[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19420-19434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8348]



[[Page 19420]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-40]


Michael J. Aruta, M.D.; Decision and Order

    On August 10, 2010, Administrative Law Judge (ALJ) John J. 
Mulrooney, II, issued the attached recommended decision.\1\ The 
Respondent did not file exceptions to the decision.
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    \1\ All citations to the ALJ's Decision (ALJ) are to the slip 
opinion as issued on August 10, 2010, and not to the attached 
decision which has been reformatted.
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    Having reviewed the record in its entirety including the ALJ's 
recommended decision, I have decided to adopt the ALJ's rulings, 
findings of fact,\2\ conclusions of law,\3\ and recommended Order.
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    \2\ The ALJ found that there is ``no evidence that the 
Respondent `prescribe[d] and dispense[d] inordinate amounts of 
controlled substances.'' ALJ at 26. While there is no evidence as to 
the amounts that Respondent directly dispensed, there is evidence, 
which is unrefuted, that Respondent prescribed inordinate amounts of 
controlled substances. In his report, an Expert witness explained 
that the usual starting dose of Xanax is .25 to .5 mg. once to twice 
per day and yet Respondent prescribed Xanax 2 mg. twice per day to 
patients ``who had not had Xanax before or recently,'' and that he 
did so without documenting that he had considered any of the 
possible underlying causes of his patients' complaint that they had 
anxiety; moreover, Respondent did not refer the patients to a mental 
health professional. GX 5, at 9-10. As the Expert explained, ``[t]he 
treatment was with a very high dose of the controlled substance 
Xanax. This was clearly not within the boundaries of professional 
practice.'' Id. at 10. There is also unrefuted evidence that 
Respondent's prescribing of drug cocktails of oxycodone and Xanax 
lacked a legitimate medical purpose. Id. at 13. In this manner, 
Respondent did prescribe inordinate amounts.
    \3\ I do not, however, adopt the ALJ's discussion of the 
standards applied by the Agency in assessing a practitioner's 
experience in dispensing controlled substances, which cites cases 
involving list chemical I distributors, a different category of 
registrant. See ALJ at 25-26. As the Agency has previously made 
clear, DEA can revoke based on a single act of intentional diversion 
and ``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.'' Jayam Krishna-Iyer, 74 
FR 459, 463 (2009). See also Dewey C. MacKay, 75 FR 49956, 49977 
(2010); Medicine Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (noting 
that pharmacy ``had 17,000 patients,'' but that ``[n]o amount of 
legitimate dispensings can render * * * flagrant violations [acts 
which are] `consistent with the public interest'''), aff'd, Medicine 
Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008). As I 
further explained, ``[w]hile 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. Krishna-Iyer, 74 
FR at 463.
    In any event, Respondent offered no evidence on the issue of his 
experience in dispensing controlled substances and the ALJ's 
ultimate conclusions that Respondent violated the CSA's prescription 
requirement because he dispensed controlled substance prescriptions 
that were not ``within `the usual course of [his] professional 
practice,' '' ALJ at 39 (quoting 21 CFR 1306.04(a)), and that ``the 
evidence under the [experience] * * * factor[] support[s]'' the 
revocation of his registration, is consistent with Agency precedent. 
Id.
    With respect to factor five, ``[s]uch other conduct which may 
threaten public health and safety,'' 21 U.S.C. 823(f)(5), the ALJ 
opined that ``an adverse finding under this factor requires some 
showing that the relevant conduct actually constituted a threat to 
public safety.'' ALJ at 39 (emphasis added). Contrary to the ALJ's 
reasoning, Congress, by inserting the word ``may'' in factor five, 
clearly manifested its intent to grant the Agency authority to 
consider conduct which creates a probable or possible threat (and 
not only an actual) threat to public health and safety. See 
Webster's Third New Int'l Dictionary 1396 (1976) (defining ``may'' 
in relevant part as to ``be in some degree likely to''); see also 
The Random House Dictionary of the English Language 1189 (1987) 
(defining ``may'' in relevant part as ``used to express 
possibility''). While the ALJ misstated the applicable standard, his 
conclusion that Respondent repeatedly ignored ``red flags'' 
indicative of likely diversion and thus ``created a significant 
potential conduit for the unchecked diversion of controlled 
substances,'' ALJ at 39, is clearly supported by substantial 
evidence and warrants an adverse finding under factor five.
    The ALJ also opined that ``[i]t is clear that in assessing 
whether the controlled substance prescribing practices of a Florida 
practitioner fall within the acceptable range of what constitutes 
being within the bounds of being `issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
his professional practice,' resort must be had to an expert.'' ALJ 
at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the 
importance of expert testimony in this case, in which the Government 
primarily relied on a review of the medical charts, whether expert 
testimony is needed in any case necessarily depends on the nature of 
the allegations and the other evidence in the case. Where, 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.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA 
Certificate of Registration, BA6733578, issued to Michael J. Aruta, 
M.D., be, and it hereby is revoked. I further order that any pending 
application of Michael J. Aruta, M.D., to renew or modify his 
registration, be, and it hereby is, denied. This Order is effective 
immediately.

    Dated: March 31, 2011.
Michele M. Leonhart,
Administrator.
Larry P. Cote., Esq., for the Government.
Bernard M. Cassidy., Esq., for the Respondent.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

    John J. Mulrooney, II, Administrative Law Judge. On February 25, 
2010, the Deputy Administrator, Drug Enforcement Administration (DEA or 
Government), issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO), immediately suspending the DEA Certificate of 
Registration (COR), Number BA6733578, of Michael J. Aruta, M.D. 
(Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging 
that such registration constitutes an imminent danger to the public 
health and safety. The OSC/ISO also seeks revocation of the 
Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial 
of any pending applications for renewal or modification of such 
registration, pursuant to 21 U.S.C. 823(f), alleging that the 
Respondent's continued registration is inconsistent with the public 
interest, as that term is used in 21 U.S.C. 823(f). On March 24, 2010, 
the Respondent timely requested a hearing, which was conducted in 
Miami, Florida, on July 7, 2010 through July 9, 2010.\4\ The immediate 
suspension of the Respondent's COR has remained in effect throughout 
these proceedings.
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    \4\ Pursuant to an order issued on April 15, 2010, the hearing 
in this matter was consolidated with the cases of four other 
registrants who were working at the same clinic as the Respondent 
and who were also issued OSC/ISOs on February 25, 2010, alleging 
similar and related conduct.
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    The issue ultimately to be adjudicated by the Deputy Administrator, 
with the assistance of this recommended decision, is whether the record 
as a whole establishes by substantial evidence that Respondent's 
registration with the DEA should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4). 
The Respondent's DEA practitioner registration expires by its terms on 
June 30, 2012.
    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
below.

The Evidence

    The OSC/ISO issued by the Government alleges that the Respondent, 
through the medical practice he had been conducting at American Pain, 
LLC (American Pain), has prescribed and dispensed inordinate amounts of 
controlled substances, primarily oxycodone,\5\ under circumstances 
wherein he knew, or should have known, that the controlled substances 
were not prescribed and/or dispensed for a legitimate medical purpose. 
ALJ Ex. 1. The OSC/ISO

[[Page 19421]]

further charges that these prescriptions were issued outside the usual 
course of professional practice based on a variety of circumstances \6\ 
surrounding the manner in which American Pain has been operated and the 
manner in which its physicians, to include the Respondent, has engaged 
in the practice of medicine. Id. The OSC/ISO also sets forth the 
Government's allegation that Respondent's former patients have apprised 
law enforcement personnel that ``they were able to obtain prescriptions 
for controlled substances from [the Respondent] for other than a 
legitimate medical purpose and with little or no medical examination.'' 
Id.
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    \5\ A schedule II controlled substance.
    \6\ The majority of which are supported by no evidence 
introduced by the Government during the course of these proceedings.
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    At the hearing, the Government presented the testimony of three 
witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan 
Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, 
M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the 
University of Miami, Miller School of Medicine.
    GS Langston testified that the investigation of the American Pain 
Clinic had its origins on November 30, 2009, during a routine 
inspection that she and a subordinate diversion investigator conducted 
at Appurtenance Biotechnology, LLC, a pharmacy doing business under the 
name Boca Drugs (Boca Drugs), and located a few blocks away from one of 
the former locations of American Pain. Tr. at 713, 717-20. According to 
Langston, an examination of the prescriptions seized from Boca Drugs 
revealed that the majority of those prescriptions were for oxycodone 
and alprazolam authorized over the signature of physicians associated 
with American Pain.\7\ Id. at 721. Under Langston's supervision, DEA 
diversion investigators catalogued the prescriptions seized at Boca 
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. A review of the 
data relative to the Respondent on the Boca Drug Prescription Log 
reveals that from November 2, 2009 through November 25, 2009, 175 
controlled substance prescriptions issued over the Respondent's 
signature, to eighty-nine patients, only five of whom resided in 
Florida. The remainder of the patients had listed addresses in 
Kentucky, Tennessee, Ohio, Georgia, Massachusetts, West Virginia, North 
Carolina, Virginia, and South Carolina.
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    \7\ Although GS Langston testified that DEA immediately 
suspended the COR that had been issued to Boca Drugs, Tr. at 715, 
and that a voluntary surrender by that registrant followed a day 
later, id. at 776, no evidence has been presented that would lend 
that fact any particular significance related to any issue that must 
or should be found regarding the disposition of the present case.
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    GS Langston also testified that, on March 3, 2010, a criminal 
search warrant was executed on the American Pain Clinic simultaneously 
with the OSC/ISO that initiated the present case. Tr. at 735. According 
to Langston, the items seized from American Pain included a sign that 
had been posted in what she believes to have served as the urinalysis 
waiting room. Tr. at 735-37. The seized sign set forth the following 
guidance:

ATTENTION PATIENTS

    Due to increased fraudulent prescriptions, [i]t's best if you 
fill your medication in Florida or your regular pharmacy. Don't go 
to a pharmacy in Ohio when you live in Kentucky and had the scripts 
written in Florida. The police will confiscate your scripts and hold 
them while they investigate. This will take up to 6 months. So only 
fill your meds in Florida or a pharmacy that you have been using for 
at least 3 months or more.

Govt. Ex. 119 at 1. This sign is attached, apparently by some sort of 
tape, to the top portion of two other signs, posted at the same 
location, the first of which reads:

ATTENTION:

Patients

Please do NOT fill your prescriptions at any WALGREENS PHARMACY \8\ 
or OUTSIDE the STATE OF FLORIDA.
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    \8\ GS Langston testified that she was unaware of the location 
of the closest Walgreens to American Pain's offices. Tr. at 779. No 
evidence was presented that would tend to establish that any 
Walgreens or any other pharmacy has taken a position regarding its 
willingness to fill prescriptions authorized by American Pain.

Id. The final attachment to the composite sign bears the words ``24 
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Hour Camera Surveillance.''

    Id. A photograph of the composite sign was admitted into evidence.

    Langston also testified that while she was present in the American 
Pain offices, she noticed that each physician's desk was equipped with 
a group of stamps, each of which depicted a controlled substance 
medication with a corresponding medication usage instruction (sig). Tr. 
at 738-39. A photograph of one set of prescription script stamps was 
admitted as an exhibit.\9\ Govt. Ex. 119 at 2.
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    \9\ Although GS Langston testified that she did not actually 
take the photographs taken during the search warrant execution at 
American Pain, she did provide sufficient, competent evidence to 
support the admission of the photographs that were ultimately 
received into evidence. Tr. at 737, 739-41.
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    GS Langston also testified that a great number of medical charts 
were seized from the American Pain offices, and that she and her staff 
selected a number of these files to be analyzed by a medical expert 
procured by the Government. Tr. at 762. According to GS Langston, after 
the execution of the warrant, the charts from the entire office were 
placed into piles in alphabetical order, and not separated by 
physician. Langston testified that she and three of her diversion 
investigators reviewed the seized files with a view towards choosing 
approximately fifteen files for each doctor with the aspirational 
criteria that each would reflect at least three to four visits by that 
doctor with a patient. Each investigator was empowered to place a chart 
on the selected pile, and when the target number (or about that number) 
was reached for each physician, the selection effort relative to that 
physician was deemed accomplished. Id. at 765. Langston credibly 
testified that there was no effort to specially select files under some 
prosecution-enhancement or ``cherry picking'' purpose. Id. at 768.
    Langston also explained DEA's Automated Record Consolidated 
Ordering System (ARCOS) \10\ and testified that she generated an ARCOS 
report relative to the Respondent's ordering of controlled substances 
from January 2009 through February 2010.\11\ Govt. Ex. 2.
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    \10\ GS Langston explained that through the ARCOS system, 
``[d]rug manufacturers and distributors are required to report the 
sale of certain controlled substances to DEA,'' and the system 
``shows the history of a drug from the point of manufacture through 
the distribution chain to the retail dispensing level.'' Tr. at 685-
86.
    \11\ For reasons that were never made clear, the ARCOS report 
begins with a 2006 entry. Govt. Ex. 2 at 1.
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    In the same fashion, Langston explained the purposes of and 
circumstances behind the generation of State prescription monitoring 
reports (PMPs) relative to the Respondent maintained by West Virginia 
and Kentucky. Govt. Exs. 3, 4. Review of the PMP report data reflects 
that during the time period of February 1, 2006 through February 11, 
2010, pharmacies filled 210 controlled substance prescriptions issued 
over the Respondent's signature to fifty-five patients located in West 
Virginia, and 182 similar prescriptions provided to seventy-eight 
Kentucky-based patients were filled between January 1, 2009 and April 
4, 2010. Id.
    No evidence was introduced at the hearing that would provide any 
reliable level of context regarding the raw data set forth in the 
databases received into evidence at the Government's request. Other 
than the observations noted above, no witness who testified at the 
hearing ever explained the significance

[[Page 19422]]

of the data set forth in any of these databases to any issue that must 
or should be considered in deciding the present case.
    GS Langston provided evidence that was sufficiently detailed, 
consistent and plausible to be deemed credible in this recommended 
decision.
    SA Michael Burt testified that he has been employed by DEA since 
March 2004 and has been stationed with the Miami Field Division (MFD) 
since September 2004. Tr. at 813-14. Burt testified that he is the lead 
case agent for DEA in the investigation of American Pain Clinic and has 
participated in the investigation since the latter part of 2008. 
According to Burt, American Pain, which was previously known by the 
name South Florida Pain, has conducted business at four different 
locations, and he surveilled the Boca Raton and Lake Worth locations 
both in person and by periodic live review of video captured via pole 
cameras \12\ set up outside the clinic. Id. at 815-17. These pole 
cameras, which were in operation during a three week period from 
January to February 2010, were initially in operation on a 24 hour 
basis, but Burt testified that they were later activated only between 
the hours of 7 a.m. through 6 p.m. due to an observed lack of activity 
at the clinic outside of that time period. Id. at 820-21. The pole 
camera recordings were not offered into evidence at the hearing or made 
available to opposing counsel.
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    \12\ SA Burt described the pole cameras as ``covert cameras that 
are installed to observe the activity in the clinic.'' Tr. at 816. 
Burt testified that he was able to use a laptop to access the live 
video feed from the cameras after inputting a username and password. 
The camera video was also recorded to DVR. Id. at 821.
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    Based on these surveillance efforts, SA Burt testified concerning 
various activities he observed occurring outside the Boca and Lake 
Worth clinic locations, which were open to the public from 8 a.m. to 5 
p.m. At the Boca location, Burt stated that on any given day, beginning 
at 7 a.m. in the morning, automobiles could be seen pulling into the 
parking lot and approximately twenty to thirty people were routinely 
lined up outside of the clinic waiting to gain admittance. 
Additionally, there was a steady stream of automobile and foot traffic 
in and out of the clinic throughout the day. Id. at 817, 821. Burt 
testified that in his estimation, approximately 80-90 percent of the 
automobiles had out-of-State tags, predominantly from Kentucky, Ohio, 
West Virginia and Tennessee. Id. at 817-18. Burt also observed security 
personnel with ``staff'' written on their shirts \13\ riding around the 
exterior of the building in golf carts and who, in Burt's assessment, 
appeared to be directing patients into the American Pain facility. Burt 
indicated his surveillance of the Lake Worth location yielded similar 
observations. Id. at 818.
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    \13\ Tr. at 910.
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    Based on his review of some (but not all) \14\ of the audio and 
video tapes made by agents and informers sent into the clinic by the 
Government at various times, SA Burt also testified about his 
understanding of the process by which patients obtained controlled 
substance prescriptions at American Pain. According to Burt, after 
entering the clinic, a patient would meet with the receptionist, who 
would determine if the patient had an MRI. If not, the receptionist 
would issue that individual an MRI prescription in exchange for a $50 
cash payment, and the patient ``would be directed to a place to obtain 
an MRI.'' Id. at 822. Burt testified that one such MRI location was 
Faye Imaging, which was a mobile MRI trailer located behind a 
gentlemen's club several miles away from American Pain. Id. at 822-23. 
The cost for the MRI was $250, and the patient could pay an additional 
fee ``to have the MRI expedited and faxed over to American Pain.'' Id. 
at 823-24. Once the MRI was procured and faxed to American Pain, the 
patient would return to the clinic and be seen by a doctor. According 
to Burt, the clinic accepted what he referred to as ``predominantly 
cash only'' \15\ for these office visits, and the six doctors at the 
clinic saw ``anywhere from 200 upward to 375 patients a day'' \16\ in 
this manner.\17\ Id. at 882-83 (emphasis supplied).
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    \14\ SA Burt conceded that although he is the designated lead 
case agent for DEA, he did not review all the audio and video tapes 
made in the case or even review the transcripts. Tr. at 1002-05.
    \15\ Later on cross-examination, SA Burt admitted that the 
clinic also accepted payment via credit card. Tr. at 916.
    \16\ Inasmuch as the Government provided no information from 
which any specific number of patients seen by any given clinic 
doctor on any day could be derived, or any expert testimony 
regarding a reasonable number of pain patients that could or should 
be seen per day, the value of providing the raw number of patients 
walking through the door at the clinic is negligible.
    \17\ Burt further testified that the doctors were paid $75.00 
per patient visit, id. at 884, but because he indicated that he 
could not disclose his basis of knowledge for this information, this 
portion of his testimony can be afforded no weight. To proceed 
otherwise would deny the Respondent the ability guaranteed by the 
APA ``to conduct such cross-examination as may be required for a 
full and true disclosure of the facts.'' 5 U.S.C. 556(d); see 
Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. 
Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 
928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 
149 (9th Cir. 1980).
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    SA Burt also testified regarding his review of some \18\ of the 
video and audio recordings made by an undercover agent (UC) who assumed 
the name Luis Lopez capturing activity inside of American Pain.\19\ In 
those recordings, Burt observed who he believed to be an American Pain 
employee inside the facility standing up in a waiting room full of 
patients and directing them ``not to have their prescriptions filled 
out of State, not to go out into the parking lot and snort their 
pills,'' and directing the patients to have their prescriptions filled 
``in house'' (meaning at American Pain), at ``a pharmacy they have in 
Orlando, Florida,'' or at ``a pharmacy they have down the street,'' 
which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26. 
Burt further testified that the purported employee on the recording 
told the patients to ``obey all the traffic laws; do not give the 
police a reason to pull you over.'' Id. Although Burt testified as to 
the contents of these recordings, the physical recordings were not 
offered into evidence by the Government or made available to opposing 
counsel.
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    \18\ Tr. at 1002-05.
    \19\ The fact that these recordings were made during the course 
of seven different office visits by an undercover agent to both the 
Boca Raton and Lake Worth locations was established on cross-
examination. Tr. at 900, 985.
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    SA Burt also testified that he received information from Dr. Eddie 
Sollie, a former physician employed during the time period American 
Pain was doing business as South Florida Pain, who terminated his 
employment at the Oakland Park clinic location in November or December 
2008 after working there for approximately two and a half to three 
months.\20\ Id. at 827, 898. During the course of an interview where 
Burt was present, Dr. Sollie related various ``concerns about how the 
practice was being handled or managed.'' Id. at 827-28. These concerns 
included medical records being, in his opinion, annotated inadequately 
by the doctors, and what he perceived as a lack of supervision during 
patient urinalysis testing, where patients would ``go[] to the 
bathrooms together, bringing items with them to the bathrooms that 
could possibly disguise the urinalysis.'' According to Burt, Sollie 
explained that he perceived that patients were substituting urine 
produced by other persons that contained the metabolites

[[Page 19423]]

for controlled substances that the patients claimed to be legitimately 
taking, with a view towards falsely providing evidence to the American 
Pain doctors showing that they were actually taking prescribed 
medications and not diverting them. Id. at 828-29. During cross-
examination, Burt explained that Dr. Sollie told him he had raised 
these concerns with Christopher George, the owner of American Pain, and 
that Burt had no evidence that the deficient practices that Sollie had 
objected to continued through 2010. Id. at 900, 906. Burt also 
acknowledged that he was aware Dr. Sollie had been involved in 
litigation with Mr. George and that their relationship was strained. 
Id. at 1009. Dr. Sollie was not called as a witness by either party.
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    \20\ On cross-examination, SA Burt stated that he did not know 
whether it was true that the Respondent began working at the clinic 
in 2009 (a representation made by Respondent's counsel, but not in 
evidence), which (at least according to the question posed) would 
have been after Sollie's employment at the clinic had already ended. 
Tr. at 898.
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    SA Burt also provided testimony concerning three confidential 
sources (only one of whom was seen by the Respondent) and their 
contacts with doctors at American Pain. Relative to the Respondent, 
Burt testified concerning his April 2009 debriefing of a confidential 
source of information (CS2) based in Kentucky who came to Burt's 
attention through his Kentucky law enforcement contacts. Id.at 866-67. 
Burt assisted the source's Kentucky handlers with arranging for CS2 to 
visit American Pain, at which time she was able to obtain a 
prescription for oxycodone from the Respondent. Burt testified that 
during the debriefing, CS2 told him the Respondent instructed her ``not 
to go out of the State of Florida and try to get this pain medication 
[prescription] filled,'' and that it should instead be filled within 
Florida. Id. at 869. According to Burt, CS2 also indicated that she did 
not have a legitimate medical need for the controlled substances when 
they were acquired from the Respondent. The Government did not submit 
evidence of, or provide opposing counsel access to, a patient file 
reflecting CS2's visit with the Respondent, or a copy of the 
prescription allegedly issued.\21\ Burt indicated CS2's cooperation in 
this investigation was as a result of ``working off'' criminal charges 
she was subject to. Id. at 895. Burt also declined to disclose the name 
of CS2 when queried on cross-examination. Id. at 893.\22\
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    \21\ On cross-examination, SA Burt responded in the negative 
when asked if he had ``anywhere'' in his possession a copy of the 
prescription at issue and whether he had supplied Government counsel 
with a copy of this individual's patient file. Tr. at 894.
    \22\ In light of the inability to identify the name of this 
source of information to opposing counsel, and the lack of detail 
and corroborating evidence related to the information derived from 
her, no weight can be assigned to SA Burt's testimony concerning 
information provided by CS2, beyond the fact that this interaction 
may have informed the course of DEA's investigation. To proceed 
otherwise would deny the Respondent the ability guaranteed by the 
APA ``to conduct such cross-examination as may be required for a 
full and true disclosure of the facts.'' 5 U.S.C. Sec.  556(d); see 
Richardson v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. 
Herman, 233 F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 
928 F.2d 227, 230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 
149 (9th Cir. 1980).
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    SA Burt also testified regarding the drug overdose deaths of TY and 
SM after obtaining controlled substances from American Pain.\23\ Burt's 
record testimony indicates that DEA Task Force Officer \24\ (TFO) Barry 
Adams informed him that a Kentucky resident named TY overdosed in 
Kentucky from oxycodone intoxication induced by medication procured at 
American Pain. Burt testified that this information was furnished 
pursuant to a working law enforcement relationship between the Kentucky 
State Police, Kentucky FBI, Kentucky DEA and Miami DEA aimed at 
addressing ``the brunt of the pill problem'' centered within the State 
of Kentucky relative to illegal use and resale of prescription pain 
medications. Id. at 833-35. However, in his testimony, Burt was unable 
to recall the name of the doctor from whom TY obtained his pills, and, 
thus, no admissible evidence was presented by the Government with 
respect to TY's death.\25\ Likewise, the record evidence concerning SM 
did not implicate prescribing activity by the Respondent.
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    \23\ Although similar testimony concerning the overdose death of 
a third individual, OB, was noticed in the Government's prehearing 
statement, it was not offered by the Government at the hearing. ALJ 
Ex. 6 at 8.
    \24\ According to SA Burt, a ``task force officer'' is a local 
police officer or sheriff's deputy that is assigned to work on a DEA 
task force, rather than a sworn DEA criminal investigator. Tr. at 
1031.
    \25\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and 
associated testimony).
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    Perhaps among the more striking aspects of SA Burt's performance on 
the witness stand is the anticipated testimony which he did not 
provide. When viewed in its entirety, SA Burt's record testimony was 
stunningly sparse when compared with his proposed testimony as noticed 
in the Government's prehearing statement.\26\ That certain information 
may be unavailable for reasons related to other litigation forums, or 
other equally valid reasons, are of no moment with respect to the 
evaluation that must be made at this administrative forum. Equally 
important, such considerations do not alter the burdens imposed upon 
the respective parties. Simply put, the admitted evidence must succeed 
or fail on its own merits, irrespective of extraneous considerations.
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    \26\ ALJ Ex. 6.
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    Even apart from the marked contrast between the Burt testimony as 
proffered and as realized, his testimony was marred by periodic memory 
failures on significant issues and an inability to supply details to an 
extent that it could arguably have diminished the weight that could be 
fairly attached to those aspects of his own investigation that he did 
manage to recollect. During his testimony, SA Burt acknowledged his own 
marked lack of preparation and unfamiliarity with the investigation and 
confessed simply that ``[t]here's no excuse * * * '' Id. at 1003-05.
    Even acknowledging its obvious suboptimal aspects, SA Burt's 
testimony had no apparent nefarious motivation or indicia of 
intentional deceit. Burt came across as an earnest and believable 
witness, who, regarding the aspects of the case that he did recall, was 
able to impart substantial information about the investigation and 
activities involving American Pain and its doctors. While frequently 
lacking in detail, his testimony was not internally inconsistent or 
facially implausible, and although the legal weight I have assigned to 
certain portions of Burt's testimony varies given the issues described, 
I find his testimony to be credible overall.
    The Government presented the bulk of its case through the report 
and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., 
Affiliate Clinical Assistant Professor at the University of Miami, 
Miller School of Medicine.\27\ Dr. Kennedy, who testified that he is 
board certified by the American Board of Pain Medicine and the American 
Board of Anesthesiology,\28\ was offered and accepted as an expert in 
the field of pain medicine. Tr. at 39.
---------------------------------------------------------------------------

    \27\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
    \28\ Tr. at 17.
---------------------------------------------------------------------------

    Dr. Kennedy prepared a report in connection with the Government's 
case against the Respondent, which is dated April 30, 2010, and was 
admitted into evidence during his testimony. Govt. Ex. 5. The report 
describes a general analysis of fifteen charts that the Respondent 
maintained on as many patients, that were (selected by and) provided to 
Dr. Kennedy by the Government \29\ from among an

[[Page 19424]]

unspecified number of patient files seized pursuant to a criminal 
search warrant executed at the Respondent's practice on March 3, 2010 
(Patient Charts Analysis).
---------------------------------------------------------------------------

    \29\ Dr. Kennedy testified that he asked that the charts be 
selected randomly and not be ``cherry picked'' or selected with a 
view towards influencing his conclusions. Tr. at 214. As discussed, 
above, GS Langston testified that the reviewed charts were not 
selected with a view toward influencing Dr. Kennedy's opinion. Tr. 
at 768.
---------------------------------------------------------------------------

    In Dr. Kennedy's expert opinion, based on a documentary review of 
the patient charts from the Respondent's practice that he reviewed, the 
Respondent's prescribing practices fell below the standards set forth 
by the Florida Medical Board. Tr. at 118. Furthermore, Dr. Kennedy 
testified that after reviewing the charts, he was unable to identify 
any legitimate basis for prescribing any of the controlled substance 
medications prescribed to the patients named in the charts. Id.
    During the course of his testimony, Dr. Kennedy explained that he 
took professional issue with several aspects of the Respondent's 
patient care as reflected in the charts regarding the prescribing of 
controlled substances. It is apparent from his testimony that Dr. 
Kennedy's analysis is restricted to those matters which can be gleaned 
from an examination of the written word in that subset of the 
Respondent's patient charts provided by the Government for his review, 
and that limitation perforce circumscribes the breadth of his 
testimony. That being said, Dr. Kennedy highlighted numerous features 
in the Respondent's chart documentation that he found wanting, or at 
least remarkable.
    While acknowledging that some standardization and utilization of 
forms is not, standing alone, improper,\30\ Dr. Kennedy took issue with 
what he perceived as flaws in the forms utilized by the Respondent to 
document patient care. According to Dr. Kennedy, the forms inadequately 
distinguished between the history and physical examinations, and failed 
to sufficiently document an adequate pain assessment. Id. at 79-80, 
128-31. According to Dr. Kennedy, the charts also did not document 
activities that improved or exacerbated pain symptoms, and did not 
document self-described patient limits, neurological signs and 
objective observations, such as gait and station. Id. at 81. Dr. 
Kennedy testified that the chart entries were so defective that the 
Respondent did not establish a sufficient doctor-patient relationship 
to justify the prescribing of controlled substances, and that ``this 
was not the practice of medicine in [his] opinion. Id. at 160-61.
---------------------------------------------------------------------------

    \30\ Tr. at 74.
---------------------------------------------------------------------------

    Dr. Kennedy explained that there are basic elements to practicing 
pain medicine. The acquisition of a thorough history and physical 
examination is important. Id. at 44. He also stressed the vital 
importance of obtaining past medical records to evaluate what 
treatments, therapies, medications, and dosages have been utilized in 
the past so that correct current treatment decisions can be made. Id. 
at 47-48. Reliance upon the patient's memory of these elements without 
the prior medical records, in Dr. Kennedy's view, is not reliable or 
acceptable. Id. at 49-51. Although the Respondent's charts routinely 
contained a form which purports to require patients to see their 
primary care physicians, Dr. Kennedy testified that none of the files 
contained any record of any communication with any primary care 
physician from any patient. Id. at 114-16.
    Kennedy also explained the importance of establishing a 
differential or working diagnosis on the first visit and modifying and 
reviewing that diagnosis as more information and results become 
available. Id. at 52. Similarly, a diagnostic plan is a systematic 
methodology of eliminating possible causes of symptoms to allow the 
treating physician to accurately determine what is causing them so that 
a successful treatment plan can be developed. Id. at 52-53. In other 
words, the diagnostic plan allows the treating doctor to eliminate or 
confirm items on the differential diagnosis. Id. at 54.
    Dr. Kennedy testified that, in his expert opinion, the medical 
histories taken by the Respondent in the reviewed files were 
insufficiently detailed to meet the standards set by the Florida Board 
of Medicine to justify the prescribing of controlled substances. Id. at 
81-82. The histories and pain assessment evaluations, as documented in 
the charts, were also ``not adequate on the initial or ongoing basis,'' 
because the forms used and the manner in which they were completed did 
not sufficiently catalogue key aspects, such as

[the] particular pain level, where the pain was located, what it 
felt like, when was it worse, what made it better, what it made it 
worse, what have you done to alleviate or past treatments, and what 
can you not do with the pain? Observations on physical examination 
about how the person walks, gait and station. Consistency of 
neurologic and inadequacy of pathologic reflexes particularly, 
presence or absence, and adequate sensory examination. 
Musculoskeletal examination. And height and weight many times were 
not present.

Id. at 80-81, see also id. at 128-32.

    Similarly, Dr. Kennedy opined that Respondent's treatment plans, as 
they were reflected in the reviewed records, were ``grossly 
inadequate'' in that the use of controlled substances was the single 
option considered and employed, ``[s]o everybody got essentially the 
same treatment regardless of their complaint, severity, physical 
examination [and] history.'' Id. at 82-83. In Kennedy's view, combining 
controlled substance medications that were utilized in the charts was 
not ``bad by itself, but it was done across the board with everybody. * 
* * [with] essentially the same drugs at the same doses for all the 
individuals'' Id. at 98. In Dr. Kennedy's view, there were a panoply of 
other treatment options that could and should have been documented and 
discussed with the Respondent's pain patients. Id. 162-64.
    Dr. Kennedy also made the ironic observation that although to the 
``extremely rare'' \31\ extent controlled substance medication 
adjustments were ever effected by the Respondent, they went up, and the 
forms utilized by the Respondent (and the practice in general) only 
provided a checkbox for reduction, or weaning. Id. at 95-96. This is 
essentially inconsistent with the normal practice of starting 
controlled substance treatment at the lowest dose possible to attain 
the desired result and adjusting upwards. Id. The form used by the 
Respondent seems to presume that the controlled substance doses would 
generally progress downward. Dr. Kennedy testified that he saw no 
evidence of medication adjustment to accommodate treatment, or 
``titration,'' in any of the charts he examined. Id. at 174.
---------------------------------------------------------------------------

    \31\ Tr. at 96.
---------------------------------------------------------------------------

    Although Dr. Kennedy conceded that it is the judgment of the 
examining physician that is generally relied upon in determining the 
necessity and appropriateness of diagnostic testing,\32\ he also 
testified that the Respondent's practice of routinely ordering magnetic 
resonance imaging (MRI) procedures before he met with the patients was 
inappropriate because an MRI is not always required and not always 
appropriate. Id. at 71-73, 153-54. In Kennedy's opinion, a physician 
has an obligation to meet with the patient before including this 
procedure as part of the utilized diagnostic tools. Id.
---------------------------------------------------------------------------

    \32\ Tr. at 59.
---------------------------------------------------------------------------

    Dr. Kennedy opined that the Respondent's prescribing of opioids 
lacked a legitimate medical purpose in that he routinely prescribed 
oxycodone in initial 30 milligram (mg) doses that significantly 
exceeded the recommended 0.5 to 2.5 mg starting dosage.\33\ Id. at 86-
87. Kennedy

[[Page 19425]]

explained that a patient who has never had opioids, or has been off 
them for two to four weeks is classified as ``opioid na[iuml]ve'' and 
would feel the affects of the medication with smaller doses that can be 
increased as needed. Id. at 83-86. The dosage levels prescribed by the 
Respondent, in Dr. Kennedy's view, would always require significant 
monitoring of the medication's effect on the patient, generally done in 
an office or hospital, and not an outpatient setting. Id. at 86-88.
---------------------------------------------------------------------------

    \33\ Dr. Kennedy testified that the recommended starting dosages 
are found in the medication product insert and divined through 
clinical knowledge. Tr. at 100.
---------------------------------------------------------------------------

    In this regard, Dr. Kennedy highlighted the chart of patient 
JR.\34\ Govt. Ex. 7. JR's patient chart reflects his disclosures that 
he had not been prescribed pain medication within the twenty-eight days 
preceding his first appointment with the Respondent. Id. at 20. A 
notation on JR's pain contract indicates that he was not currently 
taking any medications at the time of his appointment. Id. at 23. 
Notwithstanding the fact that JR, at least by his representations, 
presented as an opioid na[iuml]ve patient, the Respondent issued 
prescription scripts for 30 mg of Roxicodone and 2 mg of Xanax. Id. at 
17. Kennedy characterized prescribing these controlled substances as 
``absolutely dangerous if [the patient] took that as prescribed. There 
would be a significant incident of respiratory depression, drug 
overdose and potentially death.'' Tr. at 90. When pressed on the 
relative likelihood of adverse effects, Dr. Kennedy responded this way:
---------------------------------------------------------------------------

    \34\ At the request of the Government, a protective order was 
issued that is designed to minimize the risk of the dissemination of 
identifying information related to patients and their relatives 
associated with this case. Accordingly, initials have been 
substituted for the names of individuals within the protection of 
the protective order throughout the body of this decision. ALJ Ex. 
15.

    If the records that the patient filled out themselves [sic] are 
correct, then that especially given with the Xanax, which is a 
benzodiazepine like Valium[,] [i]ts generic name is alprazolam[,] 
[a]nd that's a high dose of Xanax as well. [] [T]he typical starting 
dose of Xanax is .25 to 0.5 [mg]. So, that's four to eight times 
higher than the usual dose on that, and that's given twice daily. 
Given that they work different areas in the nervous system and they 
both can cause sedation and potentially respiratory depression, 
there's at least an additive if not a synergistic effect between 
when you mix different components of an opioid like oxycodone, a 
narcotic pain reliever, with a benzodiazepine like Xanax, 
alprazolam, especially at those doses in a na[iuml]ve person for 
---------------------------------------------------------------------------
both drugs, that makes it even more dangerous.

Id. at 91. Dr. Kennedy was asked to clarify whether this was an area 
where reasonable medical professionals could differ and provided this 
emphatic clarification:

    No sir, this isn't even close. There's no room, wiggle room on 
this. This is absolutely beyond the pale.

Id. at 92.

    Notwithstanding his expressed concerns over the potency of some of 
the controlled substances prescribed by the Respondent, Dr. Kennedy was 
struck by the fact the charts of several of the Respondent's patients 
reflected no indication that any acceptable measure of mental status, 
cognitive ability and response time was undertaken. Id. at 102-07.
    On cross-examination, Dr. Kennedy agreed that the reviewed charts 
reflected objective signs that arguably supported medically 
determinable impairments that could cause chronic pain conditions, and 
that the controlled substance medications that were prescribed by the 
Respondent were among those that could be correctly employed to treat 
chronic pain. Id. at 132-33, 135-37, 140-42, 144-45, 148-51. However, 
Dr. Kennedy remained steadfast in his dual views that the Respondent's 
medical records simply did not contain enough information for a 
physician to reach the conclusion that the prescribing was appropriate 
and that the medication doses were simply too high. Id. at 123, 126-27, 
166. Kennedy was also consistent in his position that MRI results, 
standing alone, are not a reliable indicator of an impairment 
indicating the utilization of controlled substance medications. Id. at 
55-63, 130-31, 164-66.
    In his Patient Charts Analysis, Dr. Kennedy focuses on a patient 
chart related to GA, one of the Respondent's patients, and opines that 
the flaws identified in GA's chart are common to all fifteen of the 
Respondent's files that he reviewed. Specifically, the Patient Charts 
Analysis states that the charts he reviewed ``are essentially the same 
with regard to review issues; as stated in the report of [GA] 
referenced and discussed in this report in detail, [and that] there 
were no significant differences that affected [his] conclusions and 
summary.'' Govt. Ex. 5 at 2.
    In Dr. Kennedy's opinion, the patient charts he reviewed that were 
prepared by the Respondent reflected care that fell below the 
applicable standard on multiple levels. In his report, Dr. Kennedy 
noted that the treatment notes in the charts: (1) Contained no 
typewritten clinical notes and were ``very brief, difficult to read 
(often impossible) and not within the bounds of professional practice 
due to their brevity and quality''; \35\ (2) reflected prescriptions, 
right from the initial patient visit, that ``were almost entirely for 
controlled substances, most often one or two immediate release 
oxycodone pills with Xanax,'' and which were, in Dr. Kennedy's view, 
inappropriate and more powerful than justified by the objective signs 
documented in the written notes; \36\ (3) showed that ``the same or 
very similar `drug cocktails' were prescribed [among all patients in 
the reviewed files] in the same or very similar doses, [directions] * * 
* with a 30-day supply,'' and were affixed to the prescription scripts 
with a few prepared stamps utilized by all American Pain physicians 
that reflected ``drug, dose, sig (directions) and quantity dispensed''; 
\37\ (4) contained medication contracts that were ``not always signed'' 
and ``listed criteria that was not followed by the doctors at American 
Pain; \38\ (5) failed to adequately document the efficacy of the 
prescribed medication; (6) did not set forth a ``diagnostic plan except 
to obtain an occasional MRI, the results of which made no difference in 
the `treatment' ''; \39\ (7) reflected ``no therapeutic plan, except to 
use controlled substances to `treat' the subjective complaint of `pain' 
which was inadequately described; \40\ (8) reflected ``inadequate 
therapeutic goals * * * for improvement of quality of life (activities 
of daily living, work, sleep, mood) with the prescription of

[[Page 19426]]

controlled substance `cocktails'''; \41\ (9) did not reflect 
``consultations with other physicians or specialists outside the 
American Pain group [which] could have and in some cases should have 
included orthopedics, neurology, neurosurgery, psychiatry, addiction 
medicine and/or psychology''; \42\ (10) reflected ``a gross lack of 
past medical records in all charts reviewed and in some cases none at 
all''; \43\ and, (11) demonstrated controlled substance patient 
monitoring practices that were ``not within the standard of care and 
outside the boundaries of professional practice.'' \44\
---------------------------------------------------------------------------

    \35\ Govt. Ex. 5 at 4.
    \36\ Govt. Ex. 5 at 4. In Dr. Kennedy's opinion, the Respondent 
``prescribed, at the first visit, very high initial doses of 
controlled substance combinations despite being outside the bounds 
of professional practice for histories and physical examinations and 
absent past medical records.'' Id. at 7.
    \37\ Govt. Ex. 5 at 4.
    \38\ Govt. Ex. 5 at 3. As an example of the failure to adhere to 
the terms of the medication contract, Dr. Kennedy cites a contract 
term that provides notice that the physician may stop prescribing 
opioids or change treatment if pain or activity improvement is not 
demonstrated, and points out that pain and activity levels are 
routinely not documented in treatment notes. Id. at 4. Similarly, 
Dr. Kennedy references a medication contract warning that 
termination of services may result from failure to make regular 
follow-up appointments with primary care physicians, and notes that 
the American Pain charts contain no notes from primary care 
physicians or medical records generated by them. Id.
    \39\ Govt. Ex. 5 at 7. In Dr. Kennedy's opinion, Respondent ``in 
effect, acted as a `barrier' for [GA] to receive appropriate medical 
evaluation and treatment. In other words, the very potent, high 
doses of opioids (oxycodone) and benzodiazepine (Xanax) could mask 
or cover up [GA's] underlying disease process(s), making them more 
difficult to diagnose, and allowing the disease(s) to unnecessarily 
worsen. Without an accurate diagnosis, all [the Respondent] was 
doing was, again, masking or covering up the symptoms.'' Id. at 10.
    \40\ Govt. Ex. 5 at 7.
    \41\ Govt. Ex. 5 at 7.
    \42\ Govt. Ex. 5 at 7.
    \43\ Govt. Ex. 5 at 15. The only past medical record contained 
in GA's chart was a report from an MRI conducted one day prior to 
the patient's initial office visit at American Pain. Id. at 8.
    \44\ Govt. Ex. 5 at 14.
---------------------------------------------------------------------------

    Dr. Kennedy found the Respondent's controlled substance patient 
monitoring to be deficient in numerous respects. From the reviewed 
patient charts, Dr. Kennedy gleaned that an initial, in-office urine 
drug screen was frequently executed during the patients' initial visit 
to the office but repeated only occasionally. Govt. Ex. 5 at 14. It was 
Dr. Kennedy's observation that even a drug screen anomaly did not alter 
the seemingly inexorable continuation of controlled substance 
prescribing from the Respondent. Id. Dr. Kennedy also noted that the 
Respondent did not utilize out-of-office toxicology tests, or obtain 
out-of-State prescription monitoring program or outside pharmacy drug 
profiles, and expressed concern that the in-house urinalysis 
documentation that was maintained did not provide sufficient detail 
regarding the procuring and maintaining of the sample to meaningfully 
gauge its reliability. Id.; Tr. at 107-111. Kennedy expressed his view 
that the whole drug testing process at the Respondent's office was 
inadequate. Furthermore, the charts contained only rare evidence of 
contact with primary care physicians, treating physicians, pharmacists, 
or other health care providers. Id.
    The identified shortcomings of controlled substance patient 
monitoring systems was of particular significance where Dr. Kennedy 
identified specific evidence that he identified as ``red flags'' of 
possible or likely diversion. Red flags noted by Dr. Kennedy in the 
reviewed charts included the relatively young age of the Respondent's 
chronic pain patients,\45\ incomplete history information provided by 
the patients, periodically significant gaps between office visits,\46\ 
referrals from friends, relatives, or advertising, but not other 
physicians,\47\ and the fact that a relatively high number of patients 
were traveling significant distances to American Pain for pain 
treatment, although no physician employed at that facility had any 
specialized training in pain management.\48\ During his testimony, Dr. 
Kennedy conceded that, standing alone, the Respondent's treating out-
of-State patients has no particular significance, and that when he was 
engaged in the practice of medicine in Kentucky he had patients who 
traveled to his office from Florida.\49\ Tr. at 116. Regarding the 
Respondent's Kentucky patients, Dr. Kennedy observed that there were 
numerous medical and osteopathic schools that were much closer to the 
homes of these patients that could have provided pain management. Id. 
at 116-17.
---------------------------------------------------------------------------

    \45\ Govt. Ex. 5 at 15.
    \46\ Govt. Ex. 5 at 13.
    \47\ Govt. Ex. 5 at 7, 15.
    \48\ Govt. Ex. 5 at 15; Tr. at 67-68.
    \49\ Although the Government elicited testimony from Dr. Kennedy 
concerning his perceived significance to a ``majority'' of patients 
coming from out of State, Tr. at 116-17, since there was no evidence 
regarding what percentage of the Respondent's patients were from 
outside Florida, this inquiry and its responses have been given no 
weight.
---------------------------------------------------------------------------

    Although Dr. Kennedy's report and testimony appear to attach some 
significance to referrals that originated in family and friends, he 
later clarified that it was not unusual for a physician to treat 
patients that have been referred by relatives and friends. Id. at 154. 
Further, Kennedy conceded while in the course of his own medical 
practice he has treated patients referred by family and friends, and 
that in his report he was focusing on what he perceived as a lack of 
any referrals by physicians in the files he reviewed, or what he 
perceived as ``trends'' or ``patterns.'' Id. at 154-55. Given Dr. 
Kennedy's acknowledgement that such referrals are not unusual, coupled 
with the absence of any way to measure the relative percentage of 
physician referrals in the Respondent's practice based on the record 
evidence, the observations regarding referral sources are of limited 
value here.\50\
---------------------------------------------------------------------------

    \50\ Dr. Kennedy did not testify that a referral that emanated 
from a source other than a physician could or should be a basis for 
a diversion red flag on a given case. His opinion was limited to 
culling some manner of a trend or pattern. In view of the fact that 
the record contains no development of the numbers of files with non-
physician referrals versus the total number of files, or even an 
acceptable metric upon which the issue could be evaluated, there is 
very little useful analysis that can come from Dr. Kennedy's 
observation regarding the files he reviewed.
---------------------------------------------------------------------------

    During his testimony as well as his report, Dr. Kennedy highlighted 
several features of particular charts that, at least in his view, bore 
the indicia of some red flags that should have signaled an increased 
risk of controlled substance diversion. Kennedy detailed several 
controls that should have been, but were apparently not utilized by the 
Respondent to monitor diversion risks in a pain management practice. 
Id. at 111. Some examples of expected diversion controls that were 
available to, yet absent from the Respondent's practice included random 
pill counts, communication with family members, blood tests to 
supplement urinalysis drug screens, communication with patient 
pharmacists and the acquisition of pharmacy readout sheets to evaluate 
the prescriptions filled and sources of those prescriptions, and the 
acquisition of printouts from prescription monitoring programs (PMPs) 
in some of the States \51\ where his patients resided. Id. at 111-13.
---------------------------------------------------------------------------

    \51\ Dr. Kennedy testified that although Florida does not have a 
PMP, several of the States where some of the Respondent's patients 
resided did have such programs, and that the Respondent would have 
had access to obtain information about his patients in this manner. 
Tr. at 113.
---------------------------------------------------------------------------

    Although not touched upon by Dr. Kennedy in his testimony or 
report,\52\ there were other indications of potential red flags and 
related anomalies among the charts admitted into evidence. For example, 
patient JR's chart contains a form indicating a positive UDS for 
oxycodone and opiates from 12/30/09, yet on the same date, the 
medication contract signed by JR reflects a handwritten ``N/A'' 
notation in the section where a patient is supposed to list any 
medications they are currently taking. Govt. Ex. 7 at 10, 23; see also 
Govt. Ex. 19 at 10-11, 23 (similar issue). Patient MR's file, on the 
other hand, indicates a positive UDS for oxycodone only, yet the 
patient indicates he is currently taking Xanax (a benzodiazepine that 
should have triggered a positive UDS reading) on two different 
documents, a discrepancy which raises questions about the validity of 
the testing procedures and/or the patient's candor. Govt. Ex. 8 at 13-
14, 28; see also Govt. Exs. 10 at 9, 22; 12 at 12, 26; 17 at 12-13 
(similar discrepancies present in other patient

[[Page 19427]]

files with respect to those drugs present on UDS in comparison to 
current medications listed in medication contract and other forms). 
Patient BS's UDS indicates a negative test for all listed substances, 
yet on two different forms she indicates she is currently taking two 
strengths of Roxycodone along with Xanax. Govt. Ex. 16 at 6-7, 18. A 
prescribed controlled substance that is not reflected in a drug screen 
should have raised a sufficient suspicion of diversion to merit further 
inquiry by the registrant reflected in the patient file. The UDS form 
in patient TS's file reflects circled positive results for 
benzodiazepines, opiates, and oxycodone on ``2/12,'' yet the words 
``Neg Test'' is handwritten and circled in the margin. Govt. Ex. 13 at 
9. Numerous patient files also reflected notations that patients 
``requested'' specific types and/or strengths of controlled substances. 
Govt. Exs. 6 at 6; 7 at 2; 8 at 4; 17 at 2; 20 at 3; 21 at 3. At a 
minimum, these observations support the conclusion there was a general 
lack of vigilance on the part of the Respondent regarding his 
obligations as a registrant to minimize the risk of controlled 
substance diversion.
---------------------------------------------------------------------------

    \52\ The Government's tactical decision to essentially unload a 
pile of charts that are explained only by the representations and 
generalizations in a report, with no attempt whatsoever to have its 
expert witness explain the applicable aspects of most charts to this 
tribunal or any future reviewing body is clearly at odds with the 
directive provided by the Deputy Administrator in Gregg & Son 
Distributors that ``it is the Government's obligation as part of its 
burden of proof and not the ALJ's responsibility to sift through the 
records and highlight that information which is probative of the 
issues in the proceeding.'' 74 FR 17517 n.1.
---------------------------------------------------------------------------

    Interestingly, in his report, Dr. Kennedy also found it remarkable 
that each American Pain patient file provided notice to its patients 
that American Pain did not accept any form of health care insurance. 
Govt. Ex. 5 at 3, 16. The report reflected Kennedy's view that this 
practice was designed to ``effectively keep [the physicians at American 
Pain] `off the radar' from monitoring by any private health care 
insurance company as well as all State and Federal agencies (Medicaid 
and Medicare respectively).'' Id. at 16. Significantly, however, when 
asked, Dr. Kennedy acknowledged that he conducts his own current 
medical practice on a cash-only basis. Tr. at 151.
    Dr. Kennedy concluded his report regarding the Respondent's 
prescribing practices with the following summary:

    [The Respondent] was not engaged in the practice of medicine, 
rather he was engaged in an efficient, ``[a]ssembly [l]ine'' 
business. His ``patients'' were revenue streams, not true patients. 
This business allowed him to collect cas[h] for office visits as 
well as being a ``[d]ispensing [p]hysician'' for controlled 
substances. He prescribed controlled substances so that ``patients'' 
would return to his office on a regular basis, allowing him to 
generate further revenue. [The Respondent's] routine and excessive 
prescription of multiple controlled substances (oxycodone and Xanax) 
and lack of arriving at a valid medical diagnosis and treatment most 
likely caused harm to the ``patients'' he saw. Drug diversion most 
likely caused a ``mushroom'' effect of increased drug abuse, drug 
addiction, drug overdoses, serious bodily injury and death in those 
communities spread over several different states. [The Respondent's] 
continued ability to prescribe controlled substances will only 
perpetuate the suffering and be a threat to the public.

Govt. Ex. 5 at 16.

    The Government's presentation of Dr. Kennedy's testimony at the 
hearing was substantially consistent with the conclusions included in 
the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly 
not without its blemishes. Although he testified that he was familiar 
with prescribing practices in Florida, and that he utilized the medical 
standards applicable to Florida practice,\53\ he was unable to identify 
the documentation standard in the Florida Administrative code with any 
degree of particularity, and he also acknowledged that he was not aware 
of what the standard is in Florida Medical Board administrative 
decisions regarding the overprescribing of medication or what 
constitutes an adequate medical history. Tr. at 149-51, 233, 304. 
While, overall, Kennedy presented testimony that appeared candid and 
knowledgeable, there were areas in his written report that rang of 
hyperbole and over-embellishment. The reasoning behind some of the 
seemingly critical observations in the written report, such as the 
``cash basis'' of the Respondent's practice and the absence of doctor 
referrals among the reviewed patient files, did not well survive the 
crucible of cross examination at the hearing. However, overall, Dr. 
Kennedy's testimony was sufficiently detailed, plausible, and 
internally consistent to be considered credible, and, consistent with 
his qualifications, he spoke persuasively and with authority on some 
relevant issues within his expertise, and notwithstanding the 
Respondent's objections relative to his Florida-related experience, he 
is currently an assistant professor teaching at a Florida Medical 
School. It may well be that the greatest and most significant aspect of 
Dr. Kennedy's opinion is that on the current record, it stands 
unrefuted. Thus, his opinion is the only expert opinion available for 
reliance in this action.\54\ Dr. Kennedy testified that based on his 
review of the selected patient charts from the Respondent's medical 
practice, in his expert opinion, he ``couldn't find any legitimate 
basis for [the Respondent] prescribing medications to any of the 
[patients] and that the Respondent's prescribing practices ``were not 
in compliance at all from the very first visit on'' with the standards 
set forth by the Florida Medical Board. Id. at 118. Accordingly, Dr. 
Kennedy's expert opinion that the Respondent's controlled substance 
prescribing practices, at least as evidenced through his examination of 
the patient charts he reviewed, fell below the standards applicable in 
Florida, and that the controlled substance prescriptions contained in 
those files were not issued for a legitimate medical purpose is 
unrefuted on this record and (although by no means overwhelming) is 
sufficiently reliable to be accepted and relied upon in this 
recommended decision.
---------------------------------------------------------------------------

    \53\ Tr. at 628.
    \54\ The Respondent did not testify on his own behalf.
---------------------------------------------------------------------------

The Analysis

    Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \55\ may 
revoke a registrant's DEA Certificate of Registration if persuaded that 
the registrant ``has committed such acts that would render * * * 
registration under section 823 * * * inconsistent with the public 
interest * * * .'' The following factors have been provided by Congress 
in determining ``the public interest'':

    \55\ This authority has been delegated pursuant to 28 CFR 
0.100(b) and 0.104.
---------------------------------------------------------------------------

    (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.

21 U.S.C. 823(f).

    ``[T]hese factors are considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of 
factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Deputy Administrator may properly give each 
factor whatever weight she deems appropriate in determining whether an 
application for a registration should be denied. JLB, Inc., d/b/a Boyd 
Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see 
also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70 
FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422 
(1989). Moreover, the Deputy Administrator is ``not required to make 
findings as to all of the factors * * * .'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC 
Cir. 2005). The

[[Page 19428]]

Deputy Administrator is not required to discuss consideration of each 
factor in equal detail, or even every factor in any given level of 
detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (the 
Administrator's obligation to explain the decision rationale may be 
satisfied even if only minimal consideration is given to the relevant 
factors and remand is required only when it is unclear whether the 
relevant factors were considered at all). The balancing of the public 
interest factors ``is not a contest in which score is kept; the Agency 
is not required to mechanically count up the factors and determine how 
many favor the Government and how many favor the registrant. Rather, it 
is an inquiry which focuses on protecting the public interest * * * .'' 
Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
    In an action to revoke a registrant's DEA COR, the DEA has the 
burden of proving that the requirements for revocation are satisfied. 
21 CFR 1301.44(e). Once DEA has made its prima facie case for 
revocation of the registrant's DEA Certificate of Registration, the 
burden of production then shifts to the Respondent to show that, given 
the totality of the facts and circumstances in the record, revoking the 
registrant's registration would not be appropriate. Morall, 412 F.3d at 
174; Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S. 
Dept. of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E. 
Johnston, 45 FR 72, 311 (1980). Further, ``to rebut the Government's 
prima facie case, [the Respondent] is required not only to accept 
responsibility for [the established] misconduct, but also to 
demonstrate what corrective measures [have been] undertaken to prevent 
the reoccurrence of similar acts.'' Jeri Hassman, M.D., 75 FR 8194, 
8236 (2010).
    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Deputy Administrator that he or she can be entrusted with the 
responsibility commensurate with such a registration. Steven M. 
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 
(2007). Normal hardships to the practitioner, and even the surrounding 
community, that are attendant upon the lack of registration are not a 
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D. 
Owens, D.D.S., 74 FR 36751, 36757 (2009).
    The Agency's conclusion that past performance is the best predictor 
of future performance has been sustained on review in the courts, Alra 
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's 
consistent policy of strongly weighing whether a registrant who has 
committed acts inconsistent with the public interest has accepted 
responsibility and demonstrated that he or she will not engage in 
future misconduct. Hoxie, 419 F.3d at 483; George C. Aycock, M.D., 74 
FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 FR 
at 463; Medicine Shoppe, 73 FR at 387.
    While the burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S. 
91, 100-01 (1981), the Deputy Administrator's factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence.'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing 
two inconsistent conclusions from the evidence'' does not limit the 
Deputy Administrator's ability to find facts on either side of the 
contested issues in the case, Shatz, 873 F.2d at 1092; Trawick, 861 
F.2d at 77, all ``important aspect[s] of the problem,'' such as a 
respondent's defense or explanation that runs counter to the 
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v. 
DEA, 509 F.3d 541, 549 (DC Cir. 2007); Humphreys, 96 F.3d at 663. The 
ultimate disposition of the case must be in accordance with the weight 
of the evidence, not simply supported by enough evidence to justify, if 
the trial were to a jury, a refusal to direct a verdict when the 
conclusion sought to be drawn from it is one of fact for the jury. 
Steadman, 450 U.S. at 99 (internal quotation marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in 
application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (DC Cir. 2008) 
(citing Butz v. Glover Livestock Comm. Co., Inc., 411 U.S. 182, 188 
(1973)), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). It is 
well-settled that since the Administrative Law Judge has had the 
opportunity to observe the demeanor and conduct of hearing witnesses, 
the factual findings set forth in this recommended decision are 
entitled to significant deference, Universal Camera Corp. v. NLRB, 340 
U.S. 474, 496 (1951), and that this recommended decision constitutes an 
important part of the record that must be considered in the Deputy 
Administrator's decision, Morall, 412 F.3d at 179. However, any 
recommendations set forth herein regarding the exercise of discretion 
are by no means binding on the Deputy Administrator and do not limit 
the exercise of that discretion. 5 U.S.C. 557(b); River Forest 
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney 
General's Manual on the Administrative Procedure Act 8 (1947).

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, it is undisputed that the Respondent holds a valid 
and current State license to practice medicine. The record contains no 
evidence of a recommendation regarding the Respondent's medical 
privileges by any cognizant State licensing board or professional 
disciplinary authority. However, that a State has not acted against a 
registrant's medical license is not dispositive in this administrative 
determination as to whether continuation of a registration is 
consistent with the public interest. Patrick W. Stodola, M.D., 74 FR 
20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at 461. It is well-
established Agency precedent that a ``state license is a necessary, but 
not a sufficient condition for registration.'' Leslie, 68 FR at 15230; 
John H. Kennedy, M.D., 71 FR 35705, 35708 (2006). Even the 
reinstatement of a State medical license does not affect the DEA's 
independent responsibility to determine whether a registration is in 
the public interest. Mortimer B. Levin, D.O., 55 FR 9209, 8210 (1990). 
The ultimate responsibility to determine whether a registration is 
consistent with the public interest has been delegated exclusively to 
the DEA, not to entities within State government. Edmund Chein, M.D., 
72 FR 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (DC Cir. 
2008), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). Congress 
vested authority to enforce the CSA in the Attorney General and not 
State officials. Stodola, 74 FR at 20375. Thus, on these facts, the 
fact that the record contains no evidence of a recommendation by a 
State licensing board does not weigh for or against a determination as 
to whether continuation of the Respondent's DEA certification is 
consistent with the public interest.
    Similarly, regarding Factor 3, while testimony was received at the 
hearing

[[Page 19429]]

that indicated that a criminal search warrant was executed regarding 
the Respondent and American Pain, the record contains no evidence that 
the Respondent has ever been convicted of any crime or even arrested in 
connection with any open criminal investigation. Thus, consideration of 
the record evidence under the first and third factors does not militate 
in favor of revocation.

Factors 2, 4 and 5: The Respondent's Experience in Dispensing 
Controlled Substances, Compliance With Applicable State, Federal or 
Local Laws Relating to Controlled Substances, and Such Other Conduct 
Which May Threaten the Public Health and Safety

    In this case, the gravamen of the allegations in the OSC, as well 
as the factual concentration of much of the evidence presented, share 
as a principal focus the manner in which the Respondent has managed 
that part of his practice relative to prescribing and dispensing 
controlled substances and acts allegedly committed in connection with 
his practice at American Pain. Thus, it is analytically logical to 
consider public interest factors two, four and five together. That 
being said, factors two, four and five involve analysis of both common 
and distinct considerations.
    Regarding Factor 2, the qualitative manner and the quantitative 
volume in which a registrant has engaged in the dispensing of 
controlled substances, and how long he has been in the business of 
doing so are factors to be evaluated in reaching a determination as to 
whether he should be entrusted with a DEA certificate. In some cases, 
viewing a registrant's actions against a backdrop of how he has 
performed activity within the scope of the certificate can provide a 
contextual lens to assist in a fair adjudication of whether continued 
registration is in the public interest.
    There are two principal considerations embedded within a 
consideration of this public interest factor. In considering a similar 
factor under the List I chemical context, the Agency has recognized 
that the level of experience held by those who will be charged with 
recognizing and taking steps to minimize diversion factors greatly in 
determining whether entrusting a COR will be in the public interest. 
See Volusia Wholesale, 69 FR 69409, 69410 (2004); Xtreme Enters., Inc., 
67 FR 76195, 76197-98 (2004); Prachi Enters., 69 FR 69407, 69409 
(2004); J&S Distribs., 69 FR 62089, 62090 (2004); K.V.M. Enters., 67 FR 
70968, 70969 (2002). The Agency has also recognized that evidence that 
a registrant may have conducted a significant level of sustained 
activity within the scope of the registration for a sustained period is 
a relevant and correct consideration, which must be accorded due 
weight. However, this factor can be outweighed by acts held to be 
inconsistent with the public interest. Experience which occurred prior 
and subsequent to proven allegations of malfeasance may be relevant. 
Evidence that precedes proven misconduct may add support to the 
contention that, even acknowledging the gravity of a particular 
registrant's transgressions, they are sufficiently isolated and/or 
attenuated that adverse action against its registration is not 
compelled by public interest concerns. Likewise, evidence presented by 
the Government that the proven allegations are consistent with a 
consistent past pattern of poor behavior can enhance the Government's 
case.
    In this case, the Respondent introduced no evidence regarding his 
level of knowledge and experience, or even the quality or length of his 
experience as a physician-registrant, but the Government has elected to 
do so.
    Regarding the Government's presentation, Agency precedent has long 
held that in DEA administrative proceedings ``the parameters of the 
hearing are determined by the prehearing statements.'' CBS Wholesale 
Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, D.M.D., 61 
FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 36758, 
36759-60 (2009) (``pleadings in administrative proceedings are not 
judged by the standards applied to an indictment at common law'' and 
``the rules governing DEA hearings do not require the formality of 
amending a show cause order to comply with the evidence''). That being 
said, however, the marked difference between the amount of evidence 
that the Government noticed in its OSC/ISO and the amount that it 
introduced at the hearing is striking. For example, contrary to its 
allegations, there was no evidence that the Respondent ``prescribe[d] 
and dispense[d] inordinate amounts of controlled substances,'' that the 
``majority'' of the Respondent's patients were ``from states other than 
Florida,'' and there was no evidence that American Pain patients were 
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there 
evidence that individuals positioned outside the American Pain building 
were there to ``monitor the activity of patients in the parking lot to 
prevent patients from selling their recently obtained controlled 
substances.'' Likewise, no evidence was introduced at the hearing that 
could support the allegations that ``employees of American Pain [] 
frequently ma[d]e announcements to patients in the clinic advising them 
on how to avoid being stopped by law enforcement upon departing the 
pain clinic'' and ``frequently ma[d]e announcements [] advising 
[patients], among other things, not to attempt to fill their 
prescriptions at out-of State pharmacies and warning them against 
trying to fill their prescriptions at particular local retail 
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
    In like fashion, the Government's prehearing statement proffered 
that SA Burt would testify to several of the items described but not 
established in the OSC/ISO. Among the list of allegations that were not 
supported by any evidence introduced at the hearing, were 
representations that SA Burt would testify concerning the following:

    Law enforcement in Florida and [other states that correspond to 
license plates seen in the American Pain parking lot] frequently 
arrest people for illegal possession and/or illegal distribution of 
controlled substances who have obtained the controlled substances 
from American Pain;
    American Pain hired individuals to ``roam'' the parking lot of 
the clinic to dissuade people from selling their recently obtained 
controlled substances on the property;
    [The reason American Pain placed] signs within American Pain 
warning individuals not to have their prescriptions filled at 
Walgreens pharmacies [is] because Walgreens refuses to dispense the 
prescriptions;
    Walgreens has flagged all American Pain doctors and will not 
fill any of their prescriptions;
    [Physical exams at American Pain are] usually no more than a 
blood pressure check and some bending and stretching;
    Dismissed patients would be routed to other doctors within the 
clinic;
    [There was] co-mingling of [American Pain] physician's drugs;
    [American Pain maintained] no inventories of drugs dispensed;
    [Details surrounding] the death of [American Pain] patient OB 
[where] [t]he cause of death was determined to be drug 
intoxication--opiate and benzodiazepine;
    [Information] from a confidential source [who indicated] that 
she traveled to American Pain in order to obtain controlled 
substances that were later sold in Kentucky for $25 per pill[,] 
[that] [the American Pain physician she encountered] did not spend 
any significant time conducting a physical examination of [her] [,] 
[that she would simply ask questions regarding [her] well being and 
would then ``stamp'' a prescription for [controlled substances][,] * 
* * that on one visit [during a power failure a] security guard 
working for the clinic instructed everyone to be patient and that 
the doctors would be with them shortly to ``get your fix.''

ALJ Ex. 6 at 3-9.

    The Government's Prehearing Statement also represented that it 
would

[[Page 19430]]

be presenting the testimony of Intelligence Analyst (IA) Janet Hines, 
who would relate her encounter with a confidential source who allegedly 
obtained controlled substances from the Respondent with minimal or no 
physical examinations and intentionally diverted them. ALJ Ex. 6. The 
Government never called IA Hines and never offered an explanation for 
the differences between the expansive proffers and the less-expansive 
ultimate presentation.
    To be clear, it is not that the evidence was introduced and 
discredited; no evidence to support these (and other) allegations was 
introduced at all. To the extent the Government had this evidence, it 
left it home. While the stunning disparity between the allegations 
proffered and those that were supported with any evidence does not 
raise due process concerns, it is worthy of noting, without deciding 
the issue, that Agency precedent has acknowledged the Supreme Court's 
recognition of the applicability of the res judicata doctrine in DEA 
administrative proceedings. Christopher Henry Lister, P.A., 75 FR 
28068, 28069 (2010) (citing University of Tennessee v. Elliot, 478 U.S. 
788, 797-98 (1986) (``When an administrative agency is acting in a 
judicial capacity and resolves disputed issues of fact properly before 
it which the parties have had an adequate opportunity to litigate, the 
courts have not hesitated to apply res judicata[.]'')
    The evidence the Government did present raises issues regarding not 
only Factor 2 (experience dispensing \56\ controlled substances), but 
also Factors 4 (compliance with Federal and State law relating to 
controlled substances) and 5 (other conduct which may threaten public 
health and safety). Succinctly put, the Government's evidence related 
to the manner in which the Respondent practiced, and whether his 
practice complied with the law and/or was a threat to the public.
---------------------------------------------------------------------------

    \56\ The statutory definition of the term ``dispense'' includes 
the prescribing and administering of controlled substances. 21 
U.S.C. 802(10).
---------------------------------------------------------------------------

    While true that GS Langston convincingly testified about the course 
of her investigation and laid an adequate foundation for numerous 
database results, the Government provided no foundational context for 
any relevant uses for those database results. Without some insight into 
what types of results from these databases should be expected when 
compared to similarly-situated registrants engaged in acceptable 
prescribing practices, the raw data is without use. In short, there was 
no evidence elicited wherein the percentage of the Respondent's in-
State to out-of State patients could be assessed, and no reasonable 
measuring stick based on sound principles upon which to evaluate such 
data. Likewise, there was no reliable yardstick upon which to measure 
the amount of controlled substances reflected in the databases compared 
to what a reasonable regulator would expect to see regarding a 
compliant registrant. To the extent Langston possessed this information 
(and she well may have) it was not elicited from her. The same could be 
said of the allegation set forth in the Government's Prehearing 
Statement that alleges that from a given period the Respondent ``was 
the 16th largest practitioner purchaser of oxycodone in the United 
States.'' \57\ No evidence to support that allegation (or its 
relevance) was ever brought forth at the hearing. To the extent that 
fact may have been true or relevant, it was never developed. What's 
more, as ably pointed out by Respondent's counsel,\58\ the Florida 
Administrative Code specifically eschews pain medication prescribing 
analysis rooted only in evaluation of medication quantity. Fla. Admin. 
Code r. 64B8-9.013(g).\59\ Lastly, there was no indication that despite 
Langston's obvious qualifications to do so, that she or anyone else 
ever conducted an audit of the controlled-substance-inventory-related 
recordkeeping practices at American Pain.
---------------------------------------------------------------------------

    \57\ ALJ Ex. 6 at 11-12.
    \58\ Respt's Br. at 20.
    \59\ The Respondent's brief incorrectly sites subsection (f).
---------------------------------------------------------------------------

    SA Burt testified that, during a temporally limited period of time, 
he observed some of the images captured by a pole camera positioned 
outside American Pain, and that he observed what in his view was a high 
percentage of vehicles in the parking lot with out-of-State license 
tags. This testimony arguably provides some support for the 
Government's contention that out-of-State patients (or at least 
patients being dropped off by cars with out-of-State tags) were being 
seen at the clinic, but his testimony did not provide much else in 
terms of relevant information. In any event, recent Agency precedent 
holds that details such as ``where [a registrant's] patients were 
coming from,'' without additional factual development, can support a 
``strong suspicion that [a] respondent was not engaged in a legitimate 
medical practice'' but that ``under the substantial evidence test, the 
evidence must `do more than create a suspicion of the existence of the 
fact to be established.''' Alvin Darby, M.D., 75 FR 26993, 26999, n.31 
(2010) (citing NLRB v. Columbian Enameling & Stamping Co., 306 U.S. 
292, 300 (1939).
    Likewise, without additional details or at least some context, 
Burt's testimony that individuals with ``staff'' written on their 
shirts appeared to be directing patients into the clinic reveals 
virtually nothing about the Respondent's prescribing practices. Tr. 
818, 910. Furthermore, that Burt observed an individual on a videotape, 
who he believed to be an American Pain employee, on a single occasion, 
instruct patients not to ``snort [their] pills'' in the parking 
lot,\60\ or advising them to comply with vehicle and traffic laws,\61\ 
does not shed illumination on the Respondent's prescribing practices. 
There was no evidence that the Respondent knew that these isolated 
incidents occurred, nor was there contextual evidence from which the 
relevance to these proceedings could be gleaned. Even if this tribunal 
was inclined to engage in the unsupported assignment of motives to the 
actions of these employees, under these circumstances, such an exercise 
could not constitute substantial evidence that could be sustained at 
any level of appeal.
---------------------------------------------------------------------------

    \60\ Tr. at 825.
    \61\ Tr. at 826.
---------------------------------------------------------------------------

    Burt's testimony regarding his conversations with Dr. Sollie, who 
was formerly employed by American Pain, were also not received in a 
manner that could meaningfully assist in the decision process. 
According to Burt, Sollie told him that some (unnamed) physicians at 
American Pain were inadequately documenting their patient charts in 
some manner that was apparently never explained to Burt,\62\ and that 
some patients were intentionally evading the American Pain urinalysis 
process. Sollie did not work at American Pain at the same time the 
Respondent did, and did not specifically name any physician as being 
connected with his allegations of misconduct. Thus, this tribunal is at 
something of a loss as to how the information, as presented, would tend 
to establish a fact relevant to whether the continuation of the 
Respondent's authorization to handle controlled substances is in the 
public interest.
---------------------------------------------------------------------------

    \62\ Tr. at 898.
---------------------------------------------------------------------------

    The Government's evidence targeted not only the Respondent's 
experience practicing under Factor 2, but also his compliance with 
applicable State and Federal laws relating to controlled substances 
under Factor 4. To effectuate the dual goals of conquering drug abuse 
and controlling both legitimate and

[[Page 19431]]

illegitimate traffic in controlled substances, ``Congress devised a 
closed regulatory system making it unlawful to manufacture, distribute, 
dispense, or possess any controlled substance except in a manner 
authorized by the CSA.'' Gonzales v. Raich, 545 U.S. 1, 13 (2005). 
Consistent with the maintenance of that closed regulatory system, 
subject to limited exceptions not relevant here, a controlled substance 
may only be dispensed upon a prescription issued by a practitioner, and 
such a prescription is unlawful unless it is ``issued for a legitimate 
medical purpose by an individual practitioner acting in the usual 
course of his professional practice.'' 21 U.S.C. 829; 21 CFR 
1306.04(a). Furthermore, ``an order purporting to be a prescription 
issued not in the usual course of professional treatment * * * is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and the 
person knowingly * * * issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' Id.
    A registered practitioner is authorized to dispense,\63\ which the 
CSA defines as ``to deliver a controlled substance to an ultimate user 
\64\ * * * by, or pursuant to the lawful order of a practitioner.'' 21 
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 
(2007). The prescription requirement is designed to ensure that 
controlled substances are used under the supervision of a doctor, as a 
bulwark against the risk of addiction and recreational abuse. Aycock, 
74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006); 
United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that 
evidence established that a physician exceeded the bounds of 
professional practice when he gave inadequate examinations or none at 
all, ignored the results of the tests he did make, and took no 
precautions against misuse and diversion)). The prescription 
requirement likewise stands as a proscription against doctors 
``peddling to patients who crave the drugs for those prohibited uses.'' 
Id. The courts have sustained criminal convictions based on the issuing 
of illegitimate prescriptions where physicians conducted no physical 
examinations or sham physical examinations. United States v. Alerre, 
430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 1113 
(2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986).
---------------------------------------------------------------------------

    \63\ 21 U.S.C. 823(f).
    \64\ ``Ultimate user'' is defined as ``a person who has lawfully 
obtained, and who possesses, a controlled substance for his own use 
or for the use of a member of his household or for an animal owned 
by him or by a member of his household.'' 21 U.S.C. 802(27).
---------------------------------------------------------------------------

    While true that the CSA authorizes the ``regulat[ion] of medical 
practice so far as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and 
trafficking as conventionally understood,'' Gonzales, 546 U.S. at 266-
67, an evaluation of cognizant State standards is essential. Joseph 
Gaudio, M.D., 74 FR 10083, 10090 (2009); Kamir Garces-Mejias, M.D., 72 
FR 54931, 54935 (2007); United Prescription Servs., Inc., 72 FR 50397, 
50407 (2007). In this adjudication, the evaluation of the Respondent's 
prescribing practices must be consistent with the CSA's recognition of 
State regulation of the medical profession and its bar on physicians 
from peddling to patients who crave drugs for prohibited uses. The 
analysis must be ``tethered securely'' to State law and Federal 
regulations in application of the public interest factors, and may not 
be based on a mere disagreement between experts as to the most 
efficacious way to prescribe controlled substances to treat chronic 
pain sufferers. Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009) 
(citing Gonzales, 546 U.S. at 272, 274).
    Under the CSA, it is fundamental that a practitioner must establish 
a bonafide doctor-patient relationship in order to act ``in the usual 
course of * * * professional practice'' and to issue a prescription for 
a legitimate medical purpose.'' Stodola, 74 FR at 20731; Shyngle, 74 FR 
at 6057-58 (citing Moore, 423 U.S. at 141-43). The CSA looks to State 
law to determine whether a bonafide doctor-patient relationship 
existed. Stodola, 74 FR at 20731; Shyngle, 74 FR at 6058; Garces-
Mejias, 72 FR at 54935; United Prescription Servs., 72 FR at 50407. It 
was Dr. Kennedy's uncontroverted opinion that his evaluation of chart 
entries convinced him that they were so defective that the Respondent 
did not establish a sufficient doctor-patient relationship to justify 
the prescribing of controlled substances, and that ``this was not the 
practice of medicine in [his] opinion.'' Tr. at 160-61.
    Under Florida law, grounds for disciplinary action or denial of 
State licensure include ``prescribing * * * any controlled substance, 
other than in the course of the physician's professional practice,'' 
and prescribing such substances ``inappropriately or in excessive or 
inappropriate quantities is not in the best interest of the patient and 
is not in the course of the physician's professional practice, without 
regard to his or her intent.'' Fla. Stat. Sec.  458.331(q) (2009). 
Florida law further provides that grounds for such disciplinary action 
also include:

    Failing to keep legible, as defined by department rule in 
consultation with the board, medical records that identify the 
licensed physician * * * and that justify the course of treatment of 
the patient, including, but not limited to, patient histories; 
examination results; test results; records of drugs prescribed, 
dispensed, or administered; and reports of consultations and 
hospitalizations.

Id. Sec.  458.331(m).

    In exercising its rulemaking function,\65\ the Florida Board of 
Medicine (Florida Board) promulgated a regulation addressing 
``Standards for Adequacy of Medical Records'' applicable to all 
physicians. Fla. Admin. Code r. 64B8-9.003 (2009). That regulation 
provides, in pertinent part:
---------------------------------------------------------------------------

    \65\ Rulemaking authority regarding the practice of medicine 
within the State of Florida has been delegated to the Florida Board 
of Medicine (Florida Board). Fla. Stat. Sec.  458.309(1) (2009).

    (2) A licensed physician shall maintain patient medical records 
in English, in a legible manner and with sufficient detail to 
clearly demonstrate why the course of treatment was undertaken.
    (3) The medical record shall contain sufficient information to 
identify the patient, support the diagnosis, justify the treatment 
and document the course and results of treatment accurately, by 
including, at a minimum, patient histories; examination results; 
test results; records of drugs prescribed, dispensed or 
administered; reports of consultations and hospitalizations; and 
copies of records or reports or other documentation obtained from 
other health care practitioners at the request of the physician and 
relied upon by the physician in determining the appropriate 
treatment of the patient.
    (4) All entries made into the medical records shall be 
accurately dated and timed. Late entries are permitted, but must be 
clearly and accurately noted as late entries and dated and timed 
accurately when they are entered in to the record * * * .

Fla. Admin. Code r. 64B8-9.003 (2009).

    With respect to defining the parameters of what constitutes 
``professional practice'' in the context of pain management 
prescribing, Florida State law provides:

    Notwithstanding any other provision of law, a physician may 
prescribe or administer any controlled substance under Schedules II-
V * * * to a person for the treatment of intractable pain,\66\ 
provided the physician does so in accordance with that level of 
care, skill, and treatment recognized by a

[[Page 19432]]

reasonably prudent physician under similar conditions and 
circumstances.
---------------------------------------------------------------------------

    \66\ Florida defines ``intractable pain'' to mean ``pain for 
which, in the generally accepted course of medical practice, the 
cause cannot be removed and otherwise treated.'' Fla. Stat. Sec.  
458.326 (2009).

Fla. Stat. Sec.  458.326 (2009). Moreover, the Florida Board has 
adopted,\67\ albeit in modified version, the Model Policy for the Use 
of Controlled Substances for the Treatment of Pain (Model Policy), a 
document drafted by the Federation of State Medical Boards (FSMB) to 
provide professional guidelines for the treatment of pain with 
controlled substances. The standards adopted by Florida share the key 
tenants of the Model Policy's standards for pain management 
prescribing, including the emphasis on diligent efforts by physicians 
to prevent drug diversion, prescribing based on clear documentation of 
unrelieved pain and thorough medical records, and compliance with 
applicable Federal and State law.
---------------------------------------------------------------------------

    \67\ Pursuant to authority vested in the Florida Board by the 
Florida legislature to promulgate rules regarding State standards 
for pain management clinical practice specifically. Fla. Stat. Sec.  
458.309(5) (2009).
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    Like the Model Policy, which was promulgated ``to encourage the 
legitimate medical uses of controlled substances for the treatment of 
pain while stressing the need to safeguard against abuse and 
diversion,'' Florida's regulation providing ``Standards for the Use of 
Controlled Substances for Treatment of Pain,'' Fla. Admin. Code r. 
64B8-9.013 (2009) (Florida Standards), recognizes that ``inappropriate 
prescribing of controlled substances * * * may lead to drug diversion 
and abuse by individuals who seek them for other than legitimate 
medical use.'' The language employed by the regulation under the 
preamble section titled ``Pain Management Principles'' makes clear that 
the standards ``are not intended to define complete or best practice, 
but rather to communicate what the [Florida Board] considers to be 
within the boundaries of professional practice'' (emphasis supplied), 
id. at 9.013(1)(g); thus, the plain text supports an inference that the 
standards provide the minimum requirements for establishing conduct 
that comports with the professional practice of controlled substance-
based pain management within the State. Likewise, the level of integral 
range of acceptable practice that is built into the regulation 
underscores the importance of seeking an expert professional opinion in 
reaching a correct adjudication of whether a registrant has met the 
applicable Florida standard. It is clear that in assessing whether the 
controlled substance prescribing practices of a Florida practitioner 
fall within the acceptable range of what constitutes being within the 
bounds of being ``issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice,'' \68\ resort must be had to an expert.
---------------------------------------------------------------------------

    \68\ 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    The Florida Standards direct that ``[p]hysicians should be diligent 
in preventing the diversion of drugs for illegitimate purposes,'' id. 
at 9.013(1)(d), and provide that the prescribing of controlled 
substances for pain will be considered

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. All such prescribing must be based on clear 
documentation of unrelieved pain and in compliance with applicable 
state or Federal law.

Id. at 9.013(1)(e) (emphasis supplied).
    The Florida Standards further provide that the validity of 
prescribing will be judged ``based on the physician's treatment of the 
patient and on available documentation, rather than on the quantity and 
chronicity of prescribing'' (emphasis supplied). Id. at 9.013(1)(g). 
Furthermore, the Standards advise that physicians should not fear 
disciplinary action for ``prescribing controlled substances * * * for a 
legitimate medical purpose and that is supported by appropriate 
documentation establishing a valid medical need and treatment plan'' 
(emphasis supplied), or ``for failing to adhere strictly to the 
provisions of these standards, if good cause is shown for such 
deviation'' (emphasis supplied). Id. at 9.013(1)(b),(f).
    Although, as discussed above, the Florida Board instituted general 
guidance applicable to all physicians regarding medical records, it 
also promulgated a separate set of documentation requirements in the 
Florida Standards applicable specifically to those physicians who 
prescribe controlled substances in the pain-management context. The 
Florida Standards, under the subheading ``Medical Records,'' state that 
``[t]he physician is required to keep accurate and complete records'' 
(emphasis supplied) including, though not limited to:

    1. The medical history and physical examination, including 
history of drug abuse or dependence, as appropriate;
    2. Diagnostic, therapeutic, and laboratory results;
    3. Evaluations and consultations;
    4. Treatment objectives;
    5. Discussion of risks and benefits;
    6. Treatments;
    7. Medications (including date, type, dosage, and quantity 
prescribed);
    8. Instructions and agreements; and
    9. Periodic reviews.

    Id. at 9.013(3)(f). The same section directs that ``[r]ecords must 
remain current and be maintained in an acceptable manner and readily 
available for review. Id.
    The Florida Standards similarly emphasize the need for proper 
documentation in the patient evaluation context by specifying:

    A complete \69\ 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 also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.
---------------------------------------------------------------------------

    \69\ The original Model Policy version of the guidelines does 
not contain a reference to the need for a complete medical history, 
instead only requiring a medical history generally. Thus, the 
Florida Board has adopted a higher standard than the measure that 
has been set in the Model Policy by the FSMB.

Id. at 9.013(3)(a).
    Furthermore, the Florida Standards require a written treatment plan 
that ``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.'' Id. at 9.013(3)(b). Subsequent to the 
initiation of treatment, ``the physician should adjust drug therapy to 
the individual medical needs of each patient. Other treatment 
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.'' (emphasis supplied). Id.
    Another standard adopted by the Florida Board, under the subheading 
``Informed Consent and Agreement for Treatment,'' is the directive that

[t]he physician should discuss the risks and benefits of the use of 
controlled substances with the patient, persons designated by the 
patient, or with the patient's surrogate or guardian if the patient 
is incompetent. The patient should receive prescriptions from one 
physician and one pharmacy where possible. If the patient is 
determined to be at high risk for medication abuse or have a history 
of substance abuse, the physician should employ the use of a written 
agreement between the physician and patient outlining patient 
responsibilities, including, but not limited to:
    1. Urine/serum medication levels screening when requested;

[[Page 19433]]

    2. Number and frequency of all prescription refills; and
    3. Reasons for which drug therapy may be discontinued (i.e., 
violation of agreement.)

Id. at 9.003(3)(c).
    The Florida Standards contain a further requirement to periodically 
review ``the course of pain treatment and any new information about the 
etiology of the pain or the patient's state of health.'' Id. at 
9.013(3)(d). The Florida Standards explain the importance of periodic 
review in the following manner:

    Continuation or modification of therapy depends on the 
physician's evaluation of the patient's progress. If treatment goals 
are not being achieved, despite medication adjustments, the 
physician should reevaluate the appropriateness of continued 
treatment. The physician should monitor patient compliance in 
medication usage and related treatment plans.

Id.
    Under the subheading ``Consultation,'' the Florida Board 
promulgated the instruction that

[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 
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.

Id. at 9.003(3)(e).
    It is abundantly clear from the plain language of the Florida 
Standards that the Florida Board places critical emphasis on physician 
implementation of adequate safeguards in their practice to minimize 
diversion and the need to document the objective signs and rationale 
employed in the course of pain treatment utilizing the prescription of 
controlled substances. Conscientious documentation is repeatedly 
emphasized as not just a ministerial act, but a key treatment tool and 
a vital indicator to evaluate whether the physician's prescribing 
practices are ``within the usual course of professional practice.'' 
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert 
witness to testify at these proceedings, reflects that the 
documentation he reviewed in the Respondent's patient charts reflected 
care that was markedly below the standard of care set by the Florida 
Medical Board. Dr. Kennedy's expert assessment was consistent with the 
State statutory and regulatory guidance. In Kennedy's view, the 
Respondent's charts demonstrated minimalistic, incomplete, and 
otherwise medically inadequate documentation of his contacts with 
patients and the prescribing rationale for his issuance of controlled 
substance prescriptions to those patients for alleged pain management 
purposes. The boilerplate-style, ``one high-dosage controlled 
substances treatment plan fits all'' nature of nearly all of the 
patient medical records at issue, at least in the view of the 
uncontroverted expert, evidences a failure on the part of the 
Respondent to conduct his practice of medicine in a manner to minimize 
the potential of controlled substance abuse and diversion, and supports 
a conclusion that he failed to even substantially comply with the 
minimum obligations for professional practice imposed under the Florida 
Standards--and without ``good cause [] shown for such deviation.'' Id. 
at 9.013(1)(f).
    In his Argument, Proposed Findings of Fact and Proposed Conclusions 
of Law (Respondent's Brief), the Respondent's counsel has prepared and 
submitted a thoughtful and detailed analysis of the counsel's 
application of the relevant standards in Florida to the charts analyzed 
by Dr. Kennedy. Respt's Br. at 3-17. Unfortunately, counsel's analysis 
is the product of a lay evaluation of standards applicable to the 
nuanced and sophisticated science that is the practice of medicine. 
Where his opinion and that of the only accepted medical expert to 
provide an expert opinion conflict, his opinion cannot and will not be 
afforded controlling deference. Argument supplied by counsel (albeit a 
diligent and persuasive counsel) that the relevant standards were 
satisfactorily applied as evidenced by the protocols and procedures 
documented in the patient charts cannot supplant the unrefuted view of 
an accepted expert witness.
    The Respondent, who was in a unique position to conclusively refute 
Dr. Kennedy's views and explain the format and nuances of the reviewed 
documentation, elected not to testify in this matter. At a DEA 
administrative hearing, it is permissible to draw an adverse inference 
from the silence of the Respondent, even in the face of a Fifth 
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) 
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence 
gains more probative weight where it persists in the face of 
accusation, since it is assumed in such circumstances that the accused 
would be more likely than not to dispute an untrue accusation.'')); 
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio 
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts 
of this case, where the allegations are of a nature that a registrant 
would be more likely than not to dispute them if untrue, an adverse 
inference based on the Respondent's silence is appropriate. Where, as 
here, the Government, through its expert, has alleged that the 
Respondent's charts do not reflect genuine analysis, but rather (at 
least in its view and the opinion of its expert), a sort of sham-by-
check-box form designed specifically to present a false impression of a 
compliant registrant, it is precisely the type of allegation that would 
naturally all but oblige a registrant to spring to offer a 
contradictory account. The Respondent's choice to remain silent in the 
face of such allegations, where he could have related his version of 
his practice as a registrant, adds at least some additional credence to 
the factual and analytical views of the Government's expert in this 
regard.
    In the Social Security context, where an Administrative Law Judge 
has received expert medical opinions on the issue of the claimant's 
ability to work and they are not repudiated in any respect by 
substantial evidence, an adverse decision should be set aside as based 
on ``suspicion and speculation.'' Miracle v. Celebrezze, 351 F.2d 361, 
378 (6th Cir. 1965); see also Hall v. Celebrezze, 314 F.2d 686, 689-90 
(6th Cir. 1963); cf. Harris v. Heckler, 756 F.2d 431, 436 (6th Cir. 
1985) (improper to reject uncontroverted evidence supporting complaints 
of pain simply because of claimant's demeanor at hearing). When an 
administrative tribunal elects to disregard the uncontradicted opinion 
of an expert, it runs the risk of improperly declaring itself as an 
interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554 (6th 
Cir. 1966). While in this case it is ironically true, much like in the 
Social Security context, that the opinion of a treating physician 
should be afforded greater weight than the opinion of an expert whose 
opinion is limited to a review of the patient file, see Magallenes v. 
Bowen, 881 F.2d 747, 751 (9th Cir. 1989), the treating-source 
Respondent in this case offered no evidence, not even his own opinion, 
regarding the treatment rendered. Thus, in this adjudication, the 
record contains no dispute between experts to be resolved; instead, 
there is but one, unrefuted, uncontroverted, credible expert opinion. 
To ignore that expert opinion on this record and replace it with the 
opinion of this tribunal,

[[Page 19434]]

Respondent's counsel, or any other lay source would be a dangerous 
course and more importantly, a plainly erroneous one.
    Accordingly, after carefully balancing the admitted evidence, the 
evidence establishes, by a preponderance of the evidence, that the 
prescriptions the Respondent issued in Florida were not issued within 
``the usual course of [the Respondent's] professional practice.'' 21 
CFR 1306.04(a). Consideration of the evidence under the second and 
fourth factors support the COR revocation sought by the Government in 
this case.
    To the extent that the Respondent's prescribing practices fell 
below the requisite standard in Florida, that conduct also impacts upon 
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is 
authorized to consider ``other conduct which may threaten the public 
health and safety.'' 21 U.S.C. 823(f)(5). Although this factor 
authorizes consideration of a somewhat broader range of conduct 
reaching beyond those activities typically associated with a 
registrant's practice, an adverse finding under this factor requires 
some showing that the relevant conduct actually constituted a threat to 
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
    The evidence establishes that the Respondent engaged in a course of 
practice wherein he prescribed unsafely high doses of controlled 
substances to patients irrespective of the patients' need for such 
medication and ignoring any and red flags that could or did indicate 
likely paths of diversion. The testimony of Dr. Kennedy, the DEA 
regulations, and the Florida Standards make clear that physicians 
prescribing controlled substances do so under an obligation to monitor 
the process to minimize the risk of diversion. The patient charts 
reflect that the Respondent, contrary to his obligations as a DEA 
registrant, did not follow up in the face of multiple red flags. The 
Respondent's disregard of his obligations as a DEA registrant and 
Federal and State laws related to controlled substances militate in 
favor of revocation.
    By routinely prescribing unsafely high doses of controlled 
substances to opioid-na[iuml]ve patients and ignoring his 
responsibilities to monitor the controlled substance prescriptions he 
was authorizing to minimize diversion, and by participating in an 
insufficiently documented and thoughtful process for the issuance of 
potentially dangerous controlled substances, the Respondent created a 
significant potential conduit for the unchecked diversion of controlled 
substances. See Holloway Distrib., 72 FR at 42124 (a policy of ``see no 
evil, hear no evil'' is fundamentally inconsistent with the obligations 
of a DEA registrant). Agency precedent has long recognized that 
``[l]egally, there is absolutely no difference between the sale of an 
illicit drug on the street and the illicit dispensing of a licit drug 
by means of a physician's prescription.'' EZRX, LLC, 69 FR 63178, 63181 
(1988); Floyd A. Santner, M.D., 55 FR 37581 (1988).
    Agency precedent has consistently held that where, as here, the 
Government has met its burden to establish a prima facie case that a 
registrant has committed acts demonstrating that continued registration 
is inconsistent with the public interest, acceptance of responsibility 
is a condition precedent to continued registration. Jeri Hassman, M.D., 
75 FR 8194, 8236 (2010); Medicine Shoppe, 73 FR at 387. The record 
contains no evidence that the Respondent has either acknowledged or 
accepted responsibility for the misconduct at issue in these 
proceedings.

Recommendation

    Based on the foregoing, the evidence supports a finding that the 
Government has established that the Respondent has committed acts that 
are inconsistent with the public interest. A balancing of the statutory 
public interest factors supports the revocation of the Respondent's 
Certificate of Registration and a denial of his application to renew. 
The Respondent has not accepted responsibility for his actions, 
expressed remorse for his conduct at any level, or presented evidence 
that could reasonably support a finding that the Deputy Administrator 
should continue to entrust him with a Certificate of Registration.
    Accordingly, the Respondent's Certificate of Registration should be 
revoked and any pending applications for renewal should be denied.

    Dated: August 10, 2010.

John J. Mulrooney, II,
U.S. Administrative Law Judge.
[FR Doc. 2011-8348 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P