntarily entered into the Stipulated
Surrender, and on July 23, the MBC
adopted the order, which became
effective on August 22, 2013.
Accordingly, I find that Applicant no
longer possesses authority under
California law to dispense controlled
substances.
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In the Stipulated Surrender,
Applicant ‘‘agree[d] that, at a hearing,
[the MBC] could establish a factual basis
for the charges in the Accusation and
that those charges constitute cause for
discipline.’’ Stipulated Surrender, at 3.
Applicant agreed that if he ‘‘should ever
apply or reapply for a new license or
certification, or petition for
reinstatement of a license, by any other
health care licensing agency in the State
of California, all of the charges and
allegations contained in [the]
Accusation . . . shall be deemed to be
true, correct, and admitted by
Respondent for the purpose of any
Statement of Issues or any other
proceeding seeking to deny or restrict
licensure.’’ Id. at 4–5.
With respect to E.G. (Show Cause
Order, at 2), the MBC alleged that
Applicant ‘‘prescribed excess quantities
of controlled substances and dangerous
drugs’’ to her. Accusation, at 18. More
specifically, the MBC, after noting the
large doses that Applicant had
prescribed to her, found that he:
(1) ‘‘failed to make a specific
diagnosis regarding E.G.’s pain’’;
(2) never evaluated ‘‘her
psychological status’’;
(3) ‘‘never followed up on x-rays that
he ordered’’;
(4) never documented whether E.G.
had complied with the exercise and
stretching program he had
recommended;
(5) never specified the functional
goals of treatment in the pain treatment
plan;
(6) increased her medications but
never provided clear reasons for doing
so in the medical record and found that
the increases were ‘‘never based on [her]
functional status’’;
(7) never documented that she
brought in her pain medication bottles
even though this was required by her
pain contract;
(8) ordered an x-ray for E.G., but there
was no x-ray in E.G.’s chart and no
further reference to the x-ray in ‘‘later
progress notes’’;
(9) never spoke with other physicians
who had ordered various tests nor
‘‘formally requested the results of these
studies’’;
(10) found that ‘‘[t]he only treatment
[he] employed for E.G. was opiate
mediations, the doses of which were
increased with alarming rapidity[,] [and
that] [d]uring the initial months of
treatment[,] [he] doubled her opiate
doses every month until at one point
E.G. was receiving a mixture of opiate
medications equal to 1,035 mg a day of
oral morphine,’’ which compares with
‘‘the average dose . . . for patients with
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cancer pain [of] between 100 mg to 200
mg per day’’;
(11) ‘‘failed to document that he
informed E.G. about the risks of opiate
medications’’; and
(12) ‘‘failed to document that E.G. was
ever referred to physical therapy or any
physician specialist for evaluation or
treatment of her chronic pain
condition.’’
Id. at 17–18. Based on the above
findings, the MBC concluded that
Applicant’s conduct ‘‘constitute[d]
excessive prescribing of controlled
substances and dangerous drugs in the
care and treatment of E.G.’’ Id. at 18.
With respect to R.E. (Show Cause
Order, at 2), the MBC alleged that
Applicant ‘‘prescribed excess quantities
of controlled substances and dangerous
drugs’’ to him. Id. More specifically, the
MBC found that he:
(1) failed to comment on R.E.’s history
of drug abuse (which included one
hospitalization and three rehabilitation
programs) during any of ‘‘R.E.’s 11 office
visits, or on the ‘opiate risk tool’ that
[Applicant] used to evaluate his
patient’s risk of prescription misuse’’;
(2) prescribed controlled substances
after performing a ‘‘limited physical
examination’’ and without requesting
previous medical records;
(3) failed to document prescriptions
in the medical records;
(4) prescribed increased doses of
opiates without any explanation in the
medical records;
(5) prescribed a muscle relaxer to R.E.
despite his ‘‘occupational function and
physical improvement’’;
(6) prescribed 300 tablets of
hydromorphone 8 mg and 150 tablets of
methadone 10 mg to R.E. on April 23;
then, only 14 days later, prescribed 128
tablets of oxycodone 30 mg and 80
tablets of methadone 10 mg;
(7) increased the dose of methadone
from 50 mg to 70 mg per day ‘‘because
his pain control is slightly down’’;
(8) prescribed controlled substances
when the patient was in a detoxification
program;
(9) failed to document in the medical
record any of the prescriptions he
provided R.E. while he was in the
detoxification program;
(10) failed to address the patient’s
recent inpatient treatment for drug
detoxification, and instead refilled all
medications without adjusting the
dosage;
(11) increased the doses of opiate
medications to a point where R.E. was
receiving 740 mg of oral morphine every
day, when ‘‘the average dose of oral
morphine required by patients with
cancer pain is between 100 to 250 mg
per day’’;
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(12) failed to question R.E. when he
‘‘should have suspected that R.E. was
using the medications for a non-medical
purpose’’;
(13) failed to record any formal
referral to physical therapy; and
(14) failed to order any traditional
diagnostic tests, including laboratory
studies, MRIs, or x-rays.
Id. at 19–23. Based on the foregoing, the
MBC concluded that Applicant’s
conduct ‘‘constitute[d] excessive
prescribing of controlled substances and
dangerous drugs.’’ Id. at 24.
With respect to J.G. (Show Cause
Order, at 2), the MBC alleged that
Applicant prescribed excess controlled
substances to her. Id. at 29. More
specifically, the MBC found that he:
(1) knew that J.G. was receiving
methadone from a drug treatment clinic,
yet failed to document any substance
abuse history for J.G.;
(2) failed to order any diagnostic tests,
such as laboratory studies, x-rays, or
MRIs;
(3) falsely documented that J.G.
attended the methadone treatment clinic
for chronic right shoulder pain and back
pain instead of for her addiction;
(4) began treating J.G.’s anxiety with
narcotics instead of the previously
prescribed non-habituated medications;
(5) assumed responsibility for
treatment of J.G.’s known addiction,
‘‘but inaccurately represented this as a
treatment for a chronic pain condition’’;
(6) failed to discuss the care of J.G.
with her primary physician or with any
of the addiction specialists at the
methadone clinic she was attending;
(7) ‘‘assumed the methadone
maintenance of a known opiate addict
despite his lack of qualification and
without the guidance of qualified
addiction specialists’’; and
(8) failed to document all of the
medications J.G. was taking.
Id. at 25–28. Similarly, the MBC found
that Applicant ‘‘prescribed excess
quantities of controlled substances and
dangerous drugs to’’ J.G. Id. at 29.
The MBC relied on a medical report
prepared by an Expert, who, after
reviewing the medical files for E.G.,
R.E., and J.G., concluded that
Applicant’s conduct with respect to
each patient ‘‘reflect[ed] an extreme
departure from the usual practice of
general medicine.’’ 1 Expert Report, at
1 In reaching her conclusions, the Expert relied on
the ‘‘Model Guidelines for the Use of Controlled
Substance for the Treatment of Pain.’’ Stipulated
Surrender, at 4. California adopted these guidelines
in 1994 and later revised them in 2007. See MBC,
Guidelines for Prescribing Controlled Substances
for Pain, https://www.mbc.ca.gov/pain_
guidelines.html.
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8–32. With respect to E.G., the Expert
noted that Applicant increased the
patient’s dose of controlled substances
from the equivalent of 157.5 mg/day
oral morphine to 1,035 mg/day oral
morphine over a seven month period
(constituting a roughly 100% dose
increase per month). Id. at 6. The Expert
concluded that Applicant’s ‘‘conduct
reflect[ed] an extreme departure from
the usual practice of general medicine,
because, of his failure to ever render a
diagnosis regarding [E.G.’s] pain
complaints or to more thoroughly
evaluate her psychological status.’’ Id. at
8. The Expert noted that ‘‘[n]o specific
diagnosis corresponding to [E.G.’s] pain
complaints was ever made’’ and ‘‘[t]here
[was] no specific evaluation of her
psychological status other than frequent
notations about her anxious affect.’’ Id.
Moreover, the Expert observed that
while Applicant ordered an x-ray of
E.G.’s lumbar spine, there was no report
in E.G.’s record and while E.G. has
supposedly undergone x-rays and CT
spans which were ordered by her prior
physicians, Applicant did not request
the results. Id. at 9–10.
The Expert further observed that
Applicant failed ‘‘to develop a treatment
plan with objectives,’’ and that he
rapidly increased the dosage of opioids
‘‘with alarming rapidity.’’ Id. Applicant
did not, however, document a
justification for the increases, which in
the Expert’s observation, were ‘‘never
based on [E.G.’s] functional status.’’ Id.
Finally, the Expert found that ‘‘signs of
misuse on the part of [E.G.] did not
seem to affect [Applicant’s] prescribing’’
practices.2 Id. at 11. In sum, the Expert
found that Applicant’s ‘‘prescription
treatment of patient [E.G.] fell outside
the usual course of the professional
practice of medicine.’’ Id. at 13.
As for R.E., the Expert noted that,
notwithstanding that at the first visit,
R.E. stated that he had previously taken
Norco, OxyContin 40mg, and was
currently taking three OxyContin 80mg
tablets a day for neck pain, he ‘‘claimed
not to know the name of his treating
physician, the location of any
pharmacy[,] nor was he able to produce
a prescription bottle.’’ Id. at 26.
Moreover, the Expert noted that R.E.
told Applicant that ‘‘[h]e ha[d] no
records.’’ Id. Also, the Expert observed
that on the medical history form which
R.E. completed at the initial visit, R.E.
had disclosed that in 2004, he had a
‘‘drug related’’ hospitalization. GX 7, at
32; GX 4, at 23.
2 As example, the Expert noted that on November
4, 2008, Applicant increased E.G.’s dose of both
OxyContin and Norco because ‘‘[s]he would like to
go up on the Norco and I said fine.’’ GX 4, at 9.
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The Expert explained that under these
circumstances, ‘‘most clinicians [would]
suspect drug seeking for non-medical
uses,’’ and that ‘‘when aspects of [a]
patient’s case appear suspicious, the
standard practice is to request medical
records or to speak with the most recent
treating physician in order to verify the
patient’s history and past treatment.’’
GX 4, at 26. The Expert then found that
there was no evidence in the medical
record that Applicant ever confirmed
the medical history or prior treatment of
R.E. with prescriptions.’’ Id.
The Expert noted that at R.E.’s first
visit, Applicant documented in the
medical record that he had prescribed
only 45 dosage units of oxycodone
30mg. Id. at 23. Yet, the Expert found
that the actual prescription issued by
Applicant authorized the dispensing of
240 oxycodone 30mg. Id. at 23; GX 7, at
23 & 45.
The Expert further found that
Applicant failed ‘‘to evaluate the reason
for [R.E.’s] unremitting pain despite
high doses of controlled substances.’’ Id.
at 27. Moreover, Applicant committed
an extreme departure from the standard
of care by failing to develop ‘‘a
treatment plan with clear functional
objective.’’ Id. at 30.
Moreover, according to the Expert,
Applicant failed to address numerous
signs that R.E. ‘‘was misusing or
diverting medication.’’ Id. The Expert
found that at several visits, R.E.
requested specific drugs such as
oxycodone and methadone, sought an
increase in Xanax, and reported that his
medications had been stolen. Id. at 24
& 29. Yet the Expert also found that ‘‘[a]t
no time was laboratory testing done to
confirm medication use by the patient
and exclude [the] possibility of
diversion’’ [and] [a]t no time did
[Applicant] document having performed
a random pill count to confirm
medication adherence.’’ Id. at 29. The
Expert thus concluded that Applicant’s
continued treatment of R.E. ‘‘with
rapidly escalating doses of controlled
substances despite an unconfirmed
medical diagnosis,’’ fell outside the
usual course of the professional practice
of medicine. Id. at 32.
Finally, with respect to J.G., the
Expert noted that Applicant never
documented nor referenced her
‘‘substance abuse history, although this
was known to him’’ from prior
treatment and it was ‘‘also . . . implied
given her ongoing treatment at a
methadone maintenance clinic.’’ Id. at
16. The Expert noted that Applicant
‘‘assumed responsibility for treatment of
this known addict with methadone, but
inaccurately represented his
prescriptions for methadone as
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treatment for her chronic pain
condition.’’ Id. at 18; see also id. at 22
(Applicant ‘‘knowingly prescribed
methadone to prevent opiate
withdrawal rather than for the treatment
of pain.’’). Applicant did this ‘‘despite
his lack of qualification and without the
guidance of a qualified addiction
specialist.’’ Id. at 20. As such, ‘‘his
misrepresentation that methadone was
indicated for the treatment of her
chronic pain rather than as treatment for
her opioid addiction was patently
false.’’ Id. at 18. The Expert thus
concluded that Applicant’s ‘‘treatment
of [J.G.] fell far outside the usual
professional practice of medicine.’’ Id.
at 32.
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 the
public interest 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.
21 U.S.C. 823(f). ‘‘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 a preponderance of the
evidence, that the requirements for a
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 noncontested case. Gabriel Sanchez, M.D.,
78 FR 59060, 59063 (2013). Having
considered all of the factors,3 I conclude
3 The Government presented evidence that, as of
August 22, 2013, Applicant no longer possessed a
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76325
that the Government’s evidence with
respect to factors two and four
establishes, prima facie, that the
issuance of a DEA Certificate of
Registration to Applicant ‘‘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 Laws Related to
Controlled Substances
A. The Preclusive Effect of the MBC
Order
Under the doctrine of collateral
estoppel, the MBC’s findings of fact and
conclusions of law are entitled to
preclusive effect in this proceeding if
the parties had an adequate opportunity
to litigate the issues. Robert L.
Dougherty, M.D., 76 FR 16823, 16830
(2011); 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). Moreover, a State Board’s
findings may be entitled to preclusive
effect even where an Applicant/
Registrant chose not to dispute the
allegations and entered into a consent
agreement or stipulated settlement.
David A. Ruben, 78 FR 38363, 38365
(2013) (holding that findings of a
consent agreement which supported
state board’s disciplinary action were
not subject to relitigation before DEA,
because, inter alia, physician agreed
that he could not contest the findings in
any future proceeding involving the
Board or other state agency); cf. Jose G.
Zavaleta, M.D., 78 FR 27431, 27433–34
(2013) (holding that the findings of a
prior DEA proceeding are entitled to
preclusive effect in a subsequent DEA
proceeding notwithstanding that the
Applicant/Registrant waived his right to
a hearing in the first proceeding).
Thus, in Ruben, the Administrator
held that the findings of a consent
agreement were entitled to preclusive
state license to practice medicine. Stipulated
Surrender, at 4–5. The CSA only permits the
Attorney General to register practitioners ‘‘if the
applicant is authorized to dispense . . . controlled
s ubstances under the laws of the State in which
he practices.’’ 21 U.S.C. 823(f). As such, the CSA
requires the denial of an application for registration
when the applicant’s state license has been
suspended or revoked. Sheran Arden Yeates, M.D.,
71 FR 39130, 39131 (2006); Dominick A. Ricci, 58
FR 51104, 51105 (1993). Applicant’s loss of his state
license thus provides an independent ground to
deny his application for a DEA Certificate of
Registration.
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effect in a DEA proceeding, even though
the registrant had not actually litigated
them, noting that under the relevant
State’s law, a judgment entered by
stipulation or consent ‘‘‘may be
conclusive, with respect to one or more
issues, if the parties have entered an
agreement manifesting such intention.’ ’’
78 FR at 38366 (quoting Chaney
Building Co. v. City of Tucson, 716 P.2d
28, 30 (Ariz. 1986)). Because in Ruben,
it was clear that the parties intended
that the findings of the consent
agreement would be binding between
them and could not be relitigated in a
subsequent proceeding before the state
board (or another state agency), and
under the relevant state law, the
agreement was entitled to preclusive
effect, the Administrator rejected the
contention that the findings were
subject to relitigation before this
Agency.4 Id.
Relevant to the Order at issue here,
the Supreme Court of California has
held that ‘‘a stipulated judgment may
properly be given collateral estoppel
effect, at least when the parties manifest
an intent to be collaterally bound by its
terms.’’ Cal. State Auto. Assn. Inter-Ins.
Bureau v. Super. Ct., 50 Cal.3d 658, 665
(1990). The crux of the issue is whether
the parties, in agreeing to the settlement
order, ‘‘manifest[ed] an intent to be
collaterally bound by its terms.’’ Id.; see
also Landeros v. Pankey, 46 Cal. Rptr.
2d 165, 167 (Cal. App. 1995) (discussing
same).5
Here, I conclude that the terms of the
Stipulated Surrender and Disciplinary
Order manifest that the parties agreed to
be bound by the stipulation in
subsequent proceedings. Applicant,
who was represented by counsel,
‘‘voluntarily, knowingly, and
intelligently’’ waived his right to a
hearing before the Board, id. at 2, at
which he could have ‘‘contest[ed] that
cause for discipline exists based on’’ the
Board’s charges. Id. at 3.
Most significantly, Applicant
‘‘agree[d] that, at a hearing, [the MBC]
could establish a factual basis for the
charges in the Accusation and that those
charges constitute cause for discipline.’’
Stipulated Surrender, at 3. The Order
further provided that ‘‘if [Applicant]
should ever apply or reapply for a new
license or certification, or petition for
reinstatement of a license, by any other
health care licensing agency in the State
of California, all of the charges and
allegations contained in [the]
Accusation . . . shall be deemed to be
5 A ‘‘stipulated judgment’’ is akin to a stipulated
settlement, as a stipulated judgment arises when
‘‘parties to [a] pending litigation stipulated . . . for
settlement of the case.’’ Cal. State Auto. Assn., 50
Cal.3d at 665.
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true, correct, and admitted by
Respondent for the purpose of any
Statement of Issues or any other
proceeding seeking to deny or restrict
licensure.’’ Id. at 4–5.6 Accordingly,
because Applicant and the MBC
manifested their intent to be bound by
the terms of the Stipulated Surrender,
the Board’s findings are entitled to
preclusive effect in this proceeding.
Ruben, 78 FR at 38366.
(A) Analysis of the Public Interest
Factors
Under a longstanding Agency
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 ‘‘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. See also Cal.
Health & Safety Code § 11153(a) (a
‘‘prescription for a controlled substance
shall only be issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his or her professional practice,’’ and
‘‘an order purporting to be a
prescription which is issued not in the
usual course of professional treatment’’
is not a legal prescription).
As the Supreme Court has explained,
‘‘the prescription requirement . . .
ensures patients use controlled
substances under the supervision of a
6 It is noted that the Stipulated Surrender
contains a provision which states that ‘‘[t]he
admissions made by Respondent herein are only for
the purposes of this proceeding, or any other
proceedings in which the Medical Board of
California or other professional licensing agency is
involved, and shall not be admissible in any other
criminal or civil proceeding.’’ Stipulated Surrender,
at 3.
Under the Controlled Substances Act, ‘‘[t]o issue
lawful prescriptions’’ for any controlled substance,
a ‘‘physician[] must ‘obtain from the Attorney
General a registration issued in accordance with the
rules and regulations promulgated by him.’ ’’
Gonzales v. Oregon, 546 U.S. 250–51 (2006)
(quoting 21 U.S.C. 822(a)(2)). Thus, DEA is a
professional licensing agency with respect to the
dispensing of controlled substances. Moreover,
even if Applicant and the MBC intended to limit
the preclusive effect of the Stipulated Surrender to
proceedings involving other California health care
licensing agencies, they cannot prevent an Agency
of the United States from giving preclusive effect to
the proceeding when they have agreed that such
effect shall be given in a subsequent proceeding
between Applicant and the State. See supra n.4.
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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, 546 U.S. at
274 (citing United States v. Moore, 423
U.S. 122, 135, 143 (1975)); United States
v. Alerre, 430 F.3d 681, 691 (4th Cir.
2005), cert. denied, 574 U.S. 1113 (2006)
(prescription requirement stands as a
proscription against doctors acting not
‘‘as a healer[,] but as a seller of wares’’).
Under the CSA, it is fundamental that
a practitioner must establish and
maintain a legitimate doctor-patient
relationship in order to act ‘‘in the usual
course of . . . professional practice’’
and to issue a prescription for a
‘‘legitimate medical purpose.’’ Zavaleta,
78 FR at 27440. What constitutes a
legitimate doctor-patient relationship is
generally determined by the applicable
state law. Id.
Under California law, a physician
must first conduct ‘‘an appropriate prior
examination,’’ and determine that there
is ‘‘a medical indication’’ for prescribing
a controlled substance. Cal. Bus. & Prof.
Code § 2242(a); see also id. § 725(c).
Moreover, as the Expert explained, the
MBC has issued extensive guidelines
setting forth the standards of
professional practice in prescribing
controlled substances for the treatment
of pain. Expert’s Report, at 4. These
standards provide that:
A medical history and physical
examination must be accomplished. This
includes assessment of the pain, physical and
psychological function; a substance abuse
history; history of prior pain treatment; an
assessment of underlying or coexisting
diseases or conditions; and documentation of
the presence of a recognized medical
indication for the use of a controlled
substance.
MBC, Guidelines for Prescribing
Controlled Substances for Pain. As also
set forth in the Expert’s Report, the
Guidelines also address such other areas
as the development of a treatment plan,
the need to obtain informed consent for
treatment, the importance of conducting
periodic review of a patient’s response
treatment, the need to refer a patient for
additional evaluations and consultation,
especially where a patient presents the
‘‘risk for misusing [his] medications,’’
the obligation to keep complete and
accurate records, and the obligation to
comply with both federal and state
controlled substances laws and
regulations. Id.
With respect to patients E.G. and R.E.,
the MBC found that Applicant
overprescribed controlled substances
without documenting a medical
necessity, thereby practicing outside the
usual course of professional practice.
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See Cal. Bus. & Prof. Code § 725(c)
(requiring a medical basis for
prescribing controlled substances); 21
CFR 1306.04(a) (‘‘A prescription for a
controlled substance to be effective
must be issued for a legitimate medical
purpose’’). Applicant only treated the
patients with controlled substances,
failed to document treatment plans,
failed take into account the patient’s
past history of drug abuse, and
continuously prescribed high doses of
opiates without documenting any
explanation for doing so in their
medical records. Stipulated Surrender,
at 17–23.
Moreover, as the Expert explained,
Applicant ignored signs of misuse with
respect to E.G., and signs of misuse and
diversion with respect to R.E. Expert’s
Report, at 11 (‘‘signs of misuse on the
part of [E.G.] did not seem to affect
[Applicant’s] prescribing practices’’); id.
at 29–30 (noting that R.E. requested
specific controlled substances, reported
stolen opioids, and ‘‘reported persistent
or increased pain at almost every visit’’
notwithstanding that ‘‘the opioid . . .
doses had been significantly increased’’
and that Applicant ‘‘fail[ed] to respond
to clues that [R.E.] was misusing or
diverting medication’’). Most
significantly, with respect to both E.G.
and R.E., the Expert concluded that
Applicant’s treatment ‘‘fell far outside
the usual professional practice of
medicine.’’ Id. at 32.
I therefore find that Applicant
violated the CSA’s prescription
requirement when he prescribed
controlled substance to E.G. and R.E. 21
CFR 1306.04(a). I also find that
Applicant unlawfully distributed
controlled substances to E.G. and R.E.
See 21 U.S.C. 841(a)(1); see also Moore,
423 U.S. at 142–43 (noting that evidence
established that physician ‘‘exceeded
the bounds of ‘professional practice,’’’
when ‘‘he gave inadequate physical
examinations or none at all,’’ ‘‘ignored
the results of the tests he did make,’’
and ‘‘took no precautions against . . .
misuse and diversion’’).
Finally, with respect to patient J.G.,
the evidence shows that Applicant
‘‘assumed the methadone maintenance
of a known opiate addict despite his
lack of qualification and without the
guidance of qualified addiction
specialists.’’ Id. at 28. Applicant did so
notwithstanding that he did not hold
the registration required by the CSA to
dispense narcotic drugs for the purposes
of providing maintenance or
detoxification treatment. See 21 U.S.C.
823(g)(1) (‘‘practitioners who dispense
narcotic drugs to individuals for
maintenance treatment or detoxification
treatment shall obtain annually a
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14:45 Dec 16, 2013
Jkt 232001
separate registration for that purpose.’’)
(emphasis added); George C. Aycock,
M.D., 74 FR 17529, 17543 n.32 (2009)
(‘‘Under federal law, a practitioner must
meet extensive requirements and be
separately registered to lawfully
dispense narcotic drugs for maintenance
or detoxification treatment.’’).
Applicant further violated federal law
when he prescribed methadone, a
schedule II narcotic, for the purpose of
treating J.G.’s opioid dependency.
Expert Report, at 22. Under a DEA
regulation, a practitioner (who is
properly registered), ‘‘may administer or
dispense (but not prescribe) a narcotic
drug . . . to a narcotic depend[e]nt
person for the purpose of maintenance
or detoxification treatment.’’ 21 CFR
1306.07(a). Applicant thus also violated
this provision when he prescribed
methadone to treat J.G.’s opioid
dependency.7
Accordingly, I hold that the evidence
with respect to factors two and four
supports the conclusion that
Applicant’s registration ‘‘would be
inconsistent with the public interest.’’
21 U.S.C. 823(f). Because Applicant
waived his right to a hearing or to
submit a written statement in lieu of
hearing, there is no evidence to the
contrary. See, e.g., Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(internal quotation marks omitted).
Accordingly, I will deny Applicant’s
application.
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 hereby order that
the application of Thomas Neuschatz,
M.D., for a DEA Certificate of
Registration as a practitioner be, and it
hereby is, denied. This order is effective
immediately.
Dated: December 6, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013–29956 Filed 12–16–13; 8:45 am]
BILLING CODE 4410–09–P
76327
DEPARTMENT OF LABOR
Employment and Training
Administration
Notice of Approval of South Carolina’s
Application for Avoidance of 2013
Credit Reduction Under the Federal
Unemployment Tax Act
Employment and Training
Administration, Labor.
ACTION: Notice.
AGENCY:
Sections 3302(c)(2) and
3302(d)(3) of the Federal
Unemployment Tax Act (FUTA) provide
that employers in a state that has an
outstanding balance of advances under
Title XII of the Social Security Act at the
beginning of January 1 of two or more
consecutive years are subject to a
reduction in credits otherwise available
against the FUTA tax for the calendar
year in which the most recent such
January 1 occurs, if a balance of
advances remains at the beginning of
November 10 of that year. Because the
account of South Carolina in the
Unemployment Trust Fund had a
balance of advances at the beginning of
January 1 of 2009, 2010, 2011, 2012, and
2013, and still had a balance of
advances at the beginning of November
10, 2013, South Carolina employers
were potentially liable for a reduction in
their FUTA offset credit for 2013.
Section 3302(g) of FUTA provides
that a state may avoid credit reduction
for a year by meeting certain criteria.
South Carolina applied for avoidance of
the 2013 credit reduction under this
section. It has been determined that
South Carolina met all of the criteria of
section 3302(g) and thus qualifies for
credit reduction avoidance. Therefore,
South Carolina employers will have no
reduction in FUTA offset credit for
calendar year 2013.
SUMMARY:
Signed in Washington, DC, this 5th day of
December, 2013.
Eric M. Seleznow,
Acting Assistant Secretary for Employment
and Training.
[FR Doc. 2013–29851 Filed 12–16–13; 8:45 am]
7 To
similar effect, California law provides that a
physician cannot ‘‘administer dangerous drugs or
controlled substances to a person he or she knows
or reasonably believes is using or will use the drugs
or substances for a nonmedical purpose.’’ Cal. Bus.
& Prof. Code § 2241(b). Thus, ‘‘an order for an
addict or habitual user of controlled substances,
which is issued not in the course of professional
treatment or as part of an authorized narcotic
treatment program, for the purpose of providing the
user with controlled substances,’’ is illegal. Cal.
Health & Safety Code § 11153(a)(2); People v.
Gandotra, 14 Cal. Rptr. 2d 896, 901 (Cal. Ct. App.
1992) (‘‘[S]ection 11153 . . . prohibits practitioners
from writing controlled substance prescriptions that
. . . are outside the course of their usual
professional practice.’’).
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BILLING CODE 4510–FW–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Notice of Denial of Georgia’s
Application for a ‘‘Cap’’ of the 2013
Credit Reduction Under the Federal
Unemployment Tax Act
Employment and Training
Administration, Labor.
AGENCY:
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Agencies
[Federal Register Volume 78, Number 242 (Tuesday, December 17, 2013)]
[Notices]
[Pages 76322-76327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29956]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Thomas Neuschatz, M.D.; Decision and Order
On July 2, 2013, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Thomas Neuschatz,
M.D. (hereinafter, Applicant), of Marysville, California. GX 9. 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. (citing 21 U.S.C. 823(f)).
The Show Cause Order specifically alleged that on April 29, 2011,
Applicant had surrendered his DEA registration, and that on May 30,
2011, Applicant applied for a new registration as a practitioner. Id.
Next, the Order alleged that a DEA investigation had found that
Applicant ``prescribed and dispensed inordinate amounts of controlled
substances . . . under circumstances where [he] knew or should have
known the prescriptions were not for legitimate medical purposes.'' Id.
Next, the Show Cause Order alleged that a medical Expert had
reviewed the medical records of three of Applicant's patients (E.G.,
R.E., and J.G.) and concluded that he ``prescribed controlled
substances to those patients without a legitimate medical purpose and/
or outside the usual course of professional practice.'' Id. at 1-2.
More specifically, with respect to E.G., the Order alleged that over
the course of E.G's first five visits, Applicant escalated the daily
dose of medication from 22.5 mg of hydrocodone to 80 mg of hydrocodone
and 320 mg of oxycodone. Id. at 2. The Order further alleged that
``[f]rom approximately January 4, 2011 through April 16, 2011,
[Applicant] prescribed Dilaudid to E.G. without conducting an in-person
physical examination'' and during this period, E.G. made a single
office visit. Id. The Order then alleged that based on
[[Page 76323]]
Applicant's ``prescribing of high dosages of opioid medications and
failing to perform a diagnostic evaluation of E.G.'s pain complaints,''
the Expert concluded that Applicant's ``treatment of E.G. fell outside
the usual course of professional practice.'' Id. at 2.
After alleging that R.E. died of ``acute poisoning by multiple
pharmaceuticals and illegal substances,'' the Show Cause Order alleged
that Applicant had failed to inquire into the patient's history of drug
abuse, notwithstanding that R.E.'s intake forms had suggested that such
history existed, and that R.E. ``provided no medical records and was
unable to list previous physicians or pharmacies.'' Id. The Order
further alleged that Applicant ``performed limited physical
examinations of R.E. over the course of approximately 11 office
visits.'' Id. Based on Applicant's alleged ``failure to confirm R.E.'s
medical history, [his] failure to determine R.E.'s source of pain,
and'' that he ``escalated dosages of highly addictive pain medications
despite an unconfirmed . . . diagnosis,'' the Order further alleged
that the Expert had concluded that Applicant acted ``outside the usual
course of professional practice'' in prescribing controlled substances
to R.E. Id.
With respect to J.G., the Show Cause Order alleged that Applicant
violated federal law by prescribing methadone to treat J.G.'s ``opioid
dependence'' because he was ``not authorized to prescribe [s]chedule II
controlled substances to treat narcotic dependent patients.'' Id.
(citing 21 U.S.C. 823(g)(1); 21 CFR 1306.07(a)). The Order further
alleged that ``J.G. died of an apparent overdose of prescription
medications'' after his last visit with Applicant. Id.
The Show Cause Order, which also notified Applicant of his right to
request a hearing on the allegations or to submit a written a statement
regarding the allegations while waiving his right to a hearing, the
procedure for electing either option, and the consequences for failing
to elect either option, id. at 3, was served on Applicant by certified
mail addressed to him at the address of his proposed registered
location. GX 10, at 1. As evidenced by the signed return receipt card,
service was accomplished on July 10, 2013. Id. at 2.
On August 13, 2013, the Government submitted a Request for Final
Agency Action. Therein, the Government noted that since the date of
service of the Show Cause Order, Applicant had not requested a hearing.
Request for Final Agency Action, at 4. The Government thus contends
that Applicant has waived his right to a hearing and requests the
issuance of a final order denying the application. Id. at 4, 7.
Subsequently, on August 22, 2013, the Government filed an addendum
to its Request for Final Agency Action. Therein, the Government noted
that on July 23, 2013, the Medical Board of California (MBC) adopted a
Stipulated Surrender of License and Order (hereinafter, Stipulated
Surrender), pursuant to which Applicant surrendered his California
Physician's and Surgeon's Certificate, and that the MBC's Order
``became effective on August 22, 2013.'' Addendum to Request for Final
Agency Action, at 1-2. The Government attached a copy of the MBC's
Decision, the Stipulated Surrender of License and Order, and the
Accusation, which alleged forty-nine (49) causes for discipline. The
Government also served a copy of the addendum on Applicant.
Based on the Government's submission, I find that since the date of
service of the Order to Show Cause, neither Applicant, nor anyone
purporting to represent him, has either requested a hearing on the
allegations or submitted a written statement in lieu of a hearing. See
21 CFR 1301.43(a) & (c). Accordingly, I find that Applicant has waived
his right to a hearing or to submit a written statement. Id. Sec.
1301.43(c) & (d). I therefore issue this Decision and Final Order based
on the Investigative Record submitted by the Government. Id. Sec.
1301.43(e). I make the following findings of fact.
Findings
Applicant previously held DEA Certificate of Registration
BN5628194, which authorized him to dispense controlled substances, as a
practitioner, in schedules II-V. GX 2, at 1. However, on April 29,
2011, Applicant voluntarily surrendered this registration. Id. On May
30, 2011, Applicant submitted an application for a new registration. GX
1, at 1.
Applicant also previously held a Physician's and Surgeon's
Certificate which was issued by the MBC. However, on May 23, 2012, the
MBC's Executive Director issued a forty-nine (49) count administrative
complaint, which sought the revocation of Applicant's state license.
See Accusation, In re Thomas Neuschatz, M.D., (M.B.C. 2012) (No. 02-
2009-199792). On June 25, 2013, Applicant voluntarily entered into the
Stipulated Surrender, and on July 23, the MBC adopted the order, which
became effective on August 22, 2013. Accordingly, I find that Applicant
no longer possesses authority under California law to dispense
controlled substances.
In the Stipulated Surrender, Applicant ``agree[d] that, at a
hearing, [the MBC] could establish a factual basis for the charges in
the Accusation and that those charges constitute cause for
discipline.'' Stipulated Surrender, at 3. Applicant agreed that if he
``should ever apply or reapply for a new license or certification, or
petition for reinstatement of a license, by any other health care
licensing agency in the State of California, all of the charges and
allegations contained in [the] Accusation . . . shall be deemed to be
true, correct, and admitted by Respondent for the purpose of any
Statement of Issues or any other proceeding seeking to deny or restrict
licensure.'' Id. at 4-5.
With respect to E.G. (Show Cause Order, at 2), the MBC alleged that
Applicant ``prescribed excess quantities of controlled substances and
dangerous drugs'' to her. Accusation, at 18. More specifically, the
MBC, after noting the large doses that Applicant had prescribed to her,
found that he:
(1) ``failed to make a specific diagnosis regarding E.G.'s pain'';
(2) never evaluated ``her psychological status'';
(3) ``never followed up on x-rays that he ordered'';
(4) never documented whether E.G. had complied with the exercise
and stretching program he had recommended;
(5) never specified the functional goals of treatment in the pain
treatment plan;
(6) increased her medications but never provided clear reasons for
doing so in the medical record and found that the increases were
``never based on [her] functional status'';
(7) never documented that she brought in her pain medication
bottles even though this was required by her pain contract;
(8) ordered an x-ray for E.G., but there was no x-ray in E.G.'s
chart and no further reference to the x-ray in ``later progress
notes'';
(9) never spoke with other physicians who had ordered various tests
nor ``formally requested the results of these studies'';
(10) found that ``[t]he only treatment [he] employed for E.G. was
opiate mediations, the doses of which were increased with alarming
rapidity[,] [and that] [d]uring the initial months of treatment[,] [he]
doubled her opiate doses every month until at one point E.G. was
receiving a mixture of opiate medications equal to 1,035 mg a day of
oral morphine,'' which compares with ``the average dose . . . for
patients with
[[Page 76324]]
cancer pain [of] between 100 mg to 200 mg per day'';
(11) ``failed to document that he informed E.G. about the risks of
opiate medications''; and
(12) ``failed to document that E.G. was ever referred to physical
therapy or any physician specialist for evaluation or treatment of her
chronic pain condition.''
Id. at 17-18. Based on the above findings, the MBC concluded that
Applicant's conduct ``constitute[d] excessive prescribing of controlled
substances and dangerous drugs in the care and treatment of E.G.'' Id.
at 18.
With respect to R.E. (Show Cause Order, at 2), the MBC alleged that
Applicant ``prescribed excess quantities of controlled substances and
dangerous drugs'' to him. Id. More specifically, the MBC found that he:
(1) failed to comment on R.E.'s history of drug abuse (which
included one hospitalization and three rehabilitation programs) during
any of ``R.E.'s 11 office visits, or on the `opiate risk tool' that
[Applicant] used to evaluate his patient's risk of prescription
misuse'';
(2) prescribed controlled substances after performing a ``limited
physical examination'' and without requesting previous medical records;
(3) failed to document prescriptions in the medical records;
(4) prescribed increased doses of opiates without any explanation
in the medical records;
(5) prescribed a muscle relaxer to R.E. despite his ``occupational
function and physical improvement'';
(6) prescribed 300 tablets of hydromorphone 8 mg and 150 tablets of
methadone 10 mg to R.E. on April 23; then, only 14 days later,
prescribed 128 tablets of oxycodone 30 mg and 80 tablets of methadone
10 mg;
(7) increased the dose of methadone from 50 mg to 70 mg per day
``because his pain control is slightly down'';
(8) prescribed controlled substances when the patient was in a
detoxification program;
(9) failed to document in the medical record any of the
prescriptions he provided R.E. while he was in the detoxification
program;
(10) failed to address the patient's recent inpatient treatment for
drug detoxification, and instead refilled all medications without
adjusting the dosage;
(11) increased the doses of opiate medications to a point where
R.E. was receiving 740 mg of oral morphine every day, when ``the
average dose of oral morphine required by patients with cancer pain is
between 100 to 250 mg per day'';
(12) failed to question R.E. when he ``should have suspected that
R.E. was using the medications for a non-medical purpose'';
(13) failed to record any formal referral to physical therapy; and
(14) failed to order any traditional diagnostic tests, including
laboratory studies, MRIs, or x-rays.
Id. at 19-23. Based on the foregoing, the MBC concluded that
Applicant's conduct ``constitute[d] excessive prescribing of controlled
substances and dangerous drugs.'' Id. at 24.
With respect to J.G. (Show Cause Order, at 2), the MBC alleged that
Applicant prescribed excess controlled substances to her. Id. at 29.
More specifically, the MBC found that he:
(1) knew that J.G. was receiving methadone from a drug treatment
clinic, yet failed to document any substance abuse history for J.G.;
(2) failed to order any diagnostic tests, such as laboratory
studies, x-rays, or MRIs;
(3) falsely documented that J.G. attended the methadone treatment
clinic for chronic right shoulder pain and back pain instead of for her
addiction;
(4) began treating J.G.'s anxiety with narcotics instead of the
previously prescribed non-habituated medications;
(5) assumed responsibility for treatment of J.G.'s known addiction,
``but inaccurately represented this as a treatment for a chronic pain
condition'';
(6) failed to discuss the care of J.G. with her primary physician
or with any of the addiction specialists at the methadone clinic she
was attending;
(7) ``assumed the methadone maintenance of a known opiate addict
despite his lack of qualification and without the guidance of qualified
addiction specialists''; and
(8) failed to document all of the medications J.G. was taking.
Id. at 25-28. Similarly, the MBC found that Applicant ``prescribed
excess quantities of controlled substances and dangerous drugs to''
J.G. Id. at 29.
The MBC relied on a medical report prepared by an Expert, who,
after reviewing the medical files for E.G., R.E., and J.G., concluded
that Applicant's conduct with respect to each patient ``reflect[ed] an
extreme departure from the usual practice of general medicine.'' \1\
Expert Report, at 8-32. With respect to E.G., the Expert noted that
Applicant increased the patient's dose of controlled substances from
the equivalent of 157.5 mg/day oral morphine to 1,035 mg/day oral
morphine over a seven month period (constituting a roughly 100% dose
increase per month). Id. at 6. The Expert concluded that Applicant's
``conduct reflect[ed] an extreme departure from the usual practice of
general medicine, because, of his failure to ever render a diagnosis
regarding [E.G.'s] pain complaints or to more thoroughly evaluate her
psychological status.'' Id. at 8. The Expert noted that ``[n]o specific
diagnosis corresponding to [E.G.'s] pain complaints was ever made'' and
``[t]here [was] no specific evaluation of her psychological status
other than frequent notations about her anxious affect.'' Id. Moreover,
the Expert observed that while Applicant ordered an x-ray of E.G.'s
lumbar spine, there was no report in E.G.'s record and while E.G. has
supposedly undergone x-rays and CT spans which were ordered by her
prior physicians, Applicant did not request the results. Id. at 9-10.
---------------------------------------------------------------------------
\1\ In reaching her conclusions, the Expert relied on the
``Model Guidelines for the Use of Controlled Substance for the
Treatment of Pain.'' Stipulated Surrender, at 4. California adopted
these guidelines in 1994 and later revised them in 2007. See MBC,
Guidelines for Prescribing Controlled Substances for Pain, https://www.mbc.ca.gov/pain_guidelines.html.
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The Expert further observed that Applicant failed ``to develop a
treatment plan with objectives,'' and that he rapidly increased the
dosage of opioids ``with alarming rapidity.'' Id. Applicant did not,
however, document a justification for the increases, which in the
Expert's observation, were ``never based on [E.G.'s] functional
status.'' Id. Finally, the Expert found that ``signs of misuse on the
part of [E.G.] did not seem to affect [Applicant's] prescribing''
practices.\2\ Id. at 11. In sum, the Expert found that Applicant's
``prescription treatment of patient [E.G.] fell outside the usual
course of the professional practice of medicine.'' Id. at 13.
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\2\ As example, the Expert noted that on November 4, 2008,
Applicant increased E.G.'s dose of both OxyContin and Norco because
``[s]he would like to go up on the Norco and I said fine.'' GX 4, at
9.
---------------------------------------------------------------------------
As for R.E., the Expert noted that, notwithstanding that at the
first visit, R.E. stated that he had previously taken Norco, OxyContin
40mg, and was currently taking three OxyContin 80mg tablets a day for
neck pain, he ``claimed not to know the name of his treating physician,
the location of any pharmacy[,] nor was he able to produce a
prescription bottle.'' Id. at 26. Moreover, the Expert noted that R.E.
told Applicant that ``[h]e ha[d] no records.'' Id. Also, the Expert
observed that on the medical history form which R.E. completed at the
initial visit, R.E. had disclosed that in 2004, he had a ``drug
related'' hospitalization. GX 7, at 32; GX 4, at 23.
[[Page 76325]]
The Expert explained that under these circumstances, ``most
clinicians [would] suspect drug seeking for non-medical uses,'' and
that ``when aspects of [a] patient's case appear suspicious, the
standard practice is to request medical records or to speak with the
most recent treating physician in order to verify the patient's history
and past treatment.'' GX 4, at 26. The Expert then found that there was
no evidence in the medical record that Applicant ever confirmed the
medical history or prior treatment of R.E. with prescriptions.'' Id.
The Expert noted that at R.E.'s first visit, Applicant documented
in the medical record that he had prescribed only 45 dosage units of
oxycodone 30mg. Id. at 23. Yet, the Expert found that the actual
prescription issued by Applicant authorized the dispensing of 240
oxycodone 30mg. Id. at 23; GX 7, at 23 & 45.
The Expert further found that Applicant failed ``to evaluate the
reason for [R.E.'s] unremitting pain despite high doses of controlled
substances.'' Id. at 27. Moreover, Applicant committed an extreme
departure from the standard of care by failing to develop ``a treatment
plan with clear functional objective.'' Id. at 30.
Moreover, according to the Expert, Applicant failed to address
numerous signs that R.E. ``was misusing or diverting medication.'' Id.
The Expert found that at several visits, R.E. requested specific drugs
such as oxycodone and methadone, sought an increase in Xanax, and
reported that his medications had been stolen. Id. at 24 & 29. Yet the
Expert also found that ``[a]t no time was laboratory testing done to
confirm medication use by the patient and exclude [the] possibility of
diversion'' [and] [a]t no time did [Applicant] document having
performed a random pill count to confirm medication adherence.'' Id. at
29. The Expert thus concluded that Applicant's continued treatment of
R.E. ``with rapidly escalating doses of controlled substances despite
an unconfirmed medical diagnosis,'' fell outside the usual course of
the professional practice of medicine. Id. at 32.
Finally, with respect to J.G., the Expert noted that Applicant
never documented nor referenced her ``substance abuse history, although
this was known to him'' from prior treatment and it was ``also . . .
implied given her ongoing treatment at a methadone maintenance
clinic.'' Id. at 16. The Expert noted that Applicant ``assumed
responsibility for treatment of this known addict with methadone, but
inaccurately represented his prescriptions for methadone as treatment
for her chronic pain condition.'' Id. at 18; see also id. at 22
(Applicant ``knowingly prescribed methadone to prevent opiate
withdrawal rather than for the treatment of pain.''). Applicant did
this ``despite his lack of qualification and without the guidance of a
qualified addiction specialist.'' Id. at 20. As such, ``his
misrepresentation that methadone was indicated for the treatment of her
chronic pain rather than as treatment for her opioid addiction was
patently false.'' Id. at 18. The Expert thus concluded that Applicant's
``treatment of [J.G.] fell far outside the usual professional practice
of medicine.'' Id. at 32.
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 the public interest 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.
21 U.S.C. 823(f). ``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 a preponderance of the
evidence, that the requirements for a 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,\3\ I conclude that the
Government's evidence with respect to factors two and four establishes,
prima facie, that the issuance of a DEA Certificate of Registration to
Applicant ``would be inconsistent with the public interest.'' 21 U.S.C.
823(f).
---------------------------------------------------------------------------
\3\ The Government presented evidence that, as of August 22,
2013, Applicant no longer possessed a state license to practice
medicine. Stipulated Surrender, at 4-5. The CSA only permits the
Attorney General to register practitioners ``if the applicant is
authorized to dispense . . . controlled s ubstances under the laws
of the State in which he practices.'' 21 U.S.C. 823(f). As such, the
CSA requires the denial of an application for registration when the
applicant's state license has been suspended or revoked. Sheran
Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58
FR 51104, 51105 (1993). Applicant's loss of his state license thus
provides an independent ground to deny his application for a DEA
Certificate of Registration.
---------------------------------------------------------------------------
Factors Two and Four--The Applicant's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
A. The Preclusive Effect of the MBC Order
Under the doctrine of collateral estoppel, the MBC's findings of
fact and conclusions of law are entitled to preclusive effect in this
proceeding if the parties had an adequate opportunity to litigate the
issues. Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011); 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). Moreover, a
State Board's findings may be entitled to preclusive effect even where
an Applicant/Registrant chose not to dispute the allegations and
entered into a consent agreement or stipulated settlement. David A.
Ruben, 78 FR 38363, 38365 (2013) (holding that findings of a consent
agreement which supported state board's disciplinary action were not
subject to relitigation before DEA, because, inter alia, physician
agreed that he could not contest the findings in any future proceeding
involving the Board or other state agency); cf. Jose G. Zavaleta, M.D.,
78 FR 27431, 27433-34 (2013) (holding that the findings of a prior DEA
proceeding are entitled to preclusive effect in a subsequent DEA
proceeding notwithstanding that the Applicant/Registrant waived his
right to a hearing in the first proceeding).
Thus, in Ruben, the Administrator held that the findings of a
consent agreement were entitled to preclusive
[[Page 76326]]
effect in a DEA proceeding, even though the registrant had not actually
litigated them, noting that under the relevant State's law, a judgment
entered by stipulation or consent ```may be conclusive, with respect to
one or more issues, if the parties have entered an agreement
manifesting such intention.' '' 78 FR at 38366 (quoting Chaney Building
Co. v. City of Tucson, 716 P.2d 28, 30 (Ariz. 1986)). Because in Ruben,
it was clear that the parties intended that the findings of the consent
agreement would be binding between them and could not be relitigated in
a subsequent proceeding before the state board (or another state
agency), and under the relevant state law, the agreement was entitled
to preclusive effect, the Administrator rejected the contention that
the findings were subject to relitigation before this Agency.\4\ Id.
---------------------------------------------------------------------------
\4\ The Administrator also rejected the contention that the
parties could, by their agreement, prevent DEA, as an Agency of the
United States, from ``giv[ing] the same effect to the factual
findings and legal conclusions as would exist in a subsequent state
administrative proceeding.'' 78 FR at 38367 (citing U.S. Const. art.
VI, cl.2; Howlett v. Rose, 496 U.S. 356, 371 (1990) (citing FERC v.
Mississippi, 456 U.S. 742, 776 n.1 (1982) (opinion of O'Connor, J.)
(``State may not discriminate against federal causes of action''))).
---------------------------------------------------------------------------
Relevant to the Order at issue here, the Supreme Court of
California has held that ``a stipulated judgment may properly be given
collateral estoppel effect, at least when the parties manifest an
intent to be collaterally bound by its terms.'' Cal. State Auto. Assn.
Inter-Ins. Bureau v. Super. Ct., 50 Cal.3d 658, 665 (1990). The crux of
the issue is whether the parties, in agreeing to the settlement order,
``manifest[ed] an intent to be collaterally bound by its terms.'' Id.;
see also Landeros v. Pankey, 46 Cal. Rptr. 2d 165, 167 (Cal. App. 1995)
(discussing same).\5\
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\5\ A ``stipulated judgment'' is akin to a stipulated
settlement, as a stipulated judgment arises when ``parties to [a]
pending litigation stipulated . . . for settlement of the case.''
Cal. State Auto. Assn., 50 Cal.3d at 665.
---------------------------------------------------------------------------
Here, I conclude that the terms of the Stipulated Surrender and
Disciplinary Order manifest that the parties agreed to be bound by the
stipulation in subsequent proceedings. Applicant, who was represented
by counsel, ``voluntarily, knowingly, and intelligently'' waived his
right to a hearing before the Board, id. at 2, at which he could have
``contest[ed] that cause for discipline exists based on'' the Board's
charges. Id. at 3.
Most significantly, Applicant ``agree[d] that, at a hearing, [the
MBC] could establish a factual basis for the charges in the Accusation
and that those charges constitute cause for discipline.'' Stipulated
Surrender, at 3. The Order further provided that ``if [Applicant]
should ever apply or reapply for a new license or certification, or
petition for reinstatement of a license, by any other health care
licensing agency in the State of California, all of the charges and
allegations contained in [the] Accusation . . . shall be deemed to be
true, correct, and admitted by Respondent for the purpose of any
Statement of Issues or any other proceeding seeking to deny or restrict
licensure.'' Id. at 4-5.\6\ Accordingly, because Applicant and the MBC
manifested their intent to be bound by the terms of the Stipulated
Surrender, the Board's findings are entitled to preclusive effect in
this proceeding. Ruben, 78 FR at 38366.
---------------------------------------------------------------------------
\6\ It is noted that the Stipulated Surrender contains a
provision which states that ``[t]he admissions made by Respondent
herein are only for the purposes of this proceeding, or any other
proceedings in which the Medical Board of California or other
professional licensing agency is involved, and shall not be
admissible in any other criminal or civil proceeding.'' Stipulated
Surrender, at 3.
Under the Controlled Substances Act, ``[t]o issue lawful
prescriptions'' for any controlled substance, a ``physician[] must
`obtain from the Attorney General a registration issued in
accordance with the rules and regulations promulgated by him.' ''
Gonzales v. Oregon, 546 U.S. 250-51 (2006) (quoting 21 U.S.C.
822(a)(2)). Thus, DEA is a professional licensing agency with
respect to the dispensing of controlled substances. Moreover, even
if Applicant and the MBC intended to limit the preclusive effect of
the Stipulated Surrender to proceedings involving other California
health care licensing agencies, they cannot prevent an Agency of the
United States from giving preclusive effect to the proceeding when
they have agreed that such effect shall be given in a subsequent
proceeding between Applicant and the State. See supra n.4.
---------------------------------------------------------------------------
(A) Analysis of the Public Interest Factors
Under a longstanding Agency 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 ``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. See also Cal. Health & Safety Code Sec. 11153(a) (a
``prescription for a controlled substance shall only be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his or her professional practice,'' and ``an order
purporting to be a prescription which is issued not in the usual course
of professional treatment'' is not a legal prescription).
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, 546 U.S. at 274
(citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)); United
States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), cert. denied, 574
U.S. 1113 (2006) (prescription requirement stands as a proscription
against doctors acting not ``as a healer[,] but as a seller of
wares'').
Under the CSA, it is fundamental that a practitioner must establish
and maintain a legitimate doctor-patient relationship in order to act
``in the usual course of . . . professional practice'' and to issue a
prescription for a ``legitimate medical purpose.'' Zavaleta, 78 FR at
27440. What constitutes a legitimate doctor-patient relationship is
generally determined by the applicable state law. Id.
Under California law, a physician must first conduct ``an
appropriate prior examination,'' and determine that there is ``a
medical indication'' for prescribing a controlled substance. Cal. Bus.
& Prof. Code Sec. 2242(a); see also id. Sec. 725(c). Moreover, as the
Expert explained, the MBC has issued extensive guidelines setting forth
the standards of professional practice in prescribing controlled
substances for the treatment of pain. Expert's Report, at 4. These
standards provide that:
A medical history and physical examination must be accomplished.
This includes assessment of the pain, physical and psychological
function; a substance abuse history; history of prior pain
treatment; an assessment of underlying or coexisting diseases or
conditions; and documentation of the presence of a recognized
medical indication for the use of a controlled substance.
MBC, Guidelines for Prescribing Controlled Substances for Pain. As also
set forth in the Expert's Report, the Guidelines also address such
other areas as the development of a treatment plan, the need to obtain
informed consent for treatment, the importance of conducting periodic
review of a patient's response treatment, the need to refer a patient
for additional evaluations and consultation, especially where a patient
presents the ``risk for misusing [his] medications,'' the obligation to
keep complete and accurate records, and the obligation to comply with
both federal and state controlled substances laws and regulations. Id.
With respect to patients E.G. and R.E., the MBC found that
Applicant overprescribed controlled substances without documenting a
medical necessity, thereby practicing outside the usual course of
professional practice.
[[Page 76327]]
See Cal. Bus. & Prof. Code Sec. 725(c) (requiring a medical basis for
prescribing controlled substances); 21 CFR 1306.04(a) (``A prescription
for a controlled substance to be effective must be issued for a
legitimate medical purpose''). Applicant only treated the patients with
controlled substances, failed to document treatment plans, failed take
into account the patient's past history of drug abuse, and continuously
prescribed high doses of opiates without documenting any explanation
for doing so in their medical records. Stipulated Surrender, at 17-23.
Moreover, as the Expert explained, Applicant ignored signs of
misuse with respect to E.G., and signs of misuse and diversion with
respect to R.E. Expert's Report, at 11 (``signs of misuse on the part
of [E.G.] did not seem to affect [Applicant's] prescribing
practices''); id. at 29-30 (noting that R.E. requested specific
controlled substances, reported stolen opioids, and ``reported
persistent or increased pain at almost every visit'' notwithstanding
that ``the opioid . . . doses had been significantly increased'' and
that Applicant ``fail[ed] to respond to clues that [R.E.] was misusing
or diverting medication''). Most significantly, with respect to both
E.G. and R.E., the Expert concluded that Applicant's treatment ``fell
far outside the usual professional practice of medicine.'' Id. at 32.
I therefore find that Applicant violated the CSA's prescription
requirement when he prescribed controlled substance to E.G. and R.E. 21
CFR 1306.04(a). I also find that Applicant unlawfully distributed
controlled substances to E.G. and R.E. See 21 U.S.C. 841(a)(1); see
also Moore, 423 U.S. at 142-43 (noting that evidence established that
physician ``exceeded the bounds of `professional practice,''' when ``he
gave inadequate physical examinations or none at all,'' ``ignored the
results of the tests he did make,'' and ``took no precautions against .
. . misuse and diversion'').
Finally, with respect to patient J.G., the evidence shows that
Applicant ``assumed the methadone maintenance of a known opiate addict
despite his lack of qualification and without the guidance of qualified
addiction specialists.'' Id. at 28. Applicant did so notwithstanding
that he did not hold the registration required by the CSA to dispense
narcotic drugs for the purposes of providing maintenance or
detoxification treatment. See 21 U.S.C. 823(g)(1) (``practitioners who
dispense narcotic drugs to individuals for maintenance treatment or
detoxification treatment shall obtain annually a separate registration
for that purpose.'') (emphasis added); George C. Aycock, M.D., 74 FR
17529, 17543 n.32 (2009) (``Under federal law, a practitioner must meet
extensive requirements and be separately registered to lawfully
dispense narcotic drugs for maintenance or detoxification
treatment.'').
Applicant further violated federal law when he prescribed
methadone, a schedule II narcotic, for the purpose of treating J.G.'s
opioid dependency. Expert Report, at 22. Under a DEA regulation, a
practitioner (who is properly registered), ``may administer or dispense
(but not prescribe) a narcotic drug . . . to a narcotic depend[e]nt
person for the purpose of maintenance or detoxification treatment.'' 21
CFR 1306.07(a). Applicant thus also violated this provision when he
prescribed methadone to treat J.G.'s opioid dependency.\7\
---------------------------------------------------------------------------
\7\ To similar effect, California law provides that a physician
cannot ``administer dangerous drugs or controlled substances to a
person he or she knows or reasonably believes is using or will use
the drugs or substances for a nonmedical purpose.'' Cal. Bus. &
Prof. Code Sec. 2241(b). Thus, ``an order for an addict or habitual
user of controlled substances, which is issued not in the course of
professional treatment or as part of an authorized narcotic
treatment program, for the purpose of providing the user with
controlled substances,'' is illegal. Cal. Health & Safety Code Sec.
11153(a)(2); People v. Gandotra, 14 Cal. Rptr. 2d 896, 901 (Cal. Ct.
App. 1992) (``[S]ection 11153 . . . prohibits practitioners from
writing controlled substance prescriptions that . . . are outside
the course of their usual professional practice.'').
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Accordingly, I hold that the evidence with respect to factors two
and four supports the conclusion that Applicant's registration ``would
be inconsistent with the public interest.'' 21 U.S.C. 823(f). Because
Applicant waived his right to a hearing or to submit a written
statement in lieu of hearing, there is no evidence to the contrary.
See, e.g., Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008)
(internal quotation marks omitted). Accordingly, I will deny
Applicant's application.
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 hereby order that the application of
Thomas Neuschatz, M.D., for a DEA Certificate of Registration as a
practitioner be, and it hereby is, denied. This order is effective
immediately.
Dated: December 6, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-29956 Filed 12-16-13; 8:45 am]
BILLING CODE 4410-09-P