Cynthia M. Cadet, M.D.; Decision and Order, 19450-19466 [2011-8342]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19450-19466]
From the Federal Register Online via the Government Printing 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 sig