Registrant Actions - 2012
[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5106-5154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1972]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-20]
Randall L. Wolff, M.D.; Decision and Order
On July 25, 2011, Administrative Law Judge (ALJ) Timothy D. Wing
issued the attached recommended decision (also cited as ALJ).
Respondent filed Exceptions to the ALJ's decision.
Having considered the record in its entirety, as well as
Respondent's Exceptions, I have decided to adopt the ALJ's recommended
ruling, findings of fact and conclusions of law with respect to each of
the five public interest factors excepted as discussed below. While I
reject some of the ALJ's findings of fact and legal conclusions, I
conclude that the record as a whole supports the ALJ's ultimate
conclusion that Respondent's continued registration would be
inconsistent with the public interest and thus will adopt his
recommendation that Respondent's registrations be revoked and that any
pending applications be denied.
The ALJ made extensive findings of fact and legal conclusions with
respect to Respondent's prescribing of controlled substances to eleven
undercover officers (UCs); Respondent saw three of the UCs at a clinic
known as Commercial Medical Group (CMG) and the remaining eight at a
clinic known as Coast to Coast Healthcare Management (CCHM). See ALJ at
10-38; 44-93. With respect to the undercover officers Respondent saw at
Commercial Medical Group, the ALJ found that the Government had not
proved by substantial evidence that Respondent lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice in prescribing oxycodone to Agents Miller and McClairie; with
respect to Agent Bazile, the ALJ found that the Government had not
proved that Respondent's prescription for oxycodone lacked a legitimate
medical purpose but that a prescription he issued for Xanax did. Id. at
92.
With respect to the undercover officers Respondent saw at CCHM, the
ALJ found that the Government had proved by substantial evidence that
Respondent lacked a legitimate medical purpose and acted outside of the
usual course of professional practice in prescribing oxycodone to
Agents Marshall, O'Neil, Doklean, Brigantty, Priymak, Zdrojewski, and
Ryckeley. See id. at 44-92 (citing 21 CFR 1306.04(a)). Moreover, the
ALJ also found that Respondent had violated various provisions of the
State of Florida's Standards for the Use of Controlled Substances for
the Treatment of Pain, Fla. Admin Code 64B8-9.013, in prescribing
controlled substances to each of the aforementioned UCs. See ALJ at 44-
92. However, with respect to Agent Saenz, the ALJ found that while the
Government had proved that Respondent kept inaccurate records in
violation of Florida's regulations, it had not proved that Respondent
lacked a legitimate medical purpose in prescribing controlled
substances to her.
Respondent filed Exceptions, most of which are variations on the
same theme--that the ALJ erred in finding that he lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice. He argues that each of the UCs presented as being "[r]eal
patients," who "[c]omplain[ed] of chronic real pain," which was
"[b]ased on articulable causation." Exceptions at 6. According to
Respondent, the ALJ "fail[ed] to appropriately recognize or
acknowledge that each of the [UCs] presented themselves with valid
Florida driver's licenses, as well as authentic and verified MRI
reports that articulated an objective finding that supported the claim
of pain." Id. at 6-7 (citing various portions of transcript).
Respondent also maintains that he "believed that each [UC] was being
truthful in their claim of real pain," "that the Government failed to
offer any evidence to rebut [his] testimony * * * concerning [his]
basis for writing each of the prescriptions," that he "exercised his
good faith medical judgment that the prescriptions * * * were
appropriate" and that "although presented as 'credibility'
findings[,] the [ALJ's decision] merely disagrees with his professional
judgments [and] crosses outside of the boundary that limits DEA from
substituting its judgment for that of a physician." Id. at 7-9.\1\
Having considered the exceptions, I reject them for the reasons
explained below in my discussion of the evidence pertaining to the
various undercover patients.
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\1\ Respondent also contends that the Government's Expert
"lacked qualifications or expertise and displayed a profound lack
of knowledge concerning applicable Florida medical regulations,
state and federal law, as well as the applicable standard of care."
Id. at 3. It is acknowledged that both the Expert report and
testimony contained several factual inaccuracies and misstated the
law and state standards on several issues.
The record shows that the Government's Expert is a Diplomate of
both the American Board of Anesthesiology and the American Academy
of Pain Management and has twenty years of experience in practicing
pain management. Tr. Vol. 7, at 12. The ALJ thus properly held that
he was qualified to testify as an expert. Id. at 41. I further
conclude that the ALJ properly evaluated the Expert's testimony and
report declining to give weight to both the testimony and the report
when it was factually inaccurate; however, with respect to Agent
Saenz, I conclude that notwithstanding the Expert's factual errors,
other credible testimony supports the conclusion that Respondent
violated 21 CFR 1306.04(a) when he prescribed Roxicodone and Xanax
to her. In the individual patient findings I discuss in more detail
those areas in which the ALJ erred in relying on the Expert's
testimony regarding the requirements of federal and state rules.
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The CCHM UC Patients
SA Marshall was seen by Respondent on two occasions: On April 7 and
May 4, 2010. However, Respondent refused to prescribe to him on the
first occasion, when Marshall stated that he was homeless and lived on
the street, said his pain was "sometimes it's like a three or four * *
* How does it need [to] be?" and added that a person in the lobby had
filled out his intake forms. ALJ at 48 (citing GX 6, at 19-20; Tr. Vol.
4, at 62). Respondent asked "is this a test?" and stated that he
thought it "must be"; he then asked Marshall what being homeless had
to do with needing pain medicine. GX 6, at 19-20. Respondent then
escorted Marshall to the reception area, maintaining that "we don't
participate in such * * * folly" and told a staff member to discharge
Marshall. Id. at 23. However, the staff member told Marshall that she
would alter his chart and reschedule him to see another doctor the next
day. Id. at 25-26. The staff member further told Marshall to "never,
never say that you sell this, that, that on the street, ever. Because
they think that you're an undercover, okay. And that you're trying to
bust his nuts." GX 6, at 26. Marshall returned the next day and
obtained controlled substances from another doctor. Id.
On May 4, 2010, Marshall made another visit to CCHM and saw
Respondent. The interaction lasted less than three minutes. GX 6 (audio
and DVD recordings). After asking Marshall about his age and birthdate,
Respondent questioned him as to how everything was working out for him,
whether he was working, whether the medicine was helping, whether he
was having any complications, whether he was smoking, and if he was
doing any exercises and staying limber; Marshall answered "no" to
each question. GX 6, at 39-40. Respondent then listened to his
breathing and asked him to place his hands out with his palms up, after
which Respondent asked Marshall if he had any back pain. Id. at 40.
When Marshall answered "no," Respondent asked "Mostly in the Neck?"
to which Marshall said "yes." Id. Respondent then asked: "But
overall you are doing
[[Page 5107]]
okay?"; Marshall answered: "Yeah." Id. at 41. Respondent replied:
"That's great," and after apparently asking Marshall to confirm his
date of birth (notwithstanding that he had already asked it), stated:
"Alright, we got you all set." Id. Respondent then issued Marshall a
prescription for 120 dosage units of Roxicodone (oxycodone) 30mg, a
schedule II controlled substance (for a daily dose of 120 mg), and 30
Xanax (alprazolam) 2mg, a schedule IV controlled substance.
It is true that the ALJ credited Respondent's testimony that he did
not recognize Marshall notwithstanding the incident one month earlier.
However, this provides no comfort to Respondent as there is ample
evidence establishing that the prescriptions he issued lacked a
legitimate medical purpose. For example, on the progress note for the
May 4 visit, Respondent noted Marshall's pain level as a "5" with
medication and apparently a "9" without it. GX 21, at 2. Yet there is
no evidence that Respondent, during the brief encounter he had with
Marshall, asked him to rate his pain either with or without medication.
Likewise, on the medical history form, Marshall checked "Yes" for
whether he had emphysema/asthma, bipolar disorder, and recent
depression. Id. 21, at 10. Yet Respondent did not ask Marshall any
questions about these conditions and the chart contained no evidence of
a psychiatric consultation. Tr. Vol. 4, at 37; Vol. 7, at 67. As the
Government's Expert explained: "It's very dangerous to treat people
with depression or bipolar disorder with a combination of [an] opioid
and [a] benzodiazepine, because they potentiate each other, and you
could end up having a patient very, very depressed or even suicidal or
even die accidentally from that combination." Id. at 180.
The Government's Expert further noted that Marshall's file
contained an MRI from two days before his first visit at the CCHM, yet
there was no indication as to which physician had ordered it. Id. at
64; see also GX 21, at 27. Moreover, CCHM's Pain Assessment Form asked:
"What Current medications have you been PRESCRIBED to help your
pain?" GX 21, at 12. Marshall wrote that he was taking Roxicodone
(oxycodone) 30mg, eight times a day; oxycodone 15mg, three times a day;
and Xanax 2mg, two times a day. Id. However, nothing in the file
indicates who had previously prescribed these drugs to Marshall nor
documents how long he had been taking these drugs.
In addition, the Government's Expert noted that although the
records for Marshall's first visit indicated that his cervical spine
was "mildly painful to touch," he was assessed as having "chronic
severe back pain." Id. at 6-7; see also Tr. Vo. 7, at 64. Moreover,
with respect to Marshall's April 8 visit, the Expert observed that the
progress note indicated "yes" for whether his pain was "under
control," yet also included the notation that "pain was not well
controlled [on] present regimen." Tr. Vol. 7, at 69-70; GX 21, at 4.
The Expert further explained that "there were no objective findings *
* * to really substantiate the level of pain" and that there was
"also no mention about the activities that the patient is being
precluded from doing." Tr. Vo. 7, at 70.
According to the Government's Expert, "there is no legitimate
reason[] why a physician would choose to treat a patient with such
large doses of narcotics without going through other channels first,
which would include the review of his prior medical records from
wherever he was treated to other diagnostic tests that may have been
performed to finding out what other drugs had been tried in the past
and mentioning in the history of present illness how they were
effective or not effective in treating this pain" and "getting more
in the way of diagnostics such as x-rays, nerve conduction studies"
and an orthopedic consult. Id. at 116. The Expert further explained
that "[t]here [wa]s nothing * * * that warrants going to the 'big
guns' of narcotics so aggressively and bypassing the conservative
treatment that is recommended in the majority of the places [that]
practice safe medicine." \2\ Id.
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\2\ It is noted that Respondent issued the same prescriptions as
had Dr. C.N. on April 8, 2010, and that Dr. L.C. (another CCHM
doctor) had prescribed 120 Oxycodone 15mg and 30 Xanax 2mg. The fact
that these two physicians also prescribed both oxycodone and Xanax
does not aid Respondent. As the Government's Expert testified, "it
was incumbent upon [Respondent] to do his own assessment * * * and
not just perpetuate narcotic prescriptions where there may have been
other treatments that may have been warranted or may have actually
diminished the patient's need for narcotics." Tr. Vol. 9, at 93.
The Government's Expert further explained it "would not be within
the standard of care in Florida" for a physician to "perpetuate[]
the issuance of controlled substances ordered by another doctor
without first establishing his own valid doctor-patient
relationship." Id. at 135.
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Based on the above, I agree with the ALJ's conclusion that
Respondent acted outside of the usual course of professional practice
and lacked a legitimate medical purpose in prescribing oxycodone and
Xanax to Agent Marshall. ALJ at 51-52. However, because there is no
evidence that Respondent (as opposed to the doctors Marshall saw on his
previous visits) completed the form (GX 21, at 8) in which various
discussion items were checked off but which is neither dated nor
signed, I reject the ALJ's finding that Respondent violated Fla. Admin
Code r. 64B8-9.013(3) by failing to maintain accurate records.
Agent Saenz also visited CCHM on multiple occasions including twice
on March 10, as well as on April 8 and May 4, 2010. GX 24. However,
Agent Saenz did not see Respondent until May 4, 2010. Id. Agent Saenz
testified that she first saw Dr. L.C. on March 10, but he declined to
prescribe to her because "he didn't want [her] to be a drug addict"
and "didn't think [she] needed it." Tr. Vol. 2, at 300. However, her
patient file contains no documentation of Dr. L.C.'s findings. See GX
24.
At her March 10 visit, Agent Saenz presented an MRI which showed
that two posterior discs were bulging and that there was bilateral
neural foraminal narrowing. Id. at 28-29. She also completed a medical
history form in which she checked the "yes" box for whether she had
recent depression, id. at 11; on a pain assessment form she submitted,
Saenz wrote, with the coaching of a CCHM employee (Tr. Vol. 2, at 271),
that her pain was a "9" on a scale of 0 to 10, and that she was
currently being prescribed 240 tablets of Roxicodone 30mg (8 tablets
per day), 40 tablets of oxycodone 15mg (3 tablets per day), and 60
tablets of Zanax[sic] 2mg (2 tablets a day). Id. at 13. However, the
note for Saenz's second visit on March 10, which was with Dr. R.C.,
indicates that her pain did not "irradiate" [sic], that it did not
interfere with her daily activities, that she did not need medication
to function or work, and that her pain was in control. Id. at 6. In
addition, the form noted the intensity of her "pain without meds" as
a "3," but that the intensity of her pain "arter[sic] taken meds"
was "5-6." Id. Finally, the note documents that Agent Saenz had not
been taking opioids and "[n]o drugs" under toxic habits. At this
visit, Dr. R.C. issued her prescriptions for 90 tablets of Vicodin 5/
500mg, a schedule III control substance which combines hydrocodone and
acetaminophen, and a 21-tablet Medrol dose pack (a non-controlled
steroid) based on a diagnosis of LBP (lower back pain).
As the Government's Expert testified, the information in her file
was "very inconsistent" and this is "a tip-off to a pain specialist
that the patient isn't being forthright and may not be a suitable
candidate for controlled substance prescriptions." Tr. Vol. 7, at 133-
34. The Expert further explained that "[w]hen somebody is changing
their story, whatever it is, medication,
[[Page 5108]]
how much they're in pain, whether or not it affects them a certain way,
it really * * * shows that they are not a reliable person, and they're
not being truthful with their physician." Id. at 134. According to the
Expert, this "would make them a poor candidate to receive * * *
controlled medication prescriptions." Id.
On April 8, Agent Saenz returned to CCHM and saw Dr. N., who noted
that she was "still having moderate amount of lumbar pain" but with
"no radiation." GX 24, at 4; Tr. Vol. 2, at 283. Dr. N. also noted
that Saenz had said that the Vicodin "didn't do 'much for her.' " GX
24, at 4. Dr. N. prescribed 90 oxycodone 30mg (one tablet every six
hours as needed for a pain) and added 30 Xanax 2mg. Id. However, the
note for the visit contains no indication as to Dr. N.'s justification
for prescribing the Xanax. See id.
On May 4, Agent Saenz returned to CCHM and saw Respondent. Agent
Saenz testified that her entire encounter with Respondent lasted "no
more than ten minutes," during which Respondent asked her twice how
she was doing (with Saenz responding that she was doing "fine"), what
was bothering her, whether her current medications were helping, and
whether she had a job.\3\ Tr. Vol. 2, at 242, 244. Saenz replied that
she worked at a day care center and that the prescriptions were
helping; she then asked if she could take one more oxycodone 30mg pill
a day which Respondent agreed to. Id. at 242-43. Respondent's physical
examination was limited to listening to Saenz's heart with his
stethoscope; he did not palpate her spine or require her to perform any
movements. Id. at 245. Also, Respondent did not discuss Saenz's need
for Xanax. Id. at 245-46. Respondent then issued Saenz prescriptions
for 30 Xanax 2mg, indicating on the prescription that it was "for
sleep," and 120 Roxicodone 30mg "for pain." GX 24, at 24.
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\3\ Agent Saenz testified that while she was equipped with an
audio recording device, the device failed to record the encounter.
Tr. Vol. 2, at 231.
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In the record for this visit, Respondent wrote that Saenz's pain
level was a "7" out of 10 "with medication" and a "9" out of 10
"without medication." GX 24, at 2. He also noted that the "Meds
helping but not yet relieved @ present dose" and that Saenz was
"sleeping better [on] Xanax." Id. The ALJ did not specifically
address whether Respondent's notations as to Saenz's pain level with
and without medication and whether she was sleeping better were
accurate representations of what occurred during the encounter.\4\
Based on the testimony of Agent Saenz, which the ALJ found to be
"fully credible," ALJ at 9, I find that Respondent falsified the May
4 visit note with respect to the pain levels he documented and whether
the Xanax was helping her sleep better.
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\4\ The ALJ did, however, find that Respondent had documented
having discussed various matters such an anti-inflammatory diet,
yoga/stretching exercise, the use of fish oil/omega-3, and
glucosamine/chondroitin even though Agent Saenz testified that no
such discussion occurred. The ALJ found that Respondent violated the
State's regulation by failing to maintain accurate records. ALJ at
54 (citing Fla. Admin. Code Ann. R. 64B8-9.013(3)(f)). However,
because the evidence shows that Saenz saw other doctors at CCHM and
the form on which the ALJ's finding was based on is neither signed,
nor dated, and no other evidence establishes that he (as opposed to
the other doctors) completed the form, once again, I reject his
conclusion as not supported by substantial evidence.
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While Respondent testified that Saenz had been seen previously by
two other doctors who had prescribed medication without obtaining
relief and had an MRI which showed abnormalities in her lower back,
unlike the ALJ, I find that substantial evidence supports the
conclusion that he acted outside of the usual course of professional
practice and lacked a legitimate medical purpose in prescribing
Roxicodone and Xanax to her. As the Government's Expert testified with
respect to Agent Marshall, it "would not be within the standard of
care in Florida" for a physician to "perpetuate[] the issuance of
controlled substances ordered by another doctor without first
establishing his own valid doctor-patient relationship." Tr. Vol. 9,
at 135. Thus, I find unavailing Respondent's attempt to justify his
prescribing on the ground that he simply replicated what Dr. N. had
prescribed to Agent Saenz. See Tr. Vol. 10, at 180. While it is true
that Government's Expert misstated the evidence in attributing the
April 8 prescriptions issued by Dr. N. to Respondent and by misreading
a urine drug test as confirming the presence of various drugs when, in
fact, they were not tested for, see ALJ at 21, this does not undermine
the validity of the Expert's testimony regarding the obligation of a
physician to establish "his own valid doctor-patient relationship"
before prescribing large doses of narcotics. Tr. Vol. 9, at 135. In
addition, the Expert explained that it was "below the standard of care
to treat a patient with her pathologic findings on her MRI and her
symptoms primarily only with narcotics and escalating narcotics and
[to] not treat [her] with more conservative therapy [such as] physical
therapy, anesthesia for nerve block treatments, * * * some other non-
habituating medications, [and] behavior modification." Tr. Vol. 7, at
143.
Also unavailing is Respondent's testimony that he relied on the
truthfulness of the information contained in Saenz's patient file, and
that if he had been aware of her misrepresentations, he would not have
prescribed to her. Tr. Vol. 10, at 180. Given that Saenz's patient file
contained numerous material inconsistencies, Respondent's testimony
begs the question of which information he believed was truthful. For
example, on the Pain Assessment Form, Saenz wrote that her pain was a
"9" on a "0" to "10" scale and that she was currently being
prescribed 240 Roxicodone 30mg (a daily dose of eight tablets or
240mg), along with 40 tablets of oxycodone 15mg (for a daily dose of 3
tablets), and 60 Xanax 2mg, with a daily dose of two tablets a day. GX
24, at 13. Yet there was no indication in the file of which physician
was prescribing these drugs to her and the note for her first visit
indicated that she had not seen another doctor, that she had not been
taking opioids, and listed her pain levels as a "3" without meds and
"5-6" with meds. Id. at 6. As found above, Respondent did not
question Agent Saenz about any of these inconsistencies and falsified
the record he created for the May 4 visit. Thus, I do not find credible
Respondent's testimony that he believed Saenz to be a legitimate
patient.\5\
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\5\ The ALJ also noted Respondent's testimony that the two
strengths of oxycodone which Saenz listed on her Pain Assessment
Form "might reasonably be prescribed together" for "breakthrough
pain." ALJ at 54-55. That may be true, yet as found above, Saenz's
patient file contains no indication of who might have prescribed
this to her and the note for her first visit indicates that she had
not previously seen a doctor or taken opioids.
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Agent O'Neil also visited CCHM on three occasions (March 10, April
7, and May 4, 2010), meeting with Respondent only at the last visit. GX
23. At the first visit, O'Neil wrote on the Pain Assessment Form that
his "tummy" was the location of his pain and circled all of the
numbers from 0 to 10 for his pain rating; he also wrote that OxyContin
30mg was being currently prescribed to him. GX 23, at 13. Yet the
patient record for O'Neil's first visit documents that he complained of
having low back pain for twelve years and that Respondent found that he
had mild tenderness in his lumbosacral spine and that his right elbow
was tender to palpation. Id. at 6-7. In addition, the record states
that O'Neil was not seeing another doctor, that he drank six beers a
day, that he had been taking opioids for twelve years and that it had
been two weeks since his
[[Page 5109]]
last dose. Id. at 6. A urine test given on that date reported the
presence of benzodiazepines. Id. at 27. The attending physician
diagnosed O'Neil as having "severe" low back pain, as well "opiate
tolerance" and "dependence." \6\
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\6\ The chart also records that O'Neil had "HTN," GX 23, at 8;
an abbreviation for hypertension.
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At the May 4 visit, Agent O'Neil arrived with three Agents and
asked if they could be seen together. Tr. Vol. 3, at 305. During the
triage procedure, a clinic employee asked him if he took the pills. GX
14, at 24. O'Neil answered "Nah," to which the employee laughed and
replied: "I know you don't take them." Id. at 25. O'Neil asked: "How
can you tell?" and the employee answered: "What you mean how can I
tell? I'm stupid?" \7\ Id.
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\7\ As the ALJ explained, "[t]his conversation constitutes
evidence that Respondent's staff in this instance possessed actual
knowledge of diversion by patients. The staff's open indifference,
if not encouragement, of patients seeking controlled substances for
no legitimate medical purpose is inconsistent with Respondent's
claim that he was unaware of the problems plaguing CCHM." ALJ at
56. As the ALJ explained, "[e]pisodes such as this, while perhaps
not on their own dispositive as to Respondent's specific knowledge
of staff misconduct, * * * in the aggregate" support a finding that
he was "willfully blind to the flagrant indications of diversion
and abuse at" CCHM. Id. at 57.
I agree with the ALJ that while this incident by itself would
not establish knowledge on the part of Respondent that the CCHM
employees were facilitating diversion, the record here contains
evidence establishing multiple incidents where employees knew that
the undercover patients were seeking drugs either to abuse or sell.
To make clear, where, such incidents are as pervasive as they were
at CCHM, a registrant cannot reasonably claim ignorance of them.
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Later, O'Neil was seen by Respondent and was asked how it was
going, his age and birthdate, and "what have we got you on here
today?" Id. at 26. O'Neil replied that he took the thirties; that he
usually took about 180 fifteens, but the prescription was written "too
low last time"; as well as Xanax 2mg "and sometimes Soma." Id.
Respondent stated: "Okay, last time he wrote you one-twenty
thirties," to which O'Neil interrupted him, stating: "Yeah, it was
too low." Id. at 26-27. Respondent continued to note the other drugs
(oxycodone 15mg and Xanax 2mg) that had been prescribed at O'Neil's
previous visit and asked if he was "[t]aking a blood pressure
medicine?" Id. at 27. O'Neil answered "No," and when asked "why,"
said he "just never filled it." Id. Respondent noted that O'Neil's
blood pressure was "up again." Id.
Respondent then asked O'Neil if he had "been on medicine for a
while?"; O'Neil stated: "Yeah." Id. Respondent then asked what
O'Neil had been "on when you got here?" Id. O'Neil stated 210
thirties and 180 fifteens. Id. O'Neil replied that Dr. C. (who had
written O'Neil's previous prescriptions at his April visit) had said
the day before: "start, and you can go up each time," and that while
Dr. C. only worked Wednesdays, "he said you'd gonna increase it." Id.
Respondent then asked how O'Neil was "doing on the present dose";
O'Neil said "[f]ine." Id. Respondent followed by asking "so you're
doing okay?" Id. at 28. O'Neil then stated: "No, no. I need more. But
I don't need any less. The present dose is not * * * it would be better
if it was more. It's not, you know, not making me feel worse." Id.
Respondent stated that he understood and added: "You ran out, or it
wasn't enough?" Id. O'Neil answered: "Yeah, I ran out." Id.
After O'Neil and Respondent discussed the former's employment
status, Respondent asked: "Where is most of your pain?"; O'Neil
replied: "Lower back." Id. at 29. Respondent asked "what
happened?"; O'Neil said "[i]t was from football," that he had had
back pain since "98" and that Dr. C. "had it in my chart." Id.
After the two discussed whether O'Neil could see Respondent or Dr. C.,
Respondent conducted a physical exam. Id.
During the exam, which lasted thirty-two seconds,\8\ Respondent
told O'Neil to take a deep breath and then breathe normally, to hold
his arms up with his palms up and then put them down, and then had him
raise each leg straight up. Id.; see also GX 14 (DVD, Excerpt 2). Upon
completing the exam, Respondent stated that he could bump up O'Neil's
medicine "a little" but rejected his request to give him 210 tablets,
stating that he might do it "eventually" but could not do it "now."
GX 14, at 29-30 and DVD Excerpt 2. Of further note, at no point during
the exam did O'Neil complain of pain.
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\8\ This was from the moment Respondent got out of his chair
(prior to asking O'Neil to breathe deeply) until he returned to it.
The DVD also shows that Respondent had turned around and was
returning to his chair when he told O'Neil to raise his other leg
up. See GX 14 (DVD Excerpt 2).
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O'Neil then told Respondent that he was also taking "the liquid
drops," a reference to a liquid form of OxyContin, which he had
obtained from a friend. GX 14, at 30, Tr. Vol. 3, at 312. Respondent
replied, "Don't even tell me that," \9\ and told him that it was
"high abuse," that it could be deadly, and "don't take it." Id.
Respondent further told O'Neil to take the oxycodone "just as it says
on the bottle" and not to "take anyone else's medicine," or to sell
it or share it, noting that "[t]his is serious medicine" and was
"not for experimentation." Id. at 31. After a further discussion of
the risks of taking someone else's medicine, Respondent added that when
"[m]ost pain clinics * * * find out that * * * patients [are] taking
other people's stuff," they "instantly" discharge them. Id. at 32.
Following a short discussion of the weather, O'Neil asked Respondent if
he should just make his next appointment with Respondent, who replied
"I'm here for you." Id. at 33. O'Neill thanked Respondent, who
replied: "Yeah. We got a bond now" and added that "the goal is not
to get up to the highest number possible" but "to get pain relief."
Id.
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\9\ At the hearing, Respondent testified that he had made this
statement, because he "was very disturbed that he would do such a
thing" and what he meant was that "it hurt me to hear that because
I don't like to hear patients using that because I think it's a
dangerous product." Tr. Vol. 10, at 155. The ALJ did not find
Respondent's explanation credible. ALJ at 59. I agree with the ALJ's
finding.
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During the above conversation, Respondent printed out and signed
prescriptions for 150 Roxicodone 30mg, 90 Roxicodone 15mg, and 30 Xanax
2mg, which he gave to O'Neil, notwithstanding the latter's statement
about using liquid oxycodone which he had obtained from a friend. See
GX 14, at 54. Moreover, as the ALJ found, Respondent noted on the
record for this visit that there was "[n]o indication of substance
abuse or diversion." GX 23, at 2. In addition, Respondent noted on the
chart that O'Neil's "pain level with medication [was] 7/10" and
"without medication 9/10." Id. at 4. Here again, this was a blatant
falsification of O'Neil's record as there is no evidence that
Respondent asked O'Neil either to rate his pain numerically or had any
discussion regarding the intensity of his pain and whether it was
affecting his ability to function.
Based on O'Neil's statement that he had been using liquid OxyContin
which he obtained from a friend, and Respondent's response to it, the
ALJ concluded that "Respondent's failure to reject SA O'Neil as a
patient and his decision to issue him controlled substance[]
prescriptions is inconsistent with state and federal law." ALJ at 59
(citing and quoting Fla. Admin Code Ann. r. 64B8-9.013(1)(d)
("Physicians should be diligent in preventing the diversion of drugs
for illegitimate purposes.") and 21 CFR 1306.04(a)). As further
support for his conclusion, the ALJ also cited Respondent's statement
that "most pain clinics" would discharge a patient when they found
out they were "taking other people's stuff" and reasoned that this
"demonstrate[d] [his] awareness of the impropriety in the medical
community about prescribing to a patient known to be diverting or
abusing controlled substances." Id.
[[Page 5110]]
While I agree with the ALJ's ultimate conclusion that Respondent
violated 21 CFR 1306.04(a) in prescribing to Agent O'Neil, I conclude
that it is unnecessary to wade into the controversy within the medical
community as to the propriety of prescribing controlled substances to a
person who reports having obtained them illicitly. Instead, I conclude
that the entire body of the evidence with respect to Agent O'Neil's
prescriptions establishes that Respondent lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in prescribing to him. 21 CFR 1306.04(a).
As previously held, Respondent is not excused from the obligation
of establishing a valid doctor-patient relationship because O'Neil had
previously received prescriptions from another doctor at the same
clinic. As the Government's Expert testified, it "would not be within
the standard of care in Florida" for a physician to "perpetuate[] the
issuance of controlled substances ordered by another doctor without
first establishing his own valid doctor-patient relationship." Tr.
Vol. 9, at 135. Notably, while O'Neil's record documented that he had
been taking opioids for twelve years and had done so as recently as two
weeks before his first visit to CCHM, there was no further
documentation of how O'Neil had obtained the drugs, nor any history
documenting any prior treatments for his injury and treating
physicians. Moreover, more than two months had passed since O'Neil's
initial visit to CCHM and yet none of O'Neil's medical records had been
obtained.
Finally, as the Expert noted, during O'Neil's visit with
Respondent, he did not complain of any pain or symptoms, Tr. Vol. 7, at
120; and Respondent neither asked O'Neil to rate his pain numerically
nor questioned him regarding the nature and intensity of his pain.
Nonetheless, Respondent falsified O'Neil's medical record by noting
that his pain level was a "7/10" with medication and a "9/10"
without medication. Similarly, as found above, Respondent's physical
exam took all of thirty-two seconds during which O'Neil did not
complain of any pain. Indeed, Respondent had already turned around and
was in the process of returning to his chair when he told O'Neil to
raise his other leg.\10\ Given the totality of the evidence, it is
clear that Respondent lacked a legitimate medical purpose and acted
outside of the usual course of professional practice in prescribing
oxycodone and Xanax to Agent O'Neil.\11\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\10\ As the Government's Expert also testified, it is
"definitely below the standard of care to leave out a history and
physical in a first-time patient that you're prescribing large doses
of narcotics [to]. To not have a history and physical on the chart
is absolutely below the standard of care." Tr. Vol. 7, at 117.
\11\ Here again, the ALJ found that Respondent violated
Florida's regulation requiring the maintenance of accurate records
by checking off the boxes of a form which contain various discussion
items. See ALJ at 60 & n. 62 (discussing GX 23, at 9). Once again,
the form is neither signed, nor dated, and given that O'Neil had
previously seen other doctors at the clinic, there is an
insufficient basis to conclude that Respondent completed the form.
However, it is clear that Respondent violated the regulation by
falsely documenting O'Neil's pain levels on the record for the
latter's May 4 visit.
---------------------------------------------------------------------------
Agent Priymak was also among the Agents who also visited CCHM on
April 7, 2010 and May 4, 2010. Upon his arrival, Priymak presented his
undercover driver's license and an MRI, paid for the visit and was
given several forms to fill out. Tr. Vol. 2, at 319. On the Pain
Assessment Form, Priymak did not circle any word to describe his pain
and drew two circles around the numbers 2 and 3, and 3 and 4, on the
pain scales. GX 22, at 10. Priymak also wrote that his pain was
"between" being "occasional" and "continuous" and listed his
current prescriptions as OxyContin 40mg, four times a day; Xanax, 2
times a day; and Soma, once per day. Id. He also circled "Yes" for
whether he was having side effects from the medications and explained
that "It Feels Good!" Id. On his Medical History Form, Priymak drew a
squiggly line, which for the most part ran through the various "no"
boxes for the listed conditions. Id. at 8. However, Priymak clearly
checked the "yes" box for whether he drank alcohol and again listed
his current medications as OxyContin, Soma, Xanax, and another drug
which is indecipherable. Id. at 9. However, below this listing, Priymak
did not check either the "yes" or "no" box for the questions: "Are
all meds prescribed by a physician?" Id.
Agent Priymak's file also contains a Drug Screen Result Form with
the date of his first visit. GX 22, at 25. While this form indicates
that opiates, oxycodone, and benzodiazepines were present in his urine
specimen, see id., Priymak testified that he was not taking these drugs
and did not "recall taking a drug test." Tr. Vol. 3, at 33-34, 37-38.
Priymak did, however, recall that while being seen in the "triage
room, the staff member checked something in his file and "indicate[d]
that 'Yes, you have drugs in your system."' Tr. Vol. 3, at 37-38. I
agree with the ALJ's finding that Respondent's staff falsified Agent
Priymak's Drug Screen to document that he was taking drugs when he was
not. ALJ at 75.
Priymak was called by Respondent who asked him if it was his first
visit; Priymak said it was. GX 5, at 34. Respondent then stated "Let's
see. We gonna help with your pain in your neck." Id. Priymak replied
"[y]eap" and then complained that his shoulder was "kind [of]
tight" and that the pain had been going on "like * * * since 2001."
Id.
After discussing Priymak's age and employment status (he was
between jobs), Respondent asked him how he hurt his neck. Id. at 35.
Priymak explained that he had "tweak[ed]" his neck "playing
basketball," and that "since then [he had] tightness in [his] neck."
Id. Priymak further stated that his pain was in the middle of his neck
and when asked how bad it was, replied: "[w]ell[,] [i]t depends." Id.
Upon further questioning by Respondent, Priymak stated that his pain
was a "two or three" if he did not take medication and that he
currently was not taking any drugs. Id.
Respondent then commented that Priymak's pain level didn't "sound
too bad." Id. at 36. Priymak replied that "for the last ten years or
so," he had been "taking medication on and off" because his shoulder
got tight. Id. Respondent then asked Priymak what medicines he had
"been taking." Id. Priymak replied that he had been taking oxycodone
40mg, prompting Respondent to state: "for mild pain." Id.
Respondent and Priymak then discussed the location of the latter's
condition. Id. Priymak stated that "it gives me like tightness between
my shoulder blades and then goes to my shoulder" and complained that
when he played basketball his shoulder got "really tight." Id.
Respondent then asked if Priymak's condition "mostly * * *
affect[ed]" him when he was "playing basketball?" Id. Priymak stated
that he also did construction, suggesting that his shoulder bothered
him when he "lift[ed] it" and added that he was also "taking some
Somas," a non-controlled drug, but this drug was "not helping." Id.
at 37.
Respondent then stated "maybe we're not communicating,"
emphasizing that Priymak had stated that his pain was "mild about two
or three and mostly you * * * when you play basketball. Is that
right?" Id. Priymak answered "yes," and Respondent stated:
"otherwise you're okay, I mean * * * otherwise you do pretty good?"
Id. Priymak then stated: "No. I just * * * I need that * * * to get
through the day." Id. Respondent asked "why?" and Priymak answered,
"because of the pain," which prompted Respondent to ask: "I mean how
bad is the pain?" Id. Priymak
[[Page 5111]]
answered: "[I]t depends. It comes, it comes and goes. Goes up and
down." Id. Respondent then asked: "from what to what? Two or three,
maybe?" Id. Priymak answered that it "must be higher than that." Id.
Respondent replied: "I don't know. You tell me, I'm listening." Id.
Priymak stated: "Ah * * * five." Id.
Respondent then asked Priymak if he was "sleeping [o]kay?" Id.
Priymak said "[n]o" and explained that he was waking up three or four
times a night and that he had been taking between one half to two bars
of Xanax. Id. However, at no point in the visit did Respondent ask how
Priymak was getting the Xanax.
Respondent then questioned Priymak regarding various medical issues
including whether he had "used intravenous drugs." Id. at 38. Priymak
stated he had "a long time ago," and upon being asked how long ago,
stated "like five or six years ago." Id. Respondent then asked: "Is
there any history of drug abuse or drug dependence?" Id. Priymak
answered that he had been "taking Oxies for * * * a while." Id.
Respondent then asked how much oxycodone Priymak was taking; Priymak
stated that it depended, that the drugs were "kind of expensive,"
that he bought the forties and that he was taking up to four pills a
day. Id. at 39; see also GX 5 (DVD). Respondent asked if Priymak had
seen a doctor "lately?" GX 5, at 39. Priymak said "no," and
acknowledged that he was getting the drugs off the street. Id. Priymak
also admitted that he drank three or four beers, three times a week,
and emphasized that he was doing so because he did not have a job. Id.
Respondent then asked Priymak what other drugs he was taking;
Priymak said he was "taking Xanax and Soma sometimes to like relax
me," but added that he did not think it was helping him. Id.
Respondent and Priymak discussed how much of each drug he was taking
and why he was taking Xanax; Priymak said he was taking one half to one
and a half Xanax and doing so "to sleep." Id. at 40.
Respondent then conducted a physical exam, which lasted
approximately one minute, during which he listened to Priymak breathe
in and out, had him do several motions with his arms and turn his neck.
Id. During the exam, Respondent asked him what drug he took
intravenously (which Priymak did not answer) and whether he still
played basketball (with Priymak saying that it was hard for him because
his shoulder got tight). Id.
Upon conclusion of the exam, Respondent told Priymak that he
thought Priymak was "taking a lot of medicine for mild pain." Id.
Priymak asserted that he was big and that taking one pill did not
"help" him. Id. Respondent replied that "we don't write OxyContin"
and that "we write * * * what's appropriate." Id. at 41. Respondent
then added: "And sounds to me like your requirements for medication
are way out of proportion for the degree of pain you have. I don't
think I'm going to be able to help you." Id.
Priymak replied: "Are you serious Doc?" GX 5 (DVD).\12\
Respondent answered: "Yeah. Your pain is way less than what would be
indicated to be on what you're on. Does that make sense to you?" GX 5
(Tr. at 41). After Priymak answered "No," Respondent explained that
"somebody who has pain two or three doesn't need to be on one hundred
and sixty milligrams of OxyContin. It's just way out of proportion."
Id. Priymak asked why it was "way out of proportion," prompting
Respondent to answer: "Because in my judgment it is." Respondent then
explained: "You're on way too much and I, I can't imagine that * * * I
wouldn't even write anything for somebody who has pain at a two or
three." Id. Priymak reminded Respondent that they had talked about his
"pain as five." Id. Respondent replied: "Yeah, whatever it is. I
just think that this is too many problems here * * * too many bottles
of beer and * * * a history of * * * drug abuse." Id.
---------------------------------------------------------------------------
\12\ Having reviewed both the transcript and the DVD of this
visit, I find that Priymak made this statement.
---------------------------------------------------------------------------
Priymak asked "what do you mean?" Id. Respondent answered: "I
just don't think that I'm gonna be able to help you." Id. at 42.
Priymak then asked: "Can you help me with something less than that
amount?" Id.; see also GX 5 (DVD). Respondent asked "Like?" and
Priymak replied: "I won't be able to function, like thirties, like
twenties." Id. Respondent advised that "thirties is all we write,"
and Priymak asked for thirties. Id. Respondent then stated: "I just
don't see it for * * * what you have." Id. Priymak asked: "Can you
give me fifteens?" and Respondent stated: "You know, maybe I'll give
you some fifteens." Id. Priymak then thanked Respondent. Id.
Next, Respondent told Priymak that he should go "to some sort of
rehab facility and get on Suboxone." Id. Priymak then maintained that
he needed the drugs "to get through the day and work." Id. Respondent
stated that he understood but that it was still his "suggestion" that
Priymak go to rehab. Id. However, Respondent then asked Priymak if he
"want[ed] some Xanax?" Id. Priymak answered "yeah," Respondent said
"okay," and then asked Priymak if he was "allergic to anything."
\13\ Id.
---------------------------------------------------------------------------
\13\ Respondent and Priymak also discussed the latter's use of
Soma (carisoprodol), a drug which is currently not controlled under
federal law. GX 5, at 43. However, Respondent did not prescribe this
drug.
Priymak also sought some Viagra, stating that he wanted to try
it because he was going to a party and would like to try it. ALJ at
76 (discussing GX 5, at 43-44). Respondent asked Priymak if he had
"some problems" for which the drug would be prescribed and whether
it was "just for the party." Id. at 44. After Priymak acknowledged
that it was, Respondent said "good try" and did not prescribe the
drug. Because Viagra is not a controlled substance and DEA is not a
medical board, I do not adopt the ALJ discussion regarding the
propriety of Respondent's decision. See ALJ at 77.
---------------------------------------------------------------------------
On the History and Physical Examination on which Respondent checked
his diagnosis and plan, Respondent wrote that "PT has been on
OxyContin 40 4x/day which is out of proportion to amt of pain. Will
give Pt Rx for oxycodone 15 150 and refer to rehab. Rec. pt
see MD for Suboxone." GX 22, at 6. However, as found above, while
Respondent did suggest that Priymak go to rehab, he did not refer him
to any rehab center or a physician who is authorized to prescribe
Suboxone to treat addiction. Instead, Respondent issued Priymak
prescriptions for both 150 tablets of Roxicodone (oxycodone) 15mg and
30 Xanax 2mg. GX 22, at 24.
On May 4, 2010, Agent Priymak returned to CCHM and again saw
Respondent. Tr. Vol. 2, at 237; GX 22, at 22. After paying for the
visit and completing the triage procedure, Respondent called Priymak's
name and the two went to the former's office. Tr. Vol. 2, at 328.
According to Agent Priymak, "[i]t was a very short visit" during
which Respondent asked him how he was, if he had any problems or
complications, if the medication was helping, and if he was smoking.
Id. at 328-29; GX 5, at 54-56.
Respondent then asked Priymak "[w]here is most of your pain?" GX
5, at 56. Priymak answered that it was on the "right side" of his
"neck," but that it was "going on and off[,] [k]ind of between my
shoulders. Id. Respondent then asked: "Before you were having back[,]
uh, neck pain?" Id. Priymak stated that back in 2000, 2001, he had
"kind of like tweaked my neck roll." Id. Respondent stated "yeah,"
instructed Priymak to "take some breaths in and out," had him do
something with arms and hands," id. at 56; and then "move [his] head
from left to right." Tr. Vol. 2, at 329-30. Priymak testified that he
[[Page 5112]]
completed the movements without showing pain, id. at 330, and the rest
of the visit was spent discussing where Priymak was from (the Ukraine),
the city of Kiev, and the time it took to travel to Kiev and Moscow. GX
5, at 57-58.
Respondent did not ask Priymak to rate his pain even though he
documented on the form for the visit that Priymak's pain was a "5/10"
with medication and "9/10" without it. GX 22, at 22. He also checked
the box indicating that there was "[n]o indication of substance abuse
or diversion," notwithstanding the information he had obtained and
documented at the first visit. Id. Moreover, Respondent did not engage
in any further discussion with Priymak regarding the latter's entering
rehab. Nonetheless, Respondent issued Priymak two more prescriptions
for 150 tablets of Roxicodone 15mg and 30 tablets of Xanax 2mg. Id. at
338; see also GX 22, at 21.
Regarding the April prescriptions, Respondent testified that he had
prescribed less than half the dosage of oxycodone that Priymak had told
him he had been taking and that he made a "medical judgment based on
[his] interpretation and assessment" as to the degree of pain Priymak
had and that "he tr[ied] to correlate that with a commiserate[sic]
dose of medication" which would be "more appropriate." Tr. Vol. 10,
at 108. Respondent further maintained that Priymak was "convinc[ing]
and represented that he had significant pain." Id. He also asserted
that there had been a "considerable period of time" since Priymak had
stated that he had used intravenous drugs, id. at 113, and that he
"didn't want to totally cut [Priymak] off of medication and have him
go into withdrawal, but thought it would be more appropriate that he be
on a lower dose, something that I thought [was] more reasonable." Id.
at 128. Respondent also asserted that Priymak's MRI shows "a lot of
changes * * * that would be consistent with a patient having
significant neck pain." Id. at 138.
With respect to Priymak's second visit, Respondent testified that
"there was no immediate reason to refer him to rehab" or to even
discuss the issue because Priymak "made no representation * * * that
he had any withdrawal problems or that his pain was not sufficiently
addressed by the dose" he had prescribed. Id. at 140-41. Respondent
further justified his prescribing, stating that Priymak "was no longer
having to get his medicine on the street" and that "he was in a more
controlled environment" because he was being "taken care of by a
doctor." Id. at 141.
The ALJ addressed the credibility of only a part of Respondent's
testimony, apparently finding credible that he prescribed at the first
visit because did not want SA Priymak to suffer from withdrawal
symptoms, while finding not credible his testimony regarding why, at
the second visit, he did not discuss Priymak's entering rehab. ALJ at
77. While I agree with the ALJ's finding as to Respondent's testimony
regarding the second visit, I do not find credible his testimony
regarding his prescribing at the first visit because the transcript and
recording of that visit make clear--in Respondent's own words--that
Priymak complained only of "mild pain," notwithstanding Respondent's
successful efforts to coach him to eventually provide a higher pain
level, and that Priymak's "requirements for medication [were] way out
of proportion for the degree of pain" Priymak had. As Respondent
further stated during the visit, "I wouldn't write anything for
somebody who has pain at a two or three." Thus, Respondent's own
statements during Agent Priymak's visit manifest that his testimony--
that he believed that Priymak "had significant pain" and made a
medical judgment to prescribe something more appropriate to Priymak's
pain level--is patently disingenuous. As for Respondent's testimony
that he did not "want to totally cut [Priymak] off of medication and
have him go into withdrawal," even if this is credible, it provides no
comfort to Respondent because federal law clearly prohibits prescribing
a schedule II narcotic drug for this purpose. See 21 CFR 1306.07.\14\
---------------------------------------------------------------------------
\14\ To make clear, Respondent was not registered to provide
maintenance or detoxification treatment under 21 U.S.C. 823(g).
Under federal law, a practitioner who lacks such a registration is
authorized only to administer (and not prescribe) a schedule II
narcotic drug "to a person for the purpose of relieving acute
withdrawal symptoms when necessary while arrangements are being made
for referral to treatment" and may administer no more than one
day's dose of medication "at one time," and do so for no more than
three days. See 21 CFR 1306.07(b).
---------------------------------------------------------------------------
Given the evidence of the undercover visits, expert testimony is
hardly necessary to conclude that Respondent lacked a legitimate
medical purpose in prescribing controlled substances to Agent Priymak.
Nonetheless, it is further noted that the Government's Expert testified
that Respondent's prescriptions to Priymak were not "warranted as [a]
first-line, first-day treatment with this particular patient, who gave
a history of being an intravenous drug abuser and purchasing drugs
illicitly on the street." Tr. Vol. 7, at 92. The Expert further
explained that there were other forms of treatment including "physical
therapy," a "short course" of "anti-inflammatory medications," and
possibly "injection therapy" which were never discussed. Id. Finally,
the Expert observed that there was no significant information
documented in Priymak's patient file for his second visit to justify
the additional prescriptions. I therefore conclude that Respondent
lacked a legitimate medical purpose and acted outside of the usual
course of professional practice in prescribing controlled substances to
Agent Priymak at both visits.\15\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------
\15\ I also do not adopt the ALJ's rumination that
"Respondent's testimony that he didn't want SA Priymak to suffer
from withdrawal symptoms and the fact that Respondent's prescription
of oxycodone was less than half of the dosage that SA Priymak
represented he was previously taking perhaps mitigate[s] in
Respondent's favor." ALJ at 77. As explained above, Priymak never
complained of anything more than mild pain, which Respondent
recognized did not warrant oxycodone, and clearly presented as a
drug abuser. Thus, Respondent cannot credibly claim to have been
duped by Priymak. In short, this was a blatant drug deal.
---------------------------------------------------------------------------
On July 23, 2010, Agent Doklean, along with nine other Agents, went
as part of a "crew" to CCHM for the purpose of obtaining controlled
substances. Tr. Vol. 1, at 179. Upon her arrival, Doklean paid a clinic
employee $300 for the office visit and gave her an MRI report (of her
lumbar spine) and her undercover driver's license. Id. at 186. Several
minutes later, another Agent, who posed as the crew's ringleader and
sponsor, discussed with a clinic employee what the charge would be to
obtain expedited or VIP service; the Agent then told the other Agents
to pay the clinic employee an additional $200 for VIP service. Id. at
187.
Agent Doklean testified that she had intentionally left blank
various questions on the patient forms she had been given, and that
subsequently, another clinic employee told her that she "needed to
fill everything out." Id. This employee also gave Doklean "examples
of words to put on" the form. Id. Doklean also testified that
following her visit with Respondent, she had a conversation with
another CCHM employee, R.M. Id. at 188. R.M. related to Doklean that
Respondent "had concern over the fact that we * * * were not putting
the proper things [on] our paperwork, that we needed to say that we
were in pain on the paperwork and that any other undercover that had
not been seen yet * * * needed to make sure that they put on the paper
work and * * * needed to tell the doctors
[[Page 5113]]
that they were in pain even if they were not." Id.
On her pain assessment form, Agent Doklean wrote that her pain was
located in her "neck" and circled the words: "Tiring," "Evening/
Night," and "Occasional." GX 25, at 9. Doklean did not circle any
number on the pain scale and wrote that she was not on any current
medications. Id. On a separate medical history form, Doklean again
noted her pain was located in her "Neck" and checked "Yes" for
whether she drank alcohol and had "ever been treated for addiction."
Id. at 7-8.
Upon meeting Agent Doklean, Respondent asked her "what is your
pain that we're going to help you with today?"; she answered: "over
my neck." GX 4, at 31. Respondent asked how long the pain had been
going on; Doklean replied "six months." Id. Respondent then asked if
she had hurt herself; Doklean replied "No. I don't know where it came
from." Id. After again confirming with Doklean that she was having
neck pain, Respondent asked, "what are we doing with an MRI of your
back?" Id. Doklean answered: "That's what the other * * * you know,
what a doctor prescribed for. So * * * that's what I went for." Id.
Respondent noted: "But your pain is in your neck." Id. Doklean
replied "Well, I mean it, it, it starts in the neck and towards the
end of the day * * * it moves." Id. Referring to her MRI, Doklean then
asked: "Well, I mean, I don't know how to read that, what does that
say?" Id. Respondent replied that "this just has to do with your
back" and explained that the MRI was of Doklean's lower back. Id. at
31-32. Notably, Respondent did not ask for the name of the doctor who
had ordered the MRI.
After taking a phone call, Respondent again asked Doklean if she
had neck pain, and after she said "yes," Respondent told her: "I
guess I'm confused. You have pain in your neck but you have an MRI of
your back." Id. at 32. Doklean interrupted Respondent saying that she
thought the pain "kind of radiates"; Respondent explained that there
was a "disconnect" and that "we need to get an MRI of your neck."
Id. at 32-33. Doklean then explained that "[b]y the end of the night
it goes up and down" and that "sometimes it goes all the way
through" and she felt "stiffness * * * down at the bottom." Id. at
33.
After asking Doklean about her employment status (she was
unemployed), Respondent then confirmed that there was no trauma, with
Doklean explaining that: "maybe, running after the kids" and that she
had "two small kids." Id. Respondent then asked her how bad her pain
was on a scale of one to ten. Id. Doklean answered:
It fluctuates. Sometime is down, you know like a two or three,
sometimes it goes up. I mean, it really depends on the day * * *
sometimes I feel more than others if it's a cloudy day or if it's a
rainy day it'll go up, if not, I'm running after the kids * * * if
out running around, it, it fluctuates. Sometime, you know, it's
getting to a point where * * * I can't even. Sometimes even * * *
hang out with the kids or like do anything with them.
Id.
Respondent then asked Doklean if she was allergic to any medicines,
with Doklean answering "no," and how much she smoked, with Doklean
stating that she did not. Id. However, upon being asked whether she
drank, Doklean stated that she had been in rehab in November of the
previous year (eight months earlier) but that she was now clean and
sober. Id. at 33-34. However, Respondent did not inquire further as to
where she had been treated and who were her physicians. Id. at 34; see
also Tr. Vol. 1, at 204.
After a question about her medical history, Respondent asked
Doklean if she had been taking medication. GX 4, at 34. Doklean stated
that she would "take some Advils," but added that "every now and
then * * * I have a friend who would help me out a little bit with some
of the blues" (a term which is street slang for oxycodone 30 mg, see
Tr. Vol. 1, at 204) that seemed to help, so she decided to go "see a
pain doctor." GX 4, at 34. Respondent then asked Doklean "how long"
she had "been taking the blues?" Id. Doklean stated that she had been
taking them "on and off for like six months," but it was "kind of
hard" because "it's expensive." Id. Next, Respondent asked Doklean
if "you just take a few of those?" Id. Doklean answered that she did
so "every couple of days, when thing get really bad" and that they
seemed to help her. Id.
Respondent then asked Doklean to "describe the pain." Id. at 35.
Doklean replied: "It radiates. I mean, sometimes I get like massive
headaches * * * and it'll start up in my head and it'll go like from *
* * here and towards in here and it'll go back down and then, that's
why I say I feel it in the neck and it'll go, it'll shoot down." Id.
Respondent then proceeded to perform a physical exam (which took
fifty seconds); the exam consisted of his placing his stethoscope on
her back and instructing her to breathe in and out, as well as several
range of motion exercises including having her move her arms, open her
fingers and then make a fist, raise each of her legs straight up, then
stand up and bend over. Id. at 35; GX 4 (recording of visit); Tr. Vol.
1, at 206-08. According to the credited testimony of Agent Doklean, she
was able to completely bend over and touch the ground in "a swift
maneuver," which prompted Respondent "to chuckle." Tr. Vol. 1, at
206.
Next, Respondent had Doklean turn her head both left and right as
well as up and down. GX 4, at 35. Respondent asked if doing this caused
her any pain; Doklean stated "not right now" and added that "[t]oday
is a good day." Id. Respondent stated "[t]hat's good," and asked
Doklean if she had pain "in [her] back occasionally?" Id. Doklean
replied "Do I? Yeah, It goes, like I said, it, it radiates. It goes
different ways. Sometimes it starts up from * * * I get * * * most I
get the headaches and then it, it just goes all the way down." Id. at
36. Respondent did not, however, palpate either her neck or lower back.
Tr. Vol. 1, at 208.
Respondent then asked Doklean if she was "[t]aking anything now?"
GX 4, at 36. Doklean said "No" and Respondent replied "[w]ell, let's
just get you started on some medicine and see if we can't get you some
relief" and instructed her to "[t]ake the medicine just as it says on
the bottle," and not to buy, sell or share it. Id. Doklean then asked:
"Do I get some of the blues?" Id. Respondent answered: "Yeah. Let's
* * * let me look at your chart, we'll see how we're gonna help you
today" and told her to "[h]ave a seat out front. We'll * * * see what
we can do for you." Id. Subsequently, Respondent issued Doklean a
prescription for 120 tablets of Roxicodone 30mg and a prescription for
an MRI of her cervical spine. GX 4, at 59.
On the History and Physical Examination Form, Respondent noted that
"upon questioning," Doklean had reported that her pain was an "8
throughout the day, [with] flareups of * * * 10" on a scale of 0 to
10. GX 25, at 2. Respondent also put check marks indicating that her
pain was "aggravated by" "lifting," "twisting," and "sitting or
standing in one position too long." Id. He also checked the "yes"
box indicating that "the pain deplete[d] [her] energy/motivation,"
that she was irritable and moody because of it, that it "affect[s]
[her] relationship," and that "it cause[d] problems at work." Id.
While Respondent noted that Doklean "has taken Roxi" and gotten drugs
from friends and the street, he also wrote that she was "off any meds
now and having great difficulty." Id.
As shown by the recording and transcript of her visit, Doklean
never complained of having pain at the level Respondent documented and
[[Page 5114]]
Respondent never asked whether her pain was aggravated by any of the
activities which he checked as doing so. Moreover, Respondent did not
question her about whether the pain affected her energy, made her
irritable and moody, affected her relationships and caused problems at
work. Indeed, Doklean had told him that she was unemployed.
In addition, on pages two and three of the form, Respondent made
numerous notations as to his purported findings of his physical
examination. GX 25, at 3-4. As the Government's Expert observed, there
were "extremely serious improprieties" as Respondent fabricated in
the medical record "numerous findings, such as HEENT exam, heart exam,
abdominal exam, cervical and lumbar spine exams, range of motion
testing, reflex testing, sensory testing, peripheral pulses palpation,
neurological testing [and the] presence of muscle spasm." GX 32, at
18-19.
In his testimony, the Government's Expert further explained that
Doklean "came in complaining of neck pain but had a lumbar MRI spine
report, not a cervical MRI, so [Respondent] really was prescribing her
medication prior to a definitive diagnosis of what was going on in her
neck." Tr. Vol. 7, at 148. Moreover, when Respondent questioned why
her MRI was for her lower back and not her neck, the Expert observed
that Doklean had "pointed to her entire spine, in a diffuse manner"
and that "this is a common maneuver in a malinger patient." GX 32, at
14. The Expert also noted "that while the patient also was complaining
of 'massive' headaches, he never performed a cranial evaluation, such
as cranial nerve testing." Id. at 17.
Additionally, the Expert testified that Doklean's "MRI shows just
mild bulging of three disks in her lumbar spine, which is normally
treated conservatively with non-steroidal anti-inflammatory medications
and physical therapy." Id. at 148-49. The Expert further observed that
Doklean had "stated that her pain rating was a '2 or 3,' but could
increase during the day and vary with the weather. Certainly this pain
is not of the severity that usually requires high-dose narcotic
therapy." GX 32, at 14.
The ALJ found "dubious" Respondent's testimony that he
interpreted Doklean's pain as actually being higher. ALJ at 63 (citing
Tr. Vol. 10, at 190-91 & 201). I go a step further and find that it is
not credible. In addition, the ALJ was not impressed by Respondent's
testimony that he thought Doklean had gotten "controlled substances
from friends because 'she didn't have the money to see a doctor
previously"' and that he would be "prescrib[ing] medication for her
in a controlled way * * * [t]hat prevents diversion and prevents her
from continuing to have to get medicine in an illegitimate way." Id.
at 64.
As the ALJ found, after Doklean's meeting with Respondent, R.M., a
clinic employee, related that Respondent "had concern over the fact
that we * * * were not putting the proper things [on] our paperwork,
that we needed to say that we were in pain on the paperwork and that
any other undercover that had not been seen yet * * * needed to make
sure that they put on the paper work and * * * needed to tell the
doctors that they were in pain even if they were not." Tr. Vol. 1, at
188; see also ALJ, at 64. As this statement makes plain, Respondent's
concern was not with prescribing only for legitimate medical purposes,
but rather, with being able to justify illegitimate prescribing. In any
event, even were I to give no weight to R.M.'s statement, there is
overwhelming evidence that Respondent lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in prescribing to Agent Doklean. 21 CFR 1306.04(a).\16\
---------------------------------------------------------------------------
\16\ I also adopt the ALJ's finding that Respondent violated
Florida's regulation by failing to maintain accurate records
regarding Agent Doklean. See ALJ at 65. In addition, while the ALJ
found that Respondent violated 21 CFR 1306.04(a) in prescribing to
Agent Doklean, he also opined that the prescription "was not wholly
without some indicia of medical purpose." ALJ at 66. Because the
ALJ provided no further explanation as to the meaning of this
statement, and the basis for it, I do not adopt it.
---------------------------------------------------------------------------
Agent Zdrojewski was another member of the "crew" which visited
CCHM on July 23, 2010. As with the other Agents, Zdrojewski testified
that upon his arrival at the clinic he paid $300 for the visit and
submitted an MRI and his undercover driver's license, that he received
forms to fill out, and that another Agent, who posed as the ringleader,
had a discussion with a clinic employee after which the ringleader told
the other agents to pay over another $200 for VIP treatment, which
Zdrojewski did. Tr. Vol. 3, at 72. Zdrojewski testified that after the
Agents paid the additional fee for VIP treatment they joked around and
made comments in front of clinic employees that they were not going to
make any money off of the visit. Id. at 73. Agent Zdrojewski further
testified that he was required to provide a urine sample, but was not
supervised in doing so, and that when he turned over his sample, he
told clinic employees that he had put water in his sample and was
laughing about it, but that none of the employees said anything to him
about this. Id. at 78-79.
On the pain assessment form, Agent Zdrojewski wrote that his head
was the location of the pain and that his pain was "bothersome";
while he also circled that his pain was "Occasional," he did not
circle any of the other descriptors printed on the form. GX 28, at 9.
On the numeric pain scale, Zdrojewski drew a single circle around the
numbers "O" and "1" and wrote that "offshore boating" made his
pain worse. Id. Zdrojewski listed his current medications as 90
OxyContin 80mg, 240 oxycodone 30mg, and Xanax, and indicated that he
was not having any side effects from the medications. Id.
Agent Zdrojewski also completed a medical history form. On this
form, Zdrojewski checked the "yes" box indicating that he had high
blood pressure, bipolar disorder,\17\ and headaches. GX 28, at 7.
---------------------------------------------------------------------------
\17\ Zdrowjeski checked both the "yes" and "no" boxes for
bipolar disorder. GX 28, at 7.
---------------------------------------------------------------------------
Upon meeting Respondent, Zdrojewski was asked if it was his first
visit; Zdrojewski said it was and that he had gone to Tampa Bay
Wellness, a clinic which was now closed. GX 8, at 11. Respondent then
asked Zdrojewski where his pain was and how long it had been ongoing;
Zdrojewski replied that he had "neck" pain and that it had been
probably going on for "a year and a half." Id. Respondent asked
Zdrojewski about his employment status; the latter said he worked as a
"charter captain." Id.
Next, Respondent asked Zdrojewski how he had hurt his neck. Id.
Zdrojewski replied that he did not know and that "it just * * * over
time * * * There's a bump here and its kind [of] in here and it goes
up." Id. at 12. Zdrojewski further explained "that this comes on.
It's like, it doesn't always * * * If it moves a certain way it gets
better." Id. After stating that he had "gone through chiropractor
stuff and traction," Zdrojewski explained that "[t]he last doctor was
giving me crazy amounts but I didn't even fill [all those]. Dude was
giving me ninety count eighties." Respondent confirmed with Zdrojewski
that he had gotten eighties, with the latter adding that the clinic was
"closed now. So, I put down on the sheet what I was getting. They were
giving me sixty-two milligrams Xanax[,] and two hundred forty
Thirties[,] and then ninety count eight[ies]." Id. Zdrojewski added
that he didn't "need all that." Id.
Respondent then asked Zdrojewski to describe his pain; Zdrojewski
replied that it "comes and goes" and was "intermittent" but "the
word wasn't on there." Id. Respondent then asked
[[Page 5115]]
Zdrojewski how his pain was on a one to ten scale with ten being
severe, and added: "You got zero to one, is that right?" Id.
Zdrojewski said "Oh," and Respondent said "that means * * * you
don't have pain." Id. According to the credited testimony of Agent
Zdrojewski, he then told Respondent to "top it" and Respondent
circled the numbers 8 through 10 on the pain assessment form. Tr. Vol.
3, at 97.
Respondent then asked: "So the pain's been pretty bad?," to which
Zdrojewski said "[it] can be." GX 8, at 12. Respondent asked if "it
pretty much stays there on the neck?" Id. at 13. Zdrojewski said:
"You can say stay." Id. Upon further questioning, Zdrojewski stated
that the pain did not go into his arms. Id. Respondent then asked how
the pain affected his life, work and home. Id. Zdrowjewski stated that
he "control[ed] it" and that he had "to function, so I function * *
* I'm just not gonna sit around." Id.
Next, Respondent asked: "what makes you want to be on pain
medicine?" Id. Zdrojewski answered that it "makes me feel better.
It's not illegal like weed or something like that." Id. Respondent
then asked if when he took it before, it allowed him to function;
Zdrojewski answered "Yeap." Id. Respondent then said: "Meaning that
without it you have difficulty functioning?" Id. Zdrojewski replied:
"Without it, I've got pain." Id.
Upon questioning by Respondent, Zdrowjeski stated that he did not
know of any allergies to medicines and that he had quit smoking six
years earlier. Id. However, upon Respondent's questioning him about his
use of alcohol, Zdrojewski said that on weekends, he drank a case of
beer but that he was "trying to stay off the hard liquor." Id. at 14.
Respondent then asked him if he had "any medical problem" such as
high blood pressure or diabetes and whether he had had any surgeries.
Id. Zdrojewski stated that he had high blood pressure and was taking a
drug for that; he also stated that he had had knee surgery and eye
surgery when he "was a kid." Id.
Respondent then asked Zdrojewski if he used any recreational or IV
drugs and if he had ever had any drug abuse or dependence problems. Id.
Zdrojewski asked if "it's between us?" and when Respondent said
"yeah," stated that he used "marijuana." Id. at 14-15. Respondent
then asked him where had been going for his pain medicine, when he had
last been there, and "[h]ow long were you over there?" Id. at 15.
Zdrojewski again said that he had gone to Tampa Bay Wellness, that he
had gone there for three or four months and that he had last been there
"maybe" "two months ago." Id. Respondent again asked what drugs
they (Tampa Bay Wellness) had him on; Zdrojewski again said 90 count of
80 milligrams, 240 count of thirty milligrams, and 60 count of Xanax
two milligrams. Id.
Respondent then asked: "And you're not taking anything now?" Id.
Zdrojewski replied that he did not "have anything," and Respondent
asked: "Then, how are you doing?" Id. Zdrojewski answered that he was
"self-medicating," and when asked what "with," Zdrojewski asked if
we can "wait till there is nobody in here?" Id. Respondent said
"yeah," and eventually, Zdrojewski again said marijuana. Id.
Respondent then conducted a physical exam, which involved his
listening to Zdrojewski's breathing, followed by various movements of
his arms, legs, and fingers. Id. at 16. The exam lasted a total of 38
seconds. GX 8 (recording of visit). During the exam, Zdrojewski did not
complain that any of the movements caused him pain. Id. at 16.
After the exam, Respondent asked Zdrojewski if anyone had ever
reviewed his MRI with him; Zdrowjeski said "No." Respondent then
explained:
You've got a little inflammation going on in the joints between
your vertebrae and your neck but it's very minimal. That they
described it as trace. * * * [T]hat's what your MRI says. Other than
that it's normal. There's no disc herniations, everything else is in
place. So that's good. That there's nothing else going on.
Id . at 16.
Zdrojewski then asked what was causing his headaches. Id.
Respondent stated: "Oh, my God, there's nothing. I * * * I don't know.
There's nothing around here that * * * explains that." Id. Zdrojewski
stated that "the last doctor said it radiated up and can cause it."
Id. Respondent stated: "[Y]es if you have significant problems in your
neck, it then * * * it could do that, but I'm just saying, you[r] MRI
doesn't show that." Id. Respondent then asked Zdrojewski to stand up
and apparently to bend over, but Zdrojewski stated that he could not do
so. Id.
Respondent then said: "Well * * * we have a little issue here.
First of all your MRI doesn't show much of anything and secondly,
drinking a case of beer is not compatible with taking a strong medicine
like this." Id. at 17. Zdrojewski asserted that he could "pull that
off." Id. Respondent then stated he was "not sure how you lived
through all of this Oxy," and Zdrojewski replied: "I told you I
didn't take, I didn't take all of that." Id.
Respondent explained that he "would feel very uncomfortable
prescribing all this strong medicine * * * when I have knowledge that
beer is being consumed." Id. Continuing, Respondent stated that beer
"has alcohol and that coupled with OxyContin and oxycodone and Xanax
is being [a] very bad combination, as in you need to worry about
death." Id. After Zdrojewski said "okay," Respondent explained that
he had some people who told him that they "drink three or drink four
cans of beer and I say, 'Listen, you need [to] drink or you take
medicine.' They say, 'Fine, I, I won't drink but it's going to be hard
for me to give up a case of beer a weekend.' That's some serious
drinking." Id. After Zdrojewski said: "Well to make the headaches go
away," Respondent asked: "You understand what I'm saying?" Id.
Zdrojewski said, "I get it" and that he would "stop drinking." Id.
Respondent then asked Zdrojewski: "So you rather take the medicine
than to be drinking, is that right?" Id. Zdrojewski said "yup," and
Respondent said: "let me look at your chart to see what we can do to
help you." Id. Respondent then asked Zdrojewski what he was "taking
the Xanax for?" Id. Zdrojewski answered: "they just gave them to
me." Id. Respondent then said: "You don't really need them," to
which Zdrojewski replied: "I'll take them." Id. Respondent then said
that if "you're not * * * riddled with anxiety and you're not having a
* * * large amount of sleep problems, then we don't want to give you
medicine you don't need." Id. Zdrojewski replied: That'll work with me
doc," and Respondent stated "I just don't give you medicine just to
write a prescription. So * * * so let me look at this." Id. After
Respondent told Zdrojewski to lock up his medicine in a safe place, the
latter thanked him and the visit concluded. Id. Respondent then issued
Zdrojewski a prescription for 150 tablets of Roxicodone 30mg. GX 28, at
19.
On the history and physical examination form documenting the visit,
Respondent wrote that on a zero to ten scale, Zdrojewski's pain was an
"8 throughout the day," with "flare-ups of * * * 9-10." Id. at 2.
Respondent also wrote that Zdrojewski "was confused by pain scale on
assessment form" and indicated that his pain was "aggravated by"
lifting, bending and twisting. Id. Respondent also wrote that
Zdrowjeski had "severe pain in neck" and that "at times pain [is] so
severe he is unable to do his work" and that his pain was "sharp."
Id. Respondent also documented that he noted a muscle spasm in
Zdrojewski's cervical area;
[[Page 5116]]
however, Zdrowjeski testified that Respondent never touched his neck.
Tr. Vol. 3, at 107.
Under his treatment plan, Respondent wrote:
When pt returns pt will need to have seen NSG who will need to
have concurred that pain meds are justified. During this visit pt
expresses that pain was severe, so I Rx'ed meds sufficient to
control his pain. He previously was on a much higher dose including
OC. But in light of the MRI findings, I would not expect that pt
would have such severe * * * therefore, must obtain referral [with]
NSG and probably refer to bd cert pain mgmt before continuing care.
Most likely will be D/C if * * * he doesn't follow above plan.
Id. at 6.
In his testimony, Respondent explained that his plan was that
"when patient returns, patient will need to have seen or will need to
have seen neurosurgery who will need to have concurred that pain
medicines are justified. So my plan was to send him to neurosurgery."
\18\ There is, however, no evidence that Respondent even discussed with
Agent Zdrojewski that he needed to be evaluated by a neurosurgeon, let
alone referred him to one. See GX 8; see also Tr. Vol. 3, at 102.
---------------------------------------------------------------------------
\18\ Based on Respondent's testimony, I conclude that the
abbreviation "NSG" refers to Neurosurgeon.
---------------------------------------------------------------------------
The Government's Expert observed that it was significant that Agent
Zdrojewski represented that he smoked marijuana and engaged in
"excessive alcohol use" and "was bipolar." The Expert further
testified that prescribing Roxicodone 30mg to someone who admitted to
marijuana use was not an appropriate "first-line treatment" and was
not within the standard of care in Florida. Tr. Vol. 7, at 176.
Notwithstanding that Respondent did not prescribe Xanax to Agent
Zdrojewski, I conclude that the evidence as a whole supports a finding
that Respondent lacked a legitimate medical purpose and acted outside
of the usual course of professional practice in prescribing Roxicodone
to him. 21 CFR 1306.04(a). More specifically, Zdrojewski presented with
vague complaints, completely altered his pain rating from one end of
the scale to the other and yet at no point related other symptoms which
would be consistent with severe pain, and represented that he abused
both marijuana and alcohol. Moreover, Respondent acknowledged that
Zdrojewski's MRI was not significant, and while he conducted a physical
examination (which lasted all of 38 seconds), Respondent proceeded to
falsify the medical record by documenting findings for which he clearly
had no basis, as well as a referral which never occurred. Finally, the
Expert gave unrebutted testimony (which the ALJ credited) that
prescribing Roxicodone 30mg was not within the appropriate first-line
treatment under the standard of care. I also adopt the ALJ finding that
Respondent failed to maintain accurate records as required by Florida's
regulation.\19\ See ALJ at 84.
---------------------------------------------------------------------------
\19\ The ALJ also found that "Respondent's failure to refer SA
Zdrojewski to rehabilitation for his use of recreational and illicit
controlled substances, and what may well have been his excessive use
of licit controlled substances, is also inconsistent with Florida
standards." ALJ at 84-85 (citing Fla. Admin. Code Ann. R. 64B8-
9.013(e) (prior to Nov. 28, 2010 amendment) ("The physician should
be willing to refer the patient as necessary for additional
evaluation and treatment. * * * Special attention should be given to
those patients who are at risk for misusing their medications [or] *
* * pose a risk for medication misuse or diversion. The management
of pain in patients with a history of substance abuse or with a
comorbid psychiatric disorder requires extra care, monitoring, and
documentation, and may require consultation with or referral to an
expert in the management of such patients.").
At its text make plain, this version of the rule--which was in
effect at the time of the events at issue here--did not make such
referrals mandatory. Most significantly, there is no evidence in
this record establishing that the standard of care required that a
patient presenting in the same manner as did SA Zdrojewski be
referred at the first visit. Accordingly, I do not adopt the ALJ's
finding.
---------------------------------------------------------------------------
Agent Ryckeley was another member of the "crew" which visited
CCHM on July 23, 2010. Ryckeley likewise testified as to the monetary
payments that were made for the office visit and to receive expedited
service, and that he was given several forms to complete. Tr. Vol. 3,
at 201.
On his pain assessment form, Agent Ryckeley wrote "back
discomfort" as the location of his pain, put a question mark in the
entry for the pain's duration. GX 27, at 9. Ryckeley also indicated
that his pain was "occasional" and not "continuous," and circled
"2" on the numeric pain scale. Id. Finally, Ryckeley wrote that he
was currently on 180 oxycodone 30mg, that he had no side effects, and
that "fishing" made his pain worse. Id.
On the medical history form, Agent Ryckeley did not indicate that
he had any of the listed conditions or diseases. Id. at 7. However, in
the "location of pain" block, he wrote "Back Discomfort"; he also
indicated that he was not under the care of a physician for the
condition, and that he drank alcohol. Id. at 7-8. Moreover, he then
listed his current medications as "None." Id. at 8.
Upon entering Respondent's office and exchanging pleasantries,
Respondent asked Agent Ryckeley if it was his first visit (it was) and
where his pain was. GX 7, at 18. Ryckeley said "back discomfort" and
added: "I came in with * * * David Hays and all those guys." GX 7, at
18. Respondent said "right," and asked: "How long have you been
having back pain?" Id. Ryckeley responded: "Uh, started in, uh, I got
an MRI in May." Id. Respondent again asked when the pain started;
Ryckeley replied: "Mid May is when the * * * discomfort started" and
added that "it was just before the date on the MRI." Id.
Respondent then asked: "And what have you done to yourself?" Id.
Agent Ryckeley stated that he had been on a sport fishing charter and
"caught a decent size albacore" which he "was trying to land." Id.
Respondent then asked: "And after that things started?" Id. Ryckeley
stated that "what would happen after that" is that his girlfriend
danced and "was taking some thirties," and that he "took some of her
thirties and * * * it put me in a state where, where I liked it, it
made me feel better." Id. Continuing, Ryckeley stated: "So I
experimented with that, I know I probably shouldn't have done that * *
* but * * * I liked how it made me feel and I said, 'You know, best
thing to do is come in and get evaluated by a doctor,' and * * * get
your recommendation." Id. at 20.
Respondent then asked Ryckeley how he would "describe the pain"
and noted that he needed Ryckeley to fill out the Pain Assessment Form,
saying the words "sharp, shooting, stabbing, throbbing, aching." Id.
Ryckeley stated: "It aches, I guess," and when Respondent asked:
"Anything else?" answered: "I'm not good with words." Id.
Respondent then told Ryckeley to "stand up, turn around, and show
where the pain is." Id. Ryckeley said "okay," and apparently did not
initially comply, as Respondent then said: "No, show it, I mean can
you touch where it hurts?" Id. Ryckeley asked: "Oh, point?";
Respondent said "yeah," and Ryckeley stated "it's in * * * my lower
back area." Id. Respondent then asked if "the pain is there all the
time?" Id. Ryckeley replied: "[I]t comes and goes, mostly comes when
I fish." Id. Respondent then asked if the pain "stay[s] there or does
it travel anywhere?" Id. Ryckeley answered: "Nope, it stays * * * in
my back. Every, occasionally I get * * * headaches and stuff like
that." Id. at 21. Upon a further question by Respondent, Ryckeley
stated that the pain did not go into his buttocks and legs.
Respondent then asked Ryckeley "how bad" his pain was, apparently
noting that the latter had circled the
[[Page 5117]]
number 2 "on a scale of one to ten." Id. Ryckeley said: "probably
around two." Id. Respondent asked: "A two?," and Ryckeley said "Uh-
huh." Id. Respondent then asked Ryckeley if he had "ever tried
anything else other than all of this fancy medicine?"; Ryckeley said
"Oh, I really," but did not complete his answer before Respondent
noted, "A two here, here's the pain scale, I'm not sure, you maybe
don't understand the pain scale." Id. Ryckeley said "okay," and
Respondent stated: "a one and two is * * * just sort of * * * a very
mild kind * * * of a problem, ten is where you're screaming." Id.
Ryckely replied "okay," and Respondent asked "would you characterize
it as mild? Which is about one or two, or moderate? You know, five or
six, or is it pretty severe, like eight or nine or ten." Id. Ryckeley
stated: "Well, I guess it, it could be moderate, I would imagine * * *
middle of the road." Id. Respondent stated "see," and Ryckeley
explained: "like I said, I took my girl's pills and it made me feel
good * * * so I never, I've really never thought about it after that."
Id. at 22. Ryckeley added that he was no longer taking the pills
because he was applying for a new job and had to take a urinalysis and
that if he was "taking something, [and] didn't have a prescription,"
he "might not get the job." Id. Ryckeley then told Respondent that he
had been taking the pills "about six times a day." Id.
Respondent asked Ryckeley: "How's [the pain] affected your life,
your work, your home, has it?" Id. Ryckeley stated: "not, not really
no. Especially now since I've been on * * * my girl's medication." Id.
Respondent then asked Ryckeley about when he was not "on medication."
Id. Ryckeley answered: "it makes it more difficult to fish." Id.
Respondent laughed and said: "You're underwhelming me," and added
"you're sort of telling me, you do okay." Id. at 22-23. Respondent
then told Ryckeley to "just listen" and added:
If I came to you and I wanted pain medicine right? Cause I have
pain. And I told you that, 'Um, it's just like a one or a two and it
only bothers me when I fish and it hasn't affected my life.' You
think that would be an appropriate patient for pain medicine?
Id. at 23. Ryckeley replied: "[W]ell, it bothers me." Id.
Respondent then stated: "You're, you're like telling me that's
there's nothing going on." Id. Ryckeley attempted to interject, but
Respondent continued, stating: "I'm writing you the strongest medicine
available. So I'm like, I'm thinking * * * what are we doing here?"
Id. Ryckeley stated "yea, I think I missed," and Respondent replied:
"You're, I think, either I'm missing the point or you're missing the
point." Id.
Ryckeley said: "I think I'm missing the point." Id. Respondent
then added: "[B]ut you [are] telling me that the pain is a two and it
doesn't affect you very often and you're doing fine." Id. After
Ryckeley interjected that he was "talking on medication," Respondent
asked: "it means to me * * * you know what that means to me?" Id. at
24. Ryckeley replied "No," and Respondent said: "You should just
take Tylenol * * * Because* * * You don't have anything wrong, I don't
get it." Id. Respondent asked: "What are you doing here?" and
Ryckeley again insisted his pain level was "a two on the medication."
Id.
Respondent and Ryckeley then discussed the latter's employment as a
charter boat captain, followed by how long he had taken his
girlfriend's medicine. Id. at 24-25. Ryckeley mentioned that he had
broken up with his girlfriend and added that "sometimes people gave me
two at the club and stuff like that." Id. at 25.
Respondent then asked Ryckeley if the pain depleted his energy,
with the latter stating that it made him "less willing to do what I
like to do" because he was "in discomfort." Id. Next, Respondent
asked Ryckeley if he was "irritable or moody because of the pain?"
Ryckeley answered: "Yeah, I guess I would cause I feel a lot better on
the pills than I'm at, a lot better mood when I'm not in a
discomfort." Id. Respondent followed this by asking if it affected his
relationship in "any way." Id. Ryckeley answered: "I think it makes
it better, the medicine." Id.
Respondent then asked Ryckeley: "[D]o they cause you problems at
work?" Id. Ryckeley said "Nope," prompting Respondent to ask: "I
mean, you're able to work with the pain?" Id. at 26. Ryckeley replied:
"with the medicine, I misunderstood that question. I'm able to work
with, * * * with the medicine." Id. Respondent then asked: "But
you're now without the medicine, are you able to work without the
medicine now?" Id. Ryckeley replied: "It makes it more difficult.
Significantly more difficult." Id.
Respondent then asked Ryckeley whether he was allergic to any
medicine (Ryckeley answering that he was not aware of any), whether he
smoked (answering "no"), and whether he drank, with Ryckeley stating
he was a social drinker. Id. Respondent then discussed with Ryckeley
the danger of mixing alcohol with oxycodone, with the former saying
"I'm not sure you yet have * * * an appreciation of how strong this
medicine is, but medicine and alcohol, this medicine and alcohol is not
to be mixed." Id. at 27.
Next, Respondent asked Ryckeley if he had any medical problems or
surgeries; Ryckeley answered in the negative except for his having
broken his nose three times. Id. Respondent then asked if he had ever
"seen a doctor for this?" Id. Ryckeley said "no."
Respondent then asked: "But the thirties seem to work good for
you?" Id. at 28. Ryckeley answered: "Yeah, I like them," leading
Respondent to ask: "You like them?" Id. Ryckeley stated: "Well,
which I mean, I think they, they work good." Id.
Respondent replied: "You know, you're killing me, I can't even
believe I'm having this conversation." Id. Ryckeley maintained that he
had "never been [an] educated man," prompting Respondent to state:
"killing me." Id.
Respondent then proceeded to perform a physical examination,
telling Ryckeley to perform various movements including raising his
arms and legs, standing up, and walking across the room. Id. at 28. He
also told Ryckeley to have a seat and to show him where he was sore.
Id. In total, the exam took less than one minute. Id.; see also GX 7
(audio recording).
Respondent again asked Ryckeley whether he was on any medicines
"right now" and how bad his pain was "right now." GX 7, at 29.
Ryckeley now claimed that it was "a five or seven * * * after you
explained the chart to me" and asserted that there were "a lot [of]
words" on the forms that he "didn't understand." Id. Respondent
expressed his understanding, and asked "[w]hat makes you hurt the
most?" Id. Ryckeley replied that in charter fishing there was
"running lines" and "a lot of standing out there." Id.
After a short discussion of sport fishing, Respondent said:
"Alright * * * let's * * * get you started on some medicine, we'll see
how you do." Id. at 30. Respondent then proceeded to discuss
Ryckeley's MRI, which showed a bulging disc with "some inflammation"
at L-3, and another bulging disc between L-5 and S-1. Id. at 30-31.
Respondent then told Ryckeley not to take the medication other than as
it said on the bottle; not to buy, sell or share them; and to keep his
medicine locked up. Id. at 31. Respondent also said that it was serious
medicine, and that "if you don't need it[,] I don't want you to take
it but if your pain is such that * * * you can't function without it
then * * * that's a reasonable indication." Id. at 32. Respondent then
asked Ryckeley if his
[[Page 5118]]
work was slow, and the visit ended. Id. at 32-33.
Regarding the discussion with Respondent as to his pain level,
Agent Ryckeley testified that he believed Respondent was coaching him
to increase his pain level to justify prescribing oxycodone 30mg. Tr.
Vol. 3, at 209, 269. Agent Ryckeley also testified that Respondent
"was a box-checker * * * and he was going through and checking the
boxes and making sure [there was] every element to justify writing me *
* * one of the strongest pain level--pain medicines available. He
wanted to make sure all his Is were dotted and his Ts were crossed."
Id. at 209-10. Respondent maintained, however, that Ryckeley presented
as a person who "was not very educated" and "had difficulty in * * *
grasping his description of his pain, his degree [of] pain." Tr. Vol.
10, at 229. Respondent further testified that he "spent the time to
try to explain to him the pain scale and * * * give[] him an
opportunity to express himself fully so that * * * we were
communicating." Id. Respondent further maintained that he "had every
indication he was a real patient with pain." Id.
Although it is not entirely clear, the ALJ apparently credited
Agent Ryckeley's testimony. See ALJ at 87. In any event, as ultimate
factfinder, I find that the transcript of the visit--in particular
Respondent's statements to Ryckeley that the latter was "underwhelming
him," his asking Ryckeley "if I came to you and I wanted pain
medicine" and "it's just like a one or a two * * * You think that
would be an appropriate patient for pain medicine?," and his further
statements that "you're like telling me that there's nothing going
on" and "I think either I'm missing the point or you're missing the
point"--fully support Ryckeley's interpretation of the conversation
and demonstrates the utter implausibility of Respondent's testimony.
I therefore find that Respondent coached Agent Ryckeley to provide
a pain level sufficient to justify prescribing oxycodone. This finding
provides reason alone to conclude that Respondent lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice when he prescribed oxycodone to Agent Ryckeley.\20\ 21 CFR
1306.04(a).
---------------------------------------------------------------------------
\20\ As the Government's Expert also testified, Agent Ryckeley
"'had stated he had received these drugs from a girlfriend, so he
was not receiving them appropriately," Tr. Vol. 7, at 166, and told
Respondent that the drugs "put me in a state were, were I liked it,
it made me feel better" and he liked how the drugs made him feel.
GX 7, at 19-20. Agent Ryckeley clearly presented as a drug-seeking
patient, as Respondent himself recognized in his note for the visit
in which he wrote: "I want to make sure pt is legitimate pain
patient with chance of diversion." GX 27, at 6.
Moreover, in light of the clear evidence that Respondent
coached Ryckeley to justify his prescribing, and the latter's
presentation of as a substance abuser, I do not find that
Respondent's discussion of the risks of combining alcohol and
oxycodone mitigates his misconduct. I do, however, adopt the ALJ's
finding that Respondent failed to maintain accurate records as
required by State regulations. See ALJ at 90.
---------------------------------------------------------------------------
SA Brigantty also visited CCHM on July 23, 2010. However, in
contrast to the other undercover patients, Agent Brigantty's complaint
was generally neither vague nor inconsistent and he presented an MRI
which reported that he had three bulging disks in his lumbar spine. GX
26, at 22.
Respondent asked Agent Brigantty where his pain was (Brigantty
answering "his lower back"), how long it had been going on (Brigantty
answering "about fifteen years"), how he hurt his back ("lifting
heavy objects"), and whether he had been in an accident or fallen off
a scaffold ("No"). GX 9, at 35-36. When asked to describe his pain,
Brigantty initially complained that his back was "very stiff," but
then added that "right now, it's going down * * * my leg, sometimes in
on my [U/I], but for the most part, the left side hurts." GX 9, at 36.
Upon questioning by Respondent as to whether his pain was "sharp,"
"shooting," "aching," "throbbing," or stabbing," Brigantty
answered: "It depends on what's happening. Most of the time it's
sharp." Id. at 36-37.
Moreover, when asked to rate his pain on the numeric scale,
Brigantty stated that with the shooting it was "about six," and that
"[i]f it's the other pain, it's going to debilitate for a little
while, it's pretty f---ing bad." Id. at 37. After being told by
Respondent that he would have to figure out what number corresponded to
that, Brigantty again related that it could be "pretty f--ing bad"
and that the pain went down his left leg although it was more like "on
the lower back but towards" his buttocks. Id. Brigantty then related
that he felt the pain "sometimes even in the middle back, [and] you
feel like someone just punched you in the stomach and you can't breath
for a little while." Id. After being interrupted by an unidentified
female, Respondent then asked Brigantty what the pain felt like when it
went down his leg. Id. at 38. Brigantty replied "it feels like
electricity, I guess." Id.
Respondent then asked how the pain interfered with his work and
life; Brigantty explained that he did odd jobs and that the pain
interfered with his work ("Yeah, of course it does") and with the
kids. Id. at 38-39. Respondent then explained that Brigantty had
several bulging disks and that "when the disk is bulging, it means
it's pushed back here, pushed back into the nerve," and "[t]hat's
what gives you the pain." Id. at 39.
Agent Brigantty asked Respondent if there was "anything you can do
for that?" Id. Respondent replied that other than surgery, "there's
nothing you can do to push the disk back." Id. at 40. Brigantty then
asked how successful the surgeries are; Respondent answered that "if
you have severe disease that * * * you know, [is] affecting you or
giving you severe numbness or not letting you perform your work * * *
then they can do the surgery," but "[n]obody will give you a
guarantee." Id. Next, Respondent asked Brigantty if he smoked (with
Brigantty answering "No"), drank ("occasionally"), was using either
IV drugs ("No") or recreational drugs ("No"), as well as whether he
had "any medical problems." Id. Brigantty said that the "girl told
me my blood pressure was high today." Id. Respondent then stated that
Brigantty's blood pressure was "very high" and asked if this was the
first time he had been told this. Id. at 41. Brigantty answered: "They
mentioned it in the past, but, I feel fine." Id.
Respondent then asked Brigantty where he had gone previously for
pain medicine; Brigantty replied that he went to Jacksonville, but
"didn't like that experience" and "for the most part," he purchased
them on the street. Id. When asked what he had been taking and how
often, Brigantty said that he took Oxy thirties, but not often because
"they are pretty expensive" and that someone had given him "a Xanie
bar." Id. Respondent then asked how long Brigantty had been taking the
medicine; Brigantty said for about two to three years. Id. at 42.
Respondent then asked if the oxycodone seemed to help him; Brigantty
replied: "Yeah, I was feeling good." Id.
Respondent then told Brigantty that his blood pressure was high and
that he needed to get himself re-evaluated. Id. Respondent further
explained: "Meaning you need to find a regular medical doctor as soon
as possible and have that re-checked." Id. Brigantty asked, "Is that
bad?"; Respondent said "yes." Id. Brigantty then asked if the
condition was "life threatening bad?" Id. Respondent answered: "It
could be if this persists, it can give you a stroke, heart attack, so
it must be re-checked, if it remains at this level you probably need to
be on medication." Id. Respondent added that "[i]t sounds like other
people have mentioned it to you
[[Page 5119]]
but you haven't taken it too seriously." Id. Brigantty answered
"yeah" and Respondent added that "it's very serious. It's a serious
problem." Id. at 43.
After a further discussion of Agent Brigantty's blood pressure,
Respondent performed a physical examination during which he had
Brigantty breathe in and out and perform various exercises. Id. During
the course of the examination, Respondent asked: "[a]nd the pain * * *
just goes down that * * * that left leg?" Id. Brigantty answered:
"Yeap." Id.
Brigantty then asked if "[t]his can get worse?" Id. Respondent
said it could, and when asked if there were "things you could do,"
replied that Brigantty "could do some stretching exercises to try to *
* * increase your muscle strength." Id. at 44. He then added that
there was no "medicine to like move those discs back in place." Id.
Respondent then asked Brigantty what he had been given in
Jacksonville; the latter again said "Oxy Thirties, a while ago," but
that the "place was * * * disgusting." Id. Respondent asked if
Brigantty "use[sic] to go to American?" Id. Brigantty stated:
Well they wanted me to * * * they wanted * * * the girls outside
told me they want a physician that I was seeing, and I'm like, "I'm
not seeing a physician." Then they went, "You need to write
something." Someone said American, I was like, "F--it, I'll put
American." But I don't see doctors, doc. I can't afford constantly
going to the doctor. I barely could come in here today.
Id. Respondent acknowledged this statement, and Brigantty added that
"that's the only reason I put that down, cause * * * I didn't even
know that I had high blood pressures. You know?" Id. at 45. Respondent
replied that he "want[ed] to make sure that you get that under
control," and asked if Brigantty was "sleeping ok?" Id. Once again,
Brigantty represented that he had pain, stating, "It hurts, you know
what I mean?" Id. Respondent replied, "Right, but if the pain is
under control you'd sleep better." Id. Brigantty said that he thought
so and "absolutely." Id. Respondent then stated: "Well, we'll get
you started on some medicine and we'll see how you do? You're not on
anything now?" Id. Brigantty said he was not. Id. Respondent then
prepared a prescription for 150 Roxicodone 30mg, which he gave to
Brigantty, telling him to take the medicine as it was prescribed and
adding: "Don't buy it, sell it, share it, keep it locked up in a safe
place." Id. at 46; GX 26, at 19.
Citing "numerous violations of applicable standards and
regulations," the ALJ concluded that Respondent acted outside of the
usual course of professional practice and lacked a legitimate medical
purpose in issuing the prescription to Agent Brigantty. ALJ at 72-73.
More specifically, the ALJ noted that "[g]iven SA Brigantty's
confessed illicit use of controlled substances, Respondent failed to
'refer the patient as necessary for additional evaluation and
treatment,' notwithstanding the Florida regulations provided that
'[s]pecial attention should be given to those pain patients who are at
risk for misusing their medication' or who 'pose a risk for medication
misuse or diversion. * * *" ALJ at 68 (quoting Fla. Admin Code Ann. R.
64B8-9.013(3)(e)).
The ALJ further noted that "[t]he record reveals interactions
between Respondent and SA Brigantty that reflect poorly both as to
Respondent's standard of care as a physician and as to Respondent's
knowledge of operations at CCHM." Id. at 68-69. Among other things,
the ALJ faulted Respondent because he "did not offer to prescribe
blood pressure medication or perform any diagnostic testing for blood
pressure," id. at 68-69; and "did not refer SA Brigantty to any
particular 'regular doctor,"' which the ALJ concluded "is
inconsistent with the referral standard contained in Fla. Admin Code
Ann. R64B8-.013(3)." Id. at 70. The ALJ further found that Respondent
gave inconsistent testimony as to why he did not prescribe blood
pressure medication, noting that Respondent initially testified he
"didn't want to prescribe medication for people I was only going to
see one time," ALJ at 69 (citing Tr. Vol. 2, at 169, 214-15), yet
later testified that his goal was to put Brigantty "on a therapeutic
trial of" pain medication, and that "I was going to see him back in a
month" and see how he did. Tr. Vol. 2, at 177-78; 215 (cited at ALJ
69-70).
As for the ALJ's various criticisms of Respondent's handling of
Brigantty's high blood pressure, there is no evidence in this record
establishing that prescribing oxycodone is contraindicated for a
patient with this condition. Moreover, even if Respondent's failure to
treat Brigantty's blood pressure \21\ constitutes civil negligence--and
there is no evidence that it does--this alone does not establish a
violation of the CSA's prescription requirement. See Laurence T.
McKinney, 73 FR 43260, 43266 (2008) (citing cases). Nor is the ALJ's
conclusion that Respondent's failure to refer Brigantty "to any
particular 'regular doctor' * * * is inconsistent with the referral
standard" of the Florida pain regulation, ALJ at 70 (citing Fla.
Admin. Code Ann. R.64B8-9.013(3)), supported by either the Expert's
testimony or citation to any decision of the Florida courts or Board of
Medicine.
---------------------------------------------------------------------------
\21\ As for the ALJ's criticism that Respondent did not
"perform any diagnostic testing for blood pressure," ALJ at 69,
here again, the record is devoid of any evidence establishing what
tests are required under the standard of care, and in any event, the
issue of the adequacy of Respondent's evaluation and treatment of
Agent Brigantty's blood pressure is for the state medical board and
not this Agency.
---------------------------------------------------------------------------
To be sure, Respondent's prescribing of oxycodone to a patient who
told him he had obtained the drug on the street and whom he did not
expect to see again, raises the issue of how he would effectively
monitor his patient. However, while the Government's Expert
acknowledged on cross-examination that controlled substances can be
prescribed to a patient who presents with a history of drug abuse if it
is done "very carefully with proper monitoring in place," Tr. Vol. 8,
at 68; the Expert did not further explain what measures are required to
properly monitor a patient under the standard of professional practice
nor testify that it exceeds the bounds of professional practice to a
prescribe to a person under these circumstances.
Indeed, with respect to Agent Brigantty (as opposed to the other
patients), the testimony of the Government's Expert was not
particularly illuminating on the ultimate issue of whether Respondent
complied with 21 CFR 1306.04(a) in prescribing Roxicodone to him. See
Tr. Vol. 7, at 157-162. When asked by Government counsel what
information "was significant in considering whether controlled
substances should have been * * * prescribed," the Expert noted that
Brigantty "saw [Respondent] complaining of sharp, shooting pain in his
lower back with radiation into his left leg and buttock. Pain is
severe." Id. at 157. While the Expert observed that "the physical
exam portion * * * is a lot of check marks involving various portions
of the fill-in places for the physical exam," the Expert offered no
further testimony to the effect that the Respondent's physical exam did
not support the findings and diagnosis that were documented. Likewise,
the Expert testified that Respondent noted "bony tenderness being
present from L1 to L5 over the entire lumbar spine into the buttock,"
yet offered no testimony that this finding could not have been made
based on the physical exam that was performed. Id. at 158. Moreover,
Agent Brigantty did not remember if
[[Page 5120]]
Respondent had palpated his back. Tr. Vol. 2, at 41.
Later, Government Counsel asked the Expert "what, if any,
information did [Agent] Brigantty give to [Respondent] that's of
significant importance?" Tr. Vol. 7, at 159-60. The Expert replied:
Well, he stated he had low back pain for 15 years duration. He
wasn't sure of the cause. It may have occurred lifting at work. He
noted it shooting down into his leg, into the left leg and buttock,
and stated it was severe. He rated the pain as six throughout the
day and with flare-ups a ten, aggravated by lifting, bending,
twisting, relieved by resting.
Id. at 160.
Subsequently, the Government asked the Expert if he saw in Agent
Brigantty's Patient File "any significant medical information that
justifies the issuance of controlled substances prescriptions?" Id. at
162. The Expert answered, "I do not" and provided no further
explanation as to why the information he had previously related
regarding Brigantty's complaint, history and physical exam did not
support Respondent's diagnosis and the prescription. Id. Indeed, the
Expert did not even acknowledge the MRI report Brigantty presented, let
alone explain why the MRI's findings combined with the other
information, did not justify the diagnosis and the issuance of the
prescription.\22\ In short, substantial evidence does not support a
finding that Respondent acted outside of the usual course of
professional practice and lacked a legitimate medical purpose in
prescribing to Agent Brigantty.
---------------------------------------------------------------------------
\22\ The ALJ also cited the Government's Expert testimony "that
a patient who is illegally buying drugs on the street, and who
requests that the same drug be prescribed, should be precluded from
receiving prescriptions for controlled substances." ALJ at 72
(citing Tr. Vol. 7, at 161). However, even assuming that the
Expert's testimony reflects the accepted standards of professional
practice, neither the transcript, nor the DVD of Agent Brigantty's
visit, provide evidence that the Agent requested that Respondent
prescribe Roxicodone 30mg to him.
The Government and the ALJ also noted that there was no
evidence that Respondent discussed the risks and benefits of
controlled substances notwithstanding that he documented in the
medical record that he did so. While this may constitute a violation
of the State's regulations (which require both that he do so and
document having done so), as well as some evidence that a
practitioner exceeded the bounds of professional practice, by itself
it is not conclusive proof that a prescription was issued as part of
a drug deal.
Finally, the ALJ found it significant that Respondent
prescribed to Agent Brigantty notwithstanding that he had told
Respondent that he had falsified his medical record by listing on
his history that he had gone to a clinic to which he had not gone.
See ALJ at 71. According to the ALJ, "[a]pplicable Florida
regulations are clear about the mandatory weight of the
recordkeeping guideline: 'The physician is required to keep accurate
and complete records' before prescribing controlled substances."'
Id. (citing Fla. Admin. Code Ann. r. 64B8-9.013(f)). The ALJ then
reasoned that "Respondent's acquiescence in recordkeeping
inaccuracies weighs heavily against [his] continued registration."
Id.
While I agree that there are numerous other apparent violation
of the State's regulations (including with respect to Agency
Brigantty by documenting having discussed various items which he did
not do), see ALJ at 71-72, I do not rely on the above discussion. As
the evidence shows, on the history and physical examination form,
Respondent documented that Brigantty's "Past history of Pain
Management" included "Jacksonville and then the street." This was
an accurate statement of what Agent Brigantty had told Respondent.
---------------------------------------------------------------------------
Accordingly, with the exception of the visit of Agent Brigantty, I
reject Respondent's Exceptions to the ALJ's findings that he acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose when he prescribed controlled substances to
Agents Marshall, O'Neill, Doklean, Priymak, Zdrojewski and Ryckeley and
thus violated both federal and state law. 21 CFR 1306.04(a), 21 U.S.C.
841(a)(1); Fla. Stat. Ann. Sec. 458.331(1)(q). I further find that
substantial evidence supports a finding that Respondent acted outside
of the usual course of professional practice and lacked a legitimate
medical purpose when he prescribed controlled substances to Agent
Saenz. See id; see also 5 U.S.C. 557(b) ("On appeal from or review of
the initial decision, the agency has all the powers which it would have
in making the initial decision. * * *"). I also adopt the ALJ's
findings and legal conclusions with respect to each of the Agents who
saw Respondent at Commercial Medical Group, including his finding that
Respondent acted outside of the usual course of professional practice
and lacked a legitimate medical purpose when he prescribed Xanax to
Agent Bazile. See ALJ at 92 (citing 21 CFR 1306.04(a)). In addition,
substantial evidence also supports the ALJ's numerous findings that
Respondent failed to maintain accurate records in violation of
Florida's regulations, see ALJ at 93 (citing Fla. Admin. Code r.64B8-
9.013(3)(f)), and that he falsified numerous patient records to support
the prescribing of controlled substances.\23\
---------------------------------------------------------------------------
\23\ In his Exceptions, Respondent argues that "[t]he
Government successfully prevented Dr. Wolff from inquiring whether
undercover patients had made subsequent visits to the clinic and
whether [they] had been unsuccessful in acquiring controlled
substances from Dr. Wolff." Id. at 12. In his Exceptions,
Respondent does not identify which of the Agents the ALJ precluded
him from asking whether they had returned to the clinic. Upon
reviewing the record, it is noted that while the ALJ sustained the
Government's objection to Respondent's asking this question on
cross-examination of two of the Agents, he did so on the ground that
the question was beyond the scope of the direct examination. See Tr.
Vol. 3, at 183, 276-77. Respondent does not contend, however, that
he sought to subpoena the Agents to ask this question of them. In
addition, the patient files contain no evidence that any of the
eight Agents made undercover visits after the dates to which they
testified as having obtained controlled substances on from
Respondent. I thus reject this Exception.
---------------------------------------------------------------------------
In his Exceptions, Respondent further contends that he "was denied
the opportunity to review and produce files of patients that he had
discharged from the clinic" which "had been seized by [the Agency]
pursuant to a federal search warrant." Exceptions at 9-10. Respondent
contends that "[t]he discharge files evidence [his] compliance with
Florida Standards of Care, Florida Medical Regulations, as well as
state and federal law." Id. at 10. He further contends that the files
"would also permit [him] to [show his] methodology in determining
whether or not to write prescriptions for persons claiming to have
pain" and "that he would not automatically write prescriptions merely
because individuals claimed to be suffering from pain." Id.
As for the contention that these files would permit him to show his
methodology in determining whether to write prescriptions and that he
would not automatically write prescriptions merely because a person
complained of pain, these files are not relevant in assessing
Respondent's compliance with federal and state standards in prescribing
to the undercover CCHM patients. With respect to these patients,
Respondent had ample opportunity to testify as to his methodology in
determining whether to prescribe to the Agents as he was provided with
the files of each of the Agents whose prescriptions form the bulk of
the Government's case against him.\24\
---------------------------------------------------------------------------
\24\ It is acknowledged that the Government did not turn over
the patient file for Agent Bazile, who saw Respondent at CMG.
However, the ALJ's finding that Respondent violated 21 CFR
1306.04(a) when he prescribed Xanax to her was based on Agent
Bazile's credited testimony. More specifically, Agent Bazile
testified that she asked Respondent for something to help her sleep.
Tr. Vol. 6, at 23. Respondent then asked if she had trouble
sleeping, and Agent Bazile replied "sometimes," prompting
Respondent to remark that she was "not very convincing." Id. at
23-24. At the hearing, Respondent testified that he could not
provide the reason he prescribed Xanax to Agent Bazile without
having the opportunity to see her patient file. Tr. Vol. 10, at 53.
I adopt the ALJ's finding noting that Respondent had ample
opportunity to cross-examine her regarding the circumstances
surrounding her obtaining of the Xanax prescription and yet did not
ask her a single question about this prescription. See Tr. Vol. 6,
at 30-61. I thus find her testimony credible as did the ALJ. ALJ at
9.
---------------------------------------------------------------------------
As for the contention that the discharged patient files would show
his compliance with applicable standards, I will credit his testimony
that he has discharged hundreds of patients. Tr.
[[Page 5121]]
Vol. 9, at 272. Accordingly, the files were not necessary to prove his
assertion and Respondent cannot claim prejudice. Cf. 5 U.S.C. 706
("due account shall be taken of the rule of prejudicial error").
However, that Respondent discharged hundreds of other patients does
not render the prescriptions he issued to Agents Marshall, O'Neill,
Doklean, Priymak, Zdrojewski, Ryckeley, Saenz and Bazile any less
unlawful. See Dewey C. MacKay, 75 FR 49956, 49977 (2010) (quoting Jayam
Krishna-Iyer, 74 FR 459, 463 (2009) (holding that a physician's lawful
"prescribings to thousands of other patients [does] not * * * render
[his] prescribings to undercover officers any less unlawful, or any
less acts which 'are inconsistent with the public interest"')).
Indeed, with respect to these patients, the evidence is clear that
Respondent was not duped and that he intentionally diverted controlled
substances.\25\ See ALJ at 95. Thus, the Government has made out a
prima facie case that Respondent "has committed such acts as would
render his registration * * * inconsistent with the public interest."
\26\ 21 U.S.C. 824(a)(4).
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\25\ As I have previously explained,
Under the CSA, a practitioner is not entitled to a registration
unless [he] "is authorized to dispense * * * controlled substances
under the laws of the State in which he practices." 21 U.S.C.
823(f). Because under law, registration is limited to those who have
authority to dispense controlled substances in the course of
professional practice, and patients with legitimate medical
conditions routinely seek treatment from licensed medical
professionals, every registrant can undoubtedly point to an
extensive body of legitimate prescribing over the course of [his]
professional career.
Jayam Krishna-Iyer, 74 FR 459, 463 (2009).
In Krishna-Iyer, I further explained that in past cases, this
Agency has given no more than nominal weight to a practitioner's
evidence that he has dispensed controlled substances to thousands of
patients in circumstances which did not involve diversion. Id. See
also MacKay, 75 FR at 49977; Paul J. Caragine, 63 FR 51592, 51599
(1998) ("[T]he Government does not dispute that during Respondent's
20 years in practice he has seen over 15,000 patients. At issue in
this proceeding is Respondent's controlled substance prescribing to
18 patients."); id. at 51600 ("[E]ven though the patients at issue
are only a small portion of Respondent's patient population, his
prescribing of controlled substances to these individuals raises
serious concerns regarding [his] ability to responsibly handle
controlled substances in the future.").
While in Caragine, my predecessor did consider "that the
patients at issue ma[de] up a very small percentage of Respondent's
total patient population," he also noted--in contrast to most of
the prescriptions at issue here--"that [those] patients had
legitimate medical problems that warranted some form of treatment."
Id. at 51601. Moreover, in contrast to this case, in Caragine, there
was no evidence that the practitioner had intentionally diverted.
Id. See also Medicine Shoppe--Jonesborough, 73 FR 364, 386 & n.56
(2008) (noting that pharmacy "had 17,000 patients," but that
"[n]o amount of legitimate dispensings can render * * * flagrant
violations [acts which are] 'consistent with the public interest.'
"), aff'd, Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409
(6th Cir. 2008).
Indeed, DEA has revoked other practitioners' registrations for
committing as few as two acts of diversion, and "can revoke based
on a single act of diversion" absent a credible showing by the
registrant that he accepts responsibility for his misconduct.
MacKay, 75 FR at 49977. See also Alan H. Olefsky, 57 FR 928, 928-29
(1992) (revoking registration based on physician's presentation of
two fraudulent prescriptions to pharmacy and noting that the
respondent "refuses to accept responsibility for his actions and
does not even acknowledge the criminality of his behavior");
Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d Cir. 1974) (upholding
revocation of practitioner's registration based on nolo contendere
plea to three counts of unlawful distribution).
Accordingly, evidence that a practitioner has treated thousands
of patients does not negate a prima facie showing that the
practitioner has committed acts inconsistent with the public
interest. While such evidence may be of some weight in assessing
whether a practitioner has credibly shown that he has reformed his
practices, where a practitioner commits intentional acts of
diversion and insists he did nothing wrong, such evidence is
entitled to no weight. Krishna-Iyer, 74 FR at 463.
\26\ As the ALJ explained, the public interest factors are
"considered in the disjunctive. [I] may properly rely on any one or
a combination of those factors, and give each factor the weight [I]
deem appropriate, in determining whether a registration should be
revoked or an application for registration should be denied." ALJ
at 43 (citing cases); see also Hoxie v. DEA, 419 F.3d, 477, 482 (6th
Cir. 2005). Nor am I required to make findings as to all of the
factors. Hoxie, 419 F.3d at 482. Moreover, whether conduct is
considered under factor two--the experience factor, or factor four--
the compliance factor, or both factors, is of no legal consequence
because the fundamental question is whether the registrant "has
committed such acts as would render [his] registration * * *
inconsistent with the public interest." 21 U.S.C. 824(a)(4). Thus,
as both the Agency and various courts of appeals have recognized,
findings under a single factor are sufficient to support the
revocation of a registration, especially where the proven misconduct
involves egregious acts. See Hoxie, 419 F.3d at 482; Morall v. DEA,
412 F.3d 165, 173-74 (DC Cir. 2005); Krishna-Iyer, 74 FR at 462.
That said, I have considered the ALJ's findings with respect to
each of the factors and adopt them except as noted herein.
---------------------------------------------------------------------------
As the ALJ explained, under longstanding Agency precedent, where,
as here, "the Government has proved that a registrant has committed
acts inconsistent with the public interest, a registrant must 'present
sufficient mitigating evidence to assure the Administrator that [he]
can be entrusted with the responsibility carried by such a
registration.' " Medicine Shoppe, 73 FR at 387 (quoting Samuel S.
Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931,
21932 (1988))). "Moreover, because 'past performance is the best
predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450,
452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant
has committed acts inconsistent with the public interest, the
registrant must accept responsibility for [his] actions and demonstrate
that [he] will not engage in future misconduct." Medicine Shoppe, 73
FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR
35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995).
See also Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2008) ("admitting
fault" is "properly consider[ed]" by DEA to be an "important
factor[]" in the public interest determination). In addition, DEA has
held that a registrant's candor is an important factor in the public
interest determination. See Satinder Dang, 76 FR 51424 (2011); Alan H.
Olefsky, 76 FR 20025 (2011); The Lawsons, Inc., 72 FR 74334 (2007). See
also Hoxie, 419 F.3d at 483.
It is acknowledged that Respondent testified that he had fired
several clinic employees after he purchased CCHM and that he brought in
a risk manager to assess the clinic's procedures and to create a policy
and procedures manual. However, as the ALJ found, "Respondent's
testimony * * * repeatedly demonstrated [his] belief that he had
engaged in no past misconduct and was in full compliance with existing
laws and regulations," as well as "a remarkable lack of
acknowledgment and recognition of the risks of diversion." ALJ at 97-
98. In addition, the ALJ found that "Respondent's testimony in
numerous instances was not credible and reflected an overall lack of
admission of past misconduct, let alone acceptance of responsibility."
Id. at 98. Indeed, much of his testimony regarding the CCHM patients
was patently disingenuous. Accordingly, I adopt the ALJ's conclusion
that Respondent has "fail[ed] to accept responsibility for his
misconduct and demonstrate that he will not engage in future
misconduct," ALJ at 98, and therefore hold that he has not rebutted
the Government's prima facie case. Given the egregiousness of his
misconduct, I further adopt the ALJ's recommendation that Respondent's
registrations be revoked and that any pending application for renewal
or modification of his registrations be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of
Registration FW1453757, BW3918440, BW4448571, AW2065058, FW1338690,
BW4362935, AW2654639, AW8594233, and BW0601446, issued to Randall L.
Wolff, M.D., be, and they hereby are, revoked. I also order that any
pending application of Randall L. Wolff, M.D., to renew or modify these
registrations, as well as any pending
[[Page 5122]]
application for a new registration, be, and they hereby are denied.
This order is effective immediately.\27\
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\27\ For the same reasons that I ordered the immediate
suspension of Respondent's registrations, I conclude that the public
interest requires that his order be effective immediately. 21 CFR
1316.67.
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Dated: January 19, 2012.
Michele M. Leonhart,
Administrator.
Theresa Krause, Esq., for the Government
Bruce A. Zimet, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
A. The Order to Show Cause and Immediate Suspension of Registration
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA or Government) should revoke a physician's DEA
Certificates of Registration (CORs) as a practitioner pursuant to 21
U.S.C. 824(a)(4) and deny, pursuant to 21 U.S.C. 823(f), any pending
applications for renewal or modification thereof and any application
for a new COR. Without these registrations, Respondent Randall L.
Wolff, M.D. (Respondent), of the State of Florida, would be unable to
lawfully prescribe, dispense or otherwise handle controlled substances
in the course of his practice.
On December 16, 2010,\1\ the Deputy Administrator, DEA, served an
Order to Show Cause and Immediate Suspension of Registration (OSC/IS)
upon Respondent, dated December 14, 2010. The OSC/IS immediately
suspended Respondent's nine (9) DEA CORs as a practitioner, and also
provided notice to Respondent of an opportunity to show cause as to why
the DEA should not revoke Respondent's CORs, pursuant to 21 U.S.C.
824(a)(4), and deny, pursuant to 21 U.S.C. 823(f), any pending
applications for renewal or modification thereof and any applications
for a new COR, alleging that Respondent's continued registration is
inconsistent with the public interest as that term is defined in 21
U.S.C. 823(f).
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\1\ The Government's Notice of Service of Order to Show Cause
and Immediate Suspension of Registration states that "Service was
completed on December 16, 2010." (Notice of Service at 1.) In his
hearing request, Respondent states that "Dr. Wolff was served on
December 17, 2010. * * *" (Hg. Req. at 2.) Respondent subsequently
stipulated that service occurred on December 16, 2010.
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The OSC/IS alleges that Respondent is registered as a practitioner
in Schedules II through V under DEA registration numbers FW1453757,
BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639,
AW8594233 and BW0601446, and that on or about August 12, 2010,
Respondent submitted an application for registration, assigned Control
Number W10053115C, as a practitioner in Schedules II through V.
(Administrative Law Judge (ALJ) Ex. 1 at 1-2.)
The OSC/IS further alleges that between approximately March 5,
2010, and July 23, 2010, Respondent distributed controlled substances
(to include oxycodone and alprazolam) by issuing prescriptions to at
least eleven undercover law enforcement officers for other than a
legitimate medical purpose or outside the usual course of professional
practice. In particular, the OSC/IS alleges that on March 5, 2010,
Respondent distributed to three undercover law enforcement officers
various quantities of controlled substances after conducting little or
no physical examination, among other deficiencies.
In addition, the OSC/IS alleges that from April 7, 2010, through
July 23, 2010, Respondent distributed oxycodone and alprazolam tablets
to at least eight undercover law enforcement officers under
circumstances similar to those noted above, to include little or no
physical examination, no diagnosis warranting the prescription for
controlled substances and under circumstances which Respondent knew or
should have known that prescribing controlled substances was for other
than a legitimate medical purpose.
Finally, the OSC/IS alleges that Respondent's registered location
associated with DEA COR FW1453757 is the location of Coast to Coast
Healthcare Management Pain Clinic (CCHM) and the location where the
vast majority of the undercover activity occurred; that from
approximately July 30, 2009, through December 29, 2009, Respondent
ordered approximately 249,000 dosage units of oxycodone that were
delivered to this location; and that from approximately January 4,
2010, through September 1, 2010, Respondent ordered approximately
267,000 dosage units of oxycodone that were delivered to this location.
In addition to the OSC/IS, the Government also noticed and alleged
additional information in its initial and supplemental prehearing
statements to include Automation of Reports and Consolidated Orders
System (ARCOS) data pertaining to Respondent, along with medical expert
opinion regarding Respondent's prescribing and recordkeeping practices.
Following prehearing procedures, a hearing was held in Ft.
Lauderdale, Florida between February 15, 2011, and February 18, 2011,
and in Miami, Florida between March 8, 2011, and March 17, 2011,\2\
with the Government represented by counsel and Respondent represented
by counsel. Both parties called witnesses to testify and introduced
documentary evidence. After the hearing, both parties filed proposed
findings of fact, conclusions of law and argument. All of the evidence
and post-hearing submissions have been considered, and to the extent
the parties' proposed findings of fact have been adopted, they are
substantively incorporated into those set forth below.
---------------------------------------------------------------------------
\2\ Hearing was recessed over the weekend of March 12-13, 2011.
---------------------------------------------------------------------------
II. Issue
Whether the record establishes that Respondent's DEA CORs
FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935,
AW2654639, AW8594233 and BW0601446 as a practitioner should be revoked
and any pending applications for renewal or modification thereof and
any applications for a new COR, to include application WI0053115C,
should be denied, on the grounds that Respondent's continued
registration would be inconsistent with the public interest as that
term is used in 21 U.S.C. 824(a)(4) and 823(f).
III. Evidence and Incorporated Findings of Fact \3\
---------------------------------------------------------------------------
\3\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
Sections of this Recommended Decision.
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I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts \4\
---------------------------------------------------------------------------
\4\ (See ALJ Ex. 8; see also Tr. vol. 5, at 4-5.)
---------------------------------------------------------------------------
1. Respondent is registered with DEA as a practitioner in Schedules
II through V under DEA registration numbers FW1453757, BW3918440,
BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and
BW0601446 at 328 East Hillsboro Blvd., Deerfield Beach, Florida 33441;
Delray Beach Fire Dept., 501 W. Atlantic Avenue, Delray Beach Florida
33444; Palm Beach Fire Rescue, 300 N. County Road, Palm Beach, Florida
33480; West Palm Beach Fire Dept., 500 North Dixie, West Palm Beach,
Florida 33401; Wycliffe Golf & Country Club, 4160 Wycliffe Country Club
Drive,
[[Page 5123]]
Wellington, Florida 33449; Public Safety Fire Department, 560 US
Highway 1, North Palm Beach, Florida 33408-4902; Greenacres City Public
Safety, 2995 Jog Road, Greenacres City, Florida 33467; 10985 Blue Palm
Street, Plantation, Florida 33324-8234 and Lake Worth Fire Dept., 1020
Lucerne Ave., Lake Worth, Florida 33460, respectively.
2. Respondent's DEA registration numbers FW1453757, BW3918440,
BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and
BW0601446 expire by their terms on May 31, 2012, May 31, 2012, May 31,
2013, May 31, 2012, May 31, 2012, May 31, 2013, May 31, 2012, May 31,
2012 and May 31, 2011, respectively.
3. On or about August 12, 2010, Respondent filed an application
with DEA for a DEA COR as a practitioner to handle controlled
substances in Schedules II through V at 8609 Forest City Road, Orlando,
Florida 32809; this application was assigned DEA Control Number
W10053115C. Respondent's application is pending.
4. On December 16, 2010, a federal criminal search warrant was
executed at 328 East Hillsboro Blvd., Deerfield Beach, Florida 33441,
one of Respondent's registered locations. Respondent was simultaneously
served with the DEA OSC/IS.
5. Oxycodone is a Schedule II controlled substance pursuant to 21
CFR 1308.12(b)(1)(xiii).
6. OxyContin is a brand of oxycodone, a Schedule II narcotic
controlled substance pursuant to 21 CFR 1308.12(b)(1)(xiii).
7. Roxicodone is a brand of oxycodone, a Schedule II narcotic
controlled substance pursuant to 21 CFR 1308.12(b)(1)(xiii).
8. Alprazolam is a Schedule IV controlled substance pursuant to 21
CFR 1308.14(c)(1).
9. Xanax is a brand of alprazolam, a Schedule IV narcotic
controlled substance pursuant to 21 CFR 1308.14(c)(1).
10. Vicodin is a brand of hydrocodone combination product, a
Schedule III narcotic controlled substance pursuant to 21 CFR
1308.13(e)(1)(iv).
11. Soma is a brand of carisoprodol, a non-controlled \5\ muscle
relaxant.
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\5\ Although not pertinent to the instant proceeding, I note
that because of its potential for abuse, DEA has initiated a
proceeding to place carisoprodol into Schedule IV under the
Controlled Substances Act. See 74 FR 59,108, 59,109 (DEA 2009).
---------------------------------------------------------------------------
B. Introduction
Respondent completed his internship and residency in the field of
internal medicine in 1980, subsequently working in emergency medicine
as well as completing a fellowship in pulmonary/critical care. (Tr.
vol. 9, at 211.) Respondent worked in Florida as an emergency
department physician at JFK Medical Center beginning in 1982, later
becoming Deputy Medical Director, and eventually Medical Director from
1995 to 2001. (Tr. vol. 9, at 214.) Respondent next worked as a
regional medical director for three hospitals in California for a
little more than a year, before returning to Florida to work in several
different emergency departments. (Tr. vol. 9, at 216-17.) Respondent
began a clinic in Delray Beach, Florida, and also worked as medical
director for various municipal and community fire and emergency
departments. (Tr. vol. 9, at 217.)
In July 2009 Respondent accepted a position at Commercial Medical
Group (CMG),\6\ a pain management clinic in Fort Lauderdale, Florida.
Respondent's employment at CMG ended in February or March 2010 due to a
conflict between Respondent and the owner, Mr. Vincent Colangelo. (Tr.
vol. 9, at 220.)
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\6\ Respondent testified that CMG had previously been called
Seaside Pain Management Clinic, but that the name was changed in or
about August or September 2009. (Tr. vol. 11, at 95.)
---------------------------------------------------------------------------
Respondent next worked for another clinic known as American Pain
for approximately one week, before the clinic was closed down.\7\ (Tr.
vol. 9, at 235.) In April 2010, Respondent began working for another
pain clinic, CCHM, initially working there with three or four other
doctors until October 2010, when Respondent's role changed from
independent contractor to owner of the clinic. (Tr. vol. 9, at 221.)
Respondent remained at CCHM as owner and practicing doctor from October
2010 until mid-December 2010, when the clinic was closed by DEA. (Tr.
vol. 9, at 222.)
---------------------------------------------------------------------------
\7\ Respondent testified on cross-examination that the only pain
clinics he worked at were CMG and CCHM, except that he also worked
"for a brief time in Orlando" but did not remember the name of the
clinic. (Tr. vol. 11, at 76.)
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C. Evidence
1. Background
The Government's evidence included testimony from seventeen
witnesses, including Respondent and a pain management expert, Dr. Scott
A. Berger, M.D. Three witnesses were undercover law enforcement
officers who posed as patients and received treatment from Respondent
at CMG: DEA Special Agent (SA) Mark McClarie (SA McClarie); SA Rochelle
E. Burnett Bazile (SA Bazile); and SA Kirk Miller (SA Miller). Eight
witnesses were undercover law enforcement officers who posed as
patients and received treatment from Respondent at CCHM: SA Nicholas
Priymak (SA Priymak); SA Jeffrey K. O'Neil (SA O'Neil); SA Julia Saenz
de Viteri (SA Saenz); SA Marc A. Marshall (SA Marshall); DEA Task Force
Officer (TFO) Dana G. Doklean (TFO Doklean); SA Louis J. Ryckeley (SA
Ryckeley); SA Brian M. Zdrojewski (SA Zdrojewski); and SA Edwin
Brigantty (SA Brigantty). Mr. Kyle J. Wright, Unit Chief, DEA Office of
Diversion Control, testified regarding ARCOS data pertaining to
Respondent.\8\ DEA Diversion Investigator (DI) Barbara Boggess (DI
Boggess) testified regarding Respondent's DEA certificates of
registration. Finally, the evidence included testimony from DEA TFO
Robbie R. Weir (TFO Weir), "case agent" for the investigation of
CCHM, and SA Joseph Gill (SA Gill), "case agent" for the
investigation of CMG.
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\8\ The ARCOS evidence shows trends in Respondent's prescribing
of controlled substances over time as well as absolute numbers of
dosage units prescribed. (See Tr. vol. 1, at 100-169; see also Gov't
Exs. 13 & 30.) Mr. Wright could not testify as to the causes of the
trends other than to identify that the trends existed. (E.g., Tr.
vol. 1, at 148.) The Government concedes, correctly, that
"[s]tanding alone this ARCOS data is not persuasive * * *." (Gov't
Br. at 8.) The Government argues, however, that in conjunction with
evidence of Respondent's prescribing practices, the "ARCOS data * *
* reveals * * * the impact that the Respondent's illegal conduct had
on the health and safety of the public." (Gov't Br. at 8.) To the
contrary, in the form it was offered, the ARCOS evidence provides
little insight into whether Respondent's conduct was consistent or
inconsistent with the public interest. See Gregg & Son Distribs., 74
FR 17,517, 17,517 n.1 (DEA 2009) ("To make clear, it is the
Government's obligation as part of its burden of proof and not the
ALJ's responsibility to sift through the records and highlight that
information which is probative of the issues in the proceeding.")
---------------------------------------------------------------------------
The Government's evidence also included various audio and video
recordings of undercover meetings that occurred at CMG and CCHM, along
with transcripts of portions of the various recordings.\9\
Additionally, the evidence included eight patient files associated with
undercover visits to CCHM. No patient files were offered with regard to
undercover visits to CMG.
---------------------------------------------------------------------------
\9\ No recording was made of the meeting between SA Bazile and
Respondent at CMG, or SA Saenz and Respondent at CCHM, due to
recording failures.
---------------------------------------------------------------------------
Respondent's evidence included testimony from four witnesses,
including Respondent. Three witnesses provided testimony related to
three of Respondent's registered locations: Phil Webb, Fire Chief, West
Palm Beach Fire Department; Mark Pure, EMS Chief, Greenacres City
Department of Public Safety; and David Dyal, Assistant Fire Chief,
Stuart, Florida. Respondent testified regarding his education and
professional background, as well as his
[[Page 5124]]
prescribing practices. Respondent's evidence also included eight
patient files associated with undercover visits to CCHM,\10\ along with
six other patient files reflecting prior treatment by Respondent.
(Resp't Exs. 1-8; 11, 13, 15-17 & 19.)
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\10\ Respondent argued at hearing that use of separate copies of
patient files for the eight undercover visits to CCHM was necessary
because the source of the files, and arguably content, varied from
those presented by the Government. In the absence of an objection by
the Government, the patient files, which are substantially identical
to those offered by the Government, were admitted. (Tr. vol. 10, at
86-88; Tr. vol. 11, at 46.)
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With the exception of Respondent and Dr. Berger, I find all of the
witnesses at hearing to be fully credible in that the testimony was
generally internally consistent and evidenced a reasonable level of
memory for past events. Each witness presented testimony in a
professional manner and the material portions of the testimony was
consistent with other credible evidence of record. Respondent's
testimony was presented in a professional and serious manner, but as
more fully explained in the discussion section below, I find it to be
only partially credible. Dr. Berger's testimony was generally credible,
but was diminished in several respects by various factual errors, as
more fully explained below.
2. Expert Testimony and Report
The Government presented the testimony of Dr. Scott A. Berger,
M.D., along with a written report prepared by Dr. Berger (Gov't Ex.
32), pertaining to his review of various DEA reports of investigation
and eight patient files related to DEA undercover visits to CCHM
between April 7, 2010, and July 23, 2010. Dr. Berger did not review or
offer any testimony related to three undercover patient visits to CMG.
The Government offered Dr. Berger as an expert in the legitimate
and illegitimate use of narcotic controlled substances related to pain
management. (Tr. vol. 7, at 38.) Dr. Berger testified that he has over
twenty years of experience in treating chronic pain patients and is
certified by the American Board of Anesthesiology, as well as the
American Academy of Pain Management. (Tr. vol. 7, at 11; see Gov't Ex.
20 at 3.) Dr. Berger further testified that the American Academy of
Pain Management is not a board, but rather a peer review organization,
which predated the American Board of Pain Management. Dr. Berger
testified that he is not board certified by the American Board of Pain
Management. (Tr. vol. at 7, at 26.) Based on his experience, education,
and training, I accepted Dr. Berger as an expert within the field of
pain medicine.
Consistent with his testimony, Dr. Berger stated in his report that
the patient files for undercover special agents Brigantty, Zdrojewski
and Ryckeley reflected "extremely superficial physical examinations,
which were essentially memorialized in the record as a series of
checkboxes, which did not truly indicate what was done." (Gov't Ex. 32
at 113.) Dr. Berger's report further indicated that the three patient
files reflected referrals to a neurosurgeon in two instances, and an
interventional anesthesiologist in the third, but "these were just
words, and never actually occurred." (Gov't Ex. 32 at 114.)
Dr. Berger opined that with regard to his review of eight
undercover patient files, and related information, Respondent "fell
well below the standard of care in many if not all the standards as
they relate to the prescribing of controlled substances in the State of
Florida." (Tr. vol. 7, at 177.) Dr. Berger explained the basis for his
opinion to include the fact that evaluations of patients were
incomplete, lacked review of prior patient records, and Respondent was
"essentially taking [patients] at their word for a lot of their
stories." (Tr. vol. 7, at 178.) Dr. Berger further explained that
Respondent's treatment plans were just checked boxes, and Respondent
had not made actual referrals to other healthcare providers. Dr. Berger
also testified that it is very dangerous to treat people with
depression or bipolar disorder with a combination of opioids and
benzodiazepine. (Tr. vol. 7, at 180.)
3. Commercial Medical Group (CMG)
SA Gill testified in substance to having approximately seven years
of law enforcement experience with DEA. SA Gill testified that he was
primarily involved in the investigation of CMG, which began in
September of 2009. (Tr. vol. 5, at 203.) SA Gill testified that he was
the "case agent" and learned from a confidential source that a Mr.
Vincent Colangelo was the owner of several pain clinics, including CMG.
(Tr. vol. 5, at 203.) CMG was determined to be a cash-only business
open usually six days per week, with lines of patients outside the
door. (Tr. vol. 5, at 205.) SA Gill was also aware that Respondent
worked as a physician at CMG. (Tr. vol. 5, at 204.) SA Gill further
testified that weekly surveillance which revealed vehicles from the
states of Kentucky, Tennessee, the Carolinas and Ohio, among others,
raised DEA agents' suspicions. (Tr. vol. 5, at 205.)
SA Gill further testified that based on information from various
confidential sources, CMG saw approximately forty to one hundred
patients a day. (Tr. vol. 5, at 207-08.) SA Gill testified that Mr.
Colangelo had a well-known formula that would generate the most amount
of money for the clinic, keep patients happy and generate a lot of
money for the pharmacy. (Tr. vol. 5, at 214.) The formula was "240
oxycodone 30-milligram tablets, 90 oxycodone 15-milligram tablets, and,
then, 90 Xanax, 2-milligram bars." (Tr. vol. 5, at 214.)
SA Gill testified that as part of the investigation of CMG, three
undercover law enforcement officers posing as patients visited CMG in
early 2010 \11\ with the goal of meeting one-on-one with a doctor to
determine if there was any level of criminal behavior or if
inappropriate prescriptions were being written. (Tr. vol. 5, at 206.)
SA Gill further testified on direct examination that in January 2011,
he instructed that law enforcement officers go to CMG with release
forms and attempt to recover patient files related to three undercover
law enforcement visits to CMG in 2010.\12\ (Tr. vol. 5, at 215.) SA
Gill testified on direct examination that he was unsuccessful in
obtaining the undercover patient files from CMG.
---------------------------------------------------------------------------
\11\ The witness did not recall the exact date, but thought it
was "January or so." (Tr. vol. 5, at 205.) The testimony of the
undercover officers and other uncontroverted evidence of record
places the date at March 5, 2010.
\12\ Special Agents Miller, Bazile and McClarie.
---------------------------------------------------------------------------
On cross-examination, over Government counsel's objection,\13\ SA
Gill testified that he had recovered the patient files for at least two
of the three undercover officers that met with Respondent at CMG. (Tr.
vol. 5, at 218.) The files were recovered at a storage warehouse. (Tr.
vol. 5, at 219.) SA Gill also testified the "Colangelo formula" had
been reduced due to law enforcement and media attention, and the
formula was not consistent with every patient. (Tr. vol. 5, at 227.) SA
Gill further testified on cross-examination that he was aware
Respondent had quit CMG, but did not know the reason. (Tr. vol. 5, at
237-38.)
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\13\ As a cautionary note, although Agency precedent relieves
the Government of a duty to disclose "potentially exculpatory
information" to a respondent, there remains, of course, an ongoing
duty to ensure that material evidence and argument made to a fact-
finder is not knowingly contradicted by other material evidence in
the Government's possession, but not otherwise disclosed. See, e.g.,
Richard A. Cole, M.D., 57 FR 8677, 8677 (DEA 1992) (after hearing,
Government filed Request for In Camera Inspection of Information
advising that one of Government's witnesses at hearing failed to
disclose information in response to certain questions asked during
cross-examination).
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[[Page 5125]]
(a) SA Miller, March 5, 2010 Undercover Visit to CMG
SA Miller testified in substance to having approximately fourteen
years of law enforcement experience, including an assignment to a DEA
Tactical Diversion Squad for the past three years. SA Miller testified
that he met Respondent on March 5, 2010, at CMG while working in an
undercover capacity and posing as a patient. Upon arriving at CMG he
observed the waiting area to be very crowded and disorganized, with a
long line of people. (Tr. vol. 5, at 13.) After waiting in line, SA
Miller was handed a clipboard with paperwork and told the cost of the
visit was $250, for which he gave the receptionist $300.\14\ (Tr. vol.
5, at 14.) SA Miller completed the paperwork, noting left knee
discomfort and nothing on the pain scale, among other information.
(E.g., Tr. vol. 5, at 16.) SA Miller also provided CMG staff a copy of
an MRI report which was an actual report of SA Miller's knee using his
undercover name. (Tr. vol. 5, at 29; see Gov't Ex. 12 at 13.) After
returning the forms to the receptionist, SA Miller waited approximately
two hours, noticing that other patients arriving after him had already
been seen by a doctor. (Tr. vol. 5, at 17.) SA Miller approached the
receptionist and gave her a $100 tip to speed things along, and waited
another two hours before being called to triage. (Tr. vol. 5, at 17.)
In triage, SA Miller's blood pressure was taken and he was asked the
purpose of the visit. SA Miller also submitted to a urinalysis test.
(Tr. vol. 5, at 18.)
---------------------------------------------------------------------------
\14\ The receptionist indicated she did not have any change and
SA Miller told her to keep the difference, which she did. (Tr. vol.
5, at 14.)
---------------------------------------------------------------------------
SA Miller next testified that before he went to the triage area,
Mr. Vincent Colangelo arrived and appeared agitated, questioning why so
many people were waiting, and indicated that the doctor was not then
seeing anyone. (Tr. vol. 5, at 20.) After triage, SA Miller overheard
Mr. Colangelo speaking on the phone about prices charged for out-of-
state patients. (Tr. vol. 5, at 20.)
SA Miller continued to wait, and eventually Respondent called SA
Miller to come back and see him. (Tr. vol. 5, at 23.) SA Miller met
with Respondent in an examination room, with the visit lasting a total
of approximately five minutes. (Tr. vol. 5, at 23.) SA Miller explained
his knee issue, noting that he had seen a family practice doctor in
Colorado, but had not seen a doctor in approximately one month. (Tr.
vol. 5, at 24.) SA Miller also told Respondent he was taking Vicodin.
(Tr. vol. 5, at 26.) Upon questioning by Respondent, SA Miller stated
his pain was a five on a one-to-ten scale. (Tr. vol. 5, at 24.)
Respondent next asked SA Miller to stand, raise his arms, touch his
toes, and Respondent also placed a stethoscope on SA Miller's chest and
back. (Tr. vol. 5, at 25.) Respondent next issued SA Miller a
prescription for 60 Roxicodone 15 mg tablets.\15\ (Tr. vol. 5, at 26;
Gov't Ex. 12 at 14.)
---------------------------------------------------------------------------
\15\ The evidence also included a partial transcript of the
undercover meeting. Neither party produced a patient file.
---------------------------------------------------------------------------
Respondent testified in substance that review of the patient file
for SA Miller, including the MRI report, was critical to his ability to
respond to the Government's allegations, and would have assisted him
with testimony. (Tr. vol. 10, at 13-16.) Respondent understood SA
Miller's representation of pain to be a five located in the knee, with
pain lasting for eighteen months. (Tr. vol. 10, at 18.) Respondent
further testified to the importance he places on listening to patients
with regard to prescribing medication. (Tr. vol. 10, at 22.) Having
patients perform range-of-motion exercises included checking for track
marks. (Tr. vol. 10, at 23.) Respondent testified he believed SA Miller
was being honest, expressing reports of pain that were real and
significant. (Tr. vol. 10, at 26-27.)
Respondent also testified that part of his plan in treating SA
Miller was to assess in a follow-up appointment whether the medication
had relieved the pain. (Tr. vol. 10, at 29.) Respondent testified that
he "would not have prescribed medication unless a patient presents a
convincing story of pain and has a legitimate medical purpose for
receiving medication." (Tr. vol. 10, at 30.)
(b) SA McClarie, March 5, 2010 Undercover Visit to CMG
SA McClarie testified in substance to having approximately thirteen
years of law enforcement experience, including an assignment to a DEA
Tactical Diversion Group for the past few years. (Tr. vol. 5, at 94-
95.) SA McClarie testified to meeting Respondent on March 5, 2010, at
CMG while working in an undercover capacity and posing as a patient.
(Tr. vol. 5, at 95-96.) SA McClarie testified that upon arriving at
approximately 1:30 p.m., he observed approximately fifty people inside
the clinic. (Tr. vol. 5, at 97.) While waiting in line, SA McClarie
overheard one person state that he was from New York and "was down
here to get prescription medication." (Tr. vol. 5, at 98.) SA McClarie
further testified to observing a male who appeared to be in the company
of four or five people, and the male went to the front desk, paid cash
for all of the people with him and obtained clipboards and forms for
the group to fill out. (Tr. vol. 5, at 99.)
SA McClarie next testified that when he reached the front counter
he was charged $350 for the visit and another $100 for "VIP"
expedited service, all paid in cash. (Tr. vol. 5, at 111-12.) The
receptionist gave SA McClarie forms to fill out including a pain scale,
on which he circled all the numbers with one large circle. (Tr. vol. 5,
at 112-13.) SA McClarie also informed CMG staff that he had an MRI done
but did not have the MRI report with him, to which the staff indicated
they would have it faxed over. (Tr. vol. 5, at 113-14.) SA McClarie
next completed a triage procedure \16\ and after an additional wait,
met with Respondent.
---------------------------------------------------------------------------
\16\ The triage procedure at CMG generally consisted of an
inquiry regarding the purpose of the visit, medications, and the
measurement of biometric data such as height, weight, blood pressure
and urinalysis testing.
---------------------------------------------------------------------------
SA McClarie testified that Respondent told him that the MRI of his
knee was not very impressive. (Tr. vol. 5, at 117 & 119.) SA McClarie
also informed Respondent he was having issues with his back. (Tr. vol.
5, at 117.) Respondent asked SA McClarie about his blood pressure and
whether he was allergic to anything, listened to SA McClarie's heart
with a stethoscope and had SA McClarie perform a series of basic
movements such as standing and bending, among others. (Tr. vol. 5, at
121.) SA McClarie completed the range-of-motion test without
difficulty. (Tr. vol. 5, at 121.) Respondent asked SA McClarie how the
over-the-counter medications were working, to which SA McClarie said
they were doing nothing. (Tr. vol. 5, at 122.) Respondent indicated
there was no way he could prescribe strong pain medication and SA
McClarie said he did not want the strongest and just wanted some help.
(Tr. vol. 5, at 122.) Respondent then prescribed 120 Roxicodone 15 mg
tablets, noting that this was a "compromise." (Tr. vol. 5, at 122 &
172.) \17\
---------------------------------------------------------------------------
\17\ The Government offered a transcript of the audio recording
of SA McClarie's undercover meeting at CMG (Gov't Ex. 10), but I
excluded the transcript for lack of foundation and reliability. (Tr.
vol. 5, at 199.) SA McClarie credibly testified that he last
listened to the audio recording over a year ago. (Tr. vol. 5, at
133.) SA McClarie further testified that he was certain that
portions of the transcript marked as inaudible were in fact audible.
(Tr. vol. 5, at 146.) SA McClarie further testified that he was not
certain if other portions of the transcript were inaccurate. (Tr.
vol. 5, at 147.) The patient file for SA McClarie was not produced
at hearing by either party.
---------------------------------------------------------------------------
[[Page 5126]]
Respondent testified in substance that as with SA Miller, his
inability to review the patient file for SA McClarie significantly
impaired his ability to respond to the Government's allegations. (Tr.
vol. 10, at 32.) Respondent testified that he recalls SA McClarie
complaining of knee and back pain, but only had an MRI report of the
knee. (Tr. vol. 10, at 35.) Respondent further testified that in his
experience MRI reports reflecting abnormalities do not always correlate
to pain, explaining that there may be patients with significant
abnormalities on an MRI report with little or no pain, and other
patients with no abnormal findings and significant pain. (Tr. vol. 10,
at 36.) Respondent testified that "[w]e required them to have an MRI"
to provide some basis to support a diagnosis. (Tr. vol. 10, at 37.)
Respondent testified that in prescribing Roxicodone to SA McClarie,
his treatment plan was recorded in the patient chart, and believed the
treatment plan would have been to lower pain, increase function and
improve ability to work, among other goals. (Tr. vol. 10, at 48.)
Respondent further testified that it is sometimes more appropriate to
address other items in a treatment plan on subsequent visits, because
the doctor/patient relationship is more mature, and the patient has
already been in the office a long time on the first visit. (Tr. vol.
10, at 49.)
(c) SA Bazile, March 5, 2010 Undercover Visit to CMG
SA Bazile testified in substance that she had approximately ten
years of law enforcement experience, having previously worked as a DEA
diversion investigator for approximately six years and most recently as
a special agent. (Tr. vol. 6, at 10.) SA Bazile testified to meeting
Respondent on March 5, 2010, at CMG while working in an undercover
capacity and posing as a patient. (Tr. vol. 6, at 11-12.) SA Bazile was
in possession of a recording device to record conversations, but it
failed to operate during the entire visit including SA Bazile's meeting
with Respondent. (Tr. vol. 6, at 28.) SA Bazile noted approximately
twenty persons in the waiting room upon arrival. (Tr. vol. 6, at 12.)
SA Bazile testified to overhearing a conversation in the waiting area
between a CMG employee and a patient. SA Bazile had noticed the patient
because he was falling asleep and had slurred speech. (Tr. vol. 6, at
13.) SA Bazile also overheard the patient complain about not being seen
by a doctor because of a staff error. (Tr. vol. 6, at 14.) The patient
stated to a CMG employee that he had paid the staff member "$40 to
pass a dirty urine" and the staff member acknowledged that but was
explaining to the patient that the reason he could not be seen was due
to his appointment being too early. (Tr. vol. 6, at 14.) SA Bazile
noted the patient remained in the waiting room for some time, but was
unsure if he had been seen by a doctor. (Tr. vol. 6, at 15.)
SA Bazile next testified that upon contact with the CMG
receptionist, she was charged $350 for the office visit and was told by
the receptionist that for an additional $100 she could be placed on the
"VIP" list. (Tr. vol. 6, at 15.) SA Bazile agreed and paid a total of
$450 cash. (Tr. vol. 6, at 16.) SA Bazile filled out various forms
including a pain scale of one to ten, on which she circled five. (Tr.
vol. 6, at 17.) SA Bazile testified that in advance of the office visit
she had obtained an actual MRI of her shoulder using her undercover
name, which she believed was faxed to CMG from the MRI facility. (Tr.
vol. 6, at 26.) After completion of the paperwork, and a short triage
procedure, SA Bazile waited approximately one hour before seeing
Respondent. (Tr. vol. 6, at 19-20.) Respondent asked SA Bazile
questions about her pain and when the injury to her left shoulder
occurred, to which SA Bazile stated "about a year ago," referring to
the pain as "stiffness." Respondent also reviewed SA Bazile's MRI
during the visit, noting that there were no particular findings.
Respondent had SA Bazile stand, lift her arms up, and touch her toes,
remarking that she had good range of motion. (Tr. vol. 6, at 21.)
SA Bazile testified that after completing the range-of-motion exam
she sat down and asked Respondent what he would prescribe, stating in
substance that she likes "blues" \18\ and shares them with a friend.
Respondent did not directly respond to the statement about sharing
"blues" but asked why SA Bazile wanted them, noting they are for
patients with debilitating illnesses. (Tr. vol. 6, at 22-23.)
Respondent also indicated in substance that he was aware from news
stories that DEA was "targeting doctors like him." (Tr. vol. 6, at
23.) Respondent then prescribed SA Bazile 90 Roxicodone 15 mg tablets.
SA Bazile then asked Respondent for something to help her sleep to
which Respondent inquired if she had trouble sleeping. SA Bazile stated
"sometimes" and Respondent replied that she was not very convincing,
but prescribed 30 Xanax 1 mg tablets. (Tr. vol. 6, at 23-24.)
---------------------------------------------------------------------------
\18\ SA Bazile further explained that "Blues" are the street
name for oxycodone 30 mg tablets. (Tr. vol. 6, at 22.)
---------------------------------------------------------------------------
Respondent testified in substance that he believed SA Bazile had
been a patient truthfully seeking relief from pain, and relied on the
MRI report and SA Bazile's statements in issuing a prescription for
Roxicodone. (Tr. vol. 10, at 52.) Respondent testified that Xanax is
used to assist patients with sleep problems, which some people taking
Roxicodone may experience, but could not provide the reasons for
prescribing Xanax to SA Bazile without having the opportunity to see
her patient file. (Tr. vol. 10, at 53.)
4. Coast to Coast Healthcare Management (CCHM)
TFO Weir testified in substance to having approximately ten years
of law enforcement experience, and to becoming involved in the
investigation of CCHM as case agent. TFO Weir testified that he was
involved in redacting information from various patient files, and
explained the substance of the information redacted from Government
Exhibits 21-28. (Tr. vol. 5, at 266-305.)
(a) SA Marshall, April 7 and May 4, 2010 Undercover Visits to CCHM
SA Marshall testified in substance to having seven years of law
enforcement experience, of which the last five were with DEA. (Tr. vol.
4, at 6.) SA Marshall participated in an investigation of Respondent on
April 7 and May 4, 2010. (Tr. vol. 4, at 10 & 11.) SA Marshall had
visited CCHM in an undercover role as a first-time patient on March 3,
2010, but had seen a doctor other than Respondent. (Tr. vol. 4, at 9.)
SA Marshall testified that as he filled out paperwork in the waiting
area during the March 3, 2010 visit a person unknown to him, but who
appeared friendly with CCHM staff, provided him advice on filling out
the paperwork. (Tr. vol. 4, at 14.) SA Marshall informed the person
that he was concerned that his urinalysis would not be "dirty" and
the person informed SA Marshall that SA Marshall could give the
"girl" some money and she could "dirty" up the urine. (Tr. vol. 4,
at 14.) SA Marshall further testified that during the triage process,
he informed the female staff member about the conversation in the
waiting area, and gave the staff member $50 in cash, which she
accepted. (Tr. vol. 4, at 15.) SA Marshall then observed the staff
member indicate on the urinalysis paperwork the presence of opiates,
but had never tested his urine. (Tr. vol. 4, at 15.)
SA Marshall testified that on April 7, 2010, he again travelled to
CCHM acting
[[Page 5127]]
in the undercover role of a patient, carrying a concealed recorder, and
met with Respondent. (Tr. vol. 4, at 11.) After completing a triage
procedure, and a short wait, SA Marshall met with Respondent in a
patient examination room. During the encounter SA Marshall stated in
substance to Respondent that he was homeless and needed oxycodone, and
upon questioning by Respondent provided information on the street value
of the medication. (Gov't Ex. 6 at 18-19, 21-22.) SA Marshall further
testified that Respondent then informed him that "we don't participate
in such folly" and walked him to a nurse's station. (Tr. vol. 4, at
25.) SA Marshall testified that Respondent walked up to a nurse but
"that was in a back room, and I couldn't hear what they were saying"
and waited. (Tr. vol. 4, at 25.) SA Marshall waited and observed
Respondent call another patient.
SA Marshall testified that he then met privately with a staff
member named Cindy Mesa, who chastised SA Marshall for informing
Respondent that he was living on the street and selling the "stuff,"
because she would have to erase the information and call him back the
next day to see a different doctor. (Tr. vol. 4, at 26; Gov't Ex. 6 at
9.) SA Marshall further testified that Ms. Mesa stated that Respondent
thought SA Marshall was an "undercover" and trying to "bust"
Respondent. (Tr. vol. 4, at 26.) SA Marshall further testified that he
returned the next day, April 8, 2010, was seen by a different doctor
and was prescribed the following controlled substances: 120 oxycodone
30 mg and 30 Xanax 2 mg tablets. (Tr. vol. 4, at 27; Gov't Ex. 21 at
24.)
SA Marshall next testified that he returned to CCHM on May 4, 2010,
for a follow-up visit, and met with Respondent. (Tr. vol. 4, at 29.) SA
Marshall understood from other agents posing as patients that they had
already established a "relationship" with staff and had front-of-the-
line privileges. (Tr. vol. 4, at 29.) SA Marshall testified that he
paid $200 cash for the visit and met with a female staff member in
triage who was the same person he had met on his three previous visits
to CCHM. (Tr. vol. 4, at 29.) SA Marshall informed the staff member
that he had been kicked out by Respondent on a prior visit because he
had told Respondent he was living on the street and selling the drugs,
at which point both SA Marshall and the staff member laughed. (Tr. vol.
4, at 30.) Following the triage encounter, SA Marshall waited to be
called by Respondent.
SA Marshall further testified that he met with Respondent for a
brief visit lasting approximately three minutes, with questions
relating to how he was doing and if the medications were working.
Respondent checked SA Marshall with a stethoscope and had him perform
some body movements, and then issued prescriptions. (Tr. vol. 4, at
31.) Respondent prescribed SA Marshall 120 oxycodone 30 mg and 30 Xanax
2 mg tablets. (Gov't Ex. 6 at 45.)
Respondent testified in substance that information relating to the
April 7, 2010 meeting with SA Marshall was missing from the patient
file. (Tr. vol. 10, at 59; Resp't Ex. 1.) Respondent further testified
that he recalled how SA Marshall looked on April 7, 2010, noting some
type of gel in his hair, which was pointing up. Respondent testified
that he became concerned during the visit with SA Marshall on April 7,
2010, concluding that SA Marshall was not in need of medication, "but
instead was diverting." (Tr. vol. 10, at 61.) Respondent testified
that after he discharged SA Marshall, he did not know that SA Marshall
had returned the next day and was seen by a different doctor, or that
the patient file had been destroyed by CCHM staff. (Tr. vol. 10, at
66.)
With regard to the May 4, 2010 follow-up visit, Respondent
testified that he recalls SA Marshall's appearance as being different
in that he was wearing a hat, but did not recognize him to be the same
person he had discharged on April 7, 2010. (Tr. vol. 10, at 69.)
Respondent testified that in making his medical assessment of SA
Marshall on May 4, 2010, he reviewed the notes of two other CCHM
doctors in the patient file. (Tr. vol. 10, at 75-76.) Respondent
testified that in issuing the May 4, 2010 prescription he believed SA
Marshall had real pain and the medication was helping. (Tr. vol. 10, at
85-86.)
Dr. Berger testified in substance that the medical file for SA
Marshall contained numerous inconsistencies, to include no obvious
physical examination on the first visit, an MRI report issued two days
before the first visit with no prescribing or ordering physician noted
on the MRI report. (Tr. vol. 10, at 63-64; Gov't Ex. 21 at 8.) Dr.
Berger further testified that he found the patient file was "very
unusual" in that it reflected prescriptions in a "polypharmacy
fashion," meaning the use of both benzodiazepines with an opiate, for
a patient who had a bipolar disorder with expressions of "severe
recent depression," yet no psychiatric consultation in the chart. (Tr.
vol. 10, at 64-65.)
(b) SA Saenz May 4, 2010 Undercover Visit to CCHM
SA Saenz testified in substance to having eight years of law
enforcement experience with DEA and to participating in an
investigation of Respondent on May 4, 2010. (Tr. vol. 2, at 229-31.) SA
Saenz testified that on the morning of May 4, 2010, she travelled to
CCHM, acting in the undercover role of a patient, with a concealed
recorder,\19\ and met with Respondent. (Tr. vol. 2, at 231.) This was
SA Saenz's first time meeting with Respondent at CCHM but she had been
there on two prior occasions in an undercover patient role, and met
with different doctors on each visit.\20\ (Tr. vol. 2, at 231.) SA
Saenz also testified that on a March 10, 2010 visit to CCHM she had
listed her pain level as nine, further describing it as sharp, shooting
and unbearable. (Tr. vol. 2, at 271.) SA Saenz testified that in
filling out the pain assessment forms on March 10, 2010, she was
coached by a CCHM employee. (Tr. vol. 2, at 271.) SA Saenz testified
that her undercover role was that of a patient in pain that needed
medication, but during the March 10, 2010 visit told the doctor that
her pain was a level three or four on a pain scale of one to ten. (See
generally Tr. vol. 2, at 272-73.)
---------------------------------------------------------------------------
\19\ The recording equipment failed to record the meeting. (Tr.
vol. 2, at 231.)
\20\ March and April of 2010. (Tr. vol. 2, at 238.) A different
CCHM doctor issued SA Saenz's prescriptions for 90 oxycodone 30 mg
and 30 Xanax 2mg tablets on April 8, 2010. (Resp't Ex. 4 at 24.)
---------------------------------------------------------------------------
SA Saenz further testified that during the May 4, 2010 visit to
CCHM she was in the company of two other DEA undercover agents, and
understood that "one of the undercovers" had negotiated the cost of
the visit with CCHM staff. (Tr. vol. 2, 233.) The cost of the office
visit was $150 and SA Saenz paid $200, but was not given any change. SA
Saenz completed one form and after completing a triage procedure \21\
met with Respondent.
---------------------------------------------------------------------------
\21\ At triage, staff measured her blood pressure, height,
weight and temperature. (Tr. vol. 2, at 241.)
---------------------------------------------------------------------------
SA Saenz testified that upon meeting Respondent, Respondent asked
her about current medications, work and whether the medications were
helping. (Tr. vol. 2, at 242, 275.) SA Saenz indicated she worked in
daycare and needed one more pill per day to increase her current
prescription from ninety to 120 pills, and Respondent indicated that he
could give her an extra pill a day. (Tr. vol. 2, at 242-43.) SA Saenz
testified her medication from a previous visit to CCHM was Roxicodone
30 milligrams. (Tr. vol. 2, at 243.) Respondent checked SA Saenz's
heart
[[Page 5128]]
rate with a stethoscope and asked where the pain was located.
Respondent printed the prescriptions and advised SA Saenz not to share
or sell the medication. Respondent did not discuss prior CCHM visits
with SA Saenz, nor did he discuss a treatment plan, objectives, goals,
risks, benefits or alternative medications. (Tr. vol. 2, at 249-51.)
Respondent issued SA Saenz prescriptions for 120 Roxicodone 30 mg
and 30 Xanax 2 mg tablets on May 4, 2010. (Tr. vol. 2, at 245; Gov't
Ex. 15 at 1-2.)
Respondent testified in substance that when he met with SA Saenz on
May 4, 2010, he was aware from the patient file that she had two prior
visits to CCHM, and was seen by two different physicians with initial
complaints of back pain. (Tr. vol. 10, at 173-75.) Respondent testified
that the initial treatment regimen was Motrin, a Medrol dose pack and
Vicodin, which was changed on the second visit to oxycodone 30 mg three
times per day, as well as Xanax for sleep. (Tr. vol. 10, at 175; Resp't
Ex. 4 at 24-25.) Respondent further testified that his thought process
on the May 4, 2010 visit was to try and "dial in the right dose"
based in part on information contained in the file, and information
learned from the patient. (Tr. vol. 10, at 176-80.) Respondent also
testified that SA Saenz had convinced him that her pain was still
significant, and he relied upon the truthfulness of the information
provided by SA Saenz to increase the dose by one tablet per day. (Tr.
vol. 10, at 177 & 180.)
Dr. Berger testified in substance and in error that Respondent had
treated SA Saenz on April 8, 2010.\22\ (Tr. vol. 7, at 129, 135 & 137;
Tr. vol. 8, at 206.) Dr. Berger also erroneously stated in his report:
"On 4-8-10. Dr. Wolff sees the patient for a second time * * *"
(Gov't Ex. 32 at 78; Tr. vol. 8, at 207.) Dr. Berger further stated in
his report the belief that the April 8, 2010 patient chart had a
signature that appeared to belong to Respondent, which was also
erroneous. (Gov't Ex. 32 at 80; Tr. vol. 8, at 199-207.) Dr. Berger
also erroneously concluded in his written report that a urinalysis
report dated March 10, 2010, was "positive for Phencylidine, [a]nti-
depressants, amphetamine, clearly making her a potential dangerous
patient to prescribe narcotics to." (Gov't Ex. 32 at 82; Tr. vol. 8,
at 190-202.)
---------------------------------------------------------------------------
\22\ This error was compounded by Government counsel's questions
on direct examination, which misstated the evidence, given that SA
Saenz had previously testified during the hearing that she first met
Respondent at CCHM on May 4, 2010. (Compare Tr. vol. 7, at 137, with
Tr. vol. 2, at 231.)
---------------------------------------------------------------------------
(c) SA O'Neil, May 4, 2010 Undercover Visit to CCHM
SA O'Neil testified in substance that he had five years of law
enforcement experience with DEA and participated in an investigation of
Respondent on May 4, 2010. (Tr. vol. 3, at 301.) SA O'Neil testified
that on May 4, 2010, he travelled to CCHM acting in the undercover role
of a patient, with a concealed recorder, and met with Respondent. (Tr.
vol. 3, at 302, 308.) This was SA O'Neil's first time meeting with
Respondent at CCHM but he had been there on two prior occasions in an
undercover patient role.\23\ SA O'Neil further testified that he was in
the company of other undercover DEA agents. He paid $200 cash for the
visit costing $150, letting a CCHM staff member "keep the change."
(Tr. vol. 3, at 305.) SA O'Neil informed a female staff member that he
was with three other "patients," two with him and one on the way, but
they "were all together," and asked her to put their charts in a
stack, which she did. (Tr. vol. 3, at 305.)
---------------------------------------------------------------------------
\23\ March and April, 2010. (Tr. vol. 3, at 301-02.)
---------------------------------------------------------------------------
SA O'Neil next testified that when called to the triage area, he
stated to a female staff member "the fact that there was going to be
four of us and I'd be quadrupling my money." (Tr. vol. 3, at 306.) In
response, the staff member shook her head. SA O'Neil later stated to
the same staff member during triage that he did not take the
medication, to which the staff member indicated: "I know you don't
take them," implying that she was not "stupid." (Gov't Ex. 14 at
25.)
SA O'Neil testified that after waiting for a period of time
following triage he was called and met with Respondent. During the
meeting SA O'Neil requested an increase in medication, noting at one
point that he had run out of the previous prescription and needed more.
(Tr. vol. 3, at 340.) SA O'Neil specifically asked if Respondent could
increase the Roxicodone dosage from 120 to 210 tablets, to which
Respondent replied: "I mean maybe, maybe eventually, but * * *." and
concluded by stating he absolutely could not double the medication now.
(Tr. vol. 3, at 312; Gov't Ex. 14 at 30.) SA O'Neil also informed
Respondent that he had taken liquid oxycodone from a friend, prompting
Respondent to reply: "Don't even tell me that." (Gov't Ex. 14 at 30.)
Respondent counseled SA O'Neil about the dangers of taking liquid
oxycodone and informed SA O'Neil that talking about using another
patient's medication in a pain clinic could result in getting
discharged. (Tr. vol. 3, at 313, 354; Gov't Ex. 14 at 31-32.)
Respondent asked SA O'Neil to lift his upper and lower extremities and
had him breathe in and out. SA O'Neil testified that Respondent
discussed how he was doing on the medication and counseled him on
stretching exercises. (Tr. vol. 3, at 313-14, 361.) Respondent
counseled SA O'Neil on safekeeping and use of medication. (Tr. vol. 3,
at 351.)
On May 4, 2010, Respondent issued SA O'Neil prescriptions for 150
Roxicodone 30 mg, 90 Roxicodone 15 mg and 30 Xanax 2 mg tablets. (Gov't
Ex. 14 at 53-54.) On April 7, 2010, Dr. [L.C.] issued SA O'Neil
prescriptions for 120 oxycodone 30 mg, 90 oxycodone 15 mg, 30 Xanax 2
mg and 30 Lisinopril \24\ 20 mg tablets. (Tr. vol. 10, at 151; Resp't
Ex. 3 at 24.) On March 10, 2010, Dr. [L.C.] issued SA O'Neil
prescriptions for 120 oxycodone 15 mg and 30 Xanax 2 mg tablets. (Tr.
vol. 10, at 150-51; Resp't Ex. 3 at 24-25.)
---------------------------------------------------------------------------
\24\ Lisinopril is a blood pressure medication. (Tr. vol. 10, at
151.)
---------------------------------------------------------------------------
Respondent testified in substance that another CCHM doctor had
treated and prescribed medication to SA O'Neil on the April 7 and March
10, 2010 visits. Upon inquiry, Respondent learned from SA O'Neil that
SA O'Neil had not filled the blood pressure medication prescription.
(Tr. vol. 10, at 152.) Respondent further testified that in talking
with SA O'Neil Respondent understood most of the pain to be in the
lower back, and the present dose was insufficient. (Tr. vol. 10, at
152-53.) With regard to SA O'Neil's statement that he had used liquid
oxycodone, Respondent testified that his statement "Don't even tell me
that," was not meant to ignore the issue but rather indicated
Respondent's being "disturbed" and "hurt" to hear of patients using
a dangerous product. (Tr. vol. 10, at 155.) Respondent testified that
he explained at length the dangers of using liquid oxycodone, to
include death, and believed at the end of his comments that SA O'Neil
accepted the rules and guidelines. (Tr. vol. 10, at 159.) Respondent
also testified that he told SA O'Neil about Williams stretching
exercises, and to look them up on the computer.\25\
---------------------------------------------------------------------------
\25\ The undercover transcript (Gov't Ex. 14 at 34) reflects in
relevant part:
WOLFF: Maybe the person that gave you the, uh * * *
UC1: [LAUGHS]
WOLFF: Oxy [U/I]
UC1: Yeah
WOLFF: let you use the computer, in light [PH] of the fact that
they're trying to murder you.
UC1: [LAUGHS]
WOLF: [PAUSE] Google that. William's stretching exercises.
---------------------------------------------------------------------------
[[Page 5129]]
Dr. Berger testified in substance that the medical file for SA
O'Neil had several blank pages, including the history and physical
examination forms, as well as several forms that had dates inconsistent
with the office visit in March 2010. (Gov't Ex. 23, at 10, 12-13; Tr.
vol. 7, at 108-09.) Dr. Berger testified that the existence of blank
forms in a medical file is significant because it goes to the "degree
of caution in the practice." (Tr. vol. 7, at 117.) Not having a
history and physical in the chart is "absolutely below the standard of
care." (Tr. vol. 7, at 117.)
Dr. Berger further testified that the patient file reflected a drug
screen dated March 10, 2010, which was positive for benzodiazepines
only, but contained no indication of a test for alcohol. (Tr. vol. 7,
at 113; Gov't Ex. 23 at 27.) Dr. Berger testified that in his opinion,
there was no legitimate basis to treat SA O'Neil with "such large
doses of narcotics without going through other channels first," to
mean such things as a review of prior medical records, other diagnostic
tests, medications, x-rays, nerve conduction studies and an orthopedist
consultation. (Tr. vol. 7, at 116.) Dr. Berger further testified that
SA O'Neil's mention of using liquid oxycodone shows the patient has a
tendency to receive medications illegally through diversion, which
makes them "a very unlikely candidate to receive further narcotic
prescriptions * * *." (Tr. vol. 7, at 125-26.)
(d) TFO Doklean, July 23, 2010 Undercover Visit to CCHM
TFO Doklean testified in substance that she had approximately
fourteen years of law enforcement experience, most recently working in
a Tactical Diversion Squad, and participated in an investigation of
Respondent on July 23, 2010. (Tr. vol. 1, at 176, 178-79.) TFO Doklean
testified that on July 23, 2010, she travelled to CCHM acting in the
undercover role of a patient,\26\ with a concealed audio and video
recorder,\27\ and met with Respondent for approximately ten minutes.
(Tr. vol. 1, at 177, 178, 181 & 268; Gov't Ex. 4.) The patient file
indicates this was TFO Doklean's first visit to CCHM in her undercover
role. (See Gov't Ex. 25.) TFO Doklean was in the company of several
other DEA agents acting in undercover roles as patients, and the group
was represented by an undercover agent posing in the role of "crew
leader or ringleader" who was bringing all of the undercover patients
to the clinic. (Tr. vol. 1, at 186.) TFO Doklean testified that she
paid $300 for the office visit and another $200 to a CCHM staff member
named Linda for "VIP treatment," meaning expedited service. (Tr. vol.
1, at 186, 187.)
---------------------------------------------------------------------------
\26\ The undercover role included identification information and
an actual MRI report of the undercover officer's back taken in
advance of the appointment. The MRI was provided to the clinic. (Tr.
vol. 1, at 215; Gov't Ex. 4 at 60, 61.)
\27\ TFO Doklean testified that she had a concealed recording
device in her possession throughout her visit to CCHM, with the
exception of a few minutes when the recorder was in possession of
another undercover agent. (Tr. vol. 1, at 239.)
---------------------------------------------------------------------------
TFO Doklean further testified that the portion of the clinic she
observed during her visit to CCHM included examination rooms, waiting
areas, a pharmacy dispensary, triage area, front desk and a restroom.
(Tr. vol. 1, at 179, 180.) TFO Doklean testified that while waiting for
her appointment she engaged in a brief conversation with a male seated
next to her regarding levels of prescribing at CCHM, and he told her
that even if she was started on low levels of medication "they will
bump you up." (Tr. vol. 1, at 185.) TFO Doklean also testified that
she observed a sign in the waiting room that stated: "Please be aware
that outside pharmacies are reporting prescription transactions to law
enforcement agencies. Feel free to discuss this with your physician."
(Tr. vol. 1, at 193.)
TFO Doklean testified that following a triage process she met with
Respondent. Upon inquiry, TFO Doklean informed Respondent of issues for
the prior six months with neck pain of unknown origin. (Gov't Ex. 4 at
31.) Respondent indicated in substance confusion because TFO Doklean
had provided an MRI report of her back, not her neck. (Tr. vol. 1, at
201.) TFO Doklean further testified that she informed Respondent that
the pain fluctuates from a two or three upwards, depending on the day,
and impacts her daily activities, including child care. (Tr. vol. 1, at
202.) Later, when Respondent inquired whether TFO Doklean drank
alcohol, TFO Doklean stated to Respondent that she had been in rehab
last year in November, but was "clean and sober." (Tr. vol. 1, at
203; Gov't Ex. 4 at 34.) TFO Doklean testified that Respondent made no
further inquiry regarding where, why or how long she had been in
rehabilitation. (Tr. vol. 1, at 203; Gov't Ex. 4 at 34-36.) Upon
inquiry about taking medication, TFO Doklean stated to Respondent that
in addition to Advils she has been taking some "blues" obtained from
a friend on and off for about six months, representing that they seemed
to help. (Gov't Ex. 4 at 34.) TFO Doklean testified that the term
"blues" is street terminology for oxycodone 30 milligram tablets.
(Tr. vol. 1, at 204.)
TFO Doklean next testified that Respondent examined her breathing
with a stethoscope and requested that she perform range-of-motion
exercises, including turning her head, which she successfully completed
without display or complaint of pain. (Tr. vol. 1, at 205 & 206.)
Respondent inquired and confirmed that TFO Doklean was not currently
taking medications, and stated that he would get TFO Doklean started on
some medication, cautioning her on the use and safe storage of the
medication. (Tr. vol. 1, at 286; Gov't Ex. 4 at 36.) TFO Doklean then
asked if she was going to get some "blues" and Respondent stated in
substance that he would look at the chart and "see what we can do for
you." (Id.)
Respondent issued TFO Doklean a prescription for 120 Roxicodone 30
mg tablets, which CCHM filled for a cost of $600 cash. (Tr. vol. 1,
189, 190; Gov't Ex. 4 at 54.) TFO Doklean testified that in addition to
requesting but not receiving a prescription for Xanax from Respondent,
she also did not know what kind of prescription would be provided until
after her meeting with Respondent had already concluded.
TFO Doklean also testified that she had been unsuccessful in
persuading a CCHM office manager named Richard to increase the amount
of the Roxicodone prescription, noting to Richard that "[i]t's not
enough to finance what I need to pay," which Richard acknowledged he
understood. (Tr. vol. 1, at 290; Gov't Ex. 4 at 40.) TFO Doklean
further testified that following her meeting with Respondent, Richard
provided instruction and direction about concerns that Respondent had
about patients "not putting the proper things in the paperwork," and
that the patients needed to say that they were in pain on the
paperwork, and to tell the doctors they were in pain. This information
was also directed to the undercover patients who had not yet been seen
by a doctor. (Tr. vol. 1, at 188; Gov't Ex. 4 at 39-40.) Richard
further stated to TFO Doklean (referring to Respondent): "This guy is
a little * * * this guy is a little * * * you know * * * serious and by
the book in making sure * * * uh * * * He does everything * * * partly
because he's been in a clinic that's been shut down before, so, it's
very hard for him. He knows * * * you guys are cool." (Tr. vol. 1, at
290; id. at 40.)
Respondent testified in substance that based on TFO Doklean's
statements, he believed she had both neck and back pain, and the pain
was significant enough at times to impact her ability to provide care
for her children. (Tr. vol.
[[Page 5130]]
10, at 186, 189 & 190-91.) Respondent further testified that he was
concerned with her drinking, but understood from TFO Doklean that she
had been out of "rehab" and sober for eight or nine months. (Tr. vol.
10, at 192.) Respondent testified that with regard to the term
"blues" and whether it constituted a "red flag" for prescribing, he
did not "want to make a value judgment upon her as to why she used
that term" rather than Roxicodone 30 mg. (Tr. vol. 10, at 193.)
Respondent further explained that use of the term "blues" and
previously buying or receiving a controlled substance outside of a
prescription is not a disqualifier to his prescribing controlled
substances to such a patient.
Respondent also testified that he gave TFO Doklean a prescription
for an MRI of her neck and expected to review an MRI report on the next
follow-up visit. (Tr. vol. 10, at 197.) Respondent further testified
that he prescribed Roxicodone 30 mg tablets because of the severity of
the unrelieved pain, and planned to reevaluate the patient in one
month. (Tr. vol. 10, at 198.) Respondent testified with regard to the
patient file, explaining that he documented various statements by TFO
Doklean, including past history of alcohol use. (Tr. vol. 10, at 202.)
Dr. Berger testified in substance that the patient file reflected
that TFO Doklean had a prior history of alcohol rehabilitation, but did
not list her treating physician, type of treatment or that TFO Doklean
had mentioned that she had obtained narcotics on the street. (Tr. vol.
7, at 146.) Dr. Berger testified that this information, taken together,
"preclude her from being a good candidate for receiving controlled
drugs" on her first visit, and that such a prescription would not be
in compliance with "the established care in Florida." (Tr. vol. 7, at
147.) Dr. Berger testified that Respondent was not in compliance with
the established standard of care for TFO Doklean, based on Respondent's
failure to conduct a complete physical examination, inquire further
about past drug use and rehabilitation, or engage in appropriate
consultations, among other deficiencies. (Tr. vol. 7, at 153-55.)
Dr. Berger's report similarly concluded that Respondent's treatment
of TFO Doklean fell below the standard of care in the areas of patient
evaluation, informed consent and agreement for treatment, periodic
review, consultation, medical records and compliance with controlled
substances laws and regulations. (Gov't Ex. 32 at 32-35.)
(e) SA Brigantty, July 23, 2010 Undercover Visit to CCHM
SA Brigantty testified in substance that he had nine years of law
enforcement experience with DEA and participated in an investigation of
Respondent on July 23, 2010. (Tr. vol. 2, at 13-16.) SA Brigantty
testified that on July 23, 2010, he travelled to CCHM acting in the
undercover role of a patient,\28\ with a concealed audio and video
recorder, and met with Respondent. (Tr. vol. 2, at 16, 22 & 26.) This
was SA Brigantty's first time visiting CCHM as an undercover patient.
(Tr. vol. 2, at 17.) SA Brigantty was in the company of several other
DEA agents acting in undercover roles as patients, and the group was
represented by a DEA agent acting in the undercover role of ringleader
and patient. (Tr. vol. 2, at 17-19.) CCHM staff members also understood
this role, and treated the undercover agents as a group. (Tr. vol. 2,
at 17 & 18.) SA Brigantty paid $200 for the office visit, which was the
same for each member of the group and included an expediting fee, and
SA Brigantty later paid $750 for medication prescribed and another $50
tip to a female CCHM staff member during the clinic visit. (Tr. vol. 2,
at 19, 42.)
---------------------------------------------------------------------------
\28\ The undercover role included identification information and
an actual MRI report of the undercover officer's back taken in
advance of the appointment. The MRI was provided to the clinic prior
to the appointment. (Tr. vol. 2, at 29-30; Gov't Ex. 9 at 55; Gov't
Ex. 26 at 22.)
---------------------------------------------------------------------------
SA Brigantty further testified that prior to meeting with
Respondent he filled out various clinic forms, with assistance from
CCHM staff. (Tr. vol. 2, at 2, 60-80.) Following a triage procedure, SA
Brigantty testified that he met with Respondent. During the meeting,
which lasted approximately fifteen minutes (see Gov't Ex. 9 at 35-46),
SA Brigantty informed Respondent about lower back pain which SA
Brigantty stated had been present for fifteen years, and was caused by
heavy lifting. (Tr. vol. 2, at 22, 59 & 89; Gov't Ex. 9 at 36.) SA
Brigantty testified that he informed Respondent that he had been taking
pain medicine in the form of "Oxys, 30 milligrams" and a "Zany bar"
referring to Xanax, which he purchased "off the street." (Tr. vol. 2,
at 37; Gov't Ex. 9 at 41.) SA Brigantty also represented to Respondent
that the pain at times was a six or greater, and at times could be
debilitating. (Tr. vol. 2, at 92, 96; Gov't Ex. 9 at 37.)
SA Brigantty testified that prior to being seen by Respondent he
was standing outside Respondent's office and noted that Respondent was
"walking around, nervous like, trying to figure out what was going
on," and before seeing SA Brigantty went to see another doctor for
approximately twenty minutes. (Tr. vol. 2, at 97.) SA Brigantty further
testified that he had then heard from other undercover officers present
at CCHM that "you need to say you are in pain" in order for
Respondent and the rest of the doctors to prescribe pain. (Tr. vol. 2,
at 97-98.)
SA Brigantty further testified that during the office visit,
Respondent performed a brief examination in the form of having him
push, pull and lift his upper and lower extremities, and also showed SA
Brigantty a chart. (Tr. vol. 2, at 40-43.) During the examination
Respondent asked SA Brigantty a series of questions about past medical
issues, including blood pressure, to which SA Brigantty responded that
he had been informed earlier that it was high. (Gov't Ex. 9 at 40.)
Respondent then acknowledged it was very high and counseled SA
Brigantty on the need for re-evaluation, meaning the "need to find a
regular medical doctor as soon as possible" to be rechecked. (Gov't
Ex. 9 at 42.) Respondent inquired of SA Brigantty what he had
previously been prescribed, and SA Brigantty stated "Oxy Thirties,"
further explaining when asked by Respondent whether he "use to go to
American Pain" that he put that on the form because the "girls
outside" told him he had to write something. (Gov't Ex. 9 at 44.) SA
Brigantty explained to Respondent that he was not seeing a physician
and could barely afford to come to CCHM. Respondent made no inquiry
regarding SA Brigantty's statement of falsely listing American Pain as
a current or former treatment provider. (Gov't Ex. 9 at 44-46; 60-V-
0010.)
Respondent issued SA Brigantty a prescription for 150 Roxicodone 30
mg tablets. (Tr. vol. 2, at 45; Gov't Ex. 9 at 53-54.)
Respondent testified in substance that he believed SA Brigantty had
described significant pain, and even though SA Brigantty had previously
been on a lot of medication, Respondent felt it reasonable to start him
on a lower dose of 150 Roxicodone 30 mg tablets, to be taken up to five
times per day. (Tr. vol. 10, at 265.) Respondent further testified that
he did not believe it necessary to prescribe Xanax because the patient
stated that if his pain were under control he would sleep better. (Tr.
vol. 10, at 265.) Respondent also testified that the MRI report
reflected significant disc disease, with disc bulging and "evidence of
boney abnormality compressing the spinal cord as well as both areas
where the nerve comes out
[[Page 5131]]
* * *." which correlated with SA Brigantty's complaint of pain. (Tr.
vol. 10, at 267.)
Dr. Berger testified in substance that a patient who represents
that he is illegally buying drugs on the street, and is requesting the
same drug to be prescribed, would be precluded from receiving
prescriptions for controlled substances. (Tr. vol. 7, at 161.) Dr.
Berger further testified that based on his review of the medical file,
he did not see anything that justified the issuance of controlled
substances. (Tr. vol. 7, at 162; Gov't Ex. 26.)
(f) SA Priymak, April 7 and May 4, 2010 Undercover Visits to CCHM
SA Priymak testified in substance to having worked for DEA since
2004 and to participating in an investigation of Respondent on April 7
and May 4, 2011. (Tr. vol. 2, at 314-15.) On April 7, 2011, SA Priymak
travelled to CCHM acting in the undercover role of a patient, carrying
a concealed audio recorder. SA Priymak testified to seeing several
dozen people in the waiting room, and to paying $175 cash to the
receptionist. (Tr. vol. 2, at 318-19.) After completing a series of
forms and a triage procedure,\29\ SA Priymak met with Respondent. (Tr.
vol. 2, at 320-21.) SA Priymak further testified that he informed
Respondent that he had a little bit of pain in his neck with a pain
level of two and three, which Respondent stated was low for him to
write a prescription. (Tr. vol. 2, at 322-23.) SA Priymak also
testified that upon questioning by Respondent, SA Priymak increased the
level to five. (Tr. vol. 3, at 15.) SA Priymak informed Respondent that
he was taking 160 milligrams of OxyContin per day along with a quantity
of Xanax and Soma, stating he was buying them "off the street." (Tr.
vol. 2, at 323, 376.) SA Priymak also indicated a history of
intravenous drug use which ended five years prior and current use of
alcohol. (Gov't Ex. 5 at 38 & 41.)
---------------------------------------------------------------------------
\29\ The triage procedure at CCHM generally consisted of a
collection of biometric information such as height, weight and blood
pressure, and sometimes included urinalysis testing.
---------------------------------------------------------------------------
SA Priymak next testified that Respondent informed him he would not
write a prescription for thirty milligram "oxi's" so SA Priymak
inquired about fifteen milligrams, to which Respondent shook his head
and said yes. (Tr. vol. 2, at 324.) SA Priymak further testified that
Respondent asked him if he wanted Xanax, to which SA Priymak said yes.
(Tr. vol. 2, at 325.) Respondent also suggest to SA Priymak that he go
to a rehabilitation facility. (Tr. vol. 2, at 325.) Respondent wrote a
prescription to SA Priymak for 150 Roxicodone 15 mg and 30 Xanax 2 mg
tablets. (Gov't Ex. 5 at 63-64.)
SA Priymak further testified that he returned to CCHM on May 4,
2010, for a follow-up appointment with Respondent. (Tr. vol. 2, at
327.) The cost of the appointment was $150, for which SA Priymak paid
$200 in cash to CCHM staff but was not given change back. (Tr. vol. 2,
at 328.) After a wait and triage procedures, SA Priymak met with
Respondent for a very short visit lasting approximately less than four
minutes. (Tr. vol. 2, at 328; Gov't Ex. 5 at 2-5.) SA Priymak testified
that Respondent checked his breathing and again issued prescriptions
for 150 Roxicodone 15 mg and 30 Xanax 2 mg tablets. (Tr. vol. 2, at
328-29; Gov't Ex. 5 at 65-66.) Respondent did not raise the issue of
rehabilitation or the use of alcohol during the patient encounter on
May 4, 2010. (Gov't Ex. 5 at 54-58.)
Respondent testified in substance that the MRI report associated
with the April 7, 2010 visit had been verified. (Resp't Ex. 1 at 25;
Tr. vol. 10, at 91.) Respondent further testified that he believed SA
Priymak's reference to pain as a one, two and zero to be confusion on
the part of the patient, and Respondent attempted to "clarify" but
not coach the patient in arriving at a pain number. (Tr. vol. 10, at
94-95.) Respondent testified that during the course of his meeting with
SA Priymak, Respondent came to believe that SA Priymak was from
"another country" and was not communicating properly. (Tr. vol. 10,
at 99.) Respondent explained that he asked a series of questions,
including history of past treatment, alcohol and drug use. (Tr. vol.
10, at 102-03.) Respondent testified that he declined to write a
prescription for the type and quantity of medication requested by SA
Priymak; rather he used his medical judgment based on his
interpretation and assessment of the degree of pain, but was convinced
that SA Priymak had significant pain. (Tr. vol. 10, at 108.)
Respondent also testified that he does not believe a doctor is
precluded from prescribing controlled substances to a patient who has
previously taken or is currently taking illegal drugs or drugs without
a prescription. (Tr. vol. 10, at 111.) With regard to the prescription
for Xanax, Respondent testified that he prescribed it because SA
Priymak stated he had problems sleeping, and Respondent felt it was
medically appropriate. (Tr. vol. 10, at 116.) Respondent declined to
prescribe Viagra, which SA Priymak had requested, because he saw no
medical indication to support SA Priymak's request. (Tr. vol. 10, at
117.) Respondent testified that he diagnosed SA Priymak with neck pain,
chronic pain and cervical disc disorder. (Tr. vol. 10, at 125.)
With regard to the May 4, 2010 follow-up visit, Respondent
testified that he would have had the prior file information available
to him, and relied on the truthfulness of what patients represent,
including patient forms with attestations of truthfulness. (Tr. vol.
10, at 131; Resp't Ex. 2 at 15.) Respondent further testified that
people may try to deceive him but he is "always on the lookout to
catch that," noting he is not perfect. (Tr. vol. 10, at 132.)
Respondent testified that his interpretation of the March 10, 2010 MRI
report was "consistent with a patient having significant neck pain."
(Tr. vol. 10, at 138; Resp't Ex. 2 at 25.) Respondent testified that
based on the patient's representations that he was doing well,
Respondent prescribed SA Priymak the same dose of medications.
Dr. Berger testified in substance that after a review of the
patient file, among other information, he was of the opinion that
prescriptions for Roxicodone and Xanax on April 7, 2010, were
unwarranted, particularly given the patient's history of being an
intravenous drug user and having purchased drugs illicitly on the
street. (Tr. vol. 7, at 92.) Dr. Berger further testified that his
review of the patient file noted a discrepancy between the chart, which
referenced Roxicodone 30 mg, and the actual prescription, which
Respondent issued for Roxicodone 15 mg. (Tr. vol. 7, at 97; Gov't Ex.
22 at 22-24.) Dr. Berger also testified that from April 7, 2010 to May
4, 2010, there was no significant information to legitimize the
reissuance of a prescription for controlled substances, explaining that
the patient had not gone for another opinion, to include other
therapies to reduce narcotic requirements. (Tr. vol. 7, at 98.)
Consistent with his testimony, Dr. Berger opined in his written
report that Respondent "fell below the standard of care and treatment
of this particular UC patient." (Gov't Ex. 32 at 73.) In support of
this opinion, Dr. Berger noted that Respondent's evaluation lacked a
complete history of pain, prior treatments, effects, physicians and
records, among other deficiencies. (Gov't Ex. 32 at 73.)
(g) SA Zdrojewski, July 23, 2010 Undercover Visit to CCHM
SA Zdrojewski testified in substance that he had nine years of law
enforcement experience with DEA, most
[[Page 5132]]
recently working in a Tactical Diversion Squad, and participated in an
investigation of Respondent on July 23, 2010. (Tr. vol. 3, at 68-69.)
SA Zdrojewski testified that on July 23, 2010, he travelled to CCHM,
acting in the undercover role of a patient,\30\ with a concealed audio
recorder, and met with Respondent. (Tr. vol. 3, at 69 & 71.) SA
Zdrojewski was in the company of several other DEA agents acting in
undercover roles as patients, and the group was represented by a DEA
agent, SA Jack Lundsford, acting in the undercover role of
"ringleader" for the undercover patients. (Tr. vol. 3, at 69-72.) SA
Zdrojewski testified that he paid $300 for the office visit and another
$200 to SA Lundsford to be given to CCHM staff for "VIP treatment."
(Tr. vol. 3, at 72.)
---------------------------------------------------------------------------
\30\ The undercover role included identification information and
an actual MRI report of the undercover officer's neck taken in
advance of the appointment. The MRI was provided to the clinic. (Tr.
vol. 3, at 81; Gov't Ex. 8 at 24.)
---------------------------------------------------------------------------
SA Zdrojewski next testified that following completion of
"paperwork" he waited and was eventually called to a triage room,
where two female CCHM staff members recorded his height, weight and
blood pressure. (Tr. vol. 3, at 73 & 76.) SA Zdrojewski was asked to
provide a urine sample and noted during the process that other than
directions from staff, the urinalysis process was unsupervised. (Tr.
vol. 3, at 78.) After providing the urine sample to staff, SA
Zdrojewski testified that he told staff members that he had "fooled
around with the test" but no one said anything to him. (Tr. vol. 3, at
79.)
SA Zdrojewski further testified that he eventually was called and
met with Respondent for approximately ten minutes.\31\ (Tr. vol. 3, at
83.) Upon inquiry by Respondent, SA Zdrojewski stated in substance that
he had been having intermittent neck pain for approximately one and
one-half years, but did not know the cause. (Tr. vol. 3, at 86, 87 &
126.) SA Zdrojewski further testified that with regard to a history and
physical examination form, Respondent had not discussed with him
various items checked on the form, to include: Anti-inflammatories and
diet, yoga/stretching exercises, and use of omega-3 fish oil, three to
six grams per day, among others.\32\ (Tr. vol. 3, at 88, 89; Gov't Ex.
28 at 5; Gov't Ex. 8 at 11-18.) Upon inquiry by Respondent, SA
Zdrojewski stated that he smoked marijuana and was self-medicating for
pain. (Tr. vol. 3, at 89 & 90.) SA Zdrojewski had originally written on
the pain scale that his pain was a zero or a one but upon explanation
by Respondent that zero to one meant no pain, SA Zdrojewski told him to
"top it," meaning all the way to the high end of the pain scale. (Tr.
vol. 3, at 97, 141-42.) SA Zdrojewski stated to Respondent that other
treating sources had given him very large amounts of pain medications,
which he further indicated was more than he needed. (Gov't Ex. 8 at
12.)
---------------------------------------------------------------------------
\31\ SA Zdrojewski represented to Respondent that this was his
first visit to CCHM and that he had previously been treated at
"Tampa Bay Wellness before they were closed down." (Tr. vol. 3, at
97; Gov't Ex. 8 at 11.)
\32\ This was consistent with testimony from the other witnesses
who had posed as patients and seen Respondent.
---------------------------------------------------------------------------
SA Zdrojewski next testified that upon inquiry by Respondent about
alcohol use, SA Zdrojewski stated he drank a lot, further explaining
that he considered a "case of beer" to be "a lot" and drank no hard
liquor when working. (Tr. vol. 3, at 88, 147; Gov't Ex. 8 at 14.)
Respondent had SA Zdrojewski take some breaths and perform some
physical maneuvers including bending and touching his toes.\33\ (Gov't
Ex. 8 at 16.) Respondent then explained to SA Zdrojewski the results of
his MRI, noting that the "MRI doesn't show much of anything and
secondly, drinking a case of beer is not compatible with taking strong
medicine like this * * *." (Tr. vol. 3, at 153; Gov't Ex. 8 at 17.)
Respondent inquired of SA Zdrojewski about the alcohol consumption, to
which SA Zdrojewski stated he would stop drinking. (Gov't Ex. 8 at 17-
18; Tr. vol. 3, at 163.) Respondent noted the chart contained self-
reported use of Xanax, and SA Zdrojewski said that Xanax had been given
to him previously and that he would accept an additional Xanax
prescription if one were offered to him. (See Gov't Ex. 8 at 18.)
Respondent stated in substance that he does not give medication simply
in order to write a prescription. (Gov't Ex. 8 at 18.) Respondent
concluded the meeting with SA Zdrojewski by advising him to keep the
medication locked up in a safe place. (Tr. vol. 3, at 167.) SA
Zdrojewski further testified that at the end of the meeting with
Respondent he did not know what, or even if, he was going to be
prescribed medication. (Tr. vol. 3, at 169.)
---------------------------------------------------------------------------
\33\ SA Zdrojewski testified that he stated to Respondent that
he could not bend over and touch his toes at the same time that he
was doing so, and in fact was able to complete the maneuver. SA
Zdrojewski further testified that he over-exaggerated all of the
requested maneuvers. (Tr. vol. 3, at 159, 160 & 185.)
---------------------------------------------------------------------------
Respondent issued a prescription to SA Zdrojewski for 150
Roxicodone 30 mg tablets. (Tr. vol. 3, at 184; Gov't Ex. 28 at 19-20.)
Respondent testified in substance that he learned from SA
Zdrojewski during the patient visit that SA Zdrojewski had previously
been treated at another clinic that was now closed, had tried other
treatments, and had been taking 60 Xanax 2 mg, 240 Roxicodone 30 mg and
90 OxyContin 80 mg tablets. (Tr. vol. 10, at 239-41.) Respondent
further testified that a patient's use of marijuana is not an automatic
disqualifier for prescribing controlled substances. (Tr. vol. 10, at
243-44.) Respondent testified that it appeared SA Zdrojewski had done
"okay" on medication but he had resorted to self-medicating with
marijuana after the other clinic closed. (Tr. vol. 10, at 245.)
Respondent also testified that after his discussion with SA Zdrojewski
about use of alcohol, he understood from SA Zdrojewski's answer that he
would rather take medication than use alcohol. (Tr. vol. 10, at 248.)
Respondent testified that he did not prescribe Xanax because SA
Zdrojewski stated he did not need it, and was also concerned that SA
Zdrojewski was drinking some, so "it was more cautious to hold off on
that without a * * * strong indication." (Tr. vol. 10, at 250.)
Respondent further testified that he prescribed medication that
Respondent believed was sufficient to cover SA Zdrojewski's pain, but
noted in the patient file the need for referral to neurosurgery or a
Board Certified pain management specialist before continuing care,
because Respondent did not expect the patient to have such severe
symptoms given the MRI findings. (Tr. vol. 10, at 254.) Respondent
testified that he reviewed the patient chart after SA Zdrojewski left
because he had some lingering questions, and made a note to prompt him
to have questions answered on the next visit, which never occurred.
(Tr. vol. 10, at 254; Resp't Ex. 8 at 5.)
Dr. Berger testified in substance that SA Zdrojewski's admission to
Respondent that he was engaged in the illegal use of drugs made him a
less suitable candidate for prescribing controlled substances to reduce
pain. Dr. Berger also did not note any referral to rehabilitation in
the patient file. (Tr. vol. 7 at 175-76.) Dr. Berger testified that
issuing 150 dosage units of 30 mg Roxicodone to someone admitting use
of marijuana is not within the established standard of care "as a
first-line of treatment" in Florida. (Tr. vol. 7, at 176.)
(h) SA Ryckeley, July 23, 2010 Undercover Visit to CCHM
SA Ryckeley testified in substance that he had over ten years of
law
[[Page 5133]]
enforcement experience with DEA, most recently working in a Tactical
Diversion Squad, and that he participated in an investigation of
Respondent on July 23, 2010. (Tr. vol. 3, at 199, 200 & 233.) SA
Ryckeley testified that on July 23, 2010, he travelled to CCHM acting
in the undercover role of a patient,\34\ with a concealed audio
recorder, and met with Respondent. (Tr. vol. 3, at 200 & 206.) SA
Ryckeley was in the company of several other DEA agents acting in
undercover roles as patients, and the group was represented by a DEA
agent, SA Jack Lundsford, acting in the undercover role of "sponsor"
for the undercover patients, with the undercover "patients" following
his direction, "and he was organizing primarily everything with the
clinic staff." (Tr. vol. 3, at 201.) SA Ryckeley testified that he
paid $300 for the office visit and another $200 to a CCHM staff member
for "VIP treatment," meaning accelerated preferential treatment. (Tr.
vol. 3, at 201.)
---------------------------------------------------------------------------
\34\ The undercover role included identification information and
an actual MRI report of the undercover officer's lower back taken in
advance of the appointment. The MRI was provided to the clinic. (Tr.
vol. 3, at 216; Gov't Ex. 7 at 67.)
---------------------------------------------------------------------------
SA Ryckeley further testified that following a triage procedure
which included a urinalysis test, he was eventually called to meet with
Respondent. (Tr. vol. 3, at 206.) SA Ryckeley informed Respondent
initially during the meeting that he was suffering from back discomfort
which began in May 2010.\35\ SA Ryckeley testified that he informed
Respondent that he sustained the injury while fishing and landing a
fish, and had been taking his girlfriend's "thirties," referring to
30-milligram oxycodone, which made him feel better. (Tr. vol. 3, at
207; Gov't Ex. 7 at 12-13.) Upon inquiry as to pain level, SA Ryckeley
initially reported pain at "around a two," later adjusting the level
upward to "moderate" upon Respondent's explanation of the pain scale.
(Tr. vol. 3, at 257.) SA Ryckeley testified that in his undercover role
he was trying to avoid using the term "pain" to help gauge the
willingness and propensity of the physician to prescribe controlled
substances or discharge the patient. (Tr. vol. 3, at 236, 237.) Upon
further inquiry by Respondent about pain, use of medication and impact
on daily activities, Respondent stated in substance that SA Ryckeley
was "underwhelming" him, that he should just take Tylenol, stating:
"You don't have anything wrong, I don't get it." (Tr. vol. 3, at 209;
Gov't Ex. 7 at 23-24.) Upon inquiry, SA Ryckeley informed Respondent
that he drinks "socially," elaborating that he drank "two (2), two
(2) or, I don't know. Two (2) or three (3) drinks, max * * * a week
maybe, I don't know, maybe * * * it depends on the occasion * * *."
(Gov't Ex. 7 at 26.) Respondent advised SA Ryckeley that "we don't
prescribe medicines for people who drink alcohol" explaining further
the incompatibility of drinking and taking medications, which SA
Ryckeley acknowledged, stating "yeah" and "Okay, doc." (Id. at 26-
27.)
---------------------------------------------------------------------------
\35\ SA Ryckeley related the date of injury to the date of his
MRI. (Gov't Ex. 7 at 18-19.)
---------------------------------------------------------------------------
Respondent further inquired of SA Ryckeley whether the "thirties
(30s) seem to be working for you," and SA Ryckeley replied that he
liked them, further explaining that "they work good," prompting
Respondent to state: "You know, you're killing me, I can't even
believe I'm having this conversation." (Gov't Ex. 7 at 28.) SA
Ryckeley testified that Respondent had him perform a range-of-motion
test, including bending and walking across the room, which SA Ryckeley
performed with ease. (Tr. vol. 3, at 210; Gov't Ex. 7 at 28.) Upon
inquiry by Respondent as to SA Ryckeley's current pain, SA Ryckeley
responded that pain was a five or seven without medication. (Gov't Ex.
7 at 29.) SA Ryckeley testified that at the completion of the meeting,
Respondent told him he would be started on some medication but
Respondent "never told me that he was going to issue me oxycodone."
(Tr. vol. 3, at 211-12.)
Respondent issued SA Ryckeley a prescription for 150 Roxicodone 30
mg tablets, which CCHM filled for an initial cost of $900 cash, but
CCHM staff refunded SA Ryckeley $150 because he was a member of a
"group." (Tr. vol. 3, at 212; Gov't Ex. 7 at 62-63.)
Respondent testified in substance that he understood SA Ryckeley's
pain to have begun approximately three months prior to the appointment,
and interpreted references of "discomfort" to mean pain. (Tr. vol.
10, at 209-12.) Respondent also testified that with regard to alcohol
use, he had tried to overemphasize and caution SA Ryckeley not to
"drink and take medicine." (Tr. vol. 10, at 227.) Respondent further
testified that he interpreted various statements by SA Ryckeley to mean
that he was somewhat language-challenged, but gave him the benefit of
the doubt while finding SA Ryckeley's choice of words "a little
unusual." (Tr. vol. 10, at 227.)
Respondent also testified that he prescribed a lower dose of pain
medication than what SA Ryckeley had represented he had taken of his
girlfriend's medication, explaining to the patient not to take the
medication more often than needed. Respondent testified regarding the
patient chart, explaining the chart reflected his diagnosis of lumbar
disc displacement, chronic low back pain and muscle spasm. (Tr. vol.
10, at 237; Resp't Ex. 7 at 4.) Respondent testified that he made notes
regarding reevaluation of the patient on a follow-up visit, including a
concern if the patient was "a legitimate pain patient," and intended
to perform a urine drug screen test on the next visit with possible
referral to a "Board Certified pain management specialist." (Tr. vol.
10, at 238; Resp't Ex. 7 at 5.)
Dr. Berger testified in substance and in error that SA Ryckeley had
reported "only a three week history of back pain." \36\ (Tr. vol. 7,
at 164; Tr. vol. 9, at 49-60.) Dr. Berger also testified that
references in the medical file regarding the patient taking controlled
substances from his girlfriend makes the patient "a bad candidate for
compliance," because the patient may be willing to share or divert
medication. (Tr. vol. 7, at 167.)
---------------------------------------------------------------------------
\36\ The testimony of SA Ryckeley, which was fully consistent
with the medical file, audio recording and transcript, reflected a
reported duration of pain of approximately three months. (See Gov't
Exs. 7 & 27.) On cross-examination, Dr. Berger eventually
acknowledged the error, stating: "I felt that [Respondent] wrote
three weeks. Frankly, three weeks or three months is not that big a
difference." (Tr. vol. 9, at 60.)
---------------------------------------------------------------------------
5. Respondent's Registered Locations
The Government presented the testimony of DI Barbara Boggess, DEA,
who testified in substance to having approximately twenty-five years of
experience with DEA as a diversion investigator. (Tr. vol. 1, at 67.)
DI Boggess identified nine registered locations where Respondent had
maintained a DEA COR, along with Respondent's Internet application for
a DEA registration in Orlando, Florida. (Tr. vol. 1, at 70; Gov't Exs.
2 & 3.) The evidence also included a "returned" envelope, sent by DEA
to Respondent's registered location in Wellington, Florida, bearing a
postage date of December 22, 2010.\37\
---------------------------------------------------------------------------
\37\ Contrary to the Government's Prehearing Statement, DI
Boggess offered no testimony pertaining to her activities on
December 16, 2010, related to collecting unused copies of DEA Form
222, or inventory of controlled substances at Respondent's
registered location in Deerfield, Beach, Florida. (See ALJ Ex. 9 at
38.)
---------------------------------------------------------------------------
DI Boggess further testified that if a registrant discontinues
practice at a registered location, there is a process to return a COR
to DEA. (Tr. vol. 1, at 83-84.) A registrant that leaves a location
with the intent of returning prior to the registration expiration date
is not required to notify DEA. (Tr. vol. 1, at 86.)
[[Page 5134]]
6. Respondent's Registration History and Prescribing Practices
Respondent offered testimony related to his prescribing experience
and practice generally. Respondent also presented testimony from three
witnesses related to his work for public safety departments at three
registered locations in Florida. Mark Pure, Division Chief, Green Acres
Fire and Rescue Department, testified in substance that he has been
employed by the City of Greenacres, Florida for approximately eighteen
years, and has known Respondent the entire time. (Tr. vol. 9, at 146-
47.) Mr. Pure testified that Respondent was the Medical Director for
the fire department, overseeing emergency medical service issues, to
include writing protocols. The written protocols included guidance on
handling of controlled substances such as morphine, Dilaudid and
others. (Tr. vol. 9, at 149.) Mr. Pure testified that during his tenure
he was unaware of any issues or concerns related to Respondent's
ordering, maintenance or distribution of controlled substances.
David Dyal, Assistant Fire Chief, Stuart, Florida, testified in
substance to having previously worked for the West Palm Beach Fire
Department from 1976 to 2004, where he worked with Respondent. (Tr.
vol. 9, at 170-71.) Mr. Dyal testified that he met Respondent in the
1980's after Respondent became Medical Director, and worked with
Respondent until 2004, but has not worked with him since. (Tr. vol. 9,
at 179.) Mr. Dyal testified to interaction over the years with
Respondent related to medical treatment protocols, paramedic training
and record keeping, to include Respondent's preparation of copies of
DEA Form 222. Mr. Dyal further testified that he was not aware of any
issues with controlled substances, such as safety or diversion, during
his tenure. (Tr. vol. 9, at 174.) Mr. Dyal testified that he believed
Respondent to be an outstanding physician. (Tr. vol. 9, at 177.)
Philip Webb, Fire Chief, City of West Palm Beach, Florida,
testified in substance to having previously worked with Respondent
since in or about 1985 or 1986, but only professionally. (Tr. vol. 9,
at 191 & 196.) Mr. Webb testified that during the entire twenty-six
year period, Respondent has been the Medical Director for the fire
department, performing functions such as training, quality assurance
and protocols, among others. (Tr. vol. 9, at 192-93.) Mr. Webb further
testified that he is unaware of any problems or issues regarding
controlled substances during the time period that Respondent has been
Medical Director. (Tr. vol. 9, at 193-94.) Mr. Webb testified that he
has not observed Respondent write prescriptions or treat patients. (Tr.
vol. 9, at 198.)
Respondent testified in substance to having a twenty-eight year
history as an emergency room physician, prescribing controlled
substances to large numbers of patients over the years, in addition to
work with emergency medical services. (Tr. vol. 9, at 222.) Respondent
testified that he has experience assessing pain, as well as treating
chronic pain. (Tr. vol. 9, at 222-23.) Respondent's experience included
patients seeking pain medication, and he would attempt to validate if
the pain was real or not. (Tr. vol. 9, at 227.) Respondent further
testified that over time he developed a "sixth sense in determining
whose pain was real or not." (Tr. vol. 9, at 231.) Respondent further
testified that since residency training, he has not had any formal
training in pain management, other than a one-hour home study course
related to pain. (Tr. vol. 11, at 191-92.)
Respondent next testified that he did not receive any new or
additional training before starting work at CMG. (Tr. vol. 9, at 232.)
Respondent left CMG because of a disagreement with the owner regarding
the owner's unwillingness to fire a staff member that Respondent
believed was responsible for the falsification of a patient drug
screen. (Tr. vol. 9, at 233.) Respondent was not allowed to take his
patient files with him when he left CMG, because Respondent felt under
duress, fear and in danger, but did not report the incident to the
police. (Tr. vol. 11, at 69-70, 74.) Respondent also worked for another
pain clinic for approximately one week before it was closed. (Tr. vol.
9, at 235.)
Respondent testified that he began working at CCHM in April 2010,
as one of four or five doctors, along with five or six staff members.
(Tr. vol. 9, at 236.) In October 2010, Respondent became the owner of
CCHM, as well as practicing physician, and "fired" or "didn't
continue" a number of staff members, due to issues of trust and
comfort that they were on the "same page." (Tr. vol. 9, at 236-37.)
Respondent testified that he began making other changes at the clinic
upon becoming owner, in an attempt to implement changes that were being
contemplated but not yet enacted by the Florida Board of Medicine. (Tr.
vol. 9, at 237-38, 249; Resp't Ex. 22.) As part of that process,
Respondent hired a Florida certified risk manager, who worked with
Respondent to implement a policy and procedure manual for CCHM. (Tr.
vol. 9, at 238; Resp't Ex. 23.)
Respondent testified that after becoming owner of CCHM, he recalled
an occasion where he "learned that a triage person had dirtied, if you
will, a urine test," explaining that to be "slang that patients use"
where check boxes are made to look like the patient is taking
medication. (Tr. vol. 9, at 239.) Respondent further testified that he
confronted the employee, who admitted the misconduct, and then
Respondent fired the person. (Tr. vol. 9, at 240-41.) Respondent also
testified that on six to ten occasions Respondent or his staff
contacted the Broward County Sheriff's Office to report illegal or
deceptive activity, but found the Sheriff's Office very unresponsive.
(Tr. vol. 9, at 241-43.)
Respondent testified that the specific changes to CCHM that he
began implementing after becoming owner in October 2010 included
changes to patient drug testing, an office policy and procedure manual,
and urine drug screening process, and the discharge of hundreds of
patients. (Tr. vol. 9, at 260-74; Resp't Ex. 23.)
Respondent next testified that during his tenure at CCHM beginning
in April 2010, he had "no knowledge that a staff member or physician
filled in a form" on a patient's behalf. (Tr. vol. 9, at 285.)
Respondent testified there were times when notations might be placed on
forms based on what a patient told a doctor. (Id.) Respondent testified
that with regard to SA Priymak's patient file, an arrow on the pain
scale form filled out by the patient that reflects higher pain may have
been placed on the form by Respondent, who explained in substance that
marking a patient form in that matter is appropriate if it clarifies
what the patient meant. (Tr. vol. 11, at 63-64; Gov't Ex. 22 at 10.)
Respondent testified that he did not know how many of his patients
lived outside of Florida and "never tracked that," but based on
patient files acknowledged three lived in Kentucky, and another had
identification listing residence in Virginia. (Tr. vol. 11, at 85-87;
Resp't Exs. 13, 15, 17 & 19.) Respondent testified that his staff tried
to get medical records, but acknowledged that six of the patient files
presented at hearing contained no prior medical records or verification
of statements made by the patients.\38\ (Tr. vol. 11, at 91-92; Resp't
Exs. 11, 13, 15-17 & 19.) Respondent testified that
[[Page 5135]]
hundreds of other patient files contain prior medical records, but
acknowledged that none introduced at hearing, including undercover
files, contained any. (Tr. vol. 11, at 94.)
---------------------------------------------------------------------------
\38\ With regard to verifying patient statements, Respondent
tautologically explained: "Well, if you can't get medical records,
then you know, it can't be verified." (Tr. vol. 11, at 92.)
---------------------------------------------------------------------------
Respondent testified that he did not recall how he was paid while
working at CMG, but the salary was not tied to dispensing pills, and
Respondent received payment from the owner. (Tr. vol. 11, at 97-98.)
Respondent testified that while at American Pain he made "maybe
$1000," explaining that he "never actually made any money there,
because the checks never cleared." (Tr. vol. 11, at 104.) At CCHM,
Respondent testified that he recalls being paid "$1500 a day" by
check, and received "$250 a week" which was not "directly attached
to the distribution of pills" but had to do with time Respondent spent
in the CCHM pharmacy, on things such as record-keeping, and work with
the "pharmacy tech," among other duties.\39\ (Tr. vol. 11, at 106.)
---------------------------------------------------------------------------
\39\ Respondent testified that payment for pharmacy duties
continued up until he purchased CCHM in October 2010. (Tr. vol. 11,
at 108.)
---------------------------------------------------------------------------
Respondent further testified that he was aware of the term "VIP
service" in the context of a pain clinic visit, explaining that staff
members didn't ask for money, "but that you know, occasional patient
would add some money to their bill, in order to be expedited" at the
clinic. (Tr. vol. 11, at 183.)
IV. Discussion
A. The Applicable Statutory and Regulatory Provisions
The CSA provides that any person who dispenses (including
prescribing) a controlled substance must obtain a registration issued
by the DEA in accordance with applicable rules and regulations.\40\ "A
prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice. The responsibility
for the proper prescribing and dispensing of controlled substances is
upon the prescribing practitioner" with a corresponding responsibility
on the pharmacist who fills the prescription.\41\ It is unlawful for
any person to possess a controlled substance unless that substance was
obtained pursuant to a valid prescription from a practitioner acting in
the course of his professional practice.\42\ In addition, I conclude
that the reference in 21 U.S.C. 823(f)(5) to "other conduct which may
threaten the public health and safety" would as a matter of statutory
interpretation logically encompass the factors listed in Sec.
824(a).\43\
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\40\ 21 U.S.C. 822(a)(2); 21 U.S.C. 802(10).
\41\ 21 CFR 1306.04(a).
\42\ 21 U.S.C. 844(a).
\43\ See Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA 1993).
---------------------------------------------------------------------------
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Administrator may revoke a COR if she finds
that the continued registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. 823(f).
Pursuant to 21 U.S.C. 823(f), the Administrator may deny an
application for a DEA COR if she determines that such registration
would be inconsistent with the public interest. In determining the
public interest, the Administrator is required to consider the
following factors:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, 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.
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: the Administrator may properly
rely on any one or a combination of those factors, and give each factor
the weight she deems appropriate, in determining whether a registration
should be revoked or an application for registration denied. See David
H. Gillis, M.D., 58 FR 37,507, 37,508 (DEA 1993); see also D & S Sales,
71 FR 37,607, 37,610 (DEA 2006); Joy's Ideas, 70 FR 33,195, 33,197 (DEA
2005); Henry J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 (DEA 1989).
Application of the public interest factors requires an individualized
determination and assessment of prescribing and record-keeping
practices that are "tethered securely to state law * * * and federal
regulations." Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009).
Additionally, in an action to deny a registrant's COR, the DEA has the
burden of proving that the requirements for revocation are
satisfied.\44\ The burden of proof shifts to the respondent once the
Government has made its prima facie case.\45\
---------------------------------------------------------------------------
\44\ See 21 CFR 1301.44(e) (2010).
\45\ See Medicine Shoppe--Jonesborough, 73 FR 364, 380 (DEA
2008); see also Thomas E. Johnston, 45 FR 72,311, 72,311 (DEA 1980).
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C. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances.
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid unrestricted medical license in
Florida. Moreover, up until the time he was served with the OSC/IS in
this case, Respondent held a Florida state dispensing license.\46\ (Tr.
vol. 11, at 117.) Although not dispositive, Respondent's possession of
a valid unrestricted medical license in Florida weighs against a
finding that Respondent's registration would be inconsistent with the
public interest. See Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA
2003) (state license is a necessary, but not a sufficient condition for
registration, and therefore, this factor is not dispositive).
---------------------------------------------------------------------------
\46\ He surrendered that license because "without a DEA
license, I could not dispense." (Tr. vol. 11, at 117.)
---------------------------------------------------------------------------
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 FR at 15,230, weighs against a finding that Respondent's
registration would be inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances; and Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances
In this case, there is indeed evidence that Respondent has failed
to remain in compliance with applicable federal and state law relating
to controlled substances, and that his past experience in dispensing
controlled substances with regard to several patients was inconsistent
with the public interest. The evidence at hearing centered in
substantial part on patient files previously seized from Respondent's
office on December 16, 2010. (E.g., Tr. vol. 2, at 111.) In addition to
the patient files, the Government presented the testimony and written
report of a medical expert witness, Dr. Berger, with regard to his
review of eight patient files
[[Page 5136]]
along with his opinion as to whether Respondent issued prescriptions in
each instance for a legitimate medical purpose and in the usual course
of professional practice. The patient files related to office visits
with Respondent occurring at various dates between April and July,
2010. Respondent testified as to his standard of care and treatment for
each of the eight patients, along with his past experience, among other
testimony. Respondent also testified as to his standard of care and
treatment of six additional patients. (See Resp't Exs. 11, 13, 15-17 &
19.)
Evaluation of Respondent's prescribing conduct in this case is
governed by applicable federal and state law. The applicable standard
under federal law is whether a prescription for a controlled substance
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). The standard of care refers to that generally
recognized and accepted in the medical community rather than a standard
unique to the practitioner. Robert L. Dougherty, M.D., 76 FR 16,823,
16,832 (DEA 2011) (citing Brown v. Colm, 11 Cal.3d 639, 642-43 (1974)).
Although it is recognized that state law is a relevant factor in
determining whether a practitioner is acting in the "usual course of
professional practice," it is also appropriate in the context of an
inquiry under federal law to also consider "generally recognized and
accepted medical practices" in the United States. Bienvenido Tan,
M.D., 76 FR 17,673, 17,681 (DEA 2011).
The applicable standards under Florida law may be found in FAC
64B8-9.013 ("Standards for the Use of Controlled Substances for the
Treatment of Pain").\47\ Prevailing Florida regulation emphasizes the
importance of "prescribing, dispensing, [and] administering controlled
substances including opioid analgesics[] for a legitimate medical
purpose[] that is supported by appropriate documentation establishing a
valid medical need and treatment plan." Fla. Admin. Code Ann. r. 64B8-
9.013(1)(b) (2003). It further provides that "[p]hysicians should be
diligent in preventing the diversion of drugs for illegitimate
purposes," and that "prescribing must be based on clear documentation
of unrelieved pain * * *." Id. r. 64B8-9.013(1)(d)-(e). In support of
these principles, the Florida Board of Medicine has adopted a list of
standards for the use of controlled substances for pain control. See
id. r. 65B8-9.013(3). Pertinent obligations include the following:
---------------------------------------------------------------------------
\47\ Due to the effective dates of the applicable state
regulation, FAC 64B8-9.013 (2003) applies to conduct between October
19, 2003, and October 17, 2010; FAC 64B8-9.013 (2010) applies to
conduct thereafter. See generally https://www.flrules.org/gateway/ruleNo.asp?id=64B8-9.013.
---------------------------------------------------------------------------
(a) Evaluation of the Patient. A complete medical history and
physical examination must be conducted and documented in the medical
record. The medical record should document the nature and intensity
of the pain, current and past treatments for pain, underlying or
coexisting diseases or conditions, the effect of the pain on
physical and psychological function, and history of substance abuse.
The medical record should also document the presence of one or more
recognized medical indications for the use of a controlled
substance.
(b) Treatment Plan * * *
(c) Informed Consent and Agreement for Treatment. The physician
should discuss the risks and benefits of the use of controlled
substances with the patient * * *.
(e) Consultation. The physician should be willing to refer the
patient as necessary for additional evaluation and treatment * * *
Special attention should be given to those pain patients who are at
risk for misusing their medications and those whose living
arrangements pose a risk for medication misuse or diversion * * *.
(f) Medical Records. The physician is required to keep accurate
and complete records to include, but not be limited to:
1. The medical history and physical examination, including
history of drug abuse and dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. [D]iscussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity
prescribed);
8. Instructions and agreements; and
9. Periodic Reviews * * *.
10.
Fla. Admin. Code Ann. r. 65B8-9.013(3) (2003).
Turning to the evidence in the instant case, the record reveals
violations of federal and state law relating to Respondent's
interactions with undercover agents posing as patients at two clinics:
CCHM and CMG.
1. CCHM
(a) SA Marshall
(i) SA Marshall, March 10, 2010 Visit to CCHM
As noted above, the record reflects that SA Marshall visited CCHM
on March 10, 2010, and was ultimately treated by Dr. [L.C.].\48\ (See,
e.g., Gov't Ex. 6 at 18 & 20; Tr. vol. 4, at 7.) SA Marshall presented
the staff with an MRI. (Tr. vol. 4, at 43.) A man in the lobby filled
out some of SA Marshall's patient paperwork, to include circling the
numbers nine and eight on his pain scale, the descriptions of pain, the
times of day that pain became worse, whether pain was continuous and
side effects from medication. (Tr. vol. 4, at 22, 38-39.) A patient in
the lobby told SA Marshall that to indicate on his patient forms that
he was already receiving opiates, he should reference American Pain, a
clinic which was then closed, "because they had been closed down and
[CCHM] wouldn't be able to pull my prior history there * * *." (Tr.
vol. 4, at 41.) SA Marshall told Dr. [L.C.] that "someone in the lobby
had * * * circled the 9's, and I told him that I was more like a three
or a four." (Tr. vol. 4, at 50.) Dr. [L.C.] ultimately issued SA
Marshall a prescription for oxycodone and Xanax. (Gov't Ex. 21 at 25;
Tr. vol. 4, at 42-43; see Gov't Ex. 6 at 19, 21-23.)
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\48\ Although there is some ambiguity in the record as to the
date, the great weight of references to SA Marshall's March 2010
visit to Coast to Coast places the meeting on March 10, 2010.
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(ii) SA Marshall, April 7, 2010 Visit to CCHM
SA Marshall returned to CCHM in an undercover capacity on April 7,
2010. (E.g., Gov't Ex. 6, at 1.) A CCHM employee named Cindy Mesa
recognized him when he arrived, stating "I know you." (Gov't Ex. 6 at
2.) SA Marshall responded that he was there for a follow-up visit and
Ms. Mesa directed him to a window for follow-up patients. (Gov't Ex. 6
at 3.) Respondent later testified that on April 7, 2010, SA Marshall
appeared unshaven and his hair stood up in spikes as if there were gel
in it. (Tr. vol. 10, at 60.)
Behind closed doors in the triage nurse's office (see Tr. vol. 4,
at 20), SA Marshall had a conversation with CCHM triage nurse (Tr. vol.
4, at 13) Chera Kay Davis (e.g., Gov't Ex. 6 at 27), in which SA
Marshall recounted that an unknown white male in the lobby (Tr. vol. 4,
at 13-14) during his March 10 visit "said * * * to give you some dough
and you'd dirty up my urine * * * He told you that * * * he'd slide you
fifty dollars * * * and that you'd, you, dirty up my urine." \49\
(Gov't Ex. 6 at 10.) Ms. Davis responded that she remembered (Gov't Ex.
6 at 10) and then asked: "Oh, he just gave you fifteen's the last
time?" to which SA Marshall responded "Yeah, he didn't give me
[anything] * * * I don't have [anything] in my urine, so I hope he'll
up, he'll up me * * * You think he will?" (Gov't Ex.
[[Page 5137]]
6 at 10.) Ms. Davis replied: "You're seeing another doctor though, so
don't * * * worry about him." (Gov't Ex. 6 at 10-11.) SA Marshall
testified that "I slid her $50. Then she took it and she found the
sheet that referenced urinalysis and I noticed that she checked
opiates, specifically * * * And she never tested my urine." \50\ (Tr.
vol. 4, at 15, 18; see Gov't Ex. 21 at 26.) This conversation
constitutes evidence that at least one member of Respondent's staff was
willing to falsify SA Marshall's patient files in an effort to
facilitate the diversion of controlled substances.
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\49\ At hearing, SA Marshall explained that "what I mean by
dirty up my urine is to ensure that it showed it had narcotics in my
system * * *" (Tr. vol. 4, at 13.)
\50\ SA Marshall later testified that he gave the triage nurse
money on March 10, not April 7. (Tr. vol. 4, at 18-19.)
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The record further reflects a meeting between Respondent and SA
Marshall on April 7, 2010.\51\ (Compare Gov't Ex. 6 at 1, with id. at
16; Tr. vol. 4, at 20.) Respondent asked "what have you been treated
for here?" to which SA Marshall responded "my neck." (Gov't Ex. 6 at
18.) Respondent asked how SA Marshall hurt himself, to which SA
Marshall replied "I'm homeless * * * I live out on the streets * * *
[a]nd I can't sleep." (Gov't Ex. 6 at 18.) SA Marshall stated he was
taking an unidentified medication to help him sleep and oxycodone to
help with his stiff neck. (Gov't Ex. 6 at 19.) Respondent asked how bad
his pain was, to which SA Marshall responded that "sometimes it's like
a three or four * * * How * * * does it need [to] be?" (Gov't Ex. 6 at
19.) SA Marshall also told Respondent that a person in the lobby had
filled out his patient forms. (E.g., Tr. vol. 4, at 62; Gov't Ex. 6 at
20.) Respondent replied: "Is this a test? * * * I think this must be *
* * a test for me." (Gov't Ex. 6 at 19-20; Tr. vol. 4, at 24.)
Respondent asked what being homeless had to do with pain medicine,
confirming with SA Marshall in substance that SA Marshall was selling
the prescriptions. (Gov't Ex. 6 at 21-23.) Shortly thereafter,
Respondent escorted SA Marshall to the reception area, (Tr. vol. 4, at
25), stating: "we don't, um, participate in such * * * folly." (Gov't
Ex. 6 at 23.)
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\51\ SA Marshall testified that his first meeting with
Respondent occurred on April 8, 2010, (Tr. vol. 4, at 7), but he
later retracted this testimony and stated that his first meeting
with Respondent occurred on April 7, 2010. (Tr. vol. 4, at 10.)
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SA Marshall testified that Respondent walked up to a nurse but
"that was in a back room, and I couldn't hear what they were saying."
(Tr. vol. 4, at 25.) SA Marshall waited and observed Respondent call
another patient.
SA Marshall testified that a nurse named Cindy Mesa then took him
aside for a conversation (Tr. vol. 4, at 25) in the reception area
(Gov't Ex. 6 at 24). Ms. Mesa elaborated:
Mesa: Are you [expletive] crazy? * * * You told him you live on the
street and that you sell the pills?
UC1: Well he wouldn't * * * listen to my story about how I'm trying to
fix my neck.
Mesa: Oh my God! You know, okay, now you know what I have to do? I have
to change the files and erase this [information] that he put here, and
reschedule for [Dr.[R.C.]] tomorrow. Okay? * * * never, never say that
you sell this, that, that on the street, ever. Because they think that
you're an undercover, okay? And that you're trying to bust his nuts * *
* Now I'll have to call you tomorrow.
(Gov't Ex. 6 at 25-26.) At hearing, SA Marshall explained that Ms. Mesa
told him she would "change your chart, erase the information and call
you back tomorrow to see another doctor." (Tr. vol. 4, at 26.)
Respondent testified that he was not privy to this conversation, nor
was he made aware that records from SA Marshall's April 7, 2010 visit
would be destroyed or that SA Marshall returned the next day to see Dr.
[N.]. (Tr. vol. 4, at 65-66.) Respondent further testified that there
was no basis in the medical record to conclude that Dr. [N.] was aware
that SA Marshall had been ejected the previous day. (Tr. vol. 10, at
68.) Although I find that that Respondent did not know in April 2010
that his employee destroyed documents from SA Marshall's original
patient chart or arranged for him to be seen again, I find that
Respondent believed SA Marshall was an undercover law enforcement
officer, which served as his basis for discharging SA Marshall. At
hearing, Respondent testified that he discharged SA Marshall because he
was concerned about the possibility of diversion, which I do not find
credible. (Tr. vol. 10, at 61-62, 64.) In fact, Respondent had a
concern about law enforcement activity dating back to at least March 5,
2010, as evidenced by his statement to SA Bazile during an undercover
patient visit at CMG that he was aware from news stories that DEA was
"targeting doctors like him." (Tr. vol. 6, at 23.)
(iii) SA Marshall, April 8, 2010 Visit to CCHM
On April 8, 2010, one day after his unsuccessful visit with
Respondent, SA Marshall returned to CCHM in an undercover capacity (Tr.
vol. 4, at 27) and was seen by Dr. [N.] (Gov't Ex. 6 at 38; Tr. vol. 4,
at 27-28.) The evidence further reflects that Cindy Mesa had prepared a
new chart for SA Marshall and "She had me sign something, which was so
quick, I don't know what I signed." (Tr. vol. 4, at 27.) SA Marshall
received prescriptions for OxyContin, Roxicodone and Xanax from Dr. [N]
or Dr. [N.]'s physician's assistant. (Tr. vol. 4, at 28, 42; Gov't Ex.
21 at 24.)
(iv) SA Marshall, May 4, 2010 Visit to CCHM
SA Marshall returned to CCHM in an undercover capacity for a fourth
visit on May 4, 2010. (E.g., Gov't Ex. 6, at 27; Tr. vol. 4, at 11, 28-
29.) SA Marshall had a conversation with triage nurse Chera Kay Davis
(Tr. vol. 4, at 29) recounting how Respondent had rejected SA Marshall
as a patient on a previous visit and what happened afterward. "[H]e
went and he told Cindy and * * * she changed my paper work and brought
me back in and I saw * * * [Dr. [N.]]. So I hope he doesn't remember me
* * * my paperwork is all different,\52\ but he shouldn't * * *
recognize it." (Gov't Ex. 6 at 38; see generally Tr. vol. 10, at 59.)
Davis responded: "You go and tell that man, tell him that you are in
pain. What the hell!" (Gov't Ex. 6 at 38.) This conversation
constitutes evidence that multiple members of Respondent's staff knew,
and were not concerned, that CCHM staff member Cindy Mesa had tampered
with SA Marshall's patient files in an effort to facilitate the
diversion of controlled substances.
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\52\ The record reflects, however, that some of SA Marshall's
original paperwork remained. (E.g., Tr. vol. 4, at 38 (paperwork
completed on March 10, 2010).) I therefore infer that Cindy Mesa
destroyed only the notes relating to SA Marshall's first visit
associated with Respondent's decision to terminate SA Marshall as a
patient, clearly evidencing Ms. Mesa's disagreement with
Respondent's assessment that SA Marshall was an undercover law
enforcement officer. (See Tr. vol. 4, at 92.)
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SA Marshall then met with Respondent, who did not recognize him.
(Gov't Ex. 6 at 39-41; Tr. vol. 4, at 126; Tr. vol. 10, at 69-70.) Nor
did SA Marshall call Respondent's attention to the fact that they had
met before (see Tr. vol. 4, at 76, 125-26); Respondent testified that
SA Marshall's spiked hair was covered with a hat, that SA Marshall
presented with a different persona and that Respondent had seen
approximately 400 patients since last they met. (Tr. vol. 10, at 69,
73-74, 76.) The meeting lasted under three minutes. (Tr. vol. 4, at 30,
128.) Respondent listened to SA Marshall's breathing and directed him
to place his hands out palm up. (Tr. vol. 4, at 31.) Although SA
Marshall had indicated in his patient forms that he had emphysema/
asthma, bipolar disorder, fractures, insomnia, depression and headaches
(Tr. vol. 4, at 36-37; Gov't Ex. 21 at 10-11),
[[Page 5138]]
Respondent did not discuss any of these topics with SA Marshall. (Tr.
vol. 4, at 36-37.) As noted above, Dr. Berger found notable the absence
of psychiatric consultations in the patient chart. (See Tr. vol. 10, at
64-65.)
Respondent then inquired whether SA Marshall had pain in his back,
and SA Marshall responded in the negative. (Tr. vol. 4, at 31.)
Respondent asked if SA Marshall had pain in his neck, and SA Marshall
responded in the affirmative. (Tr. vol. 4, at 31.) Moments later,
Respondent issued SA Marshall the same prescription Dr. [N.] had
prescribed on April 8, 2010 (Tr. vol. 4, at 86): 120 oxycodone 30 mg
and 30 Xanax 3 mg tablets.\53\ (Tr. vol. 4, at 31; Gov't Ex. 6 at 45;
Gov't Ex. 21 at 22.) Respondent did not address alternative
medications, treatment plans or physical therapy. (Tr. vol. 4, at 44-
45.) Respondent did not ask SA Marshall for prior medical records from
previous doctors, which is inconsistent with the requirement and spirit
of Fla. Admin. Code Ann. r. 64B8-9.013(3)(f), which provides that a
physician must keep accurate medical records.\54\ (Tr. vol. 4, at 45.)
He ordered no diagnostic tests, provided no time table for his pain
management, discussed no objective goals for pain relief and did not
explain how SA Marshall's care would continue or be monitored. (Tr.
vol. 4, at 45.) Respondent did, however, ask whether, overall, SA
Marshall was doing okay, to which SA Marshall responded in the
affirmative. (Tr. vol. 4, at 81.) Dr. Berger testified in substance
that the medical file for SA Marshall contained numerous
inconsistencies, to include no obvious physical examination on the
first visit, an MRI report issued two days before the first visit with
no prescribing or ordering physician noted on the MRI report. (Tr. vol.
10, at 63-64; Gov't Ex. 21 at 8.)
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\53\ As Respondent testified, I find that Dr. Berger's testimony
that Respondent had doubled the prescription was inaccurate. (Tr.
vol. 10, at 82-83.)
\54\ A copy of SA Marshall's MRI report appears to have been in
his case file at the time Respondent viewed it. (E.g., Gov't Ex. 21
at 27-28; Tr. vol. 4, at 42-45.)
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The record further reveals evidence that Respondent documented in
SA Marshall's patient file discussions that did not actually occur. For
instance, despite contrary notations in the patient file (see Gov't Ex.
21 at 8), SA Marshall testified that Respondent never discussed anti-
inflammatory medication, diet, the risks and benefits of the
medication, omega-3 fish oil, glucosamine chondroitin sulfate,
avoidance of alcohol, soda and illegal drugs or weaning off of
medication or the medications SA Marshall was currently taking. (Tr.
vol. 4, at 35-36, 39.) Respondent did, however, advise SA Marshall to
do some stretching. (Tr. vol. 10, at 85.) Respondent's conduct
constitutes a failure to keep accurate records, to include evaluations,
consultations and discussion of risks and benefits, in violation of
Fla. Admin. Code Ann. r. 65B8-9.013(3).
In summary, the record reveals violations attributable to
Respondent of applicable standards and regulations concerning the
prescribing of controlled substances in the context of SA Marshall's
undercover visits to CCHM. I find that Respondent credibly testified
that he did not recognize SA Marshall on May 4, 2010, or remember
having terminated him as a patient. Nevertheless, substantial evidence
supports a finding that Respondent's prescription of controlled
substances to SA Marshall lacked a "legitimate medical purpose * * *
that is supported by appropriate documentation establishing a valid
medical need and treatment plan," in violation of Fla. Admin. Code
Ann. r. 64B8-9.013(1)(b) (2003), and was outside the usual course of
professional practice, in violation of 21 CFR Sec. 1306.04(a).
Moreover, I find that Respondent knew or should have known that staff
members and individuals posing as patients at CCHM diverted or attempt
to divert controlled substances.
(b) SA Saenz
SA Saenz visited CCHM in an undercover capacity on March 4, 2010,
twice on March 10, 2010, and again on April 8, 2010. (See Tr. vol. 2,
at 236-37, 259 & 265.) She was seen by Dr. [L.C.], Dr. [R.C.] and Dr.
[N.] and prescribed controlled substances by Dr. [R.C.] and Dr. [N.]
\55\ (Tr. vol. 2, at 237, 281-83; Gov't Ex. 24 at 25-26.) May 4, 2010,
however, was the first time SA Saenz came into contact with Respondent
at CCHM, when she visited again in an undercover capacity. (See Tr.
vol. 2, at 231, 238.) SA Saenz testified that at each visit she went to
a different doctor at CCHM, "told them I wanted something stronger"
and the doctors accommodated her request. (Tr. vol. 2, at 263-64.) She
has no legitimate medical condition that would justify taking any of
the prescriptions she was ultimately prescribed. (Tr. vol. 2, at 264.)
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\55\ SA Saenz testified that Dr. [L.C.] declined to prescribe
medication for her during a previous visit to Coast to Coast. "He
told me he didn't want me to be a drug addict, and that is why he
wasn't going to prescribe it, because he didn't think I needed it."
(Tr. vol. 2, at 300.) SA Saenz did not tell Respondent about her
conversation with Dr. [L.C.], but she did tell the clinic staff (Tr.
vol. 2, at 301), which tends to show that Respondent's staff
facilitated or acquiesced in the prescription of controlled
substances for other than a legitimate medical purpose and outside
the usual course of professional practice.
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During SA Saenz's undercover visit to CCHM on May 4, 2010 (Tr. vol.
2, at 231), she was accompanied by two other undercover agents
initially and a third who joined them later. (Tr. vol. 2, at 233 &
285.) Upon arriving at the clinic they requested to be moved to the
front of the line, paid a receptionist named Carla $200 for the $150
office visit and did not receive any change. (Tr. vol. 2, at 233-34.)
Carla then instructed SA Saenz to complete paperwork to add to her
patient file, which already contained paperwork from previous visits.
(Tr. vol. 2, at 235-36.) She was directed to wait in a waiting room,
after which she completed triage procedures with staff members. (See
Tr. vol. 2, at 241.)
The record reflects that Respondent briefly met with SA Saenz in a
patient consultation room and issued her controlled substances
prescriptions after limited conversation and a cursory physical
examination. SA Saenz testified that she met with Respondent for no
more than ten minutes. (Tr. vol. 2, at 242, 244.) He asked her how she
was, whether her current prescriptions were helping and whether she had
a job; beyond that did not discuss her previous medication. (Tr. vol.
2, at 242, 257.) She said her prescriptions, including oxycodone, were
helping and that she had a job at daycare but requested to increase her
Roxicodone 30 mg dosage from ninety to 120 pills, and Respondent
agreed. (Tr. vol. 2, at 242-43, 275-76.) Using a computer, he printed
prescriptions for 120 Roxicodone 30 mg and 30 Xanax 2 mg tablets. (Tr.
vol. 2, at 245; Gov't Ex. 15 at 1-2, 5-6; Gov't Ex. 24 at 2 & 24) and
advised her not to share or sell her prescriptions. (Tr. vol. 2, at
243-44.) SA Saenz testified that Respondent checked her heart rate with
a stethoscope but did not conduct any further testing or direct her to
complete any physical exercises. (Tr. vol. 2, at 245.) Respondent asked
what was bothering her and she indicated her lower back. (Tr. vol. 2,
at 245.) He did not use his hands to check her spine. (Tr. vol. 2, at
245.) Respondent did not discuss the prior doctors that SA Saenz saw,
additional diagnostic tests she might have, a treatment plan, the
objective and goals for pain relief, a time table for pain management
treatment, the risks and benefits of the pain medication or alternative
medication and treatments. (Tr. vol. 2, at 249-50.) Under such
circumstances, questions arise as to whether Respondent complied with
[[Page 5139]]
Florida guidelines regarding treatment plans and informed consent, to
include discussion of risks and benefits. See Fla. Admin. Code Ann. r.
65B8-9.013(3)(b) & (c).
The record further reveals evidence that Respondent documented in
SA Saenz's patient file discussions that did not actually occur. For
instance, despite contrary notations in the patient file (Gov't Ex. 24
at 2 & 9), SA Saenz testified that Respondent never discussed anti-
inflammatory medications, diet, the risks and benefits of the
medication, yoga and stretching exercises, omega-3 fish oil,
recommended at 36 grams per day, glucosamine chondroitin sulfate,
avoidance of alcohol and soda, smoking cessation, follow-up visits or
weaning off medications, in violation of compulsory language contained
in Fla. Admin. Code Ann. r. 65B8-9.013(3)(f) ("The physician is
required to keep accurate and complete medical records * * * ."
(emphasis supplied)). Of additional concern is Respondent's failure to
discuss alcohol avoidance while on the controlled substances that he
prescribed, in light of the fact that SA Saenz had indicated on patient
intake forms in her patient file that she drank alcohol. (Tr. vol. 2,
at 255; Gov't Ex. 24 at 12.)
By corollary, the record reveals evidence of discussions that
should have occurred, but didn't. SA Saenz testified that in her
patient intake form she indicated that she suffered from insomnia and
depression (Gov't Ex. 24 at 11, Tr. vol. 2, at 291) but the record
supports the inference that Respondent did not inquire about these
matters (see Tr. vol. 2, at 226 (SA Saenz's testimony that she did not
forget about anything that occurred during her visit with Respondent))
and the patient note from the visit does not reflect that Respondent
made such inquiries. (See Gov't Ex. 24 at 2.)
In support of his prescribing practices, Respondent testified as to
how SA Saenz presented as a patient on May 4, 2010. He testified that
she had been seen previously, had an MRI reflecting abnormalities in
her lower lumbar spine and that Dr. [R.C.] and Dr. [N.] prescribed
medication that did not afford her much relief. (Tr. vol. 10, at 174-
75.) Respondent opined that "trying to dial in the right dose for each
patient, sometimes takes some modifications and takes some time to
reach that dose." (Tr. vol. 10, at 175.) Moreover, Respondent
testified that "She lists back in March that * * * she was taking a
large amount of medication [and] * * * was still well below what she
represented that she had taken" previously. (Tr. vol. 10, at 176-77;
see also id. 179.) Respondent further explained that two drugs that SA
Saenz had listed on her pain assessment form, Roxicodone 30 mg and
oxycodone 50 mg tablets, might reasonably be prescribed together to
address breakthrough pain. (Tr. vo. 10, at 177-78.) Respondent
testified that he was relying on the truthfulness of the information
contained in her patient file, and that had he been aware of the
misrepresentations, he would not have prescribed medications to her.
(Tr. vol. 10, at 180.) Respondent further testified that he believed
she was using the medication for medical purposes and was not
diverting. (Tr. vol. 10, at 180-81.)
As noted above, I give little to no weight to Dr. Berger's
testimony with respect to SA Saenz because of material factual errors
in his analysis of this patient file.
In sum, the record reveals violations of applicable standards and
regulations concerning the prescribing of controlled substances in the
context of SA Saenz's May 4, 2010 visit to CCHM. Substantial evidence
supports a finding that Respondent kept inaccurate records, in
violation of Florida regulations. The Government, however, has failed
to sustain its burden of proof to support its allegation that
Respondent's issuance of controlled substances prescriptions to SA
Saenz were for other than a legitimate medical purpose.
(c) SA O'Neil
SA O'Neil visited CCHM in an undercover capacity in March and April
2010 and met with Dr. [L.C.] (Tr. vol. 3, at 301-02.) Pursuant to those
visits, SA O'Neil supplied CCHM with an MRI report. (See Tr. vol. 3, at
304; Gov't Ex. 14 at 55-56.) On May 4, 2010, he returned to CCHM in an
undercover capacity and met with Respondent for the first time. (E.g.,
Tr. vol. 3, at 301.) The circumstances of Respondent's interaction with
SA O'Neil make clear that Respondent and Respondent's staff believed SA
O'Neil was diverting and abusing controlled substances.
On May 4, 2010, SA O'Neil arrived at CCHM with three other agents
and entered the facility through the front door. (Tr. vol. 3, at 301.)
Upon arrival, SA O'Neil signed in as a returning patient and requested
that he and the other three agents be seen together. (Tr. vol. 3, at
303, 305.) A woman asked whether they were new patients. SA O'Neil
responded "No, no, no. They're * * * followers." (Gov't Ex. 14 \56\
at 3.) The staff member complied with his request and placed the
agents' charts in the same area. (Tr. vol. 3, at 306; see Gov't Ex. 14
at 16-19.) SA O'Neil paid $200 for a $150 visit and let the employee
keep the change. (Tr. vol. 3, at 305.) He also told the staff member
that he would quadruple the money. (Tr. vol. 3, at 306; Gov't Ex. 14 at
16.) Although not dispositive, this evidence indicates that the staff
of CCHM interacted with patients in unorthodox ways. For instance, the
overpayment by $50 and discussion of quadrupling provides some evidence
of a profit motive for employees to process patients according to the
patients' requests instead of according to an established or
conventional medical office procedure. Hearing the patients referred to
as "followers" provides some basis for the staff member to have
suspected, if not actually known, that the patients were together as
some sort of a common plan or scheme.
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\56\ SA O'Neil testified that in the context of the first tape
(N43.1) of Government Exhibit 23, SA O'Neil is identified as UC1.
(Tr. vol. 3, at 363.)
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SA O'Neil next proceeded to the triage area where a female staff
member named Ms. Wade measured his blood pressure, weight and
temperature and asked for his height. (Tr. vol. 3, at 306; see Gov't
Ex. 14 at 23-25.) SA O'Neil testified that "I discussed the fact that
I don't take the medication * * * And she said 'I know.' She said
something to the extent of 'I know, I'm not stupid.' " (Tr. vol. 3, at
307.) A transcription of an undercover recording of the conversation
confirms SA O'Neil's account:
WADE [Laughs]: Ah ah ah. [Pause] How could he get you on this s[tuff]?
UC1: Uh-huh.
WADE: You asked him for it?
UC1: Yeah, of course. I'm not gonna waste money * * * for nothing * * *
even more too.
WADE: You take the pills, Sean?
UC1: Nah.
WADE: I know you [unintelligible] * * * Besides, I know you don't take
them.
UC1: How can you tell?
WADE: What you mean how can I tell? I'm stupid?
(Gov't Ex. 14 at 24-25; see generally Tr. vol. 3, at 308.) This
conversation constitutes evidence that Respondent's staff in this
instance possessed actual knowledge of diversion by patients. The
staff's open indifference, if not encouragement, of patients seeking
controlled substances for no legitimate medical purpose is inconsistent
with Respondent's claim that he was
[[Page 5140]]
unaware of the problems plaguing CCHM. Episodes such as this, while
perhaps not on their own dispositive as to Respondent's specific
knowledge of staff misconduct, do in the aggregate weigh in favor of a
finding that Respondent was, at a minimum, willfully blind to the
flagrant indications of diversion and abuse at the clinic he worked in
and later owned.
Following his conversation with Ms. Wade, SA O'Neil waited and was
later seen by Respondent. (Tr. vol. 3, at 308-10.) The consultation
occurred in an office and lasted approximately fifteen minutes. (Tr.
vol. 3, at 310.) Respondent asked SA O'Neil how he was, what his age
was and what his current medication was. (Gov't Ex. 14 at 26.) SA
O'Neil responded that he was "not bad" and that he took "thirties
(30s) * * * two times. And then fifteens (15s) I usually take about one
eighty (180), but you wrote it too low last time * * * And then, Xanax,
two (2) milligrams, and sometimes soma." \57\ (Gov't Ex. 14 at 26.)
Respondent reviewed the medication SA O'Neil had been prescribed
previously by Dr. [L.C.], stating: "Well, it's inappropriate * * *
your blood pressure. You're taking a blood pressure medicine?" (See
Gov't Ex. 14 at 26-27; see generally Tr. vol. 10, at 150-51.) SA O'Neil
responded "Uh * * * I just never filled it," to which Respondent
replied that SA O'Neil's blood pressure was up again on that day.
(Gov't Ex. 14 at 27.)
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\57\ Respondent testified that he did not understand "you" to
be referring to himself, because he hadn't seen SA O'Neil before.
(Tr. vol. 10, at 151-52.)
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SA O'Neil next told Respondent what Dr. [L.C.] had told him on a
previous visit. "He told me * * * 'start, and you can go up each
time.' * * * I found out he only works Wednesdays, but, * * * he said
you'd [sic] gonna increase it." (Gov't Ex. 14 at 27.) This statement
by SA O'Neil apprised Respondent that SA O'Neil was a drug-seeking
individual and that Respondent's colleague, Dr. [L.C.], was also aware
of this fact.
Respondent asked how SA O'Neil was doing on the present dosage of
medication. (Gov't Ex. 14 at 27.) A transcript of the conversation that
followed reveals that SA O'Neil communicated that although he was doing
"Fine" (Gov't Ex. 14 at 27), he nevertheless wanted a higher dosage
of medication for other than a legitimate medical purpose:
WOLFF: Oh, so you're doing okay?
UC1: No, no. I need more. But I don't need any less. The present dose
is not * * * it would be better if it was more. It's not, you know, not
making me feel worse.
WOLFF: No, no, I understand. You ran out, or it wasn't enough
UC1: Yeah, yeah, I ran out.\58\
---------------------------------------------------------------------------
\58\ SA O'Neil had not previously indicated that he ran out of
medication until Respondent suggested the possibility.
---------------------------------------------------------------------------
(Gov't Ex. 14 at 27-28.) Respondent's comment about SA O'Neil's
medication running out represents the first instance that either of
them had suggested that SA O'Neil ran out.
SA O'Neil later requested that Respondent increase his prescription
to 210 pills, to which Respondent replied "maybe eventually, but * * *
I can't double your medicine now. Absolutely not." (Gov't Ex. 14 at
30.) The record further reflects that during the meeting, Respondent
advised SA O'Neil that "the goal is not to get up to the highest
number possible." (Gov't Ex. 14 at 33; Tr. vol. 3, at 338-39.) This
statement by Respondent is somewhat consistent with his testimony at
hearing that he prescribed controlled substances to SA O'Neil only for
a legitimate medical purpose. But other statements and actions by
Respondent cut against a finding that Respondent's continued
registration would be consistent with the public interest. SA O'Neil
provided Respondent with unmistakable evidence of diversion or abuse,
stating that he was taking liquid drops of oxycodone that a friend gave
him (Gov't Ex. 14 at 30; see id. at 34 ("Oxy"); Tr. vol. 10, at 154-
55), to which Respondent replied:
WOLFF: Don't even tell me that.
UC1: Is that still bad?
WOLFF: Yeah, high abuse.
(Gov't Ex. 14 at 30.) Incredibly, a follow-up visit sheet in SA
O'Neil's patient file dated May 4, 2010, and filled out by Respondent
(see Tr. vol. 3, at 321-22), reflects a handwritten check in the box
labeled "No indication of substance abuse or diversion." (Gov't Ex.
23 at 2.) Not only did Respondent state that he did not wish to be told
about abuse, Respondent filled out paperwork as if he had not been so
told.\59\ Nor did Respondent talk to SA O'Neil about referring him to
rehabilitation (Tr. vol. 3, at 371-72), as is contemplated by Fla.
Admin. Code Ann. r. 64B8-9.013(3)(e) ("The management of pain in
patients with a history of substance abuse * * * requires extra care,
monitoring, and documentation, and may require consultation with or
referral to an expert in the management of such patients.").
---------------------------------------------------------------------------
\59\ As noted below, I therefore reject Respondent's explanation
that his statement "Don't even tell me that" (Gov't Ex. 14 at 30)
should be understood as Respondent's emotional reaction to the
patient's behavior. (Tr. vol. 10, at 155.)
---------------------------------------------------------------------------
At hearing, Respondent testified concerning his statement "Don't
even tell me that." Respondent testified that "I was very disturbed
that he would do such a thing, and that was what I said meaning that
it--it hurt me to hear that because I don't like to hear patients using
that because I think it's a dangerous product." (Tr. vol. 10, at 155.)
Having observed the witness's demeanor at hearing I reject this
statement as not credible, particularly in light of contemporaneous
records that Respondent filled out as if SA O'Neil had never told him
he was taking liquid oxycodone. (See Gov't Ex. 23 at 2.)
In light of the foregoing evidence, it is apparent that Respondent
knew or should have known that SA O'Neil presented as a patient who
intended to divert or abuse the controlled substances he sought from
Respondent. This conclusion is confirmed by statements attributable to
Respondent: The record reflects that Respondent directed SA O'Neil not
to take anyone else's medication, to only take his own medication as
indicated on the bottle, that there was a risk of death and that
"you're living on the edge." (Gov't Ex. 14 at 30-31.) Respondent's
failure to reject SA O'Neil as a patient and his decision to issue him
controlled substances prescriptions is inconsistent with state and
federal law. See Fla. Admin. Code Ann. r. 64B8-9.013(1)(d)
("Physicians should be diligent in preventing the diversion of drugs
for illegitimate purposes."); see also 21 CFR 1306.04(a) ("A
prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice.")
Additional statements by Respondent demonstrate Respondent's
awareness of the impropriety in the medical community about prescribing
to a patient known to be diverting or abusing controlled substances:
WOLFF: Most pain clinics, when, uh, they find out that uh * * *
patients taking other people's stuff, [NOISE].\60\
---------------------------------------------------------------------------
\60\ The reference to noise on the transcript reflects
Respondent's verbal reference to being cut off. See infra note 94.
---------------------------------------------------------------------------
UC1: Really?
WOLFF: Absolutely. Instantly.
UC1: Even if you run out?
WOLFF: Yeah. [Unintelligible.] * * * because then you will have
violated what I just said * * * ."
(Gov't Ex. 14 at 32; Tr. vol. 3, at 312.) Respondent's admission that
most clinics would not continue prescribing controlled substances to SA
O'Neil under the circumstances (see also Tr. vol. 10, at 159) is strong
evidence that
[[Page 5141]]
Respondent's May 4, 2010 prescriptions to SA O'Neil were outside the
usual course of professional practice. Notwithstanding Respondent's
admission of the general consensus that further prescribing would be
inappropriate, Respondent nevertheless prescribed 150 Roxicodone 30 mg,
90 Roxicodone 15 mg and 30 Xanax 2 mg tablets, constituting an increase
of thirty dosage units of oxycodone from what Dr. [L.C.] had prescribed
previously. (E.g., Gov't Ex. 14 at 53-54; Tr. vol. 3, at 311, 331 &
356.) And Respondent made clear that SA O'Neil would be welcome again
in the future and Respondent would continue to prescribe controlled
substances:
UC1: * * * So I should probably just make my appointment in thirty (30)
days with you then, right?
WOLFF: I'm here for you.
UC1: All right. Thanks, doc.
WOLFF: Yeah. We got a bond now.\61\
---------------------------------------------------------------------------
\61\ Respondent also instructed SA O'Neil not to see other
doctors. (Gov't Ex. 14 at 29.) At hearing, Respondent testified that
"I felt he had received the message and given me feedback that he
would comply with my direction." (Tr. vol. 10, at 160.)
---------------------------------------------------------------------------
Gov't Ex. 14 at 33.) I find that Respondent's issuance of controlled
substances to SA O'Neil was outside the usual course of professional
practice, in violation of 21 CFR 1306.04(a); see Fla. Admin. Code Ann.
r. 65B8-9.013.
The record further reflects evidence that Respondent documented in
SA O'Neil's patient file discussions with the patient that did not
actually occur. For instance, contrary to the indications in SA
O'Neil's patient file \62\ (see Gov't Ex. 23 at 9), Respondent did not
discuss alternative medications, such as anti-inflammatories, a
treatment plan for SA O'Neil's pain management, omega-3 fish oil,
glucosamine chondroitin sulfate, avoiding alcohol, smoking and soda,
any of SA O'Neil's other doctors other than Dr. [L.C.], SA O'Neil's MRI
report, any diagnostic test, objectives or goals for pain relief, a
timetable for treatment, the risks and benefits of his medication or SA
O'Neil's continuing care, how he would be monitored on controlled
substances or weaning off the medications he was taking. (Tr. vol. 3,
at 315-16, 324.) Respondent's conduct constitutes a failure to keep
accurate records, to include evaluations, consultations and discussion
of risks and benefits, in violation of Fla. Admin. Code Ann. r. 65B8-
9.013(3).
---------------------------------------------------------------------------
\62\ Page nine of Government Exhibit 23 is not dated or signed
and does not on its face contain express indications that Respondent
completed it on May 4, 2010, or that it applies to SA O'Neil.
Nevertheless, the document is included in an exhibit that SA O'Neil
testified contains his medical records (see Tr. vol. 3, at 367) and
the context, including SA O'Neil's testimony that SA O'Neil did not
fill it out (Tr. vol. 3, at 323) offers a basis to conclude that
Respondent completed the form.
---------------------------------------------------------------------------
Explaining why he prescribed controlled substances to SA O'Neil
given his indications of drug abuse or diversion, Respondent testified
that "I didn't want him to have to use liquid medication to supplement
what he was previously on. I wanted him * * * to be in that controlled
environment * * * where the amount of medication that he's on is
controlled by the physician." (Tr. vol. 10, at 163.) By raising SA
O'Neil's dosage, "it was my goal to achieve pain control on * * * a
slightly increased dosage that would negate any need on his part to
supplement the medication because he may have run out." (Tr. vol. 10,
at 164.) Respondent testified that if he had thought SA O'Neil was
diverting controlled substances, "I would not have written him
anything." (Tr. vol. 10, at 164.) I reject this testimony as not
credible, because it is inconsistent with the objective evidence of
record. In short, Respondent at hearing attempted to present the
impression that Respondent took very seriously the dangers to the
patient illuminated by the patient's self-reported drug abuse or
diversion. But Respondent's contentions at hearing are not as telling
as his own statements to SA O'Neil on May 4, 2010, when Respondent
joked about the friend providing oxycodone drops to SA O'Neil, stating
"Maybe that person that gave you the, uh, * * * oxy * * * let you use
the computer, in light of the fact that they're trying to murder you *
* * Google that. William's stretching exercises." (Gov't Ex. 14 at
34.) y
Moreover, as discussed above, Dr. Berger identified numerous
problems with Respondent's prescription of controlled substances to SA
O'Neil, including, among others, reason to opine that Respondent's
documentation with respect to SA O'Neil was "absolutely below the
standard of care." (Tr. vol. 7, at 117.)
In summary, the record reveals numerous violations of applicable
standards and regulations concerning the prescribing of controlled
substances in the context of SA O'Neil's undercover visit to CCHM.
Substantial evidence supports a finding that Respondent's prescription
of controlled substances to SA O'Neil lacked a "legitimate medical
purpose * * * that is supported by appropriate documentation
establishing a valid medical need and treatment plan," in violation of
Fla. Admin. Code Ann. r. 64B8-9.013(1)(b) (2003), and was outside the
usual course of professional practice, in violation of 21 CFR
1306.04(a).
(d) TFO Doklean
The record reflects that TFO Doklean visited CCHM in an undercover
capacity on July 23, 2010. (E.g., Gov't Ex. 4, at 1.) TFO Doklean's
undercover role was as a patient with a level of neck pain that
affected her ability to interact normally with her children. (Tr. vol.
1, at 230, 253, 255-56, 258, 264 & 282.) Upon arriving at the clinic,
she wrote on patient intake forms that running and exercise made her
pain worse. (Gov't Ex. 25 at 9; Tr. vol. 1, at 316.) She also brought
an MRI report that she had acquired for the purpose of her undercover
visit using her undercover name. (See Tr. vol. 1, at 215.) At hearing,
TFO Doklean testified that she intended to determine whether she could
acquire a prescription without filling out patient intake forms in
their entirety. (Tr. vol. 1, at 237.) She therefore intentionally left
blank the questions inquiring about her pain level. (Tr. vol. 1, at
252-53.) No one else filled out any of her forms for her. (Tr. vol. 1,
at 315.) She made cash payments to office staff totaling $1100. (Tr.
vol. 1, at 190.) The payments included: $300 for an office visit (Tr.
vol. 1, at 186; Gov't Ex. 4 at 7-9); $200 for "expedite service" (Tr.
vol. 1, at 187, 314; see Gov't Ex. 4 at 13); and $600 for medication
(Tr. vol. 1, at 189-90 & 213). Respondent ultimately met with TFO
Doklean for approximately ten minutes and issued a prescription for
oxycodone.
Respondent's prescribing to TFO Doklean was marked by a number of
irregularities. First, although she complained of neck pain, the sole
MRI report TFO Doklean produced related to her lumbar region and not
her neck. (Tr. vol. 1, at 201; Gov't Ex. 4 at 60-61.) Respondent was
aware of this discrepancy, and issued a prescription directing TFO
Doklean to obtain a cervical spine MRI. (Gov't Ex. 4 at 56; Tr. vol.
10, at 196-97; see Tr. vol. 10, at 186.) Notably, however, Respondent
did not require that TFO Doklean acquire the MRI report for her neck
before prescribing controlled substances. Respondent testified that
based on TFO Doklean's statements that "it goes up and down" and that
the pain "radiates," and based on gestures she made pointing to her
lower back, Respondent believed TFO Doklean had back pain, as well as
neck pain. (Tr. vol. 10, at 188.) After TFO Doklean testified that her
pain was preventing her from playing with her children, Respondent
testified that although she stated that her pain was "two or three"
on a pain scale (Gov't Ex. 4 at 33), Respondent interpreted her pain as
actually being
[[Page 5142]]
higher, such as an eight or a ten. (Tr. vol. 10, at 190-91, 201.)
Respondent's assertion that the patient's pain was more than twice the
level that the patient herself indicated on the pain scale is dubious.
Respondent's medical examination of TFO Doklean raises additional
questions regarding whether the controlled substances prescription he
provided was pursuant to a legitimate medical purpose. TFO Doklean
testified that Respondent's physical examination of TFO Doklean
consisted of placing a stethoscope on her back, asking her to breathe
in and out; having her perform some range-of-motion exercises: Bending
down, turning her neck and standing on a foot. She displayed no
discomfort and did not complain of pain during the exercises, which she
completed successfully in less than one minute. (Tr. vol. 1, at 206-
08.) TFO Doklean further testified that Respondent seemed to chuckle at
the fact that TFO Doklean could bend down completely and touch the
ground in a swift maneuver. (Tr. vol. 1, at 206.) Respondent asked if
she had any pain when she did the exercises, and she said "not right
now." (Tr. vol. 1, at 206.) Respondent did not touch TFO Doklean's
spine or neck, the area of her professed pain (Tr. vol. 1, at 208); in
fact, he only touched her when he put the stethoscope on her. (Tr. vol.
1, at 208.)
Viewed together, the evidence relating to TFO Doklean's lumbar MRI
and Respondent's physical examination constitute a lack of objective
indicia of neck pain, along with subjective indicia of neck pain that
are inconsistent, insomuch as the patient's comments are contradicted
by her ease at performing physical exercises in the clinical setting.
This disparity further calls into question the extent to which the
prescription Respondent issued to TFO Doklean was pursuant to a
legitimate medical purpose consistent with 21 CFR 1306.04(a) and Fla.
Admin. Code Ann. r. 64B8-9.013(1)(b) & (3)(f) (2003).
Also of concern is Respondent's acquiescence to TFO Doklean's
apparent diversion or misuse of controlled substances. The record
reflects that TFO Doklean told Respondent she was getting the
"blues," referring to oxycodone 30 mg tablets, from a friend. (See
Gov't Ex. 4 at 34; Gov't Ex. 25 at 2; Tr. vol. 1, at 204, 216-17.) In
addition, for "Past History of Pain Management," Respondent wrote
"Friends & Street." (Gov't Ex. 25 at 2; see Tr. vol. 1, at 216-17.)
Respondent then asked TFO Doklean "how long have you been taking the
blues" and whether they helped. (Gov't Ex. 4 at 34.) TFO Doklean
responded that she took them every couple of days, and they did help.
Respondent did not press the matter. Nor did he "refer the patient as
necessary for additional evaluation and treatment," notwithstanding
the Florida requirement that "[s]pecial attention should be given to
those pain patients who are at risk for misusing their medication" or
who "pose a risk for medication misuse or diversion * * *" Fla.
Admin. Code Ann. r. 65B8-9.013(3)(e). Respondent explained he thought
TFO Doklean was getting controlled substances from friends because
"she didn't have the money to see a doctor previously." (Tr. vol. 10,
at 194.) He intended to "prescribe medication for her in a controlled
way * * * [t]hat prevents diversion and prevents her from continuing to
have to get medicine in an illegitimate way." (Tr. vol. 10, at 196.)
"I don't discriminate against people for their language, for their
social status, for how much money they have." (Tr. vol. 10, at 194.)
Respondent's response to TFO Doklean's professed participation in
the illicit misuse or diversion of controlled substances is all the
more concerning given TFO Doklean's indication that she had undergone
rehabilitation for addiction to alcohol. (See Gov't Ex. 4 at 34; see
also Gov't Ex. 25 at 8.) Respondent asked her when she had undergone
rehabilitation, TFO Doklean responded "last November," and the
conversation moved on to other topics. (Gov't Ex. 4 at 34.) Respondent
never asked the name of her rehabilitation clinic, how long she was in
rehabilitation or the specific reasons for her treatment. (Tr. vol. 1,
at 203.) Even if Respondent believed that TFO Doklean's acquisition
from friends of controlled substances was for purely therapeutic
purposes, Respondent should have been concerned about her history of
addiction. Indeed, although she stated she was sober in her interview
with Respondent (Gov't Ex. 4 at 34), TFO Doklean's patient forms
indicate that she presently drinks alcohol. (Gov't Ex. 25 at 8.)
Respondent was therefore faced with contradictory information but
accepted TFO Doklean's representation that she was clean and sober,
without securing confirmatory records from any medical facility.
Respondent failed to comply with his "require[ment] to keep accurate
and complete records to include, but not * * * limited to: * * * 1. The
medical history * * * including history of drug abuse and dependence *
* * ." Fla. Admin. Code Ann. r. 65B8-9.013(3)(f).
The record further contains evidence that Respondent annotated TFO
Doklean's patient file to document conversations with TFO Doklean that
did not in fact occur. (See, e.g., Tr. vol. 1, at 221-22.) For
instance, despite contrary notations in the patient file (see Gov't Ex.
25 at 5), TFO Doklean testified that Respondent never discussed anti-
inflammatory medications, diet, the risks and benefits of the
medication Respondent prescribed, the risk of abuse or addiction or
physical dependence, yoga/stretching exercises, omega-3 fish oil,
strict avoidance of alcohol, smoking cessation, illegal drugs, follow-
up in one month or issues or concerns or weaning off medication. (Tr.
vol. 1, at 217-20.) Similarly, TFO Doklean testified that Respondent
filled out the Consent for Chronic Opioid Therapy form, which recites
that Respondent has discussed alternate options of "acupuncture,
m[a]ssage, neurological evaluation and surgery" (Gov't Ex. 25, at 16),
but that Respondent never discussed those options with her. (Tr. vol.
1, at 224-25.) In fact, TFO Doklean signed the form before even being
seen by Respondent. (Tr. vol. 1, at 225.) Respondent also did not
discuss with TFO Doklean other pain medication options and did not ask
for TFO Doklean's prior medical records from another doctor, other than
the lumbar MRI noted above. (Tr. vol. 1, at 227-28.) He did not ask
about her prior treatment plan or give her a time table for pain
management. (Tr. vol. 1, at 228.) He did not suggest alternative
medications or treatment options. (Tr. vol. 1, at 228.) These facts
demonstrate that Respondent did not keep accurate medical records, in
violation of Fla. Admin. Code Ann. r. 65B8-9.013(3).
At the end of his meeting with TFO Doklean, Respondent agreed to
prescribe medication for TFO Doklean (Gov't Ex. 4 at 36), ultimately
prescribing 120 Roxicodone 30 mg tablets. (Gov't Ex. 4 at 53.)
Remarkably, TFO Doklean did not know what the medication would be until
the consultation with Respondent had already ended.
After her consultation with Respondent, TFO Doklean talked to a
manager at the clinic named Richard Mendez. (Tr. vol. 1, at 188.) TFO
Doklean testified that Mr. Mendez provided instruction and direction
about concerns that Respondent had about patients "not putting the
proper things in the paperwork," and that the patients needed to say
that they were in pain on the paperwork, and to tell the doctors that
they were in pain. (Tr. vol. 1, at 188.) This information was also
directed to the undercover patients with TFO Doklean who had not yet
been seen by a doctor. (Tr. vol. 1, at 188; Gov't Ex. 4 at 39-40; Gov't
Ex. 4, Audio Session
[[Page 5143]]
1 10:44-46.) Mr. Mendez further stated to TFO Doklean
(referring to Respondent): "This guy is a little * * * this guy is a
little * * * you know * * * serious and by the book in making sure * *
* uh * * * He does everything * * * partly because he's been in a
clinic that's been shut down before, so, it's very hard for him. He
knows * * * you guys are cool." (Tr. vol. 1, at 290; id. at 40.) I
find that Respondent in this instance subjectively did not believe that
TFO Doklean was in pain, which weighs in favor of a finding that
Respondent's prescription of controlled substances lacked a legitimate
medical purpose and was outside the usual course of professional
practice. Additionally, the fact that Respondent asked Mr. Mendez to
inform patients he had not yet seen to say they were in pain
contradicts Respondent's testimony that in all instances he believed
that the patients to whom he prescribed controlled substances were
truly reporting pain.
TFO Doklean testified that she observed a sign in the waiting room
that stated: "Please be aware that outside pharmacies are reporting
prescription transactions to law enforcement agencies. Feel free to
discuss this with your physician." (Tr. vol. 1, at 193.) This sign in
Respondent's waiting room is evidence that Respondent was aware that a
meaningful number of his patients diverted or were at risk of diverting
controlled substances.
In addition, as noted above, Dr. Berger testified, inter alia,
that, in substance, the circumstances "preclude [TFO Doklean] from
being a good candidate for receiving controlled drugs" on her first
visit, and that such a prescription would not be in compliance with
"the established care in Florida." (Tr. vol. 7, at 147.)
Viewed as a whole, although Respondent's prescription of controlled
substances to TFO Doklean was not wholly without some indicia of
medical purpose, substantial evidence supports a finding that
Respondent's prescription of controlled substances to TFO Doklean
lacked a "legitimate medical purpose * * * that is supported by
appropriate documentation establishing a valid medical need and
treatment plan," in violation of Fla. Admin. Code Ann. r. 64B8-
9.013(1)(b) (2003), and was outside the usual course of professional
practice, in violation of 21 CFR 1306.04(a).
(e) SA Brigantty
The record reflects that SA Brigantty visited CCHM in an undercover
capacity on July 23, 2010. (E.g., Gov't Ex. 9 at 3; Tr. vol. 2, at 16.)
The evidence regarding this visit reveals a number of departures from
the usual course of professional practice that call into question the
degree to which the medication that Respondent ultimately prescribed to
SA Brigantty was pursuant to a legitimate medical purpose.
As an initial matter, the context of SA Brigantty's arrival at CCHM
suggests the existence of an arrangement between undercover agents
posing as patients and CCHM's office staff. After being met outside by
an individual named Freddy, SA Brigantty entered the clinic through a
rear entrance with a group of other undercover agents posing as
patients. (Tr. vol. 2, at 17-18.) "The staff understood that we, as a
whole, all those people who went in at the same time, were together."
(Tr. vol. 2, at 18.) All the undercover officers paid a two hundred
dollar expediting fee "to get through the clinic, see the doctors, and
get out." (Id. at 19.) Although not dispositive, this arrangement
casts suspicion on the legitimacy of Respondent's medical practice at
CCHM because it provides circumstantial evidence that Respondent's
staff participated in a plan by which groups of individuals, who may or
may not have legitimate medical needs, could obtain controlled
substances. SA Brigantty's testimony that he paid a fifty dollar tip to
a female office staff member in the reception area (Tr. vol. 2, at 43)
raises similar concerns because it represents a concrete instance of a
staff member receiving cash in exchange for funneling patients to
Respondent.\63\
---------------------------------------------------------------------------
\63\ The extent and import of Respondent's knowledge of his
staff's practices is discussed in numerous locations throughout this
Recommended Decision.
---------------------------------------------------------------------------
At his meeting with Respondent, SA Brigantty presented as a patient
with pain in his lower back for the past fifteen years, which he
attributed to lifting heavy objects at a construction job. (Gov't Ex. 9
at 35-36.) He described his pain as about six on a pain scale of one to
ten. (Gov't Ex. 9 at 37.) He further described an additional kind of
his pain as "pretty [expletive] bad," to which Respondent replied:
"I don't have a number that correlates with that one * * * ." (Id.;
Tr. vol. 2, at 96.) SA Brigantty testified that he also circled the
number ten on the pain scale. (See Tr. vol. 2, at 48.)
SA Brigantty testified that Respondent did not ask him about his
past treatments, previous diagnostic tests or the names of his previous
doctors over the fifteen-year period. (Tr. vol. 2, at 34-36.) In fact,
however, Respondent did ask where SA Brigantty previously received pain
treatment, and SA Brigantty replied that he had gone to Jacksonville.
(Gov't Ex. 9 at 25.) SA Brigantty also told Respondent that he had
previously purchased "The Oxys. Thirty (30) milligrams" and "a Zanie
bar," referring to Xanax, off the street. (Gov't Ex. 9 at 41; see Tr.
vol. 2, at 37.) He said he hadn't taken medication for approximately
one month, but that the drugs helped him and he had been taking them
for two to three years. (Gov't Ex. 9 at 41.) SA Brigantty also wrote on
a Pain Assessment Form that he was presently taking oxycodone and Xanax
(Gov't Ex. 26, at 9; Tr. vol. 2, at 49), statements which he orally
contradicted when he informed Respondent that he was not presently
taking medication. (Tr. vol. 2, at 125.) Given SA Brigantty's confessed
illicit use of controlled substances, Respondent failed to "refer the
patient as necessary for additional evaluation and treatment,"
notwithstanding the Florida regulations providing that "[s]pecial
attention should be given to those pain patients who are at risk for
misusing their medications" or who "pose a risk for medication misuse
or diversion * * *" Fla. Admin. Code Ann. r. 65B8-9.013(3)(e).
Ultimately, Respondent issued a prescription to SA Brigantty for
oxycodone, explaining that many patients get their medications from the
street because they: "find that that is the only place they can get
it, short of coming to a doctor. So by starting them on medication you
can stop them * * * from having to get the medication in places that
they shouldn't be." \64\ (Tr. vol. 2, at 180.)
---------------------------------------------------------------------------
\64\ Respondent declined to issue a prescription for Xanax,
because SA Brigantty "seemed to indicate that if the pain was under
control, he would be sleeping better. So I didn't want to
prescription [sic] any Xanax if it wasn't necessary." (Tr. vol. 10,
at 265.)
---------------------------------------------------------------------------
The record reveals interactions between Respondent and SA Brigantty
that reflect poorly both as to Respondent's standard of care as a
physician and as to Respondent's knowledge of operations at CCHM.
During the patient consultation, Respondent advised SA Brigantty that
his blood pressure was high: "You need to get yourself re evaluated.
Meaning you need to find a regular medical doctor as soon as possible
and have that re checked." (Gov't Ex. 9 at 42.) Respondent, however,
did not offer to prescribe blood pressure medication or perform any
diagnostic testing for blood pressure, (Tr. vol. 2, at 38), because
I didn't want to prescribe medication for people I was only
going to see one time * * * giving a patient a strong recommendation
* * * was more in the patient's best interest * * * because it
[[Page 5144]]
prompted them to seek out a regular medical doctor, which would have
been a more appropriate place for them to receive medication on a
regular basis, and receive the follow-up that they needed.
(Tr. vol. 2, at 169.) Respondent later contradicted himself, testifying
that
My best measure of success was in my interaction with the
patient, in that we were going to prescribe some medication, we were
going to see how he did * * * I would have had to see him back, at a
follow-up appointment, and ask him questions as to how he was doing.
And then I would have been able to measure the success of the
oxycodone treatment. (Tr. vol. 2, at 214-15.)
This second statement by Respondent can be read in two ways: either
Respondent thought SA Brigantty would return for another visit,
undercutting Respondent's assertion that he did not expect SA Brigantty
would return for a follow-up appointment; or it shows that Respondent
did not truly expect ever to see SA Brigantty again, calling into
question Respondent's ability to monitor the success of his interaction
with the patient and tending to show Respondent did not believe he was
issuing the prescription in the usual course of a professional practice
or pursuant to a legitimate medical purpose.\65\
---------------------------------------------------------------------------
\65\ In support of his prescribing practices, Respondent
testified that an MRI report for SA Brigantty revealed significant
disc disease and evidence of a boney abnormality compressing the
spinal cord sac, consistent with pain. (Tr. vol. 10, at 267-68.) On
different facts devoid of irregularities in CCHM's office practice
and Respondent's conduct with respect to SA Brigantty and SA
Brigantty's indications of diversion, such evidence might have been
more persuasive.
---------------------------------------------------------------------------
In any event, even if it can be reconciled with his other
statements, Respondent's explanation as to why he failed to prescribe
blood pressure medications to SA Brigantty raises more questions than
it answers. First, Respondent's assertion that he did not expect to see
SA Brigantty again for a follow-up visit is inconsistent with
Respondent's testimony that line items on the History and Physical
Examination Form in SA Brigantty's medical file "should serve as
talking points, over time, with patients" and need not be discussed
all at once. (Tr. vol. 2, at 172; see Gov't Ex. 26 at 5.) These two
statements are inconsistent because viewing the discussion checklist as
the basis of a continuing doctor-patient dialogue over time is
incompatible with a view that the patient probably will not return for
a follow-up visit.
Moreover, Respondent's opinion that SA Brigantty should seek a
"regular doctor," speaks volumes as to Respondent's beliefs about his
own practice. Respondent explained that he considers himself "a
regular medical doctor. But in this setting, this was a clinic where we
treated pain management, or our main role was pain management." (Tr.
vol., 2, at 169.) Even if Respondent's testimony concerning the need
for SA Brigantty to see a separate "regular doctor" is to be taken at
face value, the record unambiguously reflects that Respondent did not
refer SA Brigantty to any particular "regular doctor" (Tr. vol. 2, at
170), which is inconsistent with the referral standard contained in
Fla. Admin. Code Ann. r. 65B8-9.013(3). Moreover, Respondent did not
discuss the risks to a person with high blood pressure of taking
oxycodone, the controlled substance he ultimately prescribed to SA
Brigantty (Tr. vol. 2, at 39-40), contrary to Fla. Admin. Code Ann. r.
65B8-9.013(3)(c) ("The physician should discuss the risks and benefits
of the use of controlled substances with the patient * * * .") and
Fla. Admin. Code Ann. r. 65B8-9.013(3)(f) (requiring accurate and
complete medical records of "Discussion of risks and benefits").
Additionally, Respondent's contention that the oxycodone he prescribed
to SA Brigantty was merely a "therapeutic trial" (Tr. vol. 2, at 177-
78) cannot comfortably coexist with Respondent's assertion that he did
not believe SA Brigantty would return for a follow up visit (see Tr.
vol. 2, at 169).
Also notable is evidence of SA Brigantty's misrepresentation in his
undercover role about his own medical history, and Respondent's
reaction after learning of the misrepresentation. SA Brigantty
testified that when filling out patient intake paperwork, a female
member of Respondent's office staff communicated the requirement that
"you had to put down * * * a primary doctor, or some other place you
have been to * * * . she told us you can put anything down, put
American Pain, they are closed." (Tr. vol. 2, at 20-21.) On cross-
examination, SA Brigantty elaborated that the staff member had
instructed: "I don't care what it is, where you have been, you can
write American Pain." (Tr. vol. 2, at 61.) In fact, the staff member's
actual statement as reflected in a transcribed recording was: "Your
last physician is gonna be * * * We need all the information. If you
don't have it you gotta, somehow get it. If it is American Pain, Right
[sic] American Pain, if they are no longer there or * * * you gotta put
something." (Gov't Ex. 9 at 23; see Tr. vol. 2, at 73.) SA Brigantty
testified that he interpreted this as coaching him to write "American
Pain" as his previous provider. (Tr. vol. 2, at 21.)
This incident came to light during Respondent's consultation with
SA Brigantty, when Respondent inquired if SA Brigantty had been to
American Pain. The undercover agent responded that he wasn't seeing a
physician, but that the office staff had instructed him "'You need to
write something.' Someone said American, I was like '[expletive] it,
I'll put American."' (Gov't Ex. 9 at 44.) Despite knowing that the
patient had falsified his medical record, and knowing that SA Brigantty
believed Respondent's staff had coached him to make such a
falsification, Respondent ultimately issued a prescription for 150
Roxicodone 30 mg tablets to SA Brigantty. (Gov't Ex. 9 at 53-54; Tr.
vol. 2, at 29.) SA Brigantty paid $750 cash. (Tr. vol. 2, at 31.)
Applicable Florida regulations are clear about the mandatory weight of
the recordkeeping guideline: "The physician is required to keep
accurate and complete records" before prescribing controlled
substances. Fla. Admin. Code Ann. r. 65B8-9.013(3)(f). Respondent's
acquiescence in recordkeeping inaccuracies weighs heavily against
Respondent's continued registration under Factors Two and Four of 21
U.S.C. 823(f).
SA Brigantty's undercover patient file reflects additional
irregularities. For instance, a History and Physical Examination form
not filled out by SA Brigantty (Tr. vol. 2, at 45) reflects that
Respondent prescribed to SA Brigantty Roxicodone 15 mg and Xanax 2 mg
tablets. (Gov't Ex. 26, at 5.) SA Brigantty testified, however, that he
never received any such prescriptions from Respondent. (Tr. vol. 2, at
45.) Respondent explained that his notation in the file as to the
Roxicodone 15 mg and Xanax 2 mg must have been in error. (Tr. vol. 2,
at 163-64.) Even crediting Respondent's testimony and finding that the
inaccuracy was an oversight, the error nevertheless constitutes a
violation of Florida's recordkeeping regulations. See Fla. Admin. Code
Ann. r. 65B8-9.013(3)(f). In addition, the record reflects that SA
Brigantty completed a urine test, which Respondent's office staff did
not monitor. (Tr. vol. 2, at 133-34.)
The record further reveals evidence that Respondent documented in
SA Brigantty's patient file discussions with the patient that did not
actually occur. For instance, despite contrary notations in the patient
file (Gov't Ex. 26 at 5-6), SA Brigantty testified that Respondent
never discussed anti-inflammatory medications, diet or the risks and
benefits of medication, including the
[[Page 5145]]
risk of abuse, addiction and physical dependence; yoga and stretching
exercises; omega-3 fish oil, strict avoidance of alcohol, smoking
cessation, or the avoidance of illegal or recreational drugs while on
pain medication; or the weaning off of medication or the treatment plan
objectives of pain relief or improvement, improved physical and
psychological function, improving activity of daily living, working at
full capacity, rehabilitation programs or interdisciplinary approaches
to treatment.\66\ (Tr. vol. 2, at 45-48.)
---------------------------------------------------------------------------
\66\ Respondent did, however, raise the issue of surgery. (Tr.
vol. 2, at 102.)
---------------------------------------------------------------------------
Respondent attempts to downplay these misrepresentations on the
basis that some of the information he failed to discuss with SA
Brigantty is contained in the consent form for opioid medications
provided to patients at CCHM. (E.g., Tr. vol. 2, at 170.) This attempt
is unpersuasive for two reasons. First, Respondent's argument is
undercut by his admission in a similar context that "the word
discussed should probably be whited out" because "these should serve
as talking points, over time, with patients." (Tr. vol. 2, at 172.)
Respondent's argument fails because if the items are to be discussed
over time, it is logical to check off an item only once it has actually
been discussed, and not before, as happened here. Second, Respondent's
argument cannot overcome the plain language of the Florida regulation
providing that "[t]he physician is required to keep accurate and
complete records to include * * * [e]valuations and consultations [and]
* * * [d]iscussion of risks and benefits * * * ." Fla. Admin. Code
Ann. r. 65B8-9.013(3) (emphasis supplied).
In addition, as noted above, Dr. Berger testified in substance that
a patient who is illegally buying drugs on the street, and who requests
that the same drug be prescribed, should be precluded from receiving
prescriptions for controlled substances. (Tr. vol. 7, at 161.) Dr.
Berger further testified that based on his review of the medical file,
he did not see anything that justified the issuance of controlled
substances to SA Brigantty. (Tr. vol. 7, at 162; Gov't Ex. 26.)
In summary, the record reveals numerous violations of applicable
standards and regulations concerning the prescribing of controlled
substances in the context of SA Brigantty's undercover visit to CCHM.
Substantial evidence supports a finding that Respondent's prescription
of controlled substances to SA Brigantty lacked a "legitimate medical
purpose * * * that is supported by appropriate documentation
establishing a valid medical need and treatment plan," in violation of
Fla. Admin. Code Ann. r. 64B8-9.013(1)(b) (2003), and was outside the
usual course of professional practice, in violation of 21 CFR
1306.04(a).
(f) SA Priymak
SA Priymak first visited CCHM in an undercover capacity on April 7,
2010, accompanied by two or three other undercover agents. (E.g., Tr.
vol. 2, at 315-16; Gov't Ex. 5 at 1.) He approached the front desk,
presented as a new patient and obtained patient intake forms, which he
filled out as he sat down. (Tr. vol. 2, at 317-20.) He paid $175 for
the visit. (Tr. vol. 2, at 319.) Dozens of people were waiting in the
lobby. (Tr. vol. 2, at 318.) After completing all the triage procedures
that were requested of him, SA Priymak testified that Respondent called
his name, and SA Priymak followed Respondent to an office. (Tr. vol. 2,
at 321.) This testimony, consistent with testimony of other agents,
tends to show that Respondent did have interaction with the waiting
area. Respondent therefore was not completely isolated from the waiting
or triage area and can reasonably be understood to have at least some
knowledge of things that occurred there and objects present there, to
include a sign on the waiting room wall as of July 23, 2010 stating:
"Please be aware that outside pharmacies are reporting prescription
transactions to law enforcement agencies. Feel free to discuss this
with your physician." (Tr. vol. 1, at 193.)
When SA Priymak entered the consultation room, Respondent asked if
it was SA Priymak's first visit, to which SA Priymak responded in the
affirmative. (Gov't Ex. 5 at 34.) Respondent's next statement was
"Alright. Let['s] see. We gonna help with your pain in your neck,"
(Gov't Ex. 5 at 34; Tr. vol. 2, at 321) even though SA Priymak had not
mentioned having any pain or neck issues.\67\ SA Priymak affirmed that
he had neck pain, stating also that his shoulder was "kind a * * *
tight." (Gov't Ex. 5 at 34.) Respondent asked SA Priymak how long he
had had pain, how he had injured his neck, how old he was and whether
he was working. (Gov't Ex. 5 at 34-35.) SA Priymak responded that the
pain began in 2001 when he tweaked his neck playing basketball, that he
was thirty-four years old and that he was between jobs, working in
construction. (Gov't Ex. 5 at 34-35.)
---------------------------------------------------------------------------
\67\ In mitigation, SA Priymak testified that he provided Coast
to Coast with an MRI report of his neck (Tr. vol. 2, at 331), which
Respondent later testified was consistent with a patient having
significant neck pain. (Tr. vol. 10, at 138.)
---------------------------------------------------------------------------
SA Priymak further told Respondent that he was not presently taking
medication (Gov't Ex. 5 at 35), in direct contrast to his later
statements to Respondent and also his pain assessment form dated April
7, 2010, which indicated he was taking medications consistent with
OxyContin, Xanax, Soma and Dilaudid, listing side effects from
medication as "it feels good." (Gov't Ex. 22 at 9-10; see Tr. vol. 2,
at 331, 349-50.) I find that SA Priymak's statement that "it feels
good" was evidence of potential diversion that Respondent did not
sufficiently weigh in deciding to prescribe controlled substances.
Moreover, SA Priymak testified that Respondent never discussed Dilaudid
with SA Priymak (Tr. vol. 2, at 349), constituting additional evidence
of Respondent's lack of concern for potential drug abuse or diversion.
Respondent remarked that SA Priymak's condition didn't sound so
bad, to which SA Priymak responded that he had been taking medication
on and off for the last ten years "cause it gets tight, especially in
my * * * shoulder." (Gov't Ex. 5 at 36.) Respondent stated "So the
pain is sort of mild. It's that right?" and asked what medicines SA
Priymak had been taking. (Gov't Ex. 5 at 36.) He responded that he was
taking four tablets of "Oxy forties" per day, which Respondent
confirmed was oxycodone, and "some Somas" that weren't helping him,
and agreed that the pain was mild. (Gov't Ex. 5 at 36-37, 40; Tr. vol.
2, at 323.) Respondent confirmed: "you told me that pain is mild * * *
and mostly affects you * * * when you play basketball * * * you
otherwise do pretty good?" (Gov't Ex. 5 at 37.) SA Priymak responded:
"Mm * * * No. I just * * * I need that * * * to get through the day,"
and stated that sometimes his pain was a five. (Gov't Ex. 5 at 37.)
Under the number "5" on SA Priymak's pain assessment form, there
appears a handwritten arrow that SA Priymak testified he did not draw
(Gov't Ex. 22 at 10; Tr. vol. 2, at 350), leading to the conclusion
that Respondent drew the arrow. Respondent asked if SA Priymak was
sleeping well, to which SA Priymak responded in the negative and
indicated that he had been taking one-half to two bars of Xanax. (Gov't
Ex. 5 at 37, 40.)
Upon inquiry from Respondent, SA Priymak stated that he was not
allergic to any medications, smoked approximately two cigars per day,
had high blood pressure and had used
[[Page 5146]]
intravenous drugs five or six years ago. (Gov't Ex. 5 at 38.)
Respondent then inquired:
WOLFF: Is there any history of drug abuse or drug dependence?
UC1: Mm * * * I've been taking Oxies for, for a while.
WOLFF: Ox[y]codone.
UC1: Yes.
WOLFF: How much [o]xycodone are you taking?
UC1: I mean, it depends. Uhm * * * it's kind of expensive, so * * * I *
* * buy forties. * * *
WOLFF: And have you seen a doctor at all uh lately, or no?
UC1: No, no.
WOLFF: No. So just get them off the street.
UC1: Yeah.
(Gov't Ex. 5 at 39; see also Tr. vol. 2, at 323; Tr. vol. 3, at 33.)
The record reveals evidence that Respondent's staff tampered with
SA Priymak's patient file. On cross-examination, SA Priymak admitted
that he was not actually taking controlled substances that he claimed
he obtained off the street. (Tr. vol. 3, at 33-34.) A urine drug screen
for SA Priymak, however, indicates a positive test for opiates/
morphine, benzodiazepine and oxycodone. (Gov't Ex. 22 at 25; see Tr.
vol. 3, at 34-36.) Further complicating matters is SA Priymak's
testimony that he did not recall taking a drug test. (Tr. vol. 3, at
37.) He testified that "when I was seen at the triage room, the staff
member indicated playfully that--checked something in my file like
'Yeah, you have drugs in your system.' " (Tr. vol. 3, at 37; see Gov't
Ex. 5 at 24.) I find by substantial evidence that a member of
Respondent's staff at CCHM falsified SA Priymak's patient file to
reflect false positive test results for a urine drug screen. Although
there is no indication that Respondent knew of this particular instance
of tampering with SA Priymak's medical record, the record as a whole
supports the conclusion that such practices were not uncommon at CCHM.
Each additional instance of misconduct by Respondent's staff decreases
the credibility of Respondent's contention that he was unaware of his
staff's actions.
Respondent then inquired about SA Priymak's alcohol consumption, to
which he admitted drinking three or four bottles of beer a couple times
a week. (Gov't Ex. 5 at 39.) Respondent conducted a brief physical
examination of SA Priymak, including motion exercises. (See Tr. vol. 2,
at 330.) SA Priymak successfully completed the exercises without
showing signs of pain (Tr. vol. 2, at 330), which should have given
Respondent pause before prescribing controlled substances. Perhaps it
did: Respondent then stated "I think that you're taking a lot of
medicine for mild pain." (Gov't Ex. 5 at 40.) He continued that SA
Priymak was "on requirements for medication []way out of proportions
for the degree of pain you have * * * I don't think I['m] gonna be able
to help you. * * *" (Gov't Ex. 5, at 41.) SA Priymak then proposed:
UC1: Can you help me with something of less amount?
WOLFF: Like?
UC1: I won't be able to function, like thirties (30s), twenties (20s).
WOLFF: I mean, thirties (30s) is always right, you know?
UC1: Can be thirties (30s)?
WOLFF: I just don't' see it uh for * * * what you have.
UC1: Can you give me some fifteens (15)s?
WOLFF: You know, maybe I'll give you some fifteens (15s).
UC1: Oh, thank you.
WOLFF: You probably would need to be on * * * medicine to get off of
this. You should go up to some sort of rehab facility * * * you want
some Xanax?
UC1: Yeah.
(Gov't Ex. 5 at 42; see generally Tr. vol. 2, at 347.) SA Priymak next
requested Viagra, stating that he was going to a party next week and
wanted to try it. (Gov't Ex. 5 at 43.) Respondent asked if he had
"some problems * * * that we're gonna give that for you?" to which SA
Priymak answered in the negative. (Gov't Ex. 5 at 44.) Respondent
confirmed: "Just for the party?" to which SA Priymak responded
"yeah." Respondent laughed and said "Good try." (Gov't Ex. 5 at
44.) Respondent wrote SA Priymak a prescription for 150 Roxicodone 15
mg and 30 alprazolam 2 mg tablets on April 7, 2010.\68\ (Gov't Ex. 22
at 23; Tr. vol. 2, at 325-36.)
---------------------------------------------------------------------------
\68\ SA Priymak also testified that a staff member at the
reception area said Respondent did not have a DEA license and
therefore the prescription could not be filled at Coast to Coast.
(Tr. vol. 2, at 326-27.)
---------------------------------------------------------------------------
Respondent's failure to refer SA Priymak to a particular
rehabilitation center, despite the notation in the patient chart "Rec.
pt see MD for Suboxone" (Gov't Ex. 22 at 6) is concerning and raises
questions of whether Respondent complied with Fla. Admin. Code Ann. r.
65B8-9.013(3)(f) (requiring a physician to keep accurate medical
records) and Fla. Admin. Code Ann. r. 65B8-9.013(3)(e) (stating that a
physician "should be willing to refer the patient as necessary for
additional evaluation and treatment * * *").\69\
---------------------------------------------------------------------------
\69\ Referring to a later visit by SA Priymak, Respondent
testified that he did not urge that SA Priymak get rehabilitation
treatment at his second visit to CCHM because SA Priymak said he was
not experiencing withdrawal symptoms. (Tr. vol. 10, at 140.) The
persuasiveness of Respondent's testimony in this regard is
substantially undercut by Respondent's statement that SA Priymak
"was no longer having to get his medicine on the street." (Tr.
vol. 10, at 141.) Respondent had no way to verify the truth of this
statement, nor does a transcript of the May 4, 2010 visit indicate
Respondent made such an inquiry. (See Gov't Ex. 5, at 54-58.)
---------------------------------------------------------------------------
Respondent acted correctly in declining to prescribe Viagra to SA
Priymak, in light of the patent lack of medical indication.
Respondent's prescription of pain medication, however, was another
matter. Respondent knew that SA Priymak was a drug-seeking individual
who had purchased controlled substances off the street and whom
Respondent suspected had used intravenous drugs due to "something on
his arm." (Tr. vol. 10, at 100.) As noted above, Dr. Berger opined
that prescriptions for Roxicodone and Xanax were unwarranted,
particularly given the patient's history of being an intravenous drug
user and having purchased drugs illicitly on the street. (Tr. vol. 7,
at 92.) Moreover, Respondent acknowledged that SA Priymak's mild pain
level did not support the controlled substances SA Priymak said he was
currently taking off the street. (Tr. vol. 10, at 105.) Additionally,
Respondent did not inquire as to the source of SA Priymak's drugs, nor
did he admonish him to stop acquiring off the street.
Under these circumstances, it cannot be concluded that Respondent's
controlled substances prescriptions, even at a so-called "reduced"
amounts, were pursuant to a legitimate medical purpose or within the
usual course of professional practice. To the contrary, they were not.
Respondent's testimony that he didn't want SA Priymak to suffer from
withdrawal symptoms (Tr. vol. 10, at 128) and the fact that
Respondent's prescription of oxycodone was less than half of the dosage
that SA Priymak represented he was previously taking (Tr. vol. 3, at
32; Tr. vol. 10, at 109) perhaps mitigate in Respondent's favor, but do
not alter the conclusion that the prescriptions themselves were not
justified under all the circumstances.
SA Priymak returned to CCHM in an undercover capacity on May 4,
2010. (Tr. vol. 2, at 315.) He paid $200 for the $150 visit but did not
receive any change back. (Tr. vol. 2, at 327-28.) This evidence is
consistent with payments for "VIP service," apparently common at
CCHM. As noted elsewhere in this
[[Page 5147]]
Recommended Decision, overpaying for medical service is indicative of,
or at least consistent with, a climate where patients and staff members
play an improper role in causing controlled substances to reach
patients outside the usual course of professional practice. The record
as a whole supports a finding that all or substantially all of the
undercover agents sought and received VIP treatment as a matter of
course. Given the clear prevalence of this practice at CCHM, I reject
Respondent's testimony that he had no knowledge of it, especially as
the admitted owner of CCHM as of October 2010, daily work history at
CCHM beginning in April 2010, and in light of Respondent's admission at
hearing that he was familiar with the practice for an "occasional
patient." (Tr. vol. 11, at 183.)
After completing triage procedures, SA Priymak met with Respondent.
(Tr. vol. 2, at 328.) Respondent asked whether the medication he had
prescribed was working, to which SA Priymak responded in the
affirmative. (Tr. vol. 2, at 328; Tr. vol. 3, at 56-58.) After checking
SA Priymak's breathing, Respondent asked him to move his hands up and
down and his head from left to right. (Tr. vol. 2, at 330.) Respondent
prescribed 150 Roxicodone 15 mg and 30 alprazolam 2 mg tablets. (Tr.
vol. 2, at 328-29, 338, 348, 352; Tr. vol. 3, at 60-61; Gov't Ex. 22 at
20-21.)
The record reveals evidence that Respondent documented in SA
Priymak's patient file discussions that did not actually occur. For
instance, despite contrary notations in the patient file (e.g., Gov't
Ex. 22 at 6), SA Priymak testified that Respondent did not discuss a
treatment plan with SA Priymak on either April 7 or May 4, 2011,
alternative medications or treatment options, anti-inflammatories or
diet, yoga and stretching exercises or return to functional ability
while on pain medication. (Tr. vol. 2, at 331, 333 & 345.) Respondent's
conduct constitutes a failure to keep accurate records, to include
evaluations, consultations and discussion of risks and benefits, in
violation of Fla. Admin. Code Ann. r. 65B8-9.013(3).
As noted above, Dr. Berger credibly testified that in his
professional medical opinion, Respondent's April 7, 2010 and May 4,
2010 Roxicodone and Xanax prescriptions were unwarranted and that
Respondent's treatment of SA Priymak fell below the standard of care.
(E.g., Tr. vol. 7, at 92, 98; Gov't Ex. 32 at 73.) The record as a
whole reveals numerous violations of applicable standards and
regulations concerning the prescribing of controlled substances in the
context of SA Priymak's undercover visits to CCHM. Substantial evidence
supports a finding that Respondent's prescription of controlled
substances to SA Priymak lacked a "legitimate medical purpose * * *
that is supported by appropriate documentation establishing a valid
medical need and treatment plan," in violation of Fla. Admin. Code
Ann. r. 64B8-9.013(1)(b) (2003), and was outside the usual course of
professional practice, in violation of 21 CFR 1306.04(a)
(g) SA Zdrojewski
The record reflects that SA Zdrojewski visited CCHM in an
undercover capacity on July 23, 2010, along with nine other undercover
agents. (Tr. vol. 3, at 69.) The agents arrived at the back door of the
clinic. (Tr. vol. 3, at 69-70.) The back room was bare, containing
approximately eleven chairs and "there was really no real interaction
with office staff." (Tr. vol. 3, at 70.) After a few minutes, an armed
staff member named Fred or Freddie, and a separate staff member named
Lina, came to the back room and spoke with the "ringleader" SA
Lunsford. (Tr. vol. 3, at 71-72.) The agents paid $500, including an
extra $200 for "VIP treatment, speeding it up a little bit." (Tr.
vol. 3, at 72; Gov't Ex. 8 at 3-4.) SA Zdrojewski also testified that
he gave his patient paperwork to SA Lunsford to hand in to the office
staff.\70\ (Tr. vol. 3, at 73-74.) Although not dispositive, this
evidence indicates that the staff of CCHM interacted with patients in
unorthodox ways. The existence of a ringleader, the agents' entrance
through a back door of the clinic into a back room, and the payment of
$200 for preferential treatment provides clear evidence of a profit
motive for employees to process patients according to the patients'
requests instead of according to an established and legitimate medical
procedure.
---------------------------------------------------------------------------
\70\ SA Zdrojewski also testified that he supplied a true MRI
report of his body. (Tr. vol. 3, at 81; see Gov't Ex. 8 at 24.)
---------------------------------------------------------------------------
SA Zdrojewski also testified that agents made comments within
earshot of clinic staff members that "This is costing us too much
money. We're not gonna make any money off this." (Tr. vol. 3, at 73.)
Although not dispositive, this testimony provides evidence that CCHM
staff members, at least those within earshot of the undercover agents,
knew that the "patients" sought to acquire controlled substances for
the purpose of diverting and selling them.
SA Zdrojewski proceeded to a triage area where he was weighed and
his blood pressure and other vital signs were measured. (See Tr. vol.
3, at 74-76; Gov't Ex. 8 at 8.) SA Zdrojewski's blood pressure reading
was high, and SA Zdrojewski informed staff members that he was on the
medication Diovan, which he believed they documented in his chart.\71\
(Tr. vol. 3, at 77.) Triage staff informed SA Zdrojewski that he
couldn't see a doctor without conducting a urinalysis first. (Tr. vol.
3, at 77.) SA Zdrojewski submitted a urine specimen for analysis. (Tr.
vol. 3, at 77.) SA Zdrojewski testified that
---------------------------------------------------------------------------
\71\ Respondent also asked SA Zdrojewski if he had medical
problems such as high blood pressure or diabetes, and SA Zdrojewski
responded in the affirmative, stating he was on Diovan. (Gov't Ex. 8
at 14.)
---------------------------------------------------------------------------
It was not supervised, and after I came out of [the bathroom], I
was kind of joking around that I fooled with the test, like put
water in it * * * I just said I fooled around with the test in front
of staff members and in front of those nurses to other agents and was kind of laughing about it, but then no one ever said anything.
(Tr. vol. 3, at 78-79.) The cup he used did not contain a label
identifying it as his own. (Tr. vol. 3, at 79.) The staff's non-
reaction and apparent indifference to SA Zdrojewski's manifestations
that he had tampered with his urine drug screen are indicative of a
culture at CCHM that is accepting of diversion of controlled substances
and prescribing outside the usual course of professional practice. I
find that the drug screen process, as applied to SA Zdrojewski and
other undercover agents discussed elsewhere in this Recommended
Decision, was manifestly inadequate at CCHM, which Respondent knew or
should have known. Respondent's testimony that he felt the need to
improve the urinalysis process after assuming ownership of CCHM in
October 2010 indicates that at some point prior to October 2010 he had
actual knowledge of the deficiencies in CCHM's urinalysis process. (See
Tr. vol. 9, at 260-74.)
SA Zdrojewski testified to his visit with Respondent. A staff
member directed SA Zdrojewski to stand in a dimly lit hallway with no
chairs for approximately ten to fifteen minutes. (Tr. vol. 3, at 83.)
He watched an individual named Richard Mendez enter Respondent's
office, where SA Zdrojewski saw Respondent sitting at a desk. (Tr. vol.
3, at 83.) After exiting Respondent's office, Mr. Mendez talked to an
undercover agent who then approached SA Zdrojewski, stating: "You have
pain." (Tr. vol. 3, at 84.) Although not dispositive, this statement
[[Page 5148]]
is consistent with other evidence of record that Respondent instructed
CCHM staff members to tell patients they needed to indicate pain.\72\
---------------------------------------------------------------------------
\72\ E.g., supra text at notes 26-28 (noting TFO Doklean's
testimony that a staff member voiced Respondent's concerns that
patients needed to say they were in pain in their paperwork, and
needed to tell doctors they were in pain).
---------------------------------------------------------------------------
A couple minutes later, Respondent invited SA Zdrojewski to enter
the office, which contained a desk, chairs and an examination table.
(Tr. vol. 3, at 85-86.) SA Zdrojewski approached the examination table
"and kind of vaulted myself up on it." (Tr. vol. 3, at 86.)
Respondent asked if SA Zdrojewski was visiting for the first time,
and SA Zdrojewski responded in the affirmative, stating that he had
previously been a patient at Tampa Bay Wellness, which had closed.
(Gov't Ex. 8 at 11.) Respondent inquired where SA Zdrojewski's pain was
and how long the pain had lasted, to which SA Zdrojewski responded
"Neck" and a year and a half.\73\ (Gov't Ex. 8 at 11.) SA Zdrojewski
further stated that he was self-employed as a charter captain and could
not explain how he hurt his neck.\74\ (Gov't Ex. 8 at 11-12; see Tr.
vol. 3, at 87.) He stated that his previous doctor gave him "crazy
amounts but I didn't even fill it all out. Dude was giving me ninety
(90) count eighties (80's) * * * [and] sixty (60), two (2) [m]illigrams
[X]anax and two hundred forty (240) Thirties (30's) * * * Don't need
all that." (Gov't Ex. 8 at 12.) Respondent replied by asking SA
Zdrojewski to describe his pain, noting that "You got zero (0) to one
(1), is that right?" (Gov't Ex. 8 at 12.) Respondent did not ask what
SA Zdrojewski was doing with the excess medication he was not using.
(Tr. vol. 3, at 98.)
---------------------------------------------------------------------------
\73\ Respondent asked how long SA Zdrojewski's back had been
hurting, and SA Zdrojewski replied that in fact his neck was the
issue. (E.g., Tr. vol. 3, at 86-87.)
\74\ Respondent did not inquire about SA Zdrojewski's duties as
a charter captain. (Tr. vol. 3, at 99.)
---------------------------------------------------------------------------
At hearing, SA Zdrojewski testified that he had circled zero to one
on the pain scale. (Tr. vol. 3, at 96.) SA Zdrojewski stated to
Respondent that his pain was intermittent, comes and goes, and later in
his conversation with Respondent "I just said, 'Well, then top it,
then,' meaning just, you know, 'You write it in there," and that's all
I said is, "Top it, then,' and he filled that out." \75\ (Tr. vol. 3,
at 97.) As viewed at the date of hearing, SA Zdrojewski's pain
assessment form indicates that Respondent circled the numbers eight
through ten on the pain scale. (Gov't Ex. 28 at 9; see Tr. vol. 3, at
97.) Although SA Zdrojewski stated "It can be" after Respondent
inquired whether "the pain's been pretty bad?" (Gov't Ex. 8 at 12),
SA Zdrojewski told Respondent that he controls his pain: "you know,
I'm just, not gonna sit around." (Gov't Ex. 8 at 13.) The
inconsistency in SA Zdrojewski's representations as to the degree of
his pain and SA Zdrojewski's ability to vault up onto the examination
table should have given Respondent pause before prescribing controlled
substances.
---------------------------------------------------------------------------
\75\ To similar effect, Respondent testified that SA Zdrojewski
had said "swap it." (Tr. vol. 10, at 242.)
---------------------------------------------------------------------------
SA Zdrojewski also told Respondent that he had previously received
traction treatment and treatment from a chiropractor. (Tr. vol. 3, at
87.) Respondent asked when SA Zdrojewski last received treatment from
Tampa Bay Wellness, and SA Zdrojewski responded that he had received
treatment approximately two months previously. (Gov't Ex. 8 at 15.)
Respondent, however, did not ask for these doctors' prior medical
records. (Tr. vol. 3, at 95.)
Respondent conducted a physical examination of SA Zdrojewski,
lasting approximately one to two minutes. (Tr. vol. 3, at 107.) He
directed SA Zdrojewski to complete a variety of range-of-motion
exercises (see Gov't Ex. 8 at 16), which SA Zdrojewski did with
"solid, strong movements. I kind of over-exaggerated my movements. * *
* " (Tr. vol. 3, at 106.) Moreover, SA Zdrojewski testified that he
completed all those movements without mentioning pain.\76\ (Tr. vol. 3,
at 106-07.) As noted elsewhere in this Recommended Decision in the
context of other undercover patients, the ease and overtly painless
effort with which SA Zdrojewski completed his physical examination
contradicted SA Zdrojewski's reports of pain, which varied throughout
the course of the meeting. It was an inconsistency that should have
alerted Respondent to the possibility that SA Zdrojewski was posing as
a patient who was not seeking controlled substances for a legitimate
medical purpose. Perhaps Respondent considered this possibility and
simply went through the motions in conducting a physical examination:
on a patient who complained of neck pain, Respondent never touched SA
Zdrojewski's neck. (Tr. vol. 3, at 107.)
---------------------------------------------------------------------------
\76\ The only apparent exception was one instance in which
Respondent apparently directed SA Zdrojewski to bend over, and the
latter replied "I can't bend that far down." (Gov't Ex. 8 at 16.)
Even in this case, however, SA Zdrojewski did successfully bend down
and touch his toes, even as he said he could not. (Tr. vol. 3, at
160.)
---------------------------------------------------------------------------
Consulting SA Zdrojewski's MRI report, Respondent told SA
Zdrojewski he had only trace amounts of inflammation in the joints
between SA Zdrojewski's vertebra and neck: "it's very minimal * * *
Other than that it's normal. There's no disk herniations, everything
else is in place * * * ." (Gov't Ex. 8 at 16.) SA Zdrojewski inquired
what caused his headaches, in that case. Respondent answered: "Oh, my
God, there's nothing. I * * * I don't know. There's nothing around here
that, that ah, explains that." (Gov't Ex. 8 at 16; Tr. vol. 3, at 95.)
The following colloquy ensued:
WOLFF: Well, uh * * * we have a little issue here. First of all your
MRI doesn't show much of anything and secondly, drinking a case of beer
\77\ is not compatible with taking a strong medicine like this * * *
I'm not sure * * *
---------------------------------------------------------------------------
\77\ SA Zdrojewski had told Respondent he was drinking a lot of
alcohol, to include a case of beer on the weekends. (See Tr. vol. 3,
at 88; Gov't Ex. 8 at 14.)
---------------------------------------------------------------------------
UC1: I can pull that off.
WOLFF: I'm not sure how you lived though, all of this Oxy * * *
UC1: I * * * I told you I didn't take, I didn't take all of that.
WOLFF: * * * . alcohol * * * coupled with Oxycontin and Oxycodone and
Xanax is being very bad combination, as in you need to worry about
death * * *
UC1: You got to watch your * * * I get it. I'll stop drinking.
WOLFF: Watch you! Yeah I * * * I think that * * * um * * * So, you
rather take the medicine than to be drinking, is that right?
UC1: Yeah, yup.
WOLFF: Alright, well let me look at your chart to see what we can do to
help you.
(Gov't Ex. 8 at 17-18.) On July 23, 2010, Respondent issued SA
Zdrojewski a prescription for 150 Roxicodone 30 mg tablets.\78\ (Gov't
Ex. 28 at 19; Gov't Ex. 8 at 22-23; Tr. vol. 3, at 103.) Although
Respondent testified that this prescription is much less than what SA
Zdrojewski told Respondent he had previously been prescribed (Tr. vol.
10, at 255), the import of the difference is reduced in substantial
part by SA Zdrojewski's statement to Respondent that he wasn't even
filling all of the prescriptions his previous doctor had provided,
because they were "crazy amounts." \79\ To be certain, Respondent's
lowering of the dosage
[[Page 5149]]
standing alone cuts somewhat in Respondent's favor; but I find
Respondent's reliance on SA Zdrojewski's self-reported past
prescriptions of excessive quantities of controlled substances as a
baseline for future prescriptions to be facially outside the usual
course of professional practice.
---------------------------------------------------------------------------
\78\ Respondent declined to write SA Zdrojewski a prescription
for Xanax because Respondent didn't believe SA Zdrojewski needed it.
(Gov't Ex. 8 at 18.)
\79\ Notably, Respondent demonstrated no interest in learning
any information to include the doctor's name at Tampa Bay Wellness
that had prescribed what SA Zdrojewski represented to be "crazy
amounts" of controlled substances.
---------------------------------------------------------------------------
The record further reveals evidence that Respondent documented in
SA Zdrojewski's patient file discussions that did not actually occur.
For instance, despite contrary notations in the patient file (e.g.,
Gov't Ex. 28 at 5), SA Zdrojewski testified that Respondent never
discussed anti-inflammatories and diet, the risk and benefits of
medication, including the risk of abuse and addiction and physical
dependency,\80\ yoga and stretching exercises, omega-3 fish oil, the
use of illegal drugs,\81\ weaning off medications, treatment plans for
pain relief or improvement,\82\ improving physical and psychological
functions, regaining quality of life, improving SA Zdrojewski's
activities of daily living, sleep, improved energy, mood or motivation,
working at full capacity, a rehabilitation program, exercise, diet,
lifestyle or habits. (Tr. vol. 3, at 88-92.) He did not discuss
alternative medications beside controlled substances or alternative
treatments for pain, such as back injections. (Tr. vol. 3, at 109.)
Respondent's conduct constitutes a failure to keep accurate records, to
include evaluations, consultations and discussion of risks and
benefits, in violation of Fla. Admin. Code Ann. r. 65B8-9.013(3).
Consistent with Dr. Berger's testimony as noted above (e.g., Tr. vol.
7, at 176), Respondent's failure to refer SA Zdrojewski to
rehabilitation for his use of recreational and illicit controlled
substances, and what may well have been his excessive use of licit
controlled substances, is also inconsistent with Florida standards.\83\
See Fla. Admin. Code Ann. r. 65B8-9.013(3)(e) ("The physician should
be willing to refer the patient as necessary for additional evaluation
and treatment * * * Special attention should be given to those patients
who are at risk for misusing their medications [or] * * * pose a risk
for medication misuse or diversion * * * .")
---------------------------------------------------------------------------
\80\ Respondent did counsel SA Zdrojewski, however, on the risk
of alcohol. (Tr. vol. 3, at 88.)
\81\ Strictly speaking, Respondent did ask whether SA Zdrojewski
was using recreational drugs or had any drug abuse or dependence
problems, to which SA Zdrojewski replied that he was presently self-
medicating with marijuana. (Gov't Ex. 8 at 15; see Tr. vol. 3, at
89.) But Respondent's response upon learning of SA Zdrojewski's
marijuana use was "Oh, Oh." (Gov't Ex. 8 at 15.) Respondent asked
no follow-up questions about his marijuana use. Nor does a
transcript of the interview reveal that he asked "How often?", as
SA Zdrojewski testified. (See Tr. vol. 3, at 89.) Significantly,
Respondent did not counsel SA Zdrojewski against using marijuana
while on pain medication. (Tr. vol. 3, at 90; see Gov't Ex. 8.)
Respondent's testimony tending to suggest that he believed SA
Zdrojewski "was using marijuana to get through the day" now that
the Tampa clinic was closed (Tr. vol. 10, at 245) is hard to
reconcile with SA Zdrojewski's statements to Respondent that the
medication he had been receiving there was wildly excessive.
\82\ SA Zdrojewski explained "I didn't even know how many
oxycodones I was getting [from Respondent] until I received them."
(Tr. vol. 3, at 109.)
\83\ Respondent's testimony that he intended to make referrals
to a neurosurgeon at the next visit (Tr. vol. 10, at 254) is not to
the contrary. As an initial matter, there was no subsequent visit.
Moreover, Respondent's failure to make a referral in the context of
SA Zdrojewski is generally consistent with Dr. Berger's testimony
that Respondent failed to make a proper referral in the context of
SA Priymak, providing some evidence of a trend. (See generally Tr.
vol. 8, at 298; Gov't Ex. 5 at 42.)
---------------------------------------------------------------------------
By corollary, the record reveals evidence of discussions that
should have occurred, but didn't. The record reflects that SA
Zdrojewski indicated in his patient form that he suffered from bipolar
disorder (Gov't Ex. 28 at 7), but SA Zdrojewski testified that
Respondent did not discuss bipolar disorder. (Tr. vol. 3, at 93-94.) SA
Zdrojewski further testified that Respondent did not discuss high blood
pressure. (Tr. vol. 3, at 93.)
In sum, the record reveals numerous violations of applicable
standards and regulations concerning the prescribing of controlled
substances in the context of SA Zdrojewski's July 23, 2010 visit to
CCHM. Substantial evidence supports a finding that Respondent's
prescription of controlled substances to SA Zdrojewski lacked a
"legitimate medical purpose * * * that is supported by appropriate
documentation establishing a valid medical need and treatment plan,"
in violation of Fla. Admin. Code Ann. r. 64B8-9.013(1)(b) (2003), and
was outside the usual course of professional practice, in violation of
21 CFR 1306.04(a).
(h) SA Ryckeley
The record reflects that SA Ryckeley visited CCHM in an undercover
capacity on July 23, 2010. (E.g., Gov't Ex. 7 at 2; Tr. vol. 3, at
200.) He arrived with a group of nine other undercover officers, and
the group was "shepherded in through the back door." (Tr. vol. 3, at
200, 203.) SA Ryckeley testified that the group was led by undercover
agent Jack Lunsford, who was acting as a sponsor: a person who arranged
for a group of people to come in and attempt to seek pain medicine.
(Tr. vol. 3, at 201.) A female employee of the clinic greeted the group
and requested $300 for the office visit. (Tr. vol. 3, at 201.) The
agents also paid her an additional $200 for accelerated preferential
treatment.\84\ (Tr. vol. 3, at 201; Gov't Ex. 7 at 6.)
---------------------------------------------------------------------------
\84\ As noted elsewhere in this Recommended Decision, although
not dispositive, evidence of "VIP treatment" indicates that the
staff of CCHM interacted with patients in unorthodox ways. The
existence of a sponsor and the payment of $200 for preferential
treatment provides some evidence of a profit motive for employees to
process patients according to the patients' requests instead of
according to an established and legitimate medical procedure.
---------------------------------------------------------------------------
Record evidence concerning SA Ryckeley's visit with Respondent in
Respondent's office (Tr. vol. 3, at 206) reveals a number of departures
from the usual course of professional practice. As the visit began,
Respondent asked if it was SA Ryckeley's first visit, and SA Ryckeley
said yes. (Gov't Ex. 7 at 18.) Respondent asked "where's your pain
that we're gonna help you with?" to which SA Ryckeley replied "Uh,
back discomfort. I came in with, uh, David Hays and all those guys."
(Gov't Ex. 7 at 18.) SA Ryckeley's statement gave Respondent reason to
suspect, if not to know, that SA Ryckeley was visiting CCHM with other
people as part of a common plan or scheme that may not have been
connected to legitimate complaints of pain.
It is also notable that SA Ryckeley's statements regarding the
intensity of his pain changed over the course of the interview.
Respondent asked SA Ryckeley to describe his pain with reference to the
pain descriptions on a Pain Assessment Form, which SA Ryckeley did not
complete upon intake but believed that Respondent partially completed
for him during the consultation.\85\ (Gov't Ex. 7, at 20; Gov't Ex. 27
at 9; Tr. vol. 3, at 225-26.) SA Ryckeley replied that his pain ached
in his lower back area. (Gov't Ex. 7 at 20.) "[I]t comes and goes,
mostly comes when I fish." (Gov't Ex. 7 at 20.) Respondent asked how
bad the pain was, on a scale of one to ten, to which SA Ryckeley
responded "[u]h, probably around two (2)." (Gov't Ex. 7 at 20.)
Respondent replied that maybe SA Ryckeley didn't understand the pain
scale, and that "a one (1) and two (2) is * * * just sort of * * * a
very mild kinda problem, ten (10) is were your [sic] screaming. So,
that sort of the scale * * * So * * * would you characterize it as
mild? Which is about (1) or two (2), or, or moderate? You know, five
(5) or six (6) or is it pretty severe, like, eight
[[Page 5150]]
(8) or nine (9) or ten (10)?" (Gov't Ex. 7 at 21.) SA Ryckeley
replied: "Well, I guess it, it could be moderate, I would imagine * *
* middle of the road." (Gov't Ex. 7 at 21.) SA Ryckeley later
characterized his pain as a five or a seven. (Gov't Ex. 7 at 29.) The
record does reveal one possible benign explanation for SA Ryckeley's
shifting answers: a transcript of the patient meeting shows that SA
Ryckeley stated "when I read through that twelve (12) page medical
questionnaire it was a lot of words I didn't understand on there."
(Gov't Ex. 7 at 29; see also Tr. vol. 3, at 270-71.)
---------------------------------------------------------------------------
\85\ Respondent testified that SA Ryckeley commented that he was
not very good with words, which Respondent interpreted as meaning SA
Ryckeley was not an educated man and wasn't good with language. (Tr.
vol. 10, at 215.)
---------------------------------------------------------------------------
SA Ryckeley viewed the situation less optimistically, and testified
at hearing that he interpreted remarks by Respondent as coaching him to
state he had greater pain. The record shows that Respondent asked how
the pain affected SA Ryckeley's life, work and home. (Gov't Ex. 7 at
22.) SA Ryckeley replied that it makes it more difficult to fish, to
which Respondent laughed and stated: "You're under-whelming me."
(Gov't Ex. 7 at 22.) Respondent elaborated, later saying: "[E]ither
I'm missing the point or you're missing the point." (Gov't Ex. 7 at
23.) Respondent told SA Ryckeley that he should just take Tylenol.
"You don't have anything wrong, I don't get it." (Gov't Ex. 7 at 24.)
SA Ryckeley explained that he believed Respondent was being "a box-
checker * * * going through and checking the boxes and making every
element to justify writing me * * * ." (Tr. vol. 3, at 210.) SA
Ryckeley called Respondent's comments "clear-cut coaching" (Tr. vol.
3, at 210) "that I better say the right things if I wanted to get the
prescription, so that's what I did." (Tr. vol. 3, at 224.) "[I]t was
apparent that he was coaching me to a higher level to be able to
prescribe me narcotics." (Tr. vol. 3, at 269.)
SA Ryckeley presented Respondent with evidence that he had been
taking controlled substances that he obtained without a prescription.
Respondent asked how long SA Ryckeley had had back pain, to which SA
Ryckeley responded that his pain started in May while he was fishing on
a sport fishing charter boat. (Gov't Ex. 7 at 18-19.) SA Ryckeley told
Respondent that he took some of his girlfriend's "thirties," and "it
put me in a state were [sic] I liked it, it made me feel better * * *
and so I experimented with that, I know I probably shouldn't of [sic]
done that." (Gov't Ex. 7 at 19-20.) "I've never really thought about
[my pain] after that." (Gov't Ex. 7 at 22.) SA Ryckeley testified that
Respondent wasn't fazed or set back by learning that SA Ryckeley was
using his girlfriend's oxycodone. (Tr. vol. 3, at 208.) In spite of, or
perhaps because of, the fact that SA Ryckeley indicated on a patient
form that no doctor prescribed the oxycodone he had been taking (see
Tr. vol. 3, at 228), Respondent did not ask if any doctor prescribed
the 180 oxycodone 30 mg tablets that SA Ryckeley indicated on his Pain
Assessment Form that he was taking. (Tr. vol. 3, at 226; Gov't Ex. 27
at 9.)
The record contains evidence that Respondent acknowledged the
impropriety of SA Ryckeley's illicit use and possible abuse of
oxycodone, but decided to issue a prescription for controlled
substances anyway. SA Ryckeley told Respondent he was taking oxycodone
six times per day but stopped two weeks before the consultation because
of an impending drug test for a job application. (Gov't Ex. 7 at 22 &
24.) He said that his girlfriend had been prescribed four pills per
day, but "[s]ometimes people gave me two (2) at the club and stuff
like that." (Gov't Ex. 7 at 25.) Respondent later asked:
WOLFF: But the, the thirties (30s) seem to work good for you?
UC1: Yeah, I like them.
WOLFF: You like them?
UC1: Well, which I mean, I think they, they work good.
WOLFF: You know, you're killing me, I can't even believe I'm having
this conversation. [LAUGHS]
UC1: I've never, I've never been a, uh, educated man doc, you know?
WOLFF: Killing me * * * .
(Gov't Ex. 7 at 28.) SA Ryckeley's confession that he had diverted
controlled substances from his girlfriend and others at "the club"
and his statement that he liked the opioids should have constituted
grounds for significant concern by Respondent that the patient was
abusing or diverting controlled substances. Indeed, as noted above, Dr.
Berger also testified that references in the medical file regarding the
patient taking controlled substances from his girlfriend makes "them a
bad candidate for compliance," because they may be willing to share or
divert their medication. (Tr. vol. 7, at 167.) At hearing, Respondent
testified that he found the response "I like them" to be unusual and
assumed it was related to SA Ryckeley's difficulty communicating and
gave SA Ryckeley the benefit of the doubt. (Tr. vol. 10, at 226-27.)
But Respondent's reply that "you're killing me" demonstrates
Respondent's recognition that issuing a prescription under such
circumstances would raise serious questions whether such a prescription
was within the usual course of professional practice or pursuant to a
legitimate medical purpose. Moreover, the record reflects that
Respondent did not discuss a rehabilitation program to address the fact
that SA Ryckeley was taking between four and six oxycodone pills per
day without a prescription (Tr. vol. 3, at 225), as contemplated by
Fla. Admin. Code Ann. r. 64B8-9.013(3)(e) ("The management of pain in
patients with a history of substance abuse * * * requires extra care,
monitoring, and documentation, and may require consultation with or
referral to an expert in the management of such patients.").\86\
---------------------------------------------------------------------------
\86\ Respondent did indicate in the patient file that at the
next visit he would "consider referral to a Board Certified pain
management specialist" (Tr. vol. 10, at 238; Gov't Ex. 27 at 6;
Resp't Ex. 7 at 5), but there is no indication regarding referral to
a rehabilitation program. In any event, there was no subsequent
visit and no such referral ever occurred.
---------------------------------------------------------------------------
Respondent ultimately agreed to "get you started on some
medication, we'll see how you do." (Gov't Ex. 7 at 31.) Respondent
issued a prescription for 150 Roxicodone 30 mg tablets, constituting a
decrease by thirty pills from the amount that SA Ryckeley had self-
reported. (Tr. vol. 3, at 211, 271; Gov't Ex. 7 at 62-66.) SA Ryckeley
filled the prescription at CCHM for a cost of $900. (Tr. vol. 3, at
211.) Because he was a member of a group of patients who had entered
the clinic together, the staff determined that SA Ryckeley had overpaid
and refunded him $150. (See Tr. vol. 3, at 212.) Even in the absence of
expert testimony, I find that the practice of providing a discount on
medication to patients who arrive together in a group bears no rational
connection to the legitimate practice of medicine. Moreover, although
it is not by itself conclusive proof of diversion of controlled
substances, such a practice is nevertheless consistent with diversion.
The record reflects Respondent's own uncertainty as to whether a
controlled substances prescription for SA Ryckeley was for a legitimate
medical purpose: "I don't know, if, if you don't need it I don't want
you to take it but if your pain is such that, you know, you can't
function without it, then, uh, then that's a reasonable indication."
(Gov't Ex. 7 at 32.) He cautioned SA Ryckeley not to take the
medication except as indicated, not to buy, sell or share it, and to
keep it locked in a safe place. (Gov't Ex. 7 at 31.) "I know it's out
in the street and everything, but we consider it serious stuff * * *"
(Gov't Ex. 7 at 31.) At hearing, Respondent testified that he was
merely "trying to give him an appreciation for the fact that I don't
want him to take the medication unless he needs it." (Tr. vol. 10, at
231.) Given SA Ryckeley's shifting answers regarding the scope of his
pain and the
[[Page 5151]]
other indications of diversion and abuse, however, I give Respondent's
explanation little weight. Indeed, Respondent testified that he wrote
in SA Ryckeley's patient file (Gov't Ex. 27 at 6; Resp't Ex. 7 at 5)
that "I want to make sure patient is legitimate * * * without a chance
of diversion. Will perform urine drug test next visit * * * ." (Tr.
vol. 10, at 238.) Respondent's notation effectively deferring his
present concerns of diversion to a future date is consistent with a
pattern of evidence that Respondent repeatedly and deliberately ignored
clear indications of diversion while prescribing controlled substances.
The record further reveals evidence that Respondent documented in
SA Ryckeley's patient file discussions that did not actually occur. For
instance, despite contrary notations in the patient file (e.g., Gov't
Ex. 27 at 5), SA Ryckeley testified that Respondent never discussed
sleep disturbance, anti-inflammatory medications, diet or alternative
forms of treatment, yoga and stretching exercises, omega-3 fish oil,
smoking, weaning off medication or a time frame for pain management.
(Tr. vol. 3, at 219-21, 231.) Moreover, although SA Ryckeley told
Respondent that he occasionally experienced headaches (Gov't Ex. 7 at
21), Respondent did not discuss the possibilities of neurosurgical
consultation and surgery. (Tr. vol. 3, at 228.) Respondent's conduct
constitutes a failure to keep accurate records, in violation of Fla.
Admin. Code Ann. r. 65B8-9.013(3).
In mitigation, Respondent did inquire whether SA Ryckeley drank. SA
Ryckeley responded that he drank socially: "Two (2) or three (3)
drinks, max * * * a week maybe." (Gov't Ex. 7 at 26.) Respondent
replied that "we don't prescribe medicines to people who drink alcohol
because the interaction between alcohol and medicine is bad * * * you
could die from it." (Gov't Ex. 7 at 26-27.) "[T]his medicine and
alcohol is not to be mixed." (Gov't Ex. 7 at 27.)
Moreover, Respondent did ask SA Ryckeley whether he was currently
working. (Gov't Ex. 7 at 24.) SA Ryckeley responded: "Uh, I'm between
jobs." (Gov't Ex. 7 at 24.) There is no evidence that Respondent asked
SA Ryckeley why SA Ryckeley wrote on his patient medical history that
he was currently employed. (See Gov't Ex. 27 at 8.) SA Ryckeley did,
however, tell Respondent that he occasionally works on weekends. (See
Gov't Ex. 7 at 32.) SA Ryckeley also told Respondent that he used to
work as a boat captain on a commercial charter. (Gov't Ex. 7 at 24.)
Respondent initially thought "if [SA Ryckeley] couldn't go fishing, it
wouldn't be the end of the world. But then I realized that this was his
job." (Tr. vol. 10, at 222.) Respondent asked if the pain depleted his
energy, and SA Ryckeley responded that the pain "makes me less willing
to do what I like to do * * * because * * * I'm in discomfort." (Gov't
Ex. 7 at 25.) He elaborated that he is in a better mood when on
oxycodone pills, that they improve his relationship with his girlfriend
or his sex life, and that it is significantly more difficult to work
without medicine. (Gov't Ex. 7 at 25-26.)
In addition, Respondent did conduct a physical examination of SA
Ryckeley and also explained that SA Ryckeley's MRI report showed a
bulging disk. (Gov't Ex. 7 at 28, 30; see Tr. vol. 3, at 208.) SA
Ryckeley's performance during a physical examination, however, should
have raised concerns of diversion: Respondent instructed SA Ryckeley to
perform a range-of-motion test and walk across the room (Tr. vol. 3, at
208 & 210; Tr. vol. 10, at 228; see Gov't Ex. 7 at 21), which SA
Ryckeley completed with ease and without complaining about pain. (Tr.
vol. 3, at 210.) Because SA Ryckeley told Respondent that he was not
currently taking medication (Gov't Ex. 7 at 22 & 24), Respondent could
not have believed that SA Ryckeley had pain that was satisfactorily
numbed by medication. He therefore should have been concerned that SA
Ryckeley's successful and apparently painless completion of the range-
of-motion tests contradicted SA Ryckeley's reports of pain, which, as
noted above, varied throughout the course of the meeting. It was an
inconsistency that should have apprised Respondent that SA Ryckeley may
not have been a legitimate patient.
Of still greater concern is that Respondent commenced a physical
examination of SA Ryckeley only after deciding to prescribe controlled
substances to SA Ryckeley. (See Gov't Ex. 7 at 28 ("You like
[oxycodone]? * * * You know, you're killing me, I can't even believe
I'm having this conversation * * * Alright, hold up your arms up here,
like this * * * .").) In requiring that physicians conduct a patient
evaluation prior to prescribing controlled substances, see Fla. Admin.
Code Ann. r. 64B8-9.013(3)(a), the Florida Board of Medicine intended
that the physical examination inform the practitioner's decision of
whether to prescribe controlled substances, not vice versa. Where, as
here, the physician conducts a physical examination of a first-time
patient only after having already decided to prescribe controlled
substances, the physician cannot be considered to have acted within the
usual course of professional practice.
After considering the evidence weighing in Respondent's favor with
respect to SA Ryckeley, the balance of the evidence shows that
Respondent knew or should have known that SA Ryckeley was presenting as
a patient who had previously obtained and used controlled substances
without a prescription and presently intended to use controlled
substances for other than a legitimate medical purpose. Dr. Berger was
of the opinion that statements by SA Ryckeley, if known by the
physician, "would absolutely preclude a physician practicing medicine
within the standard of care" from prescribing controlled substances.
(Gov't Ex. 32 at 111.) I further reject as inconsistent with the weight
of the evidence Respondent's statements at hearing to the effect that
he would not have prescribed controlled substances if he did not
believe SA Ryckeley was a real pain patient. (See, e.g., Tr. vol. 10,
at 233-34.) Moreover, I find that Respondent's prescription of
oxycodone to SA Ryckeley was outside of the usual course of
professional practice and lacked a legitimate medical purpose, in
violation of Fla. Admin. Code Ann. r. 64B8-9.013 and 21 CFR 1306.04(a).
2. CMG
As discussed above, the Government presented evidence relating to
prescribing practices at CMG and undercover visits to see Respondent at
that location by three agents: SA Miller, SA McClarie and SA Bazile.
The Government did not produce patient records for these undercover
agents or present expert testimony surrounding their visits. Moreover,
in light of testimony by Respondent, the treating physician, that he
acted appropriately, I give little weight to the evidence relating to
CMG except with respect to SA Bazile. The record reflects that after
Respondent issued a prescription for 90 Roxicodone 15 mg tablets, SA
Bazile testified that she said "can I have something to sleep and he
said do you have trouble sleeping? I said sometimes and he said--he
seemed a little irritated. He said you're not very convincing." (Tr.
vol. 6 at 23.) Ultimately, however, Respondent issued a prescription
for Xanax. (Tr. vol. 6, at 24.) SA Bazile's unrebutted testimony that
Respondent did not find SA Bazile's need for Xanax "very convincing,"
even without the aid of expert testimony, fully supports a finding that
Respondent's prescription for Xanax was not pursuant to a legitimate
medical purpose under 21
[[Page 5152]]
CFR 1306.04(a). See Cynthia M. Cadet, M.D., 76 FR 19,450, 19,450 (DEA
2011) (explaining that in cases of particularly flagrant conduct by a
registrant "expert testimony adds little to the proof necessary to
establish a violation of Federal law").
3. Summary of Undercover Patients
For the foregoing reasons, I find by substantial evidence that
Respondent issued a substantial number of controlled substance
prescriptions for other than a legitimate medical purpose and outside
the usual course of professional practice, in violation of federal and
state law.\87\ Additionally, Respondent repeatedly failed to comply
with the requirement to keep accurate and complete records.\88\ This
finding weighs heavily in favor of a finding under Factors Two and Four
of 21 U.S.C. 823(f) that Respondent's continued registration would be
inconsistent with the public interest.
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\87\ E.g., 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1); and Fla.
Admin. Code Ann. r. 65B8-9.013 (2003).
\88\ Fla. Admin. Code Ann. r. 65B8-9.013(3)(f).
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4. Evaluation of Expert Testimony
The evidence at hearing included opinions from Dr. Berger and
Respondent regarding Respondent's prescribing practices. Expert
testimony regarding a physician's prescribing practices is an important
but not indispensible part of evaluating whether a practitioner is
acting for a "legitimate medical purpose" in the "usual course of
his professional practice." \89\ The Agency has previously held that
"[w]here, for example, the Government produces evidence of undercover
visits showing that a physician knowingly engaged in outright drug
deals, expert testimony adds little to the proof necessary to establish
a violation of federal law." Cynthia M. Cadet, M.D., 76 FR 19,450 (DEA
2011).
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\89\ 21 CFR 1306.04(a).
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As a general matter, the opinion of a treating physician in the
context of a DEA administrative hearing should not automatically be
given greater weight than the opinion of a non-examining physician.
"Despite a certain degree of lingering confusion among the courts of
appeals, it has become overwhelmingly evident that the testimony of the
'treating physician' receives no additional weight." Eastover Mining
Co. v. Williams, 338 F.3d. 501, 509 (6th Cir. 2003). Unlike a Social
Security benefit determination that is governed by a regulation giving
deference to a treating physician, no such regulation pertains to a DEA
administrative hearing.\90\ Accordingly, I have not given Respondent's
testimony on the facts of this case greater weight simply because of
his status as a treating physician, particularly given the short
duration of his treatment of each undercover patient.
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\90\ See 20 CFR 404.1527(d)(2) and 416.927(d)(2).
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Dr. Berger's testimony at hearing, while credible for the most
part, was fraught with numerous instances of nonresponsive answers and
lapses of memory with regard to the evidence, including his written
report. Additionally, Dr. Berger's testimony and report was found to
contain substantive errors, including dates of patient treatment,
urinalysis results, identity of signatures and patient history.\91\
(See, e.g., Tr. vol. 7, at 222-24; Tr. vol. 8, at 5; Tr. vol. 8, at
199.) Notwithstanding the foregoing deficiencies, I have given Dr.
Berger's testimony and opinions with regard to seven of eight patient
files significant weight, as discussed above, since his opinions were
well supported by other objective evidence of record, including the
patient file.\92\ While I have given weight to Dr. Berger's opinions
regarding "medical standards of care" for seven of the eight patient
files relating to CCHM, I give no weight to his various opinions and
statements regarding the legality of conduct by physicians and staff at
CCHM. (Gov't Ex. 23 at 123.)
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\91\ Dr. Berger's written report was as unimpressive as his
testimony in various respects, to include factual errors and the
lack of a date and signature, among other deficiencies. Upon inquiry
as to the basis for Dr. Berger's identification of his written
report as the final draft, given the absence of a date or signature,
he responded: "It looks familiar to me." (Tr. vol. 9, at 137.)
\92\ I have given Dr. Berger's testimony with regard to SA Saenz
little to no weight due to Dr. Berger's material and erroneous
belief that Respondent had treated SA Saenz on more than one
occasion, and his erroneous interpretation of a urinalysis report,
which clearly influenced his opinion regarding Respondent's standard
of care.
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Respondent's testimony in this case was significantly diminished by
his lack of credibility in numerous instances, to include a lack of
objective patient record evidence to support his assertions that he
always conducted an adequate patient evaluation, and that he reasonably
believed each of the undercover patients to which he prescribed
controlled substances truthfully reported real pain. The evidence of
record is overwhelming that Respondent had actual knowledge of
diversion in a number of instances or simply ignored clear warning
signs in others, making incredible his assertion that he was
effectively duped into prescribing controlled substances during each
undercover visit, with the exception of SA Marshall.\93\ Respondent's
testimony and opinion that he acted in accord with the public interest
standard in numerous "other" cases, even if accurate, is unavailing
because even a single act of intentional diversion is sufficient
grounds upon which to revoke a registration, e.g., Cynthia M. Cadet,
M.D., 76 FR 19,450, 19,450 n.3 (DEA 2011), and "evidence that a
practitioner has properly treated thousands of patients does not negate
a prima facie showing that the practitioner has committed acts
inconsistent with the public interest." Jayam Krishna-Iyer, M.D., 74
FR 459, 463 (DEA 2009).
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\93\ Even with regard to SA Marshall, Respondent's decision not
to prescribe rested on his belief that SA Marshall was an undercover
law enforcement officer rather than upon a concern for preventing
diversion.
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The evidence in this case reflects in numerous instances a willful
blindness or deliberate ignorance by Respondent of facts that put him
on notice of actual or potential diversion, yet Respondent
"deliberately closed his eyes to wrongdoing that should have been
obvious to him." U.S. v. Veal, 23 F.3d 985, 988 (6th Cir. 1994). For
example, Respondent made no substantive inquiry to SA Bazile's
statement that she likes "blues" and shares them with friends. (Tr.
vol. 6, at 22-23.) Similarly, Respondent failed to inquire about the
details surrounding SA Priymak's statement that he gets oxycodone off
the street. (Gov't Ex. 5 at 39.) In response to SA O'Neil's statement
that he was illegally taking liquid oxycodone, Respondent stated:
"Don't even tell me that." (Gov't Ex. 14 at 30.) Respondent later
stated in substance that most pain clinics hearing such information
would cut the patient off.\94\ (Gov't Ex. 14.)
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\94\ Compare transcript with audio/video recording of undercover
visit, with the latter reflecting Respondent's verbal reference to
other clinics cutting a patient off from treatment. (Gov't Ex. 14 at
32; 2010-05-04--ONeil--24--vid.002 at 19:20-19:40.)
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I find Respondent's testimony explaining that his comment "[d]on't
even tell me that" was simply an expression of being "disturbed" and
"hurt" to hear such information to be palpably not credible in light
of the totality of the evidence, particularly Respondent's pattern of
ignoring similar evidence of diversion and abuse. (See Tr. vol. 10, at
155.) The context of Respondent's conversation with SA O'Neil
demonstrates that rather than being interested in finding out the facts
of the patient's liquid oxycodone use, a substance that Respondent
considered highly dangerous, Respondent clearly implied that he did not
want to hear such information. (Gov't Ex. 14 at 30-
[[Page 5153]]
32.) The evidence of Respondent's willful blindness to illicit drug use
and evidence of diversion was also evidenced by his testimony regarding
his departure from CMG over the falsification of a patient drug screen
by a staff member. Respondent testified that when he left CMG he felt
under duress, fear and danger, but did not report the incident to the
police. (Tr. vol. 9, at 69-70, 74.)
Additional examples of Respondent's willful blindness to issues of
diversion permeate the record, but further elaboration is unnecessary.
5. Respondent's Positive Experience in Dispensing Controlled Substances
Respondent offered testimony and evidence of his past positive
experience in dispensing controlled substances, including his
experience working in hospitals and with public safety departments.
Additionally, Respondent offered testimony supported by patient files
related to his positive experience in treating patients [C.E.], [D.P.],
[J.B.], [R.C.], [L.K.], and [J.R.] (Resp't Exs. 11, 13, 15-17 & 19.)
Respondent further testified that after becoming owner of CCHM, he
implemented various improvements to include staff changes, an updated
urinalysis process, and a clinic procedure manual. Respondent also
argued that additional files in the Government's possession but
otherwise unavailable to Respondent evidenced further instances of
positive experience in dispensing controlled substances.
I have considered the evidence related to Respondent's past
experience in dispensing controlled substances and find that with
regard to Respondent's work with hospitals and public safety
departments, he has in fact acted consistent with the public interest.
Additionally, the un-rebutted evidence pertaining to patients [C.E.],
[D.P.], [J.B.], [R.C.], [L.K.], and [J.R.] are consistent with
Respondent's testimony and reflect positive prescribing experiences.
Respondent's claim that patient files in the Government's
possession but not produced at hearing or otherwise made available to
Respondent may contain additional evidence of positive prescribing is
unsupported by record evidence since none of the "additional" patient
records were produced by either party at hearing. Even if Respondent's
claim of additional positive experiences were supported by patient
files, Agency precedent has held that such evidence is entitled to some
evidentiary weight only in cases where a practitioner credibly
demonstrates an acceptance of responsibility and reform of past
practices.
[E]vidence that a practitioner has treated thousands of patients
does not negate a prima facie showing that the practitioner has
committed acts inconsistent with the public interest. While such
evidence may be of some evidentiary weight in assessing whether a
practitioner has credibly shown that she has reformed her practices,
where a practitioner commits intentional acts of diversion and
insists she did nothing wrong, such evidence is entitled to no
weight.
Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (DEA 2009).
While I have carefully considered the evidence of Respondent's past
positive experiences in dispensing controlled substances, I find those
experiences are vastly outweighed by the substantial evidence of
Respondent's repeated misconduct in issuing controlled substance
prescriptions to undercover law enforcement officers for other than a
legitimate medical purpose and outside the usual course of professional
practice, in violation of Federal and state law. The weight of
Respondent's prior positive experiences is further diminished by
Respondent's failure to admit any wrongdoing with regard to his conduct
at CMG \95\ and CCHM.
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\95\ As noted above, the Government has sustained its burden of
proving by substantial evidence that Respondent prescribed Xanax to
SA Bazile for other than a legitimate medical purpose or outside of
the usual course of professional practice.
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Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Administrator is authorized to consider
"other conduct which may threaten the public health and safety." 5
U.S.C. 823(f)(5). The Agency has accordingly held that "where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for his or her actions and
demonstrate that he or she will not engage in future misconduct.
Patrick W. Stodola, 74 FR 20,727, 20,734 (DEA 2009).\96\ A
"[r]espondent's lack of candor and inconsistent explanations" may
serve as a basis for denial of a registration. John Stanford Noell,
M.D., 59 FR 47,359, 47,361 (DEA 1994). Additionally, "[c]onsideration
of the deterrent effect of a potential sanction is supported by the
CSA's purpose of protecting the public interest." Joseph Gaudio, M.D.,
74 FR 10,083, 10,094 (DEA 2009).
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\96\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005)
(decision to revoke registration "consistent with the DEA's view of
the importance of physician candor and cooperation.")
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Respondent argues generally that the Government has failed to
establish by a preponderance of evidence that Respondent's continued
registration would be inconsistent with the public interest. (Resp't
Br. at 14.) Respondent's testimony at hearing repeatedly demonstrated
Respondent's belief that he had engaged in no past misconduct and was
in full compliance with existing laws and regulations. (Tr. vol. 11, at
296.) Respondent's testimony further demonstrated a remarkable lack of
acknowledgment and recognition of the risks of diversion. For example,
Respondent testified in substance that he did not believe that a
patient's use of the street term "blues" for Roxicodone constituted a
"red flag" for diversion, even with knowledge of the patient's self-
reported recent history of alcohol rehabilitation and illicit use of
Roxicodone, because Respondent "didn't want to make a value judgment"
on the patient's use of the term "blues." (Tr. vol. 10, at 192-93.)
Respondent testified in substance that with regard to another patient,
he interpreted "in a positive way" the patient's statement that the
patient was illicitly using another person's medication because the
patient "had gotten relief" from pain, but did not make any
substantive inquiry about the details of the patient's illicit use of
the medication.
After balancing the foregoing public interest factors, I find that
the Government has established by substantial evidence a prima facie
case in support of denying Respondent's application for registration,
based on Factors Two, Four and Five of 21 U.S.C. 823(f). Once DEA has
made its prima facie case for revocation or denial, the burden shifts
to the respondent to show that, given the totality of the facts and
circumstances in the record, revoking or denying the registration would
not be appropriate. See Morall v. DEA, 412 F.3d 165, 174 (DC Cir.
2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v.
United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989);
Thomas E. Johnston, 45 FR 72, 311 (DEA 1980).
The record reveals that Respondent has not sustained his burden in
this regard. In fact, as discussed above, Respondent's testimony in
numerous instances was not credible and reflected an overall lack of
admission of past misconduct, let alone acceptance of responsibility.
In light of the foregoing, Respondent's evidence as a whole fails to
sustain his burden to accept responsibility for his misconduct and
demonstrate that he will not engage in future misconduct. I find that
Factor Five weighs heavily in favor of a finding that Respondent's
registration would be inconsistent with the public interest.
[[Page 5154]]
V. Conclusion and Recommendation
I recommend revocation of Respondent's DEA CORs FW1453757,
BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639,
AW8594233 and BW0601446 as a practitioner, and denial of any pending
applications for renewal or modification to include application
WI0053115C, on the grounds that Respondent's continued registration
would be fully inconsistent with the public interest as that term is
used in 21 U.S.C. 824(a)(4) and 823(f).
Dated: July 25, 2011.
s/Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-1972 Filed 1-31-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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