[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80160-80162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27239]



[[Page 80160]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-29]


Lisa Hofschulz, N.P.; Decision and Order

    On June 21, 2019, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause (hereinafter, OSC) to Lisa 
Hofschulz, N.P. (hereinafter, Respondent) of Wauwatosa, Wisconsin. OSC, 
at 1. The OSC proposed the revocation of Respondent's Certificate of 
Registration No. MH1088182. Id. It alleged that Respondent is without 
``authority to handle controlled substances in Wisconsin, the state in 
which [Respondent is] registered with DEA.'' Id.
    Specifically, the OSC alleged that Respondent's Wisconsin ``Advance 
Practice Nursing Prescriber [hereinafter, APNP] license expired on 
September 30, 2018, and has not been renewed. As a result of the 
expiration of [her] APNP license, [Respondent] currently lack[s] the 
authority to handle controlled substances in Wisconsin.'' Id. at 1-2 
(citing 21 U.S.C 802(21), 823(f), and 824(a)(3)).
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 2-3 (citing 21 
CFR 1301.43). The OSC also notified Respondent of the opportunity to 
submit a corrective action plan. Id. at 3 (citing 21 U.S.C. 
824(c)(2)(C)).
    By letter dated July 17, 2019, Respondent timely requested a 
hearing.\1\ Hearing Request, at 1. In the Hearing Request, Respondent 
stated that ``[o]n May 17, 2019, Respondent applied to transfer her DEA 
registration from the State of Wisconsin to the State of Florida'' and 
that ``Respondent has a current and active Nurse Practitioner license . 
. . in the State of Florida.'' Id.
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    \1\ The Hearing Request was deemed filed on July 17, 2019. Order 
for Prehearing Statements, at 1. I find that the Government's 
service of the OSC was adequate and that the Hearing Request was 
timely filed on July 17, 2019.
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    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Administrative Law Judge Mark M. Dowd 
(hereinafter, ALJ). The ALJ issued an Order for Prehearing Statements, 
dated July 18, 2019. The Government timely complied with the Briefing 
Schedule by filing a Motion for Summary Disposition on July 25, 2019 
(hereinafter, Government Motion or Govt Motion). In its Motion, the 
Government submitted evidence that the Wisconsin Board of Nursing 
(hereinafter, Board) entered a Final Decision and Order with an 
attached Stipulation on April 12, 2018, which suspended Respondent's 
APNP following an investigation into unlawful prescribing practices, 
and Respondent therefore lacked authority to handle controlled 
substances in Wisconsin, the state in which she is registered with DEA. 
Govt Motion, at 1. The Government acknowledged that Respondent had 
requested a modification of her registration to Florida, but stated 
that the ``Government's allegations in support of revocation of 
Respondent's [registration] pertain solely to Respondent's current 
authorization to handle controlled substances in Wisconsin [] and . . . 
do not address any denial of Respondent's pending application for 
modification of that [registration.]'' Id. at 4. In light of these 
facts, the Government argued that DEA must revoke her registration. 
Govt Motion, at 6.
    On July 31, 2019, Respondent requested an extension of time to file 
her Prehearing Statement and Response to Government's Motion for 
Summary Disposition, which the ALJ granted that same day. See 
Respondent's Unopposed Motion for Extension and ALJ's Order Granting 
Respondent's Unopposed Motion for Extension. On August 5, 2019,\2\ 
Respondent filed a Response in Opposition to Government's Motion for 
Summary Disposition (hereinafter, Resp Opposition). Respondent argued 
that ``Under the Administrative Procedure[ ] Act (``APA''), `[w]hen the 
licensee has made timely and sufficient application for a renewal or a 
new license in accordance with agency rules, a license with reference 
to an activity of a continuing nature does not expire until the 
application has been finally determined by the agency.' '' Resp 
Opposition, at 1 (quoting 5 U.S.C. 558). Respondent, therefore, argued 
that the Agency is obligated to act on Respondent's application for a 
registration in Florida. In the alternative, Respondent argued that 
even if the Agency decided that it must revoke Respondent's 
application, then it ``should determine that the application for 
modification is not affected.'' Id. at 4.
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    \2\ Respondent filed a Prehearing Statement on the same day.
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    On August 8, 2019, the ALJ issued an Order Granting the 
Government's Motion for Summary Disposition, and Recommended Rulings, 
Findings of Fact, Conclusions of Law, and Recommended Decision of the 
Administrative Law Judge (hereinafter, Summary Disposition or SD). The 
ALJ granted the Government Motion for Summary Disposition--finding that 
the only subject of the underlying action was Respondent's Wisconsin 
registration, Respondent had conceded that she had no authority in 
Wisconsin, and therefore, ``summary disposition of an administrative 
case is warranted where, as here, `there is no factual dispute of 
substance.' '' SD, at 7 (citing Veg-Mix, Inc. v. U.S. Dep't of Agric., 
832 F.2d 601, 607 (D.C. Cir. 1987) (``[A]n agency may ordinarily 
dispense with a hearing when no genuine dispute exists.'' (citations 
omitted))). By letter dated September 4, 2019, the ALJ certified and 
transmitted the record to me for final Agency action. In that letter, 
the ALJ advised that neither party filed exceptions. I find that the 
time period to file exceptions has expired. See 21 CFR 1316.66.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Respondent's DEA Registration

    Respondent is the holder of DEA Certificate of Registration No. 
MH1088182 at the registered address of 6163 Washington Circle, 
Wauwatosa, Wisconsin 53213. Govt Motion Exhibit (hereinafter, GX) 2, at 
1. Pursuant to this registration, Respondent is authorized to dispense 
controlled substances in schedules II through V as a ``practitioner.'' 
Id. Respondent's registration expires on October 31, 2021, and is 
currently in ``active pending status.'' Id.

The Status of Respondent's State License

    On April 12, 2018, the Wisconsin Board of Nursing issued a Final 
Decision and Order (hereinafter, Board Order), in which Respondent 
stipulated to facts and conclusions of law related to her prescribing 
practices. Respondent Exhibit (hereinafter, RX) C (Board Order). The 
Board Order was ``effective on the date of its signing.'' Id. at 29. 
According to the Board Order, Respondent ``engaged in unprofessional 
conduct . . . by departing from or failing to conform to the minimal 
standards of acceptable nursing practice that may create unnecessary 
risk or danger to a patient's life, health, or safety.'' Id. at 27. The 
Board suspended Respondent's professional nursing

[[Page 80161]]

license and advanced practice nurse prescriber certificate in Wisconsin 
for twenty-one (21) days, and further limited her license requiring 
that she ``not practice pain management'' and ``not return to practice 
in the State of Wisconsin unless she provides written notification to 
the Board, or its designee, of intent to return to Wisconsin at least 
fifteen (15) days prior to return'' at which time the Board ``may 
impose additional limitations upon Respondent's license.'' Id. at 27-
28.
    According to Wisconsin's online records, of which I take official 
notice, Respondent's Advance Practice Nurse Prescriber license status 
is listed as ``license is not current (Expired)'' and further states 
``Not Eligible to Practice (See board order).'' \3\ Wisconsin 
Department of Safety and Professional Services Credential/Licensing 
Search, https://licensesearch.wi.gov (last visited on date of this 
Order).
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    \3\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Respondent may dispute my finding by filing 
a properly supported motion for reconsideration of findings of fact 
within fifteen calendar days of the date of this Order. Any such 
motion shall be filed with the Office of the Administrator and a 
copy shall be served on the Government. In the event Respondent 
files a motion, the Government shall have fifteen calendar days to 
file a response. Any motion and response shall be filed and served 
by email to the other party and to the Office of the Administrator 
at [email protected].
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    Based on the entire record before me, I find that Respondent 
currently is not licensed as an Advance Practice Nurse Prescriber in 
Wisconsin, the state in which Respondent is registered with DEA.
    I further find, as recommended by the ALJ, that Respondent's 
application for modification is not the subject of this proceeding, and 
agree that the Government did not challenge that application 
modification in its OSC. See OSC, at 1; see also SD, at 7-8.

Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (CSA) ``upon a finding that the registrant . 
. . has had his State license or registration suspended . . . [or] 
revoked . . . by competent State authority and is no longer authorized 
by State law to engage in the . . . dispensing[\4\] of controlled 
substances.'' With respect to a practitioner, the DEA has also long 
held that the possession of authority to dispense controlled substances 
under the laws of the state in which a practitioner engages in 
professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration in that state. See, e.g., 
James L. Hooper, M.D., 76 FR 71371 (2011), pet. for rev. denied, 481 F. 
App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 
27617 (1978).
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    \4\ ``[D]ispense[ ] means to deliver a controlled substance to 
an ultimate user . . . by, or pursuant to the lawful order of, a 
practitioner, including the prescribing and administering of a 
controlled substance . . . .'' 21 CFR 802(10).
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    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a physician 
. . . or other person licensed, registered, or otherwise permitted, by 
. . . the jurisdiction in which he practices . . . , to distribute, 
dispense, . . . [or] administer . . . a controlled substance in the 
course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the CSA, the DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the state in which he practices. See, e.g., James L. Hooper, 76 
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 
FR at 27,617.
    In Wisconsin, an ``advanced practice nurse'' is a registered nurse 
who ``has a current license to practice professional nursing'' in 
Wisconsin. Wis. Admin. Code N Sec.  8.02(1) (West, Current through 
Wisconsin Register 776B, published August 31, 2020). An ``advanced 
practice nurse prescriber'' is ``an advanced practice nurse who has 
been granted a certificate to issue prescription orders'' under Wis. 
Stat. Sec.  441.16(2). Id. Sec.  8.02(2).\5\
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    \5\ An advanced practice nurse (hereinafter, APN) who meets the 
requisite education, training and examination requirements, and who 
pays the required fee, ``shall [be] grant[ed] a certificate to issue 
prescription orders.'' Wis. Stat. Sec.  441.16(2) (West, Current 
through 2019 Act 186, published April 18, 2020).
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    Under the Wisconsin Uniform Controlled Substances Act (hereinafter, 
Act), a person must have a federal controlled substances registration 
in order to lawfully dispense controlled substances in Wisconsin.\6\ 
Wis. Stat. Sec.  961.32(1m)(a) (West, Current through 2019 Act 186, 
published April 18, 2020). The Act further provides that a 
``practitioner'' includes an ``advanced practice nurse . . . licensed, 
registered, certified or otherwise permitted to . . . dispense . . . a 
controlled substance in the course of professional practice.'' Id. 
Sec.  961.01(19)(a).
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    \6\ Under Wisconsin law, ``dispensing'' a controlled substance 
includes ``prescribing'' a controlled substance. Wis. Stat. Sec.  
961.01(7) (West, Current through 2019 Act 186, published April 18, 
2020).
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    Here, the undisputed evidence in the record is that Respondent is 
not currently licensed as an APNP in Wisconsin. As such, she is not 
authorized to dispense controlled substances in Wisconsin, the state in 
which she is registered with the DEA. Because Respondent lacks 
authority to dispense controlled substances in Wisconsin, she is not 
eligible to hold a DEA registration in Wisconsin. 21 U.S.C. 823(f).
    I agree with the ALJ's finding that ``[t]he subject of the instant 
litigation is not whether the Respondent has requested to modify her 
[registration] to reflect an address in Florida, but whether she has 
state authority to dispense controlled substances in the state in which 
her [registration] is currently registered, Wisconsin, which she 
concedes, she does not.'' SD, at 7. The current issue before me is 
whether Respondent has state authority in Wisconsin, and I find that 
she does not. See Parth S. Bharill, 84 FR 39014 (2019).
    Although she admitted that her Wisconsin APRN license expired about 
forty days before she asked DEA to change the address of her 
registration from Wisconsin to Florida, Respondent opposed the 
Government's Motion for Summary Disposition and argued for my focus 
first to be on her request for a change of address. Resp Opposition, at 
1. In doing so, as already discussed, Respondent suggested that I 
ignore the fact that the Show Cause Order I am adjudicating is based on 
Respondent's lack of authority to dispense controlled substances in 
Wisconsin. 21 U.S.C. 823(f) (stating that a prerequisite to receiving a 
registration is having authorization to dispense controlled substances 
in the state of requested

[[Page 80162]]

registration). Respondent made no argument that convinces me to ignore 
the statutorily mandated show cause order process or to limit the 
Agency's enforcement discretion and prerogatives by addressing her 
modification request based merely on a chronological sequence of 
events. 21 U.S.C. 823(c). The Wedgewood Village Pharmacy case 
Respondent cited explicitly articulates this process and DEA's 
enforcement discretion and prerogatives when it states that, ``[w]hen 
an application for modification of an existing practitioner's 
registration is received by DEA, and before an approval may be given, 
DEA must determine whether there is any need to conduct a further 
investigative inquiry.'' Wedgewood Village Pharmacy, Inc. v. Ashcroft, 
293 F. Supp. 2d, 462, 467 (D.N.J. 2003). Here, Respondent's loss of 
APRN authority in Wisconsin was reason ``to conduct a further 
investigative inquiry.'' Id. Similarly, I reject Respondent's 
alternative argument that, even if I revoke her registration, ``then 
the application for modification should continue and be granted.'' Resp 
Opposition, at 4.
    Respondent suggested that, even if I revoke her registration, her 
requested modification should continue and either be granted or be the 
subject of an order to show cause and a demonstration that ``granting 
the application is not in the public interest.'' Id. She did not, 
however, address how to implement the regulatory requirement of 
maintaining the modification with the ``old certificate'' until its 
expiration when the old certificate already expired due to revocation. 
21 CFR 1301.51(c).
    Respondent argued that the statement in 21 CFR 1301.51(c), that a 
``request for modification shall be handled in the same manner as an 
application for registration,'' means that the Agency is ``required to 
register an applicant, unless it determines that the applicant's 
registration would be inconsistent with the public interest.'' Resp 
Opposition, at 2 (citing 21 U.S.C. 823). The further support Respondent 
provided for her argument is the Wedgewood Village Pharmacy federal 
district court decision. Id. (citing Wedgewood Village Pharmacy, Inc. 
v. Ashcroft, 293 F. Supp. 2d at 469).
    Respondent's arguments ignore the entirety of 21 U.S.C. 823. That 
statutory provision premises a public interest analysis, in the first 
instance, on an applicant's existing authorization ``to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Respondent admitted that she lacks 
authority to dispense controlled substances in Wisconsin. Accordingly, 
if she were to apply for a registration in Wisconsin, the public 
interest portion of section 823 would not be reached due to her failure 
to meet the threshold eligibility requirements for a registration. 
Thus, Respondent's reliance on the district court's decision in 
Wedgewood Village Pharmacy is unavailing. Although Wedgewood Village 
Pharmacy retained its state authorization to dispense controlled 
substances during its litigation and, as such, its eligibility for a 
registration, Respondent has not.
    Respondent did not address past Agency decisions concerning the 
precise portion of 21 CFR 1301.51(c) that she cited. Those decisions 
starkly show the weakness of Respondent's position. Most recently, my 
predecessor noted that this portion of the regulation ``does not mean 
that a modification request is the same as an application for a new 
registration in every respect.'' Parth S. Bharill, M.D., 84 FR 39014 
n.2 (2019) (citing Craig S. Morris, D.D.S., 83 FR 36966, 36967 (2018)). 
In Craig S. Morris, D.D.S., my predecessor had noted that ``[u]nlike a 
timely renewal application, a request to modify the registration 
address of an existing registration . . . does not remain pending after 
the registration expires, nor does it operate to extend when that 
registration expires.'' 83 FR at 36967.
    Respondent also cited the Administrative Procedure Act 
(hereinafter, APA) as ``clearly indicat[ing] a governmental policy, by 
which agencies must consider a timely application before terminating a 
current registration,'' and 21 CFR 1301.36(i) for the proposition that 
``as long as a current DEA registrant submits his renewal application 
in a timely manner, an Order to Show Cause in administrative revocation 
proceedings will not void the registration.'' Resp Opposition, at 2 
(citing 5 U.S.C. 558 and Wedgewood Village Pharmacy, 293 F. Supp. 2d at 
467). Both of these arguments fail because both section 558 of the APA 
and section 1301.36(i) of DEA's regulations concern applications for 
reregistration (renewal) or for a new registration. 5 U.S.C. 558 
(``When the licensee has made timely and sufficient application for a 
renewal or a new license . . .''); 21 CFR 1301.36(i) (``In the event 
that an applicant for reregistration (who is doing business under a 
registration previously granted and not revoked or suspended) has 
applied for reregistration . . .'').
    Respondent's request under 21 CFR 1301.51(c) was not to renew or 
obtain a new registration. Her request was ``for modification of her 
DEA registration, to change the address of her registration'' from 
Wisconsin to Florida. Resp Opposition, at 1. As discussed above, the 
regulations are clear that the request to modify is not an extension of 
an existing registration, but shall be handled in the same manner as an 
application. See Cleveland J. Enmon, Jr. M.D., 77 FR 57,116, 57,125 
(2012) (``[W]hile the address change request is pending with the DEA, 
the registrant is not authorized to handle controlled substances at the 
new location until the DEA approves the modification.'').
    Accordingly, I will order that Respondent's DEA registration in 
Wisconsin be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
MH1088182 issued to Lisa Hofschulz, N.P. This Order is effective 
January 11, 2021.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-27239 Filed 12-10-20; 8:45 am]
BILLING CODE 4410-09-P