Algirdas J. Krisciunas, M.D.; Revocation of Registration, 4940-4944 [2011-1693]
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Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices
Dated: January 18, 2011.
Michele M. Leonhart,
Administrator.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b) and 0.104, I hereby
order that the Order to Show Cause
issued to John G. Costino, D.O., be, and
it hereby is, dismissed.
[FR Doc. 2011–1694 Filed 1–26–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
John G. Costino, D.O.; Dismissal of
Proceeding
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Drug Enforcement Administration
Dated: January 18, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–1692 Filed 1–26–11; 8:45 am]
BILLING CODE 4410–09–P
On June 1, 2010, the Deputy Assistant
Administrator, Office of Diversion
Control, issued an Order to Show Cause
to John G. Costino, D.O. (Respondent),
of North Wildwood, New Jersey. The
Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, AC5210480,
and the denial of pending applications
to renew or modify his registration, on
the ground that ‘‘[a]s a result of actions
by the New Jersey State Medical Board,
[Respondent is] currently without
authority to handle controlled
substances in the State of New Jersey,
the state in which [he is] registered with
DEA.’’ Show Cause Order at 1. The
Show Cause Order also notified
Respondent of his right to request a
hearing on the allegations or to submit
a written statement in lieu of hearing,
the procedures for doing either, and the
consequence for failing to do either. Id.
at 2 (citing 21 CFR 1301.43(a), (c), (d) &
(e)).
On June 17, 2010, Respondent filed a
letter with the Hearing Clerk in which
he noted that he had filed an appeal of
some unspecified action and that he was
‘‘requesting reinstatement of [his]
medical license among other things.’’
Letter of Respondent to Hearing Clerk
(June 14, 2010). Therein, Respondent
also filed a request to waive his right to
a hearing. Id.
Thereafter, the Government submitted
the record to me for Final Agency
Action. Based on Respondent’s letter to
the Hearing Clerk, I find that
Respondent has waived his right to a
hearing. I further find, however, that
Respondent’s registration expired on
August 31, 2010, and that Respondent
has not filed a renewal application.
It is well settled that ‘‘[i]f a registrant
has not submitted a timely renewal
application prior to the expiration date,
then the registration expires and there is
nothing to revoke.’’ Ronald J. Riegel, 63
FR 67132, 67133 (1998); see also
William W. Nucklos, 73 FR 34330
(2008). Because Respondent’s
registration has expired and there is no
pending application to act upon, I
conclude that this case is now moot.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Algirdas J. Krisciunas, M.D.;
Revocation of Registration
On January 19, 2010, I, the Deputy
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration (Order) to Algirdas J.
Krisciunas, M.D. (‘‘Registrant’’), of
Lauderdale Lakes, Florida. The Order
proposed the revocation of Registrant’s
DEA Certificate of Registration,
BK4015334, and the denial of any
applications for renewal or modification
of his registration, on the ground that
his ‘‘continued registration is
inconsistent with the public interest, as
that term is defined in 21 U.S.C.
§ 823(f).’’ Order, at 1. Based on the
allegations presented, I also concluded
that Registrant’s continued registration
during the pendency of this proceeding
‘‘constitutes an imminent danger to the
public health and safety’’ and
immediately suspended his registration.
Id. at 2.
The Order alleged that Registrant was
the ‘‘owner of Social Medical Center
(SMC), a pain clinic located at [his]
registered location’’ and that he ‘‘issue[d]
many purported prescriptions for
controlled substances’’ from there. Id. at
1. The Order further alleged that
Registrant ‘‘prescribed and dispensed
controlled substances, including
oxycodone 1 and alprazolam,2 to two
undercover law enforcement officers on
five different occasions from July 13
through September 10, 2009, in
violation of 21 U.S.C. §§ 841(a)(1) and
846.’’ Id. at 2. The Order also alleged
that Registrant and his staff ‘‘falsified
medical records for the two undercover
officers’’ and that Registrant ‘‘advised
the undercover officers how to falsify
medical records to make it appear that
1 Oxycodone is a schedule II controlled
substance. 21 CFR 1308.12(b)(1)(xiii).
2 Alprazolam is a schedule IV controlled
substance. 21 CFR 1308.14(c)(1).
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they had legitimate medical conditions
warranting the use of controlled
substances.’’ Id. The Order next alleged
that Registrant and his staff ‘‘sold the
medical records of others to an
undercover officer so that the records
could be altered to appear that they
were the medical records of the
undercover officer.’’ Id.
The Order further alleged that
‘‘[b]ased on [his] consultations with, and
examinations of, the two undercover
officers,’’ Registrant ‘‘knew, or should
have known, that neither of the
undercover officers had a legitimate
medical condition warranting the
prescribing of controlled substances’’
because the ‘‘undercover officers
provided inconsistent statements
regarding the nature of their alleged
injuries and gave negative answers
when queried about any pain they were
experiencing.’’ Id. The Order thus
alleged that Registrant ‘‘issu[ed]
[controlled substance] prescriptions
outside the usual course of professional
practice or for other than a legitimate
medical purpose,’’ in violation of
Federal law. Id. (citing 21 U.S.C.
823(f)(4); 21 CFR 1306.04).
Finally, the Order alleged that on July
1, 2009, Registrant’s ‘‘office staff sold 53
oxycodone 30 mg pills to an undercover
officer for $500, in violation of 21 U.S.C.
§ [] 841(a)(1),’’ and that ‘‘[t]his
transaction occurred at [his] office
during regular business hours while [he
was] on the premises.’’ Id. The Order
thus alleged that Registrant ‘‘failed to
exercise proper oversight of [his] office
staff or take proper measures to ensure
the safeguarding of controlled
substances stored at [his] office.’’ Id.
Based on the above, I made the
‘‘preliminary finding that [Registrant’s]
continued registration is inconsistent
with the public health and safety.’’ Id.
(citing 21 U.S.C. 823(f), 824(a)(4)).
Having concluded that Registrant’s
‘‘continued registration while these
proceedings are pending constitutes an
imminent danger to the public health
and safety because [he has] repeatedly
displayed a willingness to prescribe
widely abused controlled substances for
other than a legitimate medical
purpose,’’ I further ordered the
immediate suspension of his
registration. Id. (citing 21 U.S.C. 824(d);
21 CFR 1301.36(e); 28 CFR 0.100). Id.
On January 20, 2010, the Order,
which also notified Registrant of his
rights to either request a hearing or
submit a written statement in lieu of a
hearing, the procedures for doing either,
and the consequences for failing to do
either, was personally served on
Registrant by a DEA Diversion
Investigator. Since the date of service of
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the Order, more than thirty days have
passed and neither Registrant, nor
anyone purporting to represent him, has
requested a hearing on the allegations or
submitted a written statement. 21 CFR
1301.43(a)–(c). I therefore find that
Registrant has both waived his right to
a hearing and to submit a written
statement, and I issue this Decision and
Final Order based on relevant evidence
contained in the Investigative Record
submitted by the Government.3 21 CFR
1301.43(d)–(e). I make the following
findings.
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Findings
Registrant holds DEA Certificate of
Registration, BK4015334, which
authorizes him to dispense as a
practitioner controlled substances in
schedules II through V. Cert. of Reg.
Hist. (March 18, 2010). Registrant is
registered at the address of 3401 West
Oakland Park Blvd., Lauderdale Lakes,
Florida 33311; this address was the
location of a pain clinic which was
owned by his wife, Maria Bulich, and
which did business under the name of
‘‘Social Medical Center’’ (SMC). Id.; Aff.
of Task Force Officer (TFO) 1, at 1, 3.
On July 1, 2009, a Broward County
Sheriff’s Office detective assigned to a
DEA Task Force attempted an
undercover buy at SMC. Using the name
Bill Rix,4 the detective posed as a
personal trainer who had recently
moved to the area and who ‘‘needed a
supplier of pain medicine due to
discomfort from an old auto accident.’’ 5
Aff. of TFO1, at 1.
Immediately on entering SMC, Rix
met both Registrant and his receptionist,
M.L.A. Id. M.L.A told Rix that, to obtain
3 In its Request for Final Agency Action, the
Government argues that revocation is warranted
under the additional ground that Registrant ‘‘has
been convicted of a felony under subchapter 1 of
chapter 13, Title 21, United States Code.’’ Request
for Final Agency Action, at 4. Thereafter, the
Government submitted a First Supplement to
Request for Final Agency Action which argued that
revocation was also warranted because on August
20, 2010, the State of Florida issued an Order of
Emergency Suspension, which immediately
suspended Registrant’s medical license and that he
no longer has authority under State law to dispense
controlled substances. First Supplement to Request
for Final Agency Action, at 1 (citing 21 U.S.C.
824(a)(3)). Attached to the filing was a copy of the
State order.
Finally, the Government submitted a Second
Supplement to Request for Final Agency Action,
which noted that on October 13, 2010, the U.S.
District Court for the Southern District of Florida
entered a judgment, which adjudicated Registrant
guilty of six felony counts under the Controlled
Substances Act. Attached to the filing was a copy
of the Judgment.
4 Throughout this decision, each TFO’s assumed
name is used interchangeably with the titles of TFO
1 and TFO 2.
5 The officer wore a wire during the visit to record
it; the recording was later transcribed.
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controlled substances from Registrant,
he would need an MRI report (to show
‘‘the nature and location of chronic paincausing injuries’’) and a pharmacy drug
profile (to ‘‘show the drugs the patient
has been receiving’’). Registrant stated
that this was because state regulations
required that a chronic pain patient first
undergo a thirty-day regimen with noncontrolled pain medications and that
controlled substances could only be
prescribed upon a determination that
the non-controlled medications were
not effective. Id. at 2; Tr. 3–4 (July 1,
2009). When Rix told Registrant and
M.L.A. that his most recent MRI was
from 2002, both Registrant and M.L.A.
told Rix that he needed a newer MRI
and referred him to a mobile MRI,
which could probably perform the exam
the same day and would charge $250.
Tr. 6 (July 1, 2009). Registrant further
explained that he needed to have
documentation on file to adequately
justify his prescribing of controlled
substances in the event that DEA
investigators inspected the clinic. Id. at
9.
After Registrant exited the room, Rix
asked M.L.A. and another female, M.R.,
whether he could just change the date
on his old MRI. Id. at 11. In response,
M.L.A. offered to sell Rix an MRI, on
which he could change the name and
date, as well as a pharmacy record. Id.
at 11–12. M.R. then asked Rix whether
he currently had controlled substances
or needed some, and offered to sell him
oxycodone 30 mg pills for $10 per pill;
Rix and M.R. agreed that he would buy
50 pills. Id. at 13–16. M.R. then counted
out 53 oxycodone 30 mg pills, put them
in a prescription bottle, and sold them
to Rix for $500. Aff. of TFO 1, at 2. Rix
confirmed with M.L.A. and M.R. that he
would take the MRI and change the
date, but then asked whether someone
would be calling the radiologist to verify
the study. Tr. 17 (July 1, 2009). M.L.A.
assured him that there would be no
problem with the verification, as she
was the individual who verified MRIs.
Id. She also stated that she would take
care of the pharmacy report and that Rix
just needed to alter the name and date
on the MRI and bring it back. Id. at 21.
Rix then stated, ‘‘I’m glad you guys
came back up here[.] I was like you got
to be kidding me with what he was
telling me, I’m like to go through all that
[b.s.], are you kidding.’’ Id. M.L.A.
replied: ‘‘I know I wish you would have
talked to me first, but he was there.’’ Id.
Later, M.L.A. stated that ‘‘[Registrant]
knows, he knows. He’ll write you
whatever you want, but he has to cover
his ass too.’’ Id. at 22. She then added
that Registrant would give Rix up to 240
oxycodone pills. Id.
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On July 13, 2009, Rix returned to SMC
with the altered MRI and an altered
pharmacy profile. Aff. of TFO 1, at 3.
Rix handed the records to M.L.A. and
then met with Registrant in the presence
of his wife, Maria Bulich. Id. Registrant
examined the records and inquired as to
the type of accident that had caused
Rix’s pain. Id. Rix responded that he
had been in a car accident. Id. With
regard to the pharmacy profile,
Registrant told Rix that he would have
to reduce the amount of Xanax he was
taking because it could cause memory
loss. Id. Registrant then stated that he
could not provide that much oxycodone
in 80 mg doses; Rix replied that
oxycodone 30 mg would suffice. Id.
After that, M.L.A. gave Rix a form to
complete, which included a diagram for
specifying the location of his pain and
blanks for noting his pain levels. Id. Rix
did not complete either of these
sections. Id. In the examining room,
Registrant noticed the incomplete form
and asked Rix to complete it. Id.
Although Rix’s MRI indicated that he
had back pain, on the diagram Rix noted
that he had neck pain. Id. Registrant
noticed the discrepancy and changed
the marking on the diagram, explaining
that the medical record needed to match
the MRI to satisfy any inspectors who
might examine the records. Id.
Registrant and Rix then discussed the
number of oxycodone 30 mg pills
Registrant would need to prescribe to
provide the equivalent of the dosages
noted in Rix’s pharmacy profile. Id.; Tr.
31 (July 13, 2009). While Rix’s profile
indicated that he had been taking two
80 mg pills a day (totaling 160 mg per
day), Registrant offered to prescribe six
tablets of oxycodone 30 mg per day
(totaling 180 mg per day). Tr. 31 (July
13, 2009). The conversation then turned
to Xanax, with Rix stating that he was
not ‘‘especially interested’’ in the drug.
Aff. of TFO 1, at 3–4; Tr. 32–33 (July 13,
2009).
Rix then asked Registrant what he
should write on the forms so that his
medical record would look legitimate to
the inspectors. Aff. of TFO 1, at 4.
According to Rix, Registrant instructed
him to write false information, such as
that Rix could not lift more than twenty
pounds even though he had told
Registrant that he was a personal trainer
who frequently lifted weights. Id.; Tr. 36
(July 13, 2009). As to a question
regarding whether he exercised,
Registrant told Rix that ‘‘you don’t want
to compromise yourself’’ and to ‘‘just put
down swimming and walking’’ because
‘‘any kind of catch word * * * they get
hang [sic] up on.’’ Tr. 37 (July 13, 2009).
Registrant and Rix then went through
the questions on the form together, and
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Registrant conducted a brief physical
examination of Rix. Id. at 35–45, 48–49.
Rix deliberately followed Registrant’s
instructions without complaining of any
problems and said that he felt ‘‘stiff’’ but
that he had no pain. Aff. of TFO 1, at
4. As to his pain rating, Registrant
explained that ‘‘nine is after you had an
operation, right after.’’ Tr. 36 (July 13,
2009). After Rix responded, ‘‘Okay so I
don’t have an operation,’’ Registrant
stated, ‘‘I’d say about seven or eight
maybe you know * * * Ah without the
medicines.’’ Id.
Rix then read one of the form’s
questions to Registrant: ‘‘Rate your pain
by circling the number that best
describes your pain at its worst at the
last of the month’’ and asked ‘‘is that
where I put seven or eight?’’ Id. at 38.
Registrant stated, ‘‘actually no.’’ Id. He
then explained, ‘‘you were helped with
medication so.’’ Id. Proceeding to the
next question, which asked about his
pain level ‘‘on average,’’ Rix asked
whether that should be ‘‘four.’’ Id.
Registrant answered, ‘‘Yeah five or
something like that.’’ Id.
When Registrant asked whether he
had pain radiating down his legs, Rix
replied ‘‘no.’’ Id. at 40. Registrant then
told Rix that ‘‘I would not want to put
down good or poor, just fair.’’ Id. Next,
Registrant had Rix bend at his waist and
said, ‘‘Okay this is the important thing,
are you on medicines now?’’; Rix
answered in the affirmative. Id. at 43.
Registrant then stated: ‘‘Because today
you are in no pain bending forward
because you are on medicines.’’ Id.
When Registrant had Rix bend to one
side, he stated that he did not have any
pain but was ‘‘[j]ust tight.’’ Id. at 44.
Registrant had Rix place his arms on his
hips and then turn, at which point Rix
again reported having ‘‘[t]ightness.’’ Id.
Registrant then coached Rix: ‘‘No use the
correct word, pain,’’ and explained that
tightness ‘‘does not qualify pain
medicine.’’ Id. Rix then reported pain,
and Registrant commented, ‘‘Don’t
confuse the inspectors with anything.’’
Id.
Registrant and Rix then discussed the
latter’s occupation as a personal trainer.
When Rix asked ‘‘Can we scratch that
out[?],’’ Registrant replied, ‘‘No that’s
fine * * * but ah you must say that you
don’t do anything, any heavy lifting.’’ Id.
at 45. Rix then said ‘‘I just instruct,’’ and
Registrant replied, ‘‘Yeah you instruct.’’
Id.
As the appointment neared its end,
Rix asked Registrant whether he had a
referral program and suggested that he
could refer people to him. Id. at 53.
Registrant said ‘‘sure,’’ but that ‘‘they
have to qualify of course.’’ Id.
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At the conclusion of the visit,
Registrant issued Rix three
prescriptions: One for 180 oxycodone 30
mg, One for 90 oxycodone 15 mg, and
one for 30 alprazolam (Xanax) 2 mg. Aff.
of TFO 1, at 4. Registrant then gave the
prescriptions to his wife, who filled
them and collected $740 from Rix for
both the examination and the
medication. Id. Ms. Bulich indicated
that she would pay Rix $20 for each
new patient he referred. Id.; Tr. 61 (July
13, 2009). In his affidavit, the TFO
summarized his visit stating that ‘‘[t]he
entire process was one in which
[Registrant] coached or led me into
giving answers that would qualify me to
receive pain medication, not as an
examination oriented toward
determining my medical condition and
needs.’’ Aff. of TFO 1, at 4.
On July 30, 2009, another TFO visited
Registrant using the name of Keith E.
Anderson. Aff. of TFO 2, at 1. On
entering the clinic, Anderson met
M.L.A. and told her that ‘‘Bill’’ had
referred him. Aff. of TFO 2, at 1–2.
Anderson brought with him an MRI
report and a pharmacy profile which
were copies of the ones that Rix had
received from M.L.A. on July 1, 2009,
but which were altered to state that they
were Anderson’s. Id. at 2. Another
female employee, whose name is
unknown, then gave Anderson a
medical form to complete; however, he
left much of it blank. Id.
While in Registrant’s office, Registrant
asked Anderson what kind of accident
he had had; Anderson stated that he had
been in a car accident. Id. Anderson
then told Registrant that he wanted his
help in completing the medical form ‘‘so
that [they] would not get in trouble with
the inspectors.’’ Id. As the two discussed
the forms, Registrant asked Anderson
what drugs he had been taking and
advised him to stop taking Soma and to
reduce the amount of Xanax. Id.
Registrant filled out the form and told
Anderson ‘‘you do not lift more than 15
pounds’’ and that ‘‘no heavy lifting [was]
allowed.’’ Id. He also calculated ‘‘how
many oxycodone 30 mg pills he should
prescribe to be equivalent to the 80 mg
pills reflected in the pharmacy profile.’’
Id. Registrant further ‘‘commented about
being careful about inspectors who
would look at the paperwork.’’ Id.
During the visit, Registrant
administered several movement tests on
Anderson. Id. Anderson stated that
‘‘[w]hen [he] said [he] had ‘a little pain,’
or ‘no pain,’ [Registrant] said that ‘if you
had no medicines, you would have
pain?’ ’’ Id. According to the TFO, ‘‘[t]he
effect of the conversation was to coach
me on how to respond in order to
receive the pain killers I wanted.’’ Id.
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Registrant issued Anderson
prescriptions for 60 oxycodone 30 mg,
30 Xanax 2 mg, and 120 Percocet 10/325
mg. Id. at 2–3. Registrant then gave the
prescriptions to his wife, who filled the
oxycodone and Xanax. Id. at 3.
However, because the clinic did not
have Percocet, Anderson was given the
prescription to fill elsewhere. Id.
Anderson mentioned to both Registrant
and his wife that he had been referred
by ‘‘Bill,’’ ‘‘who ‘should get a kickback’ ’’
for the referral; Registrant’s wife noted
that she would ‘‘take care of it.’’ Id.
Anderson paid a total of $320 for the
visit and the controlled substances. Id.
On August 6, 2009, Rix returned to
SMC, and noted on the medical form
that he ‘‘felt no pain and no interference
with [his] daily activities.’’ Aff. of TFO
1, at 4–5; Tr. 1 (Aug. 6, 2009). Rix asked
Registrant what he could put on the
form to obtain larger quantities of the
drugs. Aff. of TFO 1, at 5. Registrant told
him that his timing was bad because
DEA was increasing its scrutiny of pain
clinics and even sending in undercover
operatives. Id.
Rix and Registrant continued their
discussion of the possibility of
increasing the quantity of the drugs.
Registrant told Rix to fill in a response
to a certain question as ‘‘maybe two or
three you know some back pain’’ so it
would support an increase at the next
visit. Tr. 14 (Aug. 6, 2009). Later, Rix
sought to confirm that circling two or
three on the form ‘‘would give us a
reason to increase [the medications] a
little bit.’’ Id. at 19. Registrant
responded, ‘‘Yeah a little bit but not
necessarily * * * and in case,
depending on the finding in you [sic]
case you know you need.’’ Id. Registrant
then stated that Rix did ‘‘have arthritis,’’
‘‘disk dislocation,’’ ‘‘signs of * * *
trauma,’’ as well as ‘‘pressure on the
nerves,’’ specifically an ‘‘S1 * * * nerve
root abutment’’ that was ‘‘almost a
reason for [an] operation.’’ Id. at 20.
When Rix asked whether he should
have an operation, Registrant said that
he ‘‘wouldn’t do it,’’ and added that
‘‘general statistics show that you should
wait as long as you can before the
surgery because even after the surgery
some things don’t work out’’ and that
the surgery is done when the ‘‘indication
is loss of nerve * * * showing muscle
atrophy.’’ Id. at 20–21. When Rix
explained that he had not marked that
area on the medical form, Registrant
replied, ‘‘well I’ll put lower back
pain.’’ 6 Id. at 22. As the TFO stated in
his Affidavit, ‘‘it was obvious that my
6 By that point, Registrant had apparently taken
over the task of completing the medical form. See
Tr. 15 (Aug. 6, 2009), at 15.
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medical records would contain false
information about fictitious pain.’’ Aff.
of TFO 1, at 5.
The visit concluded with Registrant
issuing prescriptions for 180 oxycodone
30 mg pills, 90 oxycodone 15 mg pills,
and 30 alprazolam 2 mg pills, which
Registrant’s wife filled for Rix. Id. Rix
paid Registrant’s wife $600 after
deducting $20 for referring Anderson.
Id.
On August 19, 2009, Anderson
returned to the clinic (eleven days
before his prescriptions should have run
out) and sought more pain medication.
Aff. of TFO 2, at 3; Tr. 1 (Aug. 19, 2009).
Registrant advised him to ‘‘[t]ry next
week’’ because if the police caught him
with the drugs ‘‘they can make a big
issue * * * out of it.’’ Tr. 1 (Aug. 19,
2009). Anderson stated that he would be
going to Georgia the next day, to which
Registrant stated that ‘‘if they catch you
on the road to Georgia that’s even
worse.’’ Id. at 2. Registrant referred to
the investigation of Michael Jackson’s
doctor and stated that there had been
two recent overdose deaths in Broward
County. Id. Registrant also expressed his
concern that the police would follow
Anderson from the clinic and stop him.
Id. At this visit, Registrant did not write
any prescriptions and told Anderson
that he could come back a few days
early, but he could not come back as
early as he had this time. Aff. of TFO
2, at 3; Tr. 4 (Aug. 19, 2009).
Anderson returned to SMC on August
27, 2009. Aff. of TFO 2, at 3; Tr. 1 (Aug.
27, 2009). Anderson stated that he had
not gone to Georgia, but that he would
be leaving for Georgia imminently and
that he wanted to increase his
medications. Tr. 18 (Aug. 27, 2009).
Registrant replied that it was the
‘‘[w]rong time,’’ and that in the aftermath
of Michael Jackson’s death and the two
recent overdose deaths in Broward
County, ‘‘they have * * * extra workers
inspecting, they got a lot of money from
the government so they’re scrutinizing.’’
Id. at 19.
Anderson told Registrant that he only
wanted oxycodone and Xanax, but not
Soma or Percocet. Id. Anderson further
stated that he had run out of oxycodone
two weeks early and had bought
additional oxycodone from a friend. Id.
at 20–21.
Notwithstanding Anderson’s
statement, Registrant neither counseled
him on the danger of addiction and
abuse or that his purchase of oxycodone
from a friend was illegal. Registrant
agreed to give Anderson 90 oxycodone
30 mg, which was 30 more pills than he
had given him the previous month, and
60 oxycodone 15 mg, which Anderson
had not received at his first
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17:51 Jan 26, 2011
Jkt 223001
appointment. Id. at 22. Although
Registrant stated that he would like to
reduce Anderson’s consumption of
Xanax from 2 mg to 1 mg per day, when
Anderson stated that he ‘‘would rather
have the 2 mill,’’ Registrant relented and
agreed to prescribe the 2 mg strength. Id.
at 23–24.
Registrant then told Anderson that he
needed to complete the medical form,
and Anderson asked ‘‘[w]hat numbers
do I need’’ to put down for his pain
levels. Id. While Registrant told
Anderson that he should ‘‘[b]e honest,’’
Registrant then advised him as to the
value of the various numbers and agreed
to sign after Anderson stated he would
put down seven or eight for his pain
level in the last week. Id. at 25–26. The
visit concluded with Registrant giving
Anderson prescriptions for 90
oxycodone 30 mg, 60 oxycodone 15 mg,
and 30 alprazolam 2 mg, which were
filled by Registrant’s wife and for which
he paid $400. Aff. of TFO 2, at 4. In his
Affidavit, the TFO stated that Registrant
did not do ‘‘any physical tests for pain
response or movement restrictions’’ at
this visit. Id.
On September 10, 2009, Rix returned
to Registrant for the fourth time. Aff. of
TFO 1, at 5; Tr. 1 (Sept. 10, 2009). Rix
told Registrant that he had been out of
town training to become a stunt man, ‘‘a
job obviously incompatible with chronic
pain.’’ Aff. of TFO 1, at 5; Tr. 16 (Sept.
10, 2009). Registrant laughed and said:
‘‘You better keep a secret.’’ Tr. 16 (Sept.
10, 2009). Rix then told Registrant that
he had left the medical form ‘‘blank’’ so
that ‘‘we can increase the medications
because last time I didn’t fill it out
right,’’ to which Registrant did not
directly respond. Id. However, shortly
thereafter Registrant wrote on the form
that Rix stated that he ‘‘ran out of
medication’’ and Registrant offered to
increase the prescription for oxycodone
30 mg from 180 to 210 pills. Id. at 17.
Registrant then stated that while he
would increase the oxycodone, he
would decrease the Xanax from 2 mg
pills to 1 mg pills because ‘‘that makes
[you] look reasonable.’’ Id. at 18.
Next, Rix stated that he would refer a
female client with knee pain. Id. at 19.
Registrant stated that low back pain
would be more ‘‘substantial’’ and that
she could get an MRI done for just $250
at a couple of places. Id. Registrant told
Rix that a new law passed in February
would require that she be put on noncontrolled substances unless she could
present a pharmacy profile that showed
she was already receiving controlled
substances. Id. at 19–20.
Rix replied that the woman had said
she had used controlled substances and
that he had given her several of his
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
4943
oxycodone 15 mg pills, which she
‘‘tried’’ and reported feeling ‘‘good.’’ Id.
at 20. Registrant did not, however, tell
Rix not to share his medication. See id.
Rix then stated that he had only given
the woman five oxycodone 15 mg pills,
that he did not know ‘‘how she took em
when she did it,’’ and that ‘‘she said they
helped.’’ Id. at 21. Registrant replied,
‘‘No of course we will cover you, you
know, but the question is does she
* * * need that much.’’ Id.
Registrant then noticed that Rix had
left blank a certain question on the
medical form and mentioned it to Rix.
Id. at 23. Rix responded, ‘‘No remember
you told me last time to leave that blank
because I filled it out incorrectly where
you said it couldn’t increase the
medicines.’’ Id. at 24. Registrant replied:
‘‘If you could be thinking, insomnia.’’ Id.
Although Rix stated that he absolutely
did not have insomnia, Registrant
stated, ‘‘With Xanax, let’s put down’’
insomnia. Id.
Registrant then asked Rix to rate
numerically how his pain had affected
his general activity in the prior week. Id.
Rix answered that his pain did not
interfere, ‘‘but that’s where you told me
we had to be careful because we
couldn’t increase’’ the drugs. Id.
Continuing, Rix stated that ‘‘I put it
didn’t interfere at all last time and you
said you could not increase [the drugs]
because it said it does not interfere [and]
I think you said last time to put three
or four.’’ Registrant responded, ‘‘Okay so
three, mood about two?’’ Id.
The conversation then returned to
Rix’s having gone to a school for stunt
men and his purported bad back.
Registrant stated, ‘‘Oh I’m telling you
* * * I shouldn’t even know about it.’’
Id. at 26. Registrant then said that
‘‘sometimes there will be people coming
in here,’’ specifically undercover
officers. Id. at 28. Laughing, he stated
that the undercover officers were ‘‘trying
to provoke’’ him. Id. As they continued
to discuss Rix’s work as a stunt man,
Rix assured Registrant that he would not
do any such work in Florida. Id.
Registrant then stated that ‘‘they could
accuse’’ Rix of something and that the
authorities might say that ‘‘your MRI is
fake.’’ Id. at 30.
Registrant then issued Rix
prescriptions for 210 oxycodone 30 mg,
90 oxycodone 15 mg, and 30 Xanax
(alprazolam) 1 mg, which were
dispensed by the former’s wife. Aff. of
TFO 1, at 5. Rix paid $678 for the
controlled substances and the visit. Id.
at 5–6.
On January 7, 2010, a Federal Grand
Jury indicted Registrant. United States
v. Algirdas Krisciunas et al., No. 10–
60007–CR (S.D. Fla. Jan. 7, 2010)
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Federal Register / Vol. 76, No. 18 / Thursday, January 27, 2011 / Notices
(Indictment). The indictment charged
Registrant with one count of conspiring
with M.L.A. and M.I.R. (two of the
clinic’s staff) to distribute oxycodone, a
controlled substance, ‘‘[f]rom on or
before June 29, 2009 to on or about
September 9, 2009,’’ in violation of 21
U.S.C. 841(a)(1) and 846. Id. The
indictment further charged Registrant
with five counts of dispensing
oxycodone (on July 13 and 30, August
6 and 27, and September 9, 2009), a
controlled substance, in violation of 21
U.S.C. 841(a)(1). Id.
On March 11, 2010, a Federal Grand
Jury issued a superseding indictment.
United States v. Algirdas Krisciunas and
Maria Teresa Bulich, Superseding
Indictment (S.D. Fla. Mar. 11, 2010), No.
10–60007–CR–HURLEY(s). The new
indictment charged Registrant and his
wife with conspiring to unlawfully
dispense oxycodone; it also charged
Registrant and his wife with unlawfully
dispensing oxycodone on each of the
five dates as charged in the initial
indictment. Id. at 1–3 (citing 21 U.S.C.
841(a)(1), 846).
Thereafter, Registrant went to trial.
On July 6, 2010, a jury found Registrant
guilty on all six counts. U.S. v. Algirdas
Krisciunas, Verdict (July 6, 2010). On
October 13, 2010, the District Court
entered its Judgment adjudicating
Registrant guilty on all six counts and
sentenced him to 97 months
imprisonment to be followed by three
years of supervised release. U.S. v.
Algirdas Krisciunas, Judgment (Oct. 13,
2010).
Based on Registrant’s convictions, on
August 20, 2010, the Florida Surgeon
General ordered the summary
suspension of his medical license. Order
of Emergency Suspension of License, at
2–3 (citing Fla. Stat. § 456.074(1)).
mstockstill on DSKH9S0YB1PROD with NOTICES
Discussion
Section 304(a) of the CSA provides
that a ‘‘registration pursuant to section
823 of this title to * * * dispense a
controlled substance * * * may be
suspended or revoked by the Attorney
General upon a finding that the
registrant * * * has been convicted of
a felony under this subchapter or
subchapter II of this chapter * * *
relating to any substance defined in this
subchapter as a controlled substance.’’
21 U.S.C. 824(a)(2). Section 304(a)
further provides that a registration may
be revoked or suspended where a
registrant ‘‘has had his State license or
registration suspended, revoked, or
denied by competent State authority
and is no longer authorized by State law
VerDate Mar<15>2010
17:51 Jan 26, 2011
Jkt 223001
to engage in the * * * dispensing of
controlled substances.’’ 7 Id. § 842(a)(3).
As found above, the United States
District Court has adjudicated Registrant
guilty of one count of conspiring to
unlawfully distribute oxycodone, a
schedule II controlled substance, in
violation of 21 U.S.C. 846, and five
counts of unlawfully dispensing
oxycodone, in violation of 21 U.S.C.
841(a)(1). Both provisions are felonies
under the CSA. See 21 U.S.C.
841(b)(1)(C) (except as otherwise
provided, ‘‘[i]n the case of a controlled
substance in schedule I or II * * * such
person shall be sentenced to a term of
imprisonment of not more than 20
years’’); id. § 846 (‘‘Any person who
* * * conspires to commit any offense
defined in this subchapter shall be
subject to the same penalties as those
prescribed for the offense, the
commission of which was the object of
the * * * conspiracy.’’). Registrant’s
convictions for these offenses provide
reason alone to revoke his registration
and denied any pending applications.
21 U.S.C. 824(a)(2).
I further conclude that Registrant’s
registration should be revoked on the
ground that the State of Florida has
suspended his State medical license and
thus, he no longer has authority to
dispense controlled substances in the
State. 21 U.S.C. 824(a)(3). The CSA
defines the term ‘‘practitioner’’ as a
person ‘‘licensed, registered, or
otherwise permitted, by the United
States or the jurisdiction in which he
practices * * * to distribute, dispense
* * * [or] administer * * * a
controlled substance in the course of
professional practice.’’ Id. § 802(21).
Likewise, the CSA limits registration to
an applicant who is ‘‘authorized to
dispense * * * controlled substances
under the laws of the State in which he
practices.’’ Id. § 823(f). Based on these
provisions, DEA has held repeatedly
that a practitioner whose State authority
to dispense controlled substances has
been suspended or revoked is not
entitled to maintain his CSA
registration. See John B. Freitas, 74 FR
17524, 17525 (2009); Worth S.
Wilkinson, 71 FR 30173 (2006); Stephen
J. Graham, 69 FR 11661, 11662 (2004);
Dominick A. Ricci, 58 FR 51104, 51105
(1993); Bobby Watts, 53 FR 11919,
11920 (1988). I therefore conclude that
7 Section 304(a)(4) also provides for the
suspension or revocation of a registration ‘‘upon a
finding that the registrant * * * has committed
such acts as would render his registration * * *
inconsistent with the public interest as determined
under * * * section’’ 823(f). 21 U.S.C. 824(a)(4). In
light of my finding that Registrant has been
convicted of six felony counts of violating the CSA,
I conclude that it is not necessary to discuss the
applicability of this provision to his misconduct.
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Registrant’s loss of his State authority
provides a further ground to revoke his
registration and to deny any pending
application to renew or modify his
registration.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as by 28 CFR 0.100(b) and 0.104, I order
that DEA Certificate of Registration,
BK4015334, issued to Algirdas J.
Krisciunas, M.D., be, and it hereby is,
revoked. I further order that any
pending application of Algirdas J.
Krisciunas, M.D., to renew or modify his
registration be, and it hereby is, denied.
This Order is effective immediately.8
Dated: January 18, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–1693 Filed 1–26–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2010–0030]
Ionizing Radiation Standard; Extension
of the Office of Management and
Budget’s (OMB) Approval of
Information Collection (Paperwork)
Requirements
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Request for public comments.
AGENCY:
OSHA solicits public
comments concerning its proposal to
extend OMB approval of the
information collection requirements
specified in the Ionizing Radiation
Standard (29 CFR 1910.1096). The
information collection requirements
contained in the Ionizing Radiation
Standard protect workers from the
adverse health effects that may result
from occupational exposure to ionizing
radiation including tissue damage and
cancer.
DATES: Comments must be submitted
(postmarked, sent, or received) by
March 28, 2011.
ADDRESSES: Electronically: You may
submit comments and attachments
electronically at https://
www.regulations.gov, which is the
Federal eRulemaking Portal. Follow the
instructions online for submitting
comments.
SUMMARY:
8 For the same reason that I ordered the
immediate suspension of Registrant’s registration, I
conclude that the public interest requires that this
Order be effective immediately. 21 CFR 1316.67.
E:\FR\FM\27JAN1.SGM
27JAN1
Agencies
[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4940-4944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1693]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Algirdas J. Krisciunas, M.D.; Revocation of Registration
On January 19, 2010, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration (Order) to Algirdas J. Krisciunas, M.D.
(``Registrant''), of Lauderdale Lakes, Florida. The Order proposed the
revocation of Registrant's DEA Certificate of Registration, BK4015334,
and the denial of any applications for renewal or modification of his
registration, on the ground that his ``continued registration is
inconsistent with the public interest, as that term is defined in 21
U.S.C. Sec. 823(f).'' Order, at 1. Based on the allegations presented,
I also concluded that Registrant's continued registration during the
pendency of this proceeding ``constitutes an imminent danger to the
public health and safety'' and immediately suspended his registration.
Id. at 2.
The Order alleged that Registrant was the ``owner of Social Medical
Center (SMC), a pain clinic located at [his] registered location'' and
that he ``issue[d] many purported prescriptions for controlled
substances'' from there. Id. at 1. The Order further alleged that
Registrant ``prescribed and dispensed controlled substances, including
oxycodone \1\ and alprazolam,\2\ to two undercover law enforcement
officers on five different occasions from July 13 through September 10,
2009, in violation of 21 U.S.C. Sec. Sec. 841(a)(1) and 846.'' Id. at
2. The Order also alleged that Registrant and his staff ``falsified
medical records for the two undercover officers'' and that Registrant
``advised the undercover officers how to falsify medical records to
make it appear that they had legitimate medical conditions warranting
the use of controlled substances.'' Id. The Order next alleged that
Registrant and his staff ``sold the medical records of others to an
undercover officer so that the records could be altered to appear that
they were the medical records of the undercover officer.'' Id.
---------------------------------------------------------------------------
\1\ Oxycodone is a schedule II controlled substance. 21 CFR
1308.12(b)(1)(xiii).
\2\ Alprazolam is a schedule IV controlled substance. 21 CFR
1308.14(c)(1).
---------------------------------------------------------------------------
The Order further alleged that ``[b]ased on [his] consultations
with, and examinations of, the two undercover officers,'' Registrant
``knew, or should have known, that neither of the undercover officers
had a legitimate medical condition warranting the prescribing of
controlled substances'' because the ``undercover officers provided
inconsistent statements regarding the nature of their alleged injuries
and gave negative answers when queried about any pain they were
experiencing.'' Id. The Order thus alleged that Registrant ``issu[ed]
[controlled substance] prescriptions outside the usual course of
professional practice or for other than a legitimate medical purpose,''
in violation of Federal law. Id. (citing 21 U.S.C. 823(f)(4); 21 CFR
1306.04).
Finally, the Order alleged that on July 1, 2009, Registrant's
``office staff sold 53 oxycodone 30 mg pills to an undercover officer
for $500, in violation of 21 U.S.C. Sec. [] 841(a)(1),'' and that
``[t]his transaction occurred at [his] office during regular business
hours while [he was] on the premises.'' Id. The Order thus alleged that
Registrant ``failed to exercise proper oversight of [his] office staff
or take proper measures to ensure the safeguarding of controlled
substances stored at [his] office.'' Id.
Based on the above, I made the ``preliminary finding that
[Registrant's] continued registration is inconsistent with the public
health and safety.'' Id. (citing 21 U.S.C. 823(f), 824(a)(4)). Having
concluded that Registrant's ``continued registration while these
proceedings are pending constitutes an imminent danger to the public
health and safety because [he has] repeatedly displayed a willingness
to prescribe widely abused controlled substances for other than a
legitimate medical purpose,'' I further ordered the immediate
suspension of his registration. Id. (citing 21 U.S.C. 824(d); 21 CFR
1301.36(e); 28 CFR 0.100). Id.
On January 20, 2010, the Order, which also notified Registrant of
his rights to either request a hearing or submit a written statement in
lieu of a hearing, the procedures for doing either, and the
consequences for failing to do either, was personally served on
Registrant by a DEA Diversion Investigator. Since the date of service
of
[[Page 4941]]
the Order, more than thirty days have passed and neither Registrant,
nor anyone purporting to represent him, has requested a hearing on the
allegations or submitted a written statement. 21 CFR 1301.43(a)-(c). I
therefore find that Registrant has both waived his right to a hearing
and to submit a written statement, and I issue this Decision and Final
Order based on relevant evidence contained in the Investigative Record
submitted by the Government.\3\ 21 CFR 1301.43(d)-(e). I make the
following findings.
---------------------------------------------------------------------------
\3\ In its Request for Final Agency Action, the Government
argues that revocation is warranted under the additional ground that
Registrant ``has been convicted of a felony under subchapter 1 of
chapter 13, Title 21, United States Code.'' Request for Final Agency
Action, at 4. Thereafter, the Government submitted a First
Supplement to Request for Final Agency Action which argued that
revocation was also warranted because on August 20, 2010, the State
of Florida issued an Order of Emergency Suspension, which
immediately suspended Registrant's medical license and that he no
longer has authority under State law to dispense controlled
substances. First Supplement to Request for Final Agency Action, at
1 (citing 21 U.S.C. 824(a)(3)). Attached to the filing was a copy of
the State order.
Finally, the Government submitted a Second Supplement to
Request for Final Agency Action, which noted that on October 13,
2010, the U.S. District Court for the Southern District of Florida
entered a judgment, which adjudicated Registrant guilty of six
felony counts under the Controlled Substances Act. Attached to the
filing was a copy of the Judgment.
---------------------------------------------------------------------------
Findings
Registrant holds DEA Certificate of Registration, BK4015334, which
authorizes him to dispense as a practitioner controlled substances in
schedules II through V. Cert. of Reg. Hist. (March 18, 2010).
Registrant is registered at the address of 3401 West Oakland Park
Blvd., Lauderdale Lakes, Florida 33311; this address was the location
of a pain clinic which was owned by his wife, Maria Bulich, and which
did business under the name of ``Social Medical Center'' (SMC). Id.;
Aff. of Task Force Officer (TFO) 1, at 1, 3.
On July 1, 2009, a Broward County Sheriff's Office detective
assigned to a DEA Task Force attempted an undercover buy at SMC. Using
the name Bill Rix,\4\ the detective posed as a personal trainer who had
recently moved to the area and who ``needed a supplier of pain medicine
due to discomfort from an old auto accident.'' \5\ Aff. of TFO1, at 1.
---------------------------------------------------------------------------
\4\ Throughout this decision, each TFO's assumed name is used
interchangeably with the titles of TFO 1 and TFO 2.
\5\ The officer wore a wire during the visit to record it; the
recording was later transcribed.
---------------------------------------------------------------------------
Immediately on entering SMC, Rix met both Registrant and his
receptionist, M.L.A. Id. M.L.A told Rix that, to obtain controlled
substances from Registrant, he would need an MRI report (to show ``the
nature and location of chronic pain-causing injuries'') and a pharmacy
drug profile (to ``show the drugs the patient has been receiving'').
Registrant stated that this was because state regulations required that
a chronic pain patient first undergo a thirty-day regimen with non-
controlled pain medications and that controlled substances could only
be prescribed upon a determination that the non-controlled medications
were not effective. Id. at 2; Tr. 3-4 (July 1, 2009). When Rix told
Registrant and M.L.A. that his most recent MRI was from 2002, both
Registrant and M.L.A. told Rix that he needed a newer MRI and referred
him to a mobile MRI, which could probably perform the exam the same day
and would charge $250. Tr. 6 (July 1, 2009). Registrant further
explained that he needed to have documentation on file to adequately
justify his prescribing of controlled substances in the event that DEA
investigators inspected the clinic. Id. at 9.
After Registrant exited the room, Rix asked M.L.A. and another
female, M.R., whether he could just change the date on his old MRI. Id.
at 11. In response, M.L.A. offered to sell Rix an MRI, on which he
could change the name and date, as well as a pharmacy record. Id. at
11-12. M.R. then asked Rix whether he currently had controlled
substances or needed some, and offered to sell him oxycodone 30 mg
pills for $10 per pill; Rix and M.R. agreed that he would buy 50 pills.
Id. at 13-16. M.R. then counted out 53 oxycodone 30 mg pills, put them
in a prescription bottle, and sold them to Rix for $500. Aff. of TFO 1,
at 2. Rix confirmed with M.L.A. and M.R. that he would take the MRI and
change the date, but then asked whether someone would be calling the
radiologist to verify the study. Tr. 17 (July 1, 2009). M.L.A. assured
him that there would be no problem with the verification, as she was
the individual who verified MRIs. Id. She also stated that she would
take care of the pharmacy report and that Rix just needed to alter the
name and date on the MRI and bring it back. Id. at 21.
Rix then stated, ``I'm glad you guys came back up here[.] I was
like you got to be kidding me with what he was telling me, I'm like to
go through all that [b.s.], are you kidding.'' Id. M.L.A. replied: ``I
know I wish you would have talked to me first, but he was there.'' Id.
Later, M.L.A. stated that ``[Registrant] knows, he knows. He'll write
you whatever you want, but he has to cover his ass too.'' Id. at 22.
She then added that Registrant would give Rix up to 240 oxycodone
pills. Id.
On July 13, 2009, Rix returned to SMC with the altered MRI and an
altered pharmacy profile. Aff. of TFO 1, at 3. Rix handed the records
to M.L.A. and then met with Registrant in the presence of his wife,
Maria Bulich. Id. Registrant examined the records and inquired as to
the type of accident that had caused Rix's pain. Id. Rix responded that
he had been in a car accident. Id. With regard to the pharmacy profile,
Registrant told Rix that he would have to reduce the amount of Xanax he
was taking because it could cause memory loss. Id. Registrant then
stated that he could not provide that much oxycodone in 80 mg doses;
Rix replied that oxycodone 30 mg would suffice. Id.
After that, M.L.A. gave Rix a form to complete, which included a
diagram for specifying the location of his pain and blanks for noting
his pain levels. Id. Rix did not complete either of these sections. Id.
In the examining room, Registrant noticed the incomplete form and asked
Rix to complete it. Id. Although Rix's MRI indicated that he had back
pain, on the diagram Rix noted that he had neck pain. Id. Registrant
noticed the discrepancy and changed the marking on the diagram,
explaining that the medical record needed to match the MRI to satisfy
any inspectors who might examine the records. Id.
Registrant and Rix then discussed the number of oxycodone 30 mg
pills Registrant would need to prescribe to provide the equivalent of
the dosages noted in Rix's pharmacy profile. Id.; Tr. 31 (July 13,
2009). While Rix's profile indicated that he had been taking two 80 mg
pills a day (totaling 160 mg per day), Registrant offered to prescribe
six tablets of oxycodone 30 mg per day (totaling 180 mg per day). Tr.
31 (July 13, 2009). The conversation then turned to Xanax, with Rix
stating that he was not ``especially interested'' in the drug. Aff. of
TFO 1, at 3-4; Tr. 32-33 (July 13, 2009).
Rix then asked Registrant what he should write on the forms so that
his medical record would look legitimate to the inspectors. Aff. of TFO
1, at 4. According to Rix, Registrant instructed him to write false
information, such as that Rix could not lift more than twenty pounds
even though he had told Registrant that he was a personal trainer who
frequently lifted weights. Id.; Tr. 36 (July 13, 2009). As to a
question regarding whether he exercised, Registrant told Rix that ``you
don't want to compromise yourself'' and to ``just put down swimming and
walking'' because ``any kind of catch word * * * they get hang [sic] up
on.'' Tr. 37 (July 13, 2009).
Registrant and Rix then went through the questions on the form
together, and
[[Page 4942]]
Registrant conducted a brief physical examination of Rix. Id. at 35-45,
48-49. Rix deliberately followed Registrant's instructions without
complaining of any problems and said that he felt ``stiff'' but that he
had no pain. Aff. of TFO 1, at 4. As to his pain rating, Registrant
explained that ``nine is after you had an operation, right after.'' Tr.
36 (July 13, 2009). After Rix responded, ``Okay so I don't have an
operation,'' Registrant stated, ``I'd say about seven or eight maybe
you know * * * Ah without the medicines.'' Id.
Rix then read one of the form's questions to Registrant: ``Rate
your pain by circling the number that best describes your pain at its
worst at the last of the month'' and asked ``is that where I put seven
or eight?'' Id. at 38. Registrant stated, ``actually no.'' Id. He then
explained, ``you were helped with medication so.'' Id. Proceeding to
the next question, which asked about his pain level ``on average,'' Rix
asked whether that should be ``four.'' Id. Registrant answered, ``Yeah
five or something like that.'' Id.
When Registrant asked whether he had pain radiating down his legs,
Rix replied ``no.'' Id. at 40. Registrant then told Rix that ``I would
not want to put down good or poor, just fair.'' Id. Next, Registrant
had Rix bend at his waist and said, ``Okay this is the important thing,
are you on medicines now?''; Rix answered in the affirmative. Id. at
43. Registrant then stated: ``Because today you are in no pain bending
forward because you are on medicines.'' Id.
When Registrant had Rix bend to one side, he stated that he did not
have any pain but was ``[j]ust tight.'' Id. at 44. Registrant had Rix
place his arms on his hips and then turn, at which point Rix again
reported having ``[t]ightness.'' Id. Registrant then coached Rix: ``No
use the correct word, pain,'' and explained that tightness ``does not
qualify pain medicine.'' Id. Rix then reported pain, and Registrant
commented, ``Don't confuse the inspectors with anything.'' Id.
Registrant and Rix then discussed the latter's occupation as a
personal trainer. When Rix asked ``Can we scratch that out[?],''
Registrant replied, ``No that's fine * * * but ah you must say that you
don't do anything, any heavy lifting.'' Id. at 45. Rix then said ``I
just instruct,'' and Registrant replied, ``Yeah you instruct.'' Id.
As the appointment neared its end, Rix asked Registrant whether he
had a referral program and suggested that he could refer people to him.
Id. at 53. Registrant said ``sure,'' but that ``they have to qualify of
course.'' Id.
At the conclusion of the visit, Registrant issued Rix three
prescriptions: One for 180 oxycodone 30 mg, One for 90 oxycodone 15 mg,
and one for 30 alprazolam (Xanax) 2 mg. Aff. of TFO 1, at 4. Registrant
then gave the prescriptions to his wife, who filled them and collected
$740 from Rix for both the examination and the medication. Id. Ms.
Bulich indicated that she would pay Rix $20 for each new patient he
referred. Id.; Tr. 61 (July 13, 2009). In his affidavit, the TFO
summarized his visit stating that ``[t]he entire process was one in
which [Registrant] coached or led me into giving answers that would
qualify me to receive pain medication, not as an examination oriented
toward determining my medical condition and needs.'' Aff. of TFO 1, at
4.
On July 30, 2009, another TFO visited Registrant using the name of
Keith E. Anderson. Aff. of TFO 2, at 1. On entering the clinic,
Anderson met M.L.A. and told her that ``Bill'' had referred him. Aff.
of TFO 2, at 1-2. Anderson brought with him an MRI report and a
pharmacy profile which were copies of the ones that Rix had received
from M.L.A. on July 1, 2009, but which were altered to state that they
were Anderson's. Id. at 2. Another female employee, whose name is
unknown, then gave Anderson a medical form to complete; however, he
left much of it blank. Id.
While in Registrant's office, Registrant asked Anderson what kind
of accident he had had; Anderson stated that he had been in a car
accident. Id. Anderson then told Registrant that he wanted his help in
completing the medical form ``so that [they] would not get in trouble
with the inspectors.'' Id. As the two discussed the forms, Registrant
asked Anderson what drugs he had been taking and advised him to stop
taking Soma and to reduce the amount of Xanax. Id.
Registrant filled out the form and told Anderson ``you do not lift
more than 15 pounds'' and that ``no heavy lifting [was] allowed.'' Id.
He also calculated ``how many oxycodone 30 mg pills he should prescribe
to be equivalent to the 80 mg pills reflected in the pharmacy
profile.'' Id. Registrant further ``commented about being careful about
inspectors who would look at the paperwork.'' Id.
During the visit, Registrant administered several movement tests on
Anderson. Id. Anderson stated that ``[w]hen [he] said [he] had `a
little pain,' or `no pain,' [Registrant] said that `if you had no
medicines, you would have pain?' '' Id. According to the TFO, ``[t]he
effect of the conversation was to coach me on how to respond in order
to receive the pain killers I wanted.'' Id.
Registrant issued Anderson prescriptions for 60 oxycodone 30 mg, 30
Xanax 2 mg, and 120 Percocet 10/325 mg. Id. at 2-3. Registrant then
gave the prescriptions to his wife, who filled the oxycodone and Xanax.
Id. at 3. However, because the clinic did not have Percocet, Anderson
was given the prescription to fill elsewhere. Id. Anderson mentioned to
both Registrant and his wife that he had been referred by ``Bill,''
``who `should get a kickback' '' for the referral; Registrant's wife
noted that she would ``take care of it.'' Id. Anderson paid a total of
$320 for the visit and the controlled substances. Id.
On August 6, 2009, Rix returned to SMC, and noted on the medical
form that he ``felt no pain and no interference with [his] daily
activities.'' Aff. of TFO 1, at 4-5; Tr. 1 (Aug. 6, 2009). Rix asked
Registrant what he could put on the form to obtain larger quantities of
the drugs. Aff. of TFO 1, at 5. Registrant told him that his timing was
bad because DEA was increasing its scrutiny of pain clinics and even
sending in undercover operatives. Id.
Rix and Registrant continued their discussion of the possibility of
increasing the quantity of the drugs. Registrant told Rix to fill in a
response to a certain question as ``maybe two or three you know some
back pain'' so it would support an increase at the next visit. Tr. 14
(Aug. 6, 2009). Later, Rix sought to confirm that circling two or three
on the form ``would give us a reason to increase [the medications] a
little bit.'' Id. at 19. Registrant responded, ``Yeah a little bit but
not necessarily * * * and in case, depending on the finding in you
[sic] case you know you need.'' Id. Registrant then stated that Rix did
``have arthritis,'' ``disk dislocation,'' ``signs of * * * trauma,'' as
well as ``pressure on the nerves,'' specifically an ``S1 * * * nerve
root abutment'' that was ``almost a reason for [an] operation.'' Id. at
20.
When Rix asked whether he should have an operation, Registrant said
that he ``wouldn't do it,'' and added that ``general statistics show
that you should wait as long as you can before the surgery because even
after the surgery some things don't work out'' and that the surgery is
done when the ``indication is loss of nerve * * * showing muscle
atrophy.'' Id. at 20-21. When Rix explained that he had not marked that
area on the medical form, Registrant replied, ``well I'll put lower
back pain.'' \6\ Id. at 22. As the TFO stated in his Affidavit, ``it
was obvious that my
[[Page 4943]]
medical records would contain false information about fictitious
pain.'' Aff. of TFO 1, at 5.
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\6\ By that point, Registrant had apparently taken over the task
of completing the medical form. See Tr. 15 (Aug. 6, 2009), at 15.
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The visit concluded with Registrant issuing prescriptions for 180
oxycodone 30 mg pills, 90 oxycodone 15 mg pills, and 30 alprazolam 2 mg
pills, which Registrant's wife filled for Rix. Id. Rix paid
Registrant's wife $600 after deducting $20 for referring Anderson. Id.
On August 19, 2009, Anderson returned to the clinic (eleven days
before his prescriptions should have run out) and sought more pain
medication. Aff. of TFO 2, at 3; Tr. 1 (Aug. 19, 2009). Registrant
advised him to ``[t]ry next week'' because if the police caught him
with the drugs ``they can make a big issue * * * out of it.'' Tr. 1
(Aug. 19, 2009). Anderson stated that he would be going to Georgia the
next day, to which Registrant stated that ``if they catch you on the
road to Georgia that's even worse.'' Id. at 2. Registrant referred to
the investigation of Michael Jackson's doctor and stated that there had
been two recent overdose deaths in Broward County. Id. Registrant also
expressed his concern that the police would follow Anderson from the
clinic and stop him. Id. At this visit, Registrant did not write any
prescriptions and told Anderson that he could come back a few days
early, but he could not come back as early as he had this time. Aff. of
TFO 2, at 3; Tr. 4 (Aug. 19, 2009).
Anderson returned to SMC on August 27, 2009. Aff. of TFO 2, at 3;
Tr. 1 (Aug. 27, 2009). Anderson stated that he had not gone to Georgia,
but that he would be leaving for Georgia imminently and that he wanted
to increase his medications. Tr. 18 (Aug. 27, 2009). Registrant replied
that it was the ``[w]rong time,'' and that in the aftermath of Michael
Jackson's death and the two recent overdose deaths in Broward County,
``they have * * * extra workers inspecting, they got a lot of money
from the government so they're scrutinizing.'' Id. at 19.
Anderson told Registrant that he only wanted oxycodone and Xanax,
but not Soma or Percocet. Id. Anderson further stated that he had run
out of oxycodone two weeks early and had bought additional oxycodone
from a friend. Id. at 20-21.
Notwithstanding Anderson's statement, Registrant neither counseled
him on the danger of addiction and abuse or that his purchase of
oxycodone from a friend was illegal. Registrant agreed to give Anderson
90 oxycodone 30 mg, which was 30 more pills than he had given him the
previous month, and 60 oxycodone 15 mg, which Anderson had not received
at his first appointment. Id. at 22. Although Registrant stated that he
would like to reduce Anderson's consumption of Xanax from 2 mg to 1 mg
per day, when Anderson stated that he ``would rather have the 2 mill,''
Registrant relented and agreed to prescribe the 2 mg strength. Id. at
23-24.
Registrant then told Anderson that he needed to complete the
medical form, and Anderson asked ``[w]hat numbers do I need'' to put
down for his pain levels. Id. While Registrant told Anderson that he
should ``[b]e honest,'' Registrant then advised him as to the value of
the various numbers and agreed to sign after Anderson stated he would
put down seven or eight for his pain level in the last week. Id. at 25-
26. The visit concluded with Registrant giving Anderson prescriptions
for 90 oxycodone 30 mg, 60 oxycodone 15 mg, and 30 alprazolam 2 mg,
which were filled by Registrant's wife and for which he paid $400. Aff.
of TFO 2, at 4. In his Affidavit, the TFO stated that Registrant did
not do ``any physical tests for pain response or movement
restrictions'' at this visit. Id.
On September 10, 2009, Rix returned to Registrant for the fourth
time. Aff. of TFO 1, at 5; Tr. 1 (Sept. 10, 2009). Rix told Registrant
that he had been out of town training to become a stunt man, ``a job
obviously incompatible with chronic pain.'' Aff. of TFO 1, at 5; Tr. 16
(Sept. 10, 2009). Registrant laughed and said: ``You better keep a
secret.'' Tr. 16 (Sept. 10, 2009). Rix then told Registrant that he had
left the medical form ``blank'' so that ``we can increase the
medications because last time I didn't fill it out right,'' to which
Registrant did not directly respond. Id. However, shortly thereafter
Registrant wrote on the form that Rix stated that he ``ran out of
medication'' and Registrant offered to increase the prescription for
oxycodone 30 mg from 180 to 210 pills. Id. at 17. Registrant then
stated that while he would increase the oxycodone, he would decrease
the Xanax from 2 mg pills to 1 mg pills because ``that makes [you] look
reasonable.'' Id. at 18.
Next, Rix stated that he would refer a female client with knee
pain. Id. at 19. Registrant stated that low back pain would be more
``substantial'' and that she could get an MRI done for just $250 at a
couple of places. Id. Registrant told Rix that a new law passed in
February would require that she be put on non-controlled substances
unless she could present a pharmacy profile that showed she was already
receiving controlled substances. Id. at 19-20.
Rix replied that the woman had said she had used controlled
substances and that he had given her several of his oxycodone 15 mg
pills, which she ``tried'' and reported feeling ``good.'' Id. at 20.
Registrant did not, however, tell Rix not to share his medication. See
id. Rix then stated that he had only given the woman five oxycodone 15
mg pills, that he did not know ``how she took em when she did it,'' and
that ``she said they helped.'' Id. at 21. Registrant replied, ``No of
course we will cover you, you know, but the question is does she * * *
need that much.'' Id.
Registrant then noticed that Rix had left blank a certain question
on the medical form and mentioned it to Rix. Id. at 23. Rix responded,
``No remember you told me last time to leave that blank because I
filled it out incorrectly where you said it couldn't increase the
medicines.'' Id. at 24. Registrant replied: ``If you could be thinking,
insomnia.'' Id. Although Rix stated that he absolutely did not have
insomnia, Registrant stated, ``With Xanax, let's put down'' insomnia.
Id.
Registrant then asked Rix to rate numerically how his pain had
affected his general activity in the prior week. Id. Rix answered that
his pain did not interfere, ``but that's where you told me we had to be
careful because we couldn't increase'' the drugs. Id. Continuing, Rix
stated that ``I put it didn't interfere at all last time and you said
you could not increase [the drugs] because it said it does not
interfere [and] I think you said last time to put three or four.''
Registrant responded, ``Okay so three, mood about two?'' Id.
The conversation then returned to Rix's having gone to a school for
stunt men and his purported bad back. Registrant stated, ``Oh I'm
telling you * * * I shouldn't even know about it.'' Id. at 26.
Registrant then said that ``sometimes there will be people coming in
here,'' specifically undercover officers. Id. at 28. Laughing, he
stated that the undercover officers were ``trying to provoke'' him. Id.
As they continued to discuss Rix's work as a stunt man, Rix assured
Registrant that he would not do any such work in Florida. Id.
Registrant then stated that ``they could accuse'' Rix of something and
that the authorities might say that ``your MRI is fake.'' Id. at 30.
Registrant then issued Rix prescriptions for 210 oxycodone 30 mg,
90 oxycodone 15 mg, and 30 Xanax (alprazolam) 1 mg, which were
dispensed by the former's wife. Aff. of TFO 1, at 5. Rix paid $678 for
the controlled substances and the visit. Id. at 5-6.
On January 7, 2010, a Federal Grand Jury indicted Registrant.
United States v. Algirdas Krisciunas et al., No. 10-60007-CR (S.D. Fla.
Jan. 7, 2010)
[[Page 4944]]
(Indictment). The indictment charged Registrant with one count of
conspiring with M.L.A. and M.I.R. (two of the clinic's staff) to
distribute oxycodone, a controlled substance, ``[f]rom on or before
June 29, 2009 to on or about September 9, 2009,'' in violation of 21
U.S.C. 841(a)(1) and 846. Id. The indictment further charged Registrant
with five counts of dispensing oxycodone (on July 13 and 30, August 6
and 27, and September 9, 2009), a controlled substance, in violation of
21 U.S.C. 841(a)(1). Id.
On March 11, 2010, a Federal Grand Jury issued a superseding
indictment. United States v. Algirdas Krisciunas and Maria Teresa
Bulich, Superseding Indictment (S.D. Fla. Mar. 11, 2010), No. 10-60007-
CR-HURLEY(s). The new indictment charged Registrant and his wife with
conspiring to unlawfully dispense oxycodone; it also charged Registrant
and his wife with unlawfully dispensing oxycodone on each of the five
dates as charged in the initial indictment. Id. at 1-3 (citing 21
U.S.C. 841(a)(1), 846).
Thereafter, Registrant went to trial. On July 6, 2010, a jury found
Registrant guilty on all six counts. U.S. v. Algirdas Krisciunas,
Verdict (July 6, 2010). On October 13, 2010, the District Court entered
its Judgment adjudicating Registrant guilty on all six counts and
sentenced him to 97 months imprisonment to be followed by three years
of supervised release. U.S. v. Algirdas Krisciunas, Judgment (Oct. 13,
2010).
Based on Registrant's convictions, on August 20, 2010, the Florida
Surgeon General ordered the summary suspension of his medical license.
Order of Emergency Suspension of License, at 2-3 (citing Fla. Stat.
Sec. 456.074(1)).
Discussion
Section 304(a) of the CSA provides that a ``registration pursuant
to section 823 of this title to * * * dispense a controlled substance *
* * may be suspended or revoked by the Attorney General upon a finding
that the registrant * * * has been convicted of a felony under this
subchapter or subchapter II of this chapter * * * relating to any
substance defined in this subchapter as a controlled substance.'' 21
U.S.C. 824(a)(2). Section 304(a) further provides that a registration
may be revoked or suspended where a registrant ``has had his State
license or registration suspended, revoked, or denied by competent
State authority and is no longer authorized by State law to engage in
the * * * dispensing of controlled substances.'' \7\ Id. Sec.
842(a)(3).
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\7\ Section 304(a)(4) also provides for the suspension or
revocation of a registration ``upon a finding that the registrant *
* * has committed such acts as would render his registration * * *
inconsistent with the public interest as determined under * * *
section'' 823(f). 21 U.S.C. 824(a)(4). In light of my finding that
Registrant has been convicted of six felony counts of violating the
CSA, I conclude that it is not necessary to discuss the
applicability of this provision to his misconduct.
---------------------------------------------------------------------------
As found above, the United States District Court has adjudicated
Registrant guilty of one count of conspiring to unlawfully distribute
oxycodone, a schedule II controlled substance, in violation of 21
U.S.C. 846, and five counts of unlawfully dispensing oxycodone, in
violation of 21 U.S.C. 841(a)(1). Both provisions are felonies under
the CSA. See 21 U.S.C. 841(b)(1)(C) (except as otherwise provided,
``[i]n the case of a controlled substance in schedule I or II * * *
such person shall be sentenced to a term of imprisonment of not more
than 20 years''); id. Sec. 846 (``Any person who * * * conspires to
commit any offense defined in this subchapter shall be subject to the
same penalties as those prescribed for the offense, the commission of
which was the object of the * * * conspiracy.''). Registrant's
convictions for these offenses provide reason alone to revoke his
registration and denied any pending applications. 21 U.S.C. 824(a)(2).
I further conclude that Registrant's registration should be revoked
on the ground that the State of Florida has suspended his State medical
license and thus, he no longer has authority to dispense controlled
substances in the State. 21 U.S.C. 824(a)(3). The CSA defines the term
``practitioner'' as a person ``licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices * * * to distribute, dispense * * * [or] administer * * * a
controlled substance in the course of professional practice.'' Id.
Sec. 802(21). Likewise, the CSA limits registration to an applicant
who is ``authorized to dispense * * * controlled substances under the
laws of the State in which he practices.'' Id. Sec. 823(f). Based on
these provisions, DEA has held repeatedly that a practitioner whose
State authority to dispense controlled substances has been suspended or
revoked is not entitled to maintain his CSA registration. See John B.
Freitas, 74 FR 17524, 17525 (2009); Worth S. Wilkinson, 71 FR 30173
(2006); Stephen J. Graham, 69 FR 11661, 11662 (2004); Dominick A.
Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988). I therefore conclude that Registrant's loss of his State
authority provides a further ground to revoke his registration and to
deny any pending application to renew or modify his registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as by 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration, BK4015334, issued to Algirdas J.
Krisciunas, M.D., be, and it hereby is, revoked. I further order that
any pending application of Algirdas J. Krisciunas, M.D., to renew or
modify his registration be, and it hereby is, denied. This Order is
effective immediately.\8\
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\8\ For the same reason that I ordered the immediate suspension
of Registrant's registration, I conclude that the public interest
requires that this Order be effective immediately. 21 CFR 1316.67.
Dated: January 18, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-1693 Filed 1-26-11; 8:45 am]
BILLING CODE 4410-09-P