[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19434-19450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8345]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-37]


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

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[[Page 19435]]

    Respondent first takes exception to the ALJ's acceptance of L. 
Douglas Kennedy, M.D., as an expert on the proper prescribing of 
controlled substances. Respondent contends that Dr. Kennedy should not 
have been permitted to opine on his prescribing practices because he 
does not hold a DEA registration in Florida, has not prescribed a 
controlled substance since 2004, does not currently have either a 
medical office or hospital privileges in Florida, and ``has never 
practiced medicine regularly in Florida and has not practiced medicine 
in Florida at all in over 10 years.'' Resp. Exc. at 1.
    Respondent's contention is unavailing as Dr. Kennedy was clearly 
qualified to render an expert opinion on the proper practice for 
prescribing controlled substances to treat pain and whether 
Respondent's controlled substance prescriptions were issued in the 
usual course of professional practice and for a legitimate medical 
purpose. See 21 CFR 1306.04(a). Dr. Kennedy currently holds a Florida 
medical license, is a diplomate of both the American Board of Pain 
Medicine and the American Board of Anesthesiology, and is currently on 
the faculty of the University of Miami's Miller School of Medicine. GX 
117, at 1, 10. Previously, Dr. Kennedy was a Fellow with the Pain 
Therapy Unit of the Cleveland Clinic, served as the Director of Chronic 
Pain Management at the University of Kentucky Medical Center, and, for 
fourteen years, was the Medical Director of a multidisciplinary pain 
medicine and rehabilitation practice. Id. at 1-2.
    Dr. Kennedy has published several articles and book chapters on 
pain management issues and has made several dozen presentations on pain 
management issues at professional meetings.\4\ Id. at 3-7. In addition, 
he is a member of several professional organizations including the 
American Academy of Pain Medicine, the American Board of Pain Medicine, 
the American Pain Society, the International Association for the Study 
of Pain, the American Society of Addiction Medicine, the American Board 
of Anesthesiology, and the American Society of Anesthesiology. Id. at 
10; Tr. 22. Finally, Dr. Kennedy explained that he was familiar with 
the Florida Board of Medicine's standards for prescribing controlled 
substances to treat pain and that he had reviewed them prior to 
preparing his report. Tr. 24-26; GX 101, at 6-7.
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    \4\ He also co-edited and contributed to the State of Kentucky's 
Guidelines for Prescribing Controlled Substances, 2nd Edition. GX 
117, at 9.
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    Thus, Dr. Kennedy was clearly qualified to provide expert 
testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony 
was sufficiently reliable to constitute substantial evidence on the 
issue of whether Respondent acted within the usual course of 
professional practice and had a legitimate medical purpose in 
prescribing controlled substances to the patients whose files he 
reviewed and reject this exception. ALJ at 17.
    Next, Respondent contends that Dr. Kennedy's opinion testimony is 
entitled to no weight because it was based on only sixteen patient 
charts, which Respondent maintains were not randomly selected and is 
too small a sample to draw sufficient conclusions about the validity of 
his prescribing practices. Resp. Exc. at 2. In support of this 
contention, Respondent relies on Dr. Kennedy's testimony that `` `[i]t 
might not be fair' '' to `` `cherry-pick[]' '' sixteen charts out of a 
physician's patients because those might be the ``the only people out 
of 2,000'' and that the problems found would ``be `an administrative 
issue for education with the Board of Medical License and not' '' 
necessarily justify the revocation of Respondent's medical license (or 
DEA registration). Id. (quoting Tr. 612-13).
    However, even acknowledging that one of the sixteen files reviewed 
by Dr. Kennedy with respect to Respondent was not randomly selected 
because it was that of an undercover officer, the ALJ found credible 
the Diversion Investigator's testimony that the files were not 
specially selected to enhance the strength of the Government's case. 
ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal 
law that a prescription ``must be issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice,'' 21 CFR 1306.04(a), applies to each and every 
prescription issued by a practitioner. Thus, contrary to the Expert's 
understanding, in determining whether a practitioner has committed acts 
which render his ``registration inconsistent with the public 
interest,'' 21 U.S.C. 824(a)(4), DEA is not required to randomly select 
the files which it will base its case on.
    For example, where the Government has developed information that 
particular patients are drug dealers or engaged in self-abuse, it is 
not required to ignore the files pertaining to these patients and base 
its case on a random sample of files. Rather, it can lawfully select 
the files pertaining to those patients and base its case entirely on 
them. Moreover, where the Government has seized files, it can review 
them and choose to present at the hearing only those files which 
evidence a practitioner's most egregious acts. Of course, where, as 
here, the Government's case relies so heavily on a chart review, the 
practitioner can put on his own evidence and argue that the 
Government's evidence does not establish that he violated the 
prescription requirement or that his conduct was not so egregious as to 
warrant revocation. See Paul Caragine, 63 FR 51592 (1998). See also 
Dewey C. MacKay, 75 FR at 49977; Krishna-Iyer, 74 FR at 463 (holding 
that DEA can revoke based on a single act of diversion); Medicine 
Shoppe-Jonesborough, 73 FR at 386 & n.56.\5\ Accordingly, there is no 
merit to Respondent's contention.
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    \5\ Consistent with DEA's longstanding precedent, see ALJ at 19, 
a respondent is also entitled to put on evidence as to his 
acceptance of responsibility and any remedial measures he has 
undertaken to prevent the re-occurrence of similar acts.
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    Finally, Respondent takes exception to the ALJ's findings that he 
violated Florida's standards for prescribing controlled substances. 
Resp. Exceptions at 4-5. More specifically, Respondent contends that he 
complied with the standards set forth under Florida regulations and 
that he ``took a complete medical history and conducted a physical 
evaluation that was documented,'' that he maintained ``medical records 
documenting the

[[Page 19436]]

patient's intensity of pain, current and past treatments for pain, and 
the effect of pain on physical and psychological function.'' Id. at 4. 
He further argues that ``[h]e set out a written treatment plan, 
discussed the risks and benefits of controlled substances and conducted 
periodic reviews'' as also required by Florida's regulations. Id. at 4-
5.
    While it is true that Dr. Kennedy acknowledged that he was not 
familiar with the specific standard imposed by the State of Florida for 
excessive prescribing and that he had not reviewed any Florida Medical 
Board decisions addressing the issue of what is an adequate medical 
history, see ALJ at 17; as noted above, in his report Dr. Kennedy 
discussed at length the Florida Board of Medicine's Standards for the 
Use of Controlled Substances for the Treatment of Pain, Fla. Admin. 
Code 64B8-9.013. See GX 101, at 6-7.\6\ Nor did Respondent produce any 
evidence that his recordkeeping and prescribing complied with the 
standards of the Florida Medical Board. Moreover, there is substantial 
evidence to support the conclusion that Respondent was not engaged in 
legitimate medical practice and was diverting drugs.
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    \6\ Even after Gonzales v. Oregon, 546 U.S. 243 (2006), multiple 
courts of appeals, including the Eleventh Circuit, ``have applied a 
general-practice standard when determining whether the practitioner 
acted in the `usual course of professional practice.' '' United 
States v. Smith, 573 F.3d 639, 647-48 (8th Cir. 2009); see also id. 
at 648 (discussing United States v. Moore, 423 U.S. 122 (1975); 
``Thus informed by the Supreme Court and other controlling and 
persuasive precedent, we believe that it was not improper to measure 
the `usual course of professional practice' under Sec.  841(a)(1) 
and [21 CFR] 1306.04 with reference to generally recognized and 
accepted medical practices * * *.''). Likewise, the Eleventh Circuit 
has held that ``[t]he appropriate focus * * * rests upon whether the 
physician prescribes medicine `in accordance with a standard of 
medical practice generally recognized and accepted in the United 
States.' '' United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 
2008) (quoting Moore, 423 U.S. at 139).
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    As Dr. Kennedy explained, most of the patients were from out-of-
state, with some travelling up to 1200 miles,\7\ even though Respondent 
had no specialized training in pain management, and yet, Respondent did 
not obtain reports from the prescription monitoring programs run by the 
States where his patients lived. Id. at 16-17. Moreover, Respondent did 
not obtain adequate medical histories and perform adequate physical 
examinations; he also never obtained medical records from other 
treating physicians (or even contacted them) for any of the patients 
whose files are in evidence. Id. at 14-17.
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    \7\ Of the sixteen patients, only five were from Florida. Of the 
remaining patients, five were from Kentucky, two were from 
Tennessee, and one was from each of the following States: North 
Carolina, Ohio, Massachusetts, and Georgia. GX 101, at 9.
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    As Dr. Kennedy explained, while ``[t]he chart was set up to give 
the appearance of a legitimate medical practice in an attempt to 
justify the initial and continued prescription and dispensing of high 
dose multiple controlled substances (`drug cocktails'),'' and that 
while ``on the surface [the charts] were adequate for evaluating and 
treating a patient,'' on closer review, ``the actual contents in the 
charts, clearly evidence[] just the opposite'' as the charts ``were 
very difficult * * * to read [with] many sections left blank or 
incompletely filled in.'' Id. at 17. Continuing, Dr. Kennedy explained 
that ``[t]he notes were not within the standard of care; all were 
outside the boundaries of professional practice, lacking significant 
information and ignoring significant history that was present.'' Id. 
Moreover, Respondent's failure to obtain patients' medical records 
``was well outside the boundaries of medical practice and below the 
standard of medical care,'' especially for patients receiving ``very 
high dose[s]'' of controlled substances. Id.
    The evidence further shows that this case is not simply a matter of 
inadequate record keeping. While Respondent apparently required his 
patients to obtain an MRI, in multiple instances the MRI was obtained 
before the patient was even evaluated by Respondent, and generally, no 
other imaging studies such as x-rays or CT scans were done.\8\ Id. at 
16. Moreover, Respondent rarely referred a patient to another physician 
or health care professional for a consultation.\9\ As Dr. Kennedy 
explained, ``alternative opinions should have been sought in order to 
better diagnose and treat; not to do so was outside the boundaries of 
professional practice and not within the standard of care.'' Id. Dr. 
Kennedy thus concluded that Respondent's ``diagnoses were usually very 
vague and/or without medical merit'' and were done in an ``attempt[] to 
justify what controlled substances he prescribed.'' Id. at 17.
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    \8\ Dr. Kennedy explained that referring a patient to obtain an 
MRI prior to having some contact is unusual and medically 
inappropriate. Tr. 71-72.
    \9\ While Respondent referred one patient to his primary care 
physician for jaundice, and another to the Emergency Room to be 
evaluated for cellulitis, according to their respective medical 
records, both of these patients went to Respondent because of lower 
back pain. See GX 108, at 9; GX 109, at 1.
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    Dr. Kennedy further observed that while Respondent performed urine 
drug screens, he ignored the results even when they were inconsistent 
with other information provided by the patients such as when a patient 
tested positive for controlled substances which he had previously 
indicated that he was not currently taking. Id. at 14-15; ALJ at 15-16. 
Moreover, the drug screens were rarely performed other than at the 
patient's initial visit and lacked quality controls.\10\ GX 101, at 15.
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    \10\ Dr. Kennedy explained that the urine drug screens did not 
indicate the temperature and specific gravity of the specimen, 
whether the giving of the sample had been observed, or the type of 
drug screen used. GX 101, at 4; Tr. 100-03.
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    Also, although the charts indicate that Respondent discussed doing 
yoga and stretching, using an anti-inflammatory diet, and taking 
several over-the-counter supplements (fish oil and glucosamine 
chondroitin), Respondent's treatment plan primarily involved 
prescribing ``drug cocktails'' of high doses of controlled substances 
with the same regimen of drugs (typically two strengths of oxycodone 
immediate release and Xanax) prescribed in nearly every case. Id. at 5, 
13, 15. Most significantly, Respondent never referred any of the 
sixteen patients for consultations with specialists related to their 
pain complaints, or for physical, occupational or mental health 
therapy. GX 101, at 13.
    Dr. Kennedy further observed that while the typical starting dose 
of Xanax is 0.25 to 0.5 mg., once to twice per day, Respondent 
prescribed Xanax 2 mg., once or twice per day to fourteen of the 
sixteen patients, and he did so even with patients who had not been on 
the drug either ``before or recently'' and ``no matter the age or 
clinical situation.'' Id. While Xanax is used as an anti-anxiety agent, 
Respondent's medical records did not support the prescribings because 
``[h]e did not list important factors that could cause anxiety * * * 
such as depression, life stressors, psychosocial situation, caffeine 
intake, sleep disturbance [and a] previous medical evaluation''; he 
also did not refer these patients for evaluation by a mental health 
professional. Id. And with respect to J.S., Dr. Kennedy concluded that 
Respondent's prescribing of this very high dose of Xanax ``was clearly 
not within the boundaries of professional practice.'' Id.
    Finally, Dr. Kennedy noted that beginning with a patient's first 
visit, Respondent prescribed very high initial doses of oxycodone. Dr. 
Kennedy explained that the usual starting dose for an opioid na[iuml]ve 
patient in moderate to severe pain was five milligrams of oxycodone 
taken every four hours as needed for a total of thirty milligrams per 
day. Id. at 9. Yet at J.S.'s first visit, Respondent prescribed (in 
addition to 60 Xanax), 180 Roxicodone 30 mg. (with

[[Page 19437]]

one tablet to be taken every four hours), as well as sixty Roxicodone 
15 mg. (one tablet, twice a day, as needed for pain), an amount that is 
seven times the usual starting dose. Id. at 19. While J.S. had noted on 
his medication contract that three months earlier, he had been 
prescribed 210 oxycodone 30 mg., 90 oxycodone 15 mg., and 90 Xanax 
2mg., which was ``almost exactly what [Respondent] prescribed[,]'' 
Respondent did not identify the name of the physician who had issued 
the prescriptions and did not attempt to confirm them. Id. at 11.
    At each of J.S.'s subsequent visits, Respondent prescribed an 
additional thirty tablets of oxycodone 30 mg. (for a total of 210), 
along with sixty tablets of oxycodone 15 mg. and 60 tablets of Xanax 2 
mg. Id. at 19. While Dr. Kennedy acknowledged that prescribing an 
additional strength of oxycodone could be legitimate if it was done to 
treat breakthrough or episodic pain on an as-needed basis, with respect 
to J.S., who received prescriptions for oxycodone 30 mg. and 15 mg., 
``there was no specific reason stated in the medical record'' for 
prescribing both drugs. Id. at 12. And with respect to all of the 
patients whose files he reviewed, Dr. Kennedy explained that 
Respondent's prescribing of drug cocktails of ``a very high dose 
opioid'' (including two forms of oxycodone) and a ``high dose * * * 
benzodiazepine'' (Xanax) lacked ``any legitimate medical purpose.'' Id. 
at 15.
    As Dr. Kennedy concluded, Respondent ``was not engaged in the 
practice of medicine,'' and ``[t]he vast majority of [his] 
prescriptions for controlled substances was not for a legitimate 
medical purpose and w[as] beyond the boundaries of professional 
practice.'' Id. at 18. His ``routine and excessive prescription of 
multiple controlled substances * * * and lack of arriving at a valid 
medical diagnosis and treatment most likely caused harm to the patients 
he saw as well as * * * to other people in their communities.'' Id. I 
thus reject this exception as well.
    Finally, I also reject Respondent's exception to the ALJ's ultimate 
finding that Respondent has committed acts which render his 
registration inconsistent with the public interest. Resp. Exc. 5. 
Because the record establishes that Respondent has repeatedly violated 
Federal law by issuing controlled substance prescriptions which lacked 
a legitimate medical purpose and were issued outside of the usual 
course of professional practice, 21 CFR 1306.04, and Respondent has 
offered no evidence establishing that he has accepted responsibility 
for his misconduct and that he has reformed his practice, see Steven M. 
Abbadessa, 74 FR 10077, 10081 (2009), I adopt the ALJ's recommendation 
that Respondent's registration be revoked.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA 
Certificate of Registration, FD1201196, issued to Roni Dreszer, M.D., 
be, and it hereby is, revoked. I further order that any pending 
application of Roni Dreszer, 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
Sean M. Ellsworth., 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 FD1201196, of Roni Dreszer, 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 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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    \11\ Pursuant to an order issued on April 15, 2010, with the 
consent of the Respondent, the hearing in this matter was 
consolidated with the cases of four other registrants who were 
working at the same clinic as the Respondent and who were also 
issued OSC/ISOs on February 25, 2010, alleging similar and related 
conduct.
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    The issue ultimately to be adjudicated by the Deputy Administrator, 
with the assistance of this recommended decision, is whether the record 
as a whole establishes by substantial evidence that Respondent's 
registration with the DEA should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4). 
The Respondent's DEA practitioner registration expires by its terms on 
June 30, 2011.
    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 Respondent, engaged in the 
practice of medicine. Id. Respondent is also alleged to have provided 
undercover law enforcement personnel with controlled substances, 
including, inter alia, oxycodone and alprazolam,\14\ after cursory or 
no medical examinations, and therefore without a legitimate medical 
purpose. Id. The Government also alleges that Respondent's former 
patients have apprised law enforcement personnel that ``they were able 
to obtain prescriptions for controlled substances from [the Respondent] 
for other than a legitimate medical purpose and with the intention of 
selling the controlled substances and/or personally abusing the 
drugs.'' 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 IV 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

[[Page 19438]]

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. However, inasmuch 
as the Boca Drugs Prescription Log fails to distinguish between the 
Respondent, and another registrant with the same last name, the 
document is of no utility in reaching a disposition of the present 
case.
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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 a voluntary surrender by that registrant followed a day 
later, id. at 776, no evidence has been presented that would lend 
that fact any particular significance related to any issue that must 
or should be found regarding the disposition of the present case.
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    GS Langston also testified that, on March 3, 2010, a criminal 
search warrant was executed on the American Pain Clinic simultaneously 
with the OSC/ISO that initiated the present case. Tr. at 735. According 
to Langston, the items seized from American Pain included a sign that 
had been posted in what she believes to have served as the urinalysis 
waiting room. 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 taken during the search warrant execution at 
American Pain, she did provide sufficient, competent evidence to 
support the admission of the photographs that were ultimately 
received into evidence. Tr. at 737, 739-41.
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    GS Langston also testified that a great number of medical charts 
were seized from the American Pain offices, and that she and her staff 
selected a number of these files to be analyzed by a medical expert 
procured by the Government. Tr. at 762. According to GS Langston, after 
the execution of the warrant, the charts from the entire office were 
placed into piles in alphabetical order, and not separated by 
physician. Langston testified that she and three of her diversion 
investigators reviewed the seized files with a view towards choosing 
approximately fifteen files for each doctor with the aspirational 
criteria that each would reflect at least three to four visits by that 
doctor with a patient. Each investigator was empowered to place a chart 
on the selected pile, and when the target number (or about that number) 
was reached for each physician, the selection effort relative to that 
physician was deemed accomplished. Id. at 765. Langston credibly 
testified that there was no effort to specially select files under some 
prosecution-enhancement or ``cherry picking'' purpose. Id. at 768.
    Langston also explained DEA's Automated Record Consolidated 
Ordering System (ARCOS) 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. 97.
    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. 98-100. Review of the PMP report data 
reflects that during the time period of February 1, 2006 through 
February 11, 2010, pharmacies filled 167 controlled substance 
prescriptions issued over the Respondent's signature to fifty-four 
patients located in West Virginia, 110 similar prescriptions provided 
to fifty-seven Kentucky-based patients were filled between January 1, 
2009 and April 4, 2010, and sixty-six such prescriptions pertaining to 
twenty-eight 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 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. As discussed above, the fact that the Boca 
Drugs Prescription Log prepared by the agents does not distinguish 
between prescriptions authorized by the Respondent and another 
registrant of the same name deprives the document of virtually any 
relevance regarding the enforcement action against this Respondent.\18\
---------------------------------------------------------------------------

    \18\ Remarkably, although this unfortunate aspect of this 
document was brought to light during the course of the hearing, Tr. 
at 732, no effort on the part of the Government was made to provide 
additional details or explanation that might tend to differentiate 
between the respondents.
---------------------------------------------------------------------------

    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

[[Page 19439]]

he surveilled the Boca Raton and Lake Worth locations both in person 
and by periodic live review of video captured via pole cameras \19\ 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.
---------------------------------------------------------------------------

    \19\ SA Burt described the pole cameras as ``covert cameras that 
are installed to observe the activity in the clinic.'' Tr. at 816. 
Burt testified that he was able to use a laptop to access the live 
video feed from the cameras after inputting a username and password. 
The camera video was also recorded to DVR. Id. at 821.
---------------------------------------------------------------------------

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

    \20\ Tr. at 910.
---------------------------------------------------------------------------

    Based on his review of some (but not all) \21\ 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'' \22\ for these office visits, and the six doctors at the 
clinic saw ``anywhere from 200 upward to 375 patients a day'' \23\ in 
this manner.\24\ Id. at 882-83 (emphasis supplied).
---------------------------------------------------------------------------

    \21\ 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.
    \22\ Later on cross-examination, SA Burt admitted that the 
clinic also accepted payment via credit card. Tr. at 916.
    \23\ 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.
    \24\ 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); 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 his review of some \25\ of the 
video and audio recordings made by an undercover agent (UC) named Luis 
Lopez capturing activity inside of American Pain.\26\ In those 
recordings, Burt observed who he believed to be an American Pain 
employee inside the facility standing up in a waiting room full of 
patients and directing them ``not to have their prescriptions filled 
out of state, not to go out into the parking lot and snort their 
pills,'' and directing the patients to have their prescriptions filled 
``in house'' (meaning at American Pain), at ``a pharmacy they have in 
Orlando, Florida,'' or at ``a pharmacy they have down the street,'' 
which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26. 
Burt further testified that the purported employee on the recording 
told the patients to ``obey all the traffic laws; do not give the 
police a reason to pull you over.'' Id. Although Burt testified as to 
the contents of these recordings, the physical recordings were not 
offered into evidence by the Government or made available to opposing 
counsel.
---------------------------------------------------------------------------

    \25\ Tr. at 1002-05.
    \26\ 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.
---------------------------------------------------------------------------

    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, 
based on the investigative assistance he provided to the Palm Beach 
County, FL, Sheriff's Office (PBSO), Burt testified regarding the 
circumstances surrounding a confidential source's (CS3) visit to obtain 
controlled substances from

[[Page 19440]]

American Pain in October 2009.\27\ Burt stated that he was approached 
by an unnamed PBSO officer who advised that he had a confidential 
source ``that could go into American Pain and purchase oxycodone from 
one of the doctors.'' Id. at 870. Burt met CS3 at a predesignated 
location, at which time the source was searched for contraband and 
provided with a recording device prior to entering American Pain to 
visit the Respondent, whom he had a scheduled appointment with and had 
previously been seen by at the clinic. Id. at 871, 877, 1050. At a 
subsequent debriefing, Burt testified that ``the source told [him] that 
he went into the office with [the Respondent], put on the blood 
pressure cuff himself, took his own blood pressure, was given no 
physical exam by the doctor, and left with a prescription of 
oxycodone.'' Id. at 878. Burt testified that he was not able to 
simultaneously listen to the audio capturing the details of this office 
visit, and further admitted that has not reviewed the associated audio 
recording; instead, Burt's testimony was based on his review of a PBSO 
detective's written report and Burt's participation in the debriefing 
of CS3. Burt's testimony revealed that the investigative assistance of 
CS3 was secured as part of his cooperation with PBSO in relation to a 
pending criminal charge. Id. at 1047. Burt declined to disclose the 
name of CS3 when queried on cross-examination. Id. at 1045. The audio 
recording made by CS3 was not introduced by the Government into 
evidence or provided to opposing counsel.\28\ SA Burt was extremely 
vague and sketchy regarding the details of his encounter with CS3 
relative to the Respondent. Id. at 870-82. In fact, without a 
refreshment of his recollection, Burt was not even sure that CS3 met 
with the Respondent, and not another American Pain physician with the 
same last name. Id. at 871-77. This portion of his testimony was 
received over the vociferous objections of Respondent, based on lack of 
relevance, unfair prejudice, and the inability for meaningful cross-
examination based on a lack of access to either the recorded audio or 
even a witness who has heard the audio (or even knew the details of the 
visit), in conjunction with the absence of evidence of the name that 
would be on the patient chart reflecting the office visit. Tr. at 877-
82. Under the circumstances present here, including the tentative 
nature of his testimony as well as the manner in which it was produced, 
which, categorically denied the Respondent of any meaningful 
opportunity for the cross-examination required by the A.P.A.,\29\ this 
aspect of Burt's testimony may be accorded no weight. To proceed 
otherwise would deny the Respondent the ability guaranteed by the APA 
``to conduct such cross-examination as may be required for a full and 
true disclosure of the facts.'' 5 U.S.C. 556(d); see Richardson v. 
Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 F.3d 
1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 230 (7th 
Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 1980); see 
Tr. at 882.
---------------------------------------------------------------------------

    \27\ Tr. at 1046.
    \28\ Astonishingly, although SA Burt was offered by the 
Government as the proponent of all of the information relative to 
CS3, he conceded that he never listened to the audio tape created as 
a result of the wire worn by the informant. Tr. at 1051. According 
to Burt, the sum total of his awareness about the details regarding 
CS3 was gleaned from his presence at the post-encounter debriefing. 
Id.
    \29\ 5 U.S.C. 556(d).
---------------------------------------------------------------------------

    SA Burt also testified regarding the drug overdose deaths of TY and 
SM after obtaining controlled substances from American Pain.\30\ Burt's 
record testimony indicates that DEA Task Force Officer \31\ (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.\32\ Likewise, the record evidence concerning SM 
did not implicate prescribing activity by the Respondent.
---------------------------------------------------------------------------

    \30\ 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.
    \31\ 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.
    \32\ 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 testimony as noticed 
in the Government's prehearing statement.\33\ 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.
---------------------------------------------------------------------------

    \33\ 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.\34\ Dr. Kennedy, who testified that he is 
board certified by the American Board of Pain Medicine and the American 
Board of Anesthesiology,\35\ was offered and accepted as an expert in 
the field of pain medicine. Id. at 39.
---------------------------------------------------------------------------

    \34\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
    \35\ Tr. at 17.
---------------------------------------------------------------------------

    Dr. Kennedy testified that after a review of a group of selected 
patient files from those seized at the Respondent's practice that were 
to him provided by the Government, he

[[Page 19441]]

concluded that the Respondent's physical examinations, treatment plans, 
and patient histories were below the standard fixed by the Florida 
Medical Board and that that controlled substances was not for a 
legitimate medical purpose. Id. at 585-88.
    Dr. Kennedy took professional issue with several aspects of the 
Respondent's patient care as reflected in the charts regarding the 
prescribing of controlled substances. It is apparent from his testimony 
that Dr. Kennedy's analysis is restricted to those matters which can be 
gleaned from an examination of the written word in that subset of the 
Respondent's patient charts provided by the Government for his review, 
and that limitation perforce circumscribes the breadth of his input. 
That being said, Dr. Kennedy highlighted numerous features in the 
Respondent's chart documentation that he found wanting, or at least 
remarkable.
    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.

Id. at 357.
    Dr. Kennedy prepared a report in connection with the Government's 
case against the Respondent, which is dated April 30, 2010, and was 
admitted into evidence. Govt. Ex. 101; Tr. at 585. The report describes 
a general analysis of sixteen 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). Although this report purports to 
describe practices common to all sixteen files reviewed by Dr. Kennedy, 
much of the analysis is directed toward a chart prepared in connection 
with JS,\36\ one of the Respondent's patients.
---------------------------------------------------------------------------

    \36\ At the request of the Government, a protective order was 
issued that is designed to minimize the risk of the dissemination of 
identifying information related to patients and their relatives 
associated with this case. Accordingly, initials have been 
substituted for the names of individuals within the protection of 
the protective order throughout the body of this decision. ALJ Ex. 
15.
---------------------------------------------------------------------------

    Dr. Kennedy's report makes it unambiguously clear that, in his 
opinion, all sixteen of the Respondent's charts that he reviewed 
suffered from the same shortcomings.\37\ 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 [JS] referenced and discussed in this report in detail, 
[and that] there were no significant differences that affected [his] 
conclusions and summary.'' Govt. Ex. 101 at 2.
---------------------------------------------------------------------------

    \37\ 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.
---------------------------------------------------------------------------

    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''; \38\ (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; \39\ (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''; \40\ (4) 
contained medication contracts that were ``not always signed'' and 
``listed criteria that was not followed by the doctors at American 
Pain;'' \41\ (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' ''; \42\ (7) reflected ``no therapeutic plan, except to use 
controlled substances to `treat' the subjective complaint of `pain' 
which was inadequately described''; \43\ (8) reflected ``no real 
therapeutic goals * * * for improvement of quality of life (activities 
of daily living, work, sleep, mood)''; \44\ (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''; \45\ (10) reflected ``a gross lack of past 
medical records in all charts reviewed and in some cases none at all''; 
\46\ and, (11) demonstrated controlled substance patient monitoring 
practices that were ``not within the standard of care and was outside 
the boundaries of professional practice.'' \47\
---------------------------------------------------------------------------

    \38\ Govt. Ex. 101 at 5.
    \39\ Govt. Ex. 101 at 5. In Dr. Kennedy's opinion, the 
Respondent ``prescribed, at the first visit, very high initial doses 
of controlled substance combinations despite not being within 
standard of care for histories, physical examinations and/or absent 
past medical records.'' Id. at 8.
    \40\ Govt. Ex. 101 at 5.
    \41\ Govt. Ex. 101 at 4. As an example of the failure to adhere 
to the terms of the medication contract, Dr. Kennedy cites a 
contract term that provides notice that the physician may stop 
prescribing opioids or change treatment if pain or activity 
improvement is not demonstrated, and points out that pain and 
activity levels are routinely not documented in treatment notes. Id. 
at 4. Similarly, Dr. Kennedy references a medication contract 
warning that termination of services may result from failure to make 
regular follow-up appointments with primary care physicians, and 
notes that the American Pain charts contain no notes from primary 
care physicians or medical records generated by them. Id. at 4-5.
    \42\ Govt. Ex. 101 at 8. In Dr. Kennedy's opinion, Respondent 
``in effect, acted as a `barrier' for [JS] to receive appropriate 
medical evaluation and treatment. In other words, the very potent, 
high doses of opioids (oxycodone) and benzodiazepine (Xanax) may 
have masked [JS'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 13.
    \43\ Govt. Ex. 101 at 8.
    \44\ Govt. Ex. 101 at 8.
    \45\ Govt. Ex. 101 at 8.
    \46\ Govt. Ex. 101 at 17. JS's chart did not contain any past 
medical records, save for a Lumbar report from an MRI performed the 
day before JS's first clinic visit to see the Respondent. Id. at 11.
    \47\ Govt. Ex. 101 at 15.

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

[[Page 19442]]

    Dr. Kennedy found the Respondent's controlled substance patient 
monitoring to be deficient in numerous respects. From the reviewed 
patient charts, Dr. Kennedy gleaned that an initial, in-office urine 
drug screen was frequently executed during the patients' initial visit 
to the office but repeated only occasionally. Govt. Ex. 101 at 15. 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. at 15-16.
    The identified shortcomings of controlled substance patient 
monitoring systems was of particular significance where Dr. Kennedy 
identified specific evidence that he identified as ``red flags'' of 
possible or likely diversion. Red flags noted by Dr. Kennedy in the 
reviewed charts included the relatively young age of the Respondent's 
chronic pain patients,\48\ incomplete history information provided by 
the patients, periodically significant gaps between office visits,\49\ 
referrals from friends, relatives, or advertising, but not other 
physicians,\50\ 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.\51\
---------------------------------------------------------------------------

    \48\ Govt. Ex. 101 at 17.
    \49\ Govt. Ex. 101 at 15.
    \50\ Govt. Ex. 101 at 10, 17.
    \51\ Govt. Ex. 101 at 17.
---------------------------------------------------------------------------

    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. 101 at 3, 17. 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). 
Id. at 17. Significantly, however, when asked, Dr. Kennedy acknowledged 
that he conducts his own current medical practice on a cash-only basis. 
Tr. at 151.
    Regarding 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. Tr. 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.'' Tr. 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, the 
observations regarding referral sources are of limited value here.\52\
---------------------------------------------------------------------------

    \52\ 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 sixteen patient files that informed the analysis, 
findings and 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. For instance, in terms of evidence 
related to therapeutic plans, it is notable that Respondent's patient 
files contain at least some indications of recommended treatment 
modalities in addition to the Respondent's exclusive use of controlled 
substances for pain management. There are notations in the charts 
reflecting a patient was to see a ``PCP,'' or primary care physician, 
regarding jaundice, Govt. Ex. 108 at 9; in another patient file, a note 
listed under referrals reads ``ER for eval of Cellulite + Possible IV 
ATBx.'' Govt. Ex. 109 at 1.
    An examination of the reviewed patient charts does reveal the 
presence of other red flags that should have inspired additional 
diligence or inquiry on the part of the Respondent. RR's patient file, 
for example, contains a form indicating a positive UDS for oxycodone 
and benzodiazepine from 11/20/08, yet on the same date, the medication 
contract signed by RR is blank in that portion of the form designated 
for the patient to reveal any medications he or she is currently 
taking. Govt. Ex. 105 at 15, 31; see also Govt. Exs. 107 at 8-9, 21; 
109 at 46, 54-55; 114 at 8-9, 20 (similar issues). Patient RS's file 
indicates a positive test for oxycodone on 9/10/09, yet on her 
medication contract sharing the same date, she crosses out her 
handwritten listings of Percocet and Xanax, and notes ``*Sorry am not 
currently taking*.'' Govt. Ex. 110 at 10, 26. DS's patient file 
indicates a positive UDS for oxycodone and benzodiazepine only on 
January 14, 2010; however, the patient indicates elsewhere on a medical 
form filled out on the same date, in response to a question concerning 
whether she has taken any illegal or illicit drugs in the last 30 days, 
that she ``smoked some marijuana because of [her] cancer.'' This 
disclosure notwithstanding, the lack of an indication of a positive 
``THC'' result on the aforementioned UDS form is not addressed by the 
Respondent anywhere in the patient file. Govt. Ex. 112 at 10, 19. 
Patient JR's 7/17/09 UDS indicates a negative test for all listed 
substances, yet on two different forms dated 7/13/09 she indicates she 
is currently taking hydrocodone or Lortab, a discrepancy which raises 
questions about the validity of the testing procedures and/or the 
patient's candor. Govt. Exs. 106 at 12-13, 30; see also Govt. Ex. 113 
at 11-12, 29 \53\ (similar issue). Patient CA's \54\ UDS form, on the 
other hand, lists a positive test result for oxycodone only on 11/3/09, 
yet the patient states she is also currently taking Xanax elsewhere on 
the medical forms from the same date. Govt. Ex. 103 at 10-11, 24; see 
also Govt. Ex. 116 at 17-18, 42 (same issue). 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.
---------------------------------------------------------------------------

    \53\ Although the disclosed date the medications were last 
prescribed could provide a plausible explanation for the 
discrepancy, this misses the point. These types of inconsistencies 
raise potential red flags that require a prudent registrant to make 
additional inquiry and document, at a minimum, how the issue has 
been resolved to the satisfaction of the registrant before 
controlled substance prescriptions are issued.
    \54\ It is notable that patient ``CA'' is referred to using 
three different last names in the patient file records covering the 
period of time from 11/3/09 to 2/4/10, only one of which is present 
on her driver's license. See Govt. Ex. 103 at 1-2, 4, 8. This 
discrepancy is not addressed in any manner in the documentation.
---------------------------------------------------------------------------

    In addition to the lack of adequately completed forms in some 
patient files noted by Dr. Kennedy, other patient files appear to be 
missing key documentation altogether. For instance,

[[Page 19443]]

patient RR's file contains a South Florida Pain Management Clinic 
physical examination form that was not filled out, and no physical 
examination form is present in the file reflecting such an exam was 
conducted by the Respondent. See Govt. Ex. 105 at 9-10.
    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. 101 at 18.
    On cross examination, Dr. Kennedy agreed that he assumed, for the 
purposes of his analysis, that where the Respondent's charts reflected 
an entry or a procedure, that the event actually occurred. Tr. at 654. 
Kennedy also acknowledged that every one of the patient files he 
reviewed contained at least a complaint of chronic pain symptoms by the 
patient and MRI results that could support such a diagnosis. Id. at 
655-57.
    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,\55\ 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.\56\ 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.
---------------------------------------------------------------------------

    \55\ Tr. at 628.
    \56\ The Respondent did not testify on her own behalf.
---------------------------------------------------------------------------

The Analysis

    Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \57\ 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'':
---------------------------------------------------------------------------

    \57\ This authority has been delegated pursuant to 28 CFR 
0.100(b) and 0.104.

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

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

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

[[Page 19444]]

accept responsibility for [the established] misconduct, but also to 
demonstrate what corrective measures [have been] undertaken to prevent 
the reoccurrence of similar acts.'' Jeri Hassman, M.D., 75 FR 8194, 
8236 (2010).
    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Deputy Administrator that he or she can be entrusted with the 
responsibility commensurate with such a registration. Steven M. 
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 
(2007). Normal hardships to the practitioner, and even the surrounding 
community, that are attendant upon the lack of registration are not a 
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D. 
Owens, D.D.S., 74 FR 36751, 36757 (2009).
    The Agency's conclusion that past performance is the best predictor 
of future performance has been sustained on review in the courts, Alra 
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's 
consistent policy of strongly weighing whether a registrant who has 
committed acts inconsistent with the public interest has accepted 
responsibility and demonstrated that he or she will not engage in 
future misconduct. Hoxie, 419 F.3d at 483; George C. Aycock, M.D., 74 
FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 FR 
at 463; Medicine Shoppe, 73 FR at 387.
    While the burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S. 
91, 100-01 (1981), the Deputy Administrator's factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence.'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing 
two inconsistent conclusions from the evidence'' does not limit the 
Deputy Administrator's ability to find facts on either side of the 
contested issues in the case, Shatz, 873 F.2d at 1092; Trawick, 861 
F.2d at 77, all ``important aspect[s] of the problem,'' such as a 
respondent's defense or explanation that runs counter to the 
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v. 
DEA, 509 F.3d 541, 549 (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 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/ISO, 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 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

[[Page 19445]]

he should be entrusted with a DEA certificate. In some cases, viewing a 
registrant's actions against a backdrop of how he has performed 
activity within the scope of the certificate can provide a contextual 
lens to assist in a fair adjudication of whether continued registration 
is in the public interest.
    There are two principal considerations embedded within a 
consideration of this public interest factor. In considering a similar 
factor under the List I chemical context, the Agency has recognized 
that the level of experience held by those who will be charged with 
recognizing and taking steps to minimize diversion factors greatly in 
determining whether entrusting a COR will be in the public interest. 
See Volusia Wholesale, 69 FR 69409, 69410 (2004); Xtreme Enters., Inc., 
67 FR 76195, 76197-98 (2004); Prachi Enters., 69 FR 69407, 69409 
(2004); J&S Distribs., 69 FR 62089, 62090 (2004); K.V.M. Enters., 67 FR 
70968, 70969 (2002). The Agency has also recognized that evidence that 
a registrant may have conducted a significant level of sustained 
activity within the scope of the registration for a sustained period is 
a relevant and correct consideration, which must be accorded due 
weight. However, this factor can be outweighed by acts held to be 
inconsistent with the public interest. Experience which occurred prior 
and subsequent to proven allegations of malfeasance may be relevant. 
Evidence that precedes proven misconduct may add support to the 
contention that, even acknowledging the gravity of a particular 
registrant's transgressions, they are sufficiently isolated and/or 
attenuated that adverse action against its registration is not 
compelled by public interest concerns. Likewise, evidence presented by 
the Government that the proven allegations are consistent with a 
consistent past pattern of poor behavior can enhance the Government's 
case.
    In this case, the Respondent introduced no evidence regarding his 
level of knowledge and experience, or even the quality or length of his 
experience as a physician-registrant, but the Government has elected to 
do so.
    Regarding the Government's presentation, Agency precedent has long 
held that in DEA administrative proceedings 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 
introduced at the hearing is striking. For example, contrary to its 
allegations, there was no evidence that the Respondent ``prescribe[d] 
and dispense[d] inordinate amounts of controlled substances,'' that the 
``majority'' of the Respondent's patients were ``from states other than 
Florida,'' and there was no evidence that American Pain patients were 
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there 
evidence that individuals positioned outside the American Pain building 
were there to ``monitor the activity of patients in the parking lot to 
prevent patients from selling their recently obtained controlled 
substances.'' Likewise, no evidence was introduced at the hearing that 
could support the allegations that ``employees of American Pain [] 
frequently ma[d]e announcements to patients in the clinic advising them 
on how to avoid being stopped by law enforcement upon departing the 
pain clinic'' and ``frequently ma[d]e announcements [] advising 
[patients], among other things, not to attempt to fill their 
prescriptions at out-of state pharmacies and warning them against 
trying to fill their prescriptions at particular local retail 
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
    In like fashion, the Government's prehearing statement proffered 
that SA Burt would testify to several of the items described but not 
established in the OSC/ISO. Among the list of allegations that were not 
supported by any evidence introduced at the hearing, were 
representations that SA Burt would testify concerning the following:

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

ALJ Ex. 6 at 3-9.
    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 \58\ 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.
---------------------------------------------------------------------------

    \58\ The statutory definition of the term ``dispense'' includes 
the prescribing and administering of controlled substances. 21 
U.S.C. 802(10).

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

[[Page 19446]]

    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. Even apart from the 
unfortunate reality that one of the databases contained data that could 
not be directly tied to this Respondent as opposed to another with the 
same last name, 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 20th largest practitioner 
purchaser of oxycodone in the United States.'' \59\ 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.
---------------------------------------------------------------------------

    \59\ 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. at 
818, 910. Furthermore, that Burt observed an individual on a videotape, 
who he believed to be an American Pain employee, on a single occasion, 
instruct patients not to ``snort [their] pills'' in the parking 
lot,\60\ or advising them to comply with vehicle and traffic laws,\61\ 
does not shed illumination on the Respondent's prescribing practices. 
There was no evidence that the Respondent knew that these isolated 
incidents occurred, nor was there contextual evidence from which the 
relevance to these proceedings could be gleaned. Even if this tribunal 
was inclined to engage in the unsupported assignment of motives to the 
actions of these employees, under these circumstances, such an exercise 
could not constitute substantial evidence that could be sustained at 
any level of appeal.
---------------------------------------------------------------------------

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

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

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

    The Government's evidence targeted not only the Respondent's 
experience practicing under Factor 2, but also his compliance with 
applicable state and federal laws relating to controlled substances 
under Factor 4. To effectuate the dual goals of conquering drug abuse 
and controlling both legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the CSA.'' 
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the 
maintenance of that closed regulatory system, subject to limited 
exceptions not relevant here, a controlled substance may only be 
dispensed upon a prescription issued by a practitioner, and such a 
prescription is unlawful unless it is ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 U.S.C. 829; 21 CFR 1306.04(a). Furthermore, 
``an order purporting to be a prescription issued not in the usual 
course of professional treatment * * * is not a prescription within the 
meaning and intent of [21 U.S.C. 829] and the person knowingly * * * 
issuing it, shall be subject to the penalties provided for violations 
of the provisions of law related to controlled substances.'' Id.
    A registered practitioner is authorized to dispense,\63\ which the 
CSA defines as ``to deliver a controlled substance to an ultimate user 
\64\ * * * by, or pursuant to the lawful order of a practitioner.'' 21 
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 
(2007). The prescription requirement is designed to ensure that 
controlled substances are used under the supervision of a doctor, as a 
bulwark against the risk of addiction and recreational abuse. Aycock, 
74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006); 
United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that 
evidence established that a physician exceeded the bounds of 
professional practice when he gave inadequate examinations or none at 
all, ignored the results of the tests he did

[[Page 19447]]

make, and took no precautions against misuse and diversion)). The 
prescription requirement likewise stands as a proscription against 
doctors ``peddling to patients who crave the drugs for those prohibited 
uses.'' Id. The courts have sustained criminal convictions based on the 
issuing of illegitimate prescriptions where physicians conducted no 
physical examinations or sham physical examinations. United States v. 
Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 
1113 (2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 
1986).
---------------------------------------------------------------------------

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

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

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

Id. Sec.  458.331(m).
    In exercising its rulemaking function,\65\ the Florida Board of 
Medicine (Florida Board) promulgated a regulation addressing 
``Standards for Adequacy of Medical Records'' applicable to all 
physicians. Fla. Admin. Code r. 64B8-9.003 (2009). That regulation 
provides, in pertinent part:
---------------------------------------------------------------------------

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

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

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

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

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

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

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

    \67\ Pursuant to authority vested in the Florida Board by the 
Florida legislature to promulgate rules regarding State standards 
for pain management clinical practice specifically. Fla. Stat. Sec.  
458.309(5) (2009).
---------------------------------------------------------------------------

    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

[[Page 19448]]

within the state. Likewise, the level of integral range of acceptable 
practice that is built into the regulation underscores the importance 
of seeking an expert professional opinion in reaching a correct 
adjudication of whether a registrant has met the applicable Florida 
standard. It is clear that in assessing whether the controlled 
substance prescribing practices of a Florida practitioner fall within 
the acceptable range of what constitutes being within the bounds of 
being ``issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional practice,'' 
\68\ resort must be had to an expert.
---------------------------------------------------------------------------

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

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

to be for a legitimate medical purpose if based on accepted 
scientific knowledge of the treatment of pain or if based on sound 
clinical grounds. All such prescribing must be based on clear 
documentation of unrelieved pain and in compliance with applicable 
state or federal law.

Id. at 9.013(1)(e) (emphasis supplied).

    The Florida Standards further provide that the validity of 
prescribing will be judged ``based on the physician's treatment of the 
patient and on available documentation, rather than on the quantity and 
chronicity of prescribing'' (emphasis supplied). Id. at 9.013(1)(g). 
Furthermore, the Standards advise that physicians should not fear 
disciplinary action for ``prescribing controlled substances * * * for a 
legitimate medical purpose and that is supported by appropriate 
documentation establishing a valid medical need and treatment plan'' 
(emphasis supplied), or ``for failing to adhere strictly to the 
provisions of these standards, if good cause is shown for such 
deviation'' (emphasis supplied). Id. at 9.013(1)(b),(f).
    Although, as discussed above, the Florida Board instituted general 
guidance applicable to all physicians regarding medical records, it 
also promulgated a separate set of documentation requirements in the 
Florida Standards applicable specifically to those physicians who 
prescribe controlled substances in the pain-management context. The 
Florida Standards, under the subheading ``Medical Records,'' state that 
``[t]he physician is required to keep accurate and complete records'' 
(emphasis supplied) including, though not limited to:
    1. The medical history and physical examination, including history 
of drug abuse or dependence, as appropriate;
    2. Diagnostic, therapeutic, and laboratory results;
    3. Evaluations and consultations;
    4. Treatment objectives;
    5. Discussion of risks and benefits;
    6. Treatments;
    7. Medications (including date, type, dosage, and quantity 
prescribed);
    8. Instructions and agreements; and
    9. Periodic reviews.

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

    A complete \69\ medical history and physical examination must be 
conducted and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.
---------------------------------------------------------------------------

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

Id. at 9.013(3)(a).
    Furthermore, the Florida Standards require a written treatment plan 
that ``should state objectives that will be used to determine treatment 
success, such as pain relief and improved physical and psychosocial 
function, and should indicate if any further diagnostic evaluations or 
other treatments are planned.'' Id. at 9.013(3)(b). Subsequent to the 
initiation of treatment, ``the physician should adjust drug therapy to 
the individual medical needs of each patient. Other treatment 
modalities or a rehabilitation program may be necessary depending on 
the etiology of the pain and the extent to which the pain is associated 
with physical and psychosocial impairment.'' (emphasis supplied). Id.
    Another standard adopted by the Florida Board, under the subheading 
``Informed Consent and Agreement for Treatment,'' is the directive that

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

[[Page 19449]]

physician's prescribing practices are ``within the usual course of 
professional practice.'' Here, the uncontroverted expert opinion of Dr. 
Kennedy, the only expert opinion presented \70\ in 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 his 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).
---------------------------------------------------------------------------

    \70\ Respondent, in his brief, correctly points out that (for 
reasons not readily apparent) the Government elicited no testimony 
from Dr. Kennedy regarding any patient treated by the Respondent. 
Respt's Br. at 10-11.
---------------------------------------------------------------------------

    In his Post-Hearing Brief (Respondent's Brief), the Respondent's 
counsel has prepared and submitted a thoughtful and detailed review of 
one of the patient charts that was analyzed by Dr. Kennedy in his 
report. Respt's Br. at 22-26. While counsel argues that the patient 
chart entries were, at least by his interpretation of his client's 
obligations, satisfactory, the expert's opinion at the hearing remained 
unchanged. Even acknowledging, as this recommended decision does, that 
Dr. Kennedy's presentation was not without its deficiencies, its 
shortcomings do render it so fundamentally defective as to completely 
undermine his credibility and viability as within the scope of what a 
litigant may depend upon.\71\ As recognized in the Respondent's Brief, 
``the [G]overnment, like any party in a contested hearing, is free to 
hire an expert to advocate its position.'' Respt's Br. at 12. 
Unfortunately, counsel's analysis of the patient chart prepared by the 
Respondent is the product of a lay evaluation of standards applicable 
to the nuanced and sophisticated science that is the practice of 
medicine. Where his opinion and that of the only accepted medical 
expert to provide an expert opinion conflict, his opinion cannot and 
will not be afforded controlling deference. Argument supplied by 
counsel (albeit a diligent and persuasive counsel) that the relevant 
standards were satisfactorily applied as evidenced by the protocols and 
procedures documented in the patient charts cannot supplant the 
unrefuted view of an accepted expert witness.
---------------------------------------------------------------------------

    \71\ Likewise, contrary to the position taken by the Respondent 
in his brief (Respt's Br. at 7), Dr. Kennedy's opinions are not 
invalidated by the size of the representative sample of files he 
reviewed or the manner in which they were selected. Firstly, SA 
Langston provided credible testimony regarding the selection 
process, which although admittedly not a paradigm of scientific 
sampling methodology, was likewise not designed to achieve a 
particular result. Secondly, contrary to the assertion in the 
Respondent's brief (Respt's Br. at 15), there is no baseline magic 
number of files or registrant actions that must be examined to 
support an expert opinion and ultimately an Agency determination as 
to whether a registrant has committed acts inconsistent with the 
public interest sufficient to merit adverse action relative to a DEA 
COR. See Krishna-Iyer, 74 FR at 464.
---------------------------------------------------------------------------

    The Respondent, who was in a unique position to conclusively refute 
Dr. Kennedy's views and explain the format and nuances of the reviewed 
documentation, elected not to testify in this matter. At a DEA 
administrative hearing, it is permissible to draw an adverse inference 
from the silence of the Respondent, even in the face of a Fifth 
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) 
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence 
gains more probative weight where it persists in the face of 
accusation, since it is assumed in such circumstances that the accused 
would be more likely than not to dispute an untrue accusation.'')); 
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio 
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts 
of this case, where the allegations are of a nature that a registrant 
would be more likely than not to dispute them if untrue, an adverse 
inference based on the Respondent's silence is appropriate. Where, as 
here, the Government, through its expert, has alleged that the 
Respondent's charts do not reflect genuine analysis, but rather (at 
least in its view and the opinion of its expert), a sort of sham-by-
check-box form designed specifically to present a false impression of a 
compliant registrant, it is precisely the type of allegation that would 
naturally all but oblige a registrant to spring to offer a 
contradictory account. The Respondent's choice to remain silent in the 
face of such allegations, where he could have related his version of 
his practice as a registrant, adds at least some additional credence to 
the factual and analytical views of the Government's expert in this 
regard.
    In the Social Security context, where an Administrative Law Judge 
has received Expert medical opinions on the issue of the claimant's 
ability to work and they are not repudiated in any respect by 
substantial evidence, an adverse decision should be set aside as based 
on ``suspicion and speculation.'' Miracle v. Celebrezze, 351 F.2d 361, 
378 (6th Cir. 1965); see also Hall v. Celebrezze, 314 F.2d 686, 689-90 
(6th Cir. 1963); cf. Harris v. Heckler, 756 F.2d 431, 436 (6th Cir. 
1985) (improper to reject uncontroverted evidence supporting complaints 
of pain simply because of claimant's demeanor at hearing). When an 
administrative tribunal elects to disregard the uncontradicted opinion 
of an expert, it runs the risk of improperly declaring itself as an 
interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554 (6th 
Cir. 1966). While in this case it is ironically true, much like in the 
Social Security context, that the opinion of a treating physician 
should be afforded greater weight than the opinion of an expert whose 
opinion is limited to a review of the patient file, see Magallenes v. 
Bowen, 881 F.2d 747, 751 (9th Cir. 1989), the treating-source 
Respondent in this case offered no evidence, not even his own opinion, 
regarding the treatment rendered. Thus, in this adjudication, the 
record contains no dispute between experts to be resolved; instead, 
there is but one, unrefuted, uncontroverted, credible expert opinion. 
To ignore that expert opinion on this record and replace it with the 
opinion of this tribunal, Respondent's counsel, or any other lay source 
would be a dangerous course and more importantly, a plainly erroneous 
one.
    Accordingly, after carefully balancing the admitted evidence, the 
evidence establishes, by a preponderance, 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

[[Page 19450]]

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 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. 2011-8345 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P