[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\
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\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.
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\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 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).
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\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).
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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:
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\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.
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\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).
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\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