Judson J. Somerville, M.D.; Decision and Order, 21408-21410 [2017-09284]
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(total number of respondents) * .5 (30
minutes).
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE., 3E.405A,
Washington, DC 20530.
Dated: May 3, 2017.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2017–09213 Filed 5–5–17; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–12]
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Judson J. Somerville, M.D.; Decision
and Order
On October 20, 2016, the Assistant
Administrator, Division of Diversion
Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Judson J. Somerville,
M.D. (Respondent), of Laredo, Texas.
The Show Cause Order proposed the
revocation of Respondent’s Certificates
of Registration, on the ground that he
‘‘do[es] not have authority to handle
controlled substances in Texas, the
[S]tate in which [he is] registered with
the’’ Agency. Show Cause Order, at 1
(citing 21 U.S.C. 824(a)(3)).
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is registered as
a practitioner in schedules II through V,
pursuant to Certificate of Registration
No. BS3909718, at the address of
Saguaro Anesthesia Associates, d/b/a
The Pain Clinic, 9114 McPherson Road,
Suite 2508, Laredo, Texas.1 Id. The
Show Cause Order alleged that this
registration expires on February 28,
2018. Id. The Order also alleged that
Respondent is registered as a
practitioner in schedules II though V,
pursuant to Certificate of Registration
No. FS3571660, at the address of 4646
Corona Drive, Corpus Christi, Texas. Id.
at 2. The Show Cause Order alleged that
this registration expires on February 28,
2019. Id.
As to the substantive ground for the
proceeding, the Show Cause Order
alleged that on October 6, 2016, the
1 In the Show Cause Order, the Government listed
the number of this registration as BP3909718. Show
Cause Order, at 1. However, on December 2, 2016,
the Government notified the CALJ that the correct
number was BS3909718. See Gov. Notice of
Correction for the Order to Show Cause, at 1.
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Texas Medical Board entered an Order
of Temporary Suspension suspending
Respondent’s Texas Medical License
effective the same day, ‘‘which ‘shall
remain in effect until it is superseded by
a subsequent Order of the Board,’ ’’ and
that this ‘‘order prohibits [him] from
practicing medicine in the State of
Texas.’’ Id. The Order then alleged that
‘‘[d]ue to the Order and under state law,
[Respondent] lack[s] authority to handle
controlled substances in Texas, the
[S]tate in which [he is] registered’’ and
this ‘‘constitutes grounds to revoke [his]
[r]egistration.’’ Id. (citing 21 U.S.C.
802(21) and 824(a)(3)) (other citations
omitted).2
Following service of the Show Cause
Order, Respondent requested a hearing
on the allegations. The matter was
placed on the docket of the Office of
Administrative Law Judges and assigned
to Chief Administrative Law Judge John
J. Mulrooney, II (hereinafter, CALJ). On
November 22, 2016, the CALJ ordered
the Government to submit evidence to
support the allegation and any motion
for summary disposition no later than
December 7, 2016. See Order Directing
the Filing of Government Evidence of
Lack of State Authority Allegation and
Briefing Schedule, at 1. In the order, the
ALJ also directed Respondent to file a
response to any motion for summary
disposition no later than December 21,
2016. Id.
On December 2, 2016, the
Government filed its Motion for
Summary Disposition. Therein, it
argued that it is undisputed that based
on the Texas Medical Board’s October 6,
2016 Order of Temporary Suspension,
Respondent is prohibited from
practicing medicine in the State of
Texas and that his license remains
suspended as of the date of its Motion.
Gov. Motion, at 5. The Government
further argued ‘‘that the possession of
authority to dispense controlled
substances under the laws of the State
in which a practitioner engaged in
professional practice is a fundamental
condition for both obtaining and
maintaining a practitioner’s
registration,’’ and that under the
Agency’s precedents, revocation is
warranted even where a State has
invoked summary process to suspend a
practitioner’s state authority and has yet
to provide the practitioner with a
2 The Show Cause Order also notified Respondent
of his right to request a hearing 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. Show Cause Order, at 3 (citing 21 CFR
1301.43). Also, the Show Cause Order notified
Respondent of his right to submit a Corrective
Action Plan and the procedures for doing so. Id.
(citing 21 U.S.C. 824(c)(2)(C)).
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Sfmt 4703
hearing where he may prevail. Mot. for
Summ. Disp., at 3–7 (citations omitted).
As support for its motion, the
Government attached a copy of the
Medical Board’s Order of Temporary
Suspension and a printout from the
Medical Board’s Web site showing that
his license status was ‘‘SUSPENDED,
ACTIVE.’’ Id. at GXs C & D.
Respondent did not dispute that his
medical license has been suspended by
the Texas Board. Resp.’s Reply to Gov.
Mot. for Summ. Disp., at 1. Instead, he
argued that the Board’s Order cannot
‘‘serve as a predicate for summary
disposition’’ because the Order is not a
‘‘permanent action[] of the Board’’ and
is ‘‘not valid until and unless the
matters in the . . . order[] are brought
before a panel of the Medical Board for
an ‘Informal Settlement Conference’ and
if not resolved at the . . . conference, [a]
formal adjudication[] . . . which must
be initiated as soon as possible.’’ Id. at
1–2. Respondent argued that the
Medical Board has acted in violation of
Texas law by exempting itself from the
requirement that it initiate proceedings
within 30 days from the date of the
issuance of a summary suspension
order. Id. at 2–3. He further argued that
subsequent to the issuance of the
Board’s Order, there has been no
settlement conference and the Board did
not commence formal administrative
proceedings either within the 30 day
period or ‘‘ ‘as soon as practicable’ as
mandated by Texas’’ law. Id. at 4.
Respondent thus maintains that the
Government’s Motion is based on the
illegal actions of the Board. Id.
Respondent requested that the CALJ
deny the Government’s Motion and
‘‘hold in abeyance any decision on the
Government’s application until the
proper exhaustion of administrative and
judicial channels takes place in Texas.’’
Id. at 5.
The CALJ rejected Respondent’s
contentions, noting that ‘‘the Controlled
Substances Act (CSA) requires that, in
order to obtain or maintain a DEA
registration, a practitioner must be
authorized to handle controlled
substances in the State in which he
practices.’’ R.D. at 3–4 (citing 21 U.S.C.
823(f) and 802(21) (quotations omitted)).
While he was ‘‘not unmindful of
Respondent’s arguments regarding the
legality of the Board’s actions,’’ the
CALJ explained that ‘‘it is not within
this tribunal’s authority to evaluate the
lawfulness of the basis of a registrant’s
lack of state authority, and the validity
of other entities’ actions is not what is
at issue in these proceedings.’’ Id. at 4.
The CALJ then explained that the
‘‘disposition of the Government’s
Motion is wholly dependent upon the
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single issue of whether or not the
Respondent currently possesses the
requisite authority under state law to
handle controlled substances–which he
does not.’’ Id. The CALJ further denied
Respondent’s request to hold the
proceeding in abeyance pending the
exhaustion of his state remedies.3 Id. at
4.
The CALJ then found that there was
no dispute over the material fact that
‘‘Respondent currently lacks state
authority to handle controlled
substances in Texas due to the Board[’s]
Order dated October 6, 2016, which
temporarily suspended his state license
to practice medicine.’’ Id. at 6.
Reasoning that ‘‘[b]ecause . . .
Respondent lacks state authority at the
present time . . . he is not entitled to
maintain his . . . registrations,’’ the
CALJ granted the Government’s motion
and recommended that his registrations
be revoked and that any pending
applications be denied. Id.
Neither party filed exceptions to the
CALJ’s Recommended Decision.
Thereafter, the record was forwarded to
3 The CALJ noted that the Agency has previously
held ‘‘that a stay in administrative enforcement
proceedings is ‘unlikely to ever be justified’ due to
ancillary proceedings involving the Respondent.’’
R.D. 5 (quoting Grider Drug #1 & Grider Drug #2,
77 FR 44070, 44104 n.97 (2012)). I agree with this
statement of the Agency’s precedents. However, the
CALJ also cited Odette L. Campbell, 80 FR 41062
(2015), as contrary authority. See id. The CALJ
characterized Campbell as ‘‘holding revocation
proceedings in abeyance at the post-hearing
adjudication level for a lengthy period pending the
resolution of both criminal fraud charges and
concurrent state administrative proceedings against
the respondent.’’ Id. I respectfully disagree with the
CALJ’s reading of Campbell. In Campbell, the
respondent failed to comply with the Agency’s
regulation which, because she was subject to an
Order to Show Cause, required her to file her
renewal application at least 45 days before the
expiration of her registration. 80 FR 41063. Of note,
the respondent’s registration expired one week after
the evidentiary hearing, and she did not file a
renewal application until three months later, after
she received a largely favorable decision from the
ALJ. Id. Thus, at the time the proceeding was held
in abeyance, the proceeding did not involve a
revocation as the respondent no longer held a
registration. See 21 CFR 1301.36(i).
Most significantly, one week before the
evidentiary hearing, the respondent was indicted on
30 counts of Health Care Fraud, as well as five
counts of altering records during a federal
investigation. 80 FR at 41063. Had the respondent
been convicted of Health Care Fraud, she would
have been subject to mandatory exclusion from
federal healthcare programs under 42 U.S.C. 1320a7(a) and her application would have been subject
to denial on that basis. Id. at 41064 (citing 21 U.S.C.
824(a)(5)). Moreover, even after the respondent
successfully completed pre-trial diversion and the
charges were dismissed, the state medical board
brought a proceeding against her license, and had
the board suspended or revoked her medical
license, denial of her application would have been
required under the CSA. Id. (citing 21 U.S.C.
802(21) & 823(f)). Given the pending proceedings,
Campbell was the rare case where withholding the
issuance of a final decision was warranted.
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my Office for Final Agency Action.
Having reviewed the record, I adopt the
CALJ’s finding that by virtue of the
Texas Board’s Order, Respondent is
currently without authority to handled
controlled substances in Texas, the State
in which he holds his registrations with
the Agency, and is thus, not entitled to
maintain his registrations. I further
adopt the CALJ’s recommendation that
I revoke his registrations and deny his
pending applications. I make the
following factual findings.
Findings of Fact
Respondent is a physician who holds
Texas Medical License No. H–6622. GX
C, at 1. However, on October 6, 2016,
the Disciplinary Panel of the Texas
Medical Board issued an Order of
Temporary Suspension to Respondent
based on its finding that ‘‘Respondent’s
continuation in the practice of medicine
would constitute a continuing threat to
the public welfare.’’ Id. at 5. The Panel
further ordered that the suspension be
‘‘effective on the date rendered’’ and
‘‘shall remain in effect until it is
superseded by a subsequent Order of the
Board.’’ Id. Respondent offered no
evidence in its Opposition to the
Government’s Motion or at any time
thereafter showing that the Board has
lifted the suspension. Based on the
above, I find that Respondent does not
currently have authority under the laws
of Texas to dispense controlled
substances.
Respondent is also the holder of two
DEA Certificates of Registration,
pursuant to which he was authorized to
dispense controlled substances in
schedules II through V as a practitioner.
Pursuant to Registration No. BS3909718,
Respondent was authorized to dispense
controlled substances at the address of
Saguaro Anesthesia Associates, d/b/a
The Pain Management Clinic, 9114
McPherson Road, Suite 2508, Laredo,
Texas. GX A. This registration does not
expire until February 28, 2018. Id.
Pursuant to Registration No. FS3571660,
Respondent was authorized to dispense
controlled substances at the address of
4646 Corona Drive, Suite 256, Corpus
Christi, Texas. GX B. According to the
declaration of a Diversion Investigator,
this registration does not expire until
February 28, 2019. GX F, at 2.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (CSA), ‘‘upon a finding
that the registrant . . . has had his State
license . . . suspended [or] revoked
. . . by competent State authority and is
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21409
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ Also, DEA has
long held that the possession of
authority to dispense controlled
substances under the laws of the State
in which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a practitioner’s registration. See, e.g.,
James L. Hooper, 76 FR 71371 (2011),
pet. for rev. denied, 481 Fed. Appx. 826
(4th Cir. 2012); see also Frederick Marsh
Blanton, 43 FR 27616 (1978) (‘‘State
authorization to dispense or otherwise
handle controlled substances is a
prerequisite to the issuance and
maintenance of a Federal controlled
substances registration.’’).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to]
mean[] a . . . physician . . . or other
person licensed, registered or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f).
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a DEA registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR at 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner has lost his state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Thus, it is of no
consequence that the Texas Medical
Board has employed summary process
in suspending Registrant’s state license
and that Respondent may prevail at the
hearing schedule for late June.
Respondent further argues that the
Board’s order cannot be the basis for
revoking his registration because the
Board has acted in violation of Texas
law when it neither provided
Respondent with an informal settlement
conference nor commenced formal
administrative proceedings within the
time frame required by Texas law. DEA,
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however, ‘‘accepts as valid and lawful
the actions of a state regulatory board
unless that action is overturned by a
state court . . . pursuant to state law.’’
Kamal Tiwari, 76 FR 71604, 71607
(2011) (quoting George S. Heath, 51 FR
26610 (1986)). Rather, Respondent’s
challenge to the lawfulness of the Texas
Board’s Suspension Order must be
raised in the forums provided by the
State. Id. (quoting 51 FR at 26610). See
also Calvin Ramsey, 76 FR 20034, 20036
(2011) (quoting Hicham K. Riba, 73 FR
75773, 75774 (2008) (‘‘DEA has
repeatedly held that a registrant cannot
collaterally attack the results of a state
criminal or administrative proceeding in
a proceeding brought under section 304
[21 U.S.C. 824] of the CSA.’’)).
Here, there is no dispute over the
material fact that Respondent is no
longer currently authorized to dispense
controlled substances in Texas, the State
in which he is registered. Accordingly,
he is not entitled to maintain his
registrations. I will therefore adopt the
CALJ’s recommendation that I revoke
Respondent’s registrations and deny any
pending applications to renew his
registrations. R.D. 6.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a)(3) and 28 CFR
0.100(b), I order that DEA Certificates of
Registration Nos. BS3909718 and
FS3571660 be, and they hereby are,
revoked. Pursuant to the authority
vested in me by 21 U.S.C. 823(f), I order
that any applications to renew the above
registrations be, and they hereby are,
denied. This Order is effective
immediately.4
Dated: May 1, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–09284 Filed 5–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 15–24]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Roberto Zayas, M.D., Decision and
Order
On May 18, 2015, the Deputy
Assistant Administrator, of the thenOffice of Diversion Control, issued an
Order to Show Cause to Roberto Zayas,
M.D. (hereinafter, Respondent), of
4 For the same reasons which led the Texas Board
to order the temporary suspension of Respondent’s
medical license, I conclude that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
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Jkt 241001
Houston, Texas and Dover, Florida. ALJ
Ex. 1. The Show Cause Order proposed
the revocation of Respondent’s
Certificates of Registration Nos.
FZ2249743 and FZ2418401, the denial
of any pending applications to renew or
modify these registrations, and the
denial of any applications for new
registrations, on the ground that his
‘‘continued registration is inconsistent
with the public interest.’’ Id. at 1 (citing
21 U.S.C. 824(a)(4) and 823(f)).
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is the holder of
Registration No. FZ2249743, pursuant to
which he is authorized to dispense
schedule II through V controlled
substances as a practitioner, at the
registered address of 12121 Jones Road,
Houston, Texas; the Order alleged that
this registration was due to expire on
May 31, 2016. Id. The Show Cause
Order also alleged that Respondent is
the holder of Registration No.
FZ22418401, pursuant to which he is
authorized to dispense schedule II
through V controlled substances as a
practitioner, at the registered address of
14222 Melouga Preserve Trail, Dover,
Florida; the Order alleged that this
registration is due to expire on May 31,
2017. Id.
As grounds for the proposed actions,
the Show Cause Order alleged that on
September 20, 2010, Respondent
‘‘signed a Memorandum of Agreement’’
(MOA) which ‘‘imposed requirements
. . . regarding [the] operation,
management and supervision of seven
different clinics’’ he ‘‘own[s] and/or
manage[s] and control[s]’’ which are
located in various Texas cities. Id. at 1–
2. The Show Cause Order alleged that
‘‘pursuant to paragraph 8 of the MOA,
[Respondent] agreed that ‘[i]f controlled
substances in Schedules II through V are
purchased for any clinic, to be
administered and/or dispensed to the
clinic patient, [he] shall cause to be
made and maintained all DEA required
documents and information including
records, reports, and inventories’ ’’ and
that ‘‘[a]ll required documentation shall
be maintained as required by federal
and Texas laws and regulations.’’ Id. at
2. The Show Cause Order then alleged
that pursuant to another part of
paragraph 8, Respondent ‘‘agreed . . .
that ‘[i]f any controlled substance is
administered or dispensed at any clinic
including the [seven clinics he owns or
controls], the health care provider doing
the administering and/or dispensing to
the patient shall be registered at the
clinic as required by 21 U.S.C. 822(a)(2)
and 21 CFR 1301.12.’’ Id. And with
respect to paragraph 9 of the MOA, the
Order alleged that Respondent was
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required to submit to the DEA Houston
Division Office ‘‘on a quarterly basis,
the total number of controlled
substances dispensed, to include the
date dispensed, full name of patient,
address of patient, name of controlled
substance dispensed, quantity
dispensed and [the] dispenser’s
initials.’’ Id.
The Show Cause Order alleged that
‘‘[b]etween August 28 and September
13[,] 2013,’’ DEA conducted inspections
of each of the clinics and ‘‘determined
that [Respondent] repeatedly violated
the terms of paragraphs 8 and 9 of the
MOA.’’ Id. The Show Cause Order then
alleged that ‘‘controlled substances were
dispensed and/or administered at four
of the [clinics] during periods when the
individual doing the dispensing and/or
administering was not registered . . . at
the’’ clinic. Id. at 2.
The Show Cause Order also alleged
that Respondent failed to make and
maintain complete and accurate
controlled substance inventories at six
of the clinics; that he failed to make and
maintain complete and accurate
dispensing records at five of the clinics;
and that he failed to make and maintain
complete and accurate receipt records at
several of the clinics. Id. at 3 (citing 21
CFR 1304.11(e)(3); id. § 1304(c); 1 id.
§ 1304.22(c); and id. § 1304.22(a)(2)).
The Show Cause Order further alleged
that Respondent failed to timely submit
10 of the required quarterly dispensing
reports, that 10 of the reports that were
submitted ‘‘on July 20, 2013, were backdated and hence, failed to indicate the
true date they were prepared,’’ and that
‘‘[a]ll of these reports’’ falsely
represented that ‘‘neither [Respondent]
nor any of the . . . clinics . . . have
dispensed any controlled substances to
their patients for their medical needs.’’
Id.
Finally, the Show Cause Order alleged
that Respondent ‘‘violated 21 CFR
1306.04(b) by issuing prescriptions ‘in
order for an individual practitioner to
obtain controlled substances for
supplying the individual practitioner for
the purpose of general dispensing to
patients.’ ’’ Id. The Order then identified
two instances in which Respondent
allegedly issued prescriptions for
testosterone products which listed him
(and in one instance, a clinic) as the
patient. Id.
Following service of the Show Cause
Order, Respondent requested a hearing
on the allegations. The matter was
placed on the docket of the Office of
1 While there is no such provision, this appears
to be a mistaken citation to 21 CFR 1304.22(c),
which sets forth the records required to be
maintained by dispensers.
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[Federal Register Volume 82, Number 87 (Monday, May 8, 2017)]
[Notices]
[Pages 21408-21410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09284]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17-12]
Judson J. Somerville, M.D.; Decision and Order
On October 20, 2016, the Assistant Administrator, Division of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Judson J. Somerville, M.D. (Respondent), of Laredo,
Texas. The Show Cause Order proposed the revocation of Respondent's
Certificates of Registration, on the ground that he ``do[es] not have
authority to handle controlled substances in Texas, the [S]tate in
which [he is] registered with the'' Agency. Show Cause Order, at 1
(citing 21 U.S.C. 824(a)(3)).
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that Respondent is registered as a practitioner in schedules II
through V, pursuant to Certificate of Registration No. BS3909718, at
the address of Saguaro Anesthesia Associates, d/b/a The Pain Clinic,
9114 McPherson Road, Suite 2508, Laredo, Texas.\1\ Id. The Show Cause
Order alleged that this registration expires on February 28, 2018. Id.
The Order also alleged that Respondent is registered as a practitioner
in schedules II though V, pursuant to Certificate of Registration No.
FS3571660, at the address of 4646 Corona Drive, Corpus Christi, Texas.
Id. at 2. The Show Cause Order alleged that this registration expires
on February 28, 2019. Id.
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\1\ In the Show Cause Order, the Government listed the number of
this registration as BP3909718. Show Cause Order, at 1. However, on
December 2, 2016, the Government notified the CALJ that the correct
number was BS3909718. See Gov. Notice of Correction for the Order to
Show Cause, at 1.
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As to the substantive ground for the proceeding, the Show Cause
Order alleged that on October 6, 2016, the Texas Medical Board entered
an Order of Temporary Suspension suspending Respondent's Texas Medical
License effective the same day, ``which `shall remain in effect until
it is superseded by a subsequent Order of the Board,' '' and that this
``order prohibits [him] from practicing medicine in the State of
Texas.'' Id. The Order then alleged that ``[d]ue to the Order and under
state law, [Respondent] lack[s] authority to handle controlled
substances in Texas, the [S]tate in which [he is] registered'' and this
``constitutes grounds to revoke [his] [r]egistration.'' Id. (citing 21
U.S.C. 802(21) and 824(a)(3)) (other citations omitted).\2\
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\2\ The Show Cause Order also notified Respondent of his right
to request a hearing 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. Show Cause
Order, at 3 (citing 21 CFR 1301.43). Also, the Show Cause Order
notified Respondent of his right to submit a Corrective Action Plan
and the procedures for doing so. Id. (citing 21 U.S.C.
824(c)(2)(C)).
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Following service of the Show Cause Order, Respondent requested a
hearing on the allegations. The matter was placed on the docket of the
Office of Administrative Law Judges and assigned to Chief
Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On
November 22, 2016, the CALJ ordered the Government to submit evidence
to support the allegation and any motion for summary disposition no
later than December 7, 2016. See Order Directing the Filing of
Government Evidence of Lack of State Authority Allegation and Briefing
Schedule, at 1. In the order, the ALJ also directed Respondent to file
a response to any motion for summary disposition no later than December
21, 2016. Id.
On December 2, 2016, the Government filed its Motion for Summary
Disposition. Therein, it argued that it is undisputed that based on the
Texas Medical Board's October 6, 2016 Order of Temporary Suspension,
Respondent is prohibited from practicing medicine in the State of Texas
and that his license remains suspended as of the date of its Motion.
Gov. Motion, at 5. The Government further argued ``that the possession
of authority to dispense controlled substances under the laws of the
State in which a practitioner engaged in professional practice is a
fundamental condition for both obtaining and maintaining a
practitioner's registration,'' and that under the Agency's precedents,
revocation is warranted even where a State has invoked summary process
to suspend a practitioner's state authority and has yet to provide the
practitioner with a hearing where he may prevail. Mot. for Summ. Disp.,
at 3-7 (citations omitted). As support for its motion, the Government
attached a copy of the Medical Board's Order of Temporary Suspension
and a printout from the Medical Board's Web site showing that his
license status was ``SUSPENDED, ACTIVE.'' Id. at GXs C & D.
Respondent did not dispute that his medical license has been
suspended by the Texas Board. Resp.'s Reply to Gov. Mot. for Summ.
Disp., at 1. Instead, he argued that the Board's Order cannot ``serve
as a predicate for summary disposition'' because the Order is not a
``permanent action[] of the Board'' and is ``not valid until and unless
the matters in the . . . order[] are brought before a panel of the
Medical Board for an `Informal Settlement Conference' and if not
resolved at the . . . conference, [a] formal adjudication[] . . . which
must be initiated as soon as possible.'' Id. at 1-2. Respondent argued
that the Medical Board has acted in violation of Texas law by exempting
itself from the requirement that it initiate proceedings within 30 days
from the date of the issuance of a summary suspension order. Id. at 2-
3. He further argued that subsequent to the issuance of the Board's
Order, there has been no settlement conference and the Board did not
commence formal administrative proceedings either within the 30 day
period or `` `as soon as practicable' as mandated by Texas'' law. Id.
at 4. Respondent thus maintains that the Government's Motion is based
on the illegal actions of the Board. Id. Respondent requested that the
CALJ deny the Government's Motion and ``hold in abeyance any decision
on the Government's application until the proper exhaustion of
administrative and judicial channels takes place in Texas.'' Id. at 5.
The CALJ rejected Respondent's contentions, noting that ``the
Controlled Substances Act (CSA) requires that, in order to obtain or
maintain a DEA registration, a practitioner must be authorized to
handle controlled substances in the State in which he practices.'' R.D.
at 3-4 (citing 21 U.S.C. 823(f) and 802(21) (quotations omitted)).
While he was ``not unmindful of Respondent's arguments regarding the
legality of the Board's actions,'' the CALJ explained that ``it is not
within this tribunal's authority to evaluate the lawfulness of the
basis of a registrant's lack of state authority, and the validity of
other entities' actions is not what is at issue in these proceedings.''
Id. at 4. The CALJ then explained that the ``disposition of the
Government's Motion is wholly dependent upon the
[[Page 21409]]
single issue of whether or not the Respondent currently possesses the
requisite authority under state law to handle controlled substances-
which he does not.'' Id. The CALJ further denied Respondent's request
to hold the proceeding in abeyance pending the exhaustion of his state
remedies.\3\ Id. at 4.
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\3\ The CALJ noted that the Agency has previously held ``that a
stay in administrative enforcement proceedings is `unlikely to ever
be justified' due to ancillary proceedings involving the
Respondent.'' R.D. 5 (quoting Grider Drug #1 & Grider Drug #2, 77 FR
44070, 44104 n.97 (2012)). I agree with this statement of the
Agency's precedents. However, the CALJ also cited Odette L.
Campbell, 80 FR 41062 (2015), as contrary authority. See id. The
CALJ characterized Campbell as ``holding revocation proceedings in
abeyance at the post-hearing adjudication level for a lengthy period
pending the resolution of both criminal fraud charges and concurrent
state administrative proceedings against the respondent.'' Id. I
respectfully disagree with the CALJ's reading of Campbell. In
Campbell, the respondent failed to comply with the Agency's
regulation which, because she was subject to an Order to Show Cause,
required her to file her renewal application at least 45 days before
the expiration of her registration. 80 FR 41063. Of note, the
respondent's registration expired one week after the evidentiary
hearing, and she did not file a renewal application until three
months later, after she received a largely favorable decision from
the ALJ. Id. Thus, at the time the proceeding was held in abeyance,
the proceeding did not involve a revocation as the respondent no
longer held a registration. See 21 CFR 1301.36(i).
Most significantly, one week before the evidentiary hearing,
the respondent was indicted on 30 counts of Health Care Fraud, as
well as five counts of altering records during a federal
investigation. 80 FR at 41063. Had the respondent been convicted of
Health Care Fraud, she would have been subject to mandatory
exclusion from federal healthcare programs under 42 U.S.C. 1320a-
7(a) and her application would have been subject to denial on that
basis. Id. at 41064 (citing 21 U.S.C. 824(a)(5)). Moreover, even
after the respondent successfully completed pre-trial diversion and
the charges were dismissed, the state medical board brought a
proceeding against her license, and had the board suspended or
revoked her medical license, denial of her application would have
been required under the CSA. Id. (citing 21 U.S.C. 802(21) &
823(f)). Given the pending proceedings, Campbell was the rare case
where withholding the issuance of a final decision was warranted.
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The CALJ then found that there was no dispute over the material
fact that ``Respondent currently lacks state authority to handle
controlled substances in Texas due to the Board['s] Order dated October
6, 2016, which temporarily suspended his state license to practice
medicine.'' Id. at 6. Reasoning that ``[b]ecause . . . Respondent lacks
state authority at the present time . . . he is not entitled to
maintain his . . . registrations,'' the CALJ granted the Government's
motion and recommended that his registrations be revoked and that any
pending applications be denied. Id.
Neither party filed exceptions to the CALJ's Recommended Decision.
Thereafter, the record was forwarded to my Office for Final Agency
Action. Having reviewed the record, I adopt the CALJ's finding that by
virtue of the Texas Board's Order, Respondent is currently without
authority to handled controlled substances in Texas, the State in which
he holds his registrations with the Agency, and is thus, not entitled
to maintain his registrations. I further adopt the CALJ's
recommendation that I revoke his registrations and deny his pending
applications. I make the following factual findings.
Findings of Fact
Respondent is a physician who holds Texas Medical License No. H-
6622. GX C, at 1. However, on October 6, 2016, the Disciplinary Panel
of the Texas Medical Board issued an Order of Temporary Suspension to
Respondent based on its finding that ``Respondent's continuation in the
practice of medicine would constitute a continuing threat to the public
welfare.'' Id. at 5. The Panel further ordered that the suspension be
``effective on the date rendered'' and ``shall remain in effect until
it is superseded by a subsequent Order of the Board.'' Id. Respondent
offered no evidence in its Opposition to the Government's Motion or at
any time thereafter showing that the Board has lifted the suspension.
Based on the above, I find that Respondent does not currently have
authority under the laws of Texas to dispense controlled substances.
Respondent is also the holder of two DEA Certificates of
Registration, pursuant to which he was authorized to dispense
controlled substances in schedules II through V as a practitioner.
Pursuant to Registration No. BS3909718, Respondent was authorized to
dispense controlled substances at the address of Saguaro Anesthesia
Associates, d/b/a The Pain Management Clinic, 9114 McPherson Road,
Suite 2508, Laredo, Texas. GX A. This registration does not expire
until February 28, 2018. Id. Pursuant to Registration No. FS3571660,
Respondent was authorized to dispense controlled substances at the
address of 4646 Corona Drive, Suite 256, Corpus Christi, Texas. GX B.
According to the declaration of a Diversion Investigator, this
registration does not expire until February 28, 2019. GX F, at 2.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (CSA), ``upon a finding that the registrant .
. . has had his State license . . . suspended [or] revoked . . . by
competent State authority and is no longer authorized by State law to
engage in the . . . dispensing of controlled substances.'' Also, DEA
has long held that the possession of authority to dispense controlled
substances under the laws of the State in which a practitioner engages
in professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. See, e.g., James L. Hooper,
76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir.
2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State
authorization to dispense or otherwise handle controlled substances is
a prerequisite to the issuance and maintenance of a Federal controlled
substances registration.'').
This rule derives from the text of two provisions of the CSA.
First, Congress defined ``the term `practitioner' [to] mean[] a . . .
physician . . . or other person licensed, registered or otherwise
permitted, by . . . the jurisdiction in which he practices . . . to
distribute, dispense, [or] administer . . . a controlled substance in
the course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f).
Moreover, because ``the controlling question'' in a proceeding
brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA
registration ``is currently authorized to handle controlled substances
in the [S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62
FR 12847, 12848 (1997)), the Agency has also long held that revocation
is warranted even where a practitioner has lost his state authority by
virtue of the State's use of summary process and the State has yet to
provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR
18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus,
it is of no consequence that the Texas Medical Board has employed
summary process in suspending Registrant's state license and that
Respondent may prevail at the hearing schedule for late June.
Respondent further argues that the Board's order cannot be the
basis for revoking his registration because the Board has acted in
violation of Texas law when it neither provided Respondent with an
informal settlement conference nor commenced formal administrative
proceedings within the time frame required by Texas law. DEA,
[[Page 21410]]
however, ``accepts as valid and lawful the actions of a state
regulatory board unless that action is overturned by a state court . .
. pursuant to state law.'' Kamal Tiwari, 76 FR 71604, 71607 (2011)
(quoting George S. Heath, 51 FR 26610 (1986)). Rather, Respondent's
challenge to the lawfulness of the Texas Board's Suspension Order must
be raised in the forums provided by the State. Id. (quoting 51 FR at
26610). See also Calvin Ramsey, 76 FR 20034, 20036 (2011) (quoting
Hicham K. Riba, 73 FR 75773, 75774 (2008) (``DEA has repeatedly held
that a registrant cannot collaterally attack the results of a state
criminal or administrative proceeding in a proceeding brought under
section 304 [21 U.S.C. 824] of the CSA.'')).
Here, there is no dispute over the material fact that Respondent is
no longer currently authorized to dispense controlled substances in
Texas, the State in which he is registered. Accordingly, he is not
entitled to maintain his registrations. I will therefore adopt the
CALJ's recommendation that I revoke Respondent's registrations and deny
any pending applications to renew his registrations. R.D. 6.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a)(3) and
28 CFR 0.100(b), I order that DEA Certificates of Registration Nos.
BS3909718 and FS3571660 be, and they hereby are, revoked. Pursuant to
the authority vested in me by 21 U.S.C. 823(f), I order that any
applications to renew the above registrations be, and they hereby are,
denied. This Order is effective immediately.\4\
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\4\ For the same reasons which led the Texas Board to order the
temporary suspension of Respondent's medical license, I conclude
that the public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
Dated: May 1, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-09284 Filed 5-5-17; 8:45 am]
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