Angela L. Lorenzo, P.A.: Decision and Order, 14043-14045 [2018-06618]
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
doing, and [that he] failed to adequately
document ongoing examinations and
treatment planning . . . and/or he failed
to perform these professional functions
altogether.’’ GX 33, at 6 (D.S.), 8 (A.L.),
11 (R.H.).
With respect to D.S., Dr. Chambers
found that over the two-year period
between January 2014 and February
2016, there was no evidence in the
patient file that Registrant performed
physical exams other than to take vital
signs and that his treatment plan was
essentially non-existent. He also found
that D.S.’s chart contained multiples
notations that she was suffering from
addiction but no evidence that
Registrant addressed this with her. Most
significantly, as Dr. Chambers observed,
D.S. provided multiple aberrational
drug tests which included: (1) The
presence of controlled substances which
he did not prescribe on six occasions,
including methadone, buprenorphine,
cocaine, and amphetamines; (2) the nonpresence of controlled substances
(oxycodone and morphine) which he
had prescribed on two occasions; and
(3) the presence of oxycodone above the
recommended therapeutic range on four
occasions. Yet there is no evidence that
Registrant addressed any of these
aberrational test results with D.S.
As for A.L., Dr. Chambers found that
‘‘for the most part,’’ Registrant did not
document the performance of a physical
exam and there is no documentation in
the patient file to support Registrant’s
prescribing of the combinations of
narcotics, benzodiazepines, and
carisoprodol that he did. GX 33, at 7.
Moreover, A.L.’s MAPS report showed
that she had seen eight other providers
in the year prior to her first visit with
Registrant and that she had obtained
controlled substances on 50 occasions 15
which included hydrocodone,
oxymorphone, oxycodone, morphine,
diazepam, alprazolam and amphetamine
based on prescriptions issued by these
providers. Moreover, at her first visit
with Registrant, A.L. reported that she
was taking the Trinity of oxycodone,
Xanax, and Soma, and while at one
point, Registrant even documented that
A.L. stated that she was buying drugs off
the street, Registrant did not address
this aberrant behavior. Moreover, as Dr.
Chambers observed, her chart is devoid
of evidence that she was monitored
through the use of urine drug screens.
See GXs 18–20.
With respect to R.H., Dr. Chambers
found that ‘‘[f]or the most part there are
no physical exams documented in the
medical records’’ and ‘‘[t]here is no
documentation in R.H.’s medical
records demonstrating a legitimate
medical justification . . . for
[Registrant’s] prescribing’’ the
‘‘dangerous combination[s]’’ of
narcotics, benzodiazepines, and
carisoprodol to R.H. GX 33, at 10. Dr.
Chambers also found that R.H.’s urine
drug screens showed the presence of
controlled substances including
amphetamines and benzodiazepines
that Registrant did not prescribe to him
and that Registrant had also
documented that R.H. was
overmedicating with respect to Valium.
However, R.H.’s medical record
contains no indication that Registrant
resolved these red flags.
Accordingly, I agree with Dr.
Chambers that Registrant lacked a
legitimate medical purpose and acted
outside of the usual course of
professional practice when he issued
the various controlled substance
prescriptions identified above to D.S.,
A.L., and R.H. 21 CFR 1306.04(a); 21
U.S.C. 841(a)(1). I also agree with Dr.
Chambers that Registrant’s prescribing
to D.S., A.L. and R.H. violated Mich.
Comp. Laws § 333.7401(1) and did not
comply with the Michigan Guidelines.
I thus conclude that Registrant’s
multiple violations of 21 CFR 1306.04
(a), 21 U.S.C. 841(a)(1), and Mich.
Comp. Laws § 333.7401(1) are egregious
and support the conclusion that he ‘‘has
committed such acts as would render
his registration . . . inconsistent with
the public interest.’’ 21 U.S.C.
824(a)(4).16 I therefore conclude that the
Government’s evidence with respect to
Factors Two and Four makes out a
prima facie case for revoking his
existing registration and denying any
applications for a new registration. As
Registrant has waived his right to a
hearing or to submit a written statement
of position, there is no evidence to
refute the conclusion that his
registration is inconsistent with the
public interest. I will therefore order
that Registrant’s remaining registration
be revoked and that any pending
application be denied.
15 In some instances, she obtained the controlled
substances through a refill of a previously issued
prescription. See, e.g., GX 18, at 32 (alprazolam
refill); id. at 33–34 (refills of hydrocodone).
16 This provides a separate and independent
ground from the finding that he does not currently
possess state authority for revoking his registration
and denying his application.
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Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
FS6457407 issued to Bernard
Wilberforce Shelton, M.D., be, and it
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14043
hereby is, revoked. I further order that
any pending application of Bernard
Wilberforce Shelton to renew or modify
the above registration, as well as any
other pending application for
registration be, and it hereby is, denied.
This Order is effective immediately.17
Dated: March 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–06617 Filed 3–30–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Angela L. Lorenzo, P.A.: Decision and
Order
On December 18, 2017, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Angela L. Lorenzo,
P.A. (Registrant), of Las Vegas, Nevada.
The Show Cause Order proposed the
revocation of Registrant’s Certificate of
Registration No. ML0901985 on the
ground that she lacks ‘‘authority to
handle controlled substances in the
State of Nevada, the State in which [she
is] registered with the DEA.’’ Order to
Show Cause, Government Exhibit (GX)
A–3, at 1 (citing 21 U.S.C. 824(a)(3)).1
For the same reason, the Order also
proposed the denial of any of
Registrant’s ‘‘pending applications for a
new registration or for renewal.’’ Id.
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Registrant is registered as a
practitioner in schedules II through V,
pursuant to DEA Certificate of
Registration No. ML0901985, at the
address of 811 N Buffalo Road, Suite
113, Las Vegas, Nevada. Id. at 1–2. The
Order also alleged that this registration
17 Based on the egregious nature of Respondent’s
prescribing violations, I conclude that the public
interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
1 The Show Cause Order also proposed that
Registrant’s DEA registration should be revoked
because she ‘‘committed acts which render [her]
registration inconsistent with the public interest.’’
GX 3, at 1 (citing 21 U.S.C. 823(f), 824(a)(4)).
However, the Government did not include evidence
to support this allegation with its Request for Final
Agency Action (RFFA). Instead, the Government
requested ‘‘leave to supplement its [R]equest to
include the grounds for revocation under 21 U.S.C.
823(f), 824(a)(4)’’ should Registrant ‘‘regain her
Nevada state license during the pendency of this
Request for Final Agency Action.’’ RFFA at 1 n.1.
The Government has not filed a request to
supplement its RFFA, apparently because
Registrant has not regained her Nevada state
medical license. Accordingly, I do not consider the
Government’s public interest allegation.
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does not expire until March 31, 2018.
Id.at 2.
As substantive grounds for the
proceeding, the Show Cause Order
alleged that on September 29, 2017, the
Nevada State Board of Medical
Examiners (hereinafter NSBME) ‘‘issued
an Order of Summary Suspension
immediately and indefinitely
suspending [her] license to practice
medicine in the State of Nevada.’’ Id.
The Order alleged that, ‘‘[a]s a result,
[she is] currently without authority to
practice medicine or handle controlled
substances in the State of Nevada, the
[S]tate in which [she is] registered with
the DEA.’’ Id. Based on her ‘‘lack of
authority to handle controlled
substances in the State of Nevada,’’ the
Order asserted that ‘‘DEA must revoke’’
her registration. Id. (citing 21 U.S.C.
823(f), 824(a)(3)).
The Show Cause Order notified
Registrant of her right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for electing either option,
and the consequence for failing to elect
either option. Id. at 4 (citing 21 CFR
1301.43). The Show Cause Order also
notified Registrant of her right to submit
a corrective action plan. Id. at 4–5
(citing 21 U.S.C. 824(c)(2)(C)).
The Government states that on
December 19, 2017, a Data Analyst in
DEA’s Office of Chief Counsel sent a
copy of the Show Cause Order by firstclass mail to (1) the post office box
address provided by Registrant as the
‘‘mail to’’ address on her DEA
registration, P.O. Box 36190, Las Vegas,
Nevada, and (2) her registered address
of 911 N Buffalo Road, Suite 113, Las
Vegas, Nevada. Government’s ‘‘Request
for Final Agency Action’’ (RFFA), at 2
n.2, 3; GX B (Declaration of Data
Analyst) at 1–2. The Government also
states that only the mailing to the
registered address was returned as
undeliverable. See id. Also, on
December 19, 2017, a Diversion
Investigator (DI) ‘‘emailed a copy of the
[Show Cause Order] to’’ the ‘‘contact
email’’ address that Registrant had
provided to the Agency on her DEA
registration without receiving ‘‘any error
messages indicating that the email was
not successfully sent’’ or ‘‘any
notifications that the email was
undeliverable.’’ RFFA, at 3; GX A
(Declaration of the Diversion
Investigator), at 2.2 Based on these facts,
2 On December 19, 2017, Government counsel
represents that he ‘‘provided’’ a copy of the Show
Cause Order to the attorney representing Registrant
in the underlying NSBME proceeding. RFFA, at 2
n.3. On January 4, 2018, that attorney emailed
Government counsel ‘‘to advise [him] that, as of
today, I no longer represent Ms. Lorenzo . . . but
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I find that the Government’s attempts to
serve Registrant with the Show Cause
Order satisfied its obligation under the
Due Process Clause ‘‘to provide ‘notice
reasonably calculated, under all
circumstances, to apprise interested
parties of the pendency of the action
and afford them an opportunity to
present their objections.’ ’’ Emilio Luna,
M.D., 77 FR 4829, 4829 (2012) (quoting
Jones v. Flowers, 547 U.S. 220, 226
(2006) (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S.
306, 314 (1950))).
On February 1, 2018, the Government
forwarded its Request for Final Agency
Action and an evidentiary record to my
Office. Therein, the Government
represents that it has received neither a
hearing request nor a written statement
from Registrant regarding the Show
Cause Order. RFFA, at 2. Based on the
Government’s representation and the
record, I find that more than 30 days
have passed since the Order to Show
Cause was served on Registrant, and she
has neither requested a hearing nor
submitted a written statement in lieu of
a hearing. See 21 CFR 1301.43(d).
Accordingly, I find that Registrant has
waived her right to a hearing or to
submit a written statement and issue
this Decision and Order based on
relevant evidence submitted by the
Government. I make the following
findings.
Findings of Fact
Registrant is a physician’s assistant
who is registered as a practitioner in
schedules II–V pursuant to Certificate of
Registration No. ML0901985,3 at the
address of 911 N Buffalo Rd., Ste. 113,
Las Vegas, Nevada.4 Her registration
she is advised of her obligation to respond to the
Order to Show Cause.’’ RFFA, at 2 n.3; GX C (copy
of email from Registrant’s former attorney to
Government counsel).
3 The RFFA did not attach a copy of Registrant’s
DEA Certificate of Registration. However, I take
official notice that the Agency’s registration records
show that Registrant obtained a registration as a
mid-level practitioner-physician assistant on
December 19, 2002, in schedules II through V, and
last renewed her registration on April 15, 2015.
According to the Agency’s records, she has not
submitted an application for renewal of her
registration.
Under 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, Registrant 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).
4 The Show Cause Order states that the registered
address is at 811 N Buffalo Road, Suite 113, Las
Vegas, Nevada, even though the DEA registration
shows a registrant address at 911 N Buffalo Road.
In addition, the top of the Show Cause Order was
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does not expire until March 31, 2018.
See supra footnote 3.
On September 28, 2017, the
Investigative Committee (IC) of the
NSBME issued an ‘‘Order of Summary
Suspension’’ to Registrant that
‘‘IMMEDIATELY SUSPENDS [her]
license to practice medicine.’’ GX A–1,
at 1. Specifically, the IC suspended
Registrant’s license to practice medicine
in the State of Nevada because ‘‘the
health, safety and welfare of the public
is at imminent risk of harm by
[Registrant’s] continued performance of
medical services without supervision,
including the prescription of controlled
substances, . . . her dishonest conduct,
and . . . her continued refusal to
comply with the lawful Orders of the
[NSBME].’’ Id. at 2.5 In light of the
passage of time since the effective date
of the Order, I have queried the NSBME
website regarding the status of
Registrant’s medical license, and I take
official notice that Registrant’s Nevada
medical license remains suspended as
of the date of this decision.6
Thus, I find that that the IC’s Order
suspending Registrant from practicing
medical services, which it stated
includes dispensing controlled
substances, independently bars
Registrant from dispensing controlled
substances in Nevada. Accord Nev. Rev.
Stat. §§ 630.160 (2015) (‘‘Every person
desiring to practice medicine must,
before beginning to practice, procure
from the [NSBME] a license authorizing
the person to practice.’’); 630.020
(defining ‘‘[p]ractice of medicine’’ to
include prescribing). Based on the
above, I find that Registrant does not
currently have authority under the laws
addressed to Registrant at 911 N Buffalo Road,
consistent with the registration. Accordingly, I find
that Registrant’s address is 911 N Buffalo Road,
Suite 113, Las Vegas, Nevada, and I deem the Show
Cause Order’s reference to 811 N Buffalo Road a
scrivener’s error.
5 In its Order, the IC found, inter alia, that on
September 6, 2017, ‘‘IC staff personally notified
[Registrant] at her offices located at 911 N Buffalo
Drive, Suite 113, Las Vegas, NV’’ that she was
prohibited under Nevada law ‘‘from performing
medical services until she obtained a supervising
physician licensed and approved’’ by the NSBME.
Id. at 2. Although Registrant advised the IC on
September 6, 2017 ‘‘verbally and in writing that she
would cease practicing,’’ on September 11, 2017,
she nevertheless wrote a prescription for
Phentermine, a [s]chedule IV controlled substance.’’
Id. The IC found that this conduct demonstrated
that Registrant ‘‘perform[ed] medical services,
including the prescription of controlled
substances,’’ (1) in violation of Nevada law’s
requirement of physician supervision and (2) in
‘‘direct contradiction to her prior written statement
. . . on September 6, 2017.’’ Id.
6 I take official notice under the authority set forth
supra in footnote 3.
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of Nevada to dispense controlled
substances.7
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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 Title 21, ‘‘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.’’
With respect to a practitioner, 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 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 [s]he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the Act,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever she is no
longer authorized to dispense controlled
substances under the laws of the State
in which she engages in professional
practice. See, e.g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden
7 Registrant’s DEA registration information states
that Registrant had a Nevada Controlled Substance
License No. CS12166, but that it expired on October
31, 2016. I have queried the NSBME website
regarding the status of Registrant’s controlled
substance license, and I take official notice (see
supra footnote 3) that Nevada’s online list of
holders of active controlled substance licenses does
not include Registrant by name or by her Nevada
controlled substance registration number.
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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
27616 (1978).
Thus, ‘‘the controlling question’’ in a
proceeding brought under 21 U.S.C.
824(a)(3) is whether the holder of a
practitioner’s 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)). Here,
Registrant is no longer currently
authorized to dispense controlled
substances in Nevada, the State in
which she is registered with the Agency.
I will therefore revoke her DEA
registration, deny any pending
application to modify her registration,
or any pending application for any other
registration in Nevada.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
ML0901985, issued to Angela L.
Lorenzo, P.A., be, and it hereby is,
revoked. I further order that any
pending application of Angela L.
Lorenzo to renew or modify the above
registration, or any pending application
of Angela L. Lorenzo for any other
registration in the State of Nevada, be,
and it hereby is, denied. This Order is
effective immediately.8
Dated: March 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–06618 Filed 3–30–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Mine
Safety and Health Administration Grant
Performance Reports Office of the
Secretary
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting the Mine Safety and
Health Administration sponsored
information collection request (ICR)
proposal titled, ‘‘Mine Safety and Health
Administration Grant Performance
Reports,’’ to the Office of Management
SUMMARY:
8 For the same reasons that led the NSBME to
suspend Registrant’s license, I find that the public
interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
PO 00000
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14045
and Budget (OMB) for review and
approval for use in accordance with the
Paperwork Reduction Act (PRA) of
1995. Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that agency receives
on or before May 2, 2018.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained free of charge from the
RegInfo.gov website at https://
www.reginfo.gov/public/do/PRAView
ICR?ref_nbr=201711-1219-001 (this link
will only become active on the day
following publication of this notice) or
by contacting Michel Smyth by
telephone at 202–693–4129 (this is not
a toll-free number) or by email at DOL_
PRA_PUBLIC@dol.gov.
Submit comments about this request
by mail to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for DOL–MSHA Office of
Management and Budget, Room 10235,
725 17th Street NW, Washington, DC
20503; by Fax: 202–395–5806 (this is
not a toll-free number); or by email:
OIRA_submission@omb.eop.gov.
Commenters are encouraged, but not
required, to send a courtesy copy of any
comments by mail or courier to the U.S.
Department of Labor-OASAM, Office of
the Chief Information Officer, Attn:
Departmental Information Compliance
Management Program, Room N1301,
200 Constitution Avenue NW,
Washington, DC 20210; or by email:
DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Michel Smyth by telephone at 202–693–
4129 (this is not a toll-free number) or
by email at DOL_PRA_PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: This ICR
seeks PRA authority for the Performance
Reports for Mine Safety and Health
Administration Grants information
collection. Mine Safety and Health
Administration grantees are required by
DOL regulations to submit project and
final reports.
A grantee submits a technical project
report to the MSHA no later than 30
days after quarterly deadlines. A
technical project report provides both
quantitative and qualitative information
and a narrative assessment of
performance for the preceding threemonth period. This includes the current
grant progress against the overall grant
goals. Between reporting dates, the
grantee informs MSHA of significant
developments or problems affecting the
organization’s ability to accomplish the
work.
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]]>Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14043-14045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06618]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Angela L. Lorenzo, P.A.: Decision and Order
On December 18, 2017, the Acting Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Angela L. Lorenzo, P.A. (Registrant), of Las
Vegas, Nevada. The Show Cause Order proposed the revocation of
Registrant's Certificate of Registration No. ML0901985 on the ground
that she lacks ``authority to handle controlled substances in the State
of Nevada, the State in which [she is] registered with the DEA.'' Order
to Show Cause, Government Exhibit (GX) A-3, at 1 (citing 21 U.S.C.
824(a)(3)).\1\ For the same reason, the Order also proposed the denial
of any of Registrant's ``pending applications for a new registration or
for renewal.'' Id.
---------------------------------------------------------------------------
\1\ The Show Cause Order also proposed that Registrant's DEA
registration should be revoked because she ``committed acts which
render [her] registration inconsistent with the public interest.''
GX 3, at 1 (citing 21 U.S.C. 823(f), 824(a)(4)). However, the
Government did not include evidence to support this allegation with
its Request for Final Agency Action (RFFA). Instead, the Government
requested ``leave to supplement its [R]equest to include the grounds
for revocation under 21 U.S.C. 823(f), 824(a)(4)'' should Registrant
``regain her Nevada state license during the pendency of this
Request for Final Agency Action.'' RFFA at 1 n.1. The Government has
not filed a request to supplement its RFFA, apparently because
Registrant has not regained her Nevada state medical license.
Accordingly, I do not consider the Government's public interest
allegation.
---------------------------------------------------------------------------
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that Registrant is registered as a practitioner in schedules II
through V, pursuant to DEA Certificate of Registration No. ML0901985,
at the address of 811 N Buffalo Road, Suite 113, Las Vegas, Nevada. Id.
at 1-2. The Order also alleged that this registration
[[Page 14044]]
does not expire until March 31, 2018. Id.at 2.
As substantive grounds for the proceeding, the Show Cause Order
alleged that on September 29, 2017, the Nevada State Board of Medical
Examiners (hereinafter NSBME) ``issued an Order of Summary Suspension
immediately and indefinitely suspending [her] license to practice
medicine in the State of Nevada.'' Id. The Order alleged that, ``[a]s a
result, [she is] currently without authority to practice medicine or
handle controlled substances in the State of Nevada, the [S]tate in
which [she is] registered with the DEA.'' Id. Based on her ``lack of
authority to handle controlled substances in the State of Nevada,'' the
Order asserted that ``DEA must revoke'' her registration. Id. (citing
21 U.S.C. 823(f), 824(a)(3)).
The Show Cause Order notified Registrant of her right to request a
hearing on the allegations or to submit a written statement in lieu of
a hearing, the procedure for electing either option, and the
consequence for failing to elect either option. Id. at 4 (citing 21 CFR
1301.43). The Show Cause Order also notified Registrant of her right to
submit a corrective action plan. Id. at 4-5 (citing 21 U.S.C.
824(c)(2)(C)).
The Government states that on December 19, 2017, a Data Analyst in
DEA's Office of Chief Counsel sent a copy of the Show Cause Order by
first-class mail to (1) the post office box address provided by
Registrant as the ``mail to'' address on her DEA registration, P.O. Box
36190, Las Vegas, Nevada, and (2) her registered address of 911 N
Buffalo Road, Suite 113, Las Vegas, Nevada. Government's ``Request for
Final Agency Action'' (RFFA), at 2 n.2, 3; GX B (Declaration of Data
Analyst) at 1-2. The Government also states that only the mailing to
the registered address was returned as undeliverable. See id. Also, on
December 19, 2017, a Diversion Investigator (DI) ``emailed a copy of
the [Show Cause Order] to'' the ``contact email'' address that
Registrant had provided to the Agency on her DEA registration without
receiving ``any error messages indicating that the email was not
successfully sent'' or ``any notifications that the email was
undeliverable.'' RFFA, at 3; GX A (Declaration of the Diversion
Investigator), at 2.\2\ Based on these facts, I find that the
Government's attempts to serve Registrant with the Show Cause Order
satisfied its obligation under the Due Process Clause ``to provide
`notice reasonably calculated, under all circumstances, to apprise
interested parties of the pendency of the action and afford them an
opportunity to present their objections.' '' Emilio Luna, M.D., 77 FR
4829, 4829 (2012) (quoting Jones v. Flowers, 547 U.S. 220, 226 (2006)
(quoting Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306, 314
(1950))).
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\2\ On December 19, 2017, Government counsel represents that he
``provided'' a copy of the Show Cause Order to the attorney
representing Registrant in the underlying NSBME proceeding. RFFA, at
2 n.3. On January 4, 2018, that attorney emailed Government counsel
``to advise [him] that, as of today, I no longer represent Ms.
Lorenzo . . . but she is advised of her obligation to respond to the
Order to Show Cause.'' RFFA, at 2 n.3; GX C (copy of email from
Registrant's former attorney to Government counsel).
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On February 1, 2018, the Government forwarded its Request for Final
Agency Action and an evidentiary record to my Office. Therein, the
Government represents that it has received neither a hearing request
nor a written statement from Registrant regarding the Show Cause Order.
RFFA, at 2. Based on the Government's representation and the record, I
find that more than 30 days have passed since the Order to Show Cause
was served on Registrant, and she has neither requested a hearing nor
submitted a written statement in lieu of a hearing. See 21 CFR
1301.43(d). Accordingly, I find that Registrant has waived her right to
a hearing or to submit a written statement and issue this Decision and
Order based on relevant evidence submitted by the Government. I make
the following findings.
Findings of Fact
Registrant is a physician's assistant who is registered as a
practitioner in schedules II-V pursuant to Certificate of Registration
No. ML0901985,\3\ at the address of 911 N Buffalo Rd., Ste. 113, Las
Vegas, Nevada.\4\ Her registration does not expire until March 31,
2018. See supra footnote 3.
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\3\ The RFFA did not attach a copy of Registrant's DEA
Certificate of Registration. However, I take official notice that
the Agency's registration records show that Registrant obtained a
registration as a mid-level practitioner-physician assistant on
December 19, 2002, in schedules II through V, and last renewed her
registration on April 15, 2015. According to the Agency's records,
she has not submitted an application for renewal of her
registration.
Under 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, Registrant 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).
\4\ The Show Cause Order states that the registered address is
at 811 N Buffalo Road, Suite 113, Las Vegas, Nevada, even though the
DEA registration shows a registrant address at 911 N Buffalo Road.
In addition, the top of the Show Cause Order was addressed to
Registrant at 911 N Buffalo Road, consistent with the registration.
Accordingly, I find that Registrant's address is 911 N Buffalo Road,
Suite 113, Las Vegas, Nevada, and I deem the Show Cause Order's
reference to 811 N Buffalo Road a scrivener's error.
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On September 28, 2017, the Investigative Committee (IC) of the
NSBME issued an ``Order of Summary Suspension'' to Registrant that
``IMMEDIATELY SUSPENDS [her] license to practice medicine.'' GX A-1, at
1. Specifically, the IC suspended Registrant's license to practice
medicine in the State of Nevada because ``the health, safety and
welfare of the public is at imminent risk of harm by [Registrant's]
continued performance of medical services without supervision,
including the prescription of controlled substances, . . . her
dishonest conduct, and . . . her continued refusal to comply with the
lawful Orders of the [NSBME].'' Id. at 2.\5\ In light of the passage of
time since the effective date of the Order, I have queried the NSBME
website regarding the status of Registrant's medical license, and I
take official notice that Registrant's Nevada medical license remains
suspended as of the date of this decision.\6\
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\5\ In its Order, the IC found, inter alia, that on September 6,
2017, ``IC staff personally notified [Registrant] at her offices
located at 911 N Buffalo Drive, Suite 113, Las Vegas, NV'' that she
was prohibited under Nevada law ``from performing medical services
until she obtained a supervising physician licensed and approved''
by the NSBME. Id. at 2. Although Registrant advised the IC on
September 6, 2017 ``verbally and in writing that she would cease
practicing,'' on September 11, 2017, she nevertheless wrote a
prescription for Phentermine, a [s]chedule IV controlled
substance.'' Id. The IC found that this conduct demonstrated that
Registrant ``perform[ed] medical services, including the
prescription of controlled substances,'' (1) in violation of Nevada
law's requirement of physician supervision and (2) in ``direct
contradiction to her prior written statement . . . on September 6,
2017.'' Id.
\6\ I take official notice under the authority set forth supra
in footnote 3.
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Thus, I find that that the IC's Order suspending Registrant from
practicing medical services, which it stated includes dispensing
controlled substances, independently bars Registrant from dispensing
controlled substances in Nevada. Accord Nev. Rev. Stat. Sec. Sec.
630.160 (2015) (``Every person desiring to practice medicine must,
before beginning to practice, procure from the [NSBME] a license
authorizing the person to practice.''); 630.020 (defining ``[p]ractice
of medicine'' to include prescribing). Based on the above, I find that
Registrant does not currently have authority under the laws
[[Page 14045]]
of Nevada to dispense controlled substances.\7\
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\7\ Registrant's DEA registration information states that
Registrant had a Nevada Controlled Substance License No. CS12166,
but that it expired on October 31, 2016. I have queried the NSBME
website regarding the status of Registrant's controlled substance
license, and I take official notice (see supra footnote 3) that
Nevada's online list of holders of active controlled substance
licenses does not include Registrant by name or by her Nevada
controlled substance registration number.
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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 Title
21, ``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.'' With respect to a practitioner,
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 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 [s]he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the Act, DEA has held repeatedly that revocation of
a practitioner's registration is the appropriate sanction whenever she
is no longer authorized to dispense controlled substances under the
laws of the State in which she engages in professional practice. See,
e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); 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 27616
(1978).
Thus, ``the controlling question'' in a proceeding brought under 21
U.S.C. 824(a)(3) is whether the holder of a practitioner's 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)). Here, Registrant is no longer currently
authorized to dispense controlled substances in Nevada, the State in
which she is registered with the Agency. I will therefore revoke her
DEA registration, deny any pending application to modify her
registration, or any pending application for any other registration in
Nevada.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration No. ML0901985, issued to Angela L. Lorenzo, P.A., be, and
it hereby is, revoked. I further order that any pending application of
Angela L. Lorenzo to renew or modify the above registration, or any
pending application of Angela L. Lorenzo for any other registration in
the State of Nevada, be, and it hereby is, denied. This Order is
effective immediately.\8\
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\8\ For the same reasons that led the NSBME to suspend
Registrant's license, I find that the public interest necessitates
that this Order be effective immediately. 21 CFR 1316.67.
Dated: March 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-06618 Filed 3-30-18; 8:45 am]
BILLING CODE 4410-09-P
