John P. Moore, III, M.D.; Decision and Order, 10398-10401 [2017-02729]
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post-hearing briefs and statements
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in the report that it delivers to the
USTR. All information, including CBI,
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submitted in this investigation may be
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Commission, its employees and Offices,
and contract personnel (a) for
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of this or a related proceeding, or (b) in
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U.S.C. Appendix 3; or (ii) by U.S.
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The Commission will not otherwise
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Summaries of Written Submissions:
The Commission intends to publish
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filed by interested persons. Persons
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include a link to the Commission’s
Electronic Document Information
System (EDIS) where the full written
submission can be found.
By order of the Commission.
Issued: February 6, 2017.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2017–02752 Filed 2–9–17; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
John P. Moore, III, M.D.; Decision and
Order
On June 30, 2016, the Assistant
Administrator, Division of Diversion
Control, issued an Order to Show Cause
to John P. Moore, III, M.D. (Respondent),
of Centerville, Ohio. The Show Cause
Order proposed the revocation of
Respondent’s DEA Certificate of
Registration No. FM1335353. GX 2, at 1.
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is the holder of
Certificate of Registration No.
FM1335353, which ‘‘is valid for Drug
Schedules II–V,’’ at the address of 950
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E. Alex Bell Road, Centerville, Ohio. Id.
at 2. The Order further alleged that this
registration does not expire until
January 31, 2018. Id.
The Show Cause Order further alleged
three separate grounds for the proposed
action. First, it alleged that on April 5,
2016, Respondent pled guilty in the
Ohio courts to four state felony counts
of knowingly selling or offering to sell
zolpidem and diazepam (both schedule
IV controlled substances) and Suboxone
(buprenorphine and naloxone, a
schedule III controlled substance), as
well as a further felony count of
knowingly permitting real estate or
other premises to be used for drug
trafficking. Id. (citing Ohio Rev. Code
§§ 2925.03, 2925.13). See also 21 U.S.C.
824(a)(2).
Second, the Show Cause Order
alleged that on May 11, 2016,
Respondent’s Ohio medical license was
suspended and that he is currently
without authority to dispense controlled
substances in the State in which he is
registered with the Agency. GX 2, at 2
(citing 21 U.S.C. 802(21), 824(a)(3)).
And third, the Show Cause Order
alleged that Respondent has also been
‘‘convicted of felony Medicaid fraud,’’
thus rendering him subject to
mandatory exclusion from participation
in federal health care programs under 42
U.S.C. 1320a–7(a) and subjecting his
registration to revocation for this reason
as well. GX 2, at 2 (citing 21 U.S.C.
824(a)(5)).
The Show Cause Order also notified
Respondent of his right to request a
hearing on the allegations of the Order
or to submit a written statement of
position while waiving his right to a
hearing, the procedure for electing
either option (including the time period
for filing), and the consequence of
failing to elect either option as well as
the failure to do so in compliance with
the Agency’s regulations. Id. at 3 (citing
21 CFR 1301.43). Finally, the Show
Cause Order informed Respondent of
his right to submit a corrective action
plan under 21 U.S.C. 824(c)(2)(C). Id.
On or about June 30, 2016, the
Government sent the Show Cause Order
by certified mail, return receipt
requested, addressed to Respondent at
his residence in the Correctional
Reception Center in Orient, Ohio. GX 5,
Appendix A, at 1, 3–4. As evidenced by
the signed return receipt card, on July
6, 2016, the Government accomplished
service.1 Id. at 3,
1 While I find that the mailing provided
constitutionally adequate service, the Government
also produced evidence showing that it had emailed
a copy of the Show Cause Order to corrections
officers at the Ohio Correctional Reception Center
and that Respondent was personally served with a
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On August 11, 2016, Respondent filed
a request for a hearing with the Office
of Administrative Law Judges and the
matter was assigned to Chief
Administrative Law Judge John J.
Mulrooney, II (hereinafter, CALJ). GXs
3, 4. In his hearing request,
Respondent’s counsel acknowledged
that his request was out of time. GX 3,
at 3. Respondent, however, invoked 21
CFR 1316.47(b), which provides that
‘‘[t]he Administrative Law Judge, upon
request and showing of good cause, may
grant a reasonable extension of the time
allowed for a response to an Order to
Show Cause.’’ 2 Respondent thus argued
that ‘‘good cause exists for a reasonable
extension of time’’ to respond to the
Show Cause Order because he ‘‘did not
have timely access to his mail while
incarcerated.’’ GX 3, at 3. Respondent’s
counsel further argued that the request
came ‘‘less than 7 days beyond the . . .
30-day time frame for a response’’ and
that the Agency was not ‘‘materially
prejudiced by the’’ delay. Id.
Upon receipt of Respondent’s hearing
request, the CALJ issued an order,
directing, inter alia, that the
Government submit ‘‘proof of the date of
service’’ of the Show Cause Order, as
well as a response to Respondent’s
request for an extension or a motion to
terminate the proceeding. GX 4, at 1–2.
In response, the Government timely
submitted a motion to terminate the
proceeding and opposing Respondent’s
request for an extension. GX 5.
Therein, the Government represented
that the Show Cause Order had been
served on Respondent by both certified
mail which was received on July 6,
2016, as well as hand delivery by prison
personnel on July 7, 2016. Id. at 1–2.
The Government then noted that
copy of the order on July 7, 2016. GX 5, Appendix
A, at 2, 5.
2 While Respondent cited this provision as
authority to excuse his untimely filing, it is clear
that he submitted a hearing request which is also
subject to the good cause standard. See 21 CFR
1301.43(d). The Agency has previously explained
on interlocutory review that ‘‘where an ALJ receives
an untimely hearing request, it is within [the ALJ’s]
authority to conduct such proceedings as are
necessary to determine whether the respondent has
established good cause.’’ Mark S. Cukierman,
Denial of Interlocutory Appeal, Slip Op. at 7. This
is so even where a respondent does not establish
good cause as part of the hearing request. Id.
However, as also explained in Cukierman, once the
Government submits a request for final agency
action to this Office, the forwarding of the record
divests the ALJ of authority to rule on whether there
is good cause to excuse an untimely request for a
hearing and the timeliness of the hearing request is
to be reviewed by this Office. In those instances in
which a respondent submits a hearing request after
the Government has filed its Request for Final
Agency Action, the Government should inform the
ALJ that the matter has been forwarded to this
Office and the ALJ should issue an order forwarding
the hearing request to this Office.
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Respondent ‘‘was released from [prison]
on approximately July 27, 2016’’ and
that the Ohio Medical Board had
conducted a hearing on July 28, 2016, at
which he was physically present and
was represented by the same counsel
that was representing him in the DEA
proceeding. Id. at 2. The Government
argues that ‘‘[e]ven if Respondent did
not have timely access to mail for
communicating with his counsel
regarding the’’ Show Cause Order, he
certainly could have done so on July 28
and thus, he has failed to offer good
cause for the untimely submission of his
hearing request. Id. While the
Government acknowledged that it was
not prejudiced by Respondent’s
untimely hearing request, it argued that
Respondent was seeking to gain a
‘‘tactical advantage’’ by drawing out the
proceedings in the hope that the Ohio
Board would reinstate his license. Id.
at 2–3.
Upon receipt of the Government’s
motion, the CALJ provided Respondent
with an opportunity to respond to the
Government’s motion and Respondent
filed a response. GXs 7, 8. Therein,
Respondent explained that ‘‘[b]ecause of
[his] preoccupation with defending the
[State Board’s] allegations, he did not
notify his counsel of the [DEA] matter
until [t]he morning of August 8, 2016,’’
on which date his ‘‘counsel immediately
filed a request for [h]earing.’’ GX 8, at
1. After noting the Government’s
concession that the untimely filing of
the request had not caused it prejudice,
Respondent ‘‘denie[d]’’ that he sought
the extension to obtain ‘‘a tactical
advantage’’ and stated that he ‘‘is
willing and able to defend his interests
in this matter without a final
determination by the Ohio Medical
Board.’’ Id. Respondent then argued that
he had shown ‘‘good cause’’ under 21
CFR 1316.47(b) based on ‘‘the
importance of the constitutionally
protected interest involved in this
matter’’ and because only a ‘‘minor 2day extension’’ was requested.3 Id. at 1–
2.
Upon review, the CALJ granted the
Government’s motion to terminate the
proceeding. GX 9, at 5. The CALJ noted
that the language of 21 CFR 1316.47(b)
‘‘is arguably supportive of an
interpretation limiting the authority to
extend the time to file a hearing request
only during the time when the
[Administrative Law] Judge has
potential jurisdiction over the case, to
wit, prior to the expiration of the thirty-
day . . . period’’ from the date of
service for requesting a hearing. Id. at 2.
However, the CALJ further noted that in
contrast to several other agency
regulations, including 21 CFR
1316.47(a), which states that ‘‘[a]ny
person entitled to a hearing and desiring
a hearing shall, within the period
permitted for filing, file a request for a
hearing,’’ (emphasis added), section
1316.47(b) sets no time limit for
requesting ‘‘a reasonable extension of
the time allowed for response to an
Order to Show Cause.’’ GX 9, at 2–3.
The CALJ concluded, however, that
regardless of whether he had authority
to rule on a request for an extension
filed more than 30 days after the date of
service of the Show Cause Order, ‘‘the
Agency has made clear that it is
prepared to find a hearing waiver when
an untimely hearing request is not
supported by good cause for its
tardiness.’’ Id. at 3 (citing 21 CFR
1301.43(d) (‘‘If any person entitled to a
hearing . . . fails to file a request for a
hearing . . . such person shall be
deemed to have waived the opportunity
for a hearing . . . unless such person
shows good cause for such failure.’’);
Shannon L. Gallentine, 76 FR 45864,
45864 (2011)).
The CALJ then found that while
Respondent initially argued that he ‘‘did
not have timely access to his mail while
incarcerated,’’ once the Government
refuted this argument (by showing that
he had been released from custody on
July 27, 2016), he then changed his
position and maintained that his ‘‘preoccupation’’ with the Ohio Board’s
hearing had led him to miss the filing
deadline.4 GX 9, at 4. The CALJ rejected
the latter explanation as sufficient to
establish ‘‘good cause,’’ explaining that
‘‘in a regulatory environment where
parallel proceedings . . . are common,
even ubiquitous, ‘preoccupation’ borne
of participation in those proceedings,
standing alone, cannot constitute good
cause. . . . [T]he Respondent’s only
obligation—and the[ ] only task
negligently accomplished—was to
deliver his [Show Cause Order] to the
attorney who was already representing
him on related proceedings.’’ Id.
Continuing, the CALJ explained that
although it is ‘‘undeniably true that
counsel promptly attended to the matter
once the Respondent supplied the
[Order], promptness on the part of his
attorney can offer no dispensation here.
No excuse has been propounded to
3 In this filing, Respondent replied to the
Government’s Motion to Terminate by challenging
the Government’s Motion for Summary Disposition.
GX 8, at 2–3. I address these arguments later in this
Decision.
4 Of course, Respondent’s initial contention is
also refuted by the evidence that a correction officer
hand-delivered the Show Cause Order to him on
July 7, 2016, nearly three weeks before he was
released from prison.
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excuse his delay in providing his
counsel with the’’ Order. Id. at 4–5. The
CALJ thus concluded that Respondent
had not demonstrated ‘‘good cause’’ to
excuse his untimely filing and granted
the Government’s motion to terminate
the hearing. Id. at 5.
Thereafter, the Government submitted
a Request for Final Agency Action and
an evidentiary record to my Office. As
an initial matter, I agree with the CALJ
that Respondent has failed to
demonstrate ‘‘good cause’’ to excuse the
untimely filing of his hearing request.
While DEA has interpreted the ‘‘good
cause’’ standard for assessing the
timeliness of hearing requests as
encompassing cases of excusable
neglect, mistake or inadvertence, see
Keith Ky Ly, 80 FR 29025, 29027 & n.2
(2015) (citing Tony T. Bui, 75 FR 49979,
49980 (2010)), Respondent has failed to
make a sufficient showing to warrant
relief. While Respondent initially
claimed that his untimely filing should
be excused because he did not have
timely access to his mail, the evidence
shows that the Show Cause Order was
hand-delivered to him. As for his
subsequent claim that his untimeliness
should be excused because he was
preoccupied with the State Board
proceeding, Respondent has failed to
explain why he was so pre-occupied
with the Board proceeding in the three
weeks that passed from the date the
Order was hand delivered to him until
he was released from prison that he
could not have devoted the de minimis
amount of time it would have taken to
mail the Order to his attorney or to
personally prepare and mail his hearing
request. Moreover, even assuming that
Respondent was preoccupied with the
Board hearing during the day(s) on
which the hearing took place, he offers
no explanation for why he did not
provide the Show Cause Order to his
attorney for another 10 days after the
Board hearing concluded. And as for
Respondent’s contention that his
untimeliness should be excused because
of ‘‘the importance of the
constitutionally protected interest
involved in this matter,’’ this is true of
every case brought by the Government
against a registrant or applicant. It thus
provides no reason to excuse his
neglect, even if it the period of his
untimeliness would not prejudice the
Government.
Accordingly, I conclude that
Respondent has failed to established
‘‘good cause’’ to excuse his untimely
filing and has therefore waived his right
to a hearing. See 21 CFR 1301.43(d). I
therefore issue this Decision and Order
based on the record submitted by the
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Government and make the following
findings of fact.
Findings
Respondent is the holder of DEA
Certificate of Registration No.
FM1335353, as well DATA-Waiver
identification number XM1335353. GX
1. Pursuant to his registration,
Respondent is authorized to dispense
controlled substances in schedules II
through V as a practitioner and pursuant
to his DATA-Waiver identification
number, he is authorized to dispense or
prescribe schedule III–V narcotic
controlled substances which ‘‘have been
approved by the Food and Drug
Administration . . . specifically for use
in maintenance or detoxification
treatment’’ for up to 100 patients.’’ 21
CFR 1301.28(a) & (b)(iii); see also GX 1.
Respondent’s registered address is 950
E. Alex Bell Road, Centerville, Ohio; his
registration and the authority provided
by his DATA-Waiver number do not
expire until January 31, 2018. GX 1.
On April 5, 2016, the Prosecuting
Attorney for Greene County, Ohio
issued an Information which charged
Respondent with multiple felony
controlled substance offenses under
Ohio law; the Information also charged
Respondent with Medicaid Fraud. GX
11, at 2–4 (citing Ohio Rev. Code
§ 2913.40(B) and (E); id. § 2925.03) With
respect to the controlled substance
offenses, Respondent was charged with,
inter alia: (1) Two counts of trafficking
in zolpidem, a schedule IV controlled
substance, from ‘‘on or about February
12, 2009 to September 30, 2014’’; (2)
trafficking in suboxone, a schedule III
controlled substance, ‘‘on or about
February 12, 2009’’; and (3) trafficking
in diazepam, a schedule IV controlled
substance, also ‘‘on or about February
12, 2009.’’ Id. at 2–3 (citing Ohio Rev.
Code § 2925.03). Finally, Respondent
was charged with knowingly permitting
real property to ‘‘be use for the
commission of a felony drug offense, to
wit, trafficking . . . by another person.’’
Id. at 3–4 (citing Ohio Rev. Code
§ 2925.13).
The same day, Respondent appeared
in court and pled guilty to each of these
offenses. Id. at 11–12. On May 26, 2016,
the state court entered judgment and
sentenced Respondent to a term of
imprisonment of 10 months on each of
the above counts, but provided that the
sentence for Medicaid Fraud and
permitting real property to be used for
the commission of a drug offense were
‘‘to be served consecutively to each
other, but concurrently to the remaining
counts for a total sentence of 20
months.’’ Id. at 14, 17. The court also
ordered that Respondent forfeit $85,000,
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which included $5,531.08 in restitution
to two entities. Id. at 19. Thus, I find
that Respondent has been convicted of
felony offenses under Ohio law,
‘‘relating to any substance defined in
[the Controlled Substances Act] as a
controlled substance.’’ 21 U.S.C.
824(a)(2); see also Ohio Rev. Code
§ 2925.03(A)(1) (‘‘No person shall
knowingly . . . [s]ell or offer to sell a
controlled substance or a controlled
substance analog.’’); id.
§ 2925.03(C)(2)(a) (if drug is in
schedules III through V, offense is a fifth
degree felony). See also Ohio Rev. Code
§ 2925.13(B) (‘‘No person who is the
owner, lessee, or occupant, or who has
custody, control, or supervision, of
premises or real estate . . . shall
knowingly permit the premises or real
estate . . . to be used for the
commission of a felony drug offense by
another person.’’).5
Moreover, on May 11, 2016, the State
Medical Board of Ohio issued
Respondent a Notice of Immediate
Suspension and Opportunity for
Hearing, pursuant to which his license
to practice medicine and surgery in the
State was suspended. GX 6, Attachment
1, at 1. The Board’s Order was based on
Respondent’s guilty pleas to the four
felony counts of Trafficking in Drugs
(Ohio Rev. Code § 2925.03) and the
felony count of Permitting Drug Abuse
(Ohio Rev. Code § 2925.13). According
to the Medical Board’s Web site of
which I take official notice,6 on October
19, 2016, the Board ordered the
permanent revocation of Respondent’s
license to practice medicine and surgery
based upon his convictions on the four
trafficking counts, as well as the single
counts of Permitting Drug Abuse and
Medicaid Fraud; this Order became
effective the next day. See Ohio License
Center (John Pease Moore, III), https://
license.ohio.gov/lookup/default.asp.
(last visited February 1, 2017). I
therefore find that Respondent is
currently without authority to dispense
controlled substances in Ohio.
5 See also Ohio Rev. Code § 2925.13(C)(3)
(‘‘Permitting drug abuse is a felony of the fifth
degree[.]’’).
6 In accordance with the Administrative
Procedure Act (APA), an agency ‘‘may take official
notice of facts at any stage in a proceeding-even in
the final decision.’’ U.S. Dept. of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). In accordance with the APA and DEA’s
regulations, Respondent is ‘‘entitled on timely
request to an opportunity to show to the contrary.’’
5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To
allow Respondent the opportunity to refute the facts
of which I take official notice, Respondent may file
a motion for reconsideration within 15 calendar
days of the date of service of this Order which shall
commence on the date this Order is mailed.
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In addition, the record includes a July
29, 2016 letter from the Office of
Inspector General, Department of Health
and Human Services, to Respondent; the
letter notified Respondent that he was
‘‘being excluded from participation in
any capacity in the Medicare, Medicaid,
and all Federal health care programs as
defined in section 1128B(f) of the Social
Security Act . . . for the minimum
period of 5 years.’’ GX 12, at 1. The
letter explained that Respondent was
being excluded based on his ‘‘felony
conviction[s]’’ for ‘‘a criminal offense
related to the delivery of an item or
service under the Medicare or a State
health care program,’’ and for ‘‘criminal
offense[s] related to the unlawful
manufacture, distribution, prescription,
or dispensing of a controlled substance
as defined under Federal or State law.’’
Id. (citing 42 U.S.C. 1320a–7(a)(1) and
(4)).
Discussion
Under Section 304(a) of the
Controlled Substances Act, ‘‘[a]
registration pursuant to section 823 of
[the Act] to . . . dispense a controlled
substance . . . may be suspended or
revoked by the Attorney General upon
a finding that the registrant—
*
*
*
*
*
(2) has been convicted of a felony under
this subchapter . . . or any other law of the
United States, or of any State, relating to any
substance defined in this subchapter as a
controlled substance . . . ;
(3) has had his State license or registration
suspended, revoked, or denied by competent
State authority and is no longer authorized
by State law to engage in the . . . dispensing
of controlled substances . . . ;
*
*
*
*
*
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(5) has been excluded . . . from
participation in a program pursuant to
section 1320a–7(a) of Title 42.
21 U.S.C. 824(a).
The Government has ‘‘the burden of
proving that the requirements for such
revocation or suspension pursuant to
section 304(a) . . . (21 U.S.C. 824(a)
. . .) are satisfied. 21 CFR 1301.44(e).
Thus, even where a registrant waives his
right to a hearing, the Government is
required to produce substantial
evidence to support the proposed
action. In this matter, having considered
the evidence submitted by the
Government, I conclude that there are
three separate and independent grounds
to revoke Respondent’s registration.
First, as found above, on May 26,
2016, the Common Pleas Court of
Greene County, Ohio entered a
judgment convicting Respondent of four
counts of trafficking in drugs (suboxone,
zolpidem, and diazepam) under Ohio
law, as well as a single count of
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knowingly permitting real estate he
owned or controlled to be used for drug
trafficking. See Ohio Rev. Code
§§ 2925.03(A); 2925.13(B). Both of these
provisions are felony offenses under
Ohio law. Thus, I find that Respondent
‘‘has been convicted of a felony offense
. . . relating to any substance defined in
[the CSA] as a controlled substance.’’ 21
U.S.C. 824(a)(2). This finding provides
reason alone to revoke Respondent’s
registration and his DATA-Waiver
identification number.
Second, the evidence shows that
based on his guilty pleas in the criminal
case, on May 11, 2016, the Ohio Board
immediately suspended Respondent’s
license to practice medicine and surgery
in the State, and that on October 20,
2016, the Board revoked his license. By
virtue of the Board’s actions,
Respondent lacks authority to dispense
controlled substances under the laws of
the State of Ohio, the State in which he
is registered with DEA, and thus, he is
no longer a practitioner within the
meaning of the Act. See 21 U.S.C.
802(21) (defining ‘‘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’’); see also id. § 823(f) (directing
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’’).
As the Agency has long held, ‘‘[s]tate
authorization to dispense or otherwise
handle controlled substances is a
prerequisite to the issuance and
maintenance of a Federal controlled
substances registration.’’ Frederick
Marsh Blanton, 43 FR 27616 (1978).
Because the possession of state
authority is a prerequisite to the
maintenance of a practitioner’s
registration, the Agency has long held
that revocation is the appropriate
sanction whenever he is no longer
authorized to dispense controlled
substances under the laws of the State
in which he practices medicine. See,
e.g., James L. Hooper, 76 FR 71371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988); Blanton, 43 FR at
27616.7 Accordingly, Respondent’s
7 Thus, even if Respondent were to credibly
accept responsibility for his criminal conduct and
put forward sufficient evidence of remedial
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
10401
registration (and DATA-Waiver number)
are subject to revocation for this reason
as well. 21 U.S.C. 824(a)(3).
Finally, the evidence shows that
Respondent has now been excluded
‘‘from participation in any Federal
health care program’’ based on his state
conviction for Medicaid fraud, as well
as his felony convictions relating to the
distribution of controlled substances.
See 42 U.S.C. 1320a–7(a)(1) & (4); see
also GX 12. Respondent has thus been
excluded pursuant to the mandatory
exclusion provisions of 42 U.S.C.
1320a–7(a). Accordingly, his registration
(and DATA-Waiver number) are also
subject to revocation under 21 U.S.C.
824(a)(5).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration FM1335353 issued to John
P. Moore, III, M.D., be, and it hereby is,
revoked. I further order that DATAWaiver identification number
XM1335353 issued to John P. Moore, II,
M.D., be, and it hereby is, revoked. This
Order is effective immediately.8
Dated: February 2, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–02729 Filed 2–9–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bureau of Justice Statistics
[OMB Number 1121–0102]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of a
Currently Approved Collection: Prison
Population Reports: Summary of
Sentenced Population Movement—
National Prisoner Statistics
Bureau of Justice Statistics,
Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Office of Justice Programs,
SUMMARY:
measures, the revocation of his state authority
would still require that I revoke his DEA
registration and DATA-waiver number. I further
reject Respondent’s contention that I have
discretion in the case of a practitioner to not revoke
his registration based on his loss of state authority.
See GX 8, at 2–3; see Hooper v. Holder, 481 Fed.
Appx. at 827–28; see also Rezik A. Saqer, 81 FR
22122, 22124–27 (2016).
8 Based on the same reasons that led the Ohio
Board to immediately suspend Respondent’s
medical license, I conclude that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
E:\FR\FM\10FEN1.SGM
10FEN1
Agencies
[Federal Register Volume 82, Number 27 (Friday, February 10, 2017)]
[Notices]
[Pages 10398-10401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02729]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
John P. Moore, III, M.D.; Decision and Order
On June 30, 2016, the Assistant Administrator, Division of
Diversion Control, issued an Order to Show Cause to John P. Moore, III,
M.D. (Respondent), of Centerville, Ohio. The Show Cause Order proposed
the revocation of Respondent's DEA Certificate of Registration No.
FM1335353. GX 2, at 1.
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that Respondent is the holder of Certificate of Registration
No. FM1335353, which ``is valid for Drug Schedules II-V,'' at the
address of 950 E. Alex Bell Road, Centerville, Ohio. Id. at 2. The
Order further alleged that this registration does not expire until
January 31, 2018. Id.
The Show Cause Order further alleged three separate grounds for the
proposed action. First, it alleged that on April 5, 2016, Respondent
pled guilty in the Ohio courts to four state felony counts of knowingly
selling or offering to sell zolpidem and diazepam (both schedule IV
controlled substances) and Suboxone (buprenorphine and naloxone, a
schedule III controlled substance), as well as a further felony count
of knowingly permitting real estate or other premises to be used for
drug trafficking. Id. (citing Ohio Rev. Code Sec. Sec. 2925.03,
2925.13). See also 21 U.S.C. 824(a)(2).
Second, the Show Cause Order alleged that on May 11, 2016,
Respondent's Ohio medical license was suspended and that he is
currently without authority to dispense controlled substances in the
State in which he is registered with the Agency. GX 2, at 2 (citing 21
U.S.C. 802(21), 824(a)(3)). And third, the Show Cause Order alleged
that Respondent has also been ``convicted of felony Medicaid fraud,''
thus rendering him subject to mandatory exclusion from participation in
federal health care programs under 42 U.S.C. 1320a-7(a) and subjecting
his registration to revocation for this reason as well. GX 2, at 2
(citing 21 U.S.C. 824(a)(5)).
The Show Cause Order also notified Respondent of his right to
request a hearing on the allegations of the Order or to submit a
written statement of position while waiving his right to a hearing, the
procedure for electing either option (including the time period for
filing), and the consequence of failing to elect either option as well
as the failure to do so in compliance with the Agency's regulations.
Id. at 3 (citing 21 CFR 1301.43). Finally, the Show Cause Order
informed Respondent of his right to submit a corrective action plan
under 21 U.S.C. 824(c)(2)(C). Id.
On or about June 30, 2016, the Government sent the Show Cause Order
by certified mail, return receipt requested, addressed to Respondent at
his residence in the Correctional Reception Center in Orient, Ohio. GX
5, Appendix A, at 1, 3-4. As evidenced by the signed return receipt
card, on July 6, 2016, the Government accomplished service.\1\ Id. at
3,
---------------------------------------------------------------------------
\1\ While I find that the mailing provided constitutionally
adequate service, the Government also produced evidence showing that
it had emailed a copy of the Show Cause Order to corrections
officers at the Ohio Correctional Reception Center and that
Respondent was personally served with a copy of the order on July 7,
2016. GX 5, Appendix A, at 2, 5.
---------------------------------------------------------------------------
[[Page 10399]]
On August 11, 2016, Respondent filed a request for a hearing with
the Office of Administrative Law Judges and the matter was assigned to
Chief Administrative Law Judge John J. Mulrooney, II (hereinafter,
CALJ). GXs 3, 4. In his hearing request, Respondent's counsel
acknowledged that his request was out of time. GX 3, at 3. Respondent,
however, invoked 21 CFR 1316.47(b), which provides that ``[t]he
Administrative Law Judge, upon request and showing of good cause, may
grant a reasonable extension of the time allowed for a response to an
Order to Show Cause.'' \2\ Respondent thus argued that ``good cause
exists for a reasonable extension of time'' to respond to the Show
Cause Order because he ``did not have timely access to his mail while
incarcerated.'' GX 3, at 3. Respondent's counsel further argued that
the request came ``less than 7 days beyond the . . . 30-day time frame
for a response'' and that the Agency was not ``materially prejudiced by
the'' delay. Id.
---------------------------------------------------------------------------
\2\ While Respondent cited this provision as authority to excuse
his untimely filing, it is clear that he submitted a hearing request
which is also subject to the good cause standard. See 21 CFR
1301.43(d). The Agency has previously explained on interlocutory
review that ``where an ALJ receives an untimely hearing request, it
is within [the ALJ's] authority to conduct such proceedings as are
necessary to determine whether the respondent has established good
cause.'' Mark S. Cukierman, Denial of Interlocutory Appeal, Slip Op.
at 7. This is so even where a respondent does not establish good
cause as part of the hearing request. Id. However, as also explained
in Cukierman, once the Government submits a request for final agency
action to this Office, the forwarding of the record divests the ALJ
of authority to rule on whether there is good cause to excuse an
untimely request for a hearing and the timeliness of the hearing
request is to be reviewed by this Office. In those instances in
which a respondent submits a hearing request after the Government
has filed its Request for Final Agency Action, the Government should
inform the ALJ that the matter has been forwarded to this Office and
the ALJ should issue an order forwarding the hearing request to this
Office.
---------------------------------------------------------------------------
Upon receipt of Respondent's hearing request, the CALJ issued an
order, directing, inter alia, that the Government submit ``proof of the
date of service'' of the Show Cause Order, as well as a response to
Respondent's request for an extension or a motion to terminate the
proceeding. GX 4, at 1-2. In response, the Government timely submitted
a motion to terminate the proceeding and opposing Respondent's request
for an extension. GX 5.
Therein, the Government represented that the Show Cause Order had
been served on Respondent by both certified mail which was received on
July 6, 2016, as well as hand delivery by prison personnel on July 7,
2016. Id. at 1-2. The Government then noted that Respondent ``was
released from [prison] on approximately July 27, 2016'' and that the
Ohio Medical Board had conducted a hearing on July 28, 2016, at which
he was physically present and was represented by the same counsel that
was representing him in the DEA proceeding. Id. at 2. The Government
argues that ``[e]ven if Respondent did not have timely access to mail
for communicating with his counsel regarding the'' Show Cause Order, he
certainly could have done so on July 28 and thus, he has failed to
offer good cause for the untimely submission of his hearing request.
Id. While the Government acknowledged that it was not prejudiced by
Respondent's untimely hearing request, it argued that Respondent was
seeking to gain a ``tactical advantage'' by drawing out the proceedings
in the hope that the Ohio Board would reinstate his license. Id. at 2-
3.
Upon receipt of the Government's motion, the CALJ provided
Respondent with an opportunity to respond to the Government's motion
and Respondent filed a response. GXs 7, 8. Therein, Respondent
explained that ``[b]ecause of [his] preoccupation with defending the
[State Board's] allegations, he did not notify his counsel of the [DEA]
matter until [t]he morning of August 8, 2016,'' on which date his
``counsel immediately filed a request for [h]earing.'' GX 8, at 1.
After noting the Government's concession that the untimely filing of
the request had not caused it prejudice, Respondent ``denie[d]'' that
he sought the extension to obtain ``a tactical advantage'' and stated
that he ``is willing and able to defend his interests in this matter
without a final determination by the Ohio Medical Board.'' Id.
Respondent then argued that he had shown ``good cause'' under 21 CFR
1316.47(b) based on ``the importance of the constitutionally protected
interest involved in this matter'' and because only a ``minor 2-day
extension'' was requested.\3\ Id. at 1-2.
---------------------------------------------------------------------------
\3\ In this filing, Respondent replied to the Government's
Motion to Terminate by challenging the Government's Motion for
Summary Disposition. GX 8, at 2-3. I address these arguments later
in this Decision.
---------------------------------------------------------------------------
Upon review, the CALJ granted the Government's motion to terminate
the proceeding. GX 9, at 5. The CALJ noted that the language of 21 CFR
1316.47(b) ``is arguably supportive of an interpretation limiting the
authority to extend the time to file a hearing request only during the
time when the [Administrative Law] Judge has potential jurisdiction
over the case, to wit, prior to the expiration of the thirty-day . . .
period'' from the date of service for requesting a hearing. Id. at 2.
However, the CALJ further noted that in contrast to several other
agency regulations, including 21 CFR 1316.47(a), which states that
``[a]ny person entitled to a hearing and desiring a hearing shall,
within the period permitted for filing, file a request for a hearing,''
(emphasis added), section 1316.47(b) sets no time limit for requesting
``a reasonable extension of the time allowed for response to an Order
to Show Cause.'' GX 9, at 2-3. The CALJ concluded, however, that
regardless of whether he had authority to rule on a request for an
extension filed more than 30 days after the date of service of the Show
Cause Order, ``the Agency has made clear that it is prepared to find a
hearing waiver when an untimely hearing request is not supported by
good cause for its tardiness.'' Id. at 3 (citing 21 CFR 1301.43(d)
(``If any person entitled to a hearing . . . fails to file a request
for a hearing . . . such person shall be deemed to have waived the
opportunity for a hearing . . . unless such person shows good cause for
such failure.''); Shannon L. Gallentine, 76 FR 45864, 45864 (2011)).
The CALJ then found that while Respondent initially argued that he
``did not have timely access to his mail while incarcerated,'' once the
Government refuted this argument (by showing that he had been released
from custody on July 27, 2016), he then changed his position and
maintained that his ``pre-occupation'' with the Ohio Board's hearing
had led him to miss the filing deadline.\4\ GX 9, at 4. The CALJ
rejected the latter explanation as sufficient to establish ``good
cause,'' explaining that ``in a regulatory environment where parallel
proceedings . . . are common, even ubiquitous, `preoccupation' borne of
participation in those proceedings, standing alone, cannot constitute
good cause. . . . [T]he Respondent's only obligation--and the[ ] only
task negligently accomplished--was to deliver his [Show Cause Order] to
the attorney who was already representing him on related proceedings.''
Id. Continuing, the CALJ explained that although it is ``undeniably
true that counsel promptly attended to the matter once the Respondent
supplied the [Order], promptness on the part of his attorney can offer
no dispensation here. No excuse has been propounded to
[[Page 10400]]
excuse his delay in providing his counsel with the'' Order. Id. at 4-5.
The CALJ thus concluded that Respondent had not demonstrated ``good
cause'' to excuse his untimely filing and granted the Government's
motion to terminate the hearing. Id. at 5.
---------------------------------------------------------------------------
\4\ Of course, Respondent's initial contention is also refuted
by the evidence that a correction officer hand-delivered the Show
Cause Order to him on July 7, 2016, nearly three weeks before he was
released from prison.
---------------------------------------------------------------------------
Thereafter, the Government submitted a Request for Final Agency
Action and an evidentiary record to my Office. As an initial matter, I
agree with the CALJ that Respondent has failed to demonstrate ``good
cause'' to excuse the untimely filing of his hearing request.
While DEA has interpreted the ``good cause'' standard for assessing
the timeliness of hearing requests as encompassing cases of excusable
neglect, mistake or inadvertence, see Keith Ky Ly, 80 FR 29025, 29027 &
n.2 (2015) (citing Tony T. Bui, 75 FR 49979, 49980 (2010)), Respondent
has failed to make a sufficient showing to warrant relief. While
Respondent initially claimed that his untimely filing should be excused
because he did not have timely access to his mail, the evidence shows
that the Show Cause Order was hand-delivered to him. As for his
subsequent claim that his untimeliness should be excused because he was
preoccupied with the State Board proceeding, Respondent has failed to
explain why he was so pre-occupied with the Board proceeding in the
three weeks that passed from the date the Order was hand delivered to
him until he was released from prison that he could not have devoted
the de minimis amount of time it would have taken to mail the Order to
his attorney or to personally prepare and mail his hearing request.
Moreover, even assuming that Respondent was preoccupied with the Board
hearing during the day(s) on which the hearing took place, he offers no
explanation for why he did not provide the Show Cause Order to his
attorney for another 10 days after the Board hearing concluded. And as
for Respondent's contention that his untimeliness should be excused
because of ``the importance of the constitutionally protected interest
involved in this matter,'' this is true of every case brought by the
Government against a registrant or applicant. It thus provides no
reason to excuse his neglect, even if it the period of his untimeliness
would not prejudice the Government.
Accordingly, I conclude that Respondent has failed to established
``good cause'' to excuse his untimely filing and has therefore waived
his right to a hearing. See 21 CFR 1301.43(d). I therefore issue this
Decision and Order based on the record submitted by the Government and
make the following findings of fact.
Findings
Respondent is the holder of DEA Certificate of Registration No.
FM1335353, as well DATA-Waiver identification number XM1335353. GX 1.
Pursuant to his registration, Respondent is authorized to dispense
controlled substances in schedules II through V as a practitioner and
pursuant to his DATA-Waiver identification number, he is authorized to
dispense or prescribe schedule III-V narcotic controlled substances
which ``have been approved by the Food and Drug Administration . . .
specifically for use in maintenance or detoxification treatment'' for
up to 100 patients.'' 21 CFR 1301.28(a) & (b)(iii); see also GX 1.
Respondent's registered address is 950 E. Alex Bell Road, Centerville,
Ohio; his registration and the authority provided by his DATA-Waiver
number do not expire until January 31, 2018. GX 1.
On April 5, 2016, the Prosecuting Attorney for Greene County, Ohio
issued an Information which charged Respondent with multiple felony
controlled substance offenses under Ohio law; the Information also
charged Respondent with Medicaid Fraud. GX 11, at 2-4 (citing Ohio Rev.
Code Sec. 2913.40(B) and (E); id. Sec. 2925.03) With respect to the
controlled substance offenses, Respondent was charged with, inter alia:
(1) Two counts of trafficking in zolpidem, a schedule IV controlled
substance, from ``on or about February 12, 2009 to September 30,
2014''; (2) trafficking in suboxone, a schedule III controlled
substance, ``on or about February 12, 2009''; and (3) trafficking in
diazepam, a schedule IV controlled substance, also ``on or about
February 12, 2009.'' Id. at 2-3 (citing Ohio Rev. Code Sec. 2925.03).
Finally, Respondent was charged with knowingly permitting real property
to ``be use for the commission of a felony drug offense, to wit,
trafficking . . . by another person.'' Id. at 3-4 (citing Ohio Rev.
Code Sec. 2925.13).
The same day, Respondent appeared in court and pled guilty to each
of these offenses. Id. at 11-12. On May 26, 2016, the state court
entered judgment and sentenced Respondent to a term of imprisonment of
10 months on each of the above counts, but provided that the sentence
for Medicaid Fraud and permitting real property to be used for the
commission of a drug offense were ``to be served consecutively to each
other, but concurrently to the remaining counts for a total sentence of
20 months.'' Id. at 14, 17. The court also ordered that Respondent
forfeit $85,000, which included $5,531.08 in restitution to two
entities. Id. at 19. Thus, I find that Respondent has been convicted of
felony offenses under Ohio law, ``relating to any substance defined in
[the Controlled Substances Act] as a controlled substance.'' 21 U.S.C.
824(a)(2); see also Ohio Rev. Code Sec. 2925.03(A)(1) (``No person
shall knowingly . . . [s]ell or offer to sell a controlled substance or
a controlled substance analog.''); id. Sec. 2925.03(C)(2)(a) (if drug
is in schedules III through V, offense is a fifth degree felony). See
also Ohio Rev. Code Sec. 2925.13(B) (``No person who is the owner,
lessee, or occupant, or who has custody, control, or supervision, of
premises or real estate . . . shall knowingly permit the premises or
real estate . . . to be used for the commission of a felony drug
offense by another person.'').\5\
---------------------------------------------------------------------------
\5\ See also Ohio Rev. Code Sec. 2925.13(C)(3) (``Permitting
drug abuse is a felony of the fifth degree[.]'').
---------------------------------------------------------------------------
Moreover, on May 11, 2016, the State Medical Board of Ohio issued
Respondent a Notice of Immediate Suspension and Opportunity for
Hearing, pursuant to which his license to practice medicine and surgery
in the State was suspended. GX 6, Attachment 1, at 1. The Board's Order
was based on Respondent's guilty pleas to the four felony counts of
Trafficking in Drugs (Ohio Rev. Code Sec. 2925.03) and the felony
count of Permitting Drug Abuse (Ohio Rev. Code Sec. 2925.13).
According to the Medical Board's Web site of which I take official
notice,\6\ on October 19, 2016, the Board ordered the permanent
revocation of Respondent's license to practice medicine and surgery
based upon his convictions on the four trafficking counts, as well as
the single counts of Permitting Drug Abuse and Medicaid Fraud; this
Order became effective the next day. See Ohio License Center (John
Pease Moore, III), https://license.ohio.gov/lookup/default.asp. (last
visited February 1, 2017). I therefore find that Respondent is
currently without authority to dispense controlled substances in Ohio.
---------------------------------------------------------------------------
\6\ In accordance with the Administrative Procedure Act (APA),
an agency ``may take official notice of facts at any stage in a
proceeding-even in the final decision.'' U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act 80
(1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with
the APA and DEA's regulations, Respondent is ``entitled on timely
request to an opportunity to show to the contrary.'' 5 U.S.C.
556(e); see also 21 CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take official notice,
Respondent may file a motion for reconsideration within 15 calendar
days of the date of service of this Order which shall commence on
the date this Order is mailed.
---------------------------------------------------------------------------
[[Page 10401]]
In addition, the record includes a July 29, 2016 letter from the
Office of Inspector General, Department of Health and Human Services,
to Respondent; the letter notified Respondent that he was ``being
excluded from participation in any capacity in the Medicare, Medicaid,
and all Federal health care programs as defined in section 1128B(f) of
the Social Security Act . . . for the minimum period of 5 years.'' GX
12, at 1. The letter explained that Respondent was being excluded based
on his ``felony conviction[s]'' for ``a criminal offense related to the
delivery of an item or service under the Medicare or a State health
care program,'' and for ``criminal offense[s] related to the unlawful
manufacture, distribution, prescription, or dispensing of a controlled
substance as defined under Federal or State law.'' Id. (citing 42
U.S.C. 1320a-7(a)(1) and (4)).
Discussion
Under Section 304(a) of the Controlled Substances Act, ``[a]
registration pursuant to section 823 of [the Act] to . . . dispense a
controlled substance . . . may be suspended or revoked by the Attorney
General upon a finding that the registrant--
* * * * *
(2) has been convicted of a felony under this subchapter . . .
or any other law of the United States, or of any State, relating to
any substance defined in this subchapter as a controlled substance .
. . ;
(3) has had his State license or registration suspended,
revoked, or denied by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of
controlled substances . . . ;
* * * * *
(5) has been excluded . . . from participation in a program
pursuant to section 1320a-7(a) of Title 42.
21 U.S.C. 824(a).
The Government has ``the burden of proving that the requirements
for such revocation or suspension pursuant to section 304(a) . . . (21
U.S.C. 824(a) . . .) are satisfied. 21 CFR 1301.44(e). Thus, even where
a registrant waives his right to a hearing, the Government is required
to produce substantial evidence to support the proposed action. In this
matter, having considered the evidence submitted by the Government, I
conclude that there are three separate and independent grounds to
revoke Respondent's registration.
First, as found above, on May 26, 2016, the Common Pleas Court of
Greene County, Ohio entered a judgment convicting Respondent of four
counts of trafficking in drugs (suboxone, zolpidem, and diazepam) under
Ohio law, as well as a single count of knowingly permitting real estate
he owned or controlled to be used for drug trafficking. See Ohio Rev.
Code Sec. Sec. 2925.03(A); 2925.13(B). Both of these provisions are
felony offenses under Ohio law. Thus, I find that Respondent ``has been
convicted of a felony offense . . . relating to any substance defined
in [the CSA] as a controlled substance.'' 21 U.S.C. 824(a)(2). This
finding provides reason alone to revoke Respondent's registration and
his DATA-Waiver identification number.
Second, the evidence shows that based on his guilty pleas in the
criminal case, on May 11, 2016, the Ohio Board immediately suspended
Respondent's license to practice medicine and surgery in the State, and
that on October 20, 2016, the Board revoked his license. By virtue of
the Board's actions, Respondent lacks authority to dispense controlled
substances under the laws of the State of Ohio, the State in which he
is registered with DEA, and thus, he is no longer a practitioner within
the meaning of the Act. See 21 U.S.C. 802(21) (defining ``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'');
see also id. Sec. 823(f) (directing 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'').
As the Agency has long held, ``[s]tate authorization to dispense or
otherwise handle controlled substances is a prerequisite to the
issuance and maintenance of a Federal controlled substances
registration.'' Frederick Marsh Blanton, 43 FR 27616 (1978). Because
the possession of state authority is a prerequisite to the maintenance
of a practitioner's registration, the Agency has long held that
revocation is the appropriate sanction whenever he is no longer
authorized to dispense controlled substances under the laws of the
State in which he practices medicine. See, e.g., James L. Hooper, 76 FR
71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012);
Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A.
Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988); Blanton, 43 FR at 27616.\7\ Accordingly, Respondent's
registration (and DATA-Waiver number) are subject to revocation for
this reason as well. 21 U.S.C. 824(a)(3).
---------------------------------------------------------------------------
\7\ Thus, even if Respondent were to credibly accept
responsibility for his criminal conduct and put forward sufficient
evidence of remedial measures, the revocation of his state authority
would still require that I revoke his DEA registration and DATA-
waiver number. I further reject Respondent's contention that I have
discretion in the case of a practitioner to not revoke his
registration based on his loss of state authority. See GX 8, at 2-3;
see Hooper v. Holder, 481 Fed. Appx. at 827-28; see also Rezik A.
Saqer, 81 FR 22122, 22124-27 (2016).
---------------------------------------------------------------------------
Finally, the evidence shows that Respondent has now been excluded
``from participation in any Federal health care program'' based on his
state conviction for Medicaid fraud, as well as his felony convictions
relating to the distribution of controlled substances. See 42 U.S.C.
1320a-7(a)(1) & (4); see also GX 12. Respondent has thus been excluded
pursuant to the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a).
Accordingly, his registration (and DATA-Waiver number) are also subject
to revocation under 21 U.S.C. 824(a)(5).
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well
as 28 CFR 0.100(b), I order that DEA Certificate of Registration
FM1335353 issued to John P. Moore, III, M.D., be, and it hereby is,
revoked. I further order that DATA-Waiver identification number
XM1335353 issued to John P. Moore, II, M.D., be, and it hereby is,
revoked. This Order is effective immediately.\8\
---------------------------------------------------------------------------
\8\ Based on the same reasons that led the Ohio Board to
immediately suspend Respondent's medical license, I conclude that
the public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
Dated: February 2, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-02729 Filed 2-9-17; 8:45 am]
BILLING CODE 4410-09-P