[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80152-80157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27231]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Zeljko Stjepanovic, M.D.; Decision and Order

    On May 1, 2018, a former Acting Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government) issued an 
Order to Show Cause and Immediate Suspension of Registration to Zeljko 
Stjepanovic, M.D. (hereinafter, Registrant). Government's Request for 
Final Agency Action Exhibit (hereinafter, RFAAX) 3, at 1 (Order to Show 
Cause and Immediate Suspension Order (hereinafter, collectively OSC)). 
The OSC informed Registrant of the immediate suspension of his DEA 
Certificate of Registration FS3042885 pursuant to 21 U.S.C. 824(d), 
``because [his] continued registration constitutes an imminent danger 
to public health and safety.'' Id.
    The substantive ground for the proceeding, as alleged in the OSC, 
is that Registrant's ``continued registration is inconsistent with the 
public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. 
Specifically, the OSC alleges that on August 31, 2017, January 19, 
2018, February 16, 2018, and March 15, 2018, Registrant unlawfully 
prescribed controlled substances in violation of 21 U.S.C. 841(a) and 
842(a). The OSC further alleges that on those dates, Registrant 
prescribed controlled substances to individuals that he ``knew were not 
for a legitimate medical purpose and were not in the usual course of 
[his] professional practice,'' because he issued them ``without 
establishing bona fide practitioner-

[[Page 80153]]

patient relationships'' and ``issued prescriptions in the name of one 
patient for use by another patient, despite acknowledging the 
illegality of this behavior, in violation of federal and state law.'' 
Id. at 2 (citing 21 CFR 1306.04(a); Va. Code Ann. Sec. Sec.  54.1-
3303.A, 54.1-2915.A(3), (8), (13), (16), (17), and 18.2.248).
    In issuing the OSC, which immediately suspended the registration, 
the former Acting Administrator concluded that Registrant's ``continued 
registration is inconsistent with the public interest'' based on a 
preliminary finding that Registrant ``issued prescriptions for 
controlled substances that [Registrant] knew were illegal, without a 
legitimate medical purpose and outside the usual course of professional 
practice'' and that were ``indicative of [Registrant's] general 
illegitimate practice of prescribing controlled substances in violation 
of State and Federal laws.'' Id. at 7. Citing 21 U.S.C. 824(d), he also 
made the preliminary finding that Registrant's ``continued registration 
during the pendency of the proceedings would constitute an imminent 
danger to the public health or safety because of the substantial 
likelihood that [Registrant] will continue to unlawfully prescribe 
controlled substances, thereby allowing the diversion of controlled 
substances unless [Registrant's] DEA COR is suspended.'' Id. The former 
Acting Administrator authorized the DEA Special Agents and Diversion 
Investigators serving the OSC on Registrant to place under seal or 
remove for safekeeping all controlled substances Registrant possessed 
pursuant to the immediately suspended registration. Id. (citing 21 
U.S.C. 824(f) and 21 CFR 1301.36(f)). The former Acting Administrator 
also directed those DEA employees to take possession of Registrant's 
Certificate of Registration FS3042886 and any unused prescription 
forms. Id. at 8.
    According to the Declaration of a DEA Diversion Investigator 
(hereinafter, DI) from the Richmond District Office, the DI personally 
served the OSC on Registrant on May 4, 2018, at his registered address. 
RFAAX 5, at 2. Based on the DI's Declaration, and my review of the 
record, I find that the Government accomplished service of the OSC on 
Registrant on May 4, 2018. The OSC notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
while waiving his right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. OSC at 
7-8 (citing 21 CFR 1301.43(c)).
    On July 25, 2018, the Government forwarded a Request for Final 
Agency Action (hereinafter, RFAA), along with the evidentiary record 
for this matter, to my office, and asserted that the Government had not 
received a request for a hearing. RFAA, at 2. I find that more than 
thirty days have now passed since the Government accomplished service 
of the OSC. I further find, based on the Government's written 
representations, that neither Registrant, nor anyone purporting to 
represent the Registrant, requested a hearing, or submitted a written 
statement while waiving Registrant's right to a hearing. Accordingly, I 
find that Registrant has waived the right to a hearing and the right to 
submit a written statement. 21 CFR 1301.43(d). I, therefore, issue this 
Decision and Order based on the record submitted by the Government, 
which constitutes the entire record before me. 21 CFR 1301.43(e).
    Having considered the record in its entirety, I find that the 
record establishes, by substantial evidence, that Registrant committed 
acts rendering his continued registration inconsistent with the public 
interest. I also find that Registrant has submitted no evidence that he 
accepts responsibility for his failures to meet the responsibilities of 
a registrant nor presented any evidence of mitigation or remedial 
measures. Accordingly, I conclude that the appropriate sanctions are 
(1) for Registrant's DEA registration to be revoked; and (2) for any 
pending application by Registrant to be denied.
    Based on the representations of the Government in its RFAA, I make 
the following findings of fact.

I. Findings of Fact

A. Registrant's DEA Registration

    Registrant is registered with DEA as a practitioner in schedules II 
through V under DEA Certificate of Registration No. FS3042885, at the 
registered address of 2004 Bremo Rd, Suite 200, Richmond, VA 23226. 
RFAAX 1. This registration expires on February 28, 2021. Id. The 
registration was suspended pursuant to the Immediate Suspension Order 
dated May 1, 2018. OSC, at 7.

B. The Investigation of Registrant

    In 2017, the Richmond District Office (hereinafter, RDO) of the DEA 
Washington Field Office began an investigation of Registrant that 
included the use of undercover investigators. RFAAX 5, at 1-2. Two RDO 
Task Force Officers (hereinafter, TFO One and TFO Two) were assigned to 
investigate Registrant. Id. at 2. According to the Government, TFO One 
first visited Registrant posing as a patient on August 31, 2017, while 
Registrant was working for a practice located in Fredericksburg, VA. 
RFAAX 6 (Declaration of TFO One), at 1. TFO Two next went undercover to 
visit Registrant with TFO One on January 19, 2018 and February 16, 2018 
in Registrant's Richmond Office. Id. at 2. Finally, TFO Two went 
undercover to visit Registrant by herself on March 15, 2018. RFAAX 7 
(Declaration of TFO 2), at 2.
    The Government submitted declarations from TFO One and TFO Two, 
which summarize the events of the undercover visits to Registrant. See 
RFAAX 6 and 7. The Government also submitted copies of controlled 
substance prescriptions written by Registrant to the aliases used by 
TFO One and TFO Two that support their accounting of their visits with 
Registrant, RFAAX 4 (Copies of prescriptions), and a partial transcript 
of a recording of the February 16 undercover visit.\1\ RFAAX 2 
(Transcript of February 16, 2018 undercover visit with Registrant).
---------------------------------------------------------------------------

    \1\ The DI assigned to Registrant's case declared that TFO One 
and TFO Two recorded all of their visits with Registrant. RFAAX 5, 
at 2. The Government, however, has only provided a partial 
transcript from the recording of one of those visits. See RFAAX 2 
(Transcript of February 16, 2018 undercover visit with Registrant). 
Exhibit Two to the Government's RFAA is three pages of a twenty-four 
page transcript of the recording of the February 16, 2018 visit. Id. 
The Government has provided no explanation for only including 
certain pages from the February 16, 2018 visit transcript and for 
not including any of the recordings or transcripts of the recordings 
from the other three visits. Although I do not have the recordings 
for the majority of the undercover visits in the evidence before me, 
there is no evidence in the record that contradicts the Government's 
presentation of the facts in this matter.
---------------------------------------------------------------------------

1. August 31, 2017 Undercover Visit
    TFO One first visited Registrant posing as a patient on August 31, 
2017. RFAAX 6, at 1. At the time, Registrant was working for a practice 
located in Fredericksburg, VA. Id. During the August 31 visit, 
Registrant provided TFO One with a prescription for Tramadol (50 mg, 
QTY 84).\2\ RFAAX 4 (copy of prescription); RFAAX 6, at 2.
---------------------------------------------------------------------------

    \2\ Tramadol is a schedule IV controlled substance. 21 CFR 
1308.14(b).
---------------------------------------------------------------------------

    TFO One said that she ``specifically asked for Tramadol by name 
because it made [her] feel good.'' RFAAX 6, at 2. When Registrant 
checked the Virginia Prescription Monitoring Program and discovered 
that TFO One did not have a previous prescription for Tramadol, TFO One 
told Registrant that she ``had previously been using [her] ex-
boyfriend's Tramadol prescription.'' Id. According to TFO One, 
Registrant did

[[Page 80154]]

not conduct a physical exam, use diagnostic tools, or complete a 
urinalysis during the August 31 visit. Id. TFO One also declared that 
she did not provide any medical records from a previous medical 
provider. Id.
2. January 19, 2018 Undercover Visit
    On January 19, 2018, TFO One visited Registrant again in an 
undercover capacity at Registrant's office in Richmond, Virginia. RFAAX 
6, at 2. TFO One was accompanied on this visit by TFO Two, acting in an 
undercover capacity.\3\ Id. Registrant saw TFO One and Two together, in 
the same room, during the visit. Id.
---------------------------------------------------------------------------

    \3\ TFO One declared that this visit occurred on January 19, 
2018, while TFO Two declared that this visit occurred on January 18, 
2018. RFAAX 7, at 2. I find that the one-day discrepancy between the 
two accounts of the date of this visit does not detract from TFO 
Two's credibility, given the other supporting evidence for this 
visit, and is ultimately irrelevant in this matter. The Government 
presents the visit as having occurred on January 19, 2018, and a 
prescription Registrant issued during the visit supports a finding 
of that date; therefore, I am concluding that the visit occurred on 
that January 19, 2018.
---------------------------------------------------------------------------

    During the January 19 visit, TFO One asked Registrant for another 
prescription for Tramadol. Id. According to the declaration of TFO One, 
Registrant replied that he ``could not write [TFO One] [her] own 
prescription due to [her] status as a former Fredericksburg patient.'' 
Id. Instead, according to TFOs One and Two, Registrant issued TFO Two a 
double dose of oxycodone so TFO One and TFO Two ``could share a 
prescription until [their] next office visit to [Registrant].'' RFAAX 
6, at 2; RFAAX 7, at 2. A copy of the prescription from the January 19 
visit shows that Registrant wrote TFO Two (in the name of her alias) a 
prescription for oxycodone (10mg, QTY 90).\4\ RFAAX 4.
---------------------------------------------------------------------------

    \4\ Oxycodone is a schedule II controlled substance. 21 CFR 
1308.12(1).
---------------------------------------------------------------------------

3. February 16, 2018 Undercover Visit
    TFO One and TFO Two visited Registrant in an undercover capacity 
together for a second time on February 16, 2018.\5\ RFAAX 6, at 2. 
Registrant saw TFO One first, by herself, in Registrant's office. Id. 
TFO One stated that the office was not an examination room--that it 
contained a desk, computer, and chairs but no examination bed or 
medical equipment. Id. Registrant again stated that he could not write 
TFO One a prescription due to her status as a former Fredericksburg 
patient and offered to write TFO One a Tramadol prescription in TFO 
Two's name. Id.; see also RFAAX 2 (Excerpts from transcript of February 
16 visit), at 2. The transcript of the recording made of the visit 
demonstrates that Registrant said, ``What I was thinking in the 
beginning according [sic], that you are so nice, and I know that it is 
illegal, but I technically can write down those medications on her 
name.'' RFAAX 2, at 2.
---------------------------------------------------------------------------

    \5\ In their declarations, TFO One and TFO Two state that this 
visit occurred on February 26, 2018. RFAA 6, at 2; RFAAX 7, at 2. 
The Government stated in the RFAA that the date in the declarations 
was a typo and should read February 16, 2018. RFAA, at 4. The 
transcript of the recording of the interview states that the 
recording was made on February 16, 2018. RFAAX 2. I find that the 
date in the declarations was a typo and that the visit occurred on 
February 16, 2018. I find that this date discrepancy was a 
scrivener's error and does not detract from the overall credibility 
of the Government's evidence.
---------------------------------------------------------------------------

    TFO Two was then summoned into Registrant's office with Registrant 
and TFO One. RFAAX 6, at 2. Registrant told TFO Two that he had been 
discussing with TFO One writing a Tramadol prescription for TFO One in 
TFO Two's name. RFAAX 7, at 2. Registrant sought to confirm that TFO 
Two was comfortable with having the Tramadol prescription for TFO One 
written in TFO Two's name. Id.; RFAAX 2, at 3. After TFO Two said that 
it was fine, Registrant told TFO Two what to say if a pharmacist 
questioned her on why a doctor was prescribing two short acting drugs. 
RFAAX 2, at 3. According to the transcript, Registrant then asked, ``Is 
that Okay? I'm sorry is illegal, but you know.'' Id.
    Registrant issued two prescriptions to TFO Two, one for oxycodone 
(10mg, QTY 90) and one for Tramadol (50mg, QTY 90). RFAAX 6, at 2; 
RFAAX 7, at 2; RFAAX 4. Registrant then advised TFO Two that she should 
fill the prescriptions at the same pharmacy as the January 19, 2018 
prescription to avoid any scrutiny. RFAAX 6, at 2; RFAAX 7, at 2; RFAAX 
4. He said ``just don't change, because they're looking if you're 
changing doctors or changing pharmacies . . . .'' RFAAX 2, at 4. 
According to TFO Two, Registrant did not perform any type of physical 
exam on her during the February 16 visit. RFAAX 7, at 2.
4. March 15, 2018 Undercover Visit
    TFO Two visited Registrant by herself on March 15, 2018, and met 
with Registrant in his office. RFAAX 7, at 2. According to TFO Two, 
Registrant asked ``if I wanted him to `do the same stuff''' and ``if I 
wanted him to issue another Tramadol prescription for TFO [One] in [TFO 
Two's] name.'' Id. Registrant then asked if she had any problems with 
the pharmacy filling the previous prescriptions for oxycodone and 
Tramadol. Id. When TFO Two told him there were no problems, Registrant 
``again advised [her] that to avoid scrutiny of the illegal 
prescriptions he was writing, [she] should not change providers or 
pharmacies.'' Id.
    Registrant wrote TFO Two a prescription for oxycodone (10mg, QTY 
90) and a prescription for Tramadol (50mg, QTY 90). Id.; RFAAX 4. TFO 
Two declared that during the visit Registrant ``asked generally, how 
[she] was feeling but did not perform any physical examination.'' RFAAX 
7, at 2.
    In summary, based on the substantial evidence in the record, I find 
that Registrant issued a total of six prescriptions for controlled 
substances to TFO One and TFO Two without performing a physical 
examination of either undercover officer. I also find that Registrant 
wrote two controlled substance prescriptions for TFO One in TFO Two's 
name even though he verbally stated that doing so was illegal.

II. Discussion

    Under the Controlled Substances Act (CSA), ``[a] registration . . . 
to . . . distribute[ ] or dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a ``practitioner,'' which is defined in 21 
U.S.C. 802(21) to include a ``physician,'' Congress directed the 
Attorney General to consider the following factors in making the public 
interest determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The [registrant]'s experience in dispensing . . . controlled 
substances.
    (3) The [registrant]'s conviction record under Federal or State 
laws relating to the . . . distribution[ ] or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
21 U.S.C. 823(f). These factors are considered separately. Robert A. 
Leslie, M.D., 68 FR 15,227, 15,230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharm., LLC v. Drug Enf't Admin., 881 F.3d 
823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't Admin., 
841 F.3d 707, 711 (6th Cir.

[[Page 80155]]

2016)); MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 
2011); Volkman v. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009); 
Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). 
Moreover, while I am required to consider each of the factors, I ``need 
not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 
(quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482. 
``In short, . . . the Agency is not required to mechanically count up 
the factors and determine how many favor the Government and how many 
favor the registrant. Rather, it is an inquiry which focuses on 
protecting the public interest; what matters is the seriousness of the 
registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462 
(2009). Accordingly, findings under a single factor can support the 
revocation of a registration. MacKay, 664 F.3d at 821.
    The Government has the burden of proving that the requirements for 
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 
CFR 1301.44(e). When the Government has met its prima facie case, the 
burden then shifts to the registrant to show that revoking the 
registration would not be appropriate, given the totality of the facts 
and circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 
387 (2008).
    In this matter, while I have considered all of the Factors, the 
Government's evidence in support of its prima facie case is confined to 
Factors Two and Four.\6\ I find the Government has satisfied its prima 
facie burden of showing that Registrant's continued registration would 
be ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------

    \6\ As to Factor One, the Government alleged that Registrant 
holds a valid state medical license, and there is no evidence in the 
record of any recommendation from Registrant's ``State licensing 
board or professional disciplinary authority.'' See OSC, at 2. State 
authority to practice medicine is ``a necessary, but not a 
sufficient condition for registration . . . .'' Robert A. Leslie, 
M.D., 68 FR at 15,230. Therefore, ``[t]he fact that the record 
contains no evidence of a recommendation by a state licensing board 
does not weigh for or against a determination as to whether 
continuation of Respondent's DEA certification is consistent with 
the public interest.'' Roni Dreszer, M.D., 76 FR 19,434, 19,444 
(2011).
    As to Factor Three, there is no evidence in the record that 
Registrant has a ``conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of 
controlled substances.'' 21 U.S.C. 823(f)(3). However, as Agency 
cases have noted, there are a number of reasons why a person who has 
engaged in criminal misconduct may never have been convicted of an 
offense under this factor, let alone prosecuted for one. Dewey C. 
MacKay, M.D., 75 FR 49,956, 49,973 (2010), pet. for rev. denied, 
MacKay v. Drug Enf't Admin., 664 F.3d 808 (10th Cir. 2011). Agency 
cases have therefore held that ``the absence of such a conviction is 
of considerably less consequence in the public interest inquiry'' 
and is therefore not dispositive. Id.
---------------------------------------------------------------------------

A. Factors Two and/or Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

    The Government alleges that on August 31, 2017, January 19, 2018, 
February 16, 2018, and March 15, 2018, Registrant prescribed controlled 
substances to undercover officers posing as patients without 
establishing a bona fide practitioner-patient relationship, without a 
legitimate medical purpose, and outside the usual course of his 
professional practice in violation of 21 CFR 1306.04(a) and Va. Code 
Ann. Sec.  54.1-3303.A. RFAA, at 8; OSC, at 2. The Government further 
alleges that Registrant's actions violated 21 U.S.C. 841(a), which 
states, in relevant part, that it is unlawful for any person to 
knowingly or intentionally dispense a controlled substance except as 
authorized by the CSA. OSC, at 2.
    According to the CSA's implementing regulations, a lawful 
prescription for controlled substances is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment . 
. . is not a prescription within the meaning and intent of [21 U.S.C. 
829] and . . . the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' Id. The Supreme Court has stated that ``the prescription 
requirement . . . ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse . . . [and] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006).
    DEA has consistently stated that a practitioner must establish and 
maintain a bona fide doctor-patient relationship in order to act ``in 
the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Ralph J. Chambers, 
79 FR 4962, 4970 (2014) (citing Paul H. Volkman, 73 FR 30,629, 30,642 
(2008), pet. for rev. denied Volkman v. Drug Enf't Admin., 567 F.3d 
215, 223-24 (6th Cir. 2009)); see also U.S. v. Moore, 423 U.S. 122, 
142-43 (1975) (noting that evidence established that the physician 
exceeded the bounds of professional practice, when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against . . . misuse and 
diversion''). In recognition of the State's primary role in regulating 
the practice of medicine, the CSA generally looks to state law to 
determine whether a doctor and patient have established a legitimate 
doctor-patient relationship. Mackay, 75 FR at 49,973; Volkman, 73 FR at 
30,642.
    The law of the Commonwealth of Virginia, the state in which 
Registrant is registered with DEA, to which the Government cited in the 
OSC, echoes the CSA requirement that a practitioner may only issue a 
prescription to a person with whom the practitioner has ``a bona fide 
practitioner-patient relationship.'' Va. Code Ann. Sec.  54.1-3303A 
(West 2018).\7\ At the time of the events at issue here, Virginia law 
defined a bona fide practitioner-patient relationship as ``one in which 
a practitioner prescribes, and a pharmacist dispenses, controlled 
substances in good faith to his patient for a medicinal or therapeutic 
purpose within the course of his professional practice.'' Id. The 
Virginia law further states that
---------------------------------------------------------------------------

    \7\ Virginia amended this portion of the code in 2018 and 2020. 
This Decision cites to the law that was in effect during the time 
when Registrant issued the subject prescriptions to the undercover 
officers and when the OSC was issued.

    A bona fide practitioner-patient relationship means that the 
practitioner shall (i) ensure that a medical or drug history is 
obtained; (ii) provide information to the patient about the benefits 
and risks of the drug being prescribed; (iii) perform or have 
performed an appropriate examination of the patient, either 
physically or by the use of instrumentation and diagnostic equipment 
through which images and medical records may be transmitted 
electronically; except for medical emergencies, the examination of 
the patient shall have been performed by the practitioner himself, 
within the group in which he practices, or by a consulting 
practitioner prior to issuing a prescription; and (iv) initiate 
additional interventions and follow-up care, if necessary, 
---------------------------------------------------------------------------
especially if a prescribed drug may have serious side effects.

Id.
    The Government typically establishes that a practitioner issued 
prescriptions without a legitimate medical purpose or outside the usual 
course of professional practice in violation of 21 CFR 1306.04(a) 
through, or with the support of, expert testimony. However, DEA 
decisions have found that the nature of the allegations and the 
evidence on the record can establish violations of Section 1306.04(a) 
without necessitating

[[Page 80156]]

the support of expert opinion.\8\ Lawrence E. Stewart, M.D., 81 FR 
54,822, 54,839 (2016). DEA has not required expert testimony to 
establish a violation of 21 CFR 1306.04(a) in past matters under 
factual circumstances that include: Where a prescriber engaged in drug 
deals; where a prescriber did not conduct a physical exam of the 
patient as required by law; where a controlled substance prescription 
was based on a patient's request rather than the result of the 
application of the physician's medical judgment; and where a prescriber 
falsified patients' charts. See e.g., Stewart, 81 FR at 54,839-41 
(finding, without expert testimony, that prescriptions were issued 
outside the usual course of professional practice, where the physician 
failed to perform and document a physical exam, and lacked a legitimate 
medical purpose, where a physician prescribed controlled substances 
based on a patient's request); Morris W. Cochran, M.D., 77 FR 17,505, 
17,519-20 (2011) (finding, without expert testimony, that prescriptions 
lacked a legitimate medical purpose, where a physician noted in patient 
medical records that patients had no pain, did not document any 
findings to support a diagnosis, and yet diagnosed patients as having 
chronic pain); Robert F. Hunt, D.O., 75 FR 49,995, 50,003 (2010) 
(finding, without expert testimony, that a physician lacked a 
legitimate medical purpose based on statements made during undercover 
visits and falsification of patient chart). See also T.J. McNichol, 
M.D., 77 FR 57,133, 57,147-48 (2012), pet. for rev. denied, 537 Fed. 
Appx. 905 (11th Cir. 2013).
---------------------------------------------------------------------------

    \8\ Numerous federal courts have found in criminal cases, which 
require a higher standard of proof than is required in these 
proceedings, that expert testimony is not required to establish a 
violation of 21 U.S.C. 841 or 21 CFR 1306.04(a) based on the 
particular facts of the case. See, e.g., United States v. Pellman, 
668 F.3d 918, 924 (7th Cir. 2012) (holding that even without expert 
testimony there was ``ample evidence'' for a reasonable jury to 
determine the physician-defendant acted outside the usual course of 
his professional practice and not for a legitimate purpose); U.S. v. 
Armstrong, 550 F.3d 382, 389 (5th Cir. 2008), overruled on other 
grounds by United States v. Balleza, 613 F.3d 382 (5th Cir. 2010) 
(``While expert testimony may be both permissible and useful, a jury 
can reasonably find that a doctor prescribed controlled substances 
not in the usual course of professional practice or for other than a 
legitimate medical purpose from adequate lay witness evidence 
surrounding the facts and circumstances of the prescriptions.''); 
U.S. v. Word, 806 F.2d 658 663-64 (6th Cir. 1986).
---------------------------------------------------------------------------

    I find that, with respect to the prescriptions Registrant issued to 
the undercover officers, expert testimony is not necessary to prove 
that Registrant lacked a legitimate medical purpose and acted outside 
of the usual course of professional practice in issuing them. Virginia 
law clearly states that to establish a practitioner-patient 
relationship, the practitioner must ``perform or have performed an 
appropriate examination of the patient, either physically or by the use 
of instrumentation and diagnostic equipment through which images and 
medical records may be transmitted electronically.'' Va. Code Ann. 
Sec.  54.1-3303A(iii). The uncontested evidence in this matter shows 
that Registrant issued prescriptions for controlled substances to TFOs 
One and Two without performing any physical examination or using any 
diagnostic tools. By issuing prescriptions to TFOs One and Two without 
first establishing a bona fide practitioner-patient relationship, 
Registrant violated Va. Code Ann. Sec.  54.1-3303A and thus acted 
outside the usual course of his professional practice.
    I also find that Registrant did not issue the prescriptions to the 
undercover officers for legitimate medical purposes. First, there is 
substantial evidence that Registrant knew that TFO One was not seeking 
treatment for a legitimate medical condition but was either engaged in 
self-abuse or diversion. During her first visit with Registrant on 
August 31, 2017, TFO One asked Registrant for a prescription for 
Tramadol ``because it made [her] feel good'' and told Respondent that 
she had been taking Tramadol that was not prescribed to her. Previous 
DEA decisions have found, without the support of expert testimony, that 
controlled substance prescriptions did not have a legitimate medical 
purpose when practitioners prescribed them based on a patient request 
rather than for the treatment of a legitimate medical condition. See 
Stewart, 81 FR at 54,841; Henri Wetselaar M.D., 77 FR 57,126, 57,132 
(2012).
    Second, Registrant's statements to TFOs One and Two during the 
course of their visits make clear that Registrant was prescribing 
controlled substances to TFO Two to intentionally divert drugs to TFO 
One. On their first visit together to Registrant on January 19, 2018, 
Registrant told the undercover officers that he was prescribing TFO Two 
a double dose of oxycodone, so that they ``could share a prescription 
until [their] next office visit to [Registrant].'' RFAAX 6, at 2; RFAAX 
7, at 2. Then, during the undercover officers' second visit together to 
Registrant on February 16, 2018, Registrant told the undercover 
officers that he would write a prescription for Tramadol in TFO Two's 
name for TFO Two to give to TFO One. RFAAX 2 at 2; see also RFAAX 4 
(prescription for Tramadol in TFO Two's name). When TFO Two visited 
Registrant by herself on March 15, 2018, Registrant again issued TFO 
Two a prescription for Tramadol so that she could give the drugs to TFO 
One. RFAAX 7, at 2. Registrant's actions ``completely betrayed any 
semblance of legitimate medical treatment.'' Jack A. Danton, D.O, 76 FR 
60,900, 60,904 (quoting United States v. Feingold, 454 F.3d 1001, 1010 
(9th Cir. 2006)). Therefore, the evidence clearly supports a finding 
that Registrant issued the prescriptions without a legitimate medical 
purpose and outside the usual course of his professional practice in 
violation of 21 CFR 1306.04(a).
    Finally, despite Registrant's failure to take his responsibilities 
as a registrant seriously, he did understand the potential legal 
consequences for his action and undoubtedly knew his actions were 
wrong. Registrant repeatedly stated that the prescriptions he wrote for 
TFO Two to give to TFO One were ``illegal.'' \9\ RFAAX 2, at 2-3. He 
also gave the undercover officers instructions on how to evade scrutiny 
when filling the prescriptions. RFAAX 2, at 3; RFAAX 7, at 2. This 
evidence supports the conclusion that Registrant knowingly engaged in 
an outright drug deal in violation of 21 U.S.C. 841(a).
---------------------------------------------------------------------------

    \9\ In the transcript of recording from the February 16, 2018 
visit, regarding prescribing in TFO Two's name for TFO One, 
Registrant stated, ``I know that is illegal, but I technically can 
write down those medications on her name,'' and ``Is that Okay? I'm 
sorry is illegal, but you know.'' RFAAX 2, at 2-3.
---------------------------------------------------------------------------

    In summary, I find that Registrant committed flagrant violations of 
21 CFR 1306.04(a); violated state law, Va. Code Ann. Sec.  54.1-3303.A; 
\10\ and displayed an appalling disregard of a registrant's duty under 
the CSA to prescribe controlled substances based on a legitimate 
doctor-patient relationship.
---------------------------------------------------------------------------

    \10\ The Government also alleged that Registrant's actions 
violated Va. Code Ann. Sec.  54.1-2915.A(3), (8), (13), (16), and 
(17), which provide grounds for which the Virginia Medical Board may 
refuse to issue, suspend, or revoke a medical license. While I find 
that these provisions buttress the Government's argument that 
Registrant was acting outside the usual course of his professional 
practice, I do not find that they establish independent violations 
of state law and, as such, I am not including them in my findings 
herein.
---------------------------------------------------------------------------

B. Registrant's Registration Is Inconsistent With the Public Interest 
and Presented an Imminent Danger

    Violations of the prescription requirement strike at the core of 
the CSA's purpose of preventing the diversion of controlled substances. 
See United States v. Moore, 423 U.S. 122, 135 (1975) (``Congress was 
particularly concerned with the diversion of drugs from legitimate 
channels to illegitimate channels. It was aware that registrants,

[[Page 80157]]

who have the greatest access to controlled substances and therefore the 
greatest opportunity for diversion, were responsible for a large part 
of the illegal drug traffic.''). The Agency has previously found that 
proof of a single act of intentional or knowing diversion is sufficient 
to satisfy the Government's prima facie burden of showing that a 
practitioner's continued registration is inconsistent with the public 
interest. McNichol, 77 FR at 57,145-46 (2012); see also, Alan H. 
Olefsky, 57 FR 928, 928-29 (1992) (revoking registration based on 
physician's presentation of two fraudulent prescriptions to pharmacist 
in single act where physician failed to acknowledge his misconduct). 
Accordingly, I find that the evidence in this matter establishes 
Registrant ``has committed such acts as would render his registration . 
. . inconsistent with the public interest.'' See 21 U.S.C. 824(a)(4).
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Registrant ``fail[ed] . . . to maintain 
effective controls against diversion or otherwise comply with the 
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The 
substantial evidence that Registrant was issuing prescriptions for 
controlled substances without a legitimate medical purpose and outside 
the usual course of professional practice also establishes that there 
was ``a substantial likelihood [that an] . . . abuse of a controlled 
substance . . . [would] occur in the absence of the immediate 
suspension'' of Registrant's registration. Id. As I found above, the 
recording of the February 16, 2018 visit between Registrant and the 
undercover officers and the undercover officers' accountings of their 
other visits establish that Registrant unlawfully prescribed controlled 
substances to the officers without conducting physical examinations and 
wrote controlled substance prescriptions in TFO Two's name for her to 
give to TFO One. Thus, at the time the Government issued the OSC, the 
Government had clear evidence of Registrant's violations of law.

III. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that a Registrant's continued registration is inconsistent with 
the public interest, the burden shifts to the Registrant to show why he 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18,882, 18,910 (2018) (collecting cases). Registrant did not present 
any evidence of remorse for his past misconduct or evidence of 
rehabilitative actions taken to correct his past unlawful behavior. 
Further, he provided no assurances that he would not engage in such 
conduct in the future. Absent such evidence and such assurances in this 
matter, I find that continued registration of Registrant is 
inconsistent with the public interest. Registrant's silence weighs 
against his continued registration. Zvi H. Perper, M.D., 77 FR 64,131, 
64,142 (2012 (citing Med. Shoppe-Jonesborough, 73 FR at 387); see also 
Samuel S. Jackson, 72 FR 23,848, 23,853 (2007). Accordingly, I find 
that the factors weigh in favor of sanction, and I shall order the 
sanctions the Government requested, as contained in the Order below.

IV. 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 
FS3042885 issued to Zelijko Stjepanovic, M.D. Further, pursuant to 28 
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I 
hereby deny any pending application of Zelijko Stjepanovic, M.D. to 
renew or modify this registration. This Order is effective January 11, 
2021.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-27231 Filed 12-10-20; 8:45 am]
BILLING CODE 4410-09-P