[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.)
---------------------------------------------------------------------------

    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.)
---------------------------------------------------------------------------

    \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.)
---------------------------------------------------------------------------

    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).)
---------------------------------------------------------------------------

    \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.)
---------------------------------------------------------------------------

    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.)
---------------------------------------------------------------------------

    \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.)
---------------------------------------------------------------------------

    \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.)
---------------------------------------------------------------------------

    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.)
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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).
---------------------------------------------------------------------------

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.)
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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]
BILLING CODE 4410-09-P