[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19450-19466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8342]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-34]


Cynthia M. Cadet, M.D.; Decision and Order

    On August 10, 2010, Administrative Law Judge (ALJ) John J. 
Mulrooney, II, issued the attached recommended decision.\1\ The 
Respondent did not file exceptions to the decision.
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    \1\ All citations to the ALJ's Decision (ALJ) are to the slip 
opinion as issued on August 10, 2010, and not to the attached 
decision which has been reformatted.
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    Having reviewed the entire record including the ALJ's recommended 
decision, I have decided to adopt the ALJ's rulings, findings of 
fact,\2\ conclusions of law,\3\ and recommended Order.
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    \2\ The ALJ found that there is ``no evidence that the 
Respondent `prescribe[d] and dispense[d] inordinate amounts of 
controlled substances.'' ALJ at 27. While there is no evidence as to 
the amounts Respondent may have dispensed directly, there is such 
evidence, which is unrefuted, with respect to her prescriptions. The 
Government's Expert specifically found that Respondent ``prescribed 
very high initial and subsequent doses of oxycodone and Xanax to 
[R.A.] excessively and inappropriately without adequate medical 
justification.'' GX 55, at 9 (emphasis added). The Government's 
Expert further noted that ``[t]he typical Xanax (alprazolam) 
starting dose is 0.25 to 0.5 mg. once to twice per day,'' yet 
Respondent prescribed ``high dose[s] of Xanax'' 2 mg. ``once to 
three times per day to 12 of the 13 `patients' whose files [he] 
reviewed'' without ``consider[ing] many important factors that cause 
anxiety'' and any ``previous medical evaluation''; she also not 
refer these patients ``to a mental health professional for 
evaluation.'' Id. at 10. The Expert thus concluded that ``[t]he 
treatment was with a very high dose of the controlled substance 
Xanax'' and ``was clearly not within the boundaries of professional 
practice.'' Id. Finally, the Expert provided unrefuted evidence that 
Respondent prescribed ``drug cocktails'' of oxycodone and Xanax, 
which ``were clearly not for any legitimate medical purpose.'' Id. 
at 13. I thus reject the ALJ's finding to the extent that it states 
that there was no evidence that Respondent prescribed 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 Dec. at 26-27. 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 FR49956, 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 her 
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 conclusion that Respondent violated the CSA's prescription 
requirement because she dispensed controlled substance prescriptions 
that were not ``within `the usual course of [her] professional 
practice,' '' ALJ at 39 (quoting 21 CFR 1306.04(a)), and that ``the 
evidence under the [experience] * * * factor[] support[s]'' the 
revocation of her registration, is consistent with Agency precedent. 
Id. at 40.
    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 40 (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'' is clearly supported by substantial evidence and 
warrants an adverse finding under factor five. Id. at 41.
    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 is necessarily dependent on the nature of the 
allegations and the other evidence in the case. Where, for example, 
the Government produces evidence of undercover visits showing that a 
physician knowingly engaged in outright drug deals, expert testimony 
adds little to the proof necessary to establish a violation of 
Federal law.

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[[Page 19451]]

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, BC8112637, issued to Cynthia M. Cadet, 
M.D., be, and it hereby is revoked. I further order that any pending 
application of Cynthia M. Cadet, 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.
    Glenn B. Kritzer, 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 BC8112637, of Cynthia M. Cadet, 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 her request, was conducted in Miami, Florida, on 
July 7, 2010 through July 9, 2010.\4\ The immediate suspension of the 
Respondent's COR has remained in effect throughout these proceedings.
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    \4\ Pursuant to an order issued on April 15, 2010, the hearing 
in this matter was consolidated with the cases of four other 
registrants who were working at the same clinic as the Respondent 
and who were also issued OSC/ISOs on February 25, 2010, alleging 
similar and related conduct.
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    The issue ultimately to be adjudicated by the Deputy Administrator, 
with the assistance of this recommended decision, is whether the record 
as a whole establishes by substantial evidence that Respondent's 
registration with the DEA should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. Sec. Sec.  823(f) and 
824(a)(4). The Respondent's DEA practitioner registration expires by 
its terms on August 31, 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 she had been participating in at American 
Pain, LLC (American Pain), has prescribed and dispensed inordinate 
amounts of controlled substances, primarily oxycodone,\5\ under 
circumstances where she 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 \6\ surrounding the manner in which American Pain had 
been operated and the manner in which its physicians, including 
Respondent, engaged in the practice of medicine. 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 little or no medical examination.'' Id. 
Lastly, as an additional ground for the OSC/ISO, the Government cites 
the death of one of Respondent's patients from an overdose of oxycodone 
and alprazolam \7\ one day after obtaining prescriptions for those same 
controlled substances from a visit to the Respondent at American Pain, 
and notes that the investigation determined the deceased patient 
``frequently made trips from his home in Kentucky to Florida pain 
clinics with others for the purpose of acquiring controlled substances 
for other than a legitimate medical purpose.'' Id.
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    \5\ A schedule II controlled substance.
    \6\ The majority of which are supported by no evidence 
introduced by the Government during the course of these proceedings.
    \7\ 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 
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.\8\ Id. at 721. Under Langston's supervision, DEA 
diversion investigators catalogued the prescriptions seized at Boca 
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. A review of the 
data relative to the Respondent on the Boca Drug Prescription Log 
reveals that from November 2, 2009 through November 25, 2009, 151 
controlled substance prescriptions issued over the Respondent's 
signature, to seventy-eight patients, only seven of whom resided in 
Florida. The remainder of the patients had listed addresses in 
Kentucky, Tennessee, Ohio, Georgia, West Virginia, Indiana, and 
Missouri. The log also reflected that the Respondent wrote one non-
controlled substance prescription to a patient for cyclobenzaprine, a 
muscle relaxant.
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    \8\ 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.

[[Page 19452]]

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 
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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 
\9\ or OUTSIDE the STATE OF FLORIDA.
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    \9\ 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.\10\ Govt. Ex. 119 at 2.
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    \10\ 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) \11\ 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. 50.
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    \11\ GS Langston explained that through the ARCOS system, 
``[d]rug manufacturers and distributors are required to report the 
sale of certain controlled substances to DEA,'' and the system 
``shows the history of a drug from the point of manufacture through 
the distribution chain to the retail dispensing level.'' Tr. at 685-
86.
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    In the same fashion, Langston explained the purposes of and 
circumstances behind the generation of State prescription monitoring 
reports (PMPs) relative to the Respondent maintained by West Virginia, 
Kentucky, and Ohio. Govt. Exs. 51-53. Review of the PMP report data 
reflects that during the time period of February 1, 2006 through 
February 11, 2010, pharmacies filled 166 controlled substance 
prescriptions issued over the Respondent's signature to fifty patients 
located in West Virginia, 124 similar prescriptions provided to fifty-
one Kentucky-based patients were filled between January 1, 2009 and 
April 4, 2010, and fifty-five 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.
    GS Langston provided evidence that was sufficiently detailed, 
consistent and plausible to be deemed credible in this recommended 
decision.
    SA Michael Burt testified that he has been employed by DEA since 
March 2004 and has been stationed with the Miami Field Division (MFD) 
since September 2004. Tr. at 813-14. Burt testified that he is the lead 
case agent for DEA in the investigation of American Pain Clinic and has 
participated in the investigation since the latter part of 2008. 
According to Burt, American Pain, which was previously known by the 
name South Florida Pain, has conducted business at four different 
locations, and he surveilled the Boca Raton and Lake Worth locations 
both in person and by periodic live review of video captured via pole 
cameras \12\ set up outside the clinic. Id. at 815-17. These pole 
cameras, which were in operation during a three week period from 
January to February 2010, were initially in operation on a 24 hour 
basis, but Burt testified that they were later activated only between 
the hours of 7:00 a.m. through 6:00 p.m. due to an observed lack of 
activity at the clinic outside of that time period. Id. at 820-21. The 
pole camera recordings were not offered into evidence at the hearing or 
made available to opposing counsel.
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    \12\ SA Burt described the pole cameras as ``covert cameras that 
are installed to observe the activity in the clinic.'' Tr. at 816. 
Burt testified that he was able to use a laptop to access the live 
video feed from the cameras after inputting a username and password. 
The camera video was also recorded to DVR. Id. at 821.
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    Based on these surveillance efforts, SA Burt testified concerning 
various activities he observed occurring outside the Boca and Lake 
Worth clinic locations, which were open to the public from 8 a.m. to 5 
p.m. At the Boca location, Burt stated that on any given day, beginning 
at 7 a.m. in the morning, automobiles could be seen pulling into the 
parking lot and approximately twenty to thirty people were routinely 
lined up outside of the clinic waiting to gain admittance. 
Additionally, there was a steady stream of automobile and foot traffic 
in and out of the clinic throughout the day. Id. at 817, 821. Burt 
testified that in his estimation, approximately 80-90 percent of the 
automobiles had out-of-State tags, predominantly from Kentucky, Ohio, 
West Virginia and Tennessee. Id. at 817-18. Burt also observed security 
personnel with ``staff'' written on their shirts \13\ riding around the 
exterior of the building in golf carts and who, in Burt's assessment, 
appeared to be directing patients into the American Pain facility. Burt 
indicated his surveillance of the

[[Page 19453]]

Lake Worth location yielded similar observations. Id. at 818.
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    \13\ Tr. at 910.
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    Based on his review of some (but not all) \14\ of the audio and 
video tapes made by agents and informers sent into the clinic by the 
Government at various times, SA Burt also testified about his 
understanding of the process by which patients obtained controlled 
substance prescriptions at American Pain. According to Burt, after 
entering the clinic, a patient would meet with the receptionist, who 
would determine if the patient had an MRI. If not, the receptionist 
would issue that individual an MRI prescription in exchange for a $50 
cash payment, and the patient ``would be directed to a place to obtain 
an MRI.'' Id. at 822. Burt testified that one such MRI location was 
Faye Imaging, which was a mobile MRI trailer located behind a 
gentlemen's club several miles away from American Pain. Id. at 822-23. 
The cost for the MRI was $250, and the patient could pay an additional 
fee ``to have the MRI expedited and faxed over to American Pain.'' Id. 
at 823-24. Once the MRI was procured and faxed to American Pain, the 
patient would return to the clinic and be seen by a doctor. According 
to Burt, the clinic accepted what he referred to as ``predominantly 
cash only'' \15\ for these office visits, and the six doctors at the 
clinic saw ``anywhere from 200 upward to 375 patients a day'' \16\ in 
this manner.\17\ Id. at 882-83 (emphasis supplied).
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    \14\ SA Burt conceded that although he is the designated lead 
case agent for DEA, he did not review all the audio and video tapes 
made in the case or even review the transcripts. Tr. at 1002-05.
    \15\ Later on cross-examination, SA Burt admitted that the 
clinic also accepted payment via credit card. Tr. at 916.
    \16\ Inasmuch as the Government provided no information from 
which any specific number of patients seen by any given clinic 
doctor on any day could be derived, or any expert testimony 
regarding a reasonable number of pain patients that could or should 
be seen per day, the value of providing the raw number of patients 
walking through the door at the clinic is negligible.
    \17\ Burt further testified that the doctors were paid $75.00 
per patient visit, id. at 884, but because he indicated that he 
could not disclose his basis of knowledge for this information, this 
portion of his testimony can be afforded no weight. See Richardson 
v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 
F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 
230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 
1980).
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    SA Burt also testified regarding his review of some \18\ of the 
video and audio recordings made by an undercover agent (UC) who assumed 
the name Luis Lopez capturing activity inside of American Pain.\19\ In 
those recordings, Burt observed who he believed to be an American Pain 
employee inside the facility standing up in a waiting room full of 
patients and directing them ``not to have their prescriptions filled 
out of State, not to go out into the parking lot and snort their 
pills,'' and directing the patients to have their prescriptions filled 
``in house'' (meaning at American Pain), at ``a pharmacy they have in 
Orlando, Florida,'' or at ``a pharmacy they have down the street,'' 
which, in Burt's view, was a reference to Boca Drugs. Id. at 825-26. 
Burt further testified that the purported employee on the recording 
told the patients to ``obey all the traffic laws; do not give the 
police a reason to pull you over.'' Id. Although Burt testified as to 
the contents of these recordings, the physical recordings were not 
offered into evidence by the Government or made available to opposing 
counsel.
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    \18\ Tr. at 1002-05.
    \19\ The fact that these recordings were made during the course 
of seven different office visits by an undercover agent to both the 
Boca Raton and Lake Worth locations was established on cross-
examination. Tr. at 900, 985.
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    SA Burt also testified that he received information from Dr. Eddie 
Sollie, a former physician employed during the time period American 
Pain was doing business as South Florida Pain, who terminated his 
employment at the Oakland Park clinic location in November or December 
2008 after working there for approximately two and a half to three 
months.\20\ Id. at 827, 898. During the course of an interview where 
Burt was present, Dr. Sollie related various ``concerns about how the 
practice was being handled or managed.'' Id. at 827-28. These concerns 
included medical records being, in his opinion, annotated inadequately 
by the doctors, and what he perceived as a lack of supervision during 
patient urinalysis testing, where patients would ``go[] to the 
bathrooms together, bringing items with them to the bathrooms that 
could possibly disguise the urinalysis.'' According to Burt, Sollie 
explained that he perceived that patients were substituting urine 
produced by other persons that contained the metabolites for controlled 
substances that the patients claimed to be legitimately taking, with a 
view towards falsely providing evidence to the American Pain doctors 
showing that they were actually taking prescribed medications and not 
diverting them. Id. at 828-29. During cross-examination, Burt explained 
that Dr. Sollie told him he had raised these concerns with Christopher 
George, the owner of American Pain, and that Burt had no evidence that 
the deficient practices that Sollie had objected to continued through 
2010. Id. at 900, 906. Burt also acknowledged that he was aware Dr. 
Sollie had been involved in litigation with Mr. George and that their 
relationship was strained. Id. at 1009. Dr. Sollie was not called as a 
witness by either party.
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    \20\ On cross-examination, Burt admitted the Respondent never 
worked at the South Florida Pain Clinic in Oakland Park, the 
facility where Sollie had previously been employed. Id. at 1027.
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    The Government also presented evidence through the testimony of SA 
Burt regarding the drug overdose deaths of TY and SM after obtaining 
controlled substances from American Pain.\21\ Burt's record testimony 
indicates that DEA Task Force Officer \22\ (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.\23\
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    \21\ 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.
    \22\ 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.
    \23\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and 
associated testimony).
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    SA Burt also testified that TFO Adams notified him about the 
overdose death of SM, whose body was found at his Kentucky home. Id. at 
854; Govt. Ex. 54 at 1. SM's death occurred on January 1, 2009, the day 
after his first and only appointment with the Respondent. Govt. Ex. 69. 
Pursuant to Burt's request, Adams provided him with a packet of various 
documents pertaining to SM's death, including a narrative police 
report, medical examiner's report and toxicology report, which were 
admitted into evidence. Govt. Ex. 54. Respondent, through counsel, 
introduced a more complete version of the report, obtained directly 
from the Rockcastle County Sherriff's Office (RCSO), which was also 
admitted into evidence (RCSO Investigation).\24\ Respt. Ex. 1.
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    \24\ Although SA Burt testified that he requested ``the complete 
report'' and ``all the documents'' relating to SM's death from TFO 
Adams, id. at 860, it was clear that the Government's version 
omitted a discomforting number of pages that should have been 
included. Respt. Ex. 1; Tr. at 1041-43. The Government's version 
included a toxicology report that was not present in the 
Respondent's version. Govt. Ex. 54 at 4-7.

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[[Page 19454]]

    The certificate of death contained in the RCSO Investigation 
reflects the coroner's finding of ``acute Oxycodone and Alprazolam 
intoxication'' as SM's cause of death. Govt. Ex. 54 at 2; Respt. Ex. 1 
at 7-8. The RCSO Investigation includes a narrative report, which 
states that the responding police officer reporting the incident 
procured various statements and paperwork from the decedent's parents 
indicating he ``had been going to a pain clinic in Ft. Lauderdale, FL 
[t]o receive pain medication,'' copied said documents, and placed them 
in his case file. Id. at 1. Record evidence of these copied materials, 
absent from the Government's exhibit submission or Burt's testimonial 
presentation, includes an American Pain business card listing ``1/28'' 
under the heading ``next appointment,'' and several prescription data 
printouts reflecting that on December 31, 2008, a prescription for 
oxycodone issued to SM by the Respondent was filled at Speedy Scripts 
Pharmacy in Fort Lauderdale. Respt. Ex. 1 at 21. The Respondent's 
patient chart pertaining to SM reflects that on the date of their first 
and only encounter, she issued prescriptions for oxycodone (15 mg), 
Roxicodone (30 mg), and Xanax (2 mg). Govt. Ex. 69 at 16. This is 
consistent with patient receipts provided to RCSO personnel by SM's 
mother. Respt. Ex. 1 at 17-22.
    Also absent from the Government's version of the RCSO Investigation 
is that several prescription vials were found on SM's body at the time 
of his death. One empty prescription vial indicates that it had once 
contained forty-five hydrocodone pills filled on December 2, 2008 
(twenty-eight days prior to his death and twenty-seven days prior to 
his first and only appointment with the Respondent), another empty 
hydrocodone vial indicates that it was filled on November 21, 2008 
(forty-one days prior to his death and forty days prior to his first 
and only appointment with the Respondent), and a third vial of 
tizanidine (a non-controlled substance) was filled on November 19, 2008 
(forty-three days prior to his death and forty-two days prior to his 
first and only appointment with the Respondent). Also found on the 
Respondent was a vial with what appeared to be marijuana seeds, baggies 
and a scale of a type that is commonly used in connection with drug 
paraphernalia. Respt. Ex. 1 at 4.
    Statements of interviews contained in the RCSO Investigation 
reflect that SM's friends and family were aware that he had a pain-
killer addiction that had its origins in the treatment of pain symptoms 
from an automobile accident and that he abused marijuana. Id. at 5, 25, 
26. Witness statements also reflect that SM was emotionally upset by a 
recent break up with a girlfriend. Id. at 4, 23-29.
    Although the coroner unambiguously concluded that ``[a]cute 
Oxycodone and Alprazolam intoxication'' was the cause of death,\25\ the 
autopsy also reflected evidence that SM had ingested other controlled 
substances, including marijuana and oxymorphone. Id. at 8; Govt. Ex. 54 
at 4-7; Tr. at 1033-38.
---------------------------------------------------------------------------

    \25\ Respt. Ex. 1 at 7; Govt. Ex. 54 at 2.
---------------------------------------------------------------------------

    When viewed in its entirety, SA Burt's record testimony was 
stunningly sparse when compared with his proposed testimony as noticed 
in the Government's prehearing statement.\26\ Indeed, perhaps among the 
more striking aspects of SA Burt's performance on the witness stand is 
the anticipated testimony which he did not provide. 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.
---------------------------------------------------------------------------

    \26\ 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.\27\ Dr. Kennedy, who testified that he is 
board certified by the American Board of Pain Medicine and the American 
Board of Anesthesiology,\28\ was offered and accepted as an expert in 
the field of pain medicine. Tr. at 39.
---------------------------------------------------------------------------

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

    Dr. Kennedy 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 concluded that the charts lacked 
the individualized treatment plans and the variety of diagnostic tools 
required to meet the minimally acceptable standards of practice in the 
State of Florida, that Respondent's prescribing practices and the 
documentation present in those patient files fell below the standards 
fixed by the Florida State Medical Board, and that the controlled 
substance prescriptions contained in those files were not issued for a 
legitimate medical purpose.\29\ Id. at 384-90.
---------------------------------------------------------------------------

    \29\ At the consolidated hearing in this matter, the Government 
elicited testimony from Dr. Kennedy regarding additional aspects of 
practice that he found deficient regarding the prescribing practices 
of other respondents. For example, Dr. Kennedy opined that the 
prescribing of 30 mg of oxycodone to an opioid na[iuml]ve patient 
would, in his opinion, be dangerous and improper. Similarly, Dr. 
Kennedy provided his opinion that the practice of ordering of an MRI 
prior to a physician meeting with a patient would be improper. 
However, regarding the charts that Dr. Kennedy reviewed relative to 
this Respondent, the government adduced no testimonial evidence 
regarding issues such as opioid na[iuml]vet[eacute] or the timing of 
MRI scripts, and it would be unfair, improper and illogical for an 
Administrative Law Judge to extrapolate the testimony elicited 
relative to the patients of other physician(s) to this Respondent. 
See Gregg & Son Distribs., 74 FR 17517 n.1 (2009) (data should be 
provided while record is open, and ``[t]o make clear, it is the 
Government's obligation as part of its burden of proof and not the 
ALJ's responsibility to sift through the records and highlight that 
information which is probative of the issues in the proceeding'') 
citing Southwood Pharms., Inc., 72 FR 36487, 36503 n.25 (2007). The 
absence of testimonial support by Dr. Kennedy on these issues 
relative to this Respondent does not adversely affect the weight to 
be attached to the conclusions set forth in the reports he prepared 
in connection with this Respondent which were received into 
evidence. Govt. Exs. 28, 131.
---------------------------------------------------------------------------

    At the hearing, Dr. Kennedy explained that he took professional

[[Page 19455]]

issue with several aspects of the Respondent's patient care as 
reflected in the charts regarding the prescribing of controlled 
substances. It is apparent from his testimony that Dr. Kennedy's 
analysis is restricted to those matters which can be gleaned from an 
examination of the written word in that subset of the Respondent's 
patient charts provided by the Government for his review, and that 
limitation perforce circumscribes the breadth of his testimony. That 
being said, Dr. Kennedy highlighted numerous features in the 
Respondent's chart documentation that he found wanting, or at least 
remarkable.
    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.

    In his testimony, Dr. Kennedy related that, in his expert opinion, 
although the information in the charts required a prudent physician to 
seek out prior medical records and/or input from prior medical 
providers, none of the Respondent's charts reflected any attempt to do 
so. Id. at 525, 527-28.
    Kennedy also explained the importance of establishing a 
differential or working diagnosis on the first visit and modifying and 
reviewing that diagnosis as more information and results become 
available. Id. at 52. Similarly, a diagnostic plan is a systematic 
methodology of eliminating possible causes of symptoms to allow the 
treating physician to accurately determine what is causing them so that 
a successful treatment plan can be developed. Id. at 52-53. In other 
words, the diagnostic plan allows the treating doctor to eliminate or 
confirm items on the differential diagnosis. Id. at 54. In Kennedy's 
view, the Respondent's charts did not reflect an adequate, deliberative 
differential diagnosis process. Id. at 477-78. The ultimate diagnosis 
conclusion, at least in Kennedy's view, appears assumed by the 
Respondent without supporting analysis. Id. at 478.
    In Kennedy's view, the treatment plans in the Respondent's chart 
were also infirm in that they were not sufficiently individualized. Id. 
at 386. Although, on cross examination, Kennedy conceded that at least 
one file recommended such things as yoga, stretching, vitamins and 
smoking cessation,\30\ his testimony supported the conclusion that 
every examined chart treated the patient primarily with controlled 
substances. Id. at 386, 472. Kennedy observed that comparing the 
patient charts,
---------------------------------------------------------------------------

    \30\ Tr. at 542-44.

    basically it's the same. [The patients are] given high-dose 
oxycodone and two different strengths. The Roxicodone 15 milligrams 
is twice a day. The Roxicodone 30 looks like it's been given six 
times a day in one case and eight times a day in another. Xanax is 
---------------------------------------------------------------------------
given at 2 miligrams.

Id. at 482.

    Although Dr. Kennedy conceded that it is the judgment of the 
examining physician that is generally relied upon in determining the 
necessity and appropriateness of diagnostic testing,\31\ he also 
testified that the Respondent's practice of routinely ordering magnetic 
resonance imaging (MRI) procedures before a physician meets with the 
patients was inappropriate because an MRI is not always required and 
not always appropriate. Id. at 71-73, 153-54. In Kennedy's opinion, a 
physician has an obligation to meet with the patient before including 
this procedure as part of the utilized diagnostic tools. Id. Kennedy 
noted that the Respondent's files reflected evidence that MRIs were the 
predominant diagnostic tool and were ordered prior to the patient's 
first interaction with her at a clinic visit. Id. at 385.
---------------------------------------------------------------------------

    \31\ Tr. at 59.
---------------------------------------------------------------------------

    While acknowledging that some standardization and utilization of 
forms is not, standing alone, improper,\32\ Dr. Kennedy took issue with 
what he perceived as flaws in the forms utilized by the Respondent to 
document patient care. According to Dr. Kennedy, many of the forms used 
by the Respondent omitted too much. Id. at 472-73, 486. The error was 
not so much that every blank space was not filled in, but that 
``important areas'' such as the pain scale were left blank. Tr. at 486.
---------------------------------------------------------------------------

    \32\ Tr. at 74.
---------------------------------------------------------------------------

    Dr. Kennedy prepared two reports in connection with the 
Government's case against the Respondent, which are dated April 28 and 
April 30, 2010, respectively, and both of which were admitted into 
evidence. Govt. Exs. 55, 132; Tr. at 381-82. One of the reports 
describes a general analysis of thirteen 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). Govt. Ex. 55. Although this 
report purports to describe practices common to all thirteen files 
reviewed by Dr. Kennedy, much of the analysis is directed toward a 
chart prepared in connection with RA,\33\ one of the Respondent's 
patients. A second report (Supplemental Chart Analysis) prepared by Dr. 
Kennedy focuses on the chart of SM, the Kentucky-resident patient of 
the Respondent described in the RCSO Investigation who died from an 
overdose of the same variety of medications prescribed by the 
Respondent on the day after his first appointment with her. Govt. Ex. 
132; Resp. Ex. 1; Tr. at 854-57. The Supplemental Chart Analysis notes 
that patient SM was seen by the Respondent at American Pain on December 
31, 2008 and indicates the presence of a note found in patient SM's 
file stating ``Deceased 12/31/08/1-1-09 O.D.'' Id. at 2.
---------------------------------------------------------------------------

    \33\ 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.
---------------------------------------------------------------------------

    Many of the observations and conclusions contained within the two 
reports are remarkably similar. Dr. Kennedy's report makes it 
unambiguously clear that, at least in his opinion, all fourteen of the 
Respondent's charts that he reviewed suffered from the same 
shortcomings. The Patient Charts Analysis states that the Respondent's 
patient charts reviewed by Dr. Kennedy ``are essentially the same with 
regard to review issues; as stated in the report of [RA] referenced and 
discussed in this report in detail, [and that] there were no 
significant differences that affected [his] conclusions and summary.'' 
Govt. Ex. 55 at 2. A like-worded proviso accompanies Dr. Kennedy's 
analysis of

[[Page 19456]]

SM's patient chart in the Supplemental Chart Analysis. Govt. Ex. 132 at 
1. When, on cross examination, Kennedy was directed to differences in 
exact wording, patient statements regarding chief complaints and dosage 
variations between patients,\34\ he explained that notwithstanding some 
variation between some details, his concern was that among all the 
files, at least in his view, ``the process is the same.'' Tr. at 477.
---------------------------------------------------------------------------

    \34\ Tr. at 470-74.
---------------------------------------------------------------------------

    It is interesting to note that the SM patient chart contains no 
indication that the Respondent made any efforts to contact any prior 
doctors, pharmacists or family members. Likewise, there is no 
indication that any effort was made to query Kentucky PMP databases. A 
check to any of these sources could have informed the Respondent that 
another physician had recently prescribed oxycodone and other 
medications to SM, that SM was, at least in the opinion of his family 
and friends, addicted to pain medicine and was abusing marijuana, and 
that SM was emotionally labile due to the recent estrangement he had 
with his girlfriend. Unfortunately, because the Respondent made no 
efforts to reach out for any of that information, she merely talked to 
SM, prescribed controlled substances, and SM perished by an overdose of 
the same variety of medication she prescribed.
    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; \35\'' (2) reflected prescriptions, right from the 
initial patient visit, that ``were almost entirely for controlled 
substances, most often one or two immediate release oxycodone pills 
with Xanax,'' and which were, in Dr. Kennedy's view, inappropriate and 
more powerful than justified by the objective signs documented in the 
written notes; \36\ (3) showed that ``the same or very similar `drug 
cocktails' were prescribed [among all patients in the reviewed files] 
in the same or very similar doses, [directions] * * * with a 30-day 
supply,'' and were affixed to the prescription scripts with a few 
prepared stamps utilized by all American Pain physicians that reflected 
``drug, dose, sig (directions) and quantity dispensed; \37\'' (4) 
contained medication contracts that were ``not always signed'' and 
``listed criteria that was not followed by the doctors at American 
Pain; \38\ (5) failed to document the efficacy of the prescribed 
medication; (6) did not set forth a ``diagnostic plan, except to obtain 
an occasional MRI, the results of which made no difference in the 
`treatment;' ''\39\ (7) reflected ``no therapeutic plan, except to use 
controlled substances to `treat' the subjective complaint of `pain' 
which was inadequately described; \40\ (8) did not reflect ``real 
therapeutic goals * * * for improvement of quality of life (activities 
of daily living, work, sleep, mood); ''\41\ (9) did not reflect 
``consultations with other physicians or specialists outside the 
American Pain group [which] could have and in some cases should have 
included orthopedics, neurology, neurosurgery, psychiatry, addiction 
medicine and psychology; ''\42\ (10) reflected ``a gross lack of past 
medical records in all charts reviewed and in some cases none at all; 
\43\'' and, (11) demonstrated controlled substance patient monitoring 
practices that were ``not within the standard of care and outside the 
boundaries of professional practice.'' \44\
---------------------------------------------------------------------------

    \35\ Govt. Ex. 55 at 4.
    \36\ Govt. Ex. 55 at 4. In Dr. Kennedy's opinion, the Respondent 
``prescribed, at the first visit, very high initial doses of 
controlled substance combinations despite not being within the 
standard of care for histories, physical examinations and/or absent 
past medical records [with] no apparent consideration given to 
patient safety with initial or subsequent prescription of controlled 
substance[s].'' Id. at 7.
    \37\ Govt. Ex. 55 at 4.
    \38\ As an example of the failure to adhere to the terms of the 
medication contract, Dr. Kennedy cites a contract term that provides 
notice that the physician may stop prescribing opioids or change 
treatment if pain or activity improvement is not demonstrated, and 
points out that pain and activity levels are routinely not 
documented in treatment notes. Govt. Ex. 55 at 4. Similarly, Dr. 
Kennedy references a medication contract warning that termination of 
services may result from failure to make regular follow-up 
appointments with primary care physicians, and notes that the 
American Pain charts contain no notes from primary care physicians 
or medical records generated by them. Id.
    \39\ Govt. Ex. 55 at 7. In Dr. Kennedy's opinion, Respondent
    in effect, acted as a `barrier' for [RA] to receive appropriate 
medical evaluation and treatment. In other words, the very potent, 
high doses of opioids (oxycodone) and benzodiazepine (Xanax) could 
cover up [RA's] underlying disease process(s), making it more 
difficult to diagnose, and allowing the disease(s) to unnecessarily 
worsen. Without an accurate diagnosis, all [the Respondent] was 
doing was, again, masking or covering up the symptoms.
    Id. at 10.
    \40\ Govt. Ex. 55 at 7.
    \41\ Govt. Ex. 55 at 8.
    \42\ Govt. Ex. 55 at 7.
    \43\ Govt. Ex. 55 at 15. The only past medical record contained 
in RA's chart was a report from an MRI conducted five months prior 
to the patient's initial clinic visit with the Respondent. Id. at 8.
    \44\ Govt. Ex. 55 at 14.
---------------------------------------------------------------------------

    Dr. Kennedy found the Respondent's controlled substance patient 
monitoring to be deficient in numerous respects. From the reviewed 
patient charts, Dr. Kennedy gleaned that an initial, in-office urine 
drug screen was frequently executed during the patients' initial visit 
to the office but repeated only occasionally. Govt. Ex. 55 at 14. It 
was Dr. Kennedy's observation that even a drug screen anomaly did not 
alter the seemingly inexorable continuation of controlled substance 
prescribing from the Respondent. Id. Dr. Kennedy also noted that the 
Respondent did not utilize out-of-office toxicology tests, or obtain 
out-of-State prescription monitoring program or outside pharmacy drug 
profiles. Furthermore, the charts contained only rare evidence of 
contact with primary care physicians, treating physicians, pharmacists, 
or other health care providers. Id.
    The identified shortcomings of controlled substance patient 
monitoring systems was of particular significance where Dr. Kennedy 
identified specific evidence that he identified as ``red flags'' of 
possible or likely diversion. In addition to providing incomplete and/
or inconsistent information on his patient questionnaires, SM's file 
reflected a positive urine screen test for the presence of 
benzodiazepines, opiates, and oxycodone, significant potential 
depression, and the failure to disclose information about his Kentucky-
based primary care and orthopedics treating physicians, and his 
physical therapist. Govt. Exs. 69, 132 at 6. Other red flags noted by 
Dr. Kennedy in the reviewed charts included the relatively young age of 
the Respondent's chronic pain patients,\45\ incomplete history 
information provided by the patients, periodically significant gaps 
between office visits,\46\ referrals from friends, relatives, or 
advertising, but not other physicians,\47\ and the fact that a 
relatively high number of patients were traveling significant distances 
to American Pain for pain treatment, although no physician employed at 
that facility had any specialized training in pain management.\48\
---------------------------------------------------------------------------

    \45\ Govt. Ex. 55 at 15.
    \46\ Govt. Ex. 55 at 13.
    \47\ Govt. Ex. 55 at 8, 15.
    \48\ Govt. Ex. 55 at 16.
---------------------------------------------------------------------------

    During the course of his testimony, Dr. Kennedy highlighted 
evidence in the chart of patient RA reflecting that although he 
disclosed to the Respondent that he was currently taking oxycodone and 
Xanax, and had last been prescribed a dosage that should have still 
been sufficient to supply him with medication on the day of his first 
office

[[Page 19457]]

visit, the urinalysis conducted on that day reflected negative results. 
Tr. at 548-56; Govt. Ex. 57 at 5, 7, 10, 26. Notwithstanding this 
obvious anomaly, the Respondent issued prescriptions for Roxicodone in 
15 and 30 mg doses and Xanax in a 2 mg dose. Govt. Ex. 57 at 19. 
Furthermore, based on the disclosed prior prescription amount and date, 
the issuance of these new prescriptions was at an earlier time than the 
prior prescriptions should have run out. Id. at 552-55. RA's chart 
reflects no inquiry, analysis, or even notation of these clear red 
flags. Id. at 554-55. Failing to inquire about these issues, according 
to Dr. Kennedy, fell below the standard of care that the Respondent 
should have exercised. Id. at 555.
    Similarly, Dr. Kennedy explained that regarding RR's patient chart, 
the paperwork generated at the time of the first visit with the 
Respondent reflected that he had been prescribed controlled substance 
medications that should have, but did not, yield positive urinalysis 
results. Id. at 556-60, 573-76; Govt. Ex. 63 at 8, 14, 17, 34. 
Additionally, the patient examination form filled out by the Respondent 
based on her interview with RR reflected a chief complaint that 
included radicular symptoms extending to both legs, but the patient-
completed questionnaire reflected that he did not have those symptoms. 
Tr. at 560-62; Govt. Ex. 63 at 8, 17. The chart did not contain 
additional inquiry regarding why the controlled substances were 
apparently not being taken by the patient or why the patient may not 
have had the symptoms the controlled substances were being prescribed 
to ameliorate. Dr. Kennedy testified that these discrepancies should 
have, but did not result in additional due diligence on the part of the 
physician. Tr. at 560-62.
    Although Dr. Kennedy agreed during cross examination that a 
possible explanation for a negative urinalysis could be that the 
medication was not taken within a few days of the urinalysis, Id. at 
567, this inquiry misses the point. The question is not whether there 
could be a benign explanation from the patient, it is whether an 
explanation of any type was sought by the registrant. Here, the 
Respondent faced an obvious red flag of potential diversion and made no 
effort to resolve the conflict as best as can be divined from the 
patient file she kept. Dr. Kennedy reasonably characterized this type 
of discrepancy as ``an inconsistency that should have been developed or 
should have been explored.'' Id. at 571. Dr. Kennedy offered the 
following explanation regarding the nature of the due diligence that 
such inconsistencies should engender on the part of a physician:

    The duty was to talk with the--the first thing you do is talk 
with the person, the individual, the patient, and find out if they 
have an explanation for that; was it a misunderstanding? Did they 
mean what they wrote down? And find out exactly what's going on and 
get their side, get their story, because your job is to advocate for 
them, and also, to help them from doing any harm to themselves.

Id. at 573.
    In his report, Dr. Kennedy also found it remarkable that each 
American Pain patient file provided notice to its patients that 
American Pain did not accept any form of health care insurance. Govt. 
Ex. 55 at 3-4, 16. Dr. Kennedy's report set forth his opinion that this 
practice was designed to ``effectively keep [the physicians at American 
Pain] `off the radar' from monitoring by any private health care 
insurance company as well as all State and Federal agencies (Medicaid 
and Medicare respectively). Govt. Ex. 55 at 16. Significantly, however, 
when asked, Dr. Kennedy acknowledged that he conducts his own current 
medical practice on a cash-only basis. Tr. at 151.
    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. Id. at 154. 
Further, Kennedy conceded while in the course of his own medical 
practice he has treated patients referred by family and friends, and 
that in his report he was focusing on what he perceived as a lack of 
any referrals by physicians in the files he reviewed, or what he 
perceived as ``trends'' or ``patterns.'' Id. at 154-55. Given Dr. 
Kennedy's acknowledgement that such referrals are not unusual, coupled 
with the absence of any way to measure the relative percentage of 
physician referrals in the Respondent's practice based on the record 
evidence, the observations regarding referral sources are of limited 
value here.\49\
---------------------------------------------------------------------------

    \49\ 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.
---------------------------------------------------------------------------

    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 [s]he was engaged in an efficient, ``[a]ssembly [l]ine'' 
business. H[er] ``patients'' were revenue streams, not true 
patients. This business allowed h[er] to collect cas[h] for office 
visits as well as being a ``[d]ispensing [p]hysician'' for 
controlled substances. [Sh]e prescribed controlled substances so 
that ``patients'' would return to h[er] office on a regular basis, 
allowing h[er] 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'' 
[s]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. 55 at 16.

    On cross examination at the hearing, Dr. Kennedy's attention was 
directed to what would seem, at least to a lay person, to present as 
including a significant level of detail set forth in the charts he 
reviewed relative to the Respondent's patient documentation, including 
both subjective complaints of discomfort and objective signs of medical 
anomalies. Tr. at 497-98, 532-42. Undaunted, Dr. Kennedy (the sole 
expert to testify at the hearing), remained committed to his position 
that the manner in which the documentation was completed was 
fundamentally insufficient and too omission-plagued for a physician to 
adequately proceed to treat the patients with controlled substances. 
Id. at 473-74, 489, 522, 525. Dr. Kennedy, more than once, 
characterized the Respondent's patient charts as demonstrating ``gross 
errors of omission.'' Id. at 522, 525.
    The Supplemental Chart Analysis focused exclusively on SM's chart, 
which contained information assembled on the date of his first and only 
visit to the Respondent's practice, which occurred on the day before he 
was pronounced dead of an overdose of the controlled substances 
prescribed to him by the Respondent. Govt. Exs. 69 at 10, 132, 54; 
Respt. Ex. 1. Among the deficiencies noted by Dr. Kennedy regarding 
SM's chart was an absence of any efforts to communicate with SM's prior 
physician or obtain prior medical records, and SM's failure to list any 
medications on the applicable portion of the medication contract. Govt. 
Ex. 132. Kennedy also opined that SM's failure to provide any contact 
information regarding his prior physician, who, like SM was located in 
Kentucky, should have presented a red flag to the

[[Page 19458]]

Respondent. Id. at 6. In his report, Kennedy characterized the 
Respondent's patient evaluation and treatment regarding SM as ``very 
clearly not within the standard of medical care.'' Id. at 7.
    A review of the fourteen patient files \50\ 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. Contrary to Kennedy's 
representations that the patients were all referred by friends, family, 
and advertising, patient JA's file contains a representation by the 
patient that he was referred to the clinic by a doctor. Govt. Ex. 56 at 
28. The significance of this anomaly is, however, diminished 
considerably by the fact that the doctor's name is never furnished by 
JA or presented anywhere in the chart.
---------------------------------------------------------------------------

    \50\ 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.
---------------------------------------------------------------------------

    Regarding Dr. Kennedy's objections to what he perceives as a 
virtually uniform pattern in the Respondent's therapeutic plans, the 
record is not without exception. For example, Respondent included 
notations in one patient's records referring him to see an oncologist 
based on potential liver cancer concerns. Govt. Ex. 68 at 9.
    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. GA's patient file 
contains a notation about the patient getting Roxicodone, Xanax, and 
Percocet ``off the street,'' a patient comfort assessment guide where 
GA states that his current treatments or medicine include ``street 
drugs,'' a medication contract that is signed but does not list any 
current medications at all, along with an initial positive urinalysis 
screen for opiates and oxycodone, yet the Respondent decided to 
prescribe all three substances to GA during his initial and subsequent 
visits. Govt. Ex. 58 at 8-9, 11, 35; see also Govt. Exs. 64 at 2; 66 at 
6; 67 at 22 (similar notations involving other patients acquiring 
controlled substances ``off the street'').
    Patient JA's file also contains an indication that he had 
previously received pain medications ``off the street,'' along with a 
police incident report referring to the armed robbery of two 
``Roxycotin'' (sic) prescriptions valued at $600 from the patient on 
12/31/09 (the same date on which the Respondent provided them to him), 
and which further contains a statement that ``[t]he victim completed a 
written statement affidavit, but refused to pursue criminal charges at 
this time.'' \51\ Govt. Ex. 56 at 2-3, 7.
---------------------------------------------------------------------------

    \51\ Notably, however, there is no indication in the patient 
file that the patient sought or received replacement prescriptions 
from the Respondent.
---------------------------------------------------------------------------

    JA's patient file also contains a form indicating a positive UDS 
for oxycodone and benzodiazepine from 10/7/09, yet on the same date, 
the patient comfort assessment guide and medication contract signed by 
JA are both blank in the section where a patient is supposed to list 
any medications he or she is currently taking. Govt. Ex. 56 at 13-14, 
30; see also Govt. Exs. 59 at 9-10, 24; 61 at 7-8, 19; 66 at 11-12, 29 
(similar issues). Patient RA's 11/2/09 UDS indicates a negative test 
for all listed substances, yet on two different forms in his file which 
appear to be from the same date, he indicates he is currently taking 
oxycodone and Xanax. Govt. Ex. 57 at 10-11, 26; see also Govt. Exs. 63 
at 14-15, 34; 67 at 9-10, 22 (similar issues). Patient RS's UDS form, 
on the other hand, lists a positive test result for oxycodone and 
benzodiazepine on 10/5/09, yet the patient states she is currently 
taking only oxycodone on a medication contract signed on the same date. 
Govt. Ex. 65 at 7, 18.
    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,\52\ he was unable to identify 
the documentation standard in the Florida Administrative code with any 
degree of particularity, he also acknowledged that he was not aware of 
what the standard is in Florida Medical Board administrative decisions 
regarding the overprescribing of medication or what constitutes an 
adequate medical history. Tr. at 149-51, 233, 304. While, overall, 
Kennedy presented testimony that appeared candid and knowledgeable, 
there were areas in his written report that rang of hyperbole and over-
embellishment. The reasoning behind some of the seemingly critical 
observations in the written report, such as the ``cash basis'' of the 
Respondent's practice and the absence of doctor referrals among the 
reviewed patient files, did not well survive the crucible of cross 
examination at the hearing. However, overall, Dr. Kennedy's testimony 
was sufficiently detailed, plausible, and internally consistent to be 
considered credible, and, consistent with his qualifications, he spoke 
persuasively and with authority on some relevant issues within his 
expertise, and notwithstanding the Respondent's objections relative to 
his Florida-related experience, he is currently an assistant professor 
teaching at a Florida Medical School. It may well be that the greatest 
and most significant aspect of Dr. Kennedy's opinion is that on the 
current record, it stands unrefuted. Thus, his opinion is the only 
expert opinion available for reliance in this action.\53\ 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.
---------------------------------------------------------------------------

    \52\ Tr. at 628.
    \53\ The Respondent did not testify on her own behalf.
---------------------------------------------------------------------------

The Analysis

    Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator \54\ 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'':
---------------------------------------------------------------------------

    \54\ 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.

[[Page 19459]]

    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f).
    ``[T]hese factors are considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of 
factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Deputy Administrator may properly give each 
factor whatever weight she deems appropriate in determining whether an 
application for a registration should be denied. JLB, Inc., d/b/a Boyd 
Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see 
also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70 
FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422 
(1989). Moreover, the Deputy Administrator is ``not required to make 
findings as to all of the factors * * *.'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (DC 
Cir. 2005). The Deputy Administrator is not required to discuss 
consideration of each factor in equal detail, or even every factor in 
any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 
1988) (the Administrator's obligation to explain the decision rationale 
may be satisfied even if only minimal consideration is given to the 
relevant factors and remand is required only when it is unclear whether 
the relevant factors were considered at all). The balancing of the 
public interest factors ``is not a contest in which score is kept; the 
Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest * * *.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462 
(2009).
    In an action to revoke a registrant's DEA COR, the DEA has the 
burden of proving that the requirements for revocation are satisfied. 
21 CFR 1301.44(e). Once DEA has made its prima facie case for 
revocation of the registrant's DEA Certificate of Registration, the 
burden of production then shifts to the Respondent to show that, given 
the totality of the facts and circumstances in the record, revoking the 
registrant's registration would not be appropriate. Morall, 412 F.3d at 
174; Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S. 
Dept. of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E. 
Johnston, 45 FR 72, 311 (1980). Further, ``to rebut the Government's 
prima facie case, [the Respondent] is required not only to accept 
responsibility for [the established] misconduct, but also to 
demonstrate what corrective measures [have been] undertaken to prevent 
the reoccurrence of similar acts.'' Jeri Hassman, M.D., 75 FR 8194, 
8236 (2010).
    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Deputy Administrator that he or she can be entrusted with the 
responsibility commensurate with such a registration. Steven M. 
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 
(2007). Normal hardships to the practitioner, and even the surrounding 
community, that are attendant upon the lack of registration are not a 
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D. 
Owens, D.D.S., 74 FR 36751, 36757 (2009).
    The Agency's conclusion that past performance is the best predictor 
of future performance has been sustained on review in the courts, Alra 
Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has the Agency's 
consistent policy of strongly weighing whether a registrant who has 
committed acts inconsistent with the public interest has accepted 
responsibility and demonstrated that he or she will not engage in 
future misconduct. Hoxie, 419 F.3d at 483; George C. Aycock, M.D., 74 
FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-Iyer, 74 FR 
at 463; Medicine Shoppe, 73 FR at 387.
    While the burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S. 
91, 100-01 (1981), the Deputy Administrator's factual findings will be 
sustained on review to the extent they are supported by ``substantial 
evidence.'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing 
two inconsistent conclusions from the evidence'' does not limit the 
Deputy Administrator's ability to find facts on either side of the 
contested issues in the case, Shatz, 873 F.2d at 1092; Trawick, 861 
F.2d at 77, all ``important aspect[s] of the problem,'' such as a 
respondent's defense or explanation that runs counter to the 
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v. 
DEA, 509 F.3d 541, 549 (DC Cir. 2007); Humphreys, 96 F.3d at 663. The 
ultimate disposition of the case must be in accordance with the weight 
of the evidence, not simply supported by enough evidence to justify, if 
the trial were to a jury, a refusal to direct a verdict when the 
conclusion sought to be drawn from it is one of fact for the jury. 
Steadman, 450 U.S. at 99 (internal quotation marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in 
application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (DC Cir. 2008) 
(citing Butz v. Glover Livestock Comm. Co., Inc., 411 U.S. 182, 188 
(1973)), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). It is 
well-settled that since the Administrative Law Judge has had the 
opportunity to observe the demeanor and conduct of hearing witnesses, 
the factual findings set forth in this recommended decision are 
entitled to significant deference, Universal Camera Corp. v. NLRB, 340 
U.S. 474, 496 (1951), and that this recommended decision constitutes an 
important part of the record that must be considered in the Deputy 
Administrator's decision, Morall, 412 F.3d at 179. However, any 
recommendations set forth herein regarding the exercise of discretion 
are by no means binding on the Deputy Administrator and do not limit 
the exercise of that discretion. 5 U.S.C. 557(b); River Forest 
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney 
General's Manual on the Administrative Procedure Act 8 (1947).

Factors 1 and 3: The Recommendation of the Appropriate State Licensing 
Board or Professional Disciplinary Authority and Conviction Record 
Under Federal or State Laws Relating to the Manufacture, Distribution, 
or Dispensing of Controlled Substances

    In this case, it is undisputed that the Respondent holds a valid 
and current State license to practice medicine. The record contains no 
evidence of a recommendation regarding the Respondent's medical 
privileges by any cognizant State licensing board or professional 
disciplinary authority. However, that a State has not acted against a 
registrant's medical license is not dispositive in this administrative 
determination as to whether continuation of a registration is 
consistent with the public interest. Patrick W. Stodola, M.D., 74 FR 
20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at 461. It is well-
established Agency precedent that a ``state license is a necessary, but 
not a sufficient condition for registration.'' Leslie, 68 FR at 15230; 
John H. Kennedy, M.D., 71 FR 35705, 35708 (2006). Even the 
reinstatement of a State medical license does not affect

[[Page 19460]]

the DEA's independent responsibility to determine whether a 
registration is in the public interest. Mortimer B. Levin, D.O., 55 FR 
9209, 8210 (1990). The ultimate responsibility to determine whether a 
registration is consistent with the public interest has been delegated 
exclusively to the DEA, not to entities within State government. Edmund 
Chein, M.D., 72 FR 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 
(DC Cir. 2008), cert. denied, ---- U.S. ----, 129 S.Ct. 1033 (2009). 
Congress vested authority to enforce the CSA in the Attorney General 
and not State officials. Stodola, 74 FR at 20375. Thus, on these facts, 
the fact that the record contains no evidence of a recommendation by a 
State licensing board does not weigh for or against a determination as 
to whether continuation of the Respondent's DEA certification is 
consistent with the public interest.
    Similarly, regarding Factor 3, while testimony was received at the 
hearing 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 her practice relative to prescribing and 
dispensing controlled substances and acts allegedly committed in 
connection with her 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 she has been in the business of 
doing so are factors to be evaluated in reaching a determination as to 
whether she should be entrusted with a DEA certificate. In some cases, 
viewing a registrant's actions against a backdrop of how she 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 her 
level of knowledge and experience, or even the quality or length of her 
experience as a physician-registrant, but the Government has elected to 
do so.
    Regarding the Government's presentation, Agency precedent has long 
held that in DEA administrative proceedings ``the parameters of the 
hearing are determined by the prehearing statements.'' CBS Wholesale 
Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, D.M.D., 61 
FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 36758, 
36759-60 (2009) (``pleadings in administrative proceedings are not 
judged by the standards applied to an indictment at common law'' and 
``the rules governing DEA hearings do not require the formality of 
amending a show cause order to comply with the evidence''). That being 
said, however, the marked difference between the amount of evidence 
that the Government noticed in its OSC/ISO and the amount that it 
introduced at the hearing is striking. For example, contrary to its 
allegations, there was no evidence that the Respondent ``prescribe[d] 
and dispense[d] inordinate amounts of controlled substances,'' that the 
``majority'' of the Respondent's patients were ``from states other than 
Florida,'' and there was no evidence that American Pain patients were 
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there 
evidence that individuals positioned outside the American Pain building 
were there to ``monitor the activity of patients in the parking lot to 
prevent patients from selling their recently obtained controlled 
substances.'' Likewise, no evidence was introduced at the hearing that 
could support the allegations that ``employees of American Pain [] 
frequently ma[d]e announcements to patients in the clinic advising them 
on how to avoid being stopped by law enforcement upon departing the 
pain clinic'' and ``frequently ma[d]e announcements [] advising 
[patients], among other things, not to attempt to fill their 
prescriptions at out-of State pharmacies and warning them against 
trying to fill their prescriptions at particular local retail 
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
    In like fashion, the Government's prehearing statement proffered 
that SA Burt would testify to several of the items described but not 
established in the OSC/ISO. Among the list of allegations that were not 
supported by any evidence introduced at the hearing, were 
representations that SA Burt would testify concerning the following:

    Law enforcement in Florida and [other states that correspond to 
license plates seen in the American Pain parking lot] frequently 
arrest people for illegal possession and/or illegal distribution of 
controlled substances who have obtained the controlled substances 
from American Pain;
    American Pain hired individuals to ``roam'' the parking lot of 
the clinic to dissuade people from selling their recently obtained 
controlled substances on the property;
    [The reason American Pain placed] signs within American Pain 
warning individuals not to have their prescriptions filled at 
Walgreens pharmacies [is] because Walgreens refuses to dispense the 
prescriptions;
    Walgreens has flagged all American Pain doctors and will not 
fill any of their prescriptions;
    [Physical exams at American Pain are] usually no more than a 
blood pressure check and some bending and stretching;

[[Page 19461]]

    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 University of Tennessee v. Elliot, 478 U.S. 
788, 797-98 (1986) (``When an administrative agency is acting in a 
judicial capacity and resolves disputed issues of fact properly before 
it which the parties have had an adequate opportunity to litigate, the 
courts have not hesitated to apply res judicata[.]'')
    The evidence the Government did present raises issues regarding not 
only Factor 2 (experience dispensing \55\ 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 her 
practice complied with the law and/or was a threat to the public.
---------------------------------------------------------------------------

    \55\ The statutory definition of the term ``dispense'' includes 
the prescribing and administering of controlled substances. 21 
U.S.C. 802(10).
---------------------------------------------------------------------------

    While true that GS Langston convincingly testified about the course 
of her investigation and laid an adequate foundation for numerous 
database results, the Government provided no foundational context for 
any relevant uses for those database results. Without some insight into 
what types of results from these databases should be expected when 
compared to similarly-situated registrants engaged in acceptable 
prescribing practices, the raw data is without use. In short, there was 
no evidence elicited wherein the percentage of the Respondent's in-
State to out-of State patients could be assessed, and no reasonable 
measuring stick based on sound principles upon which to evaluate such 
data. Likewise, there was no reliable yardstick upon which to measure 
the amount of controlled substances reflected in the databases compared 
to what a reasonable regulator would expect to see regarding a 
compliant registrant. To the extent Langston possessed this information 
(and she well may have) it was not elicited from her. The same could be 
said of the allegation set forth in the Government's Prehearing 
Statement that alleges that from a given period the Respondent ``was 
the 12th largest practitioner purchaser of oxycodone in the United 
States.'' \56\ 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.
---------------------------------------------------------------------------

    \56\ 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,\57\ or advising them to comply with vehicle and traffic laws,\58\ 
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.
---------------------------------------------------------------------------

    \57\ Tr. at 825.
    \58\ 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,\59\ and that 
some patients were intentionally evading the American Pain urinalysis 
process. Also, as highlighted in Respondent's Post-Hearing Brief 
(Respondent's Brief), Sollie did not work at American Pain at the same 
time the Respondent did,\60\ and did not specifically name any 
physician as being connected with his allegations of misconduct. 
Respt's Br. at 11. 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 this Respondent's authorization 
to handle

[[Page 19462]]

controlled substances is in the public interest.
---------------------------------------------------------------------------

    \59\ Tr. at 898.
    \60\ Tr. at 1026-27.
---------------------------------------------------------------------------

    The Government's evidence targeted not only the Respondent's 
experience practicing under Factor 2, but also her 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 her 
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,\61\ which the 
CSA defines as ``to deliver a controlled substance to an ultimate user 
\62\ * * * 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 she gave inadequate examinations or none at 
all, ignored the results of the tests she did make, and took no 
precautions against misuse and diversion)). The prescription 
requirement likewise stands as a proscription against doctors 
``peddling to patients who crave the drugs for those prohibited uses.'' 
Id. The courts have sustained criminal convictions based on the issuing 
of illegitimate prescriptions where physicians conducted no physical 
examinations or sham physical examinations. United States v. Alerre, 
430 F.3d 681, 690-91 (4th Cir. 2005), cert. denied, 574 U.S. 1113 
(2006); United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986).
---------------------------------------------------------------------------

    \61\ 21 U.S.C. 823(f).
    \62\ ``Ultimate user'' is defined as ``a person who has lawfully 
obtained, and who possesses, a controlled substance for his own use 
or for the use of a member of his household or for an animal owned 
by him or by a member of his household.'' 21 U.S.C. 802(27).
---------------------------------------------------------------------------

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

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

Id. Sec.  458.331(m).

    In exercising its rulemaking function,\63\ 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:
---------------------------------------------------------------------------

    \63\ 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

[[Page 19463]]

any controlled substance under Schedules II-V * * * to a person for 
the treatment of intractable pain,\64\ 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.
---------------------------------------------------------------------------

    \64\ 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,\65\ 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.
---------------------------------------------------------------------------

    \65\ Pursuant to authority vested in the Florida Board by the 
Florida legislature to promulgate rules regarding State standards 
for pain management clinical practice specifically. Fla. Stat. Sec.  
458.309(5) (2009).

    Like the Model Policy, which was promulgated ``to encourage the 
legitimate medical uses of controlled substances for the treatment of 
pain while stressing the need to safeguard against abuse and 
diversion,'' Florida's regulation providing ``Standards for the Use of 
Controlled Substances for Treatment of Pain,'' Fla. Admin. Code r. 
64B8-9.013 (2009) (Florida Standards), recognizes that ``inappropriate 
prescribing of controlled substances * * * may lead to drug diversion 
and abuse by individuals who seek them for other than legitimate 
medical use.'' The language employed by the regulation under the 
preamble section titled ``Pain Management Principles'' makes clear that 
the standards ``are not intended to define complete or best practice, 
but rather to communicate what the [Florida Board] considers to be 
within the boundaries of professional practice'' (emphasis supplied), 
id. at 9.013(1)(g); thus, the plain text supports an inference that the 
standards provide the minimum requirements for establishing conduct 
that comports with the professional practice of controlled substance-
based pain management within the State. Likewise, the level of integral 
range of acceptable practice that is built into the regulation 
underscores the importance of seeking an expert professional opinion in 
reaching a correct adjudication of whether a registrant has met the 
applicable Florida standard. It is clear that in assessing whether the 
controlled substance prescribing practices of a Florida practitioner 
fall within the acceptable range of what constitutes being within the 
bounds of being ``issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice,'' \66\ resort must be had to an expert.
---------------------------------------------------------------------------

    \66\ 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 \67\ 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.
---------------------------------------------------------------------------

    \67\ 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

[[Page 19464]]

is incompetent. The patient should receive prescriptions from one 
physician and one pharmacy where possible. If the patient is 
determined to be at high risk for medication abuse or have a history 
of substance abuse, the physician should employ the use of a written 
agreement between the physician and patient outlining patient 
responsibilities, including, but not limited to:
    1. Urine/serum medication levels screening when requested;
    2. Number and frequency of all prescription refills; and
    3. Reasons for which drug therapy may be discontinued (i.e., 
violation of agreement.

Id. at 9.003(3)(c).

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

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

Id.

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

    [t]he physician should be willing to refer the patient as 
necessary for additional evaluation and treatment in order to 
achieve treatment objectives. Special attention should be given to 
those pain patients who are at risk for misusing their medications 
and those whose living arrangements pose a risk for medication 
misuse or diversion. The management of pain in patients with a 
history of substance abuse or with a comorbid psychiatric disorder 
requires extra care, monitoring, and documentation, and may require 
consultation with or referral to an expert in the management of such 
patients.

Id. at 9.003(3)(e).
    It is abundantly clear from the plain language of the Florida 
Standards that the Florida Board places critical emphasis on physician 
implementation of adequate safeguards in their practice to minimize 
diversion and the need to document the objective signs and rationale 
employed in the course of pain treatment utilizing the prescription of 
controlled substances. Conscientious documentation is repeatedly 
emphasized as not just a ministerial act, but a key treatment tool and 
a vital indicator to evaluate whether the physician's prescribing 
practices are ``within the usual course of professional practice.'' 
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert 
witness to testify at these proceedings, reflects that the 
documentation he reviewed in the Respondent's patient charts reflected 
care that was markedly below the standard of care set by the Florida 
Medical Board. Dr. Kennedy's expert assessment was consistent with the 
State statutory and regulatory guidance. In Kennedy's view, the 
Respondent's charts demonstrated minimalistic, incomplete, and 
otherwise medically inadequate documentation of her contacts with 
patients and the prescribing rationale for her 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 her practice of medicine in a manner to minimize 
the potential of controlled substance abuse and diversion, and supports 
a conclusion that she failed to even substantially comply with the 
minimum obligations for professional practice imposed under the Florida 
Standards--and without ``good cause [] shown for such deviation.'' Id. 
at 9.013(1)(f). The same can be said of the multiple ignored red flags 
of diversion risk, such as the seeking of premature controlled 
substance prescription refills and the urinalysis anomalies highlighted 
by Dr. Kennedy in his testimony.
    In his brief, the Respondent's counsel has prepared and submitted a 
thoughtful and detailed review of the patient charts analyzed by Dr. 
Kennedy. Respt's Br. at 5-10. While counsel argues that the patient 
chart entries were satisfactory, the expert's opinion at the hearing 
remained unchanged. Unfortunately, counsel's analysis is the product of 
a lay evaluation of standards applicable to the nuanced and 
sophisticated science that is the practice of medicine. An example of 
the problem encountered here can be seen where counsel urges that the 
medication contract clause requiring patients to follow-up with their 
primary care physicians was somehow satisfied by the patient following 
up with the Respondent. Id. at 7. Whether a pain specialist can serve 
as (or morph into) a primary care physician sufficiently to satisfy a 
medication contract term is beyond the expertise of this tribunal, and 
requires the input of an expert witness. Also illustrative of the 
potential risks of blurring the line between expert and lay opinion is 
counsel's argument that regarding the reviewed charts, ``[s]ections 
that were not filled in include details that are not necessarily 
indicated for [the Respondent's] evaluation of a patient for chronic 
pain therapy.'' Id. at 9. A lay person is simply not in a position to 
contradict otherwise reliable expert testimony regarding which details 
are ``necessarily indicated'' for inclusion in the chart of a pain 
management specialist. Where the opinion of counsel offered through 
argument and the opinion of the only accepted medical expert to provide 
an expert opinion in these proceedings conflict, counsel's opinion 
cannot and will not be afforded controlling deference. Argument 
supplied by counsel (albeit a diligent and persuasive counsel) that the 
relevant standards were satisfactorily applied as evidenced by the 
protocols and procedures documented in the patient charts cannot 
supplant the unrefuted view of an accepted expert witness.
    The Respondent, who was in a unique position to conclusively refute 
Dr. Kennedy's views and explain the format and nuances of the reviewed 
documentation, elected not to testify in this matter. At a DEA 
administrative hearing, it is permissible to draw an adverse inference 
from the silence of the Respondent, even in the face of a Fifth 
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) 
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence 
gains more probative weight where it persists in the face of 
accusation, since it is assumed in such circumstances that the accused 
would be more likely than not to dispute an untrue accusation.'')); 
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio 
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts 
of this case, where the allegations are of a nature that a registrant 
would be more likely than not to dispute them if untrue, an adverse 
inference based on the Respondent's silence is appropriate. Where, as 
here, the Government, through its expert, has alleged that the 
Respondent's charts do not reflect genuine analysis, but rather (at 
least in its view and the opinion of its expert), a sort of sham-by-
check-box form designed specifically to present a false impression of a 
compliant registrant, it is precisely the type of allegation that would 
naturally all but oblige a registrant to spring to offer a 
contradictory account. The Respondent's choice to remain silent in the 
face of such allegations, where she

[[Page 19465]]

could have related her version of her 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 her 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 of the evidence, that the 
prescriptions the Respondent issued in Florida were not issued within 
``the usual course of [the Respondent's] professional practice.'' 21 
CFR 1306.04(a). Consideration of the evidence under the second and 
fourth factors support the COR revocation sought by the Government in 
this case.
    To the extent that the Respondent's prescribing practices fell 
below the requisite standard in Florida, that conduct also impacts upon 
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is 
authorized to consider ``other conduct which may threaten the public 
health and safety.'' 21 U.S.C. 823(f)(5). Although this factor 
authorizes consideration of a somewhat broader range of conduct 
reaching beyond those activities typically associated with a 
registrant's practice, an adverse finding under this factor requires 
some showing that the relevant conduct actually constituted a threat to 
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
    Although admittedly not argued in the Government's brief, nowhere 
is the application of this fifth public interest factor more 
crystallized on this evidence than it is regarding the handling of SM. 
Inasmuch as there is no question that multiple controlled substances 
were identified in the decedent's body at the moment of death that were 
prescribed by multiple physicians, it would be difficult-to-impossible 
to precisely discern whether there was a specific one that could be 
isolated as the sole cause of his demise. An analysis centered on which 
physician's name appeared on the vial that produced the ultimately 
fatal dose misses the point. Even if it were conclusively established 
that a medication that was legitimately prescribed in the usual course 
of a professional practice resulted in an adverse consequence--even 
death--that fact alone would not necessarily decide the issue here. The 
practice of medicine has not yet developed to a condition of such 
mathematical precision that it is free of adverse consequences 
resulting from good-faith efforts on the part of treating physicians. 
The real focus of this aspect of this decision is not to conclusively 
divine which medication ultimately was the most lethal, or even which 
practitioner authorized it, but to evaluate whether the Respondent's 
prescribing practices resulted in prescriptions which were not issued 
in the usual course of a professional practice and whether her 
prescribing practices contributed to SM's death. The patient chart 
relative to SM reflected that no efforts were made to procure prior 
medical records, information from family or friends, or even to perform 
a Kentucky PMP database query. Performing the tasks that Dr. Kennedy 
opined were required by a prudent practitioner would have revealed, at 
a minimum, that SM had an addiction to pain killers, was abusing 
marijuana, was receiving controlled substance prescriptions from 
another physician and was in the midst of some manner of significant 
emotional-psychological event. None of that was done. In the case of 
SM, the Respondent did what she apparently routinely did: She 
prescribed controlled substances without performing the steps that were 
required to ensure that the prescriptions were being issued for a 
legitimate medical purpose. In the case of SM, while it is possible, 
even likely, that increased curiosity and professional attention and 
action on the Respondent's part could have saved his life, that 
determination is not required for a disposition of this case. While 
experts could argue the point of which medication actually killed him, 
there seems very little room for argument that the Respondent's poor 
prescribing practices were very problematic relative to this decedent 
and serve as a grave reminder of the potential consequences of failing 
to take the steps required by a prudent registrant to ensure the safety 
of the public. Consideration of the Respondent's conduct under Factor 5 
balances significantly in favor of revocation.
    The evidence establishes that the Respondent engaged in a course of 
practice wherein she prescribed controlled substances to patients 
irrespective of the patients' need for such medication and ignoring any 
and all red flags that could or did indicate likely paths of diversion. 
The testimony of Dr. Kennedy, the DEA regulations, and the Florida 
Standards make clear that physicians prescribing controlled substances 
do so under an obligation to monitor the process to minimize the risk 
of diversion. The patient charts reflect that the Respondent, contrary 
to her obligations as a DEA registrant, did not follow up in the face 
of multiple red flags. The Respondent's disregard of her obligations as 
a DEA registrant and Federal and State laws related to controlled 
substances militate in favor of revocation.
    By ignoring her responsibilities to monitor the controlled 
substance prescriptions she 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

[[Page 19466]]

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 her application to renew. 
The Respondent has not accepted responsibility for her actions, 
expressed remorse for her conduct at any level, or presented evidence 
that could reasonably support a finding that the Deputy Administrator 
should continue to entrust her 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. 2011-8342 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P