[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19401-19419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8344]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-35]


Beau Boshers, M.D.; Decision and Order

    On August 10, 2010, Administrative Law Judge (ALJ) John J. 
Mulrooney, II, issued the attached recommended decision.\1\ Thereafter, 
Respondent filed 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 had been reformatted.
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    Having reviewed the record in its entirety including Respondent's 
exceptions, I have decided to adopt, except as explained below, the 
ALJ's

[[Page 19402]]

rulings, findings of fact, conclusions of law, and recommended Order.
    Respondent raises two exceptions to the ALJ's recommended decision. 
First, he argues that ``he was denied the ability to present his 
positive experience in dispensing controlled substances.'' Resp. Exc. 
at 1. More specifically, he argues that he was denied ``access to files 
seized'' by the Government which show that he discharged patients, and 
that ``[w]ithout access to those files,'' he was left ``with his hands 
tied behind his back and [was] unable to demonstrate his successful 
treatment of patients with controlled substances.'' Id. at 1-2. 
Respondent contends that this ``effectively crippl[ed] his ability to 
present any evidence of his positive, or successful, experience in 
dispensing and treating patients with controlled substances.'' Id. at 
1.
    As support for his contention that he is entitled to present 
evidence of his ``positive experience,'' Respondent cites the Agency's 
decision on remand in Jayam Krishna-Iyer, 74 FR 459 (2009). That 
decision addressed an unpublished decision of the United States Court 
of Appeals for the Eleventh Circuit, which vacated the Agency's Order 
revoking a practitioner's registration on the ground that it failed to 
consider the practitioner's ``experience with twelve patients whose 
medical charts were seized by the DEA, or with thousands of other 
patients. In short, the DEA did not consider any of the Petitioner's 
positive experience in dispensing controlled substances.'' Id. (quoting 
Krishna-Iyer v. DEA, 249 Fed. Appx. 159, 160 (11th Cir. 2007)).
    While this Agency complied with the Eleventh Circuit's order, 
unpublished decisions are ``not precedential.'' United States v. Shaw, 
560 F.3d 1230, 1241 (11th Cir. 2009). Moreover, as I noted in Krishna-
Iyer, ``[t]he Court of Appeals did not cite to any decision of either 
this Agency or another court defining the term `positive experience.' 
Nor did the Court offer any guidance as to the meaning of this term, 
which is not to be found in the'' Controlled Substances Act. 74 FR at 
460.
    I thus assumed--even though there was no evidence (except for 
twelve patient files) in the record regarding the legitimacy of the 
practitioner's prescribing of controlled substances to the ``thousands 
of other patients'' she had treated--that her prescribings to these 
patients constituted ``positive experience.'' Id. at 460-61. However, 
the practitioner's ``prescribings to thousands of other patients [did] 
not * * * render her prescribings to the undercover officers any less 
unlawful, or any less acts which `are inconsistent with the public 
interest.''' Id. at 463 (quoting 21 U.S.C. 823(f)).\2\
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    \2\ As I also explained in Krishna-Iyer, while Congress directed 
the Agency to consider all of the section 823(f) factors, I am 
entitled to give each factor the weight I deem appropriate and the 
courts of appeals have recognized that findings under a single 
factor are sufficient to support the revocation of a registration. 
74 FR at 462 (citing Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 
2005); Morall v. DEA, 412 F.3d 165, 173-174 (DC Cir. 2005). As I 
further explained, ``this is not a contest in which score is kept; 
the Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct.'' Id. at 462.
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    As Krishna-Iyer explained, because the CSA limits registration as a 
practitioner ``to those who have authority to dispense controlled 
substances in the course of professional practice, and patients with 
legitimate medical conditions routinely seek treatment from licensed 
medical professionals, every registrant can undoubtedly point to an 
extensive body of legitimate prescribing over the course of her 
professional career.'' Id.; see also 21 U.S.C. 823(f) (registration 
limited to a practitioner ``authorized to dispense * * * controlled 
substances under the laws of the State in which he practices''). I 
further noted that ``in past cases, [DEA] has given no more than 
nominal weight to a practitioner's evidence that he has dispensed 
controlled substances to thousands of patients in circumstances which 
did not involve diversion.'' Id. (quoting Paul J. Caragine, Jr., 63 FR 
51592, 51599 (1998) (``[T]he Government does not dispute that during 
Respondent's 20 years in practice he has seen over 15,000 patients. At 
issue in this proceeding is Respondent's controlled substance 
prescribing to 18 patients.''); id. at 51600 (``[E]ven though the 
patients at issue are only a small portion of Respondent's patient 
population, his prescribing of controlled substances to these 
individuals raises serious concerns regarding [his] ability to 
responsibly handle controlled substances in the future.''); Medicine 
Shoppe-Jonesborough, 73 FR 364, 386 & n.56 (2008) (noting that pharmacy 
``had 17,000 patients,'' but that ``[n]o amount of legitimate 
dispensings can render * * * flagrant violations [acts which are] 
`consistent with the public interest.'''), aff'd, Medicine Shoppe-
Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008)).
    DEA has thus revoked a practitioner's registration based on a 
single act of presenting two fraudulent prescriptions to a pharmacy for 
filling; see Alan H. Olefsky, 57 FR 928, 928-29 (1992), and DEA can 
revoke based on a single act of diversion. Dewey C. MacKay, 75 FR 
49956, 49977 (2010). See also Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d 
Cir. 1974) (upholding revocation of practitioner's registration based 
on nolo contendre plea to three counts of unlawful distribution). 
Undoubtedly, each of these practitioners could have pointed to evidence 
of having treated a large number of patients in circumstances in which 
he did not divert controlled substances to drug abusers or drug 
dealers.
    Consistent with these precedents, I held in Krishna-Iyer that 
``evidence that a practitioner has treated thousands of patients in 
circumstances which do not constitute diversion,'' and has even refused 
to prescribe to certain patients,\3\ ``does not negate a prima facie 
showing that the practitioner has committed acts inconsistent with the 
public interest.'' \4\

[[Page 19403]]

74 FR at 463. I further held that while such evidence may be entitled 
to some weight in assessing ``whether a practitioner has credibly shown 
that she has reformed her practices, where a practitioner commits 
intentional acts of diversion and insists she did nothing wrong, such 
evidence is entitled to no weight.'' Id.
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    \3\ In Krishna-Iyer, I noted that the practitioner had 
discharged several patients. 74 FR at 462. However, I held that this 
evidence was not probative of the practitioner's intent in 
prescribing to the other patients who were focus of the proceeding. 
Id. & n.6.
    \4\ I do not adopt the ALJ's discussion of the standards applied 
by the Agency in assessing a practitioner's experience in dispensing 
controlled substances, which cites primarily to cases involving list 
chemical I distributors, a different category of registrant. See ALJ 
Dec. at 25-26. As one example as to why, DEA routinely issues 
registrations to newly-licensed practitioners even though they 
cannot point to any experience in dispensing controlled substances 
(provided they have not previously violated controlled substance 
laws.). Conversely, DEA has never held that a practitioner's lengthy 
experience in dispensing controlled substances without diverting 
precludes a finding (where supported by substantial evidence showing 
that he did divert) that a practitioner has committed acts which 
render his registration ``inconsistent with the public interest.'' 
21 U.S.C. 824(a)(4).
    In any event, as discussed above, Respondent offered no evidence 
on the issue of his experience in dispensing controlled substances 
and the ALJ's ultimate conclusion that Respondent violated the CSA's 
prescription requirement because he dispensed controlled substance 
prescriptions that were not ``within'' `usual course of [his] 
professional practice,'' ALJ at 41 (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 actuallys constituted a threat to 
public safety.'' ALJ at 41 (emphasis added and citation omitted.) 
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'' is clearly support by substantial evidence and warrants 
an adverse finding under factor five. ALJ at 42.
    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 37 (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 is necessarily dependent 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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    Respondent's exception is neither factually nor legally well taken. 
Contrary to his assertion that his hands were ``tie[d] behind his 
back'' and that he was ``effectively cripple[ed]'' from ``present[ing] 
any evidence of'' what he terms ``his positive * * * experience,'' \5\ 
Respondent could have testified about his dispensing practices and 
addressed those instances in which he refused to prescribe controlled 
substances; his decision to not put on evidence on this issue was not a 
matter ``of impossibility,'' but of ``choice.'' Resp. Exc. at 1.
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    \5\ Nor is it clear what Respondent means by ``positive 
experience.'' Resp. Exc. at 1. While at various points Respondent 
refers to files which he asserts show that he discharged patients, 
he then maintains that his lack of access to the files prevent him 
from presenting ``any evidence of his positive, or successful, 
experience in dispensing and treating patients with controlled 
substances.'' Id. (emphasis added). He likewise contends that he was 
``unable to demonstrate his successful treatment of patients with 
controlled substances.'' Id. at 2 (emphasis added). However, it is 
not DEA's role to assess whether a practitioner has successfully 
treated patients, but rather, to determine whether a practitioner is 
either diverting drugs or engaging in practices (whether intentional 
or not) that create a substantial risk of diversion. See Caragine, 
63 FR at 51601 (``Careless or negligent handling of controlled 
substances creates the opportunity for diversion and [can] justify 
revocation [or a registration] or denial'' of an application).
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    Most significantly, Respondent could have testified regarding his 
prescribing practices with respect to the patients whose files were 
reviewed by the Government's Expert and which formed the basis for the 
latter's (and the ALJ's) conclusion that Respondent acted outside of 
the usual course of professional practice and lacked a legitimate 
medical purpose in prescribing controlled substances to them. See ALJ 
Dec. at 41 (citing 21 CFR 1306.04(a)). Alternatively, he could have 
retained his own expert to review the files and called the expert to 
testify. Notably, Respondent makes no claim that the files, which were 
reviewed by the Government's Expert, were not timely provided to 
him.\6\
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    \6\ Indeed, it appears that the patient files (which the expert 
reviewed) were provided to Respondent nearly two months before the 
hearing.
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    Respondent also takes exception to the ALJ's finding that he was 
not prejudiced by the Government's failure to turn over ``the 
discharged patient files,'' as well as evidence pertaining to a second 
undercover officer to whom he refused to prescribe. Resp. Exc. at 2. 
Respondent asserts that his right to Due Process was violated because 
this evidence ``could have exonerated'' him, ``or at the very least, 
given him an opportunity to meaningfully defend against the 
Government's allegations,'' and that prejudice ``must [be] assume[d] * 
* * because neither he nor the Court were ever given access to it.'' 
Id.
    As an initial matter, while there is evidence that Respondent 
refused to prescribe to a second undercover officer, there is no 
evidence establishing that there were, in fact, ``discharged patient 
files.'' Respondent neither testified, nor offered any other evidence 
such as an affidavit establishing, that such files exist. Most 
significantly, in his Exceptions, Respondent does not cite any 
authority for the proposition that the Agency is required to provide 
broad discovery in a proceeding under sections 303 and 304 of the CSA. 
See generally Resp. Exc. Indeed, Respondent's contention far exceeds 
what the Supreme Court has held that an agency must do to comply with 
the Due Process Clause. See, e.g., Goldberg v. Kelly, 397 U.S. 254, 270 
(1970).
    In Goldberg, the Supreme Court held that `` `where governmental 
action seriously injures an individual, and the reasonableness of the 
action depends on fact findings, the evidence used to prove the 
Government's case must be disclosed to the individual so that he has an 
opportunity to show that it is untrue.' '' 397 U.S. at 270 (quoting 
Greene v. McElroy, 360 U.S. 474, 496 (1959) (emphasis added)). The 
Court has further explained that ``[a] party is entitled * * * to know 
the issues on which [the] decision will turn and to be apprised of the 
factual material on which the agency relies for decision so that he may 
rebut it. Indeed, the Due Process Clause forbids an agency to use 
evidence in a way that forecloses an opportunity to offer a contrary 
presentation.'' Bowman Transp., Inc., v. Arkansas-Best Freight System, 
Inc., 419 U.S. 281, 288 n.4 (1974).
    It is well settled, however, that neither the Due Process Clause, 
nor the Administrative Procedure Act (nor DEA's rules of procedure) 
require the Agency to provide a general right of discovery in 
administrative proceedings. See Echostar Comm. Corp. v. FCC, 292 F.3d 
749, 756 (DC Cir. 2002); Mister Discount Stockbrokers, Inc., v. SEC, 
768 F.2d 875, 878 (7th Cir. 1985); Nicholas A. Sychak, d/b/a/Medicap 
Pharmacy, 65 FR 75959, 75961 (2000). While ``discovery must be granted 
if in the particular situation a refusal to do so would so prejudice a 
party as to deny him due process,'' McClelland v. Andrus, 606 F.2d 
1278, 1285-86 (DC Cir. 1979), the party seeking discovery must rely on 
more than speculation and must show that the evidence is relevant, 
material, and that the denial of access to the documents is 
prejudicial. See Echostar, 292 F.3d at 756; Silverman v. CFTC, 549 F.2d 
28, 34 (7th Cir. 1977).
    In this case, the ALJ based his conclusion that Respondent issued 
numerous prescriptions outside of the usual course of professional 
practice in violation of both Federal and State laws and thus had 
committed acts which render his registration inconsistent with the 
public interest, see ALJ Dec. at 39-42, on the Expert's testimony and 
report regarding the various patients files the latter reviewed, each 
of which was provided to Respondent. Accordingly, the evidence which 
was the basis of the decision was disclosed to him, and contrary to his 
contention, see Resp. Exc. at 2, Respondent had a meaningful 
``opportunity to show that it is untrue.'' \7\ Goldberg, 397 U.S. at 
270. Respondent offers no explanation as to why other patient files 
would have ``exonerated'' him from the allegations that his 
prescriptions to the patients, whose files were reviewed by the Expert, 
were issued outside of the usual course of professional practice and 
lacked a legitimate medical purpose. Nor does Respondent offer any 
legal authority for his contention that prejudice--which he cannot 
show--

[[Page 19404]]

must be assumed. See Mister Discount Stockbrokers, 768 F.2d at 878 
(rejecting challenge to discovery procedures in administrative 
proceeding noting that party failed ``to demonstrate any prejudice * * 
* let alone prejudice to a significant degree so as to result in a 
denial of due process'').
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    \7\ The Government also attempted to introduce evidence that 
Respondent prescribed to a member of a Boston-based drug trafficking 
organization, who had been arrested with 3,000 oxycodone tablets in 
his possession, and who stated that he did not have a legitimate 
medical need for the drugs he obtained from Respondent. Tr. 829-32. 
For the reasons stated in his decision, the ALJ properly gave this 
testimony no weight. See ALJ Dec. at 10 n.23.
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    There is likewise no merit to Respondent's contention that he was 
prejudiced by the Government's failure to turn over the patient file of 
the undercover officer to whom he refused to prescribe. A Special Agent 
testified that Respondent had refused to prescribe to a second 
undercover officer and the Government failed to put forward any 
evidence regarding the circumstances of this visit (such as what the 
officer said to Respondent). For this reason alone, it was proper for 
the ALJ to draw an inference adverse to the Government and conclude 
that Respondent properly complied with the rules of the Florida Board 
of Medicine in evaluating the undercover officer. See ALJ at 32 (citing 
UAW v. NLRB, 459 F.2d 1329, 1335-39 (D.C. Cir. 1972)).\8\ However, as 
the ALJ held, that Respondent refused to prescribe controlled 
substances in this single instance does not refute the Government's 
prima facie showing that Respondent repeatedly violated the 
prescription requirement of Federal law as established by the Expert's 
review of eighteen patient files. See id. at 41 (quoting 21 CFR 
1306.04(a)) (``after carefully balancing the admitted evidence, [and] 
even applying an adverse inference that permits the assumption that the 
Respondent was approached by an undercover agent and acted 
appropriately, the evidence establishes, by a preponderance, that the 
prescriptions the Respondent issued * * * were not issued within `the 
usual course of [the Respondent's] professional practice' '').
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    \8\ The ALJ explained that drawing an adverse inference was 
``appropriate under the circumstances of this case where the 
evidence of the unsuccessful US was clearly within the Government's 
control and should, to maintain the integrity of the proceedings, 
have been disclosed if not produced.'' ALJ at 32. It is unclear 
whether the ALJ believed that disclosure of this evidence was 
required as a matter of Due Process as the ALJ did not cite any 
authority for his reasoning and numerous courts (as well as this 
Agency) have held that Brady v. Maryland, 373 U.S. 83 (1963), does 
not apply to administrative proceedings. See Mister Discount 
Stockbrokers, 768 F.2d at 878; NLRB v. Nueva Engineering, Inc., 761 
F.2d 961, 969 (4th Cir. 1985); Nicholas A. Sychak, 65 FR 75,959, 
75960-61 (2000). Even if this evidence is of the type which a 
refusal to disclose ``would so prejudice a party as to deny him due 
process,'' McClelland v. Andrus, 606 F.2d at 1286, the evidence was 
disclosed through the testimony of the Special Agent. Respondent 
thus cannot show prejudice.
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    As noted above, Respondent did not testify. Nor did he offer the 
testimony of an expert. Thus, Respondent did not refute the opinion 
testimony of the Government's Expert that he repeatedly violated the 
prescription requirement of Federal law. Because Respondent failed ``to 
testify in response to [the] probative evidence offered against'' him, 
I conclude (as did the ALJ) that it is appropriate to draw an adverse 
inference against him and hold that he knowingly issued prescriptions 
in violation of 21 CFR 1306.04(a). Baxter v. Palmigiano, 425 U.S. 308, 
316 (1976); see also The Lawsons, Inc., 72 FR 74334, 74339 (2007). 
Because Respondent failed to testify, I also conclude that he has not 
accepted responsibility for his misconduct nor demonstrated that he 
will not engage in future misconduct, and therefore, he has not 
rebutted the Government's prima facie showing that his continued 
registration is inconsistent with the public interest.\9\ See Medicine 
Shoppe-Jonesborough, 73 FR at 387; Samuel S. Jackson, 72 FR 23848, 
23853 (2007). I thus reject Respondent's Exceptions and adopt the ALJ's 
recommended Order.
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    \9\ A registrant's obligation to accept responsibility and 
demonstrate that he will not engage in future misconduct applies 
even where the Government's evidence does not establish that a 
registrant has committed intentional acts. See Krishna-Iyer, 74 FR 
at 464 n.9; Caragine, 63 FR at 51601 (granting restricted 
registration where physician showed that he underwent remedial 
``training to become better educated in controlled substances and 
how to deal with drug-seeking patients''). Thus, even if I had 
concluded that the evidence did not establish that Respondent 
knowingly diverted controlled substances, I would still revoke his 
registration because he failed to rebut the Government's prima facie 
case.
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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, FB0254918, issued to Beau Boshers, M.D., 
be, and it hereby is revoked. I further order that any pending 
application of Beau Boshers, 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
Jose M. Quinon, 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 FB02549187, of Beau 
Boshers, 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 sought 
revocation of the Respondent's registration, pursuant to 21 U.S.C. 
824(a)(4), and denial of any pending applications for renewal \10\ 
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 22, 2010, the Respondent timely requested a 
hearing, which, pursuant to a change of venue granted at his 
request, was conducted in Miami, Florida, on July 7, 2010 through 
July 9, 2010.\11\ The immediate suspension of the Respondent's COR 
has remained in effect throughout these proceedings.
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    \10\ Although the Respondent's COR expired on July 31, 2010, the 
parties stipulated that a timely renewal application has been 
submitted by the Respondent. ALJ Ex. 40.
    \11\ 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).
    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 participated in at 
American Pain, LLC (American Pain), prescribed and dispensed 
inordinate amounts of controlled substances, primarily 
oxycodone,\12\ under circumstances where he knew, or should have 
known, that the prescriptions were not dispensed for a legitimate 
medical purpose. ALJ Ex. 1. The OSC/ISO further charges that these 
prescriptions were issued outside the usual course of professional 
practice based on a variety of circumstances \13\ surrounding the 
manner in which American Pain is operated and the manner in which 
its physicians, including the Respondent, engaged in the practice of 
medicine. Id. The Respondent is also alleged, on several occasions, 
to have provided undercover law enforcement personnel with 
controlled substances, including, inter alia, oxycodone and

[[Page 19405]]

alprazolam,\14\ after cursory or no medical examinations, and 
therefore without a legitimate medical purpose. Id. The Government's 
OSC/ISO also alleges that the Respondent's former patients 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. Lastly, as an additional ground for the 
OSC/ISO, the Government cites the death of one of the Respondent's 
patients from an overdose of controlled substances one day after 
obtaining prescriptions for some of those same controlled substances 
during a visit to the Respondent at American Pain, and that the 
investigation determined the deceased patient and two companions 
obtained those substances ``for other than a legitimate medical 
purpose with the intention of selling the controlled substances in 
Kentucky.'' Id.
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    \12\ A schedule II controlled substance.
    \13\ The majority of which are supported by no evidence 
introduced by the Government during the course of these proceedings.
    \14\ A schedule IC controlled substance.
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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.\15\ 
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, 166 controlled 
substance prescriptions issued over the Respondent's signature, to 
seventy-five patients, only six of whom resided in Florida. The 
remainder of the patients had listed addresses in Kentucky, 
Tennessee, Ohio, Georgia, Indiana, Alabama and West Virginia. The 
data in the log further reflected that the Respondent issued three 
prescriptions for non-controlled substances during that time period.
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    \15\ Although GS Langston testified that DEA immediately 
suspended the COR that had been issued to Boca Drugs, Tr. at 715, 
and that aq 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. Id. 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 
\16\ or OUTSIDE the STATE OF FLORIDA.
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    \16\ 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 
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.\17\ Govt. Ex. 119 at 2.
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    \17\ Although GS Langston testified that she did not actually 
take the photographs 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.
---------------------------------------------------------------------------

    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 an 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.\18\ Id. at 768.
---------------------------------------------------------------------------

    \18\ In his Discussion and Proposed Findings of Fact and 
Conclusions of Law (Respondent's Brief), the Respondent argues that 
the selection criteria employed by Langston deprived him of due 
process and somehow created an inaccurate portrayal of his practice. 
Respt's Br. at 4. However, the Respondent never explains the casual 
connection between the manner in which the files were selected, 
which was not based on any manner of targeting derogatory 
information regarding his patient care and why any due process right 
was compromised.
---------------------------------------------------------------------------

    Langston also explained DEA's Automated Record Consolidated 
Ordering System (ARCOS) \19\ and testified that she generated an ARCOS 
report relative to the Respondent's ordering of controlled substances 
from January 2009 through February 2010. Govt. Ex. 23.
---------------------------------------------------------------------------

    \19\ 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.
---------------------------------------------------------------------------

    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, 
Kentucky and Ohio. Govt. Exs. 24-26. Review of the PMP report data 
reflects that during the time period of February 1, 2006 through 
February 11, 2010, pharmacies filled 259 controlled substance 
prescriptions issued over the Respondent's signature to sixty-eight 
patients located in West Virginia, 173 similar prescriptions provided 
to seventy-nine Kentucky-based patients were filled between January 1, 
2009 and April 4, 2010, and ninety such prescriptions pertaining to 
sixty-one patients located in Ohio were filled between April 1, 2008 
and April 19, 2010. Id.
    No evidence was introduced at the hearing that would provide any 
reliable level of context regarding the raw data

[[Page 19406]]

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 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 \20\ 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.
---------------------------------------------------------------------------

    \20\ SA Burt described the pole cameras as ``covert cameras that 
are installed to observe the activity in the clinic.'' Tr. 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 recirded to DVR. Id. at 821.
---------------------------------------------------------------------------

    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 \21\ 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.
---------------------------------------------------------------------------

    \21\ Tr. at 910.
---------------------------------------------------------------------------

    Based on his review of some (but not all) \22\ 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'' \23\ for these office visits, and the six doctors at the 
clinic saw ``anywhere from 200 upward to 375 patients a day'' \24\ in 
this manner.\25\ Id. at 882-83 (emphasis supplied).
---------------------------------------------------------------------------

    \22\ 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.
    \23\ Later on cross-examination, SA Burt admitted that the 
clinic also accepted payment via credit card. Tr. at 916. The 
parameters of what the witness meant by ``predominantly'' was not 
the subject of further explanation.
    \24\ 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.
    \25\ 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. See Richardson 
v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 
F.3d 1350, 1354 (11th Cir. 2000); Kelly v. Sullivan, 928 F.2d 227, 
230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 
1980).
---------------------------------------------------------------------------

    SA Burt also testified regarding his review of some \26\ of the 
video and audio recordings made by an undercover agent (UC) who assumed 
the name Luis Lopez capturing activity inside of American Pain.\27\ 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 Bart'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.
---------------------------------------------------------------------------

    \26\ Tr. at 1002-05.
    \27\ 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.
---------------------------------------------------------------------------

    Although noticed in SA Burt's proposed testimony identified in the 
Government's prehearing statement, testimony regarding the specifics of 
the UC's visits to see the Respondent at American Pain was not elicited 
by the Government during its direct examination, but was brought out on 
cross-examination to meet the Government's admitted evidence consisting 
of a patient file kept by the Respondent relative to the UC and the 
accompanying expert report and testimony concerning that file provided 
by Dr. Kennedy. Id. at 985-86; Govt. Exs. 46 (Patient File for Luis 
Lopez), 131 (Supplemental Expert Report Regarding Undercover Patient 
Luis Lopez). Burt testified that he did not have the UC examined by a 
physician to determine his physical condition prior to going to the 
clinic, he did not ask him whether he had any prior back problems, and 
he did not ask him whether he had any past problems that caused a 
doctor to prescribe him controlled substances; instead, Burt relied 
solely on the UC's representations he was not currently in any pain 
before sending him into the clinic. Tr. at 987-89. According to Burt, 
the only instructions he provided to the

[[Page 19407]]

UC were to be ``very vague regarding the pain,'' to ``point to a 
general area'' when asked about it, and to provide a urine sample if so 
requested by clinic staff. Id. at 989-90, 1001. It was further 
established that an MRI was taken of the UC at Faye Imaging prior to 
his seeing the Respondent. Id. at 990-91. Burt related that the UC's 
first visit to the clinic was approximately an hour and fifteen 
minutes, and his visit with the Respondent was ten to thirteen minutes 
long. Id. at 998-99. Although these encounters between the UC and the 
Respondent were recorded either via audio or video, the Government did 
not offer the recordings as evidentiary exhibits at the hearing, and 
opposing counsel did not have access to them.\28\
---------------------------------------------------------------------------

    \28\ In fact, as addressed infra, SA Burt did not review the 
recordings or read the history and physical examination form 
contained in the UC's patient file with an eye towards determining 
if the audio corroborated the information on the forms. Furthermore, 
Burt admitted these recordings were not provided to Dr. Kennedy for 
his use in formulating his expert testimony and reports. Tr. at 
1007.
---------------------------------------------------------------------------

    More troubling by far is the revelation during SA Burt's cross 
examination that in addition to UC Luis Lopez, a second UC went into 
American Pain during July 2009 and recorded his encounters with the 
Respondent. Those encounters by the second UC did not culminate with 
the Respondent prescribing controlled substances.\29\ Id. at 1027, 
1029.
---------------------------------------------------------------------------

    \29\ As discussed in more detail anon, this development was 
particularly troubling in light of the Respondent's prehearing 
motion practice where he sought the disclosure of precisely this 
variety of evidence.
---------------------------------------------------------------------------

    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. 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 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.
    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, the 
first confidential source (CS1) discussed by Burt was arrested in 
Washington, DC after transporting upwards of 3,000 oxycodone pills from 
south Florida to Massachusetts, and at the time of his arrest, Burt 
testified that an empty prescription pill bottle from American Pain 
with the Respondent's name on it was found on his person. Id. at 829. 
Burt relayed that at the time CS1 was searched, he had the 3,000 pills 
secreted in a jock strap strapped to the inside of his leg, and they 
were not in any type of bottle with the Respondent's name on it. The 
individual told Burt during a July 2009 interview \30\ that he was a 
member of a Boston-based drug trafficking organization that would 
obtain oxycodone in southern Florida and transport it back to Boston 
for resale. Id. at 831. CS1 told Burt that he did not have a legitimate 
medical need for drugs when he saw the Respondent at American Pain, and 
that during his office visit, the doctor did not physically touch him, 
but did tell him to bend over and touch his toes. Id. at 832-33. The 
Government did not submit evidence of, or provide opposing counsel 
access to, a patient file reflecting CS1's visit to the Respondent, a 
copy of the prescription allegedly issued, or the empty pill bottle 
described.\31\ Burt's testimony divulged the fact that CS1's 
cooperation with authorities was being provided in relation to his July 
2009 arrest and that a record check revealed CS1 had arrests prior to 
that incident, though Burt was unable to recall information of any 
detail concerning the nature and disposition of those arrests. Id. at 
1018-20. Burt declined to disclose the name of CS1 when queried on 
cross-examination.\32\ Id. at 1017.
---------------------------------------------------------------------------

    \30\ Tr. at 1012.
    \31\ SA Burt testified that he has never actually seen the 
described pill bottle. Tr. at 830. Burt also revealed on cross-
examination that he has never reviewed a patient file relative to 
CS1, and that said patient file was not reviewed by a doctor to 
determine the propriety of the controlled substance prescriptions 
purportedly issued by the Respondent. Id. at 1015.
    \32\ 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 
him, no weight can be assigned to SA Burt's testimony concerning 
information provided by CS1, other than the fact that it may have 
informed 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. 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).
---------------------------------------------------------------------------

    SA Burt also testified regarding the drug overdose deaths of TY and 
SM after obtaining controlled substances from American Pain.\33\ Burt's 
record testimony indicates that DEA Task Force Officer \34\ (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.\35\ Likewise, the record evidence concerning SM 
did not implicate prescribing activity by the Respondent.
---------------------------------------------------------------------------

    \33\ 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.
    \34\ 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.
    \35\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and 
associated testimony).
---------------------------------------------------------------------------

    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

[[Page 19408]]

testimony as noticed in the Government's prehearing statement.\36\ 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.
---------------------------------------------------------------------------

    \36\ ALJ Ex. 6.
---------------------------------------------------------------------------

    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.\37\ Dr. Kennedy was offered by the 
Government and accepted as an expert in the field of pain medicine. Id. 
at 39. 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. Id. at 176-77, 365. Dr. Kennedy 
stated that
---------------------------------------------------------------------------

    \37\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.

there was no true doctor/patient relationship established for the 
prescription of controlled substances at the first or any visit, and [] 
it was grossly deficient and medically dangerous to prescribe in the 
---------------------------------------------------------------------------
fashion it was prescribed for the same reasons.

Id. Furthermore, Dr. Kennedy testified that after reviewing the charts, 
he concluded that the prescribing of controlled substances by the 
Respondent to the patients named in the charts was not for a legitimate 
medical purpose. Id. at 182.

    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 files 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, during his testimony, Dr. Kennedy acknowledged that some 
level of standardization and utilization of forms is not, standing 
alone, improper,\38\ Dr. Kennedy took issue with what he perceived as 
flaws in the forms utilized by the Respondent to document patient care. 
Dr. Kennedy even acknowledged that the Respondent's possession and use 
of stamps to affix prescription descriptions and doses on scripts, was 
not, standing alone, improper. Id. at 178. However, according to Dr. 
Kennedy, the forms employed by the Respondent were ``grossly deficient 
in that [they] didn't really justify why the individual was given the 
high doses of narcotics or controlled substances that they were.'' Id. 
at 177.
---------------------------------------------------------------------------

    \38\ 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 41-42. 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 45-46. 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 46-47. Dr. Kennedy acknowledged that physicians 
customarily accept patients at their word, but on the subject of 
verifying a patient's subjective complaint and medication history, Dr. 
Kennedy explained that

[s]ometimes you have to help people understand why they're suffering or 
what their problems are. A person with an addiction or drug abuse 
problem is no worse a human being than me. I'm not any better than 
them. But it's your job as a doctor to sit down and find out what the 
truth is as well as you reasonably can under the circumstances. That 
wasn't done here, in my opinion.

Id. at 357.

    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 49. 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 49-50. In other 
words, the diagnostic plan allows the treating doctor to eliminate or 
confirm items on the differential diagnosis. Id. at 50-52.
    Dr. Kennedy testified that in his expert opinion, the Respondent's 
histories and physical examinations were ``grossly deficient in that 
[the documentation] didn't really justify why the [patient] was given 
the high doses of narcotics or controlled substance that they were.'' 
Id. at 177. Kennedy stated that, in his view, the treatment plans 
evident in the charts were also defective because there was no 
individualized consideration apparent, that ``[e]verybody got 
essentially the same thing,'' and that the treatment plans for all 
patients were invariably limited to a single option, i.e., ``the 
treatment plan was to give controlled substances, and that was 
essentially it.'' \39\ Id. at 78.
---------------------------------------------------------------------------

    \39\ At the consolidated hearing in this matter, the Government 
elicited testimony from Dr. Kennedy regarding additional aspects of 
practice that he found deficient regarding the prescribing practices 
of other respondents. For example, Dr. Kennedy opined that the 
prescribing of 30 mg of oxycodone to an opioid na[iuml]ve patient 
would, in his opinion, be dangerous and improper. Similarly, Dr. 
Kennedy provided his opinion that the practice of ordering of an MRI 
prior to a physician meeting with a patient would be improper. 
However, regarding the charts that Dr. Kennedy reviewed relative to 
this Respondent, the government adduced no testimonial evidence 
regarding issues such as opioid na[iuml]vet[eacute] or the timing of 
MRI scripts, and it would be unfair, improper and illogical for an 
Administrative Law Judge to extrapolate the testimony elicited 
relative to the patients of other physician(s) to this Respondent. 
See Gregg & Son Distribs., 74 FR 17517 n.1 (2009) (data should be 
provided while record is open, and ``[t]o make clear, it is the 
Government's obligation as part of its burden of proof and not the 
ALJ's responsibility to sift through the records and highlight that 
information which is probative of the issues in the proceeding'') 
citing Southwood Pharms., Inc., 72 FR 36487, 36503 n.25 (2007). The 
absence of testimonial support by Dr. Kennedy on these issues 
relative to this Respondent does not adversely affect the weight to 
be attached to the conclusions set forth in the reports he prepared 
in connection with this Respondent which were received into 
evidence. Govt. Exs. 28, 131.

---------------------------------------------------------------------------

[[Page 19409]]

    Although Dr. Kennedy had earlier conceded that it is the judgment 
of the examining physician that is generally relied upon in determining 
the necessity and appropriateness of diagnostic testing,\40\ he also 
testified that, at least in his view, exclusive reliance on MRI 
procedures as the sole diagnostic tool is suboptimal, because they are 
not always required and not always appropriate. Id. at 75-77, 165-66. 
Kennedy characterized MRIs as the Respondent's principal diagnostic 
tool. Id. at 177.
---------------------------------------------------------------------------

    \40\ Tr. at 63.
---------------------------------------------------------------------------

    Dr. Kennedy prepared two reports in connection with the 
Government's case against the Respondent, both of which are dated April 
30, 2010, and both of which were admitted into evidence during his 
testimony. Govt. Exs. 28, 131; Tr. at 174, 194. One of the reports 
describes a general analysis of seventeen charts that the Respondent 
maintained on as many patients, that were (selected by and) provided to 
Dr. Kennedy by the Government from among patient files seized pursuant 
to a criminal search warrant executed at the Respondent's practice on 
March 3, 2010 (Patient Charts Analysis).\41\ Govt. Ex. 28. Although 
this report purports to describe practices common to all seventeen 
files reviewed by Dr. Kennedy, much of the analysis is directed toward 
a chart prepared in connection with RZ,\42\ one of the Respondent's 
patients. A second report (Supplemental Chart Analysis) prepared by Dr. 
Kennedy focuses on the chart maintained under the name Luis Lopez, 
which was the assumed name of a law enforcement officer who visited the 
Respondent's practice in an undercover capacity. Govt. Ex. 131; Tr. at 
188, 335.
---------------------------------------------------------------------------

    \41\ During the prehearing proceedings, the Respondent moved for 
an order compelling production of, inter alia, all patient files 
seized from his office by the Government. The request (which was 
opposed by the Government) was denied in a separate order as ultra 
vires. ALJ Ex. 20; see Nicholas A. Sychak, d/b/a Medicap Pharmacy, 
65 FR 75959, 75961 (2000); Roy E. Berkowitz, M.D., 74 FR 3678, 36760 
(2009).
    \42\ 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. 
17.
---------------------------------------------------------------------------

    Many of the observations and conclusions contained within the two 
reports are remarkably similar. Dr. Kennedy's report makes it 
unambiguously clear that, at least in his opinion, all eighteen of the 
Respondent's charts that he reviewed suffered from the same 
shortcomings. The Patient Charts Analysis states that the Respondent's 
patient charts that Dr. Kennedy reviewed ``are essentially the same 
with regard to review issues; as stated in the report of [RZ] 
referenced and discussed in this report in detail, [and that] there 
were no significant differences that affected [his] conclusions and 
summary.'' Govt. Ex. 28 at 2. A like-worded proviso accompanies Dr. 
Kennedy's analysis of the chart prepared in connection with the 
undercover officer's (Luis Lopez's) interaction in the Supplemental 
Chart Analysis. Govt. Ex. 131 at 1.
    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 standard of care due to their 
brevity and quality''; \43\ (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; \44\ (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;'' \45\ (4) 
contained medication contracts that were ``not always signed'' and 
``listed criteria that was not followed by the doctors at American 
Pain; \46\ (5) failed to 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'''; \47\ (7) reflected ``no therapeutic plan, except to use 
controlled substances to `treat' the subjective complaint of `pain' 
which was inadequately described; \48\ (8) did not reflect ``real 
therapeutic goals * * * for improvement of quality of life (activities 
of daily living, work, sleep, mood)''; \49\ (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 psychology''; \50\ (10) reflected ``a gross lack of past 
medical records in all charts reviewed and in some cases none at all''; 
\51\ and, (11) demonstrated controlled substance patient monitoring 
practices that were ``not within the standard of care and outside the 
boundaries of professional practice.'' \52\
---------------------------------------------------------------------------

    \43\ Govt. Ex. 28 at 4.
    \44\ In Dr. Kennedy's opinion, the Respondent ``prescribed, at 
the first visit, very high initial doses of controlled substance 
combinations despite not being within the standard of care for 
histories, physical examinations and/or absent past medical records 
[with] no apparent consideration given to patient safety with 
initial or subsequent prescription of controlled substance[s].'' 
Govt. Ex. 28 at 7.
    \45\ Govt. Ex. 28 at 4.
    \46\ 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. Govt. Ex. 28 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.
    \47\ Govt. Ex. 28 at 7. In Dr. Kennedy's opinion, Respondent in 
effect, acted as a ``barrier'' for [RZ] to receive appropriate 
medical evaluation and treatment. In other words, the very potent, 
high doses of opioids (oxycodone) and benzodiazepine (Xanax) may 
have masked or cover[ed] up [RZ'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.
    \48\ Govt. Ex. 28 at 7.
    \49\ Govt. Ex. 28 at 8.
    \50\ Govt. Ex. 28 at 7.
    \51\ Govt. Ex. 28 at 15. RZ's chart did not contain a request 
for past medical records. Id. at 8.
    \52\ Govt. Ex. 28 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.\53\ Govt. Ex. 28 at 14; 
Tr. at

[[Page 19410]]

179-80. 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. Furthermore, the charts contained only 
rare evidence of contact with primary care physicians, treating 
physicians, pharmacists, or other health care providers. Id.
---------------------------------------------------------------------------

    \53\ However, when pressed on the issue, Dr. Kennedy declined to 
identify any specific instance regarding any of Respondent's charts 
where he would have ordered an additional drug screen. Tr. at 180.
---------------------------------------------------------------------------

    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. In addition to providing incomplete 
information on his patient questionnaires, the undercover officer (a/k/
a Luis Lopez) admitted to the Respondent that he had previously 
purchased oxycodone on the street. Govt. Exs. 46 at 9, 131 at 3. Other 
red flags noted by Dr. Kennedy in the reviewed charts included the 
relatively young age (in Kennedy's view) of the Respondent's chronic 
pain patients,\54\ incomplete history information provided by the 
patients, periodically significant gaps between office visits,\55\ 
referrals from friends, relatives, or advertising, but not other 
physicians,\56\ 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.\57\
---------------------------------------------------------------------------

    \54\ Govt. Ex. 28 at 15.
    \55\ Govt. Ex. 28 at 13.
    \56\ Govt. Ex. 28 at 8, 15.
    \57\ Govt. Ex. 28 at 16.
---------------------------------------------------------------------------

    At the hearing, Dr. Kennedy testified that the entries in some of 
the charts that reflected that the patients were acquiring controlled 
substances ``off the street,'' and urine drug screen results that were 
inconsistent with patient disclosures, were red flags that should have 
motivated a prudent physician to perform additional due-diligence 
steps, that, in addition to discussing the matter with the patient, 
could include reaching out to family members, previous treating 
physicians and pharmacists, obtaining past medical records, and 
additional testing. Tr. at 359-60, 362. Dr. Kennedy testified that his 
evaluation revealed that these red flags were present in the charts and 
precipitated no due-diligence actions on the Respondent's part. Id. at 
360-64, 368-69.
    On the issue of red flags, WA's patient file contains the 
Respondent's handwritten notation indicating the patient acquired 
oxycodone and Xanax ``off [the] streets,'' yet the Respondent 
authorized prescriptions for Roxicodone, Xanax, and Percocet to WA 
during his initial and subsequent visits. Govt. Ex. 29 at 11, 23-33. 
Like scenarios were also apparent in the charts of numerous other 
patients who had informed the Respondent that they had previously 
acquired such substances in this illegal manner, including the 
undercover law enforcement officer (Luis Lopez). See Govt. Exs. 30 at 
7; 33 at 4; 34 at 5; 37 at 1; 39 at 4; 40 at 1; 46 at 9 (notations 
indicating patients acquiring controlled substances ``off the 
street''). Another patient file contained a similar note that the 
patient had received oxycodone ``from [a] friend.'' Govt. Ex. 44 at 13.
    KA's patient file contains a form indicating a positive UDS for 
opiates and oxycodone from 7/9/09, yet on the same date, the patient 
comfort assessment guide and medication contract signed by KA are both 
blank in the section where a patient is supposed to list any 
medications he or she is currently taking. Govt. Ex. 30 at 14-15, 33; 
see also Govt. Exs. 33 at 8-9, 23; 43 at 10-11, 27 (similar issues). 
Patient JR's 5/27/[09] UDS indicates a negative test for all listed 
substances, yet on her signed medication contract from the same date, 
she indicates she is currently taking three substances which, though 
misspelled, appear to refer to oxycodone, Percocet, and Xanax, a 
discrepancy which raises questions about the validity of the testing 
procedures and/or the patient's candor. Govt. Ex. 35 at 12, 26. Patient 
AZ's \58\ UDS form, on the other hand, lists positive test results for 
oxycodone and opiates only on 11/12/09, yet the patient claims on two 
different documents from the same date that, in addition to two 
different strengths of Roxicodone, she is also currently taking 
clonazepam, a benzodiazepine that should have triggered a positive 
reading for that substance on her drug screen.\59\ Govt. Ex. 45 at 9-
10, 24. 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. 
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.
---------------------------------------------------------------------------

    \58\ Given the testimony of SA Burt regarding the level of 
activity outside American Pain parking area as observed through the 
pole cam, it is remarkable that one patient actually indicated that 
one of the reasons she left the previous pain clinic she frequented 
was because of ``people hanging outside place approaching patients 
for their medications.'' Govt. Ex. 45 at 20.
    \59\ Although a mathematically conceivable explanation for this 
discrepancy could be that the patient exhausted her prescribed 
clonazepam stock sufficiently in advance of the 11/12/09 testing so 
as to not register a positive reading, the chart should have 
reflected that the physician recognized, addressed, and documented 
this red flag regarding a potential abuse or diversion issue.
---------------------------------------------------------------------------

    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. 28 at 3-4, 16. Dr. 
Kennedy's report set forth his opinion 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). 
Govt. Ex. 28 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.
    Notwithstanding the discomfiture that Dr. Kennedy expressed 
regarding non-physician referrals in his report, during his testimony 
at the hearing he 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 record-evidence way to measure the relative 
percentage of physician referrals in the Respondent's practice based on 
this limited sample of charts, the observations regarding referral 
sources are of limited value here.\60\
---------------------------------------------------------------------------

    \60\ 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.
---------------------------------------------------------------------------

    A review of the 18 patient files that informed the analysis, 
findings and

[[Page 19411]]

conclusions offered in Dr. Kennedy's written report and testimony does 
reflect the presence of at least some of the red flag issues he 
identified therein, but there was not the unanimity among the files 
that he repeatedly urges. A review of the files reveals other treatment 
modalities beyond the exclusive regimen of controlled substances 
reflected in the selected patient charts urged by Kennedy in his 
report.\61\ Govt. Exs. 30 at 1; 34 at 1; 35 at 1; 36 at 7; 38 at 3; 43 
at 2; 44 at 2; 36 at 6, 27.
---------------------------------------------------------------------------

    \61\ 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.
---------------------------------------------------------------------------

    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. 28 at 16.
    On cross examination at the hearing, Dr. Kennedy's attention was 
directed to what would seem, at least to a lay person, to present as 
including a significant level of detail set forth in the charts he 
reviewed relative to the Respondent's patient documentation, including 
both subjective complaints of discomfort and objective signs of medical 
anomalies. Tr. at 214-27, 230, 233-38, 243-44, 246-56, 262-66, 269-70, 
273-87, 289-98, 305-08, 311-18, 320-29, 332-47, 366. Even the file 
prepared in connection with the undercover officer's interaction with 
the Respondent reflects recorded subjective complaints coupled with a 
remarkable MRI and other objective signs indicating some medical 
pathology. Id. at 335-47. Undaunted, Dr. Kennedy (the sole expert to 
testify at the hearing), remained committed to his position that the 
manner in which the documentation was completed was fundamentally 
insufficient for a physician to adequately proceed to treat the 
patients with controlled substances. Id. at 226-29, 231-32, 238-41, 
258, 262, 264, 267-68, 286, 290, 299-301, 309-11, 342-43, 366-67. Dr. 
Kennedy, more than once, succinctly stated that ``[i]t's not even 
close.'' Id. at 268, 310.
    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,\62\ 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. Id. 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.\63\ Consistent with his written report, Dr. 
Kennedy testified that from what he could glean in the charts he 
examined, the physical examinations were ``grossly deficient in that 
[the physical examination] didn't really justify why the individual was 
given the high doses of narcotics or controlled substances that they 
were,'' that MRIs were the primary diagnostic tools and they should not 
have been, that the treatment plans were improperly ``rubber stamped'' 
with few modifications, and ``there was no true doctor/patient 
relationship established for the prescription of controlled substances 
at the first of any visit, and that it was grossly deficient and 
medically dangerous to prescribe in the fashion it was prescribed for 
the same reasons.'' Id. at 177-79. 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.
---------------------------------------------------------------------------

    \62\ Tr. at 628.
    \63\ The Respondent did not testify on his own behalf.
---------------------------------------------------------------------------

The Analysis

    Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \64\ 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'':

    \64\ 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.


[[Page 19412]]


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 (D.C. 
Cir. 2005). The 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 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 (D.C. 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 (D.C. 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

[[Page 19413]]

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 (D.C. 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 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, notwithstanding the Respondent's Krishna-Iyer-based 
\65\ protestation in his brief that he has been somehow denied the 
ability to present ``positive experience in dispensing controlled 
substances,''\66\ 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. The Government, on the other hand 
did elect to present evidence on the subject.
---------------------------------------------------------------------------

    \65\ The Respondent cites the Agency's decision in Krishna-Iyer, 
74 FR at 459-01 and the unpublished 11th Circuit remand related to 
that case. Krishna-Iyer v. DEA, No. 06-15034 (11th Cir. 2007), Slip 
Op. at 3.
    \66\ Respt's Br. at 3.
---------------------------------------------------------------------------

    Regarding the Government's presentation, Agency precedent has long 
held that in DEA administrative proceedings that ``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 
ultimately 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,'' 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;

[[Page 19414]]

    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] [t]here are signs within American 
Pain warning individuals not to have their prescriptions filed 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.

    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 Univ. of Tenn. 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 \67\ 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.
---------------------------------------------------------------------------

    \67\ 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 5th largest practitioner purchaser of oxycodone in the United 
States.'' \68\ 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, 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). 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.
---------------------------------------------------------------------------

    \68\ ALJ Ex. 6 at 11-12.
---------------------------------------------------------------------------

    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,\69\ or advising them to comply with vehicle and traffic laws,\70\ 
does not shed illumination on the Respondent's prescribing practices. 
There was neither 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.
---------------------------------------------------------------------------

    \69\ Tr. at 825.
    \70\ Tr. at 826.
---------------------------------------------------------------------------

    Burt's testimony regarding his conversations with Dr. Sollie, who 
was formerly employed by American Pain, was also not received in a 
manner that could meaningfully assist in the

[[Page 19415]]

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,\71\ and that some patients were intentionally evading the 
American Pain urinalysis process. Sollie 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.
---------------------------------------------------------------------------

    \71\ Tr. at 898.
---------------------------------------------------------------------------

    The Government evidence connected with Burt's testimony concerning 
the undercover operations focused on the Respondent unfolded in a 
somewhat disquieting manner when viewed in context with the prior 
motion practice in this case. As a preliminary matter, it must be 
acknowledged that Burt's testimony regarding the details of the Luis 
Lopez evolution, because it lacked detail, was of negligible import. 
Burt related that the UC told him that American Pain employees made 
statements and Burt viewed some statements on videotape, but there is 
no indication as to who the employees were, why Burt or the UC believed 
them to be employees, or what the basis for the directions to the 
patients were. For example, American Pain employees advising patients 
to avoid a particular pharmacy would doubtless have more relevance to 
these proceedings if the Government had presented any evidence that the 
pharmacy to be avoided (Walgreens) had some aversion to filling 
American Pain prescriptions. There was no such evidence. To the extent 
the Government was seeking to introduce the UC interaction evidence 
with a view toward reflecting on the Respondent's prescribing 
practices, evidence regarding the details of the interaction between 
the Respondent and the UC would seem to have been imperative.\72\ This 
is particularly true here, where an MRI actually showed that the UC had 
a back impairment that could be treated by the use of the controlled 
substances prescribed by the Respondent. Thus, other than to provide 
contextual evidence concerning one of the patient charts reviewed by 
Dr. Kennedy, Burt's testimony regarding the UC interaction does not 
advance the Government's case for revocation.
---------------------------------------------------------------------------

    \72\ In fact, the Government actually interposed an objection 
that exploration of this issue was beyond the scope of the direct 
examination. Tr. at 986.
---------------------------------------------------------------------------

    Of somewhat more concern is the procedural context of the UC-
related portions of the Government's case. During pre-hearing 
procedures, the Respondent sought discovery in the form of, inter alia, 
``[a]ll audio and video recordings pertaining to visits to American 
Pain during which the undercover officer was seen by [the 
Respondent].'' ALJ Ex. 18 at 1. The Government correctly pointed out 
that, under the Administrative Procedure Act (APA) and Agency 
precedent, a discovery order is beyond the authority of this tribunal, 
but went on to argue that under Agency precedent ``the only formal 
discovery required in DEA hearings is the exchange of documents and 
summarized testimony,'' \73\ and that the
---------------------------------------------------------------------------

    \73\ ALJ Ex. 19 at 6.

    ``Respondent in this matter will be provided the documents and 
testimony to be used against him, and will be permitted to confront and 
cross examine witnesses and evidence presented by the Government at 
---------------------------------------------------------------------------
hearing.''

Id. at 3. In a separate order (Discovery Denial Order),\74\ the 
discovery request was denied as ultra vires, and the Respondent's 
attention was invited to explore other available procedural mechanisms, 
such as specific subpoena requests (none were submitted), applications 
to the United States District Court under Fed. R. Crim. P. 41(g), and, 
if warranted, the pursuit of the application of an evidentiary adverse 
inference before this tribunal. The Discovery Denial Order contained 
the following language:
---------------------------------------------------------------------------

    \74\ ALJ Ex. 20.

    ``While discovery beyond the regulations is not a viable option 
available to the parties in this action, the position taken by the 
Government, if taken to its natural analytical conclusion, would allow 
it to intentionally seize exculpatory evidence, render it unavailable, 
and prevail in an administrative enforcement action that requires a due 
process hearing [with a footnote that added that] [t]here is no 
indication that such a scenario has taken place or would take place 
here. [The Order went on to state that] [w]hile the analytical 
simplicity of the Government's position is facially appealing, it is 
unlikely that Congress, in enacting the APA and the Controlled 
---------------------------------------------------------------------------
Substances Act, intended such a result.''

ALJ Ex. 20 at 7. Ironically, the precise scenario that this tribunal 
expressed confidence would not likely occur, is exactly the scenario 
that unfolded at the hearing. The Government seized the Respondent's 
patient charts and proceeded under a theory that the Respondent 
inexorably prescribed controlled substances to essentially anyone 
posing as a patient who made a request. Through an agent who was ill-
equipped to provide interaction details, the Government presented 
testimony that a UC who (at least by its theory) was not a legitimate 
candidate for a controlled substance prescription, received one from 
the registrant. It was only through the cross-examination performed by 
a co-Respondent's counsel present at the consolidated hearing that it 
was revealed that another UC who attempted to procure controlled 
substances from this Respondent was refused. The Respondent (and this 
tribunal) have never been apprised of the details of the interaction or 
been given access to the patient chart regarding the rebuffed UC.
    In International Union (UAW) v. NLRB,\75\ the United States Court 
of Appeals for the District of Columbia Circuit held that the National 
Labor Relations Board committed reversible error by declining to apply 
the ``adverse inference rule'' where one of the parties had ``relevant 
evidence within his control which he fail[ed] to produce.'' \76\ This 
precedent was embraced by the Eleventh Circuit in Callahan v. Schultz, 
783 F.2d 1543, 1545 (11th Cir. 1986). The judicious utilization of the 
adverse inference rule allows an administrative tribunal to use the 
tools available to it and ``permits vindication of the tribunal's 
authority in situations where vindication might, as a practical matter, 
be impossible otherwise.'' Int'l Union, 459 F.2d at 1339. Such an 
inference is appropriate under the circumstances of this case where the 
evidence of the unsuccessful UC was clearly within the Government's 
control and should, to maintain the integrity of the proceedings, have 
been disclosed if not produced. Accordingly, an adverse interference 
will be applied here to the extent that is will be assumed in this 
recommended decision that, regarding the unsuccessful UC, his encounter 
with the Respondent reflected a correct and professional interaction 
memorialized by documentation that met with the standards set by the 
Florida Medical Board. Thus, the evidence regarding this unsuccessful 
UC, even if it had been provided to the Respondent, could have

[[Page 19416]]

logically established no greater benefit to his litigation position.
---------------------------------------------------------------------------

    \75\ 459 F.2d 1329, 1336 (D.C. Cir. 1972).
    \76\ The applicability of the adverse inference rule is not 
dependent upon the issuance of a subpoena seeking to compel 
production. Int'l Union v. NLRB, 459 F.2d at 1338.
---------------------------------------------------------------------------

    Furthermore, in this case, because SA Burt's testimony regarding 
the UC's interaction with the Respondent has been afforded no weight, 
the non-availability of the details regarding the unsuccessful UC has 
resulted in no adverse impact regarding the Respondent's case. This is 
ever so much more true where an adverse inference has resulted in the 
assumption that the only such credited interaction in the record was in 
all ways appropriate. Put another way, the Government's attempt to show 
that the Respondent's interaction with the successful UC demonstrated 
his proclivity to dole out controlled substances for insufficient 
reasons was not persuasive.\77\ However, if the testimonial vessel had 
delivered the testimony in a more effective fashion and the testimony 
regarding the successful UC had been credited, it seems that there was 
at least the potential for a significant compromise to the fairness of 
the adjudication. To the extent that a strained interpretation of the 
APA and existing DEA regulations have empowered the Government in 
espousing the position that it should rightfully be permitted to seize 
all potential evidence and dole back only those portions that adversely 
implicate the Respondent, that course is likely to result in precedent 
on judicial review that could impose unintended appellate consequences 
that could (and perhaps should) severely curtail its options in future 
enforcement actions. The point raised in the Respondent's brief that 
``[t]he Due Process Clause forbids an agency from using evidence in a 
way that forecloses an opportunity for a party to offer a contrary 
presentation,'' Respt's Br. at 3 (citing Volkman v. DEA, 567 F.3d 215, 
220 (6th Cir. 2009), is well taken. The APA guarantees that ``[a] party 
is entitled to present his case or defense.'' 5 U.S.C. 556(d). 
Irrespective of the number of assurances provided by the Government 
that a respondent will be afforded all the rights to which he is 
entitled, the practice of seizing all evidence from a Respondent, 
presenting a selective compilation of that which tends to disparage his 
case, while denying access to information from which he could 
meaningfully defend against the allegations, does not have a strong 
likelihood of ratification on appeal. More importantly, when brought to 
its logical end, it could tend to undermine the integrity of the 
adjudication in the eyes of the public. That no cognizable prejudice 
was realized to this Respondent's ability to present his case here does 
not enhance the wisdom of the procedural course embarked upon. That 
being said, no prejudice resulted to the Respondent here.
---------------------------------------------------------------------------

    \77\ As evidenced by the ultimate disposition of this 
recommended decision, other evidence of record relating to the chart 
analysis by Dr. Kennedy was more successful in this regard.
---------------------------------------------------------------------------

    The Government's evidence at the hearing 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 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,\78\ which the 
CSA defines as ``to deliver a controlled substance to an ultimate user 
\79\ * * * 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).
---------------------------------------------------------------------------

    \78\ 21 U.S.C. 823(f).
    \79\ ``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, 567 F.3d at 223 (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

[[Page 19417]]

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,\80\ 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:

    \80\ 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,\81\ provided the 
physician does so in accordance with that level of care, skill, and 
treatment recognized by a reasonably prudent physician under similar 
conditions and circumstances.

    \81\ 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,\82\ 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.
---------------------------------------------------------------------------

    \82\ 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).
---------------------------------------------------------------------------

    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,'' \83\ resort must be had to an expert.
---------------------------------------------------------------------------

    \83\ 21 CFR 306.04(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

[[Page 19418]]

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 \84\ 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.

    \84\ 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;
    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).
    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

[[Page 19419]]

(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, 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, even 
applying an adverse inference that permits the assumption that the 
Respondent was approached by an undercover agent and acted 
appropriately, the evidence establishes, by a preponderance, 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 controlled substances to patients 
irrespective of the patients' need for such medication and ignoring any 
and all 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 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. 2011-8344 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P