Registrant Actions - 2012
[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Notices]
[Pages 57133-57154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22850]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-14]
T.J. Mcnichol, M.D.; Decision and Order
On October 27, 2011, I, the Administrator of the Drug Enforcement
Administration, issued an Order to Show Cause and Immediate Suspension
of Registration to T.J. McNichol, M.D. (Respondent), of Brandon,
Florida. ALJ. Ex. 1. The Show Cause Order proposed the revocation of
Respondent's DEA Certificate of Registration FM0624139, which
authorizes him to dispense controlled substances in schedules II
through V, as a practitioner, and the denial of any pending
applications to renew or modify his registration, on the ground that
his "continued registration is inconsistent with the public
interest." Id. at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)).
As support for the proposed action and the immediate suspension,
the Show Cause Order alleged that "[o]n six separate occasions between
approximately July 28 * * * and August 25, 2011, [Respondent]
distributed controlled substances (oxycodone, a Schedule II controlled
substance, and alprazolam, a schedule IV controlled substance) by
issuing 'prescriptions' to [four] undercover law enforcement officers
[hereinafter, UC or UCs] for other than a legitimate medical purpose or
outside the usual course of professional practice." Id. at 2. More
specifically, the Order alleged that on July 28, 2011, Respondent
"distributed" 180 tablets of oxycodone 30mg and 60 tablets of
alprazolam 1mg to UC1 on the
[[Page 57134]]
officer's "first visit to [his] practice" and that he did so "after
conducting only a cursory medical examination of [the officer] and
despite [his] informing the [officer] that [his] physical exam did not
correlate to any findings of pain as outlined" on the officer's MRI,
and although "UC1 provided no history or illness that warranted the
distribution of a controlled substance." Id. The Order further alleged
that on August 25, 2011, Respondent distributed another 180 tablets of
oxycodone 30mg and 60 tablets of alprazolam 1 mg to UC1, although UC1
"provided no history of injury or illness that warranted the
distribution of a controlled substance" and after performing "a
cursory physical examination." Id.
Next, the Show Cause Order alleged that on July 28, 2011,
Respondent distributed 150 tablets of oxycodone 30mg and 90 tablets of
alprazolam 1mg to UC2 on his initial visit, even though "UC2 provided
no history of injury or illness that warranted the distribution of
controlled substances" and that Respondent "conduct[ed] only a
cursory physical examination" which lasted "approximately two
minutes" and "despite the officer telling [Respondent] that he
experienced little pain." Id. The Order further alleged that on August
25, 2011, Respondent distributed to UC2 an additional 150 tablets of
oxycodone 30mg and 90 tablets of alprazolam 1mg after performing " a
cursory medical examination" which "consisted only of [Respondent
placing his] hands on the mid to lower back area of UC2 and asking if
[he] experienced any pain in those areas." Id. The Order also alleged
that "UC2 provided no history of injury or illness that warranted the
distribution of a controlled substance" and that Respondent's "total
interaction * * * with UC2 lasted approximately two minutes." Id.
With respect to UC3, the Show Cause Order alleged that on August
25, 2011, Respondent distributed 180 tablets of oxycodone 30mg and 30
tablets of alprazolam 2mg to the UC at his first visit, "while
conducting only a cursory physical examination and despite the officer
not providing any information in his medical questionnaire about
experiencing any pain." Id. at 2-3. The Order also alleged that "UC3
provided no history of injury or illness that warranted the
distribution of a controlled substance." Id. at 3.
Finally, with respect to UC4, the Show Cause Order alleged that on
August 25, 2011, Respondent distributed 210 tablets of oxycodone 30mg
and 60 tablets of alprazolam 2mg to the UC at his first visit. Id. The
Order alleged that Respondent "conduct[ed] only a cursory physical
examination" and that "UC4 provided no history of injury or illness
that warranted the distribution of a controlled substance." \1\
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\1\ Based on the above allegations, I concluded that
Respondent's continued registration during the pendency of the
proceeding "constitute[d] an imminent danger to the public health
and safety." ALJ Ex. 1, at 3. Accordingly, I ordered the immediate
suspension of Respondent's registration. Id.
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Respondent requested a hearing on the allegations; the matter was
placed on the docket of the Office of Administrative Law Judges and
assigned to ALJ Timothy D. Wing. Following pre-hearing procedures, the
ALJ conducted a hearing on January 17-18, as well as April 10-11,
2012.\2\ Upon conclusion of the hearing, the parties submitted briefs
containing their proposed findings of fact, conclusions of law, and
argument.
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\2\ While the ALJ noted the amount of time which has passed
between the date of service of the Order to Show Cause and Immediate
Suspension, "which was exclusive of any delays attributable to
Respondent," see ALJ at 43 n.72 (citations omitted), the record is
devoid of any explanation as to why the hearing did not reconvene
until April 10. Indeed, while the ALJ cited ALJ Ex. 26 in support
for his calculation, id., this exhibit was not forwarded as part of
the record. Nor was the record timely forwarded by the ALJ to this
Office following the receipt of the Government's Exceptions.
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On May 17, 2012, the ALJ issued his recommended decision. With
respect to factor one--the recommendation of the state licensing
board--the ALJ found "that Respondent currently holds a valid,
unrestricted medical license in Florida and has never been disciplined
by the Florida Department of Health." ALJ at 45. The ALJ thus found
that, while this factor is not dispositive, it "weighs against a
finding that Respondent's continued registration would be inconsistent
with the public interest." Id.
With respect to factor three--Respondent's conviction record under
Federal or State laws related to the manufacture, distribution, or
dispensing of controlled substances--the ALJ found that there was no
evidence that Respondent has been convicted of such an offense. Id.
While noting that this factor also is not dispositive, the ALJ
concluded that it "weighs against a finding that Respondent's
continued registration would be inconsistent with the public
interest." Id.
Next, the ALJ considered factors two--Respondent's experience in
dispensing controlled substances--and four--Respondent's compliance
with applicable laws relating to controlled substances, together. Id.
at 46-91. The ALJ noted that, under Federal law, a prescription for a
controlled substance must be "issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of
professional practice." Id. at 46 (citing 21 CFR 1306.04(a)).
Reasoning that because "Respondent's prescribing practices with
regard to the undercover patients visits [were] not remotely close to
'outright drug deals,'" and that "the undercover patient visits
objectively reflect that Respondent's prescribing practices included,
to a degree, a documented medical history, physician examination,
documented urinalysis testing, medical record release forms, and
pharmacy prescribing profiles, * * * consistent with applicable Florida
law," the ALJ explained that "any finding that Respondent's
prescribing conduct * * * was not for a legitimate medical purpose and
outside the usual course of professional practice under the Florida
Standards or standards generally recognized and accepted in the medical
community will significantly depend on the evidentiary weight" given
to the opinion testimony of the Government's Expert. Id. at 50. The ALJ
then explained that, while he found the Government's Expert "qualified
by education and experience generally," he did not find the Expert
"qualified to render an expert opinion regarding Florida law and
standards of medical practice" because he was not aware of the current
state standards and the "significant change in the regulations as of
October 2010." Id. at 51.
The ALJ further stated that he found that the Expert's testimony
included "inconsistencies, factual errors, vague or nonresponsive
answers to basic questions, and an overall lack of interest or even
curiosity in examining all available information relevant to
Respondent's prescribing conduct." Id. at 53. While acknowledging that
the Expert's "testimony at various points did find some support in the
evidence, overall his testimony and related opinions repeatedly
demonstrated an unwillingness to consider positive conduct by
Respondent, or even inquire of any, beginning with his October 24, 2011
report." Id. The ALJ also cited the Expert's financial interest as a
Government Expert and what he characterized as a "history of near
uniformity of opinion testimony on behalf of the Government" as
grounds for his conclusion that the Expert's testimony lacked "the
necessary independence, objectivity, and factual basis to be relied
upon." Id. at 57-58.
Accordingly, based on what he deemed to be the absence of
"credible medical opinion testimony," or other "credible evidence of
misconduct by Respondent," the ALJ rejected the allegations that
Respondent lacked a
[[Page 57135]]
legitimate medical purpose and acted outside of the usual course of
professional practice in prescribing to each of the UCs. Id. at 69, 75,
82, 91. The ALJ reached this conclusion notwithstanding his finding
that Respondent prescribed Xanax to one of the UCs without any inquiry
into "the medical basis for continuing the prescription" and that
this "arguably supports a finding that such a prescription lacks a
legitimate medical purpose, or is outside the usual course of
professional practice." Id. at 82. The ALJ thus concluded that factors
two and four "weigh heavily against a finding that Respondent's
continued registration would be inconsistent with the public
interest." Id. at 91.
With respect to factor five--such other conduct which may threaten
public health and safety--the ALJ noted that Respondent, who had been
called to testify by the Government, invoked his Fifth Amendment
privilege and refused to testify. ALJ at 92. While the Government
requested that the ALJ draw an adverse inference based on Respondent's
refusal to testify, the ALJ declined to do so explaining that because
the Government had failed to establish a prima facie case that
"Respondent's conduct was contrary to the public interest," his
"testimonial silence with regard to acceptance of responsibility" was
not relevant. Id. While acknowledging that an adverse inference may be
permissible, the ALJ reasoned "that the failure to testify alone may
not be taken as an admission of wrongdoing, without regard to other
evidence." Id. at 92-93. Noting that "Respondent is facing uncertain
criminal liability," the ALJ reasoned that he did "not find his
testimonial silence during this parallel administrative proceeding to
make it more likely than not that he would dispute an untrue
accusation." Id. at 93. The ALJ then explained that "in light of the
fact that the Government's evidence was insufficient to establish a
prima facie case, particularly given the lack of credible medical
expert testimony, Respondent's silence in and of itself does not
appreciably tip the balance of evidence in favor of the Government."
Id. The ALJ thus explained that even were he to draw an adverse
inference, he would still find the evidence insufficient to conclude
that Respondent's prescribing practices were unlawful. Id. Because in
the ALJ's view, there was no other evidence that Respondent had engaged
in conduct which may threaten public health or safety, the ALJ
concluded that this factor also supported the continuation of
Respondent's registration. Id. The ALJ thus recommended that the Order
to Show Cause and Immediate Suspension be dismissed. Id. at 94.
On June 5, 2012, the Government filed Exceptions to the ALJ's
recommended decision. Thereafter, on June 14, 2012, the ALJ forwarded
the record to me for Final Agency Action.
I have carefully considered the entire record including the ALJ's
recommended decision and adopt his findings with respect to factors one
and three. However, I reject his findings with respect to factors two
and four because, with respect to many of the prescriptions (especially
those for alprazolam) Respondent issued to the undercover officers,
expert testimony was not necessary to prove that he lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice in issuing them. Indeed, with respect to one of the undercover
officers, the ALJ ignored nearly all of the evidence of the
conversation which occurred between Respondent and the officer which
shows that Respondent knew the undercover officer was a drug abuser and
that he engaged in an outright drug deal.
Likewise, with respect to the alprazolam prescriptions Respondent
issued to three of the undercover officers, the ALJ entirely ignored
relevant evidence and failed to discuss the evidence pertaining to
these prescriptions. In other instances, the ALJ mischaracterized the
evidence he cited. Finally, with respect to several issues, the ALJ
failed to apply properly, or ignored entirely, precedents of both the
Agency and federal courts.
Accordingly, as ultimate factfinder, I reject the ALJ's legal
conclusion that the Government has not met its prima facie burden of
showing that Respondent has committed acts which render his continued
registration inconsistent with the public interest. See Reckitt &
Coleman, Ltd., v. Administrator, 788 F.2d 22, 26 (DC Cir. 1986) (citing
5 U.S.C. 557(b) ("On appeal from or review of the initial decision,
the agency has all the power which it would have in making the initial
decision * * *")). Because even assuming, without deciding, that the
Expert's testimony is not entitled to weight (notwithstanding the ALJ's
inconsistent statements regarding the weight he was giving it), the
record still contains substantial evidence that Respondent violated 21
CFR 1306.04(a) in issuing several of the prescriptions and he has
offered no evidence that he acknowledges his misconduct and will
refrain from engaging in similar acts in the future, I will order that
Respondent's registration be revoked and that any pending application
be denied.
I make the following
Findings of Fact
Respondent Registration and Licensing Status
Respondent is the holder of DEA Certificate of Registration
FM0624139, which prior to the issuance of the Order of Immediate
Suspension, authorized him to dispense controlled substances in
schedules II through V as a practitioner, at the registered location of
Quality Care Medical Group (hereinafter, QCMG), 143 Oakfield Drive,
Suite 102, Brandon, Florida. GX 1-2. Respondent's registration does not
expire until January 31, 2014. GX 2.
Respondent is also the holder of an active medical license issued
by the Florida Board of Medicine, which does not expire until January
31, 2014. ALJ at 45 n.76. There is no evidence that Respondent's state
license has been the subject of any disciplinary proceedings. See id.
The DEA Investigation of QCMG
QCMG first came to the attention of DEA in early 2010, when a Task
Force Officer (TFO) received information from various sources including
citizens, anonymous callers and a cooperating defendant regarding a
QCMG clinic located in Bradenton, Florida. Tr. 50-53. The information
included a report that persons were traveling to QCMG from out-of-state
locations, that QCMG allowed sponsors to bring groups of people into
the clinic, and that persons were presenting fraudulent MRIs and
prescription profiles to obtain admission as patients. Id. at 53-55.
In June 2011, DEA commenced undercover operations at the Bradenton
location and sent in several undercover officers who presented MRIs and
patient profiles and were able to see the doctor who worked at that
location. Id. at 61, 70-71. During the investigation, the officers
determined that the owners of QCMG also had a clinic located in
Brandon, Florida and decided to conduct undercover operations at the
latter location as well. Id. at 72. In total, four undercover officers
made visits to the Brandon location. Id. at 73. Two of the officers,
who used the undercover names of Anthony Thompson and Robbie Payne,
each made two visits to the Brandon clinic and saw Respondent on both
occasions. Id. The other two officers, who used the undercover names of
Mike Corleone and Eric McMillen, went to the Brandon location and saw
Respondent once. Id.
[[Page 57136]]
The Undercover Visits of Robbie Payne
On some date not specified in the record but shortly before July
28, 2011, a Task Force Officer (TFO) using the undercover name of
Robbie Payne went to the QCMG Bradenton clinic but was turned away
because he did not have an appointment. Tr. 169-70. During a discussion
following the operation, the investigators decided that the TFO would
contact the Brandon clinic and make an appointment. Id. at 174. The TFO
called the Brandon clinic and was able to make an appointment for July
28th. Id.
On July 28, the TFO went to the clinic, wearing a recording device,
and brought an MRI and a profile purporting to show what prescriptions
he had obtained; the latter showed that Payne had last received
prescriptions for 210 tablets of oxycodone 30mg, 90 tablets of
oxycodone 15mg, and 90 tablets of Xanax 2mg on April 10, more than
three and a half months earlier.\3\ Id. at 174-77; RX 4, at 15; RX 1,
at 36-39. The TFO testified that he was required to fill out various
forms requiring personal information, waivers, and a questionnaire
which included historical information, previous medications, pain
levels, and how the pain "affected" his life. Tr. at 175. The TFO
further testified that the questionnaire used a "0 through 10" pain
scale and asked him to rate his "pain at that moment" and when he was
"on medications." Id. at 175-76. While the TFO did not remember "the
exact number" he wrote down for his pain at the present time, he
testified that usually writes "something between 0 and 4." Id. at
176. With respect to what he wrote as his pain level with medications,
Payne testified that he would write "the same number." Id.
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\3\ The profile also showed that Payne had filled prescriptions
for the same three drugs and strengths on a monthly basis between
December 10, 2010 and April 10, 2011.
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The TFO did not, however, recall whether the questionnaire had any
questions regarding whether he suffered from anxiety. Id. Eddie Gomez,
Respondent's Medical Assistant, testified that the medical
questionnaire which patients were required to fill out contained no
information about anxiety. Id. at 984. However, Gomez then changed his
testimony, explaining that the questionnaires, which were subsequently
shredded under the clinic's policy, did ask about anxiety. Id. at 985-
86.
The TFO also testified that one of the forms had a picture of a
human body and that he "deliberately" circled a part of the body that
was different than his MRI "to disprove * * * the MRI." Id. at 180.
After turning in his paperwork and paying for the visit, Payne took a
seat in the waiting room. Id. at 176-77.
The TFO was eventually summoned from the waiting room by Eddie
Gomez, who identified himself as the office manager and Respondent's
assistant. Id. at 178; GX 14, at 4. Gomez took the TFO's height, weight
and blood pressure; Gomez then asked him whether he was going to
another pain management clinic (with the TFO answering "no") and
stated that the clinic reported doctor shoppers to the authorities. Tr.
178; GX 14, at 4. Gomez explained that "[t]hese are Schedule II drugs,
C II drugs, uh * * * narcotics. You cannot share them, sell them,
okay?," and asked the TFO if he was "abusing pain meds or illegal
substances." Id. at 5.
Gomez then said that he was going to do a drug screen on the TFO
and asked him when the last time was that he took his meds. Id. The TFO
stated that he had been prescribed drugs "a while ago," and Gomez
acknowledged that "April was the last script." Id. The TFO then added
that "that was the last time * * * that I actually saw a doctor, but I
take them here and there, from * * * wherever." Id. Gomez asked if the
TFO had taken drugs "this morning?" Id. The TFO replied "[n]o, no,
no" and added that it was "a week or two." Id. Gomez then asked how
long the TFO had been on pain meds, with the latter replying that he
had started about a year and a half to two years ago, but that it was
"kind of sporadic." Id. at 6. Gomez then asked the TFO what clinic he
had gone to; the TFO stated that the clinic was in south Florida and
named "Real Care" but that he thought the clinic had gone out of
business. Id.
Gomez gave the TFO a cup for a urinalysis and the TFO provided a
sample. Id. at 6-7. Gomez then tested the TFO's sample, which "came
back all negative." Tr. 179; GX 14, at 8. Gomez, however, prepared a
Drug Urinalysis Test form on which he circled that the TFO was
"positive" for "Oxy." RX 1, at 40. In his testimony, Gomez insisted
that the TFO tested positive for oxycodone. Tr. 944-45, 959. However, I
find (as did the ALJ) that Gomez falsified this form. Thereafter, Gomez
escorted the TFO to an exam room.
The TFO testified that Gomez did not ask him about the source of
his pain, or whether he had any problems with anxiety or sleeplessness.
Id. at 181-82. Gomez testified at the hearing that if the TFO "was a
new patient," Respondent (and not himself) would ask the patient if he
had pain or anxiety. Id. at 959-60. Moreover, Gomez testified that one
of his responsibilities was to review the information that the patients
provided on their medical questionnaires and enter the information into
the clinic's Electronic Medical Record System (EMR). Id. at 932, 952.
Gomez testified that after the information was entered into the
EMR, "it was shredded." Id. at 940, 952.\4\ Gomez also testified that
in doing the "review of systems," his role was to review the
patient's "past medical history, social history, which was on the
initial paperwork, [and] any family history, if they had any family
history." Id. at 942.
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\4\ When asked by Respondent's counsel whether there was "a
possible explanation" for the various entries that the undercovers
had no problems with anxiety and denied problems with mood
disturbance, Gomez testified that the EMR system had various default
entries, such that "if something is not input or checked, it'll put
whatever is on default." Tr. 1004. However, Gomez could not further
identify what the default entries were for various sections of the
medical record, id. at 1004-5, and did not know if there was a
default entry for anxiety. Id. at 1008. In any event, if any of the
undercovers had represented to Gomez or Respondent that he had
anxiety, one must wonder why an entry documenting this would not
have been made in the chart.
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Respondent entered the exam room and introduced himself. GX 14, at
9. Respondent noted that the TFO had been in pain management in south
Florida but that "they went out of business." Id. The TFO said
"yes" and Respondent surmised that his previous clinic had been
"shut down." Id. The TFO replied that he did not "know what happened
to them." Id. at 10.
Respondent reviewed the TFO's MRI, noting that it showed a "mild
disc bulge" at "two levels, without significant central canal or
neuro." \5\ Id. Respondent then told the TFO that "[t]he reason why
they're out of business is cause they've been prescribing
inappropriately. Okay?" Id. The TFO replied, "uh-hum," and
Respondent stated: "I can't give you near the pills that you were
getting. Not even remotely close. You, I, I haven't even done a
physical exam * * * Just based on your MRI here, its * * * I can't do
it." Id.
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\5\ The TFO's MRI stated that he had "mild diffuse bulge of
[the] L4-5 and L5-S1 discs, without any significant central canal or
neural foraminal narrowing" and that "no other significant
abnormality is detected in this study." RX 1, at 34.
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The TFO replied that "that's just what they prescribed, that's not
what I actually took," and after Respondent said "okay," the TFO
added: "So I didn't * * * I didn't, I can't * * * tell, you're the
doctors, so I don't know * * * So that's just what they gave." Id.
After acknowledging the TFO's statement, Respondent stated "you know
you got two bulging discs, with, and it doesn't talk about pushing on
any
[[Page 57137]]
nerve roots or anything like that, I mean, this is as close to a normal
MRI as you can get without it being actually normal. You see what I'm
saying?" Id. The TFO replied "uh-hum," and Respondent added: "I
mean the most I can do for you would * * * And I'm telling you this in
case you don't want to come here. Okay? Cause I hate for you to spend
all of your money, coming here and not get what you need." Id.
The TFO said "alright" and Respondent added: "Okay? Could, and *
* * what you should get, and what you need, often sometimes is two
different things cause if you've been on a certain number of pills, for
a long time, if you don't get those number of pills, you're going to be
sick." Id. at 11. After the TFO said that he "got that," Respondent
stated: "you know what I mean? So I mean, I'm at the point * * * I
mean just by looking at this without even doing the physical exam yet.
* * * I mean I'm looking at maybe a hundred and fifty of them." Id.
The TFO replied: "And honestly that's about where I was." Id.
Respondent proceeded to conduct his physical exam which took all of one
minute and thirty-nine seconds. GX 13.
During the physical exam, Respondent asked the TFO various
questions regarding the location of his purported pain. GX 14, at 11.
For example, Respondent asked the TFO if most of his pain was in his
lower back. Id. The TFO replied: "uh-hum." Id. Next, Respondent
asked: "How about out to the sides, here?" Id. at 12. The TFO again
replied: "uh-hum." Id. Respondent then asked: Down on this side?"
Id. The TFO replied: Yeah. Id. Respondent then asked "anything like
that?" Id. The TFO answered: "a little bit." Id. Respondent then
asked: "[a]nything on this side?" Id. The TFO replied, "Uh-hum * * *
probably the same as the other side, I guess, yeah." Id.
Following an apparent test of the TFO's reflexes, Respondent asked
him to stick his legs out and whether doing so caused pain; the TFO
stated "not right now." Id. Respondent then asked the TFO to give him
"a little twist" and whether this caused pain; the TFO said "not at
the moment." Id. Respondent said "that's fine," and asked the TFO to
give him "another little twist"; the TFO again denied that the
movement caused any pain. Id. Respondent then noted that he was done
with the physical exam. Id.
Following a discussion of the EMR system, Respondent asked the TFO
if he had been getting Xanax. Id. at 13. The TFO answered "yes," and
when Respondent asked "for anxiety?" the TFO said "for sleep." Id.
Respondent noted the TFO's answer and explained that he did not
prescribe the two milligram dosage units of Xanax because of its "a
high street value" and only prescribed the one milligram strength. Id.
While Respondent told the TFO that he should not double up on the
Xanax, he did not engage the TFO in any further discussion regarding
his sleep problems. Id.
After Respondent and the TFO discussed how the latter made his
living, Respondent gave the TFO his "new patient talk," which
included telling him to take his medication as prescribed, and that
there is "no such thing in this clinic * * * of running out of
medication. Id. at 14-16. Respondent further explained that "one of
the reasons why we don't run out here" is because "I don't want you
taking medication, the way you want to take them, because that will put
you in jeopardy of overdose." Id. at 16. Respondent added that "I
don't want you to do that, that, I don't want you to, risk my license
by doing that, and on top of that I want to keep you in the clinic."
Id. Respondent explained that the TFO would be subject to random urine
testing and that it was a "no tolerance clinic." Id. Respondent also
told the TFO not give to give his "medication to anybody else," or
"take any from anybody else," and that if his medication was stolen,
he needed a police report. Id. Respondent then asked the TFO if he had
any questions; the TFO said no. Id. at 16-17.
Respondent added: "We're pretty strict here * * * but we do have
fun also," a point which he reiterated. Id. at 17 ("We have fun, we,
you know, we're a pretty fun office, uh, but we do, we uh strictly do
things by the book."). Respondent then showed the TFO the window where
he would get his prescriptions and said that he would see him "in a
month." Id. at 17-18. The visit then concluded. Id. at 18.
The evidence shows that Respondent wrote the TFO a prescription for
150 tablets of oxycodone 30mg, and a prescription for 90 tablets of
Xanax 1mg. GX 15, at 1. In the medical record for the visit, Respondent
documented the TFO's pain level as a "3" and that it was of mild
severity.\6\ RX 1, at 26. Moreover, in the physical exam portion of the
record, Respondent documented having palpated the TFO's cervical spine
as well as paravertebral muscle groups, yet the video recording of the
visit clearly shows that this was never done. RX 1, at 28; GX 13. In
addition, Respondent documented findings based on range of motion tests
(rotation, bending, flexion, and extension) for all three portions of
the TFO Payne's spine (cervical, thoracic and lumbar). RX 1, at 28.
Here again, the video shows that while Respondent had the TFO twist his
torso and do a straight leg raise of both legs, he did not test the
TFO's range of motion on bending, extension or flexion. GX 13. Nor did
he do any tests of the TFO's range of motion in his cervical spine. Id.
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\6\ Mr. Gomez testified that the pain levels recorded in the EMR
were with medications. Tr. 964-65. However, the TFO testified that
he wrote the same pain number for his pain both with and without
medications. Id. at 176. Notably, there is no evidence that
Respondent addressed this with the TFO.
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In the TFO's medical record, Respondent further recorded a
diagnosis of "generalized anxiety disorder," which he deemed to be
"active" and "chronic," notwithstanding that under the
"psychiatric" section of the "review of systems" section,
Respondent noted that "Patient denied problems with mood disturbance.
No problems with anxiety." RX 1, at 27-28.
Likewise, under the "psychiatric" section of the physical
examination, Respondent noted: "Oriented with normal memory. Mental
status, judgment and affect are grossly intact and normal for age."
Id. at 20.\7\ See also Tr. 190-92 (TFO's testimony that Respondent did
not discuss whether he had generalized anxiety disorder and whether he
saw another physician for treatment of anxiety").
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\7\ Respondent also diagnosed the TFO as having lumbar disc
displacement, lumbar lumbosacral disc degeneration, and backache
unspecified, which was chronic and active. RX 1, at 28.
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In addition, in the "Instructions" section of the medical record,
Respondent wrote the following:
Patient appears to understand risks. Patient instructed to RTC/
call clinic if patient experiences any non-urgent side effect such
as constipation, nausea, itching, rash & etc. Return to clinic as
scheduled. Patient instructed to go to emergency room immediately if
the patient has any serious symptoms such as SOB, severe allergic
reactions, LOC, Syncope, new neurologic deficits, bowel/bladder
incontinence, excessive drowsiness and vomiting.
RX 1, at 29. At no point during this visit, however, did Respondent
discuss with the TFO any of these instructions. See GX 13-14. Most
significantly, at no time did Respondent ask the TFO what caused his
pain or injury and how he gotten by when his last prescriptions were
issued more than three months earlier, or why he had tested positive
for oxycodone given when he had purportedly last filled prescriptions
for the drug.
[[Page 57138]]
On August 25, the TFO, again wearing a recording device, returned
to the Brandon clinic. Tr. 192. Upon his arrival, the TFO checked in
with the receptionist and paid the fee for the visit. RX 4, at 21-22.
Before even seeing Respondent, the receptionist gave the TFO an
appointment for a follow-up visit. Id. at 22.
After about twenty-five minutes, Eddie Gomez called the TFO back to
the triage room and took his weight and blood pressure. GX 17, at 2-3.
Gomez then told the TFO to return to the waiting room and that he would
be called next. Id. at 3. After a short wait, Gomez told the TFO to go
to an exam room. RX 4, at 22-23.
Respondent entered the exam room and asked the TFO "what's going
on"; the TFO replied: "How you doing?" GX 17, at 4. Respondent
answered, "All right, what's up? How did your month go?" Id. After
the TFO said that "everything is good," Respondent asked:
"Medication treatin[g] your pain well?" Id. The TFO answered
"Yeah," and added that he had "no problems or issues." Id.
Respondent asked: "No questions?" The TFO replied: No, mm-mm.
Everything is good." Id.
Respondent then stated that he would "be feeling [the TFO's] lower
back and get you going"; Respondent then asked: "[a]ny pain down in
this areas here, how about here?" Id. The TFO replied: "Mm-mm."
Respondent then asked: "Anything out on the sides at all?" The TFO
answered: "Nothing that was, uh, * * * any different than the last."
Id. Respondent asked: "Nothing was--nothing like this, right?" Id.
The TFO replied: "Mm-mm." Id. Respondent then said "all right.
Questions? Nope, you are all set." Id. The TFO then thanked
Respondent. Id. At the conclusion of the visit, Respondent issued the
TFO prescriptions for another 150 oxycodone 30mg and 90 Xanax 1mg. GX
18.
The entire interaction between the TFO and Respondent lasted less
than two minutes. GX 17. As the TFO wrote in his report for the visit:
[Respondent] asked the UC "are the meds treating your pain
well?" to which the UC replied "yes, no issues." [Respondent]
asked if the UC had any questions, and the UC replied that he did
not. [Respondent] then got up and walked toward the door. Before
exiting, [Respondent] stated "let me feel your lowerback and get
you going." The UC scooted forward in his chair and [Respondent]
placed his right hand on the UC's lower back. [Respondent] asked,
"pain down here in this area?" to which the UC stated "uh-huh."
[Respondent] then moved his hand to the right and left of the UC's
spine and asked "anything over here?" to which the UC stated
"nothing is different than last time." [Respondent] removed his
hand from the UC's lower back and stood straight up, asked if there
are any more questions, to which the UC stated "no," and then
[Respondent] told the UC he was all set.
RX 4, at 23.
Here again, evidence shows that Respondent made findings in the
medical record notwithstanding that he never performed various tests.
For example, the medical record for the visits noted that there was
"no change" in the pain's "status," noted that it radiated into his
"upper back," that the "timing" of the pain was "constantly,
during the day and EVENING," and that its "quality" was "radiating
and dull." The record further listed "sleep and physical activity"
as "affected daily activities." RX 1, at 30.
Respondent also documented that he had done a neurologic
examination, in which he found that the TFO had "[n]ormal and
symmetrical deep tendon reflexes with no pathological reflexes." RX 1,
at 31. Likewise, Respondent made findings that he had palpated the
TFO's cervical spine and the surrounding areas, as well as that he had
had the TFO perform various range of motion tests of various portions
of his spine. Id. at 31-32. However, as the TFO's report makes clear,
Respondent did not do anything other than palpate his lower back area.
RX 4, at 22-23.
The Undercover Visits of Anthony Thompson
On July 27, 2011, a Special Agent, who used the name of Anthony
Thompson, attempted to see a doctor at the QCMG clinic Bradenton. Tr.
240. While the Agent was turned away because he was not thirty years of
age and his MRI could not be verified, a staff member advised him to go
to the Brandon clinic because it was not "as strict as the Bradenton
clinic." Id. at 240-41.
The next day, the Agent, who was wearing a recording device, went
to the Brandon clinic and presented an MRI\8\ and a prescription
profile. Id. at 240-41. The Agent filled out various forms covering his
personal information, past history and family history of illnesses, and
a questionnaire regarding his pain levels. Id. at 243. The Agent did
not recall the actual numbers he had written on the pain questionnaire,
but stated that he would have written a five or below. Id. The Agent
did not recall whether any of the questionnaires asked if he had
anxiety. Id. at 244. According to the medical record, the Agent's pain
was of "mild" severity and was "4 on pain scale," and that it
radiated into the "neck and upper back." RX 1, at 15. In addition,
while the medical record indicates that the Agent complained that his
pain occurred "frequently and nocturnally" and was aggravated by
sleeping, walking and standing for a long period of time," the Agent
denied that he told this to either Mr. Gomez or Respondent. Tr. 282-83;
RX 1, at 15.
---------------------------------------------------------------------------
\8\ The MRI findings included: A "[l]eft posterolateral disc
herniation at L5-S1 with moderate ventral effacement of thecal sac
and moderate effacement of the left S1 nerve root"; a "[c]entral
and left posterolateral disc herniation at L4-5 with moderate
secondary central spinal stenosis"; "[s]mall central disc
herniation" at both L2-3 and L1-2; and a "[d]iffuse central disc
bulging at L3-4." RX 1, at 23. The MRI included a notation that it
was verified on "7/28/11." Id.
---------------------------------------------------------------------------
Mr. Gomez called the Agent and identified himself as the doctor's
assistant. GX 7, at 3. Mr. Gomez proceeded to review the rules of the
pain contract, told the Agent that the clinic reported doctor shoppers,
asked if he was taking "any illegal substances," and what pain
management clinic he was going to. Id. The Agent replied that he had
seen a Dr. Barton, who had since died. Id. Mr. Gomez then asked the
Agent about Dr. Burns, a physician who was listed as the Agent's
physician on the MRI. Id., RX 1, at 23. The Agent replied that Burns
was "somebody that the MRI place referred me to," noting that he
"had to get a new MRI." GX 7, at 3. Gomez then asked the Agent when
he had last gotten his pills and when he had last taken them; the Agent
replied that he thought he had filled his prescriptions "in the middle
of June." Id. Gomez then said: "So you shouldn't have anything in
your system," and the Agent answered: "Right, I don't have anything;
I've been out for a while." Id. at 3-4. Gomez then said he was going
to do a drug screen on the Agent. Id. at 4.
After taking the Agent's weight and blood pressure, Gomez asked him
about his employment status, education level, marital status, and
whether he had kids; whether he smoked, used alcohol or caffeine;
whether he had any blood transfusions; whether he had body piercings or
tattoos; whether he exercised; and whether he had any significant
family history. Id. at 5-6. Gomez then tested the Agent's urine sample.
Id.
According to the Drug Urinalysis Test form, the Agent tested
positive for benzodiazepines and oxycodone. RX 1, at 24. At the
hearing, however, the Agent testified that he did not take either
benzodiazepines or oxycodone; that in his position, he was subject to
drug testing; and that he could not take these medications unless they
were prescribed to him. Tr. 301. While Gomez insisted in his testimony
that the Agent had tested positive for these
[[Page 57139]]
drugs, and noted that the form was signed, Tr. 943-44, 962-63; the ALJ
noted that the Agent did not recall signing the form and that both the
recording and the Agent's report concerning the visit show that Gomez
had confirmed that the test was negative. ALJ at 71. Accordingly, the
ALJ did not find Gomez's testimony credible and I adopt this finding.
Following a discussion of the clinic's recordkeeping system, Gomez
took the Agent to an exam room. GX 7, at 7. Respondent eventually
entered the room, introduced himself, and proceeded to look at the
Agent's MRI. Id. at 7-8. Respondent then asked the Agent if most of his
pain was in his lower back. Id. at 8. The Agent replied: "Um kinda up
towards the mid back too." Id. Respondent replied ok, and asked how
the Agent "hurt [his] back." Id. The Agent answered that "[i]t's
just something that, it's over time." Id. Respondent asked if it had
"gotten worse?" and the Agent said "Ah huh." Id.
Respondent said "ok," and proceeded to conduct a physical exam
which lasted less than two minutes. Id. During the exam, Respondent
placed a stethoscope on the Agent's back and stomach and asked him to
breath, tested the reflexes in the Agent's knees, and had him sit on
the edge of an exam table and extend his legs out straight and asked if
this caused pain in his back; the Agent replied: "It's ok." Id.
Respondent then placed his hands on the Agent's shoulder, and pressing
downward, asked the Agent to turn his torso to each side and whether
this was painful. Id; RX 4, at 4-5. The Agent replied "mmm," to which
Respondent said "mmm? You don't have to; it doesn't mean anything it
just helps me assess." GX 7, at 9. The Agent said "ok," and the
physical exam ended. Id.
The Agent then asked Respondent how long he had been at the clinic;
Respondent said that he had been there since February and that when he
started there, the doctors who had come before him "would basically
give anything to anybody." Id. Respondent also stated that the clinic
had had an employee, who "was doing shady things" but had since been
fired and reported to DEA. Id. Respondent further maintained that he
had "clean[ed] the practice up a bit" by "dropping people down to
reasonable levels on their medications, that * * * what the state and
medical personnel would deem what is appropriate." Id. He also stated
that "it seemed like everyone was on" the "trifecta" of Oxycodone,
Xanax, and Soma, which was "just asking for trouble" in the form of
overdose deaths. Id. Respondent noted that Soma metabolizes into a
substance, which reacts and magnifies the effect of oxycodone and
Xanax, which "are respiratory suppressants to begin with." Id.
Respondent then stated that "we want to comply with all of the laws,
we want to do things appropriately, and not piss the DEA or any law
enforcement agency off." Id. Respondent added that "we're na[iuml]ve
to think they haven't sent people through here as fake patients" but
that he was fine with this because he doesn't "do anything I'm not
supposed to do." Id. at 9-10.
Respondent then told the Agent that his physical exam did not "one
hundred percent correlate with [the] finding on your MRI," and that
his "physical exam [wa]s a lot better than your MRI," but that
"there is some stuff on your MRI that would justify you having pain."
Id. at 10. Respondent then asked "why were they giving you 30's and
15's?" Id. The Agent replied, "That's what he had prescribed." Id.
Respondent replied that "that's very odd" because "the 30's and
15's are * * * both break through medications" and "do the same
thing." Id. After the Agent interrupted, asking "splitting them up
like that?," Respondent stated that this was "a common way for
doctors to hide more medication." Id. Respondent then explained that
"I wouldn't say hide" but that "the unofficial max is like 240, 210,
240 on 30's," and that doctors would write "a prescription for 240
then they'll throw in a 120 15 * * * instead of writing 300 or so" in
the event "they get investigated." Id. Continuing, Respondent added
that he would "rather not do both types of medications," meaning the
30s and the 15's. Id.
Respondent then told the Agent that based on the latter's MRI and
physical exam, he would give him 180 tablets of oxycodone 30mg but not
the 15s. Id. The Agent replied "ok," and Respondent added: "Just to
give you essentially the same amount of milligrams all along, * * *
what I'd like to do is taper you down as far as we can go, where that
you're still comfortable." Id. at 11. Respondent then noted that the
Agent was "fairly young, your [sic] 29" and that most people under
the age of 30 don't need to be on pain management." Id.
Next, Respondent said: "I take it you have some anxiety as well is
that what's going on with you?" Id. After the Agent replied, "Yeah,
that's the Zanny's help out," Respondent said: "Ok, first of all let
me tell you we don't call them Zanny's or bars or any of the street
terms in here, ok, we call them Xanax or alprazolam, whichever one you
want to call them." Id. Respondent then explained that "I don't
typically give the two milligrams out[,] I give the ones * * * the twos
have too much of a street value." Id.
Respondent then observed that "on July 1st[,] the law states now
that if the patient has a psychiatric um problem along with being on
pain management the law states we have refer you to psychiatry." Id.
After the Agent said "ok," Respondent said "that doesn't necessarily
mean you have to follow up with that, that just means I have to tell
you to go, which is I am telling you to go." Id.
Respondent did not, however, provide the Agent with the name of any
psychiatrist to see. Tr. 255. Moreover, in the psychiatric section of
the "review of systems," Respondent noted: "Patient denies problems
with mood disturbance. No problems with anxiety." RX 1, at 16.
Likewise, in the psychiatric portion of the physical examination,
Respondent documented: "Oriented with normal memory. Mental status,
judgment and affect are grossly intact and normal for age." Id. at 17.
Respondent nonetheless recorded a diagnosis of "Generalized Anxiety
Disorder" which was "active" and "chronic." Id.
Respondent then gave the Agent his "new patient speech" and the
visit ended. Id. at 11-12. According to the medical record, Respondent
diagnosed the Agent as having lumbar disc displacement, lumbar
lumbosacral disc degeneration, and backache unspecified, all of which
were "active" and "chronic." RX 1, at 17. At the conclusion of the
visit, Respondent issued the Agent prescriptions for 180 tablets of
oxycodone 30mg and 60 tablets of Xanax 1mg. GX 8, at 1.
On August 25, 2011, the Agent returned to the clinic, and again
wore a recording device. Tr. 256. The Agent met the receptionist, paid
the fee for the visit and sat down in the waiting room. RX 4, at 10-11.
After approximately thirty minutes, the Agent was called by Mr. Gomez
for triage, who took his weight and blood pressure. GX 10, at 6; RX 4,
at 11. Mr. Gomez did not, however, ask the Agent any questions
regarding his health. GX 10, at 6; RX 4, at 11. The Agent then returned
to the waiting room. RX 4, at 11. Moreover, the Agent testified that he
did not recall filling out any forms at this visit. Tr. 295.
Shortly thereafter, Mr. Gomez called the Agent and took him to an
exam room. Respondent entered the exam room, and after exchanging
pleasantries, asked the Agent if the "medication is
[[Page 57140]]
working ok?" GX 10, at 7. The Agent answered: "Yep, great." Id.
Respondent asked: "Questions for me at all?" Id. The Agent replied,
"No, I'm good." Id. Respondent then asked: "The medications are
controlling your pain well?" Id. The Agent replied: "Yeah,
everything's great." Id.
Respondent then had the Agent stand up and explained that "[t]he
state makes me do a physical exam each time." Id. Respondent placed
his hand on the Agent's mid to lower back and asked: "Most of the pain
in here at all? Is this where it is or is it down further." Id.; RX 4,
at 12. The Agent stated: "Right around that whole area." GX 10, at 7.
Respondent replied: "Right around this whole area? All right." Id.
Respondent "then directed the [Agent] out of the" exam room and the
two walked up to the receptionist's counter, where Respondent obtained
two printed prescriptions, which he signed and gave to the UC. RX 4, at
12. The prescriptions were for 180 tablets of oxycodone 30mg and 60
tablets of Xanax 1mg. GX 11.
The medical record for this visit indicates that the Agent
presented with low back pain, with a severity which was "mild" and a
"4 on the pain scale," that there was "no change" in the pain's
status, and that the pain radiated into the Agent's "neck and upper
back." RX 1, at 19. In the review of systems section, the record again
states: "Patient denied problems with mood disturbance. No problems
with anxiety." Id. And, as before, in the psychiatric section of
physical examination portion, the record states: "Oriented with normal
memory. Mental status, judgment and affect are grossly intact and
normal for age." Id.
The medical record further documents various tests as having been
performed which clearly were not. For example, under the neurologic
findings for the physical exam, the record states "normal and
symmetrical deep tendon reflexes with no reflexes." Id. Yet there is
no evidence that Respondent tested the Agent's reflexes.
Likewise, with respect to the Agent's lumbar spine, the record
states: "Full active ROM with rotation, Full active ROM with bending.
Full active ROM with flexion and Full active ROM with extension." RX
1, at 21. And with respect to the Agent's thoracic spine, the record
states: "Full active ROM with extension. Full active ROM with flexion.
Full active ROM with bending. Full active ROM with Rotation." Id. at
21. Here again, the evidence shows that these tests were not performed.
The Undercover Visit of Eric McMillen
On August 25, 2011, another Special Agent, using the name of Eric
McMillen, saw Respondent at the Brandon Clinic. However, on July 21,
2011, the Agent had seen a Dr. Mosley at the QCMG Bradenton clinic. GX
20; Tr. 348-55. The Agent acknowledged that he had provided a pharmacy
profile and MRI,\9\ id. at 385 & 353; filled out a medical
questionnaire at this clinic, which asked that he rate his pain, id. at
349-50; that a physician's assistant had asked him some questions about
the nature of his pain, as well as why he was in Bradenton when his
driver's license indicated that he was from Fort Lauderdale, id. at
352; that he had complained of pain in his "lower back, specifically
the lower back right side," id. at 355; and that it was possible that
he had noted on the paperwork that when the pain was at its worst, he
had "some trouble sleeping." Id. at 356. The Agent further testified
that he "probably" saw the doctor at the Bradenton clinic for "at
least thirty minutes," and on cross-examination agreed that Mosley's
exam was "pretty thorough." Id. at 413. At the conclusion of the
visit, the Agent obtained prescriptions from Dr. Mosley for 180 tablets
of oxycodone 30mg and 30 tablets of Xanax 2mg. Id. at 356-58; GX 20.
---------------------------------------------------------------------------
\9\ The pharmacy profile showed that McMillen had filled
prescriptions for 180 tablets of oxycodone 30mg and 60 tablets of
Xanax 2mg issued by a Dr. Malcom Foster on March 14, April 12, May
11, and June 10, 2011. RX 1, at 50-51.
The MRI report noted a "[s]mall posterocentral protrusion of
L5-S1 disc, with annular tear, cause mild narrowing of the central
canal," and a "[m]ild diffuse bulge of L4-5 disc, with left
extraforaminal annular tear, without any significant central canal
or neural foraminal narrowing." GX 19. The MRI includes a notation
that it was verified on the date of the Agent's Bradenton visit. RX
1, at 46.
---------------------------------------------------------------------------
The Agent's medical record also includes a chart for his initial
visit with Dr. Mosley. RX 1, at 60-61. While the chart lists Dr.
Mosley's prescriptions to include "Xanax 2 mg qhs PRN Anxiety
30," notably the chart contains no findings pertinent to the
Agent's having anxiety (or sleeping problems) and Mosley did not list
anxiety as one of his diagnoses in the diagnosis/assessment section of
the chart. See id. Indeed, on the first page of the chart, under
"Psych Hx," the block for anxiety (as well as other mental health
conditions) is blank, and in the portion of the form for noting whether
the patient had a family history of various conditions including
"mental health," Mosley wrote "none." Id. at 61.
On August 25, 2011, the Agent, who wore a recording device, went to
the Brandon clinic where he saw Respondent. Tr. 358-59, 363. While the
Bradenton clinic was supposed to fax over the Agent's medical record,
it had not done so; the Agent was subsequently required to fill out a
medical questionnaire which asked about the location of the pain, how
it had occurred, and what medications he was on. Id. at 365. However,
the forms did not include a pain chart with a numeric scale. Id. at
366.
The Agent was eventually called by Mr. Gomez, who asked how tall he
was and took his weight and blood pressure. Id. at 366; GX 22, at 3.
Mr. Gomez then took him to an exam room. GX 22, at 4.
After a short hiatus, Respondent entered the room, introduced
himself, reviewed the Agent's paperwork, and began making entries on a
touch screen computer monitor. RX4, at 44. Respondent asked if "[m]ost
of the pain [wa]s in his lower back" and "[h]ow it all happened?" GX
22, at 7. The Agent replied that he "use [sic] to work in a warehouse
lifting boxes and moving stuff" but didn't "remember the exact day."
Id. Respondent asked: "Wear and tear over time?" Id. The Agent
replied: "Yeah." Id.
Following a discussion of the EMR system, Respondent asked the
Agent to lean forward, placed his stethoscope on the Agent's back and
asked him to take a deep breath followed by a normal breath, and asked
if the pain was "down here in your lower back?" Id. at 8. The Agent
replied, "Yeah, right around there." Id. Respondent then said he was
going to press various places and instructed the Agent to tell him if
he had pain; according to the Agent, Respondent proceeded to press
various parts on the Agent's lower back. RX 4, at 44; GX 22, at 9. The
Agent stated that he had "a little bit" on the left and that "in the
middle it's a little worse." GX 22, at 9. Respondent then asked:
"[h]ow about over here?" Id. The Agent replied: "Yeah," Respondent
noted that "[i]t's significantly tighter right there"; the Agent
stated: "Yeah, on the right side." Id.
Respondent then asked: "How about over here?" Id. The Agent
replied: "Yeah a little more * * * right around there." Id.
Respondent asked: "How about down in this area?" Id. The Agent
answered "No." Id.
Respondent stated "okay" and that he had "just left [the Agent]
on everything that you were on down there." Id. The Agent stated,
"Okay, that's fine." Id. Respondent added: "Okay, I usually don't
try to mess with it * * *. you know, try to play with it * * * unless
I'm trying to increase it or whatever." Id. The Agent replied: "No
problem." Id.
[[Page 57141]]
Respondent then stated: "Alright we have to have a plan at some
point, okay? Cause you're not going to be able to be on these meds for
the rest of your life. You know what I mean?" Id. at 10. The Agent
stated: "Okay, yeah sure * * * I hope * * * I hope not," and
Respondent told the Agent "[y]ou're all set." Id. Respondent then
escorted the Agent to the receptionist's desk and the receptionist gave
the Agent prescriptions for 180 tablets of oxycodone 30mg and 30
tablets of Xanax 2mg, each of which bore the signature of Respondent.
RX 4, at 45; GX 23.
The oxycodone prescription listed diagnoses of "[l]umbar
lumbosacral disc degeneration" and "lumbar disc displacement." GX
23. The Xanax prescription listed a diagnosis of "GENERALIZED ANXIETY
DISORDER." Id. These diagnoses are also documented in the medical
record as "chronic" and "active." RX 1, at 43.
However, in the psychiatric portion of the review of systems
section of the medical record for the visit, Respondent wrote:
"Patient denies problems with mood disturbance. No problems with
anxiety." RX 4, at 41. Likewise, in the psychiatric portion of the
physical examination section, Respondent noted: "Oriented with normal
memory. Mental status, judgment and affect are grossly intact and
normal for age." Id. at 42.\10\ Notably, at no point during the
Agent's visit with Respondent, did Respondent (or Gomez) ask the Agent
whether he had anxiety or suffered from sleeplessness.\11\ GX 22; Tr.
372, 377-78.
---------------------------------------------------------------------------
\10\ The ALJ noted that the medical record for the August 25
visit lists "sleep, work, and physical activity" as daily
activities affected by the Agent's back pain, and that the Agent
testified that he filled out a medical questionnaire but that
"[t]he record is unclear on exactly what information [the Agent]
provided in answering the medical questionnaires on August 25, 2011
on the issue of anxiety, sleep disturbance, or pain." ALJ at 82.
However, as noted above, the evidence showed that the questionnaires
were shredded by Respondent's staff. And in any event, one would
expect that a doctor would review with the patient his answers to
questions pertinent to various conditions before prescribing a
controlled substance to treat a condition.
\11\ During cross-examination, Respondent's counsel engaged in
the following colloquy with the Agent:
Respondent's counsel: "And you presented to them [i.e., the
Bradenton clinic], a patient profile that showed that you had a
history of having pain controlled by narcotic pain medication,
correct?
Agent: "Yes sir."
Respondent's counsel: "And alprazolam to help you with the
anxiety or sleeping, right?"
Agent: "Yes sir."
Tr. 397. Notwithstanding the Agent's answers, a patient pharmacy
profile does not establish that the drugs were prescribed for any
legitimate medical condition.
---------------------------------------------------------------------------
The Undercover Visit of Michael Corleone
On August 25, 2011, a TFO, using the name Michael Corleone, also
visited Respondent at the Brandon clinic. Tr. 447, 464. The TFO had
made two previous visits to the QCMG clinic in Bradenton (June 15 and
July 20, 2011), and saw Dr. Mosley on each occasion. GX 25; RX 4, at 25
& 30.
At his first visit (to Bradenton), the TFO provided his driver's
license, an MRI, and a prescription profile to the receptionist and was
given several forms to complete including a patient questionnaire. RX
4, at 30-31. On the patient questionnaire, the TFO noted that he had
"pain in the lower back and right shoulder," that his "[c]urrent
pain level was at a two" and that his "average maximum pain level was
at a five" on a one to ten scale, that the pain was "a sharp ache,"
which "occurs on a weekly basis," that it affected his "sleep and
physical activity," and that "helpful treatments * * * included heat/
ice and physical therapy." Id. at 31. The TFO further noted that the
receptionist had verified his MRI. Id. at 31-32.
Shortly after paying the $300 office visit fee, the TFO was
summoned by a nurse, who questioned him about his driver's license
which listed his address as being in Orlando. Id. The nurse further
told the TFO about the penalties for trafficking and doctor shopping,
and that the clinic conducted urine drug tests, and that marijuana
remains in the body for thirty days but that the clinic gave patients
the option to reschedule their appointment if they tested positive. Id.
at 31-32. Subsequently, the TFO was required to provide a urine sample,
and after doing so, was told to return to the waiting room. Id. at 32.
Later, the nurse called the TFO to another room where he proceeded
to take the TFO's vital signs, asked various personal questions, and
then asked about the location of his pain, his previous clinic and his
current medications. Id. Upon completion of these tasks, the nurse
escorted the TFO to Dr. Mosley's office. Id.
Following a discussion of various non-medical subjects, Mosley
asked the TFO where his pain was, with the TFO responding that it was
in his lower back and right shoulder and that the pain was caused by
playing softball. Id. at 32-33. Mosley proceeded to perform a physical
exam, during which Mosley stated that the TFO's back felt tight. Id. at
33. However, while Mosley had the TFO perform several movements, the
TFO did not express any discomfort with the exception of one exercise
when he said his back was sore. Id. at 33-34. Mosley then had the TFO
sit on the exam table and placed his stethoscope on various portions of
the TFO's back and chest and told the TFO to breath. Id. at 34.
Thereafter, Mosley tapped the TFO's knees and then used a light to look
into the TFO's eyes, mouth and nose. Id. According to the TFO, during
this time, he was turning his upper body, with no discomfort, while he
conversed with Mosley. Id. However, during direct examination, the TFO
testified that he believed that he told Dr. Mosley that he "had some
trouble sleeping." Tr. 454. He also testified that Mosley's exam "was
fairly thorough." Id. at 455.
Mosley returned to his desk and began completing paperwork. RX 4,
at 34. Mosley then advised that he would not write the TFO
prescriptions for 240 oxycodone and 90 alprazolam, which were the
amounts the TFO had reported that he had previously received. Id.
Mosley completed the paperwork, gave the file to the TFO, and told him
to take it to the front desk, which the TFO did. Id. Upon arriving at
the front desk, the receptionist opened the file and gave the TFO two
prescriptions which were signed by Mosley: one for 199 tablets of
oxycodone 30mg, with the notation "PRN pain," and one for 60 tablets
of alprazolam 2mg "PRN anxiety." Id.; see also GX 25.
However, in the medical record for the TFO's initial visit, Dr.
Mosley made no findings in the section for psychiatric history and did
not check the line for anxiety. RX 1, at 5. In the family history
section, which included a prompt for "mental health," Mosley wrote
"none." Id. Moreover, in the diagnosis section of the chart, Mosley
wrote: "mild diffuse bulge + small [supreg] paracentral tear L5-S1
disc," and "diffuse bulge L4-5 disc." \12\ Id. at 8. No diagnosis of
anxiety was listed.
---------------------------------------------------------------------------
\12\ The MRI presented by the TFO had listed as its
"impression," a "[m]ild diffuse bulge and small right paracentral
annular tear of L5-S1 disc, causing mild narrowing of the central
canal and neural foramina, bilaterally," and a [m]ild diffuse bulge
of L4-5 disc, without any significant central canal or neural
foraminal narrowing."
---------------------------------------------------------------------------
On July 20, 2011, the TFO returned to the Bradenton clinic and
signed in. RX 4, at 25. After a short wait, the TFO was called by the
receptionist, who collected the payment for the visit and gave him an
appointment card for his next visit. RX 4, at 26. The receptionist also
gave the TFO forms to complete, including one that asked about his
current medications and pain level. Id. The TFO completed the forms and
returned them to the receptionist. Id.
Thereafter, the TFO was called to a room by a nurse, who took his
weight
[[Page 57142]]
and blood pressure, and confirmed his name. Id. The nurse asked the TFO
what his pain levels were with and without medication on a one to ten
scale; the TFO replied that his pain was six or seven without
medications and three with medications. Id. The nurse also asked the
TFO if he had adverse reactions and if he used tobacco. Id. Upon
completing the TFO's paperwork, the nurse took him to an exam room,
which was across from Dr. Mosley's office, and left the exam room door
open and placed the TFO's file in a tray on the door. Id. at 26-27.
After a patient left Dr. Mosley's office, Mosley told the TFO to
enter his office and bring his file; the TFO did as instructed and gave
his file to Mosley, who was seated at his desk facing a computer. Id.
at 27. Mosley and the TFO had a conversation in which they discussed
the TFO's clothing, beard and tattoos. Id. Mosley asked the TFO a
single question about his medication and did not perform a physical
examination. Id. Mosley then completed the paperwork and handed the
file to the TFO; the TFO took the file to the front desk and handed it
to a clinic employee. Id. The employee opened the file and gave the TFO
two prescriptions; the prescriptions were for 199 tablets of oxycodone
30mg, with the notation "PRN Pain," and 60 tablets of alprazolam 2mg,
with the notation "PRN anxiety." Id.; \13\ GX 25.
---------------------------------------------------------------------------
\13\ While Respondent introduced medical records for the
undercover officers, the record for Mike Corleone does not contain a
progress note for his second visit with Dr. Mosley. See RX 1, at 1-
13. At several points in his recommended decision, including with
respect to this undercover officer, the ALJ expressed that "I have
no confidence, based on the record evidence before me, that the
Government produced all of the relevant portions of the patient
files, particularly given various testimony at hearing that the
Government has not 'had time' to review much of the seized material
since October 28, 2011." ALJ at 84 n.111; see also id. 69 n.95
(noting absence of pharmacy profile in patient record for Anthony
Thompson notwithstanding Agent's testimony that he had provided one
at his initial visit). See also id. at 78 n.104 (reasoning that
"[it] is also worth noting that the Government bears the initial
burden of proof in this matter, yet it is not entirely clear from
any of the testimony whether the undercover patient charts produced
at hearing are complete").
The charts for the four undercover officers, however, were
entered into evidence by Respondent and not the Government.
Moreover, the custodian of records for the QCMG Brandon clinic
testified that she had reviewed Respondent's Exhibit 1
(which comprised the records maintained by the clinic on the four
undercover officers) prior to the day of her testimony, and when
asked whether the records were "a fair and accurate representation
of the medical charts," answered "yes." Tr. 893-94; see also id.
at 887. Indeed, Respondent has not contended that any of the charts
pertaining to the undercover officers were incomplete.
Nor does the testimony cited by the ALJs support his implication
that the Government failed to turn over relevant evidence. While it
is true that the TFO testified on the first day of the hearing, that
she had not time to review the paper copy all of the records, she
also testified that "we don't have any of the UC files yet"
because "[t]hey're all electronic." Tr. 140. The TFO was
subsequently recalled to testify on the issue of when certain
records were provided to the Government's Expert and testified that
the Government had not obtained the electronic medical records until
some point during or after February 2012, when it issued a subpoena
to the entity which managed the EMR system. Id. at 1003. Moreover,
both of Respondent's employees testified that various documents
including patient IDs, MRIs, patient consents, and urinalysis
results were scanned into the EMR, and that the clinic was not
"keeping papers anymore." Tr. 891, 908, & 952. To the extent there
were any missing documents (such as a pharmacy profile for Anthony
Thompson or a progress note for Mike Corleone's second visit with
Dr. Mosley, assuming Mosley even prepared one), given that the
clinic was using the EMR system and did not have hard copies of the
files for the four UCs, it is unclear why the electronic files did
not contain this information. What is clear, however, is that the
ALJ's implication is nothing more than speculation.
In any event, for reasons explained in the discussion of the
legality of the prescriptions issued to Bobby Payne, the existence
of a pharmacy profile showing that a patient had obtained controlled
substance from other physicians is not exculpatory evidence. As for
the absence of a progress note for Mike Corleone's second visit with
Dr. Mosley, there is no evidence that Mosley ever created one.
---------------------------------------------------------------------------
On August 25, 2011, the TFO went to the Brandon clinic and saw
Respondent. Tr. 464. The TFO signed in, and after a short wait, was
called by the receptionist who asked for his driver's license and
current address, and collected payment for the visit; the receptionist
then provided the TFO with an appointment card for a visit of September
22, 2011. RX 4, at 39. The TFO then took a seat in the waiting room.
Id.
Thereafter, the TFO was called by a male nurse to an exam room
where he had his vital signs taken. Id. The nurse then told the TFO to
return to the waiting room. Id. A short while later, the nurse took the
TFO to another exam room and placed his file in a tray near the door.
Id.
Respondent removed the TFO's file, entered the room, and introduced
himself. Id., GX 27, at 1. Respondent and the TFO discussed the reason
why he had come to the Brandon clinic ("I don't know if it was just
they couldn't get me in" and "[m]aybe, I told them I was thinking
about moving up here"), how many times the TFO had seen Dr. Mosley
("twice"), whether the TFO lived in Orlando ("that's an old
address") and where he now lived ("Bradenton"), and his employment
status ("I don't work right now"), and what he formerly did for
employment ("a lot of warehouse stuff" and "some heavy lifting").
GX 27, at 1-2.
Next, Respondent asked the TFO if he had insurance; the TFO said
"No." Id. at 2. Respondent remarked, "[o]k, so, you're getting two
hundred of these pills, that's probably about four hundred fifty
dollars. How are you affording all these meds?" Id. The TFO answered
that he "had some money saved up from before," and Respondent said
"ok." Id. Respondent and the TFO then discussed the problem of people
not showing for their appointments and the clinic's policy for no
shows. Id. at 2-3.
Respondent then discussed the TFO's MRI, stating:
Alright, so I reviewed your MRI. I mean, it's, you got a few
things here and there, but not a ton. You know, my honest opinion,
I'm a straight shooter, I don't BS anybody. Uh, my honest opinion is
that you're a little bit over-medicated. But I'm going to leave you
on what you've been on.
Id. at 4. The TFO replied "ok, thanks," and Respondent added:
"we'll, you know if it comes down to it later, down the road that we
need to bring you down a bit, we'll do it. But (at which point the TFO
interjected with "ok") I don't think we'll need to. The only reason
why we would need to is because if the government makes me." Id.
The TFO replied, "ok, gotcha, gotcha," Respondent stated "So,
um," and the TFO stated: "Yeah, you guys get people in and out quick
here. It's nice." Id. Respondent said "yeah" and that "we try not
to play around," and after the TFO said, "Yeah," Respondent asked
the TFO if he "ha[d] any questions for me?" Id. The TFO answered
"nope."
Respondent then asked to feel the TFO's "low back"; the TFO stood
up, and Respondent pressed against the TFO's lower back in several
locations, asking if it was painful. Id.; RX 4, at 39-40. The TFO
replied, "Yeah. It's a little sore," and then agreed with Respondent
that it was "more on the right." GX 27, at 4.
The TFO was instructed to sit in a chair, and raise each leg
separately and then simultaneously. Id. Respondent then asked, "How's
your range of motion, pretty good?" Id. The TFO replied "yeah, it
gets better when it loosens up throughout the day. Like in the
mornings, the mornings always rough." Id. Respondent said "[r]ight,"
and the TFO added: "And if I sit down for a long time, it hurts." Id.
Respondent stated: "Alright. You're all set," the TFO expressed his
thanks, and Respondent took the TFO and the file to a reception area.
Id. at 5. See also Tr. 469 (When asked to describe how brief
Respondent's physical examination was, TFO testified: "He pressed on
my lower back and had me raise both of my legs, and that was it.").
[[Page 57143]]
Respondent then gave the TFO prescriptions for 210 tablets of
oxycodone 30mg and 60 tablets of alprazolam 2mg. RX 4, at 40; GX 28. On
the oxycodone prescription, Respondent listed his diagnosis as
"[l]umbar lumbosacral disc degeneration" and "[l]umbar disc
displacement." GX 28. On the Xanax prescription, Respondent listed his
diagnosis as "generalized anxiety disorder." Id.
With respect to his visit to the Brandon clinic, the TFO testified
that he was not required to complete any paperwork. Tr. 464. In
addition, with respect to the intake process at the Brandon clinic, the
TFO testified that "I met with the nurse and he took some information,
as far as blood pressure and weight and that was really it. He also
made some reference to my name," this being the same as that of one of
the leading characters in the movie, "The Godfather." Id. at 465.
Based on the TFO's testimony and the report he filed for the visit, I
conclude that the nurse did not ask the TFO any questions regarding his
pain. Id.; see also RX 4, at 39.
In the medical record documenting this visit, Respondent noted that
there was "[n]o change" in the status of the TFO's pain, that the
severity was "4 on pain scale," that the pain radiated into his
"shoulder blades and right arm," that the "trend" was "tolerable"
and that the pain affected his "sleep and physical activity." RX 1,
at 9. Yet there is no evidence that any of these issues were raised by
the Nurse or Respondent with the TFO.
Also, in the psychiatric portion of the review of systems, the
record states: "Patient denies problems with mood disturbance. No
problems with anxiety." Id. Likewise, in the psychiatric portion of
the physical examination findings, the record states: "Oriented with
normal memory. Mental status, judgment and affect are grossly intact
and normal for age." Id. at 10.
Likewise, under the neurologic findings, Respondent noted that the
TFO had "[n]ormal and symmetrical deep tendon reflexes with no
pathological reflexes." RX 1, at 10. Yet, the TFO testified that
Respondent did not check his reflexes. Tr. 474. Moreover, for his range
of motion findings with respect to the TFO's lumbar spine, Respondent
noted that the he had "[f]ull active ROM with rotation, [f]ull active
ROM with bending, [f]ull active ROM with flexion and Full active ROM
with extension." RX 1, at 11. Yet, the TFO testified that Respondent
did not ask him to do any range of motion exercise "other than just
lifting up the legs." Tr. 474.
Respondent's Evidence
In addition to the testimony of Mr. Gomez, which was discussed
above, Respondent elicited testimony from Stephanie Baez, who was an
employee of the QCMG Brandon clinic from January 2011 until the end of
October 2011.\14\ Tr. 886-87. Ms. Baez testified that she was the
clinic's custodian of records and handled "all of the intake" of
patients. Id. at 887. She testified that as part of the intake process,
she would collect a patient's photo ID, MRI, and pharmacy history, and
that she would call the company that did the MRI and verify the
patient's name, birth date, date of the MRI and the MRI's impressions.
Id. at 888.
---------------------------------------------------------------------------
\14\ Respondent also called TFO Wendy Zarvis, who was involved
in sending materials to the Expert for his review. Tr. 1013.
Respondent called the Agent to impeach the testimony of the Expert
regarding whether he had been provided certain documents at the time
he produced his report, as well as to show what documents he had
been provided and when he received them. Id. at 1017-18. Because for
reasons explained later in this decision, the Expert's testimony is
not necessary to decide this matter, I conclude that there is no
need to make any findings regarding when she sent various documents
to him.
---------------------------------------------------------------------------
Ms. Baez also testified that if a patient transferred from the
Bradenton to Brandon clinic, his records would be transferred and that
if any form was missing, the patient would have to complete the form
again. Id. at 890-91. Ms. Baez also testified that the clinic required
the patients to complete an authorization for release of their medical
information from previous providers. Id. 899-900. While there are such
releases in the patient files of Mike Corleone and Eric McMillan, both
of whom completed these forms during the initial visits to the
Bradenton clinic, but neither of which was filled out by listing their
previous doctors, see RX 1, at 2 & 53, there are no such forms in the
patient files of Anthony Thompson and Bobby Payne, both of whom
initially presented at the Brandon clinic. See generally RX 1.
Moreover, none of the four undercover patient files contain any medical
records from prior physicians or clinics, even though they presented
that they had been treated by other physicians, or notes indicating
that the clinic attempted to obtain such records but could not do so.
Id. Also, when questioned on cross-examination as to whether Respondent
had attempted to verify whether several of the undercovers had been
treated by another doctor, Ms. Baez testified that she did not know.
Tr. 912 (testimony regarding whether Respondent verified that patient
Corleone was treated by Coast to Coast clinic with either Dr. Mosley or
Coast to Coast), id. at 925 (testimony regarding whether Respondent
verified that patient McMillan was treated by Dr. Foster).
Respondent was called to testify by the Government. However, he
invoked his Fifth Amendment privilege and declined to answer any
questions. Tr. 37-38. Nor, even after the Government presented its case
in chief, did Respondent testify regarding any of the allegations.
Discussion
Before proceeding to analyze the evidence under the public interest
factors, a review of the ALJ's discussion of the Agency's obligation to
disclose what he deemed to be exculpatory evidence is warranted.
Therein, the ALJ noted that the Government had resisted turning over
investigative reports prepared by the undercover officers (which were
relied upon by the Government's Expert) until after Respondent's
counsel had completed the first day of his cross-examination of the
Government's Expert. ALJ at 10. However, the Government did eventually
turn over the investigative reports and Respondent was able to cross-
examine the Expert with them. Notwithstanding his conclusion "that
denial of Respondent's motions for discovery were [sic] consistent with
applicable legal precedent, and supported by other procedural
deficiencies in Respondent's pleadings," and that, in fact, his
discussion was entirely gratuitous because the Government did turn over
the reports and Respondent raised no claim of prejudice in his post-
hearing brief, the ALJ found "that [the] existing Agency holdings and
practice with regard to exculpatory evidence warrants further
discussion." Id.
While noting that "the term 'exculpatory' should be carefully
defined in the context of an administrative proceeding,"--an
admonition which, as explained below, the ALJ promptly proceeded to
ignore--the ALJ reasoned that "other Agencies have found it
appropriate to establish by regulation a practice of reviewing and
disclosing exculpatory evidence to litigants during administrative
hearings, while recognizing such disclosure is not constitutionally
mandated." Id. at 12. After noting that three federal agencies have
provided for disclosure of exculpatory evidence in administrative
proceedings,\15\ the ALJ opined that "[a]
[[Page 57144]]
disclosure practice that emphasizes only what is alleged in the [Order
to Show Cause], along with only that evidence the Government chooses to
disclose in its pre-hearing statement, supplements thereto, and related
documentary evidence, by definition de-emphasizes any investigative
interest in considering evidence favorable to a Respondent, which, by
extension, permeates the entire record" and that "[s]uch a systemic
practice may also contravene clear guidance from federal appellate
courts." Id. at 13 (emphasis added).
---------------------------------------------------------------------------
\15\ Most federal agencies do not, however, provide for the
disclosure of exculpatory evidence in administrative proceedings,
and several federal appeals courts have held that Brady v. Maryland,
373 U.S. 83 (1963), does not apply in this type of proceeding. See
Mister Discount Stockbrokers, Inc. v. SEC, 768 F.2d 875, 878 (7th
Cir. 1985); NLRB v. Nueva Eng. Inc., 761 F.2d 961, 969 (4th Cir.
1985). Cf. Echostar Comm. Corp. v. FCC, 292 F.3d 749, 755-56 (D.C.
Cir. 2002) (rejecting litigant's claim that "the Agency's decision
to deny it discovery * * * denied it due process"); Silverman v.
CFTC, 549 F.2d 28, 33 (7th Cir. 1977) ("There is no basic
constitutional right to pretrial discovery in administrative
proceedings.") (citations omitted).
---------------------------------------------------------------------------
The ALJ then quoted from the unpublished decision of the Eleventh
Circuit in Jayam Krishna-Iyer, which vacated an agency order for
failing "to consider [Dr. Krishna-Iyer's] experience with twelve
patients whose medical charts were seized by the DEA * * * [or]
consider any of Petitioner's positive experience in dispensing
controlled substances." Id. at 13-14 (quoting Krishna-Iyer v. DEA, 249
Fed. Appx. 159, 160 (11th Cir. 2007)). Notwithstanding that under the
Eleventh Circuit's rules an unpublished opinion is not "binding
precedent," 11th Cir. R. 36-2, the ALJ then asserted that the "impact
of this [decision] as precedential authority in DEA decision-making, to
include the interpretation of 'positive experience,' apparently remains
a matter of some confusion." ALJ at 14. The confusion, however, rests
entirely with the ALJ, who ignored both the Agency's subsequent
decision on remand in Krishna-Iyer, which addressed the role of
"positive experience" evidence in cases where the Government has
proved intentional or knowing diversion, subsequent Agency cases
applying this rule, and several court of appeals' decisions (including
that of the Eleventh Circuit), which have since upheld the Agency's
position.
On remand in Krishna-Iyer, I assumed that the respondent's
prescribing to not only the twelve patients whose files were seized,
but also to the thousands of other patients (other than the undercover
operatives to whom she had unlawfully distributed controlled
substances) constituted evidence of dispensing controlled substances in
circumstances which did not constitute diversion. However, as I
explained, Dr. Krishna-Iyer's "prescribings to thousands of other
patients do not * * * render her prescribings to the undercover
officers any less unlawful, or any less acts which are 'inconsistent
with the public interest.'" Jayam Krishna-Iyer, 74 FR 459, 463 (2009).
As I further explained:
under the CSA, a practitioner is not entitled to a registration
unless she "is authorized to dispense * * * controlled substances
under the laws of the States in which [she] 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 her
professional career. Thus, 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. (citing Paul J. Caragine, Jr., 63 FR 51592, 51600 (1998) (noting
that "even 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"));
Medicine Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (2008) (even though
pharmacy "had 17,000 patients," "[n]o amount of legitimate
dispensings" could render the pharmacy's "flagrant violations [acts
which are] 'consistent with the public interest'"), aff'd, Medicine
Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008).
Accordingly, in Krishna-Iyer, I held that "evidence that a
practitioner has treated thousands of patients [without violating the
CSA] does not negate a prima facie showing that a practitioner has
committed acts inconsistent with the public interest." 74 FR at 463. I
further explained that "[w]hile such evidence may be of some 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." Id.
Subsequent to Krishna-Iyer, I adhered to this rule in Dewey C.
MacKay, 75 FR 49956 (2010), pet. for rev. denied, MacKay v. DEA, 664
F.3d 808 (10th Cir. 2011). To be clear, the ALJ entirely ignored both
the decision of the Agency as well as that of the Tenth Circuit in
MacKay.
In MacKay, I held that, based on the substantial evidence that the
physician had knowingly diverted controlled substances to two patients
who acted in an undercover capacity, the Government had satisfied its
prima facie burden of showing that Respondent had committed acts which
rendered his registration inconsistent with the public interest. 75 FR
at 49977. Relying on the Agency's decision on remand in Krishna-Iyer, I
rejected the physician's contention that "[a] better assessment of
[his] medical practice and habits can be ascertained from [his]
numerous positive experiences in prescribing controlled substances,
some of which were recounted by the patients themselves * * * at the
hearing." Id. (quoting Resp. Br. at 3). I therefore held that "even
assuming, without deciding, that Respondent's prescribing practices to
all of his other patients (including those whose medical records were
reviewed by the Government's Expert but who did not perform undercover
visits \16\) fully complied with the CSA and Utah law, these
prescribings do not refute the evidence showing that he intentionally
diverted to [the two undercovers] in violation of both the CSA and Utah
law." 75 FR at 49977. Noting that Dr. MacKay had failed to testify and
offer evidence that he recognized the extent of his misconduct and was
prepared to remedy his prescribing, I revoked his registration.
---------------------------------------------------------------------------
\16\ In light of the evidence provided by the undercover visits
of the two patients, I found it unnecessary to make any findings
based on the Expert's chart review. 75 FR at 49972.
---------------------------------------------------------------------------
The Tenth Circuit denied MacKay's petition for review. MacKay v.
DEA, 664 F.3d 808 (10th Cir. 2011). Of relevance here, the Tenth
Circuit specifically addressed and rejected MacKay's argument that the
Agency had failed to consider his "positive experience" in dispensing
controlled substances. As the Court of Appeals explained:
Despite Dr. MacKay's claim to the contrary, the Deputy
Administrator considered the entire record, including the evidence
in Dr. MacKay's favor. She determined, however, that none of Dr.
MacKay's evidence negated the DEA prima facie showing that Dr.
MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she
found that even if Dr. MacKay had provided proper medical care to
all of his other patients, that fact would not overcome the
government's evidence with regard to M.R. and K.D.
None of the evidence presented by Dr. MacKay undermines the
evidence relating to M.R. and K.D. Although numerous patients and
colleagues of Dr. MacKay related their positive experiences with
him, none had any personal knowledge regarding his treatment of M.R.
and K.R. Notably, Dr. MacKay's medical expert, Dr. Fine, failed to
specifically discuss and justify Dr. MacKay's treatment of M.R. and
K.D. As a result, none of Dr. MacKay's evidence contradicts the
testimony and evidence presented by the DEA relating
[[Page 57145]]
to the knowing diversion of drugs to these two patients.
664 F.3d at 819.
The Court of Appeals thus concluded that "[a]lthough Dr. MacKay
may have engaged in the legitimate practice of pain medicine for many
of his patients, the conduct found by the Deputy Administrator with
respect to K.D. and M.R. is sufficient to support her determination
that his continued registration is inconsistent with the public
interest." Id. Given that the Court of Appeals' decision in MacKay was
circulated to the Office of Administrative Law Judges, and in any
event, had been issued nearly five months prior to the ALJ's issuance
of his recommended decision in this matter, it is inexplicable that the
ALJ entirely ignored it.
More recently, I revoked the registration of a Florida-based
physician for violations of the CSA's prescription requirement. See
Ronald Lynch, M.D., 75 FR 78745, 78750-54 (2010). The physician then
filed a petition for review in the Eleventh Circuit. Before the court
of appeals, the physician argued that the Agency's order was arbitrary
and capricious because "it limited its consideration of [his]
experience to only ten prescriptions issued to out of state patients,
the two undercover patients, and the use of a rubber stamp on nine
prescriptions." Brief of Petitioner at 31, Lynch v. DEA, 2012 WL
1850092 (11th Cir. 2012) (No. 11-10207-EE). The physician further
argued that the Agency had failed to "consider the evidence that he
had been dispensing controlled substances for over twenty years," that
"[e]ven with respect to the undercover patients, the DEA Order did not
consider the fact that the two undercover patients did not get the
medication they requested or that the consultation [between the
physician and the patients] was thoughtful and thorough," and that the
Order "ignore[d] the fact that one of the undercover patients asked
[him] for stronger schedule II drugs" and that he declined the
request. Id. The physician thus contended that the Agency's order was
arbitrary and capricious because it "fail[ed] to consider any of [his]
positive experiences with dispensing controlled substances." Id. at 32
(citing Krishna-Iyer, 249 Fed. Appx. at 160).
In an unpublished decision, the Eleventh Circuit denied Lynch's
petition for review. See 2012 WL 1850092, *2. The Court of Appeals
noted that "[a]fter reviewing the record, reading the parties' briefs
and having the benefit of oral argument," it had concluded that the
Agency's order was supported by substantial evidence and that the
revocation of Lynch's registration "was not arbitrary, capricious, an
abuse of discretion, or contrary to law." Id. Significantly, the Court
of Appeals did not deem Lynch's argument that the Agency had failed to
consider his positive experience to warrant any discussion.
Ignoring both MacKay and Lynch, the ALJ opined "that the evidence
of record in this case is fully consistent with an administrative
practice that only focused on evidence in support of revocation to the
virtual exclusion of any 'positive experience' by Respondent,
particularly relating to his prescribing practices and other conduct
that may have evidenced compliance with applicable law and
regulations." ALJ at 15. The ALJ then explained that:
For purposes of this Recommended Decision, I have interpreted
'positive experience' in a common sense fashion, which appears to me
to have been the intent of the Eleventh Circuit Court of Appeals in
2007 given their decision not to define it further. In other words,
if there is investigative evidence that refutes the allegations in
the [Order to Show Cause] or materially supports a finding that
Respondent's prescribing practices are consistent with the public
interest, such as that found in patient files, it must be made
available to a respondent, and if found to be 'competent, relevant,
material, and not unduly repetitious,' must be considered in any
Agency decision.
Id. at n.16.
As support for his contention that the Agency's investigation had
failed to consider evidence of Respondent's positive experience, the
ALJ cited a TFO's purported testimony that although she was aware that
Respondent had stated to an undercover officer that he "had previously
reported misconduct by a clinic employee to DEA," the TFO "testified
that she did not view such information as 'important' to the
investigation and had not followed up on" it. Id. (quoting Tr. 120-
21). The ALJ then asserted that "[t]he significance and relevance of
such positive conduct by Respondent, if confirmed to be true, could
demonstrate Respondent's compliance with various applicable DEA
regulations, and materially refute to a degree the allegation in the
[Order to Show Cause] that Respondent's conduct was contrary to the
public interest." Id. (citing 21 CFR 1301.76, which requires a
registrant to report the theft or loss of controlled substances; 21 CFR
1301.91, stating Agency's position that the employee of a registrant
has an obligation to report diversion by another employee; and 21 CFR
1301.92, stating Agency's position that where an employee engages in
unlawful activities with controlled substances, employer should
immediately assess the need for disciplinary actions).
However, the Government did not allege that Respondent had failed
to comply with any of the regulations cited by the ALJ. See ALJ Ex. 1,
at 2-3 (Order to Show Cause); ALJ Ex. 5 (Gov. Pre-Hearing Statement).
Rather, the Government's case was based entirely on the allegations
that Respondent violated the CSA by "issuing prescriptions to
undercover law enforcement officers for other than a legitimate medical
purpose or outside the usual course of professional practice." Order
to Show Cause (ALJ Ex. 1), at 2.\17\
---------------------------------------------------------------------------
\17\ Even if such conduct was relevant, Respondent's statement
is hearsay, which was uncorroborated by any other evidence, and
because he invoked his Fifth Amendment privilege, could not be
tested by examining him. See J.A.M. Builders, Inc., v. Herman, 233
F.3d 1350 (11th Cir. 2000).
It is further noted that during the colloquy cited by the ALJ,
the TFO was not questioned as to whether she found it significant
that Respondent had stated to one of the undercovers that he had
reported a clinic employee to the Agency. See Tr. 120-21. Rather,
the question asked if she found it significant that Respondent had
said to an undercover "that he was cleaning up the clinic and had
made reports of patients to the DEA." Id. at 120. In response, the
TFO stated that she did not consider it significant "because it was
just constantly mentioned and it just doesn't seem the norm for a
doctor to talk about DEA and law enforcement, during a patient
visit, unless that's something that's a constant problem with a
medical office." Tr. 120. This is just one of many instances in
which the ALJ misstated the evidence.
---------------------------------------------------------------------------
As set forth in countless cases brought under sections 303 and 304
of the CSA, violations of the prescription requirement strike at the
core of the Act's purpose of preventing the diversion of controlled
substances. See United States v. Moore, 423 U.S. 122, 135 (1975)
("Congress was particularly concerned with the diversion of drugs from
legitimate channels to illegitimate channels. It was aware that
registrants, who have the greatest access to controlled substances and
therefore the greatest opportunity for diversion, were responsible for
a large part of the illegal drug traffic.") (citations omitted).
Accordingly, the Agency has held that proof of a single act of
intentional or knowing diversion is sufficient to satisfy the
Government's prima facie burden of showing that a practitioner's
continued registration is inconsistent with the public interest, and if
unrebutted by a showing that the practitioner accepts responsibility
for his misconduct and will not engage in future misconduct, warrants
the revocation of a registration. See MacKay, 75 FR at 49977; see also
[[Page 57146]]
Alan H. Olefsky, 57 FR 928, 928-29 (1992) (revoking registration based
on physician's presentation of two fraudulent prescriptions to
pharmacist in single act where physician failed to acknowledge his
misconduct). Contrary to the ALJ's understanding, whether Respondent
complied with other provisions of the Agency's regulations does not
"materially refute" to any degree whether he violated the CSA's
prescription requirement.
The ALJ further faulted the Government for not having reviewed the
patient charts, other than those for the four undercover officers,
which had been seized pursuant to the search warrants which were
executed at the Brandon and Bradenton locations. ALJ at 15-16. Noting
the testimony of a TFO that she had reviewed only a part of those
records, as well as the Expert's testimony that while he had received
an additional fifteen patient charts approximately one week before the
hearing but had not had time to review them, the ALJ reasoned that
"[t]he lack of investigative effort or 'time' to develop any evidence
that might enlighten the administrative record of positive prescribing
practices by Respondent, or permit access to such information by
Respondent or the fact-finder, underscores the due process limitations
of DEA's existing 'discovery' practice." Id. at 15-16.
Contrary to the ALJ's ludicrous suggestion, the Government was not
required to go through all of Respondent's patient charts looking for
evidence of his so-called "positive prescribing practices" and
"develop evidence to enlighten the administrative record." See
MacKay, 664 F.3d at 819. Having garnered evidence of what it believed
to be unlawful prescriptions issued to the four undercover officers,
the Government was entitled to go to hearing with that evidence.
Whether the Government's evidence was sufficiently "reliable,
probative, and substantial" to satisfy its burden of proof--after
considering relevant and material evidence which might refute the
allegations--is one thing. But as the Tenth Circuit recognized in
MacKay, even if Respondent prescribed controlled substances to numerous
other persons in circumstances which did not involve diversion, such
evidence is not material to the allegations that he unlawfully
prescribed to any of the four undercover officers and thus is not
exculpatory.
In short, the ALJ did not identify any undisclosed material
evidence that would tend to exculpate Respondent from the allegations
that, in prescribing to the undercover officers, he lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice. Indeed, no such claim is even raised by Respondent in his
brief. And given that the Government fully disclosed the evidence it
intended to rely on in proving the allegations, and Respondent has
raised no contention that it was prejudiced by the lateness of the
disclosure, the Government has satisfied due process. See Goldberg v.
Kelly, 397 U.S. 254, 270 (1970) ("where governmental action seriously
injures an individual, and the reasonableness of the action depends on
fact findings, the evidence used to prove the Government's case must be
disclosed to the individual so that he has an opportunity to show that
it is untrue"); see also Bowman Transp., Inc., v. Arkansas-Best
Freight System, Inc., 419 U.S. 281, 288 n.4 (1974) ("A party is
entitled * * * to know the issues on which [the] decision will turn and
to be apprised of the factual material on which the agency relies for
decision so that he may rebut it.").\18\ Indeed, given that the
Agency's procedures comply with the Supreme Court's (and various court
of appeals') teachings as to the scope of due process, it is absurd to
suggest, as the ALJ did, that the procedures are "fundamentally at
odds with basic concepts of fairness." ALJ at 17.
---------------------------------------------------------------------------
\18\ In any event, DEA precedent has already made clear that
where an expert relies on data or documents in forming his opinions,
the failure of the sponsoring party to produce the data or documents
denies the other party a meaningful opportunity to cross-examine the
expert and show that his opinions are unfounded, and that where
challenged by the other party, this also "precludes a finding that
the expert's conclusions are supported by substantial and reliable
evidence." See CBS Wholesale Distributors, 74 FR 36746, 36749
(2009); see also Bowman, 419 U.S. at 288 n.4 ("[T]he Due Process
Clause forbids an agency to use evidence in a way that forecloses an
opportunity to offer a contrary presentation."). In short, if the
Government fails to disclose underlying data or documents that its
expert relied, it runs the very substantial risk that the expert's
conclusions will be rejected. It is, however, for the Government to
assess this risk.
---------------------------------------------------------------------------
In short, neither the Supreme Court, nor any federal appeals
court--who, unlike the ALJ, are the ultimate arbiters of whether an
Agency's procedures satisfy the fundamental fairness that the Due
Process Clause requires--has ever held that the Clause imposes on any
federal agency the far-reaching obligation proposed by the ALJ. I thus
reject it.
The Public Interest Factors
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to "dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section." 21 U.S.C. 824(a)(4)
(emphasis added). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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.
Id. 823(f).
"[T]hese factors are * * * considered in the disjunctive." Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I
"may rely on any one or a combination of factors, and may give each
factor the weight [I] deem[] appropriate in determining whether a
registration should be revoked." Id.; see also MacKay, 664 F.3d at
816; Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA,
419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to
consider each of the factors, I "need not make explicit findings as to
each one." MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222
(quoting Hoxie, 419 F.3d at 482)).\19\
---------------------------------------------------------------------------
\19\ In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly,
as the Tenth Circuit has recognized, findings under a single factor
can support the revocation of a registration. MacKay, 664 F.3d at
821.
---------------------------------------------------------------------------
The Government has the burden of proving, by a preponderance of the
evidence, that the requirements for revocation or suspension pursuant
to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, "once the
[G]overnment establishes a prima facie case showing a practitioner has
committed acts which render his registration inconsistent with the
public interest, the burden shifts to the practitioner to show why his
continued registration would be consistent with the public interest.
MacKay, 664 F.3d at 817 (citing Medicine Shopper-
[[Page 57147]]
Jonesborough, 73 FR 364, 387 (2008) (citing cases)).
In this matter, while I adopt the ALJ's findings of fact and legal
conclusions that neither factor one (the recommendation of the state
licensing board), nor factor three (Respondent's conviction record
under laws related to the manufacture, distribution or dispensing of
controlled substances), supports the revocation of Respondent's
registration, it has long been settled that neither factor is
dispositive. See MacKay, 664 F.3d at 817; see also Krishna-Iyer, 74 FR
at 461; Edmund Chein, 72 FR 6580, 6593 n.22 (2007), pet. for rev.
denied 533 F.3d 828 (DC Cir. 2008); Mortimer B. Levin, 55 FR 8209, 8210
(1990). Rather, the primary focus of this proceeding is whether, as
alleged by the Government, Respondent violated the CSA's prescription
requirement, 21 CFR 1306.04(a), when he prescribed to the undercover
officers. Whether this conduct is considered under factor two--
Respondent's Experience in Dispensing Controlled Substances--or factor
four--Respondent's Compliance with Applicable Laws Related to
Controlled Substances, or both factors, is of no legal consequence,
because, if proven, the conduct would be sufficient to support a
finding that Respondent "has committed such acts as would render his
registration * * * inconsistent with the public interest." 21 U.S.C.
824(a)(4). See Krishna-Iyer, 74 FR at 462. Accordingly, I turn to
whether the record as a whole supports the allegations.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
Under a longstanding DEA regulation, a prescription for a
controlled substance is not "effective" unless it 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). Under
the CSA, it is fundamental that a practitioner must establish a
bonafide doctor-patient relationship in order to act "in the usual
course of * * * professional practice" and to issue a prescription for
a "legitimate medical purpose." See United States v. Moore, 423 U.S.
122, 142-43 (1975); United States v. Lovern, 590 F.3d 1095, 1100-01
(10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir.
2009); see also 21 CFR 1306.04(a) ("an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances").
As the Supreme Court recently explained, "the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses." Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing Moore, 423 U.S. 122, 135, 143 (1975)).
The ALJ rejected each of the Government's allegations, explaining
that he did "not find Respondent's prescribing practices with regard
to the undercover patient visits to be remotely close to 'outright drug
deals.'" ALJ at 50 (quoting Cynthia M. Cadet, 76 FR 19450, 19450 n.3
(2011)). The ALJ also reasoned that "the undercover patient visits
objectively reflect that Respondent's prescribing practices included,
to a degree, a documented medical history, physical examination,
documented urinalysis testing, medical record release forms, and
pharmacy prescribing profiles, among other information, consistent with
applicable Florida law." Id. (citations omitted). The ALJ thus
reasoned that "any finding that Respondent's prescribing conduct in
this case was not for a legitimate medical purpose and outside the
usual course of professional practice * * * will significantly depend
on the evidentiary weight to be given to the opinion testimony of the
Government's sole expert witness," whom the ALJ did not find credible.
Id.
However, with respect to the first undercover visit of Bobby Payne,
the ALJ's conclusion that the evidence does not establish that
Respondent's prescribing practices with respect to the undercover
officers were "remotely close to 'outright drug deals,'" ignores
nearly all of the evidence of the actual conversation which occurred
between Payne and Respondent. See ALJ at 61-67. Nor, contrary to the
ALJ's understanding, does the Agency's decision in Cadet stand for the
proposition that the only circumstance in which expert testimony is not
required to prove violations by a physician of 21 CFR 1306.04(a) is
where a physician manifests his knowledge that he is engaging in an
outright drug deal. Rather, as Cadet makes clear it, it simply cited a
single example of where expert testimony is not required to prove a
violation of 21 CFR 1306.04(a).
Indeed, the ALJ ignored numerous decisions of both federal and
state courts in criminal cases (which require proof beyond a reasonable
doubt rather than simply a preponderance of the evidence) which have
found violations of 21 CFR 1306.04(a) or 21 U.S.C. 841, or similar
state laws, without requiring expert testimony. See United States v.
Pellman, 668 F.3d 918, 924 (7th Cir. 2012) (quoting United States v.
Armstrong, 550 F.3d 382, 388-89 (5th Cir. 2008) ("While expert
testimony may be both permissible and useful, a jury can reasonably
find that a doctor prescribed controlled substances not in the usual
course of professional practice or for other than a legitimate medical
purpose from adequate lay witness evidence surrounding the facts and
circumstances of the prescriptions.")); Armstrong, 550 F.3d at 389
("Jurors have had a wide variety of their own experiences in doctors'
care over their lives, thus and expert testimony is not necessarily
required for jurors to rationally conclude that seeing patients for as
little as two or three minutes before prescribing powerful narcotics is
not in the usual course of professional conduct."). See also United
States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v.
Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479
F.2d 484, 488-89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215
(La. 1981).
The ALJ also ignored several decisions of this Agency which have
found violations of the prescription requirement notwithstanding the
absence of expert testimony. See Morris W. Cochran, 77 FR 17505, 17519-
20 (2011) (holding, without expert testimony, that prescriptions lacked
a legitimate medical purpose where physician noted in patient medical
records that patients had no pain, did not document any findings to
support a diagnosis, and yet diagnosed patients as having chronic
pain); Robert F. Hunt, 75 FR 49995, 50003 (2010) (holding, without
expert testimony, that physician lacked a legitimate medical purpose
based on statements made during undercover visits and falsification of
chart). See also Jack A. Danton, 76 FR 60900, 60904 (2011).
Thus, while it true that "where a physician ma[kes] some attempt
to comply with various state medical practice standards and the
adequacy of those efforts is at issue," expert testimony is typically
necessary to establish that a physician violated 21 CFR 1306.04(a), see
id. & n.13, the facts and circumstances surrounding the issuance of the
prescription may nonetheless establish a violation even
[[Page 57148]]
without expert testimony. Here, while the ALJ noted that Respondent's
prescribing practices included "a medical history, a physical
examination, documented urinalysis testing, medical record release
forms, and pharmacy prescribing profiles," ALJ at 50, a fact-finder
can nonetheless consider the totality of the facts and circumstances of
the visit and conclude that a registrant did not prescribe in the
course of legitimate medical treatment but rather was creating a sham
justification to support an unlawful prescription.
The Prescriptions for Bobby Payne
As found above, at Payne's first visit (July 28, 2011), he
presented a prescription profile showing that he had filled
prescriptions for 210 tablets of oxycodone 30mg, 90 tablets of
oxycodone 15mg, and 90 tablets of alprazolam 2mg, on a monthly basis
from December 10, 2010, but had last filled the prescriptions on April
10, 2011, more than three and a half months before his visit. Moreover,
Respondent's assistant falsified Payne's urine drug screen to show that
he was positive for oxycodone. While the ALJ observed that there was no
evidence to show that "Respondent had any knowledge of the false
entry," ALJ at 63, Respondent, notwithstanding the lengthy gap since
Payne had last filled prescriptions for oxycodone, did not question him
about why he had tested positive for the drug.
Indeed, the evidence is clear and convincing that Respondent knew
that Payne was not seeking treatment for a legitimate medical condition
but was either engaged in self-abuse or diversion. Notably, without
even discussing whether Payne had any symptoms or his pain levels,
Respondent noted that Payne's MRI showed two mild disc bulges, that the
reason Payne's prior clinic was out of business was because they were
"prescribing inappropriately," and that based on the MRI and without
even doing a physical exam, he could not give Payne "near the pills
that you were getting. Not even remotely close."
Moreover, even after Payne said that the amounts of his previous
prescriptions were "just what they prescribed, and "that's not what I
actually took," thus suggesting that he diverted some of his
prescriptions to others, Respondent did not question him regarding what
he did with the drugs he did not take. Thereafter, Respondent put to
rest any doubt as to whether he knew Payne was not a legitimate
patient, stating that Payne's MRI did not show any "pushing on any
nerve roots or anything like that" and was "as close to a normal MRI
as you can get without it being actually normal," and adding: "I mean
the most I can do for you would * * * And I'm telling you this in case
you don't want to come here. Okay? Cause I hate for you to spend all of
your money, coming here and not get what you need."
This was followed by Respondent telling Payne that what he needed
and what he should get "sometimes is two different things," because
if "you've been on a certain number of pills, for a long time, if you
don't get those number of pills, you're going to be sick." Respondent
then stated that "just by looking at this [the MRI] without even doing
the physical exam," he was looking at prescribing "maybe a hundred
and fifty," the amount of oxycodone 30mg which he subsequently
prescribed to Payne. Notably absent from Respondent's interaction with
Payne was a discussion of the causes of his pain, its nature and
intensity, and how it affected his ability to function. See Fla. Admin
Code r. 64B8-9.013(3)(a). In short, Respondent's comments manifest that
he knew that Payne was an abuser of controlled substances; his
negotiation with Payne over the amount of oxycodone he could prescribe
based on his MRI and without even having performed a physical
examination likewise manifests that this was not a legitimate medical
evaluation but rather a drug deal.
It is true that Respondent subsequently performed a physical exam.
Yet throughout the exam, Payne generally denied that the various tests
caused pain or gave vague responses such as "uh-hum," and never
complained that the tests caused anything more than "a little bit" of
pain. Indeed, given Respondent's comments prior to the exam, it is
manifest that the exam was done to go through the motions and not to
engage in a legitimate clinical evaluation. Moreover, Respondent
documented in the medical record that he palpated Payne's cervical
spine area even though the video recording shows that he did not do so.
He also documented having performed various range of motion tests on
each portion of Payne's spine (including his lumbar region) even though
the video shows that he did not do so.
Furthermore, subsequent to the exam, Respondent made additional
comments which demonstrate that he had knowledge that Payne was a self-
abuser. For example, during his "new patient talk," Respondent
stated: "I don't want you taking medication, the way you want to take
them, because that will put you in jeopardy of overdose," and that the
UC's doing so, would place his license at risk. Respondent then added
that while "we're pretty strict here * * * we do have fun also," a
point which he reiterated.
As for the alprazolam prescription, while Respondent listed a
diagnosis of "generalized anxiety disorder," which he deemed to be
"chronic" and "active," the medical record contains the findings
that "patient denies problems with mood disturbance. No problems with
anxiety." In addition, Respondent documented that Payne's "[m]ental
status, judgment and affect are grossly intact and normal for age."
While Respondent offered the testimony of his medical assistant to
the effect that the EMR provided certain default entries when
information was not entered into the patient's record, he could not
identify what any of the specific entries were. Moreover, if a patient
had actually complained of anxiety and a discussion of his symptoms had
occurred, one would expect that the complaint and the nature of the
symptoms would be documented in the patient's record. Indeed, the rules
of the Florida Board of Medicine require such. See Fla. Admin. Code
r.64B8-9.003(3) ("The medical record shall contain sufficient
information to identify the patient, support the diagnosis, [and]
justify the treatment * * * ."); Fla. Admin. Code r. 64B8-9.013(3)(f)
("The physician is required to keep accurate and complete records * *
* ."). Finally, other than his single question to the TFO of whether
he was getting Xanax "for anxiety," with Payne saying he was getting
it for sleep, there is no evidence that Respondent (or Gomez for that
matter) discussed with Payne any problems he had with anxiety or with
sleeping.
In rejecting the Government's evidence, the ALJ noted that at the
time of Respondent's initial evaluation, he "had evidence of [Payne's]
prior treatment for pain from December 2010 until April 10, 2011, by
two different physicians." ALJ at 67. This is a gross
mischaracterization of the evidence, as Respondent did not have any
medical records from the two physicians showing that they treated Payne
for pain, but rather only a prescription profile showing that the two
physicians had prescribed drugs to Payne. That profile, however,
establishes only the dates and drugs that various doctors prescribed
and says nothing about the legitimacy of the prescriptions. Moreover,
given the date of the profile (June 14, 2011) and the absence of any
prescriptions since April 10, one might reasonably ask whether the
patient had been discharged by his prior doctor and attempt to contact
that doctor. Beyond this, as Respondent's own comments
[[Page 57149]]
manifest, he surmised that Respondent's prior clinic had been shut down
for prescribing inappropriately.
The ALJ also noted that Respondent had a "verified MRI report,
correlating, to a limited extent, [the TFO's] statement of pain and
reported history of 'low back pain.' " Id. The ALJ ignored, however,
that Payne testified that one of the forms he filled out had a picture
of a human body and that he deliberately circled a part of his body
different than his MRI, to, in his words, "disprove basically the
MRI." Tr. 180; see also ALJ at 20 (ALJ finding that "[w]ith regard to
his stated pain complaint, [the] TFO * * * recalled one of the forms
had a picture of a human body and he believed he circled part of the
body that was different than his MRI, 'just to disprove basically the
MRI.'"). Notably, the ALJ did not reconcile his finding that the MRI
correlated with Payne's "reported history of 'low back pain'" and his
earlier finding that the TFO had circled a different part of the body
as the area in which he had pain. See ALJ at 67. In addition, it should
be noted that Respondent's own witness testified that the clinic
shredded the patient questionnaires.
The ALJ then noted that "at the outset of the patient visit,
[Respondent] made clear that he intended to decrease the amount of
controlled substances [Payne] had previously been provided,
particularly given the limited correlation of reported pain in the MRI
report." Id. Contrary to the ALJ's understanding, that a practitioner
prescribes a lesser quantity of a controlled substance than what a
patient had previously received does not establish that the
prescription was lawfully issued. Rather, what determines whether a
prescription complies with Federal law is whether the physician had a
legitimate medical purpose and acted within the usual course of
professional practice. 21 CFR 1306.04(a)
The ALJ also reasoned that Respondent's statement that "[w]hat you
should get and what you need, oftentimes is two different things cause
if you've been on a certain number of pills, for a long time, if you
don't get those number of pills, you're going to be sick,"
"reflect[s] positively on his prescribing conduct or intent in this
case." ALJ 66. However, when considered in the context of the entire
conversation which occurred between Respondent and the TFO, and as
demonstrated by Respondent's subsequent statement that "I don't want
you taking medication, the way you want to take them, because that will
put you in jeopardy of overdose," it is clear that Respondent believed
that Payne was a drug abuser.
The ALJ's reasoning likewise reflects a stunning disregard for
Federal law, which, however, does not permit a practitioner to
prescribe schedule II controlled substances such as oxycodone to a
narcotic dependent person for the purpose of maintaining him on
narcotics and preventing withdrawal symptoms.\20\ See 21 CFR
1306.04(c). Rather, when a patient presents as narcotic dependent, a
practitioner may only administer (and not prescribe) narcotic drugs
"for the purpose of relieving acute withdrawal symptoms when necessary
while arrangements are being made for referral for treatment," may not
administer more than "one day's medication at a time," and may not do
so "for more than three days." 21 CFR 1306.07. Thus, contrary to the
ALJ's understanding, there is nothing positive in Respondent's decision
to prescribe 150 tablets of oxycodone 30mg (as well as Xanax) to a
person he knew was a drug abuser.\21\
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\20\ A practitioner may prescribe narcotic drugs for the purpose
of maintenance or detoxification treatment only if "the
prescription is for a Schedule III, IV, or V narcotic drug approved
by the Food and Drug Administration specifically for use in
maintenance or detoxification treatment and the practitioner is in
compliance with requirements in 1301.28 of this chapter." 21 CFR
1306.04(c). Oxycodone is a Schedule II drug and cannot be prescribed
for this purpose. Moreover, Respondent is not authorized to dispense
narcotic drugs for maintenance or detoxification treatment under
either 21 U.S.C. 823(g)(1) or 823(g)(2).
\21\ So too, that Respondent explained various clinic policies
in his new patient speech, see ALJ at 67, does nothing to refute the
conclusion that he knowingly prescribed oxycodone to a drug abuser.
Rather, it is simply a case of Respondent's going through the
motions.
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I therefore conclude that Respondent lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in prescribing oxycodone and Xanax (alprazolam) to Payne. Moreover, by
themselves, Respondent's issuance of these two prescriptions is enough
to establish a prima facie showing that he has committed such acts as
to render his registration inconsistent with the public interest. 21
U.S.C. 824(a)(4). See Dewey C. MacKay, 75 FR at 49977; Jayam Krishna-
Iyer, 74 FR at 463; Olefsky, 57 FR at 928-29 (revoking registration
based on physician's presentation of two fraudulent prescriptions to
pharmacy).
Likewise, with respect to the TFO's second visit, the ALJ did not
find the evidence sufficient to support the conclusion that Respondent
violated federal law. According to the ALJ, the evidence showed that
"Respondent did review the course of treatment with the patient, to
include an inquiry about how the medication was working and a physical
examination, albeit short." ALJ at 68. Indeed, the entire interaction
between Respondent and Payne lasted two minutes. See Armstrong, 550
F.3d at 389.
Respondent is, of course, charged with the knowledge he obtained at
Payne's first visit that he was a substance abuser, none of which is
documented in the medical record. See Fla Admin Code r. 64B8-
9.013(3)(a) & (f) (requiring documentation of history of substance
abuse). Moreover, while Respondent asked Payne if the medication was
treating his "pain well," neither Respondent nor Gomez asked Payne if
there was any change in the status of his pain, whether it still
radiated into his upper back, nor any questions about the timing and
quality of the pain, and whether it still affected his sleep and
physical activity. See id. r.64B8-9.013(3)(d). Yet such findings were
documented in the medical record for the visit.
Moreover, as found above, the medical record documented that
Respondent had performed a neurologic exam, that he had palpated
Payne's cervical spine and surrounding areas, and that he had required
Payne to perform range of motion tests for various portions of his
spine. However, Respondent did not perform a neurologic exam, nor any
range of motion tests of any portions of Payne's spine, and the only
area that he palpated was Payne's lower back. Once again, the evidence
shows that Respondent falsified the medical record.\22\ Respondent also
falsified the
[[Page 57150]]
record by documenting that Payne had "active" and "chronic"
"generalized anxiety disorder."
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\22\ While the ALJ opined that there was no evidence that
Respondent knowingly falsified the medical records, each of the
visit notes (for all four UCs) prepared by Respondent includes the
statement:
I declare that I have read and verified the document.
T.J. McNichol, MD.
See RX 1, at 29; id. at 33. See also id. at 12(8/25/11 visit
note for Mike Corleone); id. at 18 & 22 (7/28/11 and 8/25/11 visit
notes for Anthony Thompson); id. at 44 (8/25/11 visit note for Eric
McMillen).
The ALJ also noted that "[t]here are also various entries in
the relevant patient chart for the[UCs] that do not correlate to
other objective evidence and testimony of what transpired during the
examination." ALJ at 70. As an example, the ALJ cited a statement
in the chart for Anthony Thompson that "there were 'no external
hemorrhoids or rectal masses. Stool Hemoccult was negative[,]' "
and that the Agent testified that "no examination was performed
consistent with such findings in the patient chart." Id. (quoting
RX 1, at 17; and citing Tr. 253). The ALJ then reasoned that there
was no evidence that "the forgoing errors, such as gastrointestinal
findings as to hemorrhoids, had any rational relationship to
Respondent's prescribing of controlled substances[,]" and that
"[t]here is also no evidence that any of the discrepancies in the
patient chart were * * * related in any material way to his
prescribing of controlled substances in this case." Id.
Even if gastrointestinal findings are not materially related to
a complaint of lower back pain, as found above, there was evidence
with respect to several of the undercovers (including the TFO who
posed as Bobbie Payne) that Respondent documented various findings
including having performed various range of motion tests on the
TFO's lumbar spine, which was the area of his purported pain
complaint. See RX 1, at 21. However, the ALJ entirely ignored this
evidence. As for the ALJ's reasoning that there is no evidence these
discrepancies were materially related to Respondent's prescribing,
if findings related to the area of the body which a patient
complains is causing him pain are not materially related to the
making of the diagnosis and decision to prescribe controlled
substances, then nothing in a medical record is material. The
Florida standards, however, suggest otherwise. See Fla. Admin Code
r.64B8-9.003(3) ("The medical record shall contain sufficient
information to identify the patient, support the diagnosis, justify
the treatment and document the course and results of treatment
accurately, by including, at a minimum, * * * examination results. *
* *").
---------------------------------------------------------------------------
Here again, the evidence shows that Respondent's evaluation of
Payne was simply a case of going through the motions. Moreover,
notwithstanding the substantial probative evidence of irregularities in
his prescribing practices, Respondent failed to testify regarding them.
Under these circumstances, an adverse inference is warranted that
Respondent knowingly diverted oxycodone and alprazolam to Payne on his
second visit as well.\23\ See Baxter v. Palmigiano, 425 U.S. 308, 318
(1976) ("[T]he Fifth Amendment does not forbid adverse inference
against parties to civil actions when they refuse to testify in
response to probative evidence offered against them") (emphasis
added); MacKay, 664 F.3d at 820 (quoting Keating v. Office of Thrift
Supervision, 45 F.3d 322, 326 (9th Cir. 1995) ("Not only is it
permissible to conduct a civil [administrative] proceeding at the same
time as a related criminal proceeding, even if that necessitates
invocation of the Fifth Amendment privilege, but it is even permissible
for the trier of fact to draw adverse inferences from the invocation of
the Fifth Amendment in a civil [administrative] proceeding."); Hoxie,
419 F.3d at 483. See also 21 CFR 1306.04(a). Respondent's issuance of
these prescriptions provides further support for the conclusion that he
has committed acts which render his registration inconsistent with the
public interest. 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------
\23\ I reject the ALJ's reasoning that "in light of the fact
that the Government's evidence was insufficient to establish a prima
facie case * * * Respondent's silence in and of itself does not
appreciably tip the balance of evidence in favor of the Government"
as contrary to settled law. See Baxter, 425 U.S. at 318. Here, the
Government did not rely solely on Respondent's failure to testify to
prove its case. Rather, it introduced independent and probative
evidence as to the illegality of the prescriptions through the
testimony of the undercovers officers and the recordings (and
transcripts) of their visits. Moreover, Respondent's own evidence,
which included the patient charts and the undercover officers'
reports of investigation, also provides independent and probative
evidence of Respondent's illegal conduct, which he failed to
address. Accordingly, as ultimate factfinder, I conclude that an
adverse inference is warranted with respect to the prescriptions
issued to Payne, as well as the alprazolam prescriptions issued to
the other three undercover officers.
---------------------------------------------------------------------------
The Prescriptions Issued To Anthony Thompson
With respect to Thompson's first visit, the ALJ noted that there
were "various entries in the relevant patient charts for [this
undercover], * * * that do not correlate to other objective evidence
and testimony of what transpired during the examination," ALJ at 70,
that Respondent's medical assistant had falsified the urine drug screen
report to show that Thompson tested positive for benzodiazepines and
oxycodone, id. at 71, and that Respondent's physical examination at the
initial visit lasted all of two minutes. Id. at 72. The ALJ nonetheless
concluded that these "irregularities" do not "support a finding by a
preponderance of the evidence that Respondent's prescribing conduct on
July 28 * * * 2011, was not for a legitimate medical purpose or outside
the usual course of professional practice." ALJ at 75.
However, even if expert testimony was required to demonstrate that
Respondent acted outside of the usual course of professional practice
and lacked a legitimate medical purpose in issuing the oxycodone
prescription, there is nonetheless substantial evidence to support the
conclusion that Respondent's prescribing of alprazolam to Thompson
lacked a legitimate medical purpose. Here, Respondent's discussion of
Thompson's need for Xanax was limited to Respondent's asking: "I take
it you have some anxiety as well[,] is that what's going on with
you?," with Thompson using the street term for Xanax to reply, "Yeah,
that's the Zanny's help out." While Respondent then advised Thompson
that "we don't call them Zanny's or bars or any of the street terms,
here, ok?" Respondent engaged in no further inquiry as to whether
Thompson actually had symptoms consistent with generalized anxiety
disorder, let alone symptoms which warranted the prescribing of
alprazolam. Moreover, while Respondent then stated that under state law
if a pain patient had a psychiatric problem, he had to be referred to
psychiatry, he then added that Thompson did not necessarily have to go.
Nor did Respondent provide the name of any psychiatrists to see.
Most significantly, in the medical record for this visit,
Respondent noted in the psychiatric portion of the review of systems
that "Patient denies problems with mood disturbance. No problems with
anxiety." And in the physical examination findings, Respondent
documented that Thompson's "[m]ental status, judgment and affect are
grossly intact and normal for age." Notwithstanding these findings,
Respondent documented a diagnosis of generalized anxiety disorder which
was "active" and "chronic" and prescribed 60 Xanax 1mg to
Thompson.\24\
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\24\ The progress note for the visits of the Agent include the
following statement under the caption of "History of Present
Illness" and "Low Back Pain":
Associated Conditions: None. Aggravated by standing, walking,
and exercise. Denies None with pertinent positives of stiffness and
anxiety and [sic] relieved by rest and pain medications.
RX 1, at 15, 19. Similar statements are found in the progress
notes for two of the other UCs. See RX 1, at 9 (Corleone;
"Associated conditions: None. Aggravated by sitting, climbing
stairs, cold, lifting, exercise, and driving. Denies None with
pertinent positives of anxiety and [sic] relieved by ice, rest, and
pain medications"); id. at 26 (Payne; "Associated Conditions:
None. Aggravated by movement, climbing stairs, and lifting. Denies
None with pertinent positives of stiffness and anxiety and [sic]
relieved by lying down, rest, and pain medications").
No explanation was offered as to how either Respondent or Gomez
could have documented that the UCs had no history of associated
conditions but nonetheless had "pertinent positives" of anxiety,
and given that each of the charts contains the finding that the
"Patient denies problems with mood disturbance. No problem with
anxiety[,]" see, e.g., RX 1, at 16, the statements are obvious
gibberish.
---------------------------------------------------------------------------
In his discussion of Thompson's visits, the ALJ completely ignored
the evidence showing that: (1) Respondent's discussion of Thompson's
use of Xanax was limited to a single question with Thompson using the
street name for the drug and involved no discussion of the nature and
duration of any symptoms which might support a diagnosis of "chronic"
and "active" generalized anxiety disorder; (2) the evidence that
Respondent documented that Thompson had "[n]o problems with anxiety";
and (3) Respondent's finding that Thompson's "mental status, judgment
and affect are grossly intact and normal for age." See ALJ at 69-74.
And while it is true that the Florida standards of practice do not
mandate a referral for psychiatric treatment, see id. at 74 & n.98
(characterizing Respondent's referral as "half-hearted"), this does
nothing to refute the
[[Page 57151]]
conclusion that Respondent lacked a legitimate medical purpose and
acted outside of the usual course of professional practice in
prescribing Xanax to Thompson.
In short, where a medical record contains no findings that support
a diagnosis, or, as in this case, those findings contradict a
diagnosis, in the absence of credible testimony from Respondent
explaining the reason for the inconsistency, expert testimony is not
necessary to conclude that a prescription lacked a legitimate medical
purpose. 21 CFR 1306.04(a); see also Baxter, 425 U.S. at 318; Cochrane,
76 FR at 17519-20. I thus hold that there is substantial evidence to
support the conclusion that the Respondent lacked a legitimate medical
purpose and acted outside the course of professional practice when he
prescribed Xanax to the Agent at the July 28 visit.
Likewise, on Thompson's second visit, neither Respondent's
assistant, nor Respondent, discussed with Thompson whether he had any
symptoms consistent with an anxiety diagnosis and which warranted a
prescription for Xanax. Moreover, here again, the medical record
contains the same findings as on the previous visit that "Patient
denies problems with mood disturbance. No problems with anxiety" and
that Thompson's "[m]ental status, judgment and affect are grossly
intact and normal for age." Yet, once again, Respondent prescribed
Xanax to Thompson.
Here again, the ALJ failed to even consider any of the evidence
regarding Respondent's prescribing of Xanax to Thompson. ALJ at 74-75.
For the same reasons as discussed above, I conclude that Respondent
lacked a legitimate medical purpose and acted outside of the usual
course of professional practice in prescribing Xanax to Thompson at the
latter's second visit. See 21 CFR 1306.04(a).
The Prescriptions Issued to Michael Corleone
As found above, a TFO, using the name of Michael Corleone, saw
Respondent on August 25, 2011, after having seen Dr. Mosley at the
Brandon clinic on two prior occasions. With respect to Respondent's
prescribing of controlled substance to Corleone, the ALJ noted
Respondent's statements to the TFO that he believed that the TFO "was
'a little bit over-medicated," but that he was "going to leave [him]
on what [he had] been on," as well as his statement that "'you know
if it comes down to it later, down the road that we need to bring you
down a bit, we'll do it * * * I don't think we'll need to. The only
reason why we would need to is because the government makes me." "
ALJ at 87.
The ALJ further noted that Respondent "conducted a brief physical
examination * * * which in context appears to be somewhat perfunctory
since Respondent had also communicated his intent to leave [the TFO] on
his current medications prior to initiating the examination." Id. As
the ALJ noted, the exam was limited to Respondent pressing against the
TFO's lower back in several locations and asking if it was painful,
with the TFO responding that his back was "a little sore," as well as
Respondent directing the TFO to sit in a chair and raise each leg both
separately and simultaneously, with the TFO expressing "no
discomfort." Id.
The ALJ then noted that "[t]he forgoing evidence is certainly
suggestive of questionable prescribing by Respondent in this instance,
particularly given Respondent's comments about dosing and future
reductions based on government action, rather than his medical
judgment," and that "Respondent's physical examination appears
perfunctory since his decision to prescribe was made moments after his
review of the patient file, apparently in reliance on the medical
judgment of Dr. Mosley." Id. at 88. However, the ALJ explained that
notwithstanding this evidence, "Respondent's deference to another
physician's medical judgment appears to be a relevant factor since a
comparison of the limited patient files made available by the
Government in this case reflects that Respondent initially prescribed
lower doses of oxycodone and alprazolam to similarly situated patients
than his colleague, Dr. Mosley." Id. The ALJ further noted the
testimony of the Government's Expert that "physicians can and do
ascribe some deference to the prior prescriber's approach, assuming
that the physician has either spoken with the prior prescriber or has
the records from the prior prescriber's intervention." Id. (citing Tr.
591).\25\
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\25\ It is strange, given the ALJ's finding that the
Government's Expert was so biased as to "preclude[] any reliance on
his opinion testimony," ALJ at 89 n.118 (emphasis added), that the
ALJ then disregarded his own finding and relied on this testimony.
However, the Expert's entire testimony was that "it still is an
absolute expectation of a physician, even if you've inherited a
patient on certain medications, it's certainly--it's an expectation
that a physician evaluate the database and form their own opinion."
Tr. 591. Continuing, the expert testified that while the new
physician's opinion "can be influenced. It can be, in some ways,
deferential to the prior prescriber, but it still is the individual
physician[']s opinion and decision, when it comes to prescribing to
that patient, when that physician has taken over the care of that
patient." Id. at 591-92. No explanation was provided by the ALJ for
disregarding the rest of the Expert's testimony on this issue.
---------------------------------------------------------------------------
It is true that Respondent had available to him the TFO's medical
records which were maintained by Dr. Mosley. However, in the absence of
testimony by Respondent that he deferred to Dr. Moseley's medical
judgment when he prescribed to the TFO, the ALJ's suggestion is
unsupported by substantial evidence and is pure speculation. As the ALJ
was want to explain, "[s]peculation is, of course, no substitute for
evidence." ALJ at 90 (internal quotations and citations omitted).
Moreover, even assuming, that under the Florida standards of
medical practice, a physician can appropriately prescribe a controlled
substance based on his review of the records from the patient's prior
physician, the evidence still establishes that Respondent lacked a
legitimate medical purpose when he prescribed alprazolam to the TFO. As
the record for the TFO's first visit with Dr. Mosley shows, Mosley did
not make any findings which support a diagnosis of anxiety.
More specifically, in the section of the progress note for
documenting Corleone's primary complaint, Mosley did not document a
complaint of anxiety. Moreover, in the section for documenting
Corleone's psychiatric history, Mosley did not check the blank for
anxiety or any other mental illness. And in the section for documenting
whether Corleone had a family history of mental health (as well as
other conditions), Mosley wrote "none." Finally, Mosley did not
document a diagnosis of any type of anxiety disorder. Indeed, in the
record for the visit, the only mention of anxiety is where Mosley
listed the medications he was prescribing and wrote: "Xanax 2mg,
q12hrs, PRN anxiety 60."
Thus, there were no findings, let alone a diagnosis, to support the
prescribing of Xanax for anxiety, in the record maintained by Dr.
Mosley on the TFO. The ALJ did not, however, explain why it would be
reasonable to defer to the medical judgment of a prior physician when
that prior physician did not make any findings which would support a
diagnosis, let alone a make a diagnosis of anxiety. Indeed,
notwithstanding his surmise that Respondent had deferred "to another
physician's medical judgment" when he prescribed controlled substances
to Corleone, ALJ at 88, the ALJ completely ignored the evidence showing
a total lack of documentation of findings to
[[Page 57152]]
support an anxiety diagnosis in the medical record created by Dr.
Mosley.\26\
---------------------------------------------------------------------------
\26\ As found above, the patient file for Corleone does not
contain a progress note for the TFO's second visit with Dr. Mosley,
which was of an extremely short duration. Respondent produced no
evidence that Mosley ever prepared a note for the visit, and in any
event, Respondent did not testify and thus cannot claim to have
relied on any findings contained in such a note when he decided to
prescribe to the TFO.
---------------------------------------------------------------------------
It is true that in the medical record for the TFO's August 25 visit
with Respondent, there is a notation that his pain affected his sleep
and physical activity. Yet there is no evidence that any of these
issues were raised by the nurse or Respondent with the TFO. Nor is
there any evidence that Respondent discussed with the TFO whether he
had anxiety.
There is also evidence in the psychiatric portion of the record's
review of systems section that "[p]atient denies problems with mood
disturbance. No problems with anxiety." Likewise, in the findings for
the physical examination, Respondent wrote: "Oriented with normal
memory. Mental status, judgment and affect are grossly intact and
normal for age." Yet Respondent diagnosed Corleone as having chronic
and active generalized anxiety disorder and prescribed to him 60
alprazolam 2mg.\27\
---------------------------------------------------------------------------
\27\ As found above, on the alprazolam prescription, Respondent
listed his diagnosis as "Generalized Anxiety Disorder." GX 28.
---------------------------------------------------------------------------
Just as he ignored the evidence showing that Mosley had failed to
make any findings to support a diagnosis of anxiety, the ALJ entirely
ignored the evidence showing that the findings Respondent made during
the TFO's August 25 visit were inconsistent with his diagnosis of
generalized anxiety disorder and did not support his prescription for
alprazolam. See ALJ at 83-91. Here again, Respondent failed to testify
and offer an explanation for the inconsistency between his findings and
his diagnosis. I therefore conclude that Respondent lacked a legitimate
medical purpose and acted outside of the usual course of professional
practice when he prescribed 60 tablets of alprazolam 2mg to the TFO.
The Prescriptions Issued To Eric McMillen
As with the previous undercover officer, a DEA Special Agent, who
used the name of Eric McMillen, initially saw Dr. Mosley at the
Bradenton clinic prior to seeing Respondent. The Agent acknowledged
that he had seen Mosley for at least thirty minutes and performed a
physical exam, and on cross-examination, agreed that the exam was
"pretty thorough." He also testified that it was "possible" that he
noted on paperwork he completed that he had "some trouble sleeping."
At the conclusion of the visit, Dr. Mosley prescribed 180 tablets of
oxycodone 30mg and 30 tablets of Xanax 2mg.
Regarding the Agent's visit with Respondent, the ALJ found that
Respondent had available to him the Agent's file including the progress
note from the previous visit, as well as the information obtained
during the triage procedures. ALJ at 79. The ALJ also noted that the
Agent had filled out a medical questionnaire during his second visit.
Id. However, the ALJ credited the Agent's testimony that during the
triage procedures Mr. Gomez did not ask him about anxiety or
sleeplessness. ALJ at 80 (citing Tr. 366-67). Moreover, at no point
during the Agent's visit with Respondent did the latter ask the Agent
whether he had problems with anxiety or sleeplessness.
Regarding the alprazolam prescription Respondent issued to the
Agent, the ALJ noted that "[t]he evidence * * * reflect[sic] some
irregularities," noting that "the final diagnosis of generalized
anxiety disorder facially conflicts with the patient chart entry
stating " '[p]atient denies problems with mood disturbance. No
problems with anxiety.' " ALJ at 81-82. The ALJ also noted that the
Agent's "testimony also reflects no questioning by Mr. Gomez or
Respondent about ongoing issues with anxiety or sleeplessness" and
that "[t]he absence of any inquiry by Respondent about the medical
basis for continuing the prescription for Xanax arguably supports a
finding that such a prescription lacks a legitimate medical purpose, or
is outside the usual course of professional practice." Id. at 82.
However, the ALJ then concluded that the Government had failed to
established by preponderance of the evidence that the prescription
lacked a legitimate medical purpose or was issued outside the usual
course of professional practice, reasoning that "there is other
credible evidence of record that Respondent had information available
to him as of August 25, 2011 that would support the continued
prescription for Xanax." Id. According to the ALJ, this information
included "Dr. Mosley's initial diagnosis of anxiety and corresponding
prescription for two milligram Xanax over a thirty day time period,"
as well as a pharmacy printout showing that similar prescriptions had
been issued by "another physician * * * covering the time period from
March 14, 2011 to June 10, 2011." ALJ at 82. In addition, the ALJ
noted that the Agent testified that he had filled out a medical
questionnaire on August 25, 2011, but that "[t]he record is unclear on
exactly what information [the Agent] provided in answering the medical
questionnaire * * * on the issue of anxiety, sleep disturbance, or
pain." Id. However, the ALJ noted that the August 25 patient file
stated that the patient's affected daily activities included "sleep,
work, and physical activity." Id.
Here again, Respondent did not testify and explain what he relied
on in concluding that a prescription for Xanax was medically
warranted,\28\ and thus the ALJ's conclusion is nothing more than
speculation. Moreover, even assuming that Respondent relied on the
evidence cited by the ALJ, contrary to the ALJ's understanding, none of
it refutes the conclusion that Respondent lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in prescribing Xanax to the Agent.
---------------------------------------------------------------------------
\28\ It is acknowledged that during the visit, Respondent told
the Agent had he had "just left [him] on everything that you were
on down there." GX 22, at 9. This does not, however, establish
anything more than that he reviewed the prescription issued by Dr.
Mosley. As explained previously, that another physician has issued a
prescription does not establish that that physician issued the
prescription for a legitimate medical purpose and acted within the
usual course of professional practice.
---------------------------------------------------------------------------
As for Dr. Mosley's purported "initial diagnosis," once again the
ALJ misstated the evidence. As found above, in the medical record Dr.
Mosley prepared for the Agent's July 21 visit, Mosley did not document
that the Agent had a psychiatric history even though the form included
a place for indicating that the Agent had anxiety, nor document that
there was a family history of mental health conditions, or make any
other findings consistent with an anxiety diagnosis. Indeed, Dr. Mosley
did not list anxiety as among his various diagnoses. Thus, Mosley's
record did not support the prescription he issued and Respondent could
not have reasonably relied on it as a basis for concluding that the
Agent had generalized anxiety disorder.\29\
---------------------------------------------------------------------------
\29\ The ALJ also stated that there is no "evidence to support
a finding that Respondent's reliance on records of Dr. Mosley's
prescribing in this instance was unreasonable or unlawful." ALJ at
79. However, absent from the ALJ's discussion of the note for the
Agent's visit with Dr. Mosley is any acknowledgement that Mosley
made no findings that the Agent had anxiety and did not include
anxiety among his diagnoses. See id. at 78.
---------------------------------------------------------------------------
As for the prescription profile which the Agent provided, as
explained previously, that profile establishes only that another doctor
had prescribed alprazolam (and oxycodone) to the Agent on various
occasions. The profile, however, says nothing about whether
[[Page 57153]]
the prescriptions issued by the previous doctor were for a legitimate
medical purpose and issued within the usual course of professional
practice.
As for the Respondent's purported reliance on the information in
the August 25 progress note that the Agent's pain affected his sleep,
the ALJ noted that the record is unclear as to what information the
Agent provided in answering the medical questionnaire on the issues of
anxiety [and] sleep disturbance," thus suggesting the possibility that
the information the Agent provided was not consistent with what Mr.
Gomez (who falsified two urine drug screen reports and admitted that he
shredded the medical questionnaires pursuant to clinic policy) entered
into the EMR. However, even if Gomez's destruction of the questionnaire
does not support an adverse inference, the ALJ's conclusion is not
supported by substantial evidence.
As explained above, Respondent did not testify that he relied on
this notation. Moreover, if Respondent was engaged in legitimate
medical practice, one would expect that at some point he (or Gomez)
would have inquired of the Agent as to how the pain was affecting his
sleep. Yet there was no such inquiry of the Agent. Also, while it may
be that a patient's sleep problems may be a symptom of generalized
anxiety disorder, there is no evidence establishing that this alone is
sufficient to diagnose a patient as having generalized anxiety
disorder, especially when the doctor finds that the patient "denies
any problems with anxiety" and that the patient's "[m]ental status,
judgment and affect are grossly intact and normal for age." Again,
because Respondent failed to testify and address the basis for his
diagnosis and offer a credible explanation for why he diagnosed the
Agent with general anxiety disorder while finding that he "denies any
problems with anxiety," I conclude that an adverse inference is
warranted and hold that Respondent lacked a legitimate medical purpose
and acted outside of the usual course of professional practice when he
prescribed Xanax to the Agent.\30\
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\30\ With respect to the oxycodone prescription issued by
Respondent, the ALJ wrote: "Notably, Dr. Parran's report and
testimony neglect to make any reference to [the Agent's] report of
mild pain on the right side during the August 25, 2011 physical
examination, or discuss whether such a report of mild pain would be
consistent with a patient taking pain medication in the quantities
and strengths prescribed to SA Rice by Dr. Mosely [sic]." ALJ at
81. Contrary to the ALJ's statement, the Expert testified at length
as to the appropriateness of prescribing schedule II narcotics to a
patient who complains of only mild pain.
For example, after the Expert noted that the UCs had generally
complained of pain levels which "were four or less," the
Government asked if a "reported pain level of four or less" was
significant in his review. Tr. 628. The Expert answered: "A pain
level of a four or less indicates mild pain, and a pain which is
typically not treated with opiate analgesics, certainly not treated
with around the clock opiate analgesics that are Schedule II." Id.
at 629. Subsequently, the expert explained that "typically, reports
that are certainly below four are considered mild pain and pain
which is, you know, not impactful or very impactful on patient
function, and typically not prescribed certainly * * * high potency
Schedule II opiate analgesics." Id. at 630-31. The Expert then
explained that there are risks and benefits to prescribing opiate
analgesics and that while the drugs can help patients improve their
function, there is "[t]he risk * * * that patients can and will
develop physical dependence," as well as other problems such as
endocrine changes and sedation, and that "if a person's impairment
of function and/or pain level is in the mild range, then the risk of
putting a person on these kinds of medications are [sic] typically
considered to outweigh the potential benefit." Id. at 631-32.
Notably, none of this testimony was refuted or shown to be
inconsistent through other evidence.
Subsequently, the Expert was asked (albeit with respect to his
review of the visit of another UC), whether Respondent's prescribing
of alprazolam was problematic. After noting that based upon the
information contained on the recordings there did not seem "to be a
diagnosis established [to] prescribe the alprazolam," the Expert
further testified:
And my concern goes beyond that, that prescribing Alprazolam on
top of Schedule II opiate medication increases the risk of the
Schedule II opiate medications, because Alprazolam potentiates the
problematic side of opiate medications. It potentiates the sedation,
the respiratory depression and the euphoria of opiate medications.
Id. at 636. Notably, the ALJ did not offer any explanation for
why he rejected this testimony other than his view that the Expert
was so biased as to "preclude[] any reliance on his opinion
testimony," ALJ at 89 n. 118, except for when he did rely on it.
---------------------------------------------------------------------------
Summary of Evidence as to Factors Two and Four
As explained above, even assuming, without deciding, that the ALJ
properly failed to give weight to the Expert's testimony, there is
still substantial evidence that Respondent violated 21 CFR 1306.04(a)
when he prescribed oxycodone and alprazolam to the undercover officer
who presented as Robbie Payne. Moreover, the record contains
substantial evidence that Respondent violated 21 CFR 1306.04(a) when he
prescribed alprazolam to the undercover officers who presented as
Anthony Thompson, Michael Corleone, and Eric McMillen.
I therefore conclude that the Government has satisfied its prima
facie burden of showing that Respondent "has committed such acts as
would render his registration * * * inconsistent with the public
interest." 21 U.S.C. 824(a)(4). See also MacKay, 664 F.3d at 819
(Upholding Agency determination, noting that "[i]n light of Dr.
MacKay's misconduct relating to factors two and four, the government
made a prima facie showing that Dr. MacKay's continued registration is
inconsistent with the public interest. Although Dr. MacKay may have
engaged in the legitimate practice of pain medicine for many of his
patients, the conduct found by the Deputy Administrator with respect to
[two patients] is sufficient to support her determination that his
continued registration is inconsistent with the public interest.").
Sanction
Under Agency precedent, where, as here, the Government has made out
a prima facie case that a registrant has committed acts which render
his "registration inconsistent with the public interest," he must
"'present[] sufficient mitigating evidence to assure the Administrator
that [he] can be entrusted with the responsibility carried by such a
registration.'" 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), this Agency 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-Jonesborough, 73 FR at 387. As the Sixth
Circuit has recognized, this Agency also "properly considers" a
registrant's admission of fault and his candor during the investigation
and hearing to be "important factors" in the public interest
determination. See Hoxie, 419 F.3d at 483.
More recently, the Tenth Circuit upheld the Agency's rule,
explaining that:
When faced with evidence that a doctor has a history of
distributing controlled substances unlawfully, it is reasonable for
the * * * Administrator to consider whether that doctor will change
his or her behavior in the future. And that consideration is vital
to whether [his] continued registration is in the public interest.
Without Dr. MacKay's testimony, the * * * Administrator had no
evidence that Dr. MacKay recognized the extent of his misconduct and
was prepared to remedy his prescribing practices.
MacKay, 664 F.3d at 820.
So too, here, Respondent failed to testify and acknowledge his
wrongdoing and provide evidence that he will not engage in future
misconduct. In short, Respondent put on no evidence to rebut the
Government's showing that his registration is inconsistent with the
[[Page 57154]]
public interest.\31\ And here, too, it is appropriate to draw an
adverse inference from Respondent's failure to testify. See MacKay, 664
F.3d at 820.
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\31\ Respondent did not even put on evidence that Mr. Gomez, who
clearly falsified the urine drug screens of two of the undercovers
to show they were taking drugs when they were not, had been fired.
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Contrary to the ALJ's understanding, the existence of a pending
criminal prosecution does not preclude the Agency from drawing an
adverse inference from Respondent's failure to testify. See id. Indeed,
as the Tenth Circuit recognized in MacKay, "'[n]ot only is it
permissible to conduct a civil [administrative] proceeding at the same
time as a related criminal proceeding, even if that necessitates
invocation of the Fifth Amendment privilege, but it is even permissible
for the trier of fact to draw adverse inferences from the invocation of
the Fifth Amendment in a civil [administrative] proceeding.'" Id.
(quoting Keating, 45 F.3d at 326). See also Baxter, 425 U.S. at 318
("[T]he Fifth Amendment does not forbid adverse inferences against
parties to civil actions when they refuse to testify in response to
probative evidence offered against them * * * ."); Hoxie, 419 F.3d at
483. Moreover, "the Fifth Amendment privilege is not 'a sword whereby
a claimant asserting the privilege [is] freed from adducing proof in
support of a burden which would otherwise have been his.'" Grider Drug
#1 & Grider Drug #2, 77 FR 44069, 44104 (2012) (quoting United States
v. Rylander, 460 U.S. 752, 758 (1983)).
I therefore hold that Respondent has failed to rebut the
Government's prima facie case. Moreover, as the Supreme Court explained
in Gonzales, the core purpose of the Act's prescription requirement is
to prevent the diversion of controlled substances to those who seek the
drugs for the purpose of engaging in self-abuse or selling them to
others. See 546 U.S. at 274 ("the prescription requirement * * *
ensures patients use controlled substances under the supervision of a
doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.") (citing Moore, 423 U.S. at 135
& 143).\32\
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\32\ See Jayam Krishna-Iyer, 74 FR at 463 (quoting National
Center on Addiction and Substance Abuse, Under the Counter: The
Diversion and Abuse of Controlled Prescription Drugs in the U.S. 3
(2005) [hereinafter, Under the Counter]). As noted in Krishna-Iyer,
"[t]he diversion of controlled substances has become an
increasingly grave threat to this nation's public health and safety.
According to The National Center on Addiction and Substance Abuse
(CASA), '[t]he number of people who admit abusing controlled
prescription drugs increased from 7.8 million in 1992 to 15.1
million in 2003.'" 74 FR at 463 (quoting Under the Counter, at 3).
CASA also found that "'[a]pproximately six percent of the U.S.
population (15.1 million people) admitted abusing controlled
prescription drugs in 2003, 23 percent more than the combined number
abusing cocaine (5.9 million), hallucinogens (4.0 million),
inhalants (2.1 million) and heroin (328,000).'" Id. (quoting Under
the Counter, at 3). Finally, CASA found that "'[b]etween 1992 and
2003, there has been a * * * 140.5 percent increase in the self-
reported abuse of prescription opioids," and in the same period,
the "abuse of controlled prescription drugs has been growing at a
rate twice that of marijuana abuse, five times greater than cocaine
abuse and 60 times greater than heroin abuse." Id. (quoting Under
the Counter, at 4).
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As I have previously explained, the Agency has revoked other
practitioners' registrations for committing as few as two acts of
diversion, see Krishna-Iyer, 74 FR at 463 (citing Alan H. Olefsky, 57
FR at 928-29), and the Agency can revoke based on a single act of
intentional or knowing diversion. See MacKay, 75 FR at 49977. Because
Respondent's misconduct in diverting controlled substances is egregious
and he has failed to accept responsibility for his misconduct and
demonstrate why he can be entrusted with a registration, I conclude
that his continued registration is inconsistent with the public
interest. 21 U.S.C. 824(a)(4). Accordingly, I will order that
Respondent's registration be revoked and that any pending application
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 Certificate of
Registration FM0624139, issued to T.J. McNichol, M.D., be, and it
hereby is, revoked. I further order that any application of T.J.
McNichol, M.D., to renew or modify his registration, be, and it hereby
is, denied. This Order is effectively immediately.\33\
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\33\ For the same reasons which led me to order the immediate
suspension of Respondent's registration, I conclude that the public
interest necessitates that this Order be effective immediately. 21
CFR 1316.67
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Dated: August 29, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-22850 Filed 9-14-12; 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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