[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58150-58170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23058]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-28]
Rene Casanova, M.D.; Decision and Order
On September 29, 2011, Administrative Law Judge Timothy D. Wing
issued the attached recommended decision.\1\ Neither party filed
exceptions to the decision.\2\
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\1\ All citations to the ALJ's decision are to the slip opinion
as originally issued.
\2\ On October 21, 2011, Respondent moved for a ten-day
extension of the deadline for filing his exceptions, stating that he
had ``been in trial in a state court proceeding this week and has
not had sufficient time to properly draft exceptions to the
Recommended Order''; the Government consented to the motion. Consent
Mot. to Extend Deadline for Filing Exceptions to Recommended Order,
at 1. Noting that the exceptions were due the same day that
Respondent filed his motion, the ALJ denied the motion finding that
he had not demonstrated good cause for the extension. Ruling on
Consent Mot., at 1. As the First Circuit has explained, the claim
that one's ``attorney was preoccupied with other matters * * * has
been tried before, and regularly has been found wanting.'' De la
Torre v. Continental Ins. Co., 15 F.3d 12, 15 (1st Cir. 1994)
(citing Mendez v. Banco Popular de Puerto Rico, 900 F.2d 4, 7 (1st
Cir. 1990)). See also De la Torre, 15 F.3d at 15 (quoting Pinero
Schroeder v. FNMA, 574 F.2d 1117, 1118 (1st Cir. 1978)) (`` `Most
attorneys are busy most of the time and they must organize their
work so as to be able to meet the time requirements of matters they
are handling or suffer the consequences.' ''); McLaughlin v. City of
LaGrange, 662 F.2d 1385, 1387 (11th Cir. 1981) (``[t]he fact that
counsel has a busy practice does not establish `excusable neglect'
''); see also Kamir Garces-Mejias, 72 FR 54931, 54932 (2007).
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[[Page 58151]]
Having considered the entire record, I have decided to adopt the
ALJ's findings of fact and conclusions of law except as discussed
below.\3\ While I agree with the ALJ that substantial evidence supports
the conclusion that Respondent lacked a legitimate medical purpose and
acted outside of the usual course of professional practice in issuing
controlled substance prescriptions to three undercover officers, ALJ
62-64, I find some of his reasoning unsupported by substantial
evidence.
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\3\ I do not adopt the ALJ's conclusion ``that the reference in
21 U.S.C. 823(f)(5) to `other conduct which may threaten the public
health and safety' would as a matter of statutory interpretation
logically encompass the factors listed in Sec. 824(a).'' ALJ at 32-
33 & n 62. See Kwan Bo Jin, 77 FR 35021, 35021 n.2 (2012).
Nor do I adopt the ALJ's finding that ``Respondent's biennial
inventory did not go back a full two years from the date of the
audit.'' ALJ at 36 (citing Tr. 200). Whether a biennial inventory
has been timely completed is based on either the date that a
``registrant first engages in the manufacture, distribution, or
dispensing of controlled substances,'' or on the date of a
subsequent biennial inventory. 21 U.S.C. 827(a); see also 21 CFR
1304.11(c) (``After the initial inventory is taken, the registrant
shall take a new inventory of all stocks of control substances on
hand at least every two years. The biennial inventory may be taken
on any date which is within two years of the previous biennial
inventory date.''). In short, a registrant's compliance with this
requirement is not measured from the date of an audit.
The ALJ also made various factual findings related to the
manner in which the clinic administered urine tests. See ALJ at 42-
44 (crediting testimony of Agent that no one monitored his urine
test, that one patient had said that he had simply scooped urine and
water from the toilet and used that as his sample, and one patient
had another person provide his urine sample for him); see also ALJ
at 50 (``there was no supervision while [a second S/A] provided a
urine specimen''). Based on this evidence, the ALJ concluded that
``[t]he emerging image of [the clinic] on February 16, 2010, is that
of a clinic in which patients collude with one another and with
staff members to fabricate urinalysis results and thereby obtain
controlled substances outside the usual course of professional
practice or for other than a legitimate medical purpose. Although
not for the most part directly attributable to Respondent, this
misconduct calls into question the legitimacy of APM as a whole.''
ALJ at 44.
There is, however, no evidence that Respondent was aware of
this misconduct. It is further noted that while the Government
elicited testimony from an Expert on prescribing controlled
substances to treat pain, the Expert did not offer any testimony
regarding what the standards of professional practice require with
respect to the monitoring/supervision of urine tests. I thus do not
place any weight on this evidence.
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More specifically, with respect to the undercover officer who posed
as patient J.S., the ALJ, citing the evidence that she had a negative
drug screen, used slang to refer to oxycodone and admitted that ``she
had not seen a doctor for the controlled substances she admitted
taking,'' concluded that J.S.'s `` `risk for medication misuse or
diversion' was patent.'' ALJ at 56. The ALJ then concluded that because
``Respondent conceded that he did not refer [J.S.] to a specialist,''
and did not ``otherwise display[] `special attention' to her heightened
risk of diversion,'' his conduct was ``inconsistent with'' Fla. Admin.
Code Ann. r. 64B8-9.013(e). Id. at 56-57. According to this provision,
which has since been superceded:
the physician should be willing to refer the patient as necessary
for additional evaluation and treatment in order to achieve
treatment objectives. Special attention should be given to those
pain patients who are at risk for misusing their medications and
those whose living arrangements pose a risk for medication misuse or
diversion. The management of pain in patients with a history of
substance abuse or with a comorbid psychiatric disorder requires
extra care, monitoring, and documentation, and may require
consultation with or referral to an expert in the management of such
patients.
Fla. Admin. Code Ann. r. 64B8-9.013(e).
Of significance, no authority (i.e., such as a decision of either
the Florida Board of Medicine or Florida courts), is cited to establish
that this provision has been interpreted as imposing a mandatory
obligation of consultation or referral. Moreover, at no point did the
Government's Expert testify that given the presentation of J.S. as a
patient, the accepted standard of medical practice required that
Respondent refer her to another physician.
It is true that the Government's expert criticized Respondent ``for
failing to inquire whether the patient had a substance abuse history or
history of addiction.'' ALJ at 61. While this appears to be a violation
of the standard governing the ``evaluation of the patient,'' and the
Government's Expert testified as to the importance of determining
whether a patient has a substance abuse and addiction history, Tr. 372-
73, it is not clear why the failure to do so establishes that his
conduct was inconsistent with the then-existing referral standard. See
ALJ at 61.
There is, however, substantial evidence to support the finding that
Respondent acted outside of the usual course of professional practice
and lacked a legitimate medical purpose when he prescribed controlled
substances to J.S. (as well as the two other undercover officers). With
respect to all three patients, the Government's Expert testified that
Respondent did not take an appropriate history or perform an
appropriate physical examination. Tr. 335. While each of the
undercovers provided an MRI, the Government Expert explained that an
MRI is ``simply a diagnostic tool'' and that ``finding [a] pathology on
an MRI does not entitle any practitioner to prescribe controlled
substances,'' id. at 336, because a ``pathology of an MRI in no way
indicates that there is any painful condition'' and must be correlated
with the patient's history and physical examination findings. Id. at
365. The Government further testified that Respondent's documentation
was ``substandard'' and ``very sketchy,'' id. at 337, and that he did
not ``support the need for the controlled substances with appropriate
documentation establishing a valid medical need and treatment plan.''
\4\ Id. at 339. Finally, the Government's Expert testified that ``[i]n
all of the cases, the [Respondent] prescribed controlled substances
outside the usual course of professional practice or for other than a
legitimate medical purpose.'' Id.
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\4\ The Government's Expert also testified that it is incumbent
on a physician to outline a treatment plan at the time he writes a
prescription. See Tr. 345-46, 382, 386.
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Under Agency precedent, these findings establish a prima facie case
that Respondent ``has committed such as acts as would render his
registration * * * inconsistent with the public interest.'' 21 U.S.C.
824(a)(4). I further agree with the ALJ's conclusion that Respondent
has failed to accept responsibility for his misconduct in prescribing
controlled substances to the undercover officers and that he has also
failed ``to demonstrate that he will not engage in future misconduct.''
Id. at 72. Accordingly, I will adopt the ALJ's recommendation that
Respondent's registration be revoked.
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 BC8677746, issued to Rene Casanova, M.D., be, and it
hereby is, revoked. I further order that
[[Page 58152]]
any pending application of Rene Casanova, M.D., to renew or modify the
above registration, be, and it hereby is, denied. This Order is
effective October 19, 2012.
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
Dedra S. Curteman, Esq., for the Government
Bradford Beilly, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
A. The Order to Show Cause
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. Sec. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA, Agency or Government) should revoke a
physician's DEA Certificate of Registration (COR) as a practitioner
pursuant to 21 U.S.C. Sec. 824(a)(4) and deny, pursuant to 21
U.S.C. Sec. 823(f), any pending applications for renewal or
modification and any applications for a new COR. Without this
registration, Rene Casanova, M.D. (Respondent), of the State of
Florida, would be unable to lawfully prescribe, dispense or
otherwise handle controlled substances in the course of his
practice.
The DEA Deputy Assistant Administrator issued an Order to Show
Cause (OSC) relating to CORs BC8677746, FC1777260 and FC1881211,
dated February 22, 2011, and served on Respondent. The OSC provided
notice to Respondent of an opportunity to show cause as to why the
DEA should not revoke Respondent's DEA CORs BC8677746, FC1777260 and
FC1881211, pursuant to 21 U.S.C. Sec. 824(a)(4), and deny any
pending applications for renewal or modification, and any
applications for any other DEA registration, pursuant to 21 U.S.C.
Sec. 823(f), alleging that Respondent's continued registration
would be inconsistent with the public interest as that term is
defined in 21 U.S.C. Sec. 823(f).
The OSC alleged that Respondent is registered with DEA as a
practitioner in Schedules II-V under DEA COR BC8677746 at 750 South
Federal Highway, Deerfield Beach, Florida, 33441, under DEA COR
FC1777260 at 1655 E. Oakland Park Boulevard, Oakland Park, Florida
33334 and under DEA COR FC1881211 at 640 East Ocean Avenue, Suites
18 and 19, Boynton Beach, Florida 33435, with expiration dates of
August 31, 2012. The OSC further alleged that Respondent distributed
controlled substances including oxycodone (a Schedule II controlled
substance), hydrocodone (a Schedule III controlled substance) and
alprazolam (a Schedule IV controlled substance) ``by issuing
`prescriptions' to undercover law enforcement officers for other
than a legitimate medical purpose or outside the usual course of
professional practice.'' (ALJ Ex. 1 at 2.)
In particular, the OSC alleged that in February 2010, Respondent
distributed 180 oxycodone 30 mg tablets and 60 alprazolam 2 mg
tablets to an undercover law enforcement officer (UC1) at the
request of UC1 after conducting little or no physical examination
and without providing any diagnosis warranting the prescriptions.
Additionally, the OSC alleged that in February 2010, Respondent
distributed 120 hydrocodone 7.5 mg tablets to a second undercover
law enforcement officer (UC2) after conducting little or no physical
examination and without providing any diagnosis warranting the
prescription. The OSC alleged that Respondent distributed controlled
substances to UC2 after UC2 informed Respondent that UC2 had
obtained hydrocodone tablets from his girlfriend, without a
legitimate prescription.
In addition to the OSC, the Government also noticed and alleged
additional information in its initial and supplemental prehearing
statements. In addition to noticing in greater detail its
allegations related to the visits by UC1 and UC2 (e.g., ALJ Ex. 4 at
6-16; ALJ Ex. 7 at 4-5), the Government further alleged that:
1. Vincent Colangelo, the owner/operator of several pain clinics
in the Broward County area, including All Pain Management (APM),\1\
where Respondent practiced, was involved in an illicit multi-level
distribution enterprise of pharmaceutical controlled substances, to
include, but not limited to, oxycodone (ALJ Ex. 4 at 4);
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\1\ The testimony at hearing reflected that APM is located at
3300 Griffin Road, Dania Beach, Florida. (Tr. 209.)
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2. Mr. Colangelo controlled the issuing, ordering and dispensing
of controlled substances for APM, to include among other things a
requirement that physicians prescribe the highest quantity of
oxycodone and hydrocodone possible (ALJ Ex. 4 at 4-5);
3. Respondent ordered Schedule III-IV controlled substances at
his registered location at 750 South Federal Highway, Deerfield
Beach, Florida 33441, but did not maintain a current biennial
inventory as of February 23, 2011 (ALJ Ex. 4 at 6);
4. A March 29, 2011 on-site inspection and audit of Respondent's
registered location for a period from November 16, 2009, through
March 29, 2011, revealed that:
a. Discrepancies existed in Respondent's accounting for four
controlled substances, constituting a failure to maintain complete
and accurate records of controlled substances as required by 21
C.F.R. Sec. Sec. 1304.21(a) and 1304.22(c) (see ALJ Ex. 7 at 2);
b. Respondent failed to note whether required inventory was
taken at the open or close of the business day as required by 21
C.F.R. Sec. 1304.11(a) (see ALJ Ex. 7 at 3);
c. Respondent failed to properly document the date received on
twenty of thirty-seven receiving invoices, as required by 21 C.F.R.
Sec. Sec. 1304.21(a) and 1304.22(c) (see ALJ Ex. 7 at 3);
d. Respondent failed to maintain two receiving invoices or
packing slips documenting the receipt of controlled substances from
Stat Rx as required by 21 C.F.R. Sec. 1304.21(a) (see ALJ Ex. 7 at
3);
5. On March 1, 2011, Respondent surrendered for cause DEA CORs
FC1777260 and FC1881211 (ALJ Ex. 4 at 6); and
6. Within minutes of one another, Respondent issued nearly
identical prescriptions for controlled substances to two patients
\2\ from Kentucky, who traveled together to see Respondent (ALJ Ex.
7 at 2).
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\2\ The Government's Supplemental Prehearing Statement
referenced three customers and related prescriptions. (ALJ Ex. 7 at
2.)
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Following prehearing procedures, a hearing was held in Miami,
Florida between June 14, 2011, and June 15, 2011, with the
Government and Respondent each represented by counsel. Both parties
called witnesses to testify and introduced documentary evidence.
After the hearing, both parties filed proposed findings of fact,
conclusions of law and argument. All of the evidence and post-
hearing submissions have been considered, and to the extent the
parties' proposed findings have been adopted, they are substantively
incorporated into those set forth below.
II. Issue
Whether the record establishes that Respondent's DEA COR as a
practitioner BC8677746 \3\ should be revoked and any pending
applications for renewal or modification, and any applications for a
new registration, should be denied on the grounds that Respondent's
continued registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. Sec. Sec. 824(a)(4) and
823(f).
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\3\ As noted above, the OSC in this case identified three CORs.
(ALJ Ex. 1.) On March 1, 2011, Respondent surrendered CORs FC1777260
and FC1881211. (Gov't Exs. 3 & 4; see also Jt. Stips. 4 & 5.)
Respondent concedes that he surrendered the CORs but denies having
done so for cause. (E.g., ALJ Ex. 5 at 2-3.)
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III. Evidence and Incorporated Findings of Fact \4\
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\4\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
Sections of this Recommended Decision.
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I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts \5\
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\5\ See ALJ Ex. 9; see also Tr. 5-6, 301.
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1. Respondent is registered with the DEA as a practitioner in
Schedules II-V under DEA COR BC8677746 at 750 South Federal Highway,
Deerfield Beach, Florida 33441.
2. Respondent is licensed by the Florida Department of Health as
a medical doctor and has been licensed to practice medicine in
Florida since August 12, 1999.
3. Respondent has never been disciplined by the Florida
Department of Health.\6\
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\6\ See Tr. 448-49. At hearing, Respondent testified that his
drug inventory has been audited annually by the Florida Department
of Health with no negative results. (See Tr. 449.)
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4. Respondent was registered with DEA as a practitioner in
Schedules II-V under DEA COR FC1777260. He surrendered registration
FC1777260 on March 1, 2011.
5. Respondent was registered with DEA as a practitioner in
Schedules II-V under DEA COR FC1881211. He surrendered registration
FC1881211 on March 1, 2011.
[[Page 58153]]
6. On February 16, 2010, Respondent saw and treated an
individual who identified himself as ``Eugene O'Neal'' at APM Urgent
Care, 3300 Griffin Road, Dania Beach, Florida. Respondent wrote the
prescriptions listed as Government Exhibit 9 for this individual.
The patient file for ``Eugene O'Neal'' as produced by the Government
is listed as Government Exhibit 10.
7. On February 16, 2010, Respondent saw and treated an
individual who identified himself as ``Alfredo Mondego'' at APM
Urgent Care, 3300 Griffin Road, Dania Beach, Florida. Respondent
wrote the prescriptions listed as Government Exhibit 13 for this
individual. The patient file for ``Alfredo Mondego'' as produced by
the Government is listed as Government Exhibit 14.
8. On March 10, 2010, Respondent saw and treated an individual
who identified herself as ``Julia Sanchez'' at Coast to Coast
Healthcare Management (CCHM), 328 East Hillsboro Boulevard,
Deerfield Beach, Florida 33441. Respondent wrote the prescriptions
listed as Government Exhibit 17 for this individual. The patient
file for ``Julia Sanchez'' as produced by the Government is listed
as Government Exhibit 18.
B. Introduction
Respondent is licensed to practice medicine in Florida and
Massachusetts. (Jt. Stips. 2, 3; Tr. 412-13.) He possesses a medical
degree from Tufts University and currently practices in Deerfield
Beach, Florida at MinorEmergi Center--Primary Care, 762 South
Federal Highway, Deerfield Beach, Florida, and at MinorEmergi
Center--Urgent Care & Walk-In Medicine, 750 South Federal Highway,
Deerfield Beach, Florida (collectively ``MEC'').\7\ (See Tr. 17;
Gov't Ex. 5.) He has been at MEC for five to six years. (Tr. 22.)
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\7\ The evidence at hearing tended to show that these two
addresses are physically connected and are part of a unified
practice, as discussed below.
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Respondent testified that he previously practiced in Miami at
the emergency room of Westchester Hospital and also at another
office in the Miami area. (Tr. 22; see Tr. 412.) In addition, he
previously worked at a Level Two Trauma Center in Boston,
Massachusetts.\8\ (Tr. 35, 411-12.) He possesses no board
certifications and is not employed as a faculty member of a medical
school. (Tr. 454.)
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\8\ Respondent also completed an internship in general surgery
at St. Elizabeth's Hospital in Boston, Massachusetts for one year
and a residency in ear, nose and throat surgery at Tufts Medical
School New England Medical Center. (Tr. 410.)
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Respondent also worked as a physician at APM one day per week
from December 2009 to February 2010 (Tr. 22-24, 28; see Gov't Ex.
20) and at CCHM from March to April 2010.\9\ (Tr. 22-23.)
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\9\ Respondent testified that he dispensed Schedule III and IV
controlled substances at these clinics, to include hydrocodone,
Roxicodone, Valium and Xanax, as well as muscle relaxants and anti-
inflammatories. (Tr. 23.)
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The gravamen of the Government's allegations relate to
Respondent's recordkeeping at MEC and prescribing practices at APM
and CCHM.
C. Evidence
1. Background
(a) Witnesses
The Government's evidence included testimony from eight
witnesses, including Respondent and a pain management expert, David
M. Glener, M.D. (Dr. Glener). Two witnesses were undercover law
enforcement officers who posed as patients and received treatment
from Respondent at APM: DEA Special Agent (SA) Gene George
Grafenstein, Jr. (SA Grafenstein) and SA Alfred Cortes \10\ (SA
Cortes). In addition, the evidence included testimony from SA Joe
Gill (SA Gill) ``case agent'' for the investigation of APM, as well
as Group Supervisor (GS) Susan Langston (GS Langston), Diversion
Investigator (DI) William Stockmann (DI Stockmann) and DI James
Graumlich (DI Graumlich), all of whom played a role in
investigations relating to Respondent.
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\10\ Spellings in the transcript vary between ``Cortes'' and
``Cortez.'' Because the Government's exhibits reflect the spelling
``Cortes'' (e.g., Gov't Ex. 12), that spelling is adopted in this
Recommended Decision.
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The Government's evidence also included various audio and video
recordings of undercover meetings that occurred at APM and CCHM,
along with transcripts of portions of the recordings. (Gov't Exs. 8-
18.)
Respondent's evidence included testimony from one witness,
Respondent. Respondent testified regarding his education and
professional background, as well as his prescribing practices.
Respondent's evidence also included a handwritten Biennial
Medication Inventory dated November 16, 2009.\11\ (See Resp't Ex.
1.)
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\11\ Respondent Exhibit 1 appears to be substantially the same
as Government Exhibit 19 at 2.
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With the exception of Respondent, I find all of the witnesses at
hearing to be fully credible in that the testimony was generally
internally consistent and evidenced a reasonable level of memory for
past events. Each witness presented testimony in a professional
manner and the material portions of the testimony were consistent
with other credible evidence of record. Respondent's testimony was
generally presented in a professional and serious manner, but, in
certain instances discussed below, I find Respondent not credible to
the extent his statements are contradicted by the weight of the
objective evidence of record.
(b) Identified Controlled Substances
Uncontradicted testimony at hearing indicated that Lortab and
Vicodin are brand names for hydrocodone, a Schedule III controlled
substance. (Tr. 126, 137, 499.) Guaifenesin Ac is a controlled
substance because it contains codeine. (Tr. 179.) Ambien is a brand
of zolpidem. (See Tr. 199.) In addition, I take official notice that
Zolvit is hydrocodone, a narcotic and Schedule III controlled
substance; Percocet and Roxicodone are oxycodone, narcotics and
Schedule II controlled substances; and Xanax is alprazolam, a
benzodiazepine and Schedule IV controlled substance.\12\
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\12\ Under the APA, an agency ``may take official notice of
facts at any stage in a proceeding--even in the final decision.''
U.S. Dept. of Justice, Attorney General's Manual on the
Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc.,
Reprint 1979). In accordance with the APA and DEA's regulations,
Respondent is ``entitled on timely request, to an opportunity to
show to the contrary.'' 5 U.S.C. Sec. 556(e); 21 C.F.R. Sec.
1316.59(e) (2011); see, e.g., R & M Sales Co., 75 Fed. Reg. 78,734,
78,736 n.7 (DEA 2010). Respondent can dispute the facts of which I
take official notice by filing a properly supported motion for
reconsideration within twenty days of service of this Recommended
Decision, which shall begin on the date it is mailed. See, e.g.,
Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,088 (DEA 2009)
(granting respondent opportunity to dispute officially noticed facts
within fifteen days of service).
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2. MEC
(a) Background
Respondent testified that his current practice is located at 750
and 762 Federal Highway, consisting of ``two offices that are
centrally based that are adjoined through a door * * * one of them
is urgent care and one of them is primary care * * * .'' (Tr. 414-
15.) Respondent's DEA registration is for 750 South Federal Highway.
(Jt. Stip. 1; Tr. 463.) Respondent explained that the primary care
practice ``is more of a practice where patients are scheduled to be
seen and so forth where they have regularly scheduled visits. * * *
They're patients who you know who you've developed a rapport with,
who you have developed a treatment plan over an extensive period of
time * * * .'' (Tr. 415.) In the urgent care practice, by contrast,
``usually patients come in for an acute issue that has to be dealt
with'' urgently, to include patients suffering from acute pain. (See
Tr. 415.) Respondent explained that ``there is no dispensing of any
narcotics at 762'' South Federal Highway and no controlled
substances are kept on hand in that portion of the facility. (Tr.
464.)
Consistent with Respondent's testimony, DI Stockmann testified
that 750 and 762 South Federal Highway are storefronts. (Tr. 115.)
One is a primary care center and the other is an urgent care center,
at different ends of the same building. (Tr. 115.) Although each
address had a separate entrance, 762 and 750 are physically
connected. (Tr. 141.) When inside one office, it is possible to get
to the other office via interior access.\13\ (Tr. 142-43.)
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\13\ DI Stockmann elaborated that on February 23, 2011, he
collected a copy of the clinic's prescription dispensing summary
report and two MEC business cards, one of which lists Respondent as
Medical Director. (See Tr. 109, 136; Gov't Ex. 5.) DI Stockmann
testified that the business cards reflect addresses of ``Minor
Emergency Center, Primary Care, with Dr. Casanova's name on it, with
an address of 762 South Federal Highway, Deerfield Beach, Florida. *
* * [T]he second card displays Dr. Casanova's name and also Minor
Emergency Center, Urgent Care and Walk-In Medical Center, with an
address of 750 South Federal Highway, Deerfield Beach, Florida.''
(Tr. 109; see Gov't Ex. 5.)
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(b) Dispensing at MEC
Respondent dispenses medication at MEC in conjunction with a
company called InstyMeds.\14\ (Tr. 17, 416.) InstyMeds
[[Page 58154]]
supplied MEC with a machine located in the corner of the waiting
room that dispenses a variety of medications to patients, to include
antibiotics and Schedule III and IV controlled substances. (See Tr.
19-20.) DI Graumlich described it as a ``vending machine where
people can get their prescriptions filled after they've been written
by the doctor.'' \15\ (Tr. 165.) Medications are stored in racks and
when patients enter an access code ``it provides them the
medication.'' (Tr. 18-19; see Tr. 165-66.)
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\14\ MEC previously worked with a company called Linear
Solutions, but ended the relationship approximately two months
before the hearing. (Tr. 18.)
\15\ Respondent described the machine as a large box,
approximately six feet tall and three or four feet wide. (Tr. 19.)
He called it a ``vehicle to allow the patients [sic] to get
medications after the patient has been seen, treated, examined and
determined that the patient needs medications for their [sic]
diagnosis.'' (Tr. 18.)
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The machine, which is loaded by Respondent's staff, provides
medication only while the office is open, and only after patients
have received ``all the paperwork from the prescribing provider.''
(Tr. 19, 36-37.) The technology has been available for ten to
fifteen years in hospitals and other local facilities. (Tr. 19, 21.)
The InstyMeds machine is provided for ease or convenience. (Tr. 21.)
Respondent believes using InstyMeds is compliant and assists with
all ordering, stocking, dispensing, reporting and recording
requirements related to controlled substances.\16\ (Tr. 36-37; see
Tr. 450.) MEC makes a small profit from using InstyMeds to dispense
controlled substances. (Tr. 21.)
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\16\ According to DI Graumlich, ``[t]he benefit of the InstyMeds
machine * * * was that the computer system tracks what is in the
machine and what has been dispensed, and therefore they can tell
which drugs they are running low on to place orders for.'' (Tr.
170.)
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(c) February 23, 2011 Interview with Respondent
DI Stockmann \17\ participated in an investigation of Respondent
by serving the OSC and a notice of inspection upon Respondent and
interviewing him on February 23, 2011, at MEC. (See Tr. 105-06.) DI
Stockmann testified that at this interview Respondent identified
MEC's hours of operation as Monday to Friday, 9:00 a.m. to 7:00
p.m., and weekends from 9:00 a.m. to 3:00 p.m. (See Tr. 106.)
Respondent also stated that he employed four to five physician
attendants and that his weekly hours were Monday, Wednesday and
Friday, 9:00 a.m. to 5:00 p.m., and Tuesdays and Thursdays 9:00 a.m.
to 1:00 p.m. (Tr. 106-07.) Respondent saw approximately fourteen or
fifteen thousand patients each year, or approximately fifty patients
per day. (Tr. 107.) Respondent acknowledged ordering Schedule III
and IV controlled substances for MEC. (Tr. 107-08.)
---------------------------------------------------------------------------
\17\ DI Stockmann testified to having been a DEA DI for the past
eight years. (Tr. 104-05.) In this role he investigates and inspects
registered locations, seeking to prevent the diversion of controlled
substances from legal distribution channels into the illicit market.
(Tr. 104.) DI Stockmann previously worked for twelve years as a St.
Louis City Metropolitan Police Officer, for the last three of which
as a DEA Task Force Officer. (Tr. 105.) His total law enforcement
experience is twenty years, and he has a bachelor's degree in
criminology and criminal justice. (Tr. 105.)
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DI Stockmann further testified that he inspected MEC on February
22, 2011, finding ``no evidence of a biennial inventory for that
registered location of the controlled substances on hand.'' (Tr.
108.) He testified that Respondent acknowledged this was a violation
of federal regulations. (Tr. 108.)
Additionally, DI Stockmann recounted Respondent's surrender of
two of his DEA CORs on March 1, 2011. (Tr. 111; see Gov't Exs. 3,
4.) Because Respondent was not operating at those locations, DI
Stockmann asked Respondent if he would surrender those certificates.
(Tr. 130.) At Respondent's request, DI Stockmann called Respondent's
counsel and explained he was asking Respondent to surrender licenses
for facilities that were not being operated. (Tr. 130.) He did not
explain which box he intended to check on the surrender form.
(Compare Tr. 130, with Gov't Ex. 3 at 1; Gov't Ex. 4 at 1.) DI
Stockmann explained to Respondent that he had found violations of
federal and state law at those locations, to include recordkeeping
violations. (Tr. 133.) DI Stockmann further testified that the
surrender forms were ``presented to him and [they were] explained to
him. And I actually read the top section and he was asked to make
sure he read it and understood it.'' (Tr. 139.) The Government's
evidence reflects that boxes are checked on the surrender forms next
to text indicating that the surrender would be made: ``In view of my
alleged failure to comply with the Federal requirements pertaining
to controlled substances, and as an indication of my good faith in
desiring to remedy any incorrect or unlawful practices on my part *
* *.'' (Gov't Exs. 3, 4.) Respondent signed at the bottom of the
page. (Tr. 139.)
DI Stockmann testified that a ``pill mill'' is an operation
containing ``a doctor and a pharmacy, located basically in the same
building, and the doctor sees the patients and then he dispenses''
hydrocodone or oxycodone. (Tr. 117.) Pill mills are marked by
``[t]ons of patients in the patient room, they've got patients lined
up outside, they've got people that are, for lack of a better term,
obsessing about getting in to see physicians.'' (Tr. 118.) DI
Stockmann testified that MEC is not a pill mill.\18\ (See Tr. 118,
127-28.)
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\18\ DI Stockmann testified that the non-controlled substance
medications listed in MEC's ``Prescriptions Dispensed Summary
Report'' were of the sort that would typically be dispensed in a
general medical practice. (Tr. 122; see Gov't Ex. 6; see also Tr.
389-90 (concurrence in this assessment of Government's expert
witness, Dr. Glener).) He also testified that the six prescriptions
of the controlled substance Guaifenesin AC Syrup 100 mg recorded as
having been dispensed over a two-year period (Gov't Ex. 6 at 15) was
not an inordinate amount. (Tr. 125.) He also opined that 145
prescriptions for hydrocodone dispensed over a two-year period
(Gov't Ex. 6 at 17) was not consistent with pill mill dispensing.
(Tr. 125.) Additionally, the clinic did not buy medication in bulk
and then repackage it. (Tr. 126.)
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Respondent fully and completely cooperated in the inspection of
MEC on February 23, 2011, to include granting access to records and
inventory. (Tr. 114-15, 119-20.) Without Respondent's consent, the
Government would have needed to acquire search warrants. (Tr. 113-
14.)
In summary, DI Stockmann saw nothing that was outside the scope
of normal medical practice. (Tr. 128.) His statement to Respondent
that he could not locate a copy of a biennial inventory was his sole
critique. (Tr. 128.)
(d) March 29, 2011 Audit of MEC
DI Graumlich \19\ testified that he conducted an inspection and
audit of MEC on March 29, 2011. (See Tr. 148.) Respondent consented
and cooperated, giving agents full access to everything they needed,
although he was not required to do so. (Tr. 152, 184; Gov't Ex.
19(a).)
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\19\ DI Graumlich has worked as a DEA DI for twenty-two years
and holds a bachelor's degree. (Tr. 147-48.) His duties include
ensuring compliance with the regulations under the Controlled
Substances Act (CSA). (Tr. 147.) Consistent with these duties, DI
Graumlich has conducted over 100 accountability audits. (Tr. 149.)
An accountability audit ensures certain records are being kept and
that rules are being followed. (Tr. 148-49.)
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DI Graumlich's audit covered a time frame from November 16,
2009, through March 29, 2011. (Tr. 149.) The audit occurred on-site
\20\ and reflected a physical hand count verified by members of
Respondent's staff of dosage units present (Tr. 171, 174, 196-97),
to include two different strengths of hydrocodone, Guaifenesin with
codeine, Zolvit and zolpidem. (Tr. 150.)
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\20\ As DI Graumlich explained, ``[w]e didn't actually remove
hard documents. We copied documents on site at the location and left
the original documents with the registrant.'' (Tr. 189.)
---------------------------------------------------------------------------
DI Graumlich requested that Respondent provide any inventory
records MEC had taken within the past two years, specifically, the
biennial inventory and Respondent's distribution and receiving
records. (Tr. 158-59, 174.) Respondent's staff provided a binder
containing copies of receiving invoices and pedigree information for
drugs purchased, ranging from November 2009 to March 29, 2011. (Tr.
174.) DI Graumlich then calculated the total amount of controlled
substances for which Respondent was accountable, as compared to the
total amount Respondent had records of distributing or transferring.
(See Tr. 174-77; Gov't Ex. 19(e).)
At hearing, DI Graumlich testified that Joy Egan, Respondent's
office manager (Tr. 26, 153, 202), identified Danny McBride as the
representative from Linear Solutions. (Tr. 153-54.) MEC's records
indicated that Mr. McBride physically counted all the pills located
at the clinic on November 16, 2009, but it is unclear whether this
count occurred ``at the beginning or end of the business day, so we
didn't know whether to give them credit for the prescriptions that
were written that day.'' (Tr. 154, 164; Gov't Ex. 19(b).) DI
Graumlich testified that the failure to indicate whether the
biennial inventory was taken at the opening or closing of the
business day constituted a violation of federal regulations. (Tr.
164, 181, 199.) He stated that Respondent's biennial inventory was
also noncompliant because it did not go back a full two years from
the date of the audit. (Tr. 200.)
Based on the audit, DI Graumlich found that Respondent was
accountable for thirty-five bottles of Guaifenesin Ac but could only
account for twenty-seven bottles, resulting in a shortage of eight
bottles, a 22.86 percent difference. (Tr. 177, 198-99; Gov't Ex.
19(e).)
[[Page 58155]]
Moreover, with respect to Hydrocodone Apap 5/500 30-count bottles,
the audit revealed an overage \21\ of one bottle, thirty dosage
units or 0.89 percent. (Tr. 177-78, 197-98.) With respect to
Hydrocodone Apap 7.5/500 30-count bottles, the audit revealed a
shortage \22\ of five bottles, 150 dosage units or four percent.
(Tr. 178-79, 198.) As for zolpidem, the audit revealed a shortage of
three bottles, 180 dosage units or twenty-five percent. (Tr. 180,
199.)
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\21\ An overage occurs ``when they account for distributing more
drugs than they can account for purchasing.'' (Tr. 178.)
\22\ Shortages can occur for various reasons, to include
recordkeeping issues, theft or loss. (Tr. 180.)
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DI Graumlich explained that DEA registrants are ``required to
maintain records of all controlled drugs received, distributed or
otherwise dispensed. And if we have records of all the drugs
received or distributed, the account should zero out.'' (Tr. 180-
81.) He testified that the fact that Respondent's records of
controlled substances did not zero out constituted a failure to
maintain complete and accurate records, in violation of federal
regulations.\23\ (Tr. 181, 203-04.)
---------------------------------------------------------------------------
\23\ He conceded, however, that regulated audits of
manufacturers and distributors of controlled substances do not
always zero out. (Tr. 187.)
---------------------------------------------------------------------------
In addition, DI Graumlich noted that approximately twenty of
MEC's receiving invoices did not reflect the date received,
constituting a failure to maintain complete and accurate records.
(Tr. 181.) MEC ``provided me with copies of pedigree documents,
rather than invoices. * * * They said they * * * had been moved to
storage and that they would get those for me. They never did get
those for me.'' \24\ (Tr. 193.) After Respondent's office provided
pedigree records, DI Graumlich gave the clinic several opportunities
to provide missing records, to include emailing Ms. Egan after the
inspection. (Tr. 202.) He again requested invoices, but ``we were
never provided with any other documents. According to Ms. Egan, I
believe they could not find the other binder.'' (Tr. 194.)
---------------------------------------------------------------------------
\24\ DI Graumlich testified that DEA does not require that
physicians maintain pedigree records. (Tr. 194.)
---------------------------------------------------------------------------
The audit further revealed ``two receiving invoices that they
did not have a record of'' based on ``a printout of their receipts
from Stat Rx, their distributor * * *.'' (Tr. 182.)
The audit also reflected MEC's change from using Linear
Solutions to InstyMeds. (See Tr. 156-57; Gov't Ex. 19(e).) The audit
of the InstyMeds machine reflected no discrepancies.
There were, moreover, no discrepancies in the audit of Zolvit
oral solution, although ``they originally didn't have any records
for that but we had them get copies of their records from their
vendor.'' (Tr. 197.)
Although I credit DI Graumlich's uncontested testimony as to his
audit's factual findings, I grant no weight to his opinions as to
the legality of the findings because these opinions speak to the
ultimate issues in the case. A later section of this Recommended
Decision addresses the legal ramifications of the March 29, 2011
audit.
(e) Respondent's Position on the MEC Audit
Respondent credibly testified that regarding recordkeeping,
[t]he bottom line is that I ultimately am responsible and was held
accountable and I wasn't aware of the fact that he had not gotten
the rest of the information. Maybe there was a misunderstanding in
regards to the pedigree paperwork and so forth. I am fully aware of
that and irrespective of the results of these hearings, I plan to
provide all the appropriate information that is required and
necessary.
(Tr. 449-50; see also Resp't Br. at 8.) Upon inquiry from his
attorney, Respondent testified that he ``fully understand[s]'' that
audit results need to zero out, and that he ``[o]ne hundred
percent'' intends to ensure future deliveries are properly
documented. (Tr. 450.)
3. All Pain Management (APM)
(a) Background of Investigation of APM and its Owners
SA Gill \25\ testified to being the ``case agent'' for an
investigation of APM (Tr. 84), and that Respondent was a physician
there. (Tr. 43.) In approximately September 2009, SA Gill received
information that a Mr. Vincent Colangelo owned several pain clinics
in South Florida. (Tr. 43.) He opened an investigation on Mr.
Colangelo and discovered that APM was one of the clinics in which
Mr. Colangelo owned an interest in approximately October or November
of 2009. (Tr. 43-44.) The investigation also revealed that Mr.
Colangelo operated a number of clinics without possessing a DEA COR.
(Tr. 44.) Joel Ortega and Maite del Rey were two other co-owners of
APM but Mr. Colangelo was the primary owner, although he was not
there on a daily basis.\26\ (Tr. 44, 46-47.)
---------------------------------------------------------------------------
\25\ SA Gill testified in substance to having eight years of
experience working for the DEA. (Tr. 41.) He has worked for two
years in a tactical diversion squad, a working group that focuses on
pain clinics, doctors and pharmaceuticals. (Tr. 41.) Prior to
joining DEA he worked for three-and-one-half years at a police
department in New Jersey and as a crime analyst and statistician.
(Tr. 42.) He holds a bachelor's and a master's degree in criminal
justice. (Tr. 43.)
\26\ SA Gill testified that Mr. Ortega and Ms. del Rey were the
original owners of APM. (Tr. 83.) The business was not doing well,
and Mr. Colangelo offered to become part owner in exchange for
providing patients. (Tr. 83-84.) Mr. Ortega and Ms. del Rey oversaw
daily operations. (Tr. 84.)
---------------------------------------------------------------------------
SA Gill testified that based on his investigation, Mr. Colangelo
was responsible for finding, interviewing and hiring ``doctors that
would write scripts and see the number of patients that he wanted to
be seen, basically.'' (Tr. 46.) SA Gill testified that Mr. Colangelo
would collect the clinic's money or it would be delivered to him at
the end of the night or several times per week. (Tr. 46-47.)
Based on information from a confidential source, SA Gill
testified that Mr. Colangelo only employed doctors ``that would
follow his rules and there weren't specific quantities or types that
doctors had to write, but if they weren't writing high enough
scripts they would be fired.'' (Tr. 47.) Mr. Colangelo initially had
a mandatory prescription ``formula'' of 240/90/90, meaning 240
oxycodone 30 mg dosage units, 90 oxycodone 15mg dosage units, and 90
Xanax 2 mg dosage units. (Tr. 48.) The formula was not something
doctors started with initially and not every patient received it.
(Tr. 67, 69.) SA Gill explained that ``[o]n the first visit, for
someone to get 240/90/90, they would die * * *. So the doctor builds
up to that.'' \27\ (Tr. 69.) Respondent's prescriptions \28\ at APM
did not appear to comply with the 240/90/90 rule.\29\ (Tr. 67.)
---------------------------------------------------------------------------
\27\ SA Gill elaborated that ``if you were an existing patient
at another clinic and went in and told the doctor that you were
currently getting 240/90/90, chances are you would get the maximum
or close to it. If you were a new patient and didn't have any prior
medical records from the pain clinic then the doctors would start
you out lower and build you up to that level.'' (Tr. 85-86.)
\28\ SA Gill testified that the Government obtained patient
files after executing a search warrant on March 1, 2011, at a
storage unit owned by Mr. Colangelo. (Tr. 52.) The Government
obtained undercover patient files for SA Grafenstein, SA Cortes and
SA Saenz in this manner. (Tr. 56-58.)
\29\ For instance, SA Grafenstein received a prescription for
180 oxycodone 30 mg tablets and 60 Xanax 2 mg tablets, SA Cortes
received a prescription for 120 hydrocodone 7.5 mg tablets and SA
Saenz received a prescription for 90 hydrocodone 5 mg tablets, 90
Motrin 800 mg tablets and a pack of Medrol. (Tr. 67-69; Gov't Ex. 9;
Gov't Ex. 10 at 3-4; Gov't Ex. 13; Gov't Ex. 17.)
---------------------------------------------------------------------------
SA Gill testified that the investigation of Mr. Colangelo led to
an indictment and superseding indictment against Mr. Colangelo. (Tr.
62.) Respondent is not mentioned in either document, and SA Gill is
aware of no evidence that Respondent knew Mr. Colangelo, was in
contact with him or knew he owned an interest in APM. (See Tr. 63,
82.) SA Gill does not know who hired Respondent. (Tr. 64.) Moreover,
SA Gill is aware of no evidence that Mr. Colangelo had anything to
do with Respondent's treatment of patients, or what patients he saw
or turned away. (Tr. 64-65.)
Similarly, Respondent testified that he had no knowledge of Mr.
Colangelo's ownership of APM.\30\ (Tr. 462.) He testified that APM
was owned by a married couple named Maite and Joel, who also ran the
facility. (Tr. 24-25, 38, 458. But see Tr. 84.) Respondent testified
that Maite and Joel hired him after he interviewed with Maite. (Tr.
39.) Maite told him at his employment interview that she was the
owner of APM. (Tr. 39.) He did not look up the ownership records of
APM on a Florida government Web site.\31\ (Tr. 39.)
---------------------------------------------------------------------------
\30\ In light of the evidence, I agree with Respondent that
``the Government has failed to offer any evidence that Dr. Casanova
was somehow part of or even aware of Vincent Colangelo's alleged
criminal activity and his alleged hidden ownership of All Pain and
Coast to Coast.'' (Resp't Br. 29.)
\31\ SA Gill testified that www.sunbiz.org, the Florida Web site
that provides public information as to the form of a business
entity, does not provide information as to who owns a corporation.
(Tr. 80.) For instance, with respect to APM, Mr. Colangelo's name is
not reflected on the Web site. (Tr. 81.)
---------------------------------------------------------------------------
(b) Respondent's Employment and Practice at APM
Respondent testified that he worked as an independent contractor
at APM for six to eight weeks from December 2009 to February 2010.
(Tr. 22-23; see Tr. 416, 454-55.) He
[[Page 58156]]
started working at APM based on a referral from a friend of a friend
and intended to conduct clinical research there. (Tr. 455-58.) He
testified that he approached patients about possibly participating
in clinical research, but acknowledged that he did not ask either SA
Grafenstein or SA Cortes. (See Tr. 459.)
Respondent further testified that he was not APM's medical
director and that his duties included evaluating patients,
conducting an appropriate examination and providing appropriate
care. (Tr. 416-17.) Respondent did not schedule appointments but
believes APM accepted walk-in patients.\32\ (See Tr. 417.)
Respondent explained that most patients came to APM as referrals
from other physicians and patients, and from Internet marketing.\33\
(Tr. 29-30.) He testified that APM did not dispense controlled
substances. (Tr. 24.) He worked one day per week and maintained a
separate practice elsewhere. (Tr. 28, 455.)
---------------------------------------------------------------------------
\32\ Respondent equivocated on this point, also testifying that
the clinic at one point accepted only scheduled appointments and did
not accept walk-ins. (Tr. 28-29.)
\33\ Respondent never saw the Internet marketing, but the owners
told him about it. (Tr. 29.)
---------------------------------------------------------------------------
Respondent testified that APM patients paid a fee of
approximately $250 to see him, but those transactions were handled
at the front desk. (Tr. 25-26, 456.) APM accepted insurance but most
of the patients were private pay. (Tr. 29.) As compensation,
Respondent received fifty dollars per patient he saw and did not
receive bonuses. (Tr. 27-28; see Tr. 456.) Initially he saw between
ten and fifteen patients per week, and later between twenty and
thirty. (Tr. 28.) Respondent estimated that he saw approximately
four or five patients per hour and worked from 2:00 p.m. to 9:00
p.m. (Tr. 28.)
Respondent testified that patients who came to APM brought
medical records, to include MRI reports, to the best of their
ability. (Tr. 31, 33.) Respondent required an MRI report from every
patient. (Tr. 31.) Maite was responsible for verifying the validity
of each MRI report. (Tr. 31-32.)
Respondent testified that he performed a physical examination
and ``made a diagnosis and we talked about how we're going to
progress and provide care'' for each patient he saw. (Tr. 32.)
Respondent further testified that paperwork provided to each patient
addressed the risks and benefits associated with a course of
treatment. (Tr. 32-33.) In addition, Respondent testified that a
``treatment plan was formulated either in terms of the documentation
on the paperwork or mentally in terms of the documentation and a
plan and a process.'' (Tr. 33-34.)
Respondent testified to being familiar with the term ``track
marks,'' which he said referred to people making injections on their
arms. (Tr. 34.) He testified that he checked his patients for track
marks.\34\ (Tr. 34-35.)
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\34\ In addition, the refund policy at APM indicates that
refunds will not be granted for ``signs of IV drug use (track
marks).'' (Gov't Ex. 10 at 5.)
Respondent ended his relationship with APM because after a
period of time, I was told or I explained that I had certain
requirements and so forth and that I was looking to try to provide
care on a multi-disciplinary level with a variety of different
specialties and so forth and as I proceeded to go on, some of these
---------------------------------------------------------------------------
things were not coming to fruition so I decided to part ways.
(Tr. 455.)
(c) Undercover Patient Visits to APM
(i) SA Grafenstein February 16, 2010 Undercover Visit to APM
SA Grafenstein \35\ visited APM in an undercover capacity on
February 16, 2010, posing as a patient.\36\ Aside from noting that
APM staff measured his vital signs and did not supervise him while
he submitted a urine sample (see Tr. 240), SA Grafenstein's
testimony related primarily to conversations he overheard in the
waiting area and his visit with Respondent.
---------------------------------------------------------------------------
\35\ SA Grafenstein has worked as a DEA SA for approximately two
years. (Tr. 206.) He previously worked for approximately eight and
one-half years as an officer with U.S. Customs and Border Protection
and as a park ranger in Arlington County, Virginia. (Tr. 207.) He
holds a bachelor's degree in criminal justice. (Tr. 207.)
\36\ The following summary of SA Grafenstein's undercover visit
to APM is supplemented in a later section of this Recommended
Decision by additional findings of fact, and by conclusions of law.
---------------------------------------------------------------------------
Among approximately fifteen people in the waiting area, SA
Grafenstein conversed with patient [M.B.],\37\ who indicated that
existing patients were always seen before new patients (Tr. 228) and
recommended that SA Grafenstein avoid the pharmacy Generic Drug
Depot, because it was ``very hot right now and there were cops all
over the place and that there were people standing outside trying to
buy pills off the people who came, who just got their prescriptions
filled there.'' (Tr. 228-29.) [M.B.] also asked SA Grafenstein to
provide a urine sample for [M.B.]'s drug test, and SA Grafenstein
complied. (Tr. 231-32.) APM staff left the restroom unsupervised and
[M.B.] later left the clinic carrying more than one prescription.
(Tr. 232.)
---------------------------------------------------------------------------
\37\ To protect patient privacy, initials are used in this
Recommended Decision to refer to non-undercover patients.
---------------------------------------------------------------------------
Another patient recounted submitting urine mixed with water from
a toilet for a drug screen. (Tr. 235.) SA Grafenstein also testified
that patient [M.I.] was carrying a Gatorade bottle containing urine
of a person who had driven [M.I.] to the clinic ``because the
individual who was seeing the doctor told him that he would give him
half of whatever he was prescribed for driving him down there.''
(Tr. 239.) [M.I.] stated that ``two hours prior to that specific
time he had gone home and did cocaine, not knowing that he'd have to
take a drug test. And after he learned that, he ingested bleach to
attempt to detoxify it so that he would be able to beat the drug
test.'' (Tr. 237.) SA Grafenstein testified that Respondent later
issued a prescription to [M.I.] (Tr. 239.) SA Grafenstein also
related overhearing that ``if you failed the drug test for
marijuana, you could pay $50 * * * and the administrator would make
your hot, or your failed test, clean.'' (Tr. 237.)
SA Grafenstein also testified to his interactions with
Respondent, which began approximately six hours after the agent
arrived at APM. (See Tr. 220, 241-44, 247.) SA Grafenstein indicated
he was in ``[a] lot of pain. My upper [back] is bother [sic] me, a
little sore. My lower, nothing that's * * * like excruciating * * *
sometimes I can't move my neck.'' (Gov't Ex. 8 at 33.) He indicated
his pain without medication was a two and with medication was a
zero, on a scale of one to ten. (See Tr. 242.) After reviewing the
patient's MRI report, Respondent said ``I can't tell you anything
about your neck `cause you don't have an MRI.'' (Gov't Ex. 8 at 34;
see Tr. 241.) ``The one you have there tells me that you have some
problems in your low back * * * It tells me nothing about your
neck.'' (Gov't Ex. 8 at 35.) But Respondent did not order an MRI of
the patient's neck. (Tr. 244.)
Respondent directed SA Grafenstein to raise his hands and inhale
and listened to his breathing. (Tr. 242; Gov't Ex. 8 at 37, 39.) He
also felt along SA Grafenstein's back and neck while asking him to
bend over, and performed reflex tests. (Tr. 242-43; Gov't Ex. 8 at
40.)
SA Grafenstein had written in his patient paperwork that he was
currently taking 180 oxycodone 30 mg tablets. (Gov't Ex. 10 at 3,
4.) Respondent asked whether the medication was working (Gov't Ex. 8
at 42), to which SA Grafenstein responded in the affirmative and
orally requested Xanax. (Gov't Ex. 8 at 42; Tr. 243.) Respondent
inquired ``how much Xanax are you taking? `Cause it didn't get put
on there, but I'll, I'll get it for you.'' (Gov't Ex. 8 at 42.) SA
Grafenstein responded that he was taking about sixty. (Gov't Ex. 8
at 42.)
Respondent issued SA Grafenstein prescriptions for 180
Roxicodone 30 mg tablets and 60 Xanax 2 mg tablets, reflecting the
medications SA Grafenstein had indicated on his patient intake form
and requested orally. (Tr. 216, 243; Gov't Ex. 9; Gov't Ex. 10 at 3,
4.) The patient's urine drug screen, contained in the patient file,
reflected that SA Grafenstein tested negative for both oxycodone and
alprazolam. (Tr. 427-28, 477.)
(ii) SA Cortes February 16, 2010 Undercover Visit to APM
SA Cortes \38\ visited APM in an undercover capacity on February
16, 2010, posing as a patient.\39\ (See generally Jt. Stip. 7.)
Aside from noting that office staff measured his vital signs, that
he was not supervised while submitting a urine sample and that he
overheard a staff member discussing different methods to inject
heroin (Tr. 273-75), SA Cortes's testimony related primarily to his
visit with Respondent.
---------------------------------------------------------------------------
\38\ SA Cortes has worked as a DEA SA for approximately three
years, following approximately ten years as a state trooper and
local police officer. (Tr. 257.) He holds a bachelor's degree in
criminal justice. (Tr. 257.)
\39\ The following summary of SA Cortes's undercover visit to
APM is supplemented in a later section of this Recommended Decision
by additional findings of fact, and by conclusions of law.
---------------------------------------------------------------------------
Respondent called SA Cortes into his office after a wait of more
than five hours. (Tr. 273, 275.) SA Cortes stated that he was ``not
really hurt, doc. Um * * * what I'm experiencing
[[Page 58157]]
is * * * more and more stiffness [in the shoulders and waist] * * *
after each practice,'' elaborating that he had been studying martial
arts. (Gov't Ex. 12 at 2-3; Tr. 276.) Upon inquiry from Respondent,
SA Cortes stated that he worked at a warehouse and that lifting made
his discomfort worse. (Gov't Ex. 12 at 6-7.) He rated his pain as a
three or four while on medication, and an eight without medication,
on a scale from one to ten. (See Gov't Ex. 12 at 6; Tr. 277-78.)
SA Cortes told Respondent that he had been taking Tylenol and
one or two tablets of his girlfriend's hydrocodone per day. (Gov't
Ex. 12 at 3-4; Tr. 276.) He stated that the hydrocodone hadn't been
prescribed to him, to which Respondent stated ``I understand.''
(Gov't Ex. 12 at 9; see Tr. 278.) SA Cortes's urine drug screen,
however, tested negative for hydrocodone. (See Tr. 482; see also
Gov't Ex. 14 at 1.) Moreover, SA Cortes did not indicate he was
taking any medication on his Pain Assessment Form. (Gov't Ex. 14 at
2.)
Respondent directed SA Cortes to sit on an examination table and
inhale, listened to his breathing and tested his reflexes. (Tr.
278.) Respondent inquired whether SA Cortes was taking three or four
hydrocodone pills per day, to which SA Cortes agreed, even though he
had previously indicated taking only one or two per day. (Compare
Gov't Ex. 12 at 9, with Gov't Ex. 12 at 3-4.) Respondent issued SA
Cortes a prescription for 120 hydrocodone 7.5 mg tablets. (Gov't Ex.
13; Tr. 277, 288.) No diagnosis is listed on SA Cortes's Consent for
Chronic Opioid Therapy form, nor are alternative treatments listed.
(Tr. 398; see Gov't Ex. 14 at 8.)
4. Coast to Coast Healthcare Management (CCHM)
Respondent worked at CCHM in Deerfield Beach, Florida as an
independent contractor for six to eight weeks in March to April
2010, approximately two weeks after he stopped working at APM. (See
Tr. 22-23, 448, 456, 460; Gov't Ex. 20.) He testified that he was
told there would be a possibility of conducting clinical research at
CCHM.\40\ (Tr. 459.) But ``one thing was said and then what happened
was actually a different thing and that's why we decided to part on
amicable terms.'' (Tr. 460; see Tr. 462.)
---------------------------------------------------------------------------
\40\ Respondent did not ask SA Saenz if she would participate in
a clinical research project when she visited him at CCHM, posing as
a patient. (Tr. 461.)
---------------------------------------------------------------------------
GS Langston \41\ testified to participating in an investigation
of Respondent by obtaining from Wood's Pharmacy in Margate, Florida
prescriptions written by Respondent at CCHM. (Tr. 89-90; see Gov't
Ex. 20.) GS Langston recovered the following prescriptions: 90
Percocet 10 mg tablets and 220 Roxicodone 30 mg tablets, dated April
6, 2010, for patient [C.C.] of Wallingford, Kentucky (Tr. 90, 95);
100 Roxicodone 15 mg tablets and 210 Roxicodone 30 mg tablets dated
March 31, 2010, for patient [C.G.] of Essie, Kentucky (Tr. 91-92,
96); and 100 Roxicodone 15 mg tablets and 210 Roxicodone 30 mg
tablets dated March 31, 2010, for patient [R.C.] of Helton, Kentucky
(Tr. 92, 97; Gov't Ex. 20 at 5).
---------------------------------------------------------------------------
\41\ GS Langston testified to serving as a diversion group
supervisor for the DEA for two years, where she manages a group of
DIs in Palm Beach County, Broward County and five other counties.
(Tr. 88.) She previously worked for approximately thirteen years as
a DI and has worked for the DEA for approximately sixteen years.
(Tr. 88-89.)
---------------------------------------------------------------------------
GS Langston testified that in light of her background, training
and experience the prescriptions to patients [C.G.] and [R.C.]
``raised red flags to me because they are both prescribed by Dr.
Casanova to patients in Kentucky that * * * apparently traveled from
Kentucky to see Dr. Casanova at Coast to Coast in Deerfield Beach
and then dr[o]ve to Margate to have their prescriptions filled.''
(Tr. 98.) As additional ``red flags,'' GS Langston noted that the
prescriptions to [C.G.] and [R.C.] were for the same amounts of
drugs (Tr. 98); the prescriptions were filled on the same day at
close to the same time at the same pharmacy (Tr. 98); and the cities
of Essie, Kentucky and Helton, Kentucky are located close to each
other, and approximately 900 to 1000 miles and fifteen to sixteen
hours away from Respondent's office in Deerfield Beach, Florida.
(Tr. 99.) GS Langston testified that based on the foregoing factors
it appeared that patients [C.G.] and [R.C.] traveled together from
Kentucky to see Respondent. (Tr. 99.) GS Langston testified that
although she had not seen the patients' medical files, the
pharmacist should have regarded the prescriptions as suspicious.
(Tr. 101.) She did concede, however, that without seeing the
patients' medical files, she could not determine whether the
prescriptions were medically necessary. (Tr. 103.)
(a) SA Saenz March 10, 2010 Undercover Visit to CCHM
SA Julia Saenz (SA Saenz) visited CCHM in an undercover capacity
on March 10, 2010.\42\ (E.g., Jt. Stip. 8; Gov't Ex. 18 at 1; Tr.
442; Gov't Ex. 18 at 2, 4-6, 8-11, 13-15, 17.) Although the
Government listed SA Saenz as a witness in its prehearing statement
(ALJ Ex. 4 at 3, 14-16), the Government did not offer her testimony
at hearing. (Tr. 11.) The undercover recording of SA Saenz's visit,
her patient file and prescriptions Respondent issued to her were
admitted without objection. (Tr. 84-85, 404; see Gov't Ex. 16, 17,
18.)
---------------------------------------------------------------------------
\42\ The following summary of SA Saenz's undercover visit to
CCHM is supplemented in a later section of this Recommended Decision
by additional findings of fact and conclusions of law.
---------------------------------------------------------------------------
Respondent met with SA Saenz, first asking her age and how she
hurt herself. (Gov't Ex. 16 at 4.) She stated she was thirty-four
and that she injured herself a week earlier by lifting children at a
daycare center where she worked. (See Gov't Ex. 16 at 4; Gov't Ex.
18 at 1.) SA Saenz indicated she was taking ``Tones, Dones'' (Gov't
Ex. 16 at 7), which Respondent identified at hearing as slang for
oxycodone. (Tr. 445.) Similarly, SA Saenz's patient paperwork
indicates that she was taking Roxicodone 40 mg tablets eight times
per day, oxycodone 15 mg tablets three times per day and 2 mg Xanax
tablets twice per day. (Gov't Ex. 18 at 8.) Her urine drug screen,
however, was negative for oxycodone. (Gov't Ex. 18 at 18; Tr. 446.)
SA Saenz also told Respondent that she had not seen any doctor
for medicines. (Gov't Ex. 16 at 7; see also Gov't Ex. 18 at 1.)
Respondent testified that he didn't ask SA Saenz how she had
obtained the oxycodone and Xanax she had indicated taking. (See Tr.
495.) At the patient interview, SA Saenz repeatedly told Respondent
that the pain did not interfere with her work or daily activities.
(Gov't Ex. 16 at 6.) When Respondent asked SA Saenz whether she had
ever taken narcotics before, she responded in the negative. (Gov't
Ex. 16 at 13.) Respondent found it ``somewhat confusing that she did
state just on tomes and domes and didn't state anything about an
anxiolytic with this piece of information and her drug screen was
negative.'' (Tr. 446.)
SA Saenz indicated that her pain was about a three while on
ibuprofen and a five or six without, on a scale from one to ten.
(See Gov't Ex. 16 at 7; see also Gov't Ex. 18 at 1.) She stated that
she drank on occasion (Gov't Ex. 16 at 7-8) and indicated that she
suffered from insomnia and depression. (Gov't Ex. 18 at 6.)
Respondent directed SA Saenz to take a deep breath, bend forward
and indicate where she had pain. (Gov't Ex. 16 at 9.) She indicated
pain on her left side and sensitivity in her neck. (Gov't Ex. 16 at
9.) Respondent demonstrated a stretching exercise and recommended an
Icy Hot patch. (Gov't Ex. 16 at 10.) He then prescribed 90 Motrin
800 mg tablets, 90 Vicodin oral 5 mg--500 mg tablets and one pack
containing twenty-one Medrol 4 mg tablets. (Gov't Ex. 17.) The
portions of her Consent for Chronic Opioid Therapy (Consent Form)
indicating a diagnosis and alternative treatment options are blank.
(Tr. 494; Gov't Ex. 18 at 15.)
Near the end of the meeting, Respondent asked SA Saenz ``Why,
for this kind of thing, you go to a pain management clinic? Why not
go see a doctor?'' (Gov't Ex. 16 at 13.) She replied that she didn't
have a doctor, and Respondent suggested she visit Respondent's
Urgent Care Center. (Gov't Ex. 16 at 13-14.)
5. Government's Expert Testimony and Report
The Government presented the testimony of David M. Glener, M.D.,
along with a written report he prepared based on his review of
patient files, audio recordings and transcripts associated with
Respondent's treatment of three undercover agents posing as patients
on February 16, 2010, and March 10, 2010. (See Tr. 321-22, 353-54.)
(a) Dr. Glener's Background
Dr. Glener, a physician, has practiced in St. Lucie, Florida
since April 2002. (Tr. 306, 308-09.) He has practiced medicine for
twenty-two years and pain medicine since 1993, and presently treats
between six hundred and one thousand patients. (Tr. 309.) Dr. Glener
has been board certified by the American Board of Anesthesiology
since April 1995 and the American Board of Pain Medicine since
February 2005.\43\ (Tr. 307-
[[Page 58158]]
08.) After graduating from New York Medical College in 1989, Dr.
Glener completed an internship in general surgery and a residency in
anesthesiology. (Tr. 309-10; see Gov't Ex. 21.) He later worked at
two anesthesiology practices. (Tr. 309.) In addition to being a
member of the American Society of Interventional Pain Physicians and
its subsidiary Florida Society of Pain Physicians, Dr. Glener is a
clinic assistant professor at Florida State University School of
Medicine and an associate professor at the University of Central
Florida School of Medicine. (Tr. 311.) He stays apprised of
developments in the field of pain management by reviewing journals,
speaking with colleagues, attending meetings of the Florida Society
of Interventional Pain Physicians and completing continuing medical
education courses. (Tr. 311-12.) Upon the Government's unopposed
motion, I qualified Dr. Glener as an expert witness in the area of
pain management. (Tr. 312-13.)
---------------------------------------------------------------------------
\43\ Dr. Glener itemized the prerequisites of certification from
the American Board of Anesthesiology to include graduating from an
accredited medical school, possessing an unrestricted medical
license, completing an internship in one of five categories,
accumulating three years of training in anesthesiology and passing
written and oral examinations. (Tr. 307.) The certification process
for the American Board of Pain Medicine is slightly different, in
ways not pertinent to the instant proceeding. (See Tr. 308.)
---------------------------------------------------------------------------
(b) Weight of Dr. Glener's Testimony
At hearing and in his post-hearing filings, Respondent raised
the issue of whether Dr. Glener possessed bias or prejudice against
Respondent. (E.g., Resp't Br. 13-14, 27.) Respondent argues that Dr.
Glener displayed ``textbook bias and prejudice[,] which
substantially diminished the credibility of Dr. Gleaner [sic] and
the weight to be given his testimony.'' (Resp't Br. 27.)
A review of the record reveals some evidence of bias on the part
of Dr. Glener. For instance, when asked on cross-examination whether
he would ``render an opinion [about Respondent] before looking at
the materials'' relating to Respondent, such as patient files and
undercover recordings (Tr. 342), Dr. Glener responded as follows:
It's not that I would leap to conclusions, but with all of these
cases that I've reviewed in totality for both the state and a couple
for the federal government now, I've seen a pattern emerge and there
have been problems every single time I've reviewed them. So while I
couldn't say with certainty or testify to that fact, I would say
there would be a very high likelihood there'd be something
inappropriate going on with Respondent's prescribing practices.\44\
---------------------------------------------------------------------------
\44\ Dr. Glener conceded that he was unfamiliar with Respondent
before the Government asked him to testify. (Tr. 321).
(Tr. 343.) Dr. Glener ultimately testified that based on his review
of Respondent's medical files, Respondent was incompetent as a
physician. (See Tr. 357.)
In addition, when asked if he knew whether his expert review of
Respondent's medical files was based on complete records, Dr. Glener
stated:
I can't say with certainty if the file is complete or not. I asked
for materials; materials were provided. Other medical records to
these people or files may exist but I would strongly doubt it would
change my opinion. In fact, I could tell you with certainty it would
not change my opinion.\45\
---------------------------------------------------------------------------
\45\ Moreover, when asked if it was important to review the
complete medical files of the patients he was asked to analyze, Dr.
Glener answered in the negative. (Tr. 343.)
---------------------------------------------------------------------------
(Tr. 344.)
In partial mitigation, Dr. Glener explained that the existence
of a treatment plan in a file associated with a patient's subsequent
visit would not alter his findings regarding Respondent's conduct
``because at the time the prescription was made, it is incumbent
upon the physician to outline a treatment plan * * * I don't get
that out of guidelines. That's called being a physician and those of
us who are qualified to practice know that.'' (Tr. 345.) Although
this statement reflects a legitimate basis for concluding that
subsequent medical records would be irrelevant to evaluating whether
Respondent's previous documentation practices were adequate, Dr.
Glener's tone and demeanor at hearing corresponding to his comment
about ``those of us who are qualified to practice'' did not reflect
the completely dispassionate observations of an objective
reviewer.\46\
---------------------------------------------------------------------------
\46\ After opining that Respondent's behavior was consistent
with that of a pill-mill physician (Tr. 352), Dr. Glener was asked
on cross-examination ``Would it also be fair to say that you don't
like what you call pill mill doctors?'' (Tr. 353.) Dr. Glener
responded: ``I don't like what they do, I don't like what they
represent, I don't like the damage they inflict on society and
individuals in the practice of medicine as a whole, but other than
that, I'm sure they're great people.'' (Tr. 353.)
---------------------------------------------------------------------------
In light of the evidence that Dr. Glener displayed a degree of
prejudice or bias against Respondent, an initial issue is what
weight to give Dr. Glener's testimony against Respondent, of whom
Dr. Glener was unfailingly critical.\47\ Having considered all the
evidence, and as further discussed below, I find Dr. Glener's
testimony to be generally credible notwithstanding any prejudice or
bias, because it is wholly consistent with and is supported by the
objective evidence of record.\48\
---------------------------------------------------------------------------
\47\ Dr. Glener testified at one point that ``I was just trying
to illustrate that the doctor's incompetent, not that he--whether he
was or--treating pain. * * * [H]e's clearly incompetent.'' (Tr.
357.)
\48\ For instance, as discussed below, Dr. Glener's observations
about missing documentation are fully supported by the objective
evidence of record, to include patient files and undercover
recordings.
---------------------------------------------------------------------------
(c) Dr. Glener's Practice and Testimony Regarding the Florida Standard
of Care
Dr. Glener testified that sixty percent of his patients are of
retirement or Medicare age, and that he sees all different pain
complaints. (Tr. 313.) The majority of his patients are referred to
him by other physicians, who provide Dr. Glener with patients'
medical records.\49\ (Tr. 313-14.) With the exception of existing
patients under emergency circumstances, Dr. Glener never sees walk-
in patients. (Tr. 314.) Instead, new walk-in patients are scheduled
for future appointments and Dr. Glener's office attempts to obtain
the patients' prior medical records in the interim. (Tr. 314-15.)
---------------------------------------------------------------------------
\49\ Dr. Glener explained that he obtains patients' prior
medical records if they have not already been provided. (Tr. 313.)
---------------------------------------------------------------------------
Dr. Glener testified that except in ``extraordinary
circumstances,'' he would not likely prescribe controlled substances
to a patient who had not provided medical records. (Tr. 315.) Dr.
Glener further testified that he would inquire what other physicians
the patient has seen, and would consult the assembled medical
records, which he noted ``sometimes have very little clinical
value'' if they are irrelevant to the pain complaint. (Tr. 316-17.)
Dr. Glener testified that in his practice ``I take a history. *
* * I ask [patients] to show me where they're having their pain and
I ask them what's the quality of the pain, and I help them along
with a few adjectives if they're at a loss for words.'' (Tr. 317.)
He tries to ``ascertain what increases the pain, what decreases the
pain, what other therapies they may have had * * * what medications
have been tried and failed.'' (Tr. 317.) Dr. Glener further
explained that ``I can't say, well, the patient uttered the word
`pain,' therefore, I'm entitled and I should be prescribing a
controlled substance.'' (Tr. 396.)
After taking a patient history, Dr. Glener completes a physical
examination, to include examination of the body system relevant to
the patient's pain complaint.\50\ (Tr. 316.) He also records ``a
complete medical history, current medications, previous medical
problems, previous surgeries [and] allergies.'' (Tr. 316.)
Additionally, Dr. Glener records ``a complete history of present
illness which is really the who, what, where, when and why of their
pain.'' (Tr. 316.)
---------------------------------------------------------------------------
\50\ ``If there was a question to their overall health,'' Dr.
Glener testified, ``then I'd probably listen to their heart, maybe
their lungs.'' (Tr. 316.)
---------------------------------------------------------------------------
Following these steps, Dr. Glener forms a differential diagnosis
and orders appropriate diagnostic studies, if necessary, and
recommends a treatment plan. (Tr. 318.) He ``discuss[es] the most
common side effects and adverse events that can occur as well as the
benefit'' from proposed medications, although he ``do[es]n't go
through every possible side effect right down to one or two percent
incidents * * * .'' (Tr. 318.)
Dr. Glener emphasized that it is extremely important to document
a patient's medical history, physical exam, diagnosis, treatment
plan and discussion of risks and benefits,\51\ adding that it is the
standard of care, ``the law and it's appropriate medical practice.''
\52\ (Tr. 318-319.) Dr. Glener allowed that the medical record need
not appear like a transcript from a court proceeding, but should be
a ``useful tool'' reflecting ``a cogent record of what has
transpired, what the physician was thinking at the time.'' (Tr.
319.) In case the patient later moves to a
[[Page 58159]]
different physician, ``it's incumbent upon [the physician] to
document [the physician's] thought process * * *.'' (Tr. 319.)
---------------------------------------------------------------------------
\51\ Dr. Glener finds it more effective to conduct an oral
discussion of risks and benefits of opioid therapy, but conceded
that not all doctors rely on verbal consent. (Tr. 399.) If he were
to use a written consent form, however, he testified that he would
ensure its completeness. (Tr. 399.)
\52\ Dr. Glener testified that taking the patient's medical
history, performing a physical exam, formulating a diagnosis and
treatment plan and discussing risks and benefits of a treatment plan
is essential whether or not treating a patient with controlled
substances. (Tr. 319.)
---------------------------------------------------------------------------
Dr. Glener does not treat all his patients with controlled
substances. (Tr. 319-20.) He recognizes, however, that ``[t]he
Florida Board of Medicine considers prescribing or dispensing
controlled substances for pain to be for a legitimate medical
purpose if based on accepted scientific knowledge of the treatment
of pain or if based on sound clinical grounds.'' (Gov't Ex. 22 at
2.) As alternative therapies to controlled substances, Dr. Glener
recommends stretching, over-the-counter drugs, physical therapy,
chiropractic and massage therapy, interventional pain
procedures,\53\ nerve blocks and referral to the appropriate medical
specialist.\54\ (Tr. 320.)
---------------------------------------------------------------------------
\53\ An interventional pain procedure is ``where I actually do a
procedure to make the patient better instead of giving [her] a
medication or a noninvasive therapy * * *. It involves the spine and
at least a three and a half-inch needle, but it's not exclusive to
that.'' (Tr. 320.)
\54\ Dr. Glener testified that the appropriate medical
specialist is often an orthopedic surgeon, neurologist,
neurosurgeon, physiatrist, internist or infectious disease
specialist. (Tr. 320.)
---------------------------------------------------------------------------
(d) Dr. Glener's Review of Respondent's Patient Files, Generally
Dr. Glener reviewed patient files, audio recordings and
transcripts reflecting consultations with Respondent by DEA Special
Agents using the undercover names Julia Sanchez, Eugene O'Neil, and
Alfredo Mondego.\55\ (See Tr. 321, 353-54; Gov't Ex. 14.) His review
of the patient files pertained to the adequacy of Respondent's
performance across elements such as history of present illness,
physical examination, medical and surgical history, family history,
social history and possibly a review of systems, with reference to
the Florida Standards for the Use of Controlled Substances for the
Treatment of Pain (Florida Standards), Fla. Admin. Code Ann. r.
64B8-9.013 (2003). (Tr. 322-23; Gov't Ex. 22 at 2; see Gov't Ex.
23.) Based on his review, Dr. Glener prepared a report (see Gov't
Ex. 22) and concluded that ``[i]n all of the cases, the doctor
prescribed controlled substances outside the usual course of
professional practice or for other than a legitimate medical
purpose.'' (Tr. 338-39.)
---------------------------------------------------------------------------
\55\ These materials reflect undercover visits to see Respondent
by SA Saenz, SA Grafenstein and SA Cortes.
---------------------------------------------------------------------------
Dr. Glener called the level of documentation in Respondent's
patient files ``substandard,'' ``cookie cutter'' and ``very
sketchy.'' (Tr. 337.) He opined that with respect to each patient,
Respondent ``did not support the need for controlled substances with
appropriate documentation establishing a valid medical need and
treatment plan.'' (Gov't Ex. 22 at 2.) He criticized Respondent for
prescribing controlled substances ``rather than refer[ring] to [a]
physician with the appropriate expertise'' to include a physical
therapist, orthopedic surgeon, physiatrist, neurologist,
neurosurgeon or interventional pain specialist'' (Gov't Ex. 22 at 2)
and testified that there was no record that Respondent made any such
referrals. (Tr. 336-37.) Although acknowledging that the patient
files contained medical histories and diagnostic, therapeutic or
laboratory results (Tr. 377-78), Dr. Glener called Respondent's
histories and physical examinations ``perfunctory.'' (Gov't Ex. 22
at 2.) He further testified that Respondent ``did not by
professional standards perform a proper evaluation as has been
defined by my medical training and experience.'' (Tr. 378.)
In addition, Dr. Glener testified that every time a physician
prescribes an opioid, there should be a treatment plan. (Tr. 382.)
Dr. Glener testified that with respect to all three undercover
patients, Respondent did not discuss the risks and benefits of
medications he prescribed; did not take the appropriate history; did
not perform an appropriate physical examination; did not document a
treatment plan other than the prescription of controlled substances;
\56\ and did not indicate a rationale for treatment. (Tr. 334-35,
379.)
---------------------------------------------------------------------------
\56\ The only exception Dr. Glener noted was that Respondent
prescribed ``an inappropriate combination of high doses of
nonsteroidals and steroidal medications * * * with a recommendation
for an Icy Hot patch'' to SA Saenz. (Tr. 335.)
---------------------------------------------------------------------------
Dr. Glener concluded that ``[a]fter reviewing the totality of
the above three patient encounters, Dr. Casanova has established a
pattern of behavior that indicates he regularly prescribes
controlled substances outside the usual course of professional
practice or for other than a legitimate medical purpose.'' (Gov't
Ex. 22 at 2.) As to all three patients, Dr. Glener testified that
``the treatment definitely deviated from the standard of care, was
not appropriate in all cases and the focus of treatment appeared to
be the prescription of controlled substances.'' \57\ (Tr. 324-25.)
---------------------------------------------------------------------------
\57\ Dr. Glener provided additional and specific analysis of
Respondent's prescribing practices with respect to each patient.
This analysis is discussed in a later section of this Recommended
Decision.
---------------------------------------------------------------------------
6. Additional Aspects of Respondent's Professional History and Outlook
In addition to his employment history as summarized previously,
Respondent testified that he gained experience dealing with acute
and chronic pain patients and treating them with opioids while
working at Westchester Hospital in Florida. (Tr. 414.) During this
time he familiarized himself with the Florida Standards. (Tr. 414.)
With respect to the three undercover patients at CCHM and APM,
Respondent testified that he executed a treatment objective, not a
treatment plan:
Q: And you've testified that you executed a treatment plan, isn't
that true?
A: The treatment objective.
Q: You executed a treatment objective?
A: Correct.
Q: And why didn't you execute a treatment plan?
A: Because as I've mentioned previously, a treatment plan is
something in my opinion that differs from other physicians. I
believe that a treatment plan doesn't happen over one visit, it
happens over time when you garner all the information and collect
all the data and put it together and slowly but surely whittle
things down and put everything together.
(Tr. 467.) He elaborated that ``a treatment objective begins the
treatment plan and that develops over time.'' (Tr. 467.)
In addition, Respondent testified that he no longer works at any
pain management facilities other than MEC, and that ``I don't have
any plans to ever do that again.'' (Tr. 448.) He testified that he
would be willing to enter into an agreement with the Government that
he would never work in a pain clinic and that he would never
prescribe Schedule II opioid narcotic controlled substances.\58\
(Tr. 452-53.)
---------------------------------------------------------------------------
\58\ Respondent also testified that he ``could consider''
agreeing not to prescribe Schedule III controlled substances, and
that he would be willing to agree not to prescribe Schedule II-III
medications for a limited period of years. (Tr. 499, 502.)
---------------------------------------------------------------------------
Finally, Respondent testified that while working at APM and
CCHM, he turned away a large number of patients ``that I thought
might have issues with medications, issues potentially with the
injection of medications and so forth,'' to include patients
presenting with track marks. (Tr. 500.)
IV. Discussion
A. The Applicable Statutory and Regulatory Provisions
The CSA provides that any person who dispenses (including
prescribing) a controlled substance must obtain a registration
issued by the DEA in accordance with applicable rules and
regulations.\59\ ``A prescription for a controlled substance to be
effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice. The responsibility for the proper prescribing
and dispensing of controlled substances is upon the prescribing
practitioner'' with a corresponding responsibility on the pharmacist
who fills the prescription.\60\ It is unlawful for any person to
possess a controlled substance unless that substance was obtained
pursuant to a valid prescription from a practitioner acting in the
course of his professional practice.\61\ Federal law also provides a
detailed framework for keeping records of controlled substances a
practitioner orders, receives and dispenses. E.g., 21 C.F.R.
Sec. Sec. 1304.11, 1304.21, 1304.22. In addition, I conclude that
the reference in 21 U.S.C. Sec. 823(f)(5) to ``other conduct which
may threaten the public health and safety'' would as a matter of
statutory interpretation logically encompass the factors listed in
Sec. 824(a).\62\
---------------------------------------------------------------------------
\59\ 21 U.S.C. Sec. 822(a)(2); 21 U.S.C. Sec. 802(10).
\60\ 21 C.F.R. Sec. 1306.04(a).
\61\ 21 U.S.C. Sec. 844(a).
\62\ See Kuen H. Chen, M.D., 58 Fed. Reg. 65,401, 65,402 (DEA
1993).
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B. The Public Interest Standard
The CSA, at 21 U.S.C. Sec. 824(a)(4), provides, insofar as
pertinent to this proceeding, that the Administrator may revoke a
COR if she finds that the registrant's continued registration would
be inconsistent with the public interest as that term is used in 21
U.S.C. Sec. 823(f). In determining the public interest, the
Administrator is required to consider the following factors pursuant
to Section 823(f):
[[Page 58160]]
(1) The recommendation of the appropriate state licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under federal or state
laws relating to the manufacture, distribution or dispensing of
controlled substances.
(4) Compliance with applicable state, federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
As a threshold matter, the factors specified in Section 823(f)
are to be considered in the disjunctive: the Administrator may
properly rely on any one or a combination of those factors, and give
each factor the weight she deems appropriate, in determining whether
a registration should be revoked or an application for registration
denied. See David H. Gillis, M.D., 58 Fed. Reg. 37,507, 37,508 (DEA
1993); see also D & S Sales, 71 Fed. Reg. 37,607, 37,610 (DEA 2006);
Joy's Ideas, 70 Fed. Reg. 33,195, 33,197 (DEA 2005); Henry J.
Schwarz, Jr., M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989).
Application of the public interest factors requires an
individualized determination and assessment of prescribing and
recordkeeping practices that are ``tethered securely to state law .
. . and federal regulations.'' Volkman v. DEA, 567 F.3d 215, 223
(6th Cir. 2009). Additionally, in an action to revoke a registrant's
COR, the DEA has the burden of proving that the requirements for
revocation are satisfied.\63\ The burden of proof shifts to the
respondent once the Government has made a prima facie case.\64\
---------------------------------------------------------------------------
\63\ See 21 CFR Sec. 1301.44(e) (2011).
\64\ See Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380
(DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311
(DEA 1980).
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C. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid unrestricted medical license in
Florida and has never been disciplined by the Florida Department of
Health. (E.g., Jt. Stips. 2, 3; Tr. 448-49.) Although not
dispositive, Respondent's possession of a valid unrestricted medical
license in Florida weighs against a finding that Respondent's
continued registration would be inconsistent with the public
interest. See Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,230
(DEA 2003) (identifying state licensure as necessary but not
sufficient condition for registration).
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances.
(See Tr. 502.) I therefore find that Factor Three, although not
dispositive, see Leslie, 68 Fed. Reg. at 15,230, weighs against a
finding that Respondent's continued registration would be
inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances and Compliance with Applicable State, Federal or Local Laws
Relating to Controlled Substances
As Respondent correctly argues, the record reflects that
Respondent ``has significant experience in prescribing controlled
substances. Dr. Casanova has practiced medicine for approximately
[twenty] years and, in that time, has treated both chronic and acute
pain and has prescribed controlled substances for the treatment of
pain.'' (Resp't Br. 30-31.) But the record also contains substantial
evidence that on multiple recent occasions, Respondent failed to
comply with applicable federal and state law relating to keeping
records of and prescribing controlled substances.
1. Respondent's Recordkeeping Practices
Pursuant to federal regulations such as 21 C.F.R. Sec. Sec.
1304.03, 1304.11(a), 1304.21(a), 1304.22(a)(2)(iv),
1304.22(a)(2)(ix), and 1304.22(c), a registered individual
practitioner is required to maintain records of controlled
substances in Schedules II-V that are dispensed and received,
including the number of dosage units, the date of receipt or
disposal, and the name, address and registration number of the
distributor. It is unlawful to fail to make, keep or furnish
required records.\65\ Under longstanding Agency precedent, ``the
failure to comply with record keeping requirements is a basis for
revoking a registration.'' Alexander Drug Co., 66 Fed. Reg. 18,299,
18,303 (DEA 2001) (citing Singer-Andreini Pharmacy, Inc., 63 Fed.
Reg. 4,668 (DEA 1998); Arthur Sklar, d/b/a King Pharmacy, 54 Fed.
Reg. 34,623 (DEA 1989); Summer Grove Pharmacy, 54 Fed. Reg. 28,522
(DEA 1989); and The Boro Pharmacy and Bell Apothecary, 53 Fed. Reg.
15,151 (DEA 1988)). The CSA's emphasis on recordkeeping constitutes
```an attempt to regulate closely the distribution of certain
substances determined by Congress to pose dangers, if freely
available, to the public at large.''' United States v. Poulin, 926
F. Supp. 246, 250 (D. Mass. 1996) (quoting United States v. Averi,
715 F. Supp. 1508, 1510 (M.D. Ala. 1989)). The evidence offered at
hearing reflected a number of recordkeeping violations by
Respondent.
---------------------------------------------------------------------------
\65\ 21 U.S.C. Sec. 842(a)(5).
---------------------------------------------------------------------------
(a) February 22, 2011 Absence of Biennial Inventory at MEC
DEA registrants are required to maintain ``a complete and
accurate record of all controlled substances on hand * * *.'' 21
C.F.R. Sec. 1304.11(a). They must ``take a new inventory * * * at
least every two years.'' 21 C.F.R. Sec. 1304.11(c). The inventory
``must be kept by the registrant and be available[] for at least 2
years'' from the date of its creation. 21 C.F.R. Sec. 1304.04(a).
As noted above, the record reflects that DI Stockmann conducted an
inspection of MEC on February 22, 2011, and he found ``no evidence
of a biennial inventory for that registered location of the
controlled substances on hand.'' (Tr. 108, 128, 137.) The absence of
a biennial inventory as of February 22, 2011, constitutes a
violation of these requirements. See 21 C.F.R. Sec. 1304.11(a).
(b) March 29, 2011 Discovery of McBride Biennial Inventory
Federal Regulations require that DEA registrants ``take a new
inventory * * * at least every two years.'' 21 C.F.R. Sec.
1304.11(c); see also 21 C.F.R. Sec. 1304.04(a) (``every inventory *
* * must be kept by the registrant and be available * * * for at
least two years from the date of such inventory * * *'').\66\ ``The
inventory may be taken either as of opening of business or as of the
close of business on the inventory date and it shall be indicated on
the inventory.'' 21 C.F.R. Sec. 1304.11(a). The record reflects
that DI Graumlich conducted an accountability audit of MEC on March
29, 2011, covering a period from November 16, 2009, to March 29,
2011. (E.g., Tr. 148, 149.) At this audit, Respondent's staff
produced a biennial inventory completed by Mr. McBride of Linear
Solutions, dated November 16, 2009.\67\ (Tr. 153-54, 163; Gov't Ex.
19(b).) DI Graumlich testified, and the document reflects, that the
inventory does not indicate whether it was taken at the opening or
closing of the business day, in violation of 21 C.F.R. Sec.
1304.11(a). (Tr. 164, 181, 199.) The evidence also reflected that
Respondent's biennial inventory did not go back a full two years
from the date of the audit. (Tr. 200.) Respondent ``has not disputed
the results of the audit and inspection, but instead has
acknowledged that he will take steps to cure the violations * * *.''
(Resp't Br. at 30.) Consistent with the consensus reached by the
parties, I find that Respondent has violated 21 C.F.R. Sec.
1304.04(a) in failing to keep a biennial inventory covering a full
two years of activity.
---------------------------------------------------------------------------
\66\ Although the Government's prehearing statements did not
explicitly cite 21 C.F.R. Sec. 1304.04, the Government did allege
violations of recordkeeping regulations, to include failure to
maintain complete and accurate records (see ALJ Ex. 7 at 2), as well
as failure to comply with requirements for biennial inventories (see
ALJ Ex. 7 at 3). In the absence of an objection by Respondent, there
is no basis to depart from the conclusion that Respondent was fairly
apprised ``that this allegation would be litigated.'' CBS Wholesale
Distribs., 74 Fed. Reg. 36,746, 36,749 (DEA 2009).
\67\ The record is unclear as to why this report was not made
available to DI Stockmann on February 22, 2011.
---------------------------------------------------------------------------
(c) March 29, 2011 Audit Results Indicating Shortage and Overage
The March 29, 2011 audit of Respondent's controlled substances
and records covering a period from November 16, 2009, to March 29,
2011, revealed a number of irregularities. DI Graumlich found that
Respondent was accountable for thirty-five bottles of Guaifenesin Ac
but could only account for twenty-seven, resulting in a shortage of
eight bottles or 22.86 percent. (Tr. 177, 198-99; Gov't Ex. 19(e).)
Moreover, with respect to Hydrocodone Apap 5/500 30-count bottle,
the audit revealed an overage of one bottle, thirty dosage units or
0.89 percent. (Tr. 177-78, 197-98.) Regarding Hydrocodone Apap 7.5/
500 30-count bottles, the audit revealed
[[Page 58161]]
a shortage of five bottles, 150 dosage units or four percent. (Tr.
178-79, 198.) With respect to Zolpidem, the audit revealed a
shortage of three bottles, 180 dosage units or twenty-five percent.
(Tr. 180, 199.)
Although various factors can contribute to audit results
indicating a shortage, to include recordkeeping issues, theft or
loss (Tr. 180), DEA registrants are nevertheless ``required to
maintain records of all controlled drugs received, distributed or
otherwise dispensed. And if we have records of all the drugs
received or distributed, the account should zero out.'' (Tr. 180-
81.) See 21 C.F.R. Sec. Sec. 1304.11(a) (``Each inventory shall
contain a complete and accurate record of all controlled substances
on hand * * *.''), 1304.21(a) (registrants required to keep ``a
complete and accurate record of each such substance * * * received,
sold, delivered * * * or otherwise disposed of * * *.''), 1304.22(c)
(``records shall be maintained of the number of units * * *
dispensed * * *.''). The evidence of two shortages in Respondent's
controlled substances records, one by more than twenty percent, and
one overage, is inconsistent with the requirement to maintain
accurate and complete records. See 21 C.F.R. Sec. Sec. 1304.04(a),
1304.22(c).
(d) Twenty Undated Receiving Invoices and Two Missing Stat Rx Invoices
In addition to the foregoing issues, DI Graumlich testified that
approximately twenty of the receiving invoices provided by
Respondent did not reflect the date received. (Tr. 181.) DI
Graumlich gave the clinic ``several'' opportunities to provide
missing records, including emailing MEC's office manager Ms. Egan
after the inspection and asking whether the clinic had located the
missing documents. (Tr. 202.) He again requested invoices, ``and we
were never provided with any other documents. According to Ms. Egan,
I believe they could not find the other binder.'' (Tr. 194.) DI
Graumlich further testified that the March 29, 2011 audit revealed
``two receiving invoices that they did not have a record of and we
found that out when we got a printout of their receipts from Stat
Rx, their distributor * * *.'' (Tr. 182.)
Federal regulations require that practitioners ``shall maintain
on a current basis a complete and accurate record of [controlled
substances] received * * *, '' 21 C.F.R. Sec. 1304.21(a), further
providing that ``[i]n recording dates of receipt * * * the date on
which the controlled substances are actually received * * * shall be
used as the date of receipt or distribution of any documents of
transfer (e.g., invoices or packing slips).'' Id. at Sec.
1304.21(d). Respondent's failure to indicate the date received on
approximately twenty receiving invoices constitutes a violation of
21 C.F.R. Sec. 1304.21. Moreover, the evidence that Respondent had
no records of two receiving invoices from Stat Rx reveals a
violation of the requirement to keep a current, ``complete and
accurate record of each such substance * * * received, sold,
delivered * * * or otherwise disposed of * * *.'' Id. at Sec.
1304.21(a).
(e) Evidence of Compliant Records
The results of the audit with respect to the InstyMeds machine
reflected no discrepancies.\68\ (Tr. 195.) There were no
discrepancies in the audit of Zolvit oral solution, although
Respondent's staff ``originally didn't have any records for that but
we had them get copies of their records from their vendor.'' (Tr.
197.)
---------------------------------------------------------------------------
\68\ The audit reflected Respondent's office's change from using
Linear Solutions to InstyMeds. (See Tr. 156; Gov't Ex. 19(e).)
---------------------------------------------------------------------------
(f) Conclusion With Respect to Recordkeeping
The record reveals multiple violations of federal recordkeeping
regulations.\69\ This conclusion weighs in favor of a finding under
Factors Two and Four that Respondent's continued registration would
be inconsistent with the public interest.
---------------------------------------------------------------------------
\69\ E.g., 21 C.F.R. Sec. Sec. 1304.04(a), 1304.11(a) & (c).
---------------------------------------------------------------------------
2. Respondent's Prescribing Practices at APM and CCHM
The evidence at hearing centered in substantial part on office
visits by three undercover agents posing as patients in February and
March 2010. In addition to the testimony of two of the agents and
records associated with all three agents, the Government presented
the testimony of a medical expert witness, Dr. Glener. Dr. Glener
provided a written report and testified as to his review of the
three patient files and associated undercover recordings and medical
records, opining whether Respondent prescribed controlled substances
for a legitimate medical purpose in the usual course of professional
practice. Respondent also testified as to his standard of care and
treatment for each of the three patients, along with his past
experience.
Evaluation of Respondent's prescribing conduct in this case is
governed by federal and state law. The applicable standard under
federal law is whether Respondent's prescriptions for controlled
substances were ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice.'' 21 C.F.R. Sec. 1306.04(a) (2011). This
standard of care refers to that generally recognized and accepted in
the medical community rather than a standard unique to the
practitioner. Robert L. Dougherty, M.D., 76 Fed. Reg. 16,823, 16,832
n.11 (DEA 2011) (citing Brown v. Colm, 11 Cal.3d 639, 642-43
(1974)). Although state law is a relevant factor in determining
whether a practitioner is acting in the ``usual course of
professional practice,'' it is appropriate in the context of an
inquiry under federal law to also consider ``generally recognized
and accepted medical practices'' in the United States. Bienvenido
Tan, M.D., 76 Fed. Reg. 17,673, 17,681 (DEA 2011). Moreover,
``[u]nder the CSA, it is fundamental that a practitioner must
establish a bona fide doctor-patient relationship in order to act
`in the usual course of * * * professional practice' and to issue a
prescription for a `legitimate medical purpose' as required by 21
C.F.R. Sec. 1306.04(a).'' Gilbert Eugene Johnson, M.D., 75 Fed.
Reg. 65,663, 65,666 (DEA 2010) (citing Patrick W. Stodola, M.D., 74
Fed. Reg. 20,727, 20,731 (DEA 2009) (citing United States v. Moore,
423 U.S. 122, 135, 143 (1975))). ``The CSA generally looks to state
law to determine `whether a doctor and patient have established a
bona fide patient relationship.''' Id.; see also Kamir Garces-
Mejias, M.D., 72 Fed. Reg. 54,931, 54,935 (DEA 2007); United
Prescription Services, Inc., 72 Fed. Reg. 50,397, 50,407 (DEA 2007).
As for the principles of Florida law applicable to this case,
the Florida Standards constitute, as Respondent correctly argues,
the ``guiding law as to prescribing controlled substances.'' \70\
(Resp't Br. 24, 31.) The Florida Standards emphasize the importance
of ``prescribing, dispensing, [and] administering controlled
substances including opioid analgesics[] for a legitimate medical
purpose[] that is supported by appropriate documentation
establishing a valid medical need and treatment plan.'' Fla. Admin.
Code Ann. r. 64B8-9.013(1)(b) (2003). The Florida Standards further
provide that ``[p]hysicians should be diligent in preventing the
diversion of drugs for illegitimate purposes,'' and that
``prescribing must be based on clear documentation of unrelieved
pain * * * .'' Id. at r. 64B8-9.013(1)(d)-(e). In support of these
principles, the Florida Board of Medicine has adopted a list of
standards for the use of controlled substances for pain control. See
id. at r. 64B8-9.013(3). Pertinent obligations include the
following:
\70\ Due to the effective dates of the applicable state
regulation, Florida Administrative Code Rule 64B8-9.013 (2003)
applies to conduct between October 19, 2003, and October 16, 2010;
Rule 64B8-9.013 (2010) applies to conduct thereafter. See generally
https://www.flrules.org/gateway/ruleNo.asp?id=64B8-9.013.
(a) Evaluation of the Patient. A complete medical history and
physical examination must be conducted and documented in the medical
record. The medical record should document the nature and intensity
of the pain, current and past treatments for pain, underlying or
coexisting diseases or conditions, the effect of the pain on
physical and psychological function, and history of substance abuse.
The medical record should also document the presence of one or more
recognized medical indications for the use of a controlled
substance.
(b) Treatment Plan. The written treatment plan should state
objectives that will be used to determine treatment success, such as
pain relief and improved physical and psychosocial function, and
should indicate if any further diagnostic evaluations or other
treatments are planned * * * .
(c) Informed Consent and Agreement for Treatment. The physician
should discuss the risks and benefits of the use of controlled
substances with the patient * * * .
* * * * *
(e) Consultation. The physician should be willing to refer the
patient as necessary for additional evaluation and treatment * * * .
Special attention should be given to those pain patients who are at
risk for misusing their medications and those whose living
arrangements pose a risk for medication misuse or diversion * * * .
(f) Medical Records. The physician is required to keep accurate
and complete records to include, but not be limited to:
[[Page 58162]]
1. The medical history and physical examination, including
history of drug abuse and dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. [D]iscussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity
prescribed);
8. Instructions and agreements; and
9. Periodic Reviews * * * .
Fla. Admin. Code Ann. r. 64B8-9.013(3) (2003). ``Each case of
prescribing for pain will be evaluated on an individual basis.''
Fla. Admin. Code Ann. r. 64B8-9.013(1)(f).
Turning to the evidence in the instant case, the record reveals
violations of federal and state law relating to Respondent's
prescribing of controlled substances to undercover agents posing as
patients at APM and CCHM.
(a) SA Grafenstein February 16, 2010 Undercover Visit to APM
The record reflects that SA Grafenstein visited APM in an
undercover capacity on February 16, 2010. (Tr. 208.) He arrived at
approximately 1:45 p.m. and provided the receptionist with a Florida
driver's license, $250 and a copy of a legitimate MRI report of
another person's body labeled with SA Grafenstein's undercover name.
(Tr. 208, 221.) He filled out patient intake forms, including forms
that asked about his pain, on which he indicated occasional aching
and that he was taking 180 oxycodone 30 mg tablets. (Tr. 222; see
Gov't Ex. 10 at 3.) After submitting the forms to the receptionist,
SA Grafenstein sat down in the waiting area. (Tr. 222.)
Approximately fifteen people were in the waiting area when SA
Grafenstein first arrived. (Tr. 223.) He conversed with a patient
named [M.B.]\71\ (Tr. 226.) SA Grafenstein testified that [M.B.]
remarked that it was [M.B.]'s second visit to the clinic and that at
the first visit, he waited approximately five hours before a doctor
saw him. (Tr. 227-28.) [M.B.] further indicated that follow-up
patients were always seen before new patients, regardless of the
order they arrived. (Tr. 228.) [M.B.] also advised SA Grafenstein to
go to Rise and Shine Pharmacy in Pembroke Pines, Florida, because
``he said that it was cheap and that you can get whatever you wanted
to get there.'' (Tr. 228.) [M.B.] also said to ``stay away from a
pharmacy called Generic Drug Depot, because it was very hot right
now and there were cops all over the place and that there were
people standing outside trying to buy pills off the people who came,
who just got their prescriptions filled there.'' (Tr. 228-29.) Based
on his training and experience, SA Grafenstein believed [M.B.]'s
remarks indicated that some APM patients engaged in illegal
activity. (Tr. 229.)
---------------------------------------------------------------------------
\71\ SA Grafenstein later looked up the patient's name in the
Florida driver's license database and identified the patient by
photo. (Tr. 226.)
---------------------------------------------------------------------------
While waiting to be called by a doctor, SA Grafenstein stepped
outside to the front of the clinic to make a phone call. (Tr. 230.)
``[W]hile I was on the phone * * * a security guard * * * came up to
me and said that I couldn't talk in front of the building, but I
could go to the side or to the rear of the building and continue my
phone call.'' (Tr. 230.)
Upon returning to the waiting area, [M.B.] approached SA
Grafenstein and asked him to provide a urine sample for [M.B.]'s
drug test. (Tr. 231-32.) SA Grafenstein followed [M.B.] to the
restroom, entering and partially closing the door. (Tr. 232.) [M.B.]
gave SA Grafenstein [M.B.]'s cup, and SA Grafenstein urinated into
it, closed it, placed it on the sink and left. (Tr. 232.) [M.B.]
then entered the restroom and picked up the cup and submitted it as
[M.B.]'s own. (Tr. 232.) No staff members supervised or watched the
restroom during this interchange. (Tr. 232.) SA Grafenstein later
saw [M.B.] leaving the clinic carrying more than one prescription.
(Tr. 232.)
SA Grafenstein also recounted that a person in the waiting area
``was informing the group as a whole that when he had to take his
urine test * * * he had the cup in his hand but he forgot to go to
the bathroom in it, so once he realized it after he was done, he
scooped into the toilet and just grabbed a bunch of urine and water
and submitted it as his drug sample.'' (Tr. 235.) Moreover, SA
Grafenstein testified that an unidentified individual, who was
waiting but did not intend to see a doctor, urinated into a Gatorade
bottle carried by patient [M.I.] ``and then they both came back
together and [M.I.] informed us all what had happened but also
showed us the Gatorade bottle full of urine, which he kept in his
pocket.'' (Tr. 238.) The individual who urinated in the Gatorade
bottle said that he drove a patient ``down to the clinic * * *
because the individual who was seeing the doctor told him that he
would give him half of whatever he was prescribed for driving him
down [t]here.'' (Tr. 239.) SA Grafenstein testified that this
behavior indicated that ``the patients ran the clinic. * * * [I]f I
could go in and urinate in the cup and * * * pass it off as somebody
else's, you know, the patients were the ones that ran the show
there.'' (Tr. 238.)
After [M.B.] left, SA Grafenstein asked the receptionist how
much longer the wait would be. (Tr. 232.) She responded that the
doctor on the premises was only seeing follow-up patients, but that
in approximately one hour or one-and-one-half hours, another doctor
would arrive.\72\ (Tr. 232-33.)
---------------------------------------------------------------------------
\72\ SA Grafenstein testified that the initial doctor was Dr.
[S.B.], who left when Respondent arrived. (Tr. 233.)
---------------------------------------------------------------------------
SA Grafenstein returned to the waiting area. A ``female in the
group stated that the doctor that was currently there did not have a
valid DEA registration so that anyone that had received a script
from this doctor would not get their prescriptions filled that
day.'' (Tr. 234.) He overheard someone ``inquire[] to the female how
strict the doctor was. To which she replied, not very. He also asked
the female if the doctor checked for trackmarks, and she said he had
not.'' \73\ (Tr. 235.) Although not dispositive, SA Grafenstein
testified that he did not recall Respondent checking him for track
marks. (Tr. 236. But see Tr. 34-35.)
---------------------------------------------------------------------------
\73\ SA Grafenstein testified that the term ``track marks''
refers to indications of extensive intravenous needle usage
consistent with drug addiction. (Tr. 235-36.)
---------------------------------------------------------------------------
Another individual in the waiting area ``mentioned that the new
doctor that would be coming in has a valid DEA registration so that
whoever was seen by that doctor would be able to get their
prescriptions filled that day.'' (Tr. 236-37.) Respondent arrived at
the clinic at approximately 4:30 or 5:00 p.m. (Tr. 246.)
SA Grafenstein further testified that he overheard [M.I.] state
that two hours earlier ``he had gone home and did cocaine, not
knowing that he'd have to take a drug test. And after he learned
that he ingested bleach * * * to beat the drug test.'' \74\ (Tr.
237.) Respondent later issued a prescription to [M.I.] \75\ (Tr.
239-40.)
---------------------------------------------------------------------------
\74\ SA Grafenstein believed [M.I.] actually ingested bleach.
(Tr. 248.) At hearing, Respondent testified that ``if you were to
swallow bleach, you would get a severe esophagitis--You would have
to require an immediate endoscopy and you would be acutely ill.''
(Tr. 501-02.)
\75\ SA Grafenstein did not actually see the prescription, but
the patient said ``the doctor had hooked him up.'' (Tr. 249.)
---------------------------------------------------------------------------
SA Grafenstein also related that ``[a]nother individual in the
group stated that if you failed the drug test for marijuana, you
could pay $50 to the drug test administrator and the administrator
would make your hot, or your failed test, clean.'' (Tr. 237.)
SA Grafenstein was eventually called to have his vitals taken
and submit a urine sample. (See Tr. 240.) Security did not watch as
SA Grafenstein provided a urine sample. (Tr. 240.)
The foregoing evidence regarding patient conversations in the
APM waiting area and the lack of supervision and fabrication of drug
tests, although partially based upon hearsay, is internally
consistent, contains indicia of reliability and is generally
consistent with other evidence of record. The emerging image of APM
on February 16, 2010, is that of a clinic in which patients collude
with one another and with staff members to fabricate desirable
urinalysis results and thereby obtain controlled substances outside
the usual course of professional practice or for other than a
legitimate medical purpose. Although not for the most part directly
attributable to Respondent, this misconduct calls into question the
legitimacy of APM as a whole.
Approximately six hours after SA Grafenstein arrived at APM,
Respondent called SA Grafenstein into his office. (Tr. 241; 247; see
Gov't Ex. 8 at 33.) SA Grafenstein sat approximately three feet from
Respondent, on the other side of a desk. (Tr. 241.) Respondent asked
SA Grafenstein's age and how he hurt himself. (Gov't Ex. 8 at 33.)
SA Grafenstein responded ``[b]asically * * * kind of, sort of, maybe
just from work stuff. So I ache in the upper and lower * * * .''
(Gov't Ex. 8 at 33.) Respondent inquired whether he was in a car
accident or fell, to which SA Grafenstein responded ``[m]ore * * *
like a lot of lifting, monotonous daily [stuff].'' (Gov't Ex. 8 at
34.) At hearing, SA Grafenstein testified that he informed
Respondent that he was not in any pain but had ``mainly tightness,
soreness and achiness
[[Page 58163]]
[due] to a tight lower back, upper back and neck area.'' \76\ (Tr.
at 241.) Respondent marked in SA Grafenstein's record that his pain
was a ten on a scale of one to ten (Gov't Ex. 18 at 18), and
conceded at hearing that SA Grafenstein never gave him that number
(Tr. 475).
---------------------------------------------------------------------------
\76\ A transcript of the undercover recording reflects that SA
Grafenstein described his pain as ``[a] lot of pain. My upper is
bother me [sic], a little sore. My lower, nothing that's * * * like
excruciating * * * .'' (Gov't Ex. 8 at 34.) The audio recording of
the conversation is inconsistent with the transcript with regard to
SA Grafenstein's reference to ``[a] lot of pain'', and is consistent
with SA Grafenstein's testimony that he did not use the word pain.
(Gov't Ex. 7, UC Audio Pt 2.002 at 19:51:43-19:52:00.
---------------------------------------------------------------------------
Respondent told SA Grafenstein that ``the issue is that I can't
tell you anything about your neck `cause you don't have an MRI.''
(Gov't Ex. 8 at 34; see Tr. 241.) ``The one you have there tells me
that you have some problems in your low back * * * It tells me
nothing about your neck.'' (Gov't Ex. 8 at 35.) Respondent asked SA
Grafenstein how bad the pain was with and without medicines, on a
scale of one to ten. (Gov't Ex. 8 at 36.) At hearing, SA Grafenstein
testified that ``I said that my tightness and soreness with
medication was zero and without medication it was a [two].'' \77\
(Tr. 242.) SA Grafenstein testified that Respondent wrote two or
three in the patient chart. (Tr. 242; see Gov't Ex. 10 at 18. See
generally Tr. 220.)
---------------------------------------------------------------------------
\77\ In fact, the record of the undercover visit reflects that
Respondent asked SA Grafenstein to ``[g]ive me a number'' to which
SA Grafenstein responded ``Two.'' (Gov't Ex. 8 at 36.)
---------------------------------------------------------------------------
Upon inquiry from Respondent, SA Grafenstein stated that
standing, bending or sitting made his pain worse; that he did not
use drugs, alcohol or cigarettes; and that he had not had surgery
and had no allergies or medical problems. (Gov't Ex. 8 at 36.)
At approximately 8:00 p.m., Respondent directed SA Grafenstein
to sit on an examination table. (Tr. 242, 247.) Respondent told SA
Grafenstein to raise his hands (see Gov't Ex. 8 at 37) and inhale
deeply (Gov't Ex. 8 at 39) while Respondent listened with a
stethoscope (Tr. 242). Respondent also asked SA Grafenstein to bend
over and felt along SA Grafenstein's back and neck with his hand.
(Tr. 242; Gov't Ex. 8 at 40.) He asked where the pain was and
performed reflex tests. (Tr. 242-43.)
Respondent asked SA Grafenstein whether he was taking medication
six times a day and whether ``that seems to work out good for you?''
(Gov't Ex. 8 at 42.) SA Grafenstein responded in the affirmative
\78\ and stated that he was also taking Xanax. (Gov't Ex. 8 at 42;
Tr. 243.) Respondent inquired ``how much Xanax are you taking?
`Cause it didn't get put on there, but I'll, I'll get it for you.''
(Gov't Ex. 8 at 42.) SA Grafenstein responded that he was taking
about sixty. Id.
---------------------------------------------------------------------------
\78\ Consistent with the transcript of the visit, SA Grafenstein
completed a patient form indicating he was currently taking 180
oxycodone 30 mg tablets. (Gov't Ex. 10 at 3 & 4.)
---------------------------------------------------------------------------
Respondent issued SA Grafenstein prescriptions for 180
Roxicodone 30 mg tablets and 60 Xanax 2 mg tablets, reflecting the
medications SA Grafenstein indicated on his patient forms and
requested orally.\79\ (Tr. 216, 243; Gov't Ex. 9; Gov't Ex. 10 at 3,
4.) Dr. Glener opined that of the files he reviewed associated with
Respondent's patients, ``the most egregious is [SA Grafenstein],
where [Respondent] prescribe[d] a potentially fatal combination of
oxycodone and alprazolam \80\ without any justification
whatsoever.'' \81\ (Gov't Ex. 22 at 2; see Tr. 329-30.)
---------------------------------------------------------------------------
\79\ SA Grafenstein testified that following his meeting he
checked out with the receptionist, who gave him prescriptions and
scheduled a follow-up appointment for March 16, 2010. (Tr. 244.)
There is no indication that SA Grafenstein kept the appointment.
\80\ Regarding his comment as to the dangers of prescribing
alprazolam 2 mg tablets with oxycodone 30 mg tablets six times
daily, Dr. Glener remarked that ``[t]he potential for disaster is
very high * * * .'' (Tr. 332.) He explained that ``most people would
be rendered unconscious and very many of those people would die from
using the medications as prescribed so they are almost certainly
being diverted on that basis.'' (Tr. 330.) In Dr. Glener's opinion,
a dosage of .25 or possibly .5 milligrams of alprazolam would be
more appropriate because ``there is really little indication for the
ongoing prescription of large doses of a short-acting benzodiazepine
* * * . Most physicians will use a long-acting benzodiazepine if
they even feel one is necessary.'' (See Tr. 330-31.)
\81\ Dr. Glener further explained: ``Dr. Casanova makes no
notation that the patient is experiencing anxiety in his Review of
Systems, the only reason to prescribe this medication.'' (Gov't Ex.
22 at 2.)
---------------------------------------------------------------------------
In response, Respondent testified that he prescribed Xanax based
on the patient's representation that he was taking the medication,
despite being aware that the patient had tested negative for both
oxycodone and alprazolam.\82\ (Tr. 427-28, 476.) Respondent also
testified that he performed an appropriate and complete history and
physical examination on SA Grafenstein, made findings and developed
a treatment objective, and that his treatment of SA Grafenstein with
controlled substances was based on sound clinical grounds, to
include an MRI report.\83\ (Tr. 418, 433.) I reject Respondent's
testimony in this regard as not credible and inconsistent with the
weight of the evidence. Although Respondent may have been concerned
that the patient would experience withdrawal symptoms without Xanax,
Respondent conceded at hearing that he did not ask the patient when
he had last taken the Schedule IV controlled substance. (See Tr.
476-77.) Moreover, although the existence of an MRI report evincing
``an abutment of the nerve * * * that can lead to pain * * * .''
(Tr. 419) suggests some medical basis for prescribing an opioid
analgesic, Dr. Glener credibly testified that the combination of
oxycodone and alprazolam was both ``egregious'' and ``potentially
fatal.'' (Tr. 329; Gov't Ex. 22 at 2.) Upon consideration of all the
evidence, to include the competing evaluations of Respondent's
conduct by Respondent and by Dr. Glener, I find by substantial
evidence that Respondent's prescriptions to SA Grafenstein were
outside the usual course of professional practice or for other than
a legitimate medical purpose, in violation of state and federal law.
See 21 C.F.R. Sec. 1306.04(a); Fla. Admin. Code Ann. r. 64B8-
9.013(1)(b).
---------------------------------------------------------------------------
\82\ In mitigation, Respondent explained that alprazolam has a
short half-life and can quickly vanish from a person's system,
meaning that patients ``can potentially experience some withdrawal''
to include a risk of seizure. (Tr. 428.)
\83\ For instance, he identified findings in the MRI report
evincing ``an abutment of the nerve * * * that can lead to pain * *
* .'' (Tr. 419.) He concluded that the patient was suffering from
low-back pain and occasional neck pain. (Tr. 422-23.)
---------------------------------------------------------------------------
The record further reflects that although he knew the MRI report
focused on the wrong area of SA Grafenstein's body (see Gov't Ex. 8
at 33; Tr. 241), Respondent did not order a new MRI, nor did he
discuss a treatment plan or the risks and benefits of the medication
he provided. (Tr. 244.) On cross-examination, SA Grafenstein
conceded that he had received and signed a Consent Form, containing
a discussion of risks and benefits. (Tr. 245; see Gov't Ex. 10 at 9-
10; see also Tr. 429-30.) The Consent Form, however, reflects an
empty space next to the line reading ``Dr. Rene Casanova is
prescribing opioid medicine * * * for a diagnosis of:'',\84\ (Gov't
Ex. 10 at 9; Tr. 253) and SA Grafenstein testified that Respondent
did not provide him with a diagnosis. (Tr. 253.) Dr. Glener opined
that the Consent Form is incomplete because the diagnosis is not
listed, but the box is checked, and because no alternative
treatments were listed, but that box is checked as well. (Tr. 398;
see Gov't Ex. 10 at 9.) In addition, the patient's signature is not
witnessed. (Tr. 399.) The foregoing evidence is inconsistent with
the Florida Standards, which provide that ``[t]he physician is
required to keep accurate and complete records * * * .'' Fla. Admin.
Code Ann. r. 64B8-9.013(3)(f).
---------------------------------------------------------------------------
\84\ The Consent Form also reflects an empty space next to the
line reading ``[t]he other alternatives discussed include
acupuncture, massage'' (Gov't Ex. 10 at 9), and Respondent did not
discuss acupuncture, massage or any other alternative treatments
with SA Grafenstein. (Tr. 253-54.)
---------------------------------------------------------------------------
Dr. Glener further opined that ``[SA Grafenstein] stated his
pain without medication was 2/10, a complaint of minimal pain, and a
huge dosage of oxycodone was prescribed. Alprazolam 2 mg twice daily
was then prescribed without documenting any anxiety. Prescription of
other psychotropic medication or referral to a mental health
professional was not considered.'' (Gov't Ex. 22 at 2; see also Tr.
333.) Respondent further conceded that he did not refer SA
Grafenstein to a specialist.\85\ (Tr. 476.) Respondent's conduct is
inconsistent with Florida Administrative Code Rule 64B8-9.013(3)(e),
which provides that ``[t]he physician should be willing to refer the
patient as necessary for additional evaluation and treatment * * *
.'' Fla. Admin. Code Ann. r. 64B8-9.013(3)(e).
---------------------------------------------------------------------------
\85\ Respondent explained that he intended to ``make some
decisions relative to consultations or referrals'' at a follow-up
visit. (Tr. 476.) There was no follow-up visit.
---------------------------------------------------------------------------
The record reflects additional irregularities in Respondent's
treatment of SA Grafenstein. Consistent with his report, Dr. Glener
testified at hearing that he found it interesting that SA
Grafenstein stated that his pain was two out of ten, ``which is
extremely mild pain'' and ``the very definition of tenderness.''
(Tr. 328-29; see also Tr. 393 (describing difference between pain
and
[[Page 58164]]
tenderness).) Dr. Glener wrote that Respondent ``found lower lumbar
tenderness on physical examination, also noting `pain with
palpation,' indicating that he does not understand that this is the
definition of tenderness.'' (Gov't Ex. 22 at 1.) At hearing, Dr.
Glener elaborated that ``I was just trying to show that even a
medical student knows what that means and what kind of expertise
could this doctor have if he doesn't even know something a first-
year medical student would know.'' (Tr. 394-95.) He also wrote that
Respondent ``[w]ould not evaluate [SA Grafenstein]'s neck because he
had no MRI report, consistent with a common belief among `pill mill'
doctors that having pathology on an MRI report somehow justifies the
prescription of controlled substances.'' \86\ (Gov't Ex. 22 at 2.)
---------------------------------------------------------------------------
\86\ Dr. Glener explained that ``it's very prevalent * * * that
physicians who are engaged in this sort of practice demand an MRI in
order to use that as what I like to call the golden ticket to
prescribe opioid analgesics. * * * An MRI is nothing magical. It's
simply a diagnostic tool. Finding pathology on an MRI does not
entitle any practitioner to prescribe a controlled substance. You
need to connect the dots.'' (Tr. 336; see also Tr. 364-66, 373-74.)
---------------------------------------------------------------------------
At hearing, Respondent asserted that SA Grafenstein's medical
file contains a physical examination, history of drug abuse and
dependence and diagnostic, therapeutic and laboratory results as
required by the Florida Standards. (Tr. 423.) He argued that it is
difficult to develop a treatment plan over the course of a single
visit and instead, a treatment plan slowly progresses over time.
(Tr. 425-26.) Although I accept Respondent's testimony that a
treatment plan progresses over time, Respondent was still bound to
document a treatment plan compliant with the Florida Standards \87\
before issuing a prescription for controlled substances. See Robert
L. Dougherty, M.D., 76 Fed. Reg. 16,823, 16,832 n.11 (DEA 2011)
(practitioner's standard of care refers to that generally recognized
in medical community, rather than standard personal to
practitioner).
---------------------------------------------------------------------------
\87\ See Fla. Admin. Code Ann. r. 64B8-9.013(3)(b) (``The
written treatment plan should state objectives that will be used to
determine treatment success * * * '' as well as other elements).
---------------------------------------------------------------------------
Respondent also explained that he had inadvertently transposed
numbers on SA Grafenstein's history and physical examination form,
erroneously indicating that SA Grafenstein's pain while on
medication was a ten and his pain without medication was a two or
three, on a scale of one to ten. (See Tr. 474; see also Gov't Ex. 10
at 18.) Although apparently inadvertent, Respondent's inaccurate
notation in SA Grafenstein's patient file is inconsistent with the
Florida Standards. See Fla. Admin. Code Ann. r. 64B8-9.013(3)(f)
(``[t]he physician is required to keep accurate and complete records
* * * .''); see also Tr. 319 (expert testimony that ``it's incumbent
upon [the physician] to document [the physician's] thought process *
* * .'').
In summary, the record reveals numerous violations of standards
and regulations concerning Respondent's prescribing of controlled
substances in the context of SA Grafenstein's undercover visit to
APM. Substantial evidence supports a finding that Respondent's
prescription of controlled substances to SA Grafenstein lacked a
``legitimate medical purpose * * * that is supported by appropriate
documentation establishing a valid medical need and treatment
plan,'' in violation of Florida Administrative Code Rule 64B8-
9.013(1)(b) (2003), and was outside the usual course of professional
practice, in violation of 21 C.F.R. Sec. 1306.04(a).
(b) SA Cortes February 16, 2010 Undercover Visit to APM
SA Cortes visited APM in an undercover capacity on February 16,
2010, and wore a functioning concealed audio recording device. (Tr.
257-58, 263.) He submitted new patient paperwork, provided a
fictitious MRI report \88\ and undercover Florida driver's license
and picked up a business card for Simfa Rose pharmacy. (Tr. 272-73;
see Tr. 268-69.) He intentionally left blank the section of the
paperwork inquiring about current medications. (Tr. 265.) He also
checked a box indicating that he was not in pain. (Tr. 266; see
Gov't Ex. 14 at 3.) After paying for the visit, SA Cortes waited in
the waiting area for approximately five-and-one-half hours.\89\ (Tr.
265, 273.)
---------------------------------------------------------------------------
\88\ SA Cortes testified that he didn't know anything specific
about the MRI report he provided, other than that it listed his
undercover name and birth date and that it contained information
about the spine or back area. (Tr. 281-82.)
\89\ SA Cortes testified that he spent approximately eight-and-
one-half hours at APM on February 16, 2010. (Tr. 273.)
---------------------------------------------------------------------------
During his wait, a staff member named Jeremiah Flowers conducted
triage procedures to include measuring blood pressure and weight and
performing a urinalysis. (Tr. 273-74.) There was no supervision
while SA Cortes provided a urine specimen. (Tr. 274.) Mr. Flowers
evaluated the urine drug test in SA Cortes's presence, stating that
the test was negative, meaning no opioids or controlled substances
were detected. (Tr. 274-75.) SA Cortes's testimony regarding the
absence of supervision during his urine drug screen is consistent
with, and tends to corroborate, other evidence of record indicating
that APM did not carefully supervise urine drug screens, among other
deficiencies.\90\
---------------------------------------------------------------------------
\90\ SA Cortes also testified that he overheard a conversation
between Mr. Flowers and an unknown individual discussing different
methods to inject heroin. (Tr. 275.)
---------------------------------------------------------------------------
After SA Cortes had waited more than five hours, Respondent
called him into his office. (Tr. 273, 275.) Respondent directed him
to sit across from him at a desk, approximately three feet away.
(Tr. 275.) Respondent asked SA Cortes how old he was and how he hurt
himself. (Gov't Ex. 12 at 2.) SA Cortes responded ``Uh * * * not
really hurt, doc. Um * * * what I'm experiencing is * * * more and
more stiffness * * * after each practice.'' (Gov't Ex. 12 at 2; Tr.
275-76.) Respondent asked where, and SA Cortes indicated his
shoulders and lower waist. (Gov't Ex. 12 at 2.) Respondent asked how
it happened, to which SA Cortes responded that he was studying
martial arts and that ``lately, more and more, after each practice,
it's getting * * * worse.'' (Gov't Ex. 12 at 2-3.)
Although there had not yet been any discussion of medication and
SA Cortes did not indicate he was taking any medication on his Pain
Assessment Form (Gov't Ex. 14 at 2), Respondent asked how long SA
Cortes had been taking ``these medications'' and then asked ``Are
you taking? You didn't write anything.'' (Gov't Ex. 12 at 3.) SA
Cortes asked if his responses were confidential, to which Respondent
answered in the affirmative. (Gov't Ex. 12 at 3.) SA Cortes
explained that he had been taking Tylenol and his girlfriend's
hydrocodone left over from her gallstone surgery.\91\ (Gov't Ex. 12
at 3-4; Tr. 276.) Respondent asked how the medication worked for him
and how many he was taking per day. (Gov't Ex. 12 at 4.) SA Cortes
responded in the affirmative and indicated ``only about one (1) or
two (2) a day.'' (Gov't Ex. 12 at 4.) Respondent attempted to
identify the strength of the dosage, and SA Cortes identified the
medication as a white oval tablet. (Gov't Ex. 12 at 5; Tr. 277.)
Respondent asked if he experienced any side effects and SA Cortes
said he felt woozy for a couple of days but the wooziness wore off.
(Gov't Ex. 12 at 5.)
---------------------------------------------------------------------------
\91\ SA Cortes acknowledged on cross-examination that his
statement to Respondent that he was taking opioids was false and was
part of the undercover operation. (Tr. 283.)
---------------------------------------------------------------------------
Contrary to SA Cortes's statements to Respondent that he had
been taking his girlfriend's hydrocodone, SA Cortes's urine drug
screen tested negative for that controlled substance. (See Tr. 482;
see also Gov't Ex. 14 at 1.) Moreover, Dr. Glener testified that
``when someone admits to felonious behavior in my office, that
certainly would prompt a follow-up.'' (Tr. 396.) By contrast,
Respondent offered that he did not ask SA Cortes when he had last
taken his girlfriend's hydrocodone because ``based on the
information from the drug screen, given the half-life of the
medicine and so forth, you can sort of backtrack that information.''
\92\ (See Tr. 482.) Nor did he inquire whether SA Cortes had
obtained a prescription for hydrocodone from another doctor. (Tr.
482.) Respondent testified that the information SA Cortes gave him
was privileged \93\ and that
[[Page 58165]]
because SA Cortes indicated his girlfriend's hydrocodone was
``providing some sort of relief * * * my thought process was to
bring him into a plan under physician supervision to provide him
appropriate treatment for his medical ailments.'' (Tr. 435.) Having
carefully considered all the evidence, I find that Respondent's
reaction to SA Cortes's confessed diversion of controlled substances
and his failure to follow up in the face of contradictory
information were inconsistent with the Florida Standards, which
state that ``[p]hysicians should be diligent in preventing the
diversion of drugs for illegitimate purposes.'' Fla. Admin. Code
Ann. r. 64B8-9.013(1)(d).
---------------------------------------------------------------------------
\92\ At the interview, SA Cortes remarked that the hydrocodone
prescription had run out without being renewed (Gov't Ex. 12 at 4),
but Respondent did not address this point at hearing.
\93\ Consistent with his testimony at hearing, Respondent argues
that SA Cortes's statement that he was using his girlfriend's
hydrocodone was privileged. (Resp't Br. 18.) But ``privileges can be
waived if the parties affirmatively do something to destroy the
privilege * * * .'' Harley v. Health Center of Coconut Creek, Inc.,
469 F. Supp. 2d 1212, 1212 (S.D. Fla. 2006). Therefore, assuming,
arguendo, that SA Cortes held a privilege in the contents of his
communications with Respondent, SA Cortes waived that privilege by
testifying at hearing. E.g., Matter of Certain Complaints Under
Investig. by an Investig. Cmtee. of the Judicial Council of the
Eleventh Circuit, 783 F.2d 1488, 1523 n.32 (11th Cir. 1986) (``the
holder of a privilege can also waive it by permitting a breach of
the privilege in his presence''), superseded by statute on other
grounds as stated in In re McBryde, 120 F.3d 519 (5th Cir. 1997).
More importantly, Respondent failed to ``refer the patient as
necessary for additional evaluation and treatment'' or give
``[s]pecial attention * * * to those pain patients who are at risk
for misusing their medications and those who * * * pose a risk for
medication misuse or diversion.'' Fla. Admin. Code Ann. r. 64B8-
9.013(3)(e).
---------------------------------------------------------------------------
Respondent asked SA Cortes how bad his pain was with and without
medication, on a scale from one to ten. (Gov't Ex. 12 at 5.) SA
Cortes replied that the pain was three or four while on medication.
(Gov't Ex. 12 at 6.)
CASANOVA: With the medicines?
S/A: Right.
CASANOVA: And without?
S/A: And without * * * um * * * worse than that. I mean, I
[unintelligible]
CASANOVA: Eight (8) or a nine (9)?
S/A: Yeah * * * eight (8) or * * *
(Gov't Ex. 12 at 6; Tr. 277-78.) Respondent asked whether SA
Cortes's pain radiated, to which SA Cortes replied in the negative.
(Tr. 279.) Respondent asked SA Cortes where he worked, and SA Cortes
responded that he worked the midnight shift at a warehouse, loading
trucks. (Gov't Ex. 12 at 6.) He stated that lifting made his
discomfort worse. (Gov't Ex. 12 at 7.)
Respondent asked whether SA Cortes smoked, used drugs or alcohol
or had any surgery, allergies or medical problems, to which SA
Cortes replied in the negative, indicating only that he was allergic
to aspirin. (Gov't Ex. 12 at 7.) Respondent directed SA Cortes to
sit on an examination table and to inhale while Respondent listened
to his respiration with a stethoscope and tested his reflexes. (Tr.
278.) Respondent inquired again whether SA Cortes was taking
hydrocodone. (Gov't Ex. 12 at 8; Tr. 278.) SA Cortes responded in
the affirmative and that it wasn't prescribed to him, and Respondent
stated ``I understand.'' (Gov't Ex. 12 at 9; see Tr. 278.) Dr.
Glener testified that in Respondent's interaction with SA Cortes
``there really was no significant physical examination pertaining to
the appropriate organ systems * * * .'' (Tr. 327.) Respondent
testified to the contrary (see Tr. 434), but I find the objective
evidence of record supports Dr. Glener's conclusion and also find
that Respondent's conduct was contrary to Florida Administrative
Code Rule 64B8-9.013(3)(f)(1), which provides that a ``physician is
required to keep accurate and complete records to include, but not
be limited to * * * [t]he medical history and physical examination *
* *.'' Fla. Admin. Code Ann. r. 64B8-9.013(3)(f)(1).
Despite SA Cortes's previous indication that he had been taking
only one or two hydrocodone pills per day (Gov't Ex. 12 at 4; Tr.
279), Respondent said:
CASANOVA: You said you were taking about three (3) or four (4) a
day?
S/A: Yes. [PAUSE: 00:09:02-00:09:31]
CASANOVA: Correct? * * * I'm going to give you four (4) * * * a day.
Alright?
S/A: Okay.
CASANOVA: Alright?
S/A: Hopefully that works.
(Gov't Ex. 12 at 9.) Respondent explained that SA Cortes was to take
one tablet four times per day, and that ``I gave you, uh, the higher
dose: the seven point five (7.5) milligrams.'' (Gov't Ex. 12 at 10;
Tr. 279.) Respondent issued SA Cortes a prescription for 120
hydrocodone 7.5 mg tablets on February 16, 2010. (Gov't Ex. 13; Tr.
277, 288.)
At hearing, Respondent conceded that he did not discuss the
risks and benefits of the medication because ``[t]he information was
provided in the documentation that is here that a patient checked
off and signed off.'' \94\ (Tr. 483.) But SA Cortes's Consent Form
reflects an empty space next to the line reading ``Dr. Rene Casanova
is prescribing opioid medicine * * * for a diagnosis of:'' (Gov't
Ex. 14 at 8; Tr. 267.) In addition, Respondent did not discuss a
diagnosis or treatment plan with SA Cortes, nor did he document a
treatment plan in the patient file.\95\ (Tr. 279-80, 486-87.)
Moreover, the Consent Form reflects an empty space next to the line
reading ``[t]he other alternatives discussed include acupuncture,
massage [and]:'' (Gov't Ex. 14 at 8), and Respondent failed to
discuss acupuncture, massage or any other alternative treatments
with SA Cortes. (See generally Gov't Ex. 12.) As Dr. Glener
observed, the Consent Form in SA Cortes's patient file is incomplete
because the diagnosis is not listed, but the box is checked, and
because no alternative treatments were listed, but that box is
checked. (Tr. 398; see Gov't Ex. 14 at 8.)
---------------------------------------------------------------------------
\94\ Similarly, on cross-examination, SA Cortes acknowledged
that the Consent Form discusses risks and benefits of taking
opioids. (Tr. 284.)
\95\ Respondent conceded that the Florida Standards required a
written treatment plan. (Tr. 486-87.) See also Fla. Admin. Code Ann.
r. 64B8-9.013(3)(f).
---------------------------------------------------------------------------
In light of the foregoing, I find that Respondent failed to
comply with the Florida Standards requiring that physicians maintain
accurate and complete records, see Fla. Admin. Code Ann. r. 64B8-
9.013(3)(f) (``The physician is required to keep accurate and
complete records * * * .''), discuss the risks and benefits of the
use of controlled substances, see Fla. Admin. Code Ann. r. 64B8-
9.013(3)(c) (``The physician should discuss the risks and benefits
of the use of controlled substances with the patient * * * .'') and
document a written treatment plan,\96\ see Fla. Admin. Code Ann. r.
64B8-9.013(3)(f).
---------------------------------------------------------------------------
\96\ I accordingly reject Respondent's contention at hearing
that his treatment of SA Cortes was, on the whole, proper.
Respondent's assertion in this regard consisted of a number of
claims, some demonstrably false. For instance, Respondent asserted
that he formulated a treatment objective and on that basis treated
the patient (Tr. 434); that the medical file contains the complete
required documentation for medical records under the Florida
regulations, to include medical history, diagnostic tests,
evaluation, treatment objective and discussion of risks and
benefits, albeit not orally (Tr. 439); that the treatment plan ``is
formulated over time with numerous visits to gather more
information, get all the appropriate documentation and so forth and
review all the data'' (Tr. 439); and that his prescription of
controlled substances to SA Cortes was based on accepted scientific
knowledge of the treatment of pain and based on sound clinical
grounds. (Tr. 441.)
---------------------------------------------------------------------------
In addition, Dr. Glener testified that Respondent's prescription
of hydrocodone to SA Cortes was ``entirely inappropriate'' because
``[o]nce the patient emphasized that [he was] having stiffness and
not pain, there's no indication for treatment with an opioid
analgesic.'' (Tr. 327.) Dr. Glener elaborated that opioid analgesics
are indicated for pain, and that the patient's comments suggested
the existence of a muscular problem for which referral to a physical
therapist would be appropriate. (Tr. 327.) Respondent conceded that
he did not refer SA Cortes to a specialist,\97\ (Tr. 476)
notwithstanding the Florida standard stating that ``[t]he physician
should be willing to refer the patient as necessary for additional
evaluation and treatment in order to achieve treatment objectives.''
Fla. Admin. Code Ann. r. 64B8-9.013(3)(e).
---------------------------------------------------------------------------
\97\ Respondent explained that he intended to ``make some
decisions relative to consultations or referrals'' at a follow-up
visit. (Tr. 476.) There was no follow-up visit.
---------------------------------------------------------------------------
In summary, the record reveals numerous violations of standards
and regulations concerning Respondent's prescribing of controlled
substances in the context of SA Cortes's undercover visit to APM.
Substantial evidence supports a finding that Respondent's
prescription of controlled substances to SA Cortes lacked a
``legitimate medical purpose * * * that is supported by appropriate
documentation establishing a valid medical need and treatment
plan,'' in violation of Florida Administrative Code Rule 64B8-
9.013(1)(b) (2003), and was outside the usual course of professional
practice, in violation of 21 C.F.R. Sec. 1306.04(a).
(c) SA Saenz March 10, 2010 Undercover Visit to CCHM
The transcript of SA Saenz's March 10, 2010 undercover visit to
CCHM reflects that when Respondent met with SA Saenz, he first asked
her age and how she hurt herself. (Gov't Ex. 16 at 4.) She stated
she was thirty-four years old and that she thought she injured
herself by lifting children at a daycare center where she worked.
(See Gov't Ex. 16 at 4; Gov't Ex. 18 at 1.) Respondent stated that
he assumed SA Saenz had lower back pain, to which she responded
``Uh-um, sometimes * * * about a week'' and indicated that she had
hurt herself one week earlier. (Gov't Ex. 16 at 5, 8-9.)
SA Saenz's patient file includes an MRI report dated March 8,
2010.\98\ (Gov't Ex. 18 at 19-20.) Respondent asked if she obtained
the MRI two days ago, to which she responded in the affirmative.
(Gov't Ex. 16 at
[[Page 58166]]
5.) At hearing, Respondent testified that the MRI report was
consistent with her complaints of pain. (Tr. 444.)
---------------------------------------------------------------------------
\98\ Respondent had not ordered the MRI; SA Saenz brought it
with her on her own accord. (See Tr. 443.)
---------------------------------------------------------------------------
At the patient interview, Respondent asked SA Saenz ``[a]re you
taking any medicines for this? I assume not, `cause it's just a
week. Right?'' (Gov't Ex. 16 at 5.) SA Saenz responded that she was
taking ``[i]buprofen and stuff.'' (Gov't Ex. 16 at 5.) Respondent
asked if she was taking anything else, to which she responded ``Uh *
* * what did I had [sic] * * * Tones, Dones'' (Gov't Ex. 16 at 7),
which Respondent identified at hearing as slang for ``[o]xycodone,
some kind of a narcotic pain medication.'' (Tr. 445-46.) Consistent
with this interpretation, patient paperwork that SA Saenz completed
indicates she was taking Roxicodone 40 mg tablets eight times per
day, oxycodone 15 mg tablets three times per day and 2 mg Xanax
tablets two times per day, a not inconsequential quantity of
controlled substances. (See Gov't Ex. 18 at 8.) An examination note
in her patient file also reflects the notion ``dones.'' (Gov't Ex.
18 at 1.) Her urine drug screen, however, was negative for
oxycodone. (Gov't Ex. 18 at 18; Tr. 446.) And, notably, SA Saenz
told Respondent that she had not seen any doctor for medicines
(Gov't Ex. 16 at 7; see also Gov't Ex. 18 at 1), raising the
questions of how she obtained them and whether she was using them,
and suggesting that she had participated in the diversion or abuse
of controlled substances.\99\
---------------------------------------------------------------------------
\99\ In an additional inconsistency, a medical history form
completed by SA Saenz indicated she was not currently taking any
medication. (Gov't Ex. 18 at 7.)
---------------------------------------------------------------------------
If Respondent had any concerns about SA Saenz's apparent
diversion or abuse of controlled substances, or irregularities in
her statements and medical file, there is no evidence that he voiced
them. Indeed, Respondent testified at hearing that he did not ask SA
Saenz how she had obtained oxycodone and Xanax. (See Tr. 495.) This
omission reflects a degree of willful blindness by Respondent to
issues of diversion, especially given that he proceeded to prescribe
controlled substances to SA Saenz. (Gov't Ex. 17.) Moreover, under
the Florida Standards, ``[t]he physician should be willing to refer
the patient as necessary for additional evaluation and treatment in
order to achieve treatment objectives. Special attention should be
given to those pain patients who are at risk for misusing their
medications and [who] * * * pose a risk for medication misuse or
diversion.'' Fla. Admin. Code Ann. r. 64B8-9.013(3)(e) (emphasis
supplied). In light of her negative drug screen, her use of slang to
refer to oxycodone and her statement that she had not seen a doctor
for the controlled substances she admitted taking, SA Saenz's ``risk
for medication misuse or diversion'' was patent. But at hearing,
Respondent conceded that he did not refer SA Saenz to a specialist
(Tr. 476), and there is no indication that Respondent otherwise
displayed ``special attention'' to her heightened risk of
diversion.\100\ Respondent's conduct in this regard is inconsistent
with Florida Administrative Code Rule 64B8-9.013(3)(e).
---------------------------------------------------------------------------
\100\ Respondent explained that he intended to ``make some
decisions relative to consultations or referrals'' at a follow-up
visit. (Tr. 476.) There was no follow-up visit.
---------------------------------------------------------------------------
In partial mitigation, SA Saenz did confirm to Respondent that
the medication was helping with her pain. (Gov't Ex. 16 at 7.)
Moreover, Respondent explained at hearing that because SA Saenz's
urine drug screen was negative, he was concerned she might suffer
from withdrawal symptoms. (Tr. 446.) But Respondent's statement in
this regard is not credible, as neither the transcript of
Respondent's interview with SA Saenz nor handwritten notes in the
patient file contain any reference to withdrawal,\101\ and
physicians are required to document their thought processes in the
medical record. E.g., Tr. 319. See generally Fla. Admin. Code Ann.
r. 64B8-9.013(3)(f) (``The physician is required to keep accurate
and complete records * * * .''). I do credit, however, Respondent's
statement that ``this was somewhat confusing that she did state just
on tomes and domes and didn't state anything about an anxiolytic
with this piece of information and her drug screen was negative.''
(Tr. 446.) I also find that Respondent's conduct is inconsistent
with a physician's duty to ``be diligent in preventing the diversion
of drugs for illegitimate purposes.'' Fla. Admin. Code Ann. r. 64B8-
9.013(1)(d). I moreover reject Respondent's argument that he ``had
no reasons to believe that the undercover agents were lying or
otherwise falsifying information to illegally obtain medication.''
(Resp't Br. 28.) To the contrary, by prescribing controlled
substances (Gov't Ex. 17) in the face of a drug screen revealing
negative results for the very controlled substances the patient
claimed she was taking without a prescription, Respondent failed to
give ``[s]pecial attention * * * to those pain patients who are at
risk for misusing their medications and * * * [who] pose a risk for
medication misuse or diversion * * * .'' Fla. Admin. Code Ann. r.
64B8-9.013(3)(e).
---------------------------------------------------------------------------
\101\ Gov't Ex. 18. Respondent similarly suggested at hearing
that he prescribed Xanax to SA Grafenstein out of a concern that SA
Grafenstein would experience withdrawal symptoms without such a
prescription. (Tr. 476-77.) Respondent conceded, however, that he
never asked SA Grafenstein when he had last taken Xanax. (Tr. 477.)
In any event, Respondent did not adequately address the heightened
risk of diversion in either situation.
---------------------------------------------------------------------------
The record reflects that during the patient meeting, Respondent
asked SA Saenz to describe her pain. (Gov't Ex. 16 at 5.) She
responded that the pain was dull and throbbing, but was not
constant, and that it bothered her mostly in the morning. (Gov't Ex.
16 at 5-6.) At hearing, Respondent testified that SA Saenz had
circled a number of adjectives to describe her pain on her Pain
Assessment Form (Tr. 444), to include words such as ``sharp,''
``aching,'' ``tender,'' ``shooting,'' ``numb,'' ``throbbing'' and
``unbearable'' (Gov't Ex. 18 at 8).
Respondent also asked SA Saenz whether the pain interfered with
her ``daily activities, your ability to function at work.'' (Gov't
Ex. 16 at 6.) SA Saenz responded in the negative, simply stating
``No.'' (Gov't Ex. 16 at 6.)
CASANOVA: It doesn't?
UC: I suck it up.
CASANOVA: So then, but that's, those are two (2) different answers.
UC: Oh.
CASANOVA: Yes or no?
UC: Uh-um, no.
CASANOVA: Does it interfere with your activities?
UC: No.
CASANOVA: Does it interfere would mean * * * function or your
ability to work.
UC: Not enough.
(Gov't Ex. 16 at 6.) This interchange reveals Respondent's
persistence in inquiring whether SA Saenz's pain interfered with her
ability to work, repeatedly pressing her even after she indicated
that the pain did not interfere with her lifestyle. At hearing,
Respondent denied that his treatment objective was to get SA Saenz
back to work and noted that SA Saenz presented as ``stoic'' with
respect to her pain from an acute injury. (Tr. 443, 447.) A note in
SA Saenz's patient file contains circles around the word ``no''
associated with questions whether the pain interferes with daily
activities and whether the patient needs medication to function or
work. (Gov't Ex. 18 at 1.)
When Respondent inquired into the intensity of SA Saenz's pain
(Gov't Ex. 16 at 7), she indicated that when she took Motrin the
pain was about a three on a scale from one to ten and without Motrin
her pain was about a five or a six. (Gov't Ex. 16 at 7; see also
Gov't Ex. 18 at 1.) Respondent inquired whether SA Saenz had any
surgeries or allergies or had gotten any medicines from other
doctors, to which SA Saenz responded in the negative. (Gov't Ex. 16
at 7.) Respondent asked if she used drugs or alcohol, to which she
replied that she drank socially on occasion. (Gov't Ex. 16 at 7-8.)
He asked about her parents' health, and she responded that her
parents both had high blood pressure and her father had high
cholesterol. (Gov't Ex. 16 at 8.)
In addition, upon inquiry by Respondent, SA Saenz stated that
she did not have any other medical problems. (Gov't Ex. 16 at 8.) SA
Saenz's statement in this regard contradicted notations she made on
her medical history indicating she suffered from insomnia and
depression. (Gov't Ex. 18 at 6.) Respondent made no attempt to
clarify this disparity, and the record reveals no evidence that he
was even aware of it. The Florida Standards recognize that ``[t]he
management of pain in patients with a history of substance abuse or
with a comorbid psychiatric disorder requires extra care,
monitoring, and documentation, and may require consultation with or
referral to an expert in the management of such patients.'' Fla.
Admin. Code Ann. r. 64B8-9.013(3)(e). Respondent's failure to notice
the disparity between SA Saenz's written and oral statements, let
alone perform ``extra care, monitoring and documentation,'' is
facially inconsistent with the Florida Standards.
Respondent next conducted a physical examination of SA Saenz,
asking her to uncross her legs, take a deep breath, bend forward and
indicate where she had pain. (Gov't Ex. 16 at 9.) She indicated pain
on her left side and sensitivity in her neck. (Gov't Ex. 16 at 9.)
Respondent demonstrated a
[[Page 58167]]
stretching exercise and recommended an Icy Hot patch. (Gov't Ex. 16
at 10.) Respondent stated he would prescribe high dose Motrin 800
mg, an anti-inflammatory ``and then I'm gonna write you for some
narcotic pain medicine.'' (Gov't Ex. 16 at 11.) Respondent
prescribed 90 Motrin 800 mg tablets, 90 Vicodin oral 5 mg--500 mg
tablets and one pack containing twenty-one Medrol 4 mg tablets.
(Gov't Ex. 17.) At hearing, Respondent explained that he prescribed
a steroid to ``balance[] the effects of the medications.'' (Tr.
446.)
The record reflects that Respondent documented in the patient
file conversations that did not occur. In particular, SA Saenz's
patient file includes a document entitled ``Plan'' with handwritten
check marks through boxes corresponding to the following text:
Discussed anti-inflammatory diet, handout given to
patient
Patient has been counseled on risks/benefits of
medications above; Pt. Will take exactly as prescribed
Fish Oil/Omega-3 recommended at 3-6 grams per day
Glucosamine + Chondroitin Sulfate recommended
Strict avoidance of alcohol has been discussed at
length
Recommended avoidance of soda
Goal is to wean off all medications has been explained
to patient
(Gov't Ex. 18 at 4.) But the transcript of SA Saenz's undercover
visit with Respondent contains no record of a discussion of an anti-
inflammatory diet, the risks and benefits of medications, fish oil,
Omega-3 or chondroitin sulfate. (See Gov't Ex. 16.) And as
Respondent conceded on cross-examination, he did not have a
conversation with SA Saenz regarding risk and benefits of the
medications he gave her, and the portions of her Consent Form
indicating a diagnosis and alternative treatment options are blank.
(Tr. 496; Gov't Ex. 18 at 15.) This conduct is inconsistent with
Florida Standards. See Fla. Admin. Code Ann. r. 64B8-9.013(3)(c)
(``The physician should discuss the risks and benefits of the use of
controlled substances with the patient.* * *'' )
Moreover, the notation in the chart that ``[s]trict avoidance of
alcohol has been discussed at length'' is patently false, given that
Respondent merely asked whether SA Saenz drank, and when she
answered in the affirmative, he asked whether she drank socially.
(Gov't Ex. 16 at 7-8.) There is no suggestion in the record that
Respondent counseled her ``at length'' to ``strictly'' avoid
alcohol. Finally, there is no support in the record for the
assertion that Respondent recommended that SA Saenz avoid soda or
that he counseled her that a goal of treatment included weaning her
off all medications. (Tr. 372-73.) By substantial evidence, I find
that Respondent failed to keep accurate medical records in violation
of Florida Administrative Code Rule 64B8-9.013(3)(f) (``The
physician is required to keep accurate and complete records. * * *''
) Moreover, in light of Dr. Glener's critique of Respondent for
failing to inquire whether the patient had a substance abuse history
or history of addiction (Tr. 372-73), a critique which is fully
supported by the record, I find Respondent's conduct inconsistent
with Florida Administrative Code Rule 64B8-9.013(3)(e), which states
that a physician should ``refer the patient as necessary for
additional evaluation and treatment in order to achieve treatment
objectives.'' Fla. Admin. Code Ann. r. 648-9.013(3)(e).
After Respondent had already voiced his decision to prescribe
controlled substances, he asked SA Saenz whether she had ever taken
narcotics before, to which she responded in the negative. (Gov't Ex.
16 at 13.) That Respondent's inquiry into SA Saenz's history with
narcotics occurred only after he had already decided to prescribe
controlled substances is striking. Additionally, SA Saenz's
statement that she had never before taken narcotics is flatly
contradicted by her notations in her medical file and her statements
to Respondent that she was presently taking oxycodone. (Gov't Ex. 16
at 7; see Gov't Ex. 18 at 8.)
Near the end of the meeting, Respondent stated: ``I, let me . .
. let me ask you a question, you seem like a smart young lady. Why,
for this kind of thing, you go to a pain management clinic? Why not
go see a doctor?'' (Gov't Ex. 16 at 13.) She replied that she didn't
have a doctor, and Respondent suggested she visit Respondent's
Urgent Care Center on Federal Highway. (Gov't Ex. 16 at 13-14.) He
explained that seeing him at the CCHM pain clinic would cost $400 or
more, but she could see him for free and possibly get referred to an
orthopedist or physical therapist if she filed for worker's
compensation and saw him at his Urgent Care Center.\102\ (See Gov't
Ex. 16 at 15; see also id. at 11-12.)
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\102\ Respondent also asked SA Saenz to call him in a week to
assess how she was feeling. (Gov't Ex. 16 at 11.) He offered to
write her a note for work ``[b]ecause you shouldn't be lifting kids
at work'' or do certain kinds of bending. (Gov't Ex. 16 at 11, 16.)
---------------------------------------------------------------------------
Dr. Glener testified that Respondent's treatment of SA Saenz
``deviated from the standard of care and prescription of controlled
substances were [sic] inappropriate.'' (Tr. 333.) Based on
Respondent's comment ``Why not go see a doctor?'' (Gov't Ex. 16 at
13), Dr. Glener opined that Respondent ``admits that he is
functioning other than as a doctor * * * '' while at CCHM. (Gov't
Ex. 22 at 2; Tr. 334.)
Respondent testified at hearing that SA Saenz's patient file
contained all the items required by Section 3(f) of the Florida
Standards. (Tr. 447.) But in light of Respondent's concession on
cross-examination that he did not document a treatment plan or
treatment objectives in SA Saenz's medical record (Tr. 490-92), the
fact that the ``History and Physical Examination'' form describing
objects of treatment and the portions of her Consent Form describing
the diagnosis and alternative treatments are completely blank (Gov't
Ex. 18 at 5, 15) and the lack of a history of substance abuse or
addiction as noted above, I reject this testimony as not credible.
Moreover, Respondent's admission that ``[t]here is no specific
treatment plan . * * * '' (Tr. 492; see also Tr. 493) is
inconsistent. with the Florida Standards. See, e.g., Fla. Admin.
Code Ann. r. 64B8-9.013(1)(b) (describing parameters of
``appropriate documentation''); Fla. Admin. Code Ann. r. 64B8-
9.013(3)(b) (contemplating a ``written treatment plan''). On the
weight of the record evincing numerous violations of laws and
regulations relating to Respondent's prescription of controlled
substances to SA Saenz, I afford little weight to Respondent's
assertion that his treatment was based on accepted scientific
knowledge of the treatment of pain and was supported by sound
clinical grounds. (Tr. 447.)
In summary, the record reveals numerous violations of standards
and regulations concerning Respondent's prescribing of controlled
substances in the context of SA Saenz's undercover visit to CCHM.
Substantial evidence supports a finding that Respondent's
prescription of controlled substances to SA Saenz lacked a
``legitimate medical purpose . . . that is supported by appropriate
documentation establishing a valid medical need and treatment
plan,'' in violation of Florida Administrative Code Rule 64B8-
9.013(1)(b) (2003), and was outside the usual course of professional
practice, in violation of 21 C.F.R. Sec. 1306.04(a).
(d) Evaluation of Expert Testimony
As discussed above, the evidence at hearing included opinions
from Dr. Glener and Respondent regarding Respondent's prescribing
practices. Expert testimony regarding a physician's prescribing
practices is an important but not indispensable part of evaluating
whether a practitioner is acting for a ``legitimate medical
purpose'' in the ``usual course of his professional practice.''
\103\ The Agency has previously held that ``[w]here, for example,
the Government produces evidence of undercover visits showing that a
physician knowingly engaged in outright drug deals, expert testimony
adds little to the proof necessary to establish a violation of
federal law.'' Cynthia M. Cadet, M.D., 76 Fed. Reg. 19,450, 19,450
(DEA 2011).
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\103\ 21 C.F.R. Sec. 1306.04(a).
---------------------------------------------------------------------------
As for the opinion of a treating physician, in the context of a
DEA administrative hearing a treating physician's opinion should not
automatically be given greater weight than the opinion of a non-
examining physician. ``Despite a certain degree of lingering
confusion among the courts of appeals, it has become overwhelmingly
evident that the testimony of the `treating physician' receives no
additional weight.'' Eastover Mining Co. v. Williams, 338 F.3d 501,
509 (6th Cir. 2003). Unlike a Social Security benefit determination
that is governed by a regulation giving deference to a treating
physician, no such regulation pertains to a DEA administrative
hearing.\104\ Accordingly, I have not given Respondent's testimony
greater weight simply because of his status as a treating physician,
particularly given the short duration of his treatment of each
undercover patient.\105\
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\104\ See 20 C.F.R. Sec. Sec. 404.1527(d)(2), 416.927(d)(2).
\105\ I accordingly reject Respondent's argument that ``Dr.
Casanova's testimony as to his compliance with Rule 64B8-9.013,
Florida Administrative Code must be given great weight'' (Resp't Br.
25) and instead give Respondent's testimony weight where credible.
---------------------------------------------------------------------------
[[Page 58168]]
As noted above, based on his review of the undercover patient
files, Dr. Glener found that ``[i]n all of the cases, the doctor
prescribed controlled substances outside the usual course of
professional practice or for other than a legitimate medical
purpose.'' (Tr. 338-39.) After an extensive review of the record, I
find Dr. Glener's opinion to be supported and corroborated by
objective evidence. Therefore, although as noted above the record
supports a finding that Dr. Glener demonstrated some bias against
Respondent, Dr. Glener's conclusions as to Respondent's conduct
discussed in this Recommended Decision are fully supported by the
record.\106\ Moreover, the discussions above relating to each
undercover patient visit reveal multiple instances in which expert
testimony is not required to make findings under 21 U.S.C. Sec.
823(f) because the conduct is plainly and facially inconsistent with
straightforward provisions of law. See generally Cadet, 76 Fed. Reg.
at 19,450. I therefore reject as not credible and unfounded
Respondent's testimony and argument that he complied with Florida
Administrative Code Rule 64B8-9.013. (E.g., Resp't Br. 24-25.) As
detailed above, the record reveals numerous instances in which
Respondent failed to maintain complete and accurate records or
document a treatment plan consistent with the Florida Administrative
Code, among other deficiencies.
---------------------------------------------------------------------------
\106\ Respondent argues that ``to Dr. Gleaner [sic], the only
acceptable method of practicing medicine or treating pain would be
his way and his way only.'' (Resp't Br. 26.) This statement is not
supported by the record. Dr. Glener's testimony as to standard of
care refers to ``the law . . . and appropriate medical practice'' as
well as the expectations of other physicians. (Tr. 318-19.)
Additionally, his testimony as to the requirements of Florida law is
internally consistent and corroborated by general and specific
statements contained in the Florida Administrative Code. Compare Tr.
319 (emphasizing importance of discussion of risks and benefits,
performing a physical examination and formulating a diagnosis and
treatment plan), with Fla. Admin. Code Ann. rr. 64B8-9.013(3)(c),
(3)(a), (3)(f)(1) & (3)(b).
---------------------------------------------------------------------------
(e) Summary of Undercover Patients
After reviewing the entire record, I find that substantial
evidence that is both objective and otherwise reliable supports Dr.
Glener's conclusion that Respondent's treatment of three undercover
agents posing as patients ``deviated from the standard of care, was
not appropriate in all cases and the focus of treatment appeared to
be the prescription of controlled substances.'' (Tr. 324-25.) I
further find by substantial evidence that Respondent issued three
sets of controlled substance prescriptions for other than a
legitimate medical purpose and outside the usual course of
professional practice, in violation of federal and state law.\107\
This finding weighs heavily in favor of a finding under Factors Two
and Four of 21 U.S.C. Sec. 823(f) that Respondent's continued
registration would be inconsistent with the public interest.
---------------------------------------------------------------------------
\107\ See, e.g., 21 C.F.R. Sec. 1306.04(a) (controlled
substances prescription must be ``issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
his professional practice.''); Fla. Admin. Code Ann. r. 64B8-
9.013(1)(b) (controlled substances prescription must be for a
``legitimate medical purpose * * * that is supported by appropriate
documentation establishing a valid medical need and treatment
plan''); see also, e.g., Fla. Admin. Code Ann. r. 64B8-9.013(1)(d)
(physician's duty to ``be diligent in preventing the diversion of
drugs for illegitimate purposes''); Fla. Admin. Code Ann. r. 64B8-
9.013(3)(b) (``The written treatment plan should state objectives
that will be used to determine treatment success * * *'' as well as
other elements); Fla. Admin. Code Ann. r. 64B8-9.013(3)(c) (``The
physician should discuss the risks and benefits of the use of
controlled substances with the patient * * *''); Fla. Admin. Code
Ann. r. 64B8-9.013(3)(e) (``[t]he physician should be willing to
refer the patient as necessary for additional evaluation and
treatment* * * Special attention should be given to those pain
patients who are at risk for misusing their medications and [who] *
* * pose a risk for medication misuse or diversion.''); Fla. Admin.
Code Ann. r. 64B8-9.013(3)(f) (``The physician is required to keep
accurate and complete records to include, but not be limited to .* *
* [t]he medical history and physical examination * * *'').
---------------------------------------------------------------------------
Respondent's argument in mitigation that he ``complied with many
aspects of the law'' (Resp't Br. 25; see also id. at 26) is
misplaced; in DEA registration proceedings compliance with one
provision of law does not generally excuse the failure to comply
with another. Cf. Michael J. Aruta, M.D., 76 Fed. Reg. 19,420,
19,420 n.3 (DEA 2011) (holding that even ``evidence that a
practitioner has treated thousands of patients'' in circumstances
that do not constitute diversion ``does not negate a prima facie
showing that the practitioner has committed acts inconsistent with
the public interest'' (citing Jayam Krishna-Iyer, 74 Fed. Reg. 459,
463 (DEA 2009))); Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364,
386 & n.56 (DEA 2008) (noting that pharmacy ``had 17,000 patients,''
but that ``[n]o amount of legitimate dispensing[] can render * * *
flagrant violations `consistent with the public interest'''), aff'd,
Medicine Shoppe--Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir.
2008). ``While such evidence may be [entitled to] some weight in
assessing whether a practitioner has credibly shown that [he] has
reformed his practices,'' it is entitled to no weight where a
practitioner fails to acknowledge his wrongdoing.\108\ Krishna-Iyer,
74 Fed. Reg. at 463. ``Put another way, even where the Government
proves only a few instances of illegal prescribing in the `entire
corpus' of a practitioner's experience, the Government has
nonetheless made out a prima facie case and thus shifted the burden
to the registrant to show why he should be entrusted with a new
registration.'' Id. at 464.
---------------------------------------------------------------------------
\108\ As discussed below, I find that Respondent has failed to
accept responsibility for his prescribing-related misconduct.
---------------------------------------------------------------------------
(f) Respondent's Prescribing to Kentucky Patients at CCHM
The testimony adduced at hearing reflects that three Kentucky
patients visited Respondent at CCHM. On April 6, 2010, Respondent
prescribed 90 Percocet 10 mg tablets and 220 Roxicodone 30 mg
tablets to patient [C.C.] of Wallingford, Kentucky. (Tr. 90, 95;
Gov't Ex. 20 at 1-2.) Neither party offered additional evidence
relating to patient [C.C.], and there is no basis to conclude that
Respondent's prescription to [C.C.] was improper.
The record further reflects that on March 31, 2010, Respondent
issued identical prescriptions of 100 Roxicodone 15 mg tablets and
210 Roxicodone 30 mg tablets to patient [C.G], age fifty, of Essie,
Kentucky, and patient [R.C.], age forty-eight, of Helton, Kentucky.
(Tr. 91-92, 96-97; Gov't Ex. 20 at 3, 5.)
On the same day, at Wood's Pharmacy in Margate, Florida (Tr.
90), [C.G.] filled [C.G.]'s prescriptions at 4:07 p.m. and [R.C.]
filled [R.C.]'s prescriptions at 4:01 p.m. and 4:11 p.m. (Gov't Ex.
20 at 4 & 6.)
The record therefore reflects that Respondent issued identical
prescriptions on the same day to two Kentucky patients of similar
age; that the prescriptions were filled at the same Florida pharmacy
within a single ten-minute window; and that the cities of Essie,
Kentucky and Helton, Kentucky are located close to each other but
approximately 900 to 1000 miles and fifteen to sixteen hours away
from Respondent's office in Deerfield Beach, Florida (Tr. 98-99).
Respondent argues that ``the Government's Exhibit 20 and [GS]
Langston's testimony do not provide any indication whatsoever that
Dr. Casanova improperly wrote prescriptions or otherwise violated
any law.'' \109\ (Resp't Br. 29-30.) Although these circumstances
may be suspicious (see Tr. 98-99), there is no indication that the
prescriptions were other than for a legitimate medical purpose or
pursuant to the usual course of professional practice, because the
patient files are not in evidence and were not discussed at hearing.
(See Tr. 101-03.) Accordingly, I do not find the evidence of record
with regard to the three Kentucky patients sufficient to constitute
substantial evidence that Respondent's prescriptions and conduct
violated any applicable law or regulation.
---------------------------------------------------------------------------
\109\ Making a finding that Respondent's prescribing in these
instances was improper would require engaging in pure speculation.
``Speculation is, of course, no substitute for evidence, and a
decision based on speculation is not supported by substantial
evidence.'' White ex rel. Smith v. Apfel, 167 F.3d 369, 375 (7th
Cir. 1999) (citing Erhardt v. Sec'y, DHS, 969 F.2d 534, 538 (7th
Cir. 1992)).
---------------------------------------------------------------------------
(g) Respondent's Positive Experience in Dispensing Controlled
Substances
Respondent offered testimony and pointed to evidence of his past
positive experience in dispensing controlled substances, including
his experience at MEC. Additionally, DI Stockmann testified that MEC
is not a pill mill, and that aside from the absence of a biennial
inventory on February 23, 2011, MEC appeared to be within the scope
of a normal medical practice. (See Tr. 118, 127-28, 137.)
Additionally, Respondent offered testimony that he gained experience
dealing with acute and chronic pain patients and treating them with
opioids, and familiarized himself with the Florida Standards, while
working at Westchester Hospital in Florida. (Tr. 414.) Finally,
Respondent testified that while working at APM and CCHM, he turned
away a large number of patients ``that I thought might have issues
with medications, issues potentially with the injection of
medications and so forth,'' to include patients presenting with
track marks. (Tr. 500.)
[[Page 58169]]
Agency precedent has held that such evidence is entitled to some
evidentiary weight only in cases where a practitioner credibly
demonstrates an acceptance of responsibility and reform of past
practices.
[E]vidence that a practitioner has treated thousands of patients
does not negate a prima facie showing that the practitioner has
committed acts inconsistent with the public interest. While such
evidence may be of some evidentiary weight in assessing whether a
practitioner has credibly shown that she has reformed her practices,
where a practitioner commits intentional acts of diversion and
insists she did nothing wrong, such evidence is entitled to no
weight.
Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 463 (DEA 2009).
Although I have carefully considered the evidence of
Respondent's past positive experiences in dispensing controlled
substances, to include his present practice at MEC, I find those
experiences are considerably outweighed by the substantial evidence
of Respondent's repeated misconduct in issuing controlled substance
prescriptions to undercover law enforcement officers for other than
a legitimate medical purpose and outside the usual course of
professional practice, in violation of federal and state law. The
weight of Respondent's prior positive experiences is further
diminished by Respondent's failure on the whole to admit or accept
responsibility for any wrongdoing with regard to his prescribing-
related misconduct at APM and CCHM.\110\
---------------------------------------------------------------------------
\110\ The extent, vel non, of Respondent's acceptance of
responsibility for his misconduct is discussed below.
---------------------------------------------------------------------------
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Administrator is authorized to consider
``other conduct which may threaten the public health and safety.'' 5
U.S.C. Sec. 823(f)(5). The Agency has accordingly held that ``where
a registrant has committed acts inconsistent with the public
interest, the registrant must accept responsibility for his or her
actions and demonstrate that he or she will not engage in future
misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA
2009).\111\ ``[A]n applicant/registrant is required not only to
accept responsibility for [his] misconduct, but also to demonstrate
what corrective measures [he] has undertaken to prevent the re-
occurrence of similar acts.'' Jeri Hassman, M.D., 75 Fed. Reg.
8,194, 8,236 (DEA 2010) (quoting Jayam Krishna-Iyer, M.D., 74 Fed.
Reg. 459, 464 n.8 (DEA 2009)).
---------------------------------------------------------------------------
\111\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005)
(decision to revoke registration ``consistent with the DEA's view of
the importance of physician candor and cooperation.'')
---------------------------------------------------------------------------
A ``[r]espondent's lack of candor and inconsistent
explanations'' may serve as a basis for denial of a registration.
John Stanford Noell, M.D., 59 Fed. Reg. 47,359, 47,361 (DEA 1994).
Additionally, ``[c]onsideration of the deterrent effect of a
potential sanction is supported by the CSA's purpose of protecting
the public interest.'' Joseph Gaudio, M.D., 74 Fed. Reg. 10,083,
10,094 (DEA 2009).
Respondent argues generally that the Government has failed to
establish by a preponderance of evidence that Respondent's continued
registration would be inconsistent with the public interest. (Resp't
Br. 23.) To the contrary, after balancing the foregoing public
interest factors, I find that the Government has established by
substantial evidence a prima facie case in support of revoking
Respondent's registration.\112\
---------------------------------------------------------------------------
\112\ I base this conclusion on Factors Two and Four of 21
U.S.C. Sec. 823(f) for the reasons described above, and on Factor
Five for reasons discussed in this Section.
---------------------------------------------------------------------------
Once DEA has made a prima facie case for revocation or denial,
the burden shifts to the respondent to show that, given the totality
of the facts and circumstances in the record, revoking or denying
the registration would not be appropriate. See Morall v. DEA, 412
F.3d 165, 174 (DC Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d
Cir. 1996); Shatz v. United States Dep't of Justice, 873 F.2d 1089,
1091 (8th Cir. 1989); Thomas E. Johnston, 45 Fed. Reg. 72, 311 (DEA
1980). Respondent argues that if the Government has ``met its burden
and made a prima facie case for the revocation of Dr. Casanova's
license, Dr. Casanova has put forth sufficient mitigating evidence
to assure the DEA Deputy Administrator that he can be entrusted with
a Certificate of Registration.'' (Resp't Br. at 23.)
In fact, Respondent's testimony pertaining to whether he
accepted responsibility for his past misconduct is ambivalent. To
his credit, Respondent testified that regarding his recordkeeping
violations,
[t]he bottom line is that I ultimately am responsible and was held
accountable and I wasn't aware of the fact that he had not gotten
the rest of the information. Maybe there was a misunderstanding in
regards to the pedigree paperwork and so forth. I am fully aware of
that and irrespective of the results of these hearings, I plan to
provide all the appropriate information that is required and
necessary.
(Tr. 449.) Upon inquiry from his attorney on direct examination,
Respondent testified that he ``fully understand[s]'' that audit
results need to zero out, and that he ``[o]ne hundred percent''
intends to take all steps necessary to make sure that any future
deliveries are properly documented. (Tr. 450.) In addition, it is
undisputed that Respondent fully and completely cooperated in the
inspection of his registered location on February 23, 2011, to
include access to records and inventory. (Tr. 114-15, 119-20.)
Moreover, Respondent consented to a March 29, 2011 inspection of his
registered location and cooperated, giving agents full access to
everything they needed, although he was not required to do so. (Tr.
152, 184; Gov't Ex. 19(a).) Respondent's expression of remorse for
his recordkeeping violations, his cooperation with authorities
throughout the inspection and audit process and his promise of
future compliance all reflect favorably on Respondent and weigh in
favor of a finding that Respondent's continued registration would be
consistent with the public interest.
In stark contrast to his acceptance of responsibility regarding
his recordkeeping violations, however, Respondent in numerous
instances declined to accept responsibility for his prescribing-
related misconduct. For instance, Respondent unapologetically stated
at hearing that he adheres to a standard of conduct that is
different than that of other doctors. (See Tr. 446-47.) Under the
Florida Administrative Code, a treatment plan is one of the
standards for the use of controlled substances for pain control. See
Fla. Admin. Code Ann. r. 64B8-9.013(3). ``The written treatment plan
should state objectives that will be used to determine treatment
success, such as pain relief and improved physical and psychosocial
function and should indicate if any further diagnostic evaluations
or other treatments are planned * *.'' Fla. Admin. Code Ann. r.
64B8-9.013(3)(b). But when asked whether his own approach complied
with the Florida Standards, Respondent became evasive and testified
that ``a treatment plan is something [that] in my opinion differs
from the other physicians. I believe that a treatment plan doesn't
happen over one visit, * * *.'' (Tr. 467.) Respondent's belief that
he is entitled to follow standards that depart from those
promulgated by the Florida Department of Health is not consistent
with accepting responsibility and showing evidence of likely future
compliance.\113\
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\113\ Respondent proposes that ``it was not possible to develop
a proper treatment plan as treatment plans develop over time based
on further information and physical examinations.'' (Resp't Br. 16
(internal citations omitted).) But before prescribing controlled
substances, Respondent was nevertheless required to document a
treatment plan and other elements ``not intended * * * [as] complete
or best practice[s], but rather * * * what the Board considers to be
within the boundaries of professional practice.'' Fla. Admin. Code
Ann. r. 64B8-9.013(1)(g). Conduct falling below the minimal
requirements of the Florida Standards is therefore outside the usual
course of professional practice.
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The following colloquy is illustrative:
Q: Wouldn't you agree that the Florida guidelines require that you
execute a treatment plan for every patient according to these
guidelines, [Fla. Admin. Code Ann. r. 64B8-9.013(3)(b)], page two?
A: I would agree that I have done the--I have taken the proper steps
to start a treatment objective and a treatment plan and that with
only one visit that I had for the patient, I did everything that was
necessary based on the information that I had in front of me.
(Tr. 468.) Respondent further testified that ``[n]ot everything is
down on paper. Just because it's [not] down on paper, it's not
something that didn't happen.'' \114\ (Tr. 470.) This comment is
flatly inconsistent with the Florida Standards, which contemplate a
``written treatment plan,'' see Fla. Admin. Code Ann. r. 64B8-
9.013(3)(b) (emphasis supplied), and written records generally.
While I find credible Respondent's testimony that just ``[b]ecause
it's not written down on paper doesn't mean that there wasn't a
[[Page 58170]]
thought process * * *.'' (Tr. 486), the Florida Standards are
unequivocal in their demand for records documenting the thought
process, ``maintained in an accessible manner and readily available
for review.'' Fla. Admin. Code Ann. r. 64B8-9.013(3)(f)(9)
(``Periodic reviews.'') (emphasis supplied). The standard of care
against which Respondent's conduct is measured is not his own
personal standard, but is instead a standard generally accepted and
recognized in the medical community. Robert L. Dougherty, M.D., 76
Fed. Reg. 16,823, 16,832 n.11 (DEA 2011).
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\114\ Respondent also testified that a ``treatment plan was
formulated either in terms of the documentation in the paperwork or
mentally in terms of the documentation and a plan and a process.''
(Tr. 33-34.)
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Moreover, when repeatedly asked to identify the location of his
treatment plan in SA Grafenstein's patient file, Respondent conceded
that both the treatment plan and the treatment objective for SA
Grafenstein consisted solely of the medications listed in the
patient's discharge summary.\115\ (See Tr. 470-72; see also Gov't
Ex. 10 at 1.) A plain reading of the Florida Standards, however,
reveals that a medication alone cannot constitute a treatment plan.
Instead, the Florida Standards provide that a treatment plan should
\115\ Respondent also stated that the treatment plan ``begins
with the diagnosis and * * * includes the medications * * * and that
is the initial process of the treatment plan * * *.'' (Tr. 469.)
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state objectives that will be used to determine treatment success,
such as pain relief and improved physical and psychosocial function
and should indicate if any further diagnostic evaluations or other
treatments are planned* * * . [T]reatment modalities or a
rehabilitation program may be necessary depending on the etiology of
the pain and the extent to which the pain is associated with
physical and psychosocial impairment.
Fla. Admin. Code Ann. r. 64B8-9.013(3)(b). At a minimum,
Respondent's treatment plan for SA Grafenstein lacks: (1)
``objectives that will be used to determine treatment success'' and
(2) ``indicat[ions of whether] any further diagnostic evaluations *
* * are planned.'' Id. Respondent's refusal to acknowledge these
deficiencies is incompatible with a finding that Respondent has
accepted responsibility for his past misconduct.
In addition, regarding his prescribing of Xanax to SA
Grafenstein without first inquiring when SA Grafenstein had last
taken that controlled substance, Respondent stated that ``I don't
agree that by me not doing that that was [not] preventing the
diversion of controlled substances.'' (Tr. 481.) Respondent's
comment indicates that in similar circumstances involving real
patients exhibiting warning signs of abuse or diversion, Respondent
would likely repeat the same course of conduct in the future.
Respondent's evidence fails to overcome the rebuttable presumption
that ``past performance is the best predictor of future performance
* * *.'' Medicine Shoppe--Jonesborough, 73 Fed. Reg. at 387 (citing
ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995)).
Respondent's testimony at hearing provided additional
indications that he believes the Florida Standards do not
necessarily apply to him and that he might not comply with them in
the future. As noted above, Respondent failed to discuss the risks
and benefits of the controlled substances he provided to SA Cortes
(Tr. 482-83; see Gov't Ex. 14 at 8), in violation of Florida
Administrative Code Rule 64B8-9.013(3)(c). His testimony suggested
that he did not engage in such a discussion during SA Cortes's
initial visit, but that he might on a subsequent visit. (See Tr.
483.) When asked if the Florida Standards contained an exception for
the first visit, Respondent testified ``[i]t could be a matter of
style or what have you in terms of how you do things with the
initial visits and follow-up visits and so forth.'' (Tr. 484.) Yet
Respondent later acknowledged that ``[t]here's no particular
exemptions here for the first visit.'' (Tr. 484.) Respondent barely
acknowledges that he violated the informed consent provision of the
Florida Standards, much less accepts responsibility for the
violation and promises future compliance.
Similarly, Respondent acknowledged on cross-examination that he
failed to document a treatment plan in SA Saenz's patient record
(Tr. 490-91, 492), but also stated: ``I think you keep on using and
harping on treatment plan in regards to being an issue. An
appropriate treatment care [sic] was delivered for this acute injury
without question.'' (Tr. 491.) Respondent's statement is not
consistent with accepting responsibility for his violation of
Florida Administrative Code Rule 64B8-9.013(1)(b) (describing
parameters of ``appropriate documentation'' to include a treatment
plan); and Rule 64B8-9.013(3)(b) (contemplating a ``written
treatment plan''). To the contrary, Respondent's testimony reflects
an attempt to trivialize his noncompliance.
Additional examples of Respondent's failure to accept
responsibility for past misconduct exist but further elaboration is
unnecessary. In summary, Respondent's testimony reflected an overall
lack of admission of his past misconduct with respect to his
prescribing practices, let alone acceptance of responsibility. In
light of the foregoing, Respondent's evidence as a whole fails to
sustain his burden to accept responsibility for his misconduct and
to demonstrate that he will not engage in future misconduct. I find
that Factor Five weighs in favor of a finding that Respondent's
continued registration would be inconsistent with the public
interest.
V. Conclusion and Recommendation
Under Factors Two, Four and Five of 21 U.S.C. Sec. 823(f), I
recommend that Respondent's DEA COR BC8677746 be revoked on the
grounds that Respondent's continued registration would be
inconsistent with the public interest as that term is used in 21
U.S.C. Sec. Sec. 824(a)(4) and 823(f).
Dated: September 29, 2011
Timothy D. Wing
Administrative Law Judge
[FR Doc. 2012-23058 Filed 9-18-12; 8:45 am]
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