Roni Dreszer, M.D.; Decision and Order, 19434-19450 [2011-8345]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19434-19450]
From the Federal Register Online via the Government Printing 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.

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[[Page 19442]]

    Dr. Kennedy found the Responde