[Federal Register Volume 76, Number 67 (Thursday, April 7, 2011)]
[Notices]
[Pages 19386-19401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8340]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-36]


Jacobo Dreszer, M.D., Decision and Order

    On August 10, 2010, Administrative Law Judge (ALJ) John J. 
Mulrooney, II, issued the attached recommended decision.\1\ Thereafter, 
Respondent filed exceptions to the decision.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    Having reviewed the entire record including the ALJ's recommended 
decision and Respondent's exceptions, I have decided to adopt the ALJ's 
rulings, findings of fact,\2\ conclusions of law,\3\ and recommended 
Order.
---------------------------------------------------------------------------

    \2\ The ALJ found that there is ``no evidence that the 
Respondent `prescribe[d] and dispense[d] inordinate amounts of 
controlled substances.'' ALJ at 21. While there is no evidence as to 
the amounts Respondent may have dispensed directly, there is such 
evidence, which is unrefuted, with respect to his prescriptions. As 
explained in my discussion of Respondent's Exceptions, an Expert 
witness testified as to the usual starting doses of oxycodone and 
Xanax and that the prescriptions Respondent issued for both drugs, 
even at the initial visit, greatly exceeded the usual starting doses 
and lacked a legitimate medical purpose. 21 CFR 1306.04(a). 
Moreover, there is also unrefuted evidence that Respondent's 
prescribing of drug cocktails of oxycodone and Xanax lacked a 
legitimate medical purpose. 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 20-21. 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 his 
wrongdoing. Krishna-Iyer, 74 FR at 463.
    In any event, Respondent offered no evidence on the issue of his 
experience in dispensing controlled substances and the ALJ's 
ultimate conclusion that Respondent violated the CSA's prescription 
requirement because he dispensed controlled substance prescriptions 
that were not ``within `the usual course of [his] professional 
practice,'' ALJ at 33 (quoting 21 CFR 1306.04(a)), and that ``the 
evidence under the [experience] * * * factor[] support[s]'' the 
revocation of his registration, is consistent with Agency precedent. 
Id.
    With respect to factor five, ``[s]uch other conduct which may 
threaten public health and safety,'' 21 U.S.C. 823(f)(5), the ALJ 
opined that ``an adverse finding under this factor requires some 
showing that the relevant conduct actually constituted a threat to 
public safety.'' ALJ at 34 (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. ALJ at 34.
    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 29 (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.

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

[[Page 19387]]

    Respondent first takes exception to the ALJ's acceptance of L. 
Douglas Kennedy, M.D., as an expert on the proper prescribing of 
controlled substances. Respondent contends that Dr. Kennedy should not 
have been permitted to opine on his prescribing practices because he 
does not hold a DEA registration in Florida, has not prescribed a 
controlled substance since 2004, does not currently have either a 
medical office or hospital privileges in Florida, and ``has never 
practiced medicine regularly in Florida and has not practiced medicine 
in Florida at all in over 10 years.'' Resp. Exc. at 1.
    Respondent's contention is unavailing as Dr. Kennedy was clearly 
qualified to render an expert opinion on the proper practice for 
prescribing controlled substances to treat pain and whether 
Respondent's controlled substance prescriptions were issued in the 
usual course of professional practice and for a legitimate medical 
purpose. See 21 CFR 1306.04(a). Dr. Kennedy currently holds a Florida 
medical license, is a diplomate of both the American Board of Pain 
Medicine and the American Board of Anesthesiology, and is currently on 
the faculty of the University of Miami's Miller School of Medicine. GX 
117, at 1, 10. Previously, Dr. Kennedy was a Fellow with the Pain 
Therapy Unit of the Cleveland Clinic, served as the Director of Chronic 
Pain Management at the University of Kentucky Medical Center, and, for 
fourteen years, was the Medical Director of a multidisciplinary pain 
medicine and rehabilitation practice. Id. at 1-2.
    Dr. Kennedy has published several articles and book chapters on 
pain management issues and has made several dozen presentations on pain 
management issues at professional meetings.\4\ Id. at 3-7. In addition, 
he is a member of several professional organizations including the 
American Academy of Pain Medicine, the American Board of Pain Medicine, 
the American Pain Society, the International Association for the Study 
of Pain, the American Society of Addiction Medicine, the American Board 
of Anesthesiology, and the American Society of Anesthesiology. Id. at 
10; Tr. 22. Finally, Dr. Kennedy explained that he was familiar with 
the Florida Board of Medicine's standards for prescribing controlled 
substances to treat pain and that he had reviewed them prior to 
preparing his report. Tr. 24-26; GX 76, at 5-6.
---------------------------------------------------------------------------

    \4\ He also co-edited and contributed to the State of Kentucky's 
Guidelines for Prescribing Controlled Substances, 2nd Edition. GX 
117, at 9.
---------------------------------------------------------------------------

    Thus, Dr. Kennedy was clearly qualified to provide expert 
testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony 
was sufficiently reliable to constitute substantial evidence on the 
issue of whether Respondent acted within the usual course of 
professional practice and had a legitimate medical purpose in 
prescribing controlled substances to the patients whose files he 
reviewed and reject this exception.
    Next, Respondent contends that Dr. Kennedy's opinion testimony is 
entitled to no weight because it was based on only seventeen patient 
charts, which Respondent maintains were not randomly selected and is 
too small a sample to draw sufficient conclusions about the validity of 
his prescribing practices. Resp. Exc. at 2. Based on Dr. Kennedy's 
testimony that `` `[i]t might not be fair' '' to `` `cherry-pick[]' '' 
a small and non-random sample of charts out of a physician's patients 
because this might not provide `` `a reasonable representation of what 
the practice was actually like,' '' Respondent argues that ``[e]ven 
improper prescribing practices reflected in a small and non-random 
sample of 17 charts * * * may be `an administrative issue for education 
with the Board of Medical License' '' and not necessarily justify the 
revocation of Respondent's medical license (or DEA registration). Id. 
(quoting Tr. 645).
    However, even acknowledging that two of the seventeen files 
reviewed by Dr. Kennedy with respect to Respondent were not randomly 
selected (one being that of an undercover officer), the ALJ found 
credible the Diversion Investigator's testimony that the files were not 
specially selected to enhance the strength of the Government's case. 
ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal 
law that a prescription ``must be issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice,'' 21 CFR 1306.04(a), applies to each and every 
prescription issued by a practitioner. Thus, contrary to the Expert's 
understanding, in determining whether a practitioner has committed acts 
which render his registration ``inconsistent with the public 
interest,'' 21 U.S.C. 824(a)(4), the Government is not required to 
randomly select the files which it will base its case on.
    For example, where the Government has developed information that 
particular patients are drug dealers or engaged in self-abuse, it is 
not required to ignore the files pertaining to these patients and base 
its case on a random sample of files. Rather, it can select the files 
pertaining to those patients and base its case entirely on them. 
Moreover, where the Government has seized files, it can review them and 
choose to present at the hearing only those files which evidence a 
practitioner's most egregious acts. Of course, where, as here, the 
Government's case relies so heavily on a chart review, the practitioner 
can put on his own evidence and argue that the Government's evidence 
does not establish that he violated the prescription requirement; the 
practitioner can also argue that even

[[Page 19388]]

though the Government has made out a prima facie case, his conduct was 
not so egregious as to warrant revocation. See Paul Caragine, 63 FR 
51592 (1998) (granting restricted registration where practitioner did 
not engage in intentional misconduct, patients had legitimate medical 
conditions requiring treatment, and practitioner accepted 
responsibility and testified as to remedial measures he had 
undertaken). See also Dewey C. MacKay, 75 FR at 49977 (revoking 
registration based on intentional acts of diversion to two patients); 
Krishna-Iyer, 74 FR at 463 (holding that DEA can revoke based on a 
single act of diversion); Medicine Shoppe-Jonesborough, 73 FR at 386 & 
n.56; Alan H. Olefsky, 57 FR 928, 929 (1992) (revoking registration 
based on physician's single act of presenting two fraudulent 
prescriptions to pharmacist where physician failed to acknowledge 
wrongdoing).\5\ Accordingly, there is no merit to Respondent's 
exception.
---------------------------------------------------------------------------

    \5\ Consistent with DEA's longstanding precedent, see ALJ at 17, 
a respondent is also entitled to put on evidence as to his 
acceptance of responsibility and any remedial measures he has 
undertaken to prevent the re-occurrence of similar acts.
---------------------------------------------------------------------------

    Finally, Respondent takes exception to the ALJ's findings that he 
violated Florida's standards for prescribing controlled substances. 
Resp. Exceptions at 4-5. More specifically, Respondent contends that he 
complied with the standards set forth under Florida regulations and 
that he ``took a complete medical history and conducted a physical 
evaluation that was documented,'' that he maintained ``medical records 
documenting the patient's intensity of pain, current and past 
treatments for pain, and the effect of pain on physical and 
psychological function.'' Id. at 4-5. He further argues that ``[h]e set 
out a written treatment plan, discussed the risks and benefits of 
controlled substances and conducted periodic reviews'' as also required 
by Florida's regulations. Id. at 5.
    While it is true that Dr. Kennedy acknowledged that he was not 
familiar with the specific standard imposed by the State of Florida for 
excessive prescribing and that he had not reviewed any Florida Medical 
Board decisions addressing the issue of what is an adequate medical 
history, see ALJ at 15, in his report Dr. Kennedy discussed at length 
the Florida Board of Medicine's Standards for the Use of Controlled 
Substances for the Treatment of Pain, Fla. Admin. Code 64B8-9.013.\6\ 
See GX 76, at 5-6.
---------------------------------------------------------------------------

    \6\ Even after Gonzales v. Oregon, 546 U.S. 243 (2006), several 
courts of appeals, including the Eleventh Circuit, ``have applied a 
general-practice standard when determining whether the practitioner 
acted in the `usual course of professional practice.''' United 
States v. Smith, 573 F. 3d 639, 647-48 (8th Cir. 2009); see also id. 
at 648 (discussing United States v. Moore, 423 U.S. 122 (1975); 
``Thus informed by the Supreme Court and other controlling and 
persuasive precedent, we believe that it was not improper to measure 
the `usual course of professional practice' under Sec.  841(a)(1) 
and [21 CFR] 1306.04 with reference to generally recognized and 
accepted medical practices * * * .''). To similar effect, the 
Eleventh Circuit has held that ``[t]he appropriate focus * * * rests 
upon whether the physician prescribes medicine `in accordance with a 
standard of medical practice generally recognized and accepted in 
the United States.' '') (United States v. Merrill, 513 F.3d 1293, 
1306 (11th Cir. 2008) (quoting Moore, 423 U.S. at 139)).
---------------------------------------------------------------------------

    In any event, Respondent produced no evidence that his 
recordkeeping and prescribing complied with the standards of the 
Florida Medical Board. Moreover, there is substantial evidence to 
support the conclusion that Respondent was not engaged in legitimate 
medical practice and was diverting drugs.
    As Dr. Kennedy explained, the patients whose files he reviewed were 
relatively young (with an average age of 36), and most were from out-
of-state, with some travelling up to 1200 miles,\7\ even though 
Respondent had no specialized training in pain management. Id. at 15-
16. Yet, Respondent did not obtain reports from the prescription 
monitoring programs run by the States where his patients lived. Id. at 
1-2; 14. Moreover, Respondent did not obtain adequate medical histories 
and perform adequate physical examinations; he also never obtained 
medical records from other treating physicians (or even contacted them) 
for any of the patients whose files are in evidence. Id. at 4, 8-9.
---------------------------------------------------------------------------

    \7\ Of the seventeen patients, only four were from Florida. Of 
the remaining patients, five were from Kentucky, three were from 
Ohio, two were from Tennessee and West Virginia, and one was from 
Georgia. GX 76, at 1.
---------------------------------------------------------------------------

    As Dr. Kennedy explained, while ``[t]he chart was set up to give 
the appearance of a legitimate medical practice in an attempt to 
justify the initial and continued prescription and dispensing of high 
dose multiple controlled substances (`drug cocktails'),'' and that 
while ``on the surface [the charts] were adequate for evaluating and 
treating a patient,'' on closer review, ``the actual contents in the 
charts, clearly evidence just the opposite'' as the charts were ``very 
difficult * * * to read [with] many sections * * * left blank or 
incompletely filled in.'' Id. at 15. Continuing, Dr. Kennedy explained 
that ``[t]he notes were not within the standard of care; all were 
outside the boundaries of professional practice, lacking significant 
information and ignoring significant history that was present.'' Id. 
Moreover, Respondent's failure to obtain his patients' medical records 
``was well outside the boundaries of medical practice and below the 
standard of medical care,'' especially because the patients were 
receiving ``very high dose[s]'' of controlled substances. Id.
    The evidence further shows that this case is not simply a matter of 
inadequate record keeping. While Respondent apparently required his 
patients to obtain an MRI, in multiple instances the MRI was obtained 
before the patient was even evaluated by Respondent, and generally, no 
other imaging studies such as x-rays or CT scans were done.\8\ Id. at 
14-15.
---------------------------------------------------------------------------

    \8\ Dr. Kennedy explained that referring a patient to obtain an 
MRI prior to having some contact is unusual and medically 
inappropriate. Tr. 71-73.
---------------------------------------------------------------------------

    Moreover, notwithstanding the doses the patients were seeking, 
Respondent rarely referred a patient to another physician or health 
care professional for a consultation.\9\ As Dr. Kennedy explained, 
``[a]lternative opinions should have been sought in order to better 
diagnose and treat; not to do so was outside the boundaries of 
professional practice and not within the standard of care.'' Id. at 14. 
Dr. Kennedy thus concluded that Respondent's ``diagnoses were usually 
very vague and/or without medical merit'' and were done in an 
``attempt[] to justify what controlled substances he prescribed.'' Id. 
at 15.
---------------------------------------------------------------------------

    \9\ In only two of the seventeen files is there an indication 
that Respondent referred the patient to another physician.
---------------------------------------------------------------------------

    Dr. Kennedy also observed that while Respondent performed urine 
drug screens, he ignored the results even when they were inconsistent 
with other information provided by the patients such as when a patient 
tested positive for controlled substances which he had previously 
indicated that he was not currently taking. See id. at 11, 14. 
Moreover, the drug screens were rarely performed other than at the 
patient's initial visit and lacked quality controls.\10\ Id. at 14.
---------------------------------------------------------------------------

    \10\ Dr. Kennedy explained that the urine drug screens did not 
indicate the temperature and specific gravity of the specimen, 
whether the giving of the sample had been observed, or the type of 
drug screen used. GX 76, at 14; Tr. 100-01.
---------------------------------------------------------------------------

    Although the charts indicate that Respondent discussed doing yoga 
and stretching, using an anti-inflammatory diet, and taking several 
over-the-counter supplements (fish oil and glucosamine chondroitin), 
Respondent's treatment plan primarily involved prescribing high doses 
of controlled substances with the same regimen of drugs (oxycodone and 
Xanax) prescribed in nearly every case. Id. at 4, 6-7, 13. And while 
Respondent referred two patients to

[[Page 19389]]

their primary care physicians because they had high blood pressure, see 
GXs 78, 79; he never referred any patients for consultations with 
specialists, or for physical, occupational, or mental health therapy. 
GX 76, at 11.
    Dr. Kennedy noted that Respondent frequently prescribed ``drug 
cocktails'' of two strengths of oxycodone immediate release and a high 
dose of Xanax, a benzodiazepine. Id. at 4, 9, 13. While Dr. Kennedy 
acknowledged that prescribing an additional strength of oxycodone could 
be legitimate if it was done to treat breakthrough or episodic pain on 
an as-needed basis, with respect to M.B., who received prescriptions 
for oxycodone 30 mg. and 15 mg., ``there was no specific reason stated 
in the medical record'' for prescribing both drugs. Id. at 9.
    Dr. Kennedy further noted that while the typical starting dose of 
Xanax is 0.25 to 0.5 mg., once to twice per day, Respondent prescribed 
Xanax 2 mg., twice per day, to fifteen of the seventeen patients 
(including M.B.); another patient B.R. (GX 87) received Xanax 2 mg. 
once per day.\11\ Id. at 9-10; GXs 78-86, 88-93. Moreover, Respondent 
prescribed this dose even for patients who had not been on the drug 
either before or recently and ``no matter the [patient's] age or 
clinical situation.'' GX 76, at 10. While Xanax is used as an anti-
anxiety agent, Respondent's medical records did not support the 
prescribing because ``[h]e did not list * * * many important factors 
that could cause anxiety * * * such as depression, life stressors, 
psychosocial situation, caffeine intake, sleep disturbance [and] 
previous medical evaluation;'' he also did not refer these patients for 
evaluation by a mental health professional. Id. With respect to M.B., 
Dr. Kennedy observed not only that ``there was no specific reason 
stated in the medical record'' for prescribing Xanax, but also that 
Respondent's prescribing of a very high dose of the drug ``was clearly 
not within the boundaries of professional practice.'' Id. at 9-10.
---------------------------------------------------------------------------

    \11\ The remaining patient, L.A., received Valium 10 mg. GX 77.
---------------------------------------------------------------------------

    Dr. Kennedy further noted that beginning with M.B.'s first visit, 
Respondent ``prescribed very high initial and subsequent high doses of 
oxycodone and Xanax'' and that these drugs ``were prescribed 
excessively and inappropriately without medical justification.'' Id. at 
9. Sections of the history and physical examination form ``were grossly 
incomplete or missing entirely,'' and Respondent did not identify 
``past treating and prescribing physicians'' and communicate them 
regarding M.B.'s previous treatment (and obtain medical records) even 
though M.B. had indicated that he had previously seen a doctor and had 
physical therapy for his condition. Id. at 9; GX 78, at 16.
    While M.B. apparently told Respondent that he was taking 210 to 240 
oxycodone 30 mg. per month, which he had obtained ``off the street,'' 
and he also tested positive for the drug in a urine drug screen (UDS) 
done at his initial visit, Respondent prescribed 180 Roxicodone 30 mg., 
60 Roxicodone 15 mg., and 60 Xanax 2 mg. to M.B. at each of the seven 
visits he made between August 20, 2009 and February 4, 2010. GX 78, at 
7, 9, 13, 18-24.
    M.B.'s statement that he was getting ``large quantities of 
oxycodone 30 mg. pills `off the street''' was a clear ``warning sign'' 
that he was ``at high risk for drug abuse, addiction and/or 
diversion.'' GX 76, at 12; see also id. at 8. Yet, as Dr. Kennedy 
observed, Respondent ``did not appropriately act on the initial UDS'' 
and M.B.'s admission that he had obtained drugs off the street by 
requiring him to undergo ``[f]urther testing.'' Id. at 11. Indeed, 
``[t]here were no other UDS tests obtained [after the initial visit] 
nor other toxicology testing.'' Id. Dr. Kennedy further noted that 
Respondent ``did not obtain any pharmacy drug profiles [from] where 
[M.B.] had his prescriptions filled,'' his chart did not indicate where 
he was filling his prescriptions, and he did not obtain prescription 
monitoring reports from States where M.B. may have filled 
prescriptions. Id. He also did not obtain prescription monitoring 
reports for any of the other sixteen patients. Id.
    Finally, Dr. Kennedy explained that the ``drug cocktails'' 
Respondent prescribed of ``very potent, high doses'' of oxycodone and 
Xanax (or Valium), id. at 11, are ``attractive to `patients' who abuse, 
are addicted and/or divert (sell or trade) their prescribed controlled 
substances. They might take them all together to achieve a `high,' sell 
some for cash, or trade some for other drugs they prefer.'' Id. at 9. 
Dr. Kennedy also noted that ``[w]hen opioids and benzodiazepines are 
used in combination, the potential for [a] drug overdose and death is 
increased,'' and ``[t]he risk of abuse, addiction and/or diversion is 
also significantly increased.'' Id. at 7. As Dr. Kennedy observed, 
``[t]hese `drug cocktails' were clearly not for any legitimate medical 
purpose.'' Id. at 13.
    As Dr. Kennedy concluded, Respondent ``was not engaged in the 
practice of medicine,'' and ``[t]he vast majority of his prescriptions 
for controlled substances w[as] not for a legitimate medical purpose 
and w[as] beyond the boundaries of professional practice.'' Id. at 18. 
His ``routine and excessive prescription of multiple controlled 
substances * * * and lack of arriving at a valid medical diagnosis and 
treatment most likely caused harm to the patients he saw as well as to 
other people in their communities.'' Id. I therefore reject this 
exception as well.
    I therefore also reject Respondent's Exception to the ALJ's 
ultimate finding that Respondent has committed acts which render his 
registration inconsistent with the public interest. Resp. Exc. at 5. 
Because the record establishes that Respondent has repeatedly violated 
Federal law by issuing controlled substance prescriptions which lacked 
a legitimate medical purpose and were issued outside of the usual 
course of professional practice, 21 CFR 1306.04, and Respondent has 
offered no evidence establishing that he has accepted responsibility 
for his misconduct and that he has reformed his practice, see Steven M. 
Abbadessa, 74 FR 10077, 10081 (2009), I adopt the ALJ's recommendation 
that Respondent's registration be revoked.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA 
Certificate of Registration, AD7585865, issued to Jacobo Dreszer, M.D., 
be, and it hereby is, revoked. I further order that any pending 
application of Jacobo Dreszer, M.D., to renew or modify his 
registration, be, and it hereby is, denied. This Order is effective 
immediately.

    Dated: March 31, 2011.
Michele M. Leonhart,
Administrator.
Larry P. Cote., Esq., for the Government
Sean M. Ellsworth, Esq., for the Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

    John J. Mulrooney, II, Administrative Law Judge. On February 25, 
2010, the Deputy Administrator, Drug Enforcement Administration (DEA or 
Government), issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO), immediately suspending the DEA Certificate of 
Registration (COR), Number AD7585865, of Jacobo Dreszer, M.D. 
(Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging

[[Page 19390]]

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 \12\ or modification of such 
registration, pursuant to 21 U.S.C. 823(f), alleging that the 
Respondent's continued registration is inconsistent with the public 
interest, as that term is used in 21 U.S.C. 823(f). On March 22, 2010, 
the Respondent timely requested a hearing, which, pursuant to a change 
of venue granted at his request, was conducted in Miami, Florida, on 
July 7, 2010 through July 9, 2010.\13\ The immediate suspension of the 
Respondent's COR has remained in effect throughout these proceedings.
---------------------------------------------------------------------------

    \12\ Although the Respondent's COR expired on July 31, 2010, the 
parties stipulated that a timely renewal application has been 
submitted by the Respondent. ALJ Ex. 31.
    \13\ Pursuant to an order issued on April 15, 2010, with the 
consent of the Respondent, ALJ Ex. 9, 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.
---------------------------------------------------------------------------

    The issue ultimately to be adjudicated by the Deputy Administrator, 
with the assistance of this recommended decision, is whether the record 
as a whole establishes by substantial evidence that Respondent's 
registration with the DEA should be revoked as inconsistent with the 
public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
    After carefully considering the testimony elicited at the hearing, 
the admitted exhibits, the arguments of counsel, and the record as a 
whole, I have set forth my recommended findings of fact and conclusions 
below.

The Evidence

    The OSC/ISO issued by the Government alleges that the Respondent, 
through the medical practice he participated in at American Pain, LLC 
(American Pain), prescribed and dispensed inordinate amounts of 
controlled substances, primarily oxycodone,\14\ under circumstances 
where he knew, or should have known, that the prescriptions were not 
dispensed for a legitimate medical purpose. ALJ Ex. 1. The OSC/ISO 
further charges that these prescriptions were issued outside the usual 
course of professional practice based on a variety of circumstances 
\15\ surrounding the manner in which American Pain is operated, and the 
manner in which its physicians, including Respondent, engaged in the 
practice of medicine. Id. The Government also alleges that Respondent's 
former patients have apprised law enforcement personnel that ``they 
were able to obtain prescriptions for controlled substances from [the 
Respondent] for other than a legitimate medical purpose and with the 
intention of selling the controlled substances and/or personally 
abusing the drugs.'' Id. Lastly, in its Prehearing Statement, the 
Government further alleges that one of the Respondent's patients died 
from an overdose of oxycodone and alprazolam \16\ one day after 
obtaining prescriptions for those same controlled substances from a 
visit to the Respondent at American Pain. Id.
---------------------------------------------------------------------------

    \14\ A schedule II controlled substance.
    \15\ The majority of which are supported by no evidence 
introduced by the Government during the course of these proceedings.
    \16\ A schedule IV controlled substance.
---------------------------------------------------------------------------

    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.\17\ Id. at 721. Under Langston's supervision, DEA 
diversion investigators catalogued the prescriptions seized at Boca 
Drugs (Boca Drugs Prescription Log). Govt. Ex. 118. However, inasmuch 
as the Boca Drugs Prescription Log fails to distinguish between the 
Respondent, and one of the other co-Respondents (his son), the document 
is of no utility in reaching a disposition of the present case.
---------------------------------------------------------------------------

    \17\ 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.
---------------------------------------------------------------------------

    GS Langston also testified that, on March 3, 2010, a criminal 
search warrant was executed on the American Pain Clinic simultaneously 
with the OSC/ISO that initiated the present case. Tr. at 735. According 
to Langston, the items seized from American Pain included a sign that 
had been posted in what she believes to have served as the urinalysis 
waiting room. Id. at 735-37. The seized sign set forth the following 
guidance:
ATTENTION PATIENTS
    Due to increased fraudulent prescriptions, [i]t's best if you 
fill your medication in Florida or your regular pharmacy. Don't go 
to a pharmacy in Ohio when you live in Kentucky and had the scripts 
written in Florida. The police will confiscate your scripts and hold 
them while they investigate. This will take up to 6 months. So only 
fill your meds in Florida or a pharmacy that you have been using for 
at least 3 months or more.
Govt. Ex. 119 at 1. This sign is attached, apparently by some sort of 
tape, to the top portion of two other signs, posted at the same 
location, the first of which reads:
ATTENTION:

Patients

    Please do NOT fill your prescriptions at any WALGREENS PHARMACY 
\18\ or OUTSIDE the STATE OF FLORIDA.
---------------------------------------------------------------------------

    \18\ GS Langston testified that she was unaware of the location 
of the closest Walgreens to American Pain's offices. Tr. at 779. No 
evidence was presented that would tend to establish that any 
Walgreens or any other pharmacy has taken a position regarding its 
willingness to fill prescriptions authorized by American Pain.

Id. The final attachment to the composite sign bears the words ``24 
Hour Camera Surveillance.'' Id. A photograph of the composite sign 
---------------------------------------------------------------------------
was admitted into evidence.

    Langston also testified that while she was present in the 
American Pain offices, she noticed that each physician's desk was 
equipped with a group of stamps, each of which depicted a controlled 
substance medication with a corresponding medication usage 
instruction (sig). Tr. at 738-39. A photograph of one set of 
prescription script stamps was admitted as an exhibit.\19\ Govt. Ex. 
119 at 2.
---------------------------------------------------------------------------

    \19\ 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.
---------------------------------------------------------------------------

    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 an 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

[[Page 19391]]

investigators reviewed the seized files with a view towards choosing 
approximately fifteen files for each doctor with the aspirational 
criteria that each would reflect at least three to four visits by 
that doctor with a patient. Each investigator was empowered to place 
a chart on the selected pile, and when the target number (or about 
that number) was reached for each physician, the selection effort 
relative to that physician was deemed accomplished. Id. at 765. 
Langston credibly testified that there was no effort to specially 
select files under some prosecution-enhancement or ``cherry 
picking'' purpose. Id. at 768.
    Langston also explained DEA's Automated Record Consolidated 
Ordering System (ARCOS) and testified that she generated an ARCOS 
report relative to the Respondent's ordering of controlled 
substances from January 2009 through February 2010. Govt. Ex. 71.
    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. 72-74. Review of the PMP 
report data reflects that during the time period of February 1, 2006 
through February 11, 2010, pharmacies filled 229 controlled 
substance prescriptions issued over the Respondent's signature to 
seventy-three patients located in West Virginia, 135 similar 
prescriptions provided to fifty-three Kentucky-based patients were 
filled between January 1, 2009 and April 4, 2010, and 144 such 
prescriptions pertaining to sixty-three patients located in Ohio 
were filled between April 1, 2008 and April 19, 2010. Id.
    No evidence was introduced at the hearing that would provide any 
reliable level of context regarding the raw data set forth in the 
databases received into evidence at the Government's request. Other 
than the observations noted above, no witness who testified at the 
hearing ever explained the significance of the data set forth in any 
of these databases to any issue that must or should be considered in 
deciding the present case. As discussed above, the fact that the 
Boca Drugs Prescription Log prepared by the agents does not 
distinguish between prescriptions authorized by the Respondent and 
another registrant of the same name deprives the document of 
virtually any relevance regarding the enforcement action against 
this Respondent.\20\
---------------------------------------------------------------------------

    \20\ Remarkably, although this unfortunate aspect of this 
document was brought to light during the course of the hearing, Tr. 
at 732, no effort on the part of the Government was made to provide 
additional details or explanation that might tend to differentiate 
between the respondents.
---------------------------------------------------------------------------

    GS Langston provided evidence that was sufficiently detailed, 
consistent and plausible to be deemed credible in this recommended 
decision.
    SA Michael Burt testified that he has been employed by DEA since 
March 2004 and has been stationed with the Miami Field Division 
(MFD) since September 2004. Tr. at 813-14. Burt testified that he is 
the lead case agent for DEA in the investigation of American Pain 
Clinic and has participated in the investigation since the latter 
part of 2008. According to Burt, American Pain, which was previously 
known by the name South Florida Pain, has conducted business at four 
different locations, and he surveilled the Boca Raton and Lake Worth 
locations both in person and by periodic live review of video 
captured via pole cameras \21\ set up outside the clinic. Id. at 
815-17. These pole cameras, which were in operation during a three 
week period from January to February 2010, were initially in 
operation on a 24-hour basis, but Burt testified that they were 
later activated only between the hours of 7 a.m. through 6:00 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.
---------------------------------------------------------------------------

    \21\ 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 user name and 
password. The camera video was also recorded to DVR. Id. at 821.
---------------------------------------------------------------------------

    Based on these surveillance efforts, SA Burt testified 
concerning various activities he observed occurring outside the Boca 
and Lake Worth clinic locations, which were open to the public from 
8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given 
day, beginning at 7 a.m. in the morning, automobiles could be seen 
pulling into the parking lot and approximately twenty to thirty 
people were routinely lined up outside of the clinic waiting to gain 
admittance. Additionally, there was a steady stream of automobile 
and foot traffic in and out of the clinic throughout the day. Id. at 
817, 821. Burt testified that in his estimation, approximately 80-90 
percent of the automobiles had out-of-state tags, predominantly from 
Kentucky, Ohio, West Virginia and Tennessee. Id. at 817-18. Burt 
also observed security personnel with ``staff'' written on their 
shirts \22\ riding around the exterior of the building in golf carts 
and who, in Burt's assessment, appeared to be directing patients 
into the American Pain facility. Burt indicated his surveillance of 
the Lake Worth location yielded similar observations. Id. at 818.
---------------------------------------------------------------------------

    \22\ Tr. at 910.
---------------------------------------------------------------------------

    Based on his review of some (but not all) \23\ 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'' \24\ for these office visits, and 
the six doctors at the clinic saw ``anywhere from 200 upward to 375 
patients a day'' \25\ in this manner.\26\ Id. at 882-83 (emphasis 
supplied).
---------------------------------------------------------------------------

    \23\ 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.
    \24\ Later on cross-examination, SA Burt admitted that the 
clinic also accepted payment via credit card. Tr. at 916.
    \25\ 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.
    \26\ Burt further testified that the doctors were paid $75.00 
per patient visit, id. at 884, but because he indicated that he 
could not disclose his basis of knowledge for this information, this 
portion of his testimony can be afforded no weight. See Richardson 
v. Perales, 402 U.S. 389, 402 (1971); J.A.M. Builders v. Herman, 233 
F.3d 1350, 1354 (11th Cir. 2000); Keller v. Sullivan, 928 F.2d 227, 
230 (7th Cir. 1991); Calhoun v. Bailar, 626 F.2d 145, 149 (9th Cir. 
1980).
---------------------------------------------------------------------------

    SA Burt also testified regarding his review of some \27\ of the 
video and audio recordings made by an undercover agent (UC) who 
assumed the name Luis Lopez, capturing activity inside of American 
Pain.\28\ 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.
---------------------------------------------------------------------------

    \27\ Tr. at 1002-05.
    \28\ The fact that these recordings were made during the course 
of seven different office visits by an undercover agent to both the 
Boca Raton and Lake Worth locations was established on cross-
examination. Tr. at 900, 985.
---------------------------------------------------------------------------

    SA Burt also testified that he received information from Dr. 
Eddie Sollie, a former physician employed during the time period 
American Pain was doing business as South Florida Pain, who 
terminated his employment at the Oakland Park clinic location in 
November or December 2008 after working there for approximately two 
and a half to three months. Id. at 827, 898. During the course of an 
interview where Burt was present, Dr. Sollie related various 
``concerns about how the practice was being handled or

[[Page 19392]]

managed.'' Id. at 827-28. These concerns included medical records 
being, in his opinion, annotated inadequately by the doctors, and 
what he perceived as a lack of supervision during patient urinalysis 
testing, where patients would ``go[] to the bathrooms together, 
bringing items with them to the bathrooms that could possibly 
disguise the urinalysis.'' According to Burt, Sollie explained that 
he perceived that patients were substituting urine produced by other 
persons that contained the metabolites for controlled substances 
that the patients claimed to be legitimately taking, with a view 
towards falsely providing evidence to the American Pain doctors 
showing that they were actually taking prescribed medications and 
not diverting them. Id. at 828-29. During cross-examination, Burt 
explained that Dr. Sollie told him he had raised these concerns with 
Christopher George, the owner of American Pain, and that Burt had no 
evidence that the deficient practices that Sollie had objected to 
continued through 2010. Id. at 900, 906. Burt also acknowledged that 
he was aware Dr. Sollie had been involved in litigation with Mr. 
George and that their relationship was strained. Id. at 1009. Dr. 
Sollie was not called as a witness by either party.
    SA Burt also testified regarding the drug overdose deaths of TY 
and SM after obtaining controlled substances from American Pain.\29\ 
Burt's record testimony indicates that DEA Task Force Officer \30\ 
(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.\31\ Likewise, the record evidence concerning SM did not 
implicate prescribing activity by the Respondent.
---------------------------------------------------------------------------

    \29\ 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.
    \30\ 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.
    \31\ See Tr. at 836-53 (addressing exclusion of Govt. Ex. 27 and 
associated testimony).
---------------------------------------------------------------------------

    Perhaps among the more striking aspects of SA Burt's performance 
on the witness stand is the anticipated testimony which he did not 
provide. When viewed in its entirety, SA Burt's record testimony was 
stunningly sparse when compared with his proposed testimony as 
noticed in the Government's prehearing statement.\32\ 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.
---------------------------------------------------------------------------

    \32\ 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.\33\ Dr. Kennedy, who testified that he is 
board certified by the American Board of Pain Medicine and the 
American Board of Anesthesiology,\34\ was offered and accepted as an 
expert in the field of pain medicine. Id. at 39.
---------------------------------------------------------------------------

    \33\ Dr. Kennedy's CV was admitted into evidence. Govt. Ex. 117.
    \34\ 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 
Respondent's physical examinations, treatment plans, and patient 
histories were below the standard fixed by the Florida Medical Board 
and that that controlled substances was not for a legitimate medical 
purpose. Id. at 579-82.
    Dr. Kennedy took professional issue with several aspects of the 
Respondent's patient care as reflected in the charts regarding the 
prescribing of controlled substances. It is apparent from his 
testimony that Dr. Kennedy's analysis is restricted to those matters 
which can be gleaned from an examination of the written word in that 
subset of the Respondent's patient charts provided by the Government 
for his review, and that limitation perforce circumscribes the 
breadth of his input. That being said, Dr. Kennedy highlighted 
numerous features in the Respondent's chart documentation that he 
found wanting, or at least remarkable.
    Dr. Kennedy explained that there are basic elements to 
practicing pain medicine. The acquisition of a thorough history and 
physical examination is important. Id. at 41-42. He also stressed 
the vital importance of obtaining past medical records to evaluate 
what treatments, therapies, medications, and dosages have been 
utilized in the past so that correct current treatment decisions can 
be made. Id. at 45-46. Reliance upon the patient's memory of these 
elements without the prior medical records, in Dr. Kennedy's view is 
not reliable or acceptable. Id. at 46-47. Dr. Kennedy acknowledged 
that physicians customarily accept patients at their word, but on 
the subject of verifying a patient's subjective complaint and 
medication history, Dr. Kennedy explained that

[s]ometimes you have to help people understand why they're suffering 
or what their problems are. A person with an addiction or drug abuse 
problem is no worse a human being than me. I'm not any better than 
them. But it's your job as a doctor to sit down and find out what 
the truth is as well as you reasonably can under the circumstances.

Id. at 357.
    Dr. Kennedy also prepared a report in connection with the 
Government's case against the Respondent, which is dated April 30, 
2010, and was admitted into evidence. Govt. Ex. 76; Tr. at 579. The 
report describes a general analysis of seventeen charts that the 
Respondent maintained on as many patients, that were (selected by and) 
provided to Dr. Kennedy by the Government from among patient files 
seized pursuant to a criminal search warrant executed at the 
Respondent's practice on March 3, 2010 (Patient Charts Analysis). 
Although this report purports to describe practices common to all 
seventeen files reviewed by Dr. Kennedy, much of the analysis is 
directed toward a chart prepared in connection with MB,\35\ one of the 
Respondent's patients.
---------------------------------------------------------------------------

    \35\ At the request of the Government, a protective order was 
issued that is designed to minimize the risk of the dissemination of 
identifying information related to patients and their relatives 
associated with this case. Accordingly, initials have been 
substituted for the names of individuals within the protection of 
the protective order throughout the body of this decision. ALJ 
Ex.15.
---------------------------------------------------------------------------

    Dr. Kennedy's report makes it unambiguously clear that, in his 
opinion, all seventeen of the Respondent's charts that he reviewed 
suffered from the same shortcomings.\36\

[[Page 19393]]

The Patient Charts Analysis states that the Respondent's patient charts 
that Dr. Kennedy reviewed ``are essentially the same with regard to 
review issues; as stated in the report of [MB] referenced and discussed 
in this report in detail, [and that] there were no significant 
differences that affected [his] conclusions and summary.'' Govt. Ex. 76 
at 2.
---------------------------------------------------------------------------

    \36\ The Government's tactical decision to essentially unload a 
pile of charts that are explained only by the representations and 
generalizations in a report, with no attempt whatsoever to have its 
expert witness explain the applicable aspects of most charts to this 
tribunal or any future reviewing body is clearly at odds with the 
directive provided by the Deputy Administrator in Gregg & Son 
Distributors that ``it is the Government's obligation as part of its 
burden of proof and not the ALJ's responsibility to sift through the 
records and highlight that information which is probative of the 
issues in the proceeding'' 74 FR 17517 n.1.
---------------------------------------------------------------------------

    In Dr. Kennedy's opinion, the patient charts he reviewed that were 
prepared by the Respondent reflected care that fell below the 
applicable standard on multiple levels. In his report, Dr. Kennedy 
noted that the treatment notes in the charts: (1) Contained no 
typewritten clinical notes and were ``very brief, difficult to read 
(often impossible) and not within the standard of care due to their 
brevity and quality''; \37\ (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; \38\ (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''; \39\ (4) 
contained medication contracts that were ``not always signed'' and 
``listed criteria that was not followed by the doctors at American 
Pain; \40\ (5) failed to adequately 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' ''; \41\ (7) reflected ``no therapeutic plan, except to 
use controlled substances to `treat' the subjective complaint of `pain' 
which was inadequately described''; \42\ (8) reflected ``no real 
therapeutic goals * * * for improvement of quality of life (activities 
of daily living, work, sleep, mood)''; \43\ (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''; \44\ (10) reflected ``a gross lack of past 
medical records in all charts reviewed and in some cases none at all''; 
\45\ and, (11) demonstrated controlled substance patient monitoring 
practices that were ``not within the standard of care and was outside 
the boundaries of professional practice.'' \46\
---------------------------------------------------------------------------

    \37\ Govt. Ex. 76 at 4.
    \38\ Govt. Ex. 76 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.'' Id. at 7.
    \39\ Govt. Ex. 76 at 4.
    \40\ Govt. Ex. 76 at 3. As an example of the failure to adhere 
to the terms of the medication contract, Dr. Kennedy cites a 
contract term that provides notice that the physician may stop 
prescribing opioids or change treatment if pain or activity 
improvement is not demonstrated, and points out that pain and 
activity levels are routinely not documented in treatment notes. Id. 
at 3-4. Similarly, Dr. Kennedy references a medication contract 
warning that termination of services may result from failure to make 
regular follow-up appointments with primary care physicians, and 
notes that the American Pain charts contain no notes from primary 
care physicians or medical records generated by them. Id. at 4.
    \41\ Govt. Ex. 76 at 7. In Dr. Kennedy's opinion, Respondent in 
effect, acted as a `barrier' for [MB] to receive appropriate medical 
evaluation and treatment. In other words, the very potent, high 
doses of opioids (oxycodone) and benzodiazepine (Xanax) could mask 
or cover up [MB's] underlying disease process(s), making them more 
difficult to diagnose, and allowing the disease(s) to unnecessarily 
worsen. Without an accurate diagnosis[] and no plan to obtain one, 
[the Respondent] was masking the symptoms. Id. at 10-11.
    \42\ Govt. Ex. 76 at 7.
    \43\ Govt. Ex. 76 at 7.
    \44\ Govt. Ex. 76 at 7.
    \45\ Govt. Ex. 76 at 15. MB's chart did not contain any past 
medical records, save for a Lumbar report from an MRI performed six 
weeks before MB's first clinic visit to see the Respondent. Id. at 
8.
    \46\ Govt. Ex. 76 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. 76 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. For instance, Dr. Kennedy notes 
that MB's patient file contains a notation about the patient getting 
Roxicodone ``off the street,'' along with an initial positive 
urinalysis screen for oxycodone, yet the Respondent continued to 
prescribe MB with additional Roxicodone during his initial and 
subsequent visits. Id. at 8-9, 11; see also Govt. Ex. 87 at 4, 9; 90 at 
3, 9; 91 at 4, 8; 93 at 5, 10 (similar notations involving other 
patient's acquiring controlled substances ``off the street''). 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. Red flags noted by Dr. Kennedy in the 
reviewed charts included the relatively young age of the Respondent's 
chronic pain patients,\47\ incomplete history information provided by 
the patients, periodically significant gaps between office visits,\48\ 
referrals from friends, relatives, or advertising, but not other 
physicians,\49\ 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.\50\
---------------------------------------------------------------------------

    \47\ Govt. Ex. 76 at 16.
    \48\ Govt. Ex. 76 at 13.
    \49\ Govt. Ex. 76 at 8, 15.
    \50\ Govt. Ex. 76 at 16.
---------------------------------------------------------------------------

    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. 76 at 3, 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). 
Id. 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.
    A review of the seventeen patient files that informed the analysis, 
findings and conclusions offered in Dr. Kennedy's written report and 
testimony does reflect the presence of at least some of the red flag 
issues he identified therein, but there was not the unanimity among the 
files that he repeatedly urges. For instance, in terms of evidence 
related to therapeutic plans, it is notable that Respondent's patient 
files contain at least some indications of recommended treatment 
modalities in addition to the Respondent's exclusive use of

[[Page 19394]]

controlled substances for pain management. For example, Respondent 
included notations in the records of referring patients to see a 
``PCP,'' or primary care physician, for elevated blood pressure. Govt. 
Exs. 78 at 1-3, 6; 79 at 1. Furthermore, some of the patient history 
and physical exam forms contain some effort in documenting medication 
efficacy. Govt. Exs. 83 at 7; 92 at 2.
    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. LA's patient file, 
for example, contains a form indicating a positive UDS for oxycodone 
and benzodiazepine from 5/18[/09], yet on the same date, the medication 
contract signed by LA is blank in the section where a patient is 
supposed to list any medications they are currently taking; likewise, 
the similarly worded section on the ``Patient Comfort Assessment 
Guide'' form also has no medications listed. Govt. Ex. 77 at 12-13, 30; 
see also Govt. Exs. 78 at 13-14, 32; 86 at 14-15, 30; 89 at 8-9, 22 
(similar issues). CR's patient file, on the other hand, indicates a 
positive UDS for ``THC'' in addition to benzodiazepine and hydrocodone, 
yet the patient does not disclose marijuana as a ``medication'' he is 
currently taking on any of the relevant forms, and, in fact, this 
positive test is not addressed by the Respondent in any discernible 
manner in the chart. Govt. Ex. 79 at 9. Patient KL's 7/17/09 UDS 
indicates a negative test for all listed substances, yet on two 
different forms dated 7/13/09 he indicates he is currently taking two 
strengths of oxycodone along with Xanax. Govt. Ex. 82 at 13-14, 31. The 
UDS form in patient GE's file reflects circled positive results for 
benzodiazepines, opiates, and oxycodone. This is noteworthy in that the 
currently-taking list of medications includes seven other drugs, but 
not these three. Govt. Ex. 80 at 9, 24-25. Patient BR's UDS form, on 
the other hand, lists a positive test result for oxycodone only on July 
24, 2009, yet the patient states she is also currently taking Xanax 
elsewhere on the medical forms from the same date. Govt. Ex. 88 at 11-
12, 25; see also Govt. Exs. 90 at 9-10, 22; 92 at 8-9; 93 at 5, 10-11, 
26 (same issue). A prescribed controlled substance that is not 
reflected in a drug screen should have raised a sufficient suspicion of 
diversion to merit further inquiry by the registrant reflected in the 
patient file. At a minimum, these observations support the conclusion 
there was a general lack of vigilance on the part of the Respondent 
regarding his obligations as a registrant to minimize the risk of 
controlled substance diversion.
    In addition to the lack of adequately completed forms in some 
patient files noted by Dr. Kennedy, other patient files appear to be 
missing key documentation altogether. See Govt. Ex. 92 (no pain 
management agreement, medication contract, or diversion policy 
present).
    Dr. Kennedy concluded his report regarding the Respondent's 
prescribing practices with the following summary:

    [The Respondent] was not engaged in the practice of medicine, 
rather he was engaged in an efficient, ``[a]ssembly [l]ine'' 
business. His ``patients'' were revenue streams, not true patients. 
This business allowed him to collect cas[h] for office visits as 
well as being a ``[d]ispensing [p]hysician'' for controlled 
substances. He prescribed controlled substances so that ``patients'' 
would return to his office on a regular basis, allowing him to 
generate further revenue. [The Respondent's] routine and excessive 
prescription of multiple controlled substances (oxycodone and Xanax) 
and lack of arriving at a valid medical diagnosis and treatment most 
likely caused harm to the ``patients'' he saw. Drug diversion most 
likely caused a ``mushroom'' effect of increased drug abuse, drug 
addiction, drug overdoses, serious bodily injury and death in those 
communities spread over several different states. [The Respondent's] 
continued ability to prescribe controlled substances will only 
perpetuate the suffering and be a threat to the public.

Govt. Ex. 76 at 16.

    On cross examination, Dr. Kennedy agreed that he assumed, for the 
purposes of his analysis, that where the Respondent's charts reflected 
an entry or a procedure, that the event actually occurred. Tr. at 654. 
Kennedy also acknowledged that every one of the patient files he 
reviewed contained at least a complaint of chronic pain symptoms by the 
patient and MRI results that could support such a diagnosis. Id. at 
655-57.
    The Government's presentation of Dr. Kennedy's testimony at the 
hearing was substantially consistent with the conclusions included in 
the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly 
not without its blemishes. Although he testified that he was familiar 
with prescribing practices in Florida, and that he utilized the medical 
standards applicable to Florida practice,\51\ he was unable to identify 
the documentation standard in the Florida Administrative code with any 
degree of particularity, and he also acknowledged that he was not aware 
of what the standard is in Florida Medical Board administrative 
decisions regarding the overprescribing of medication or what 
constitutes an adequate medical history. Id. at 149-51, 233, 304. 
While, overall, Kennedy presented testimony that appeared candid and 
knowledgeable, there were areas in his written report that rang of 
hyperbole and over-embellishment. The reasoning behind some of the 
seemingly critical observations in the written report, such as the 
``cash basis'' of the Respondent's practice and the absence of doctor 
referrals among the reviewed patient files, did not well survive the 
crucible of cross examination at the hearing. However, overall, Dr. 
Kennedy's testimony was sufficiently detailed, plausible, and 
internally consistent to be considered credible, and, consistent with 
his qualifications, he spoke persuasively and with authority on some 
relevant issues within his expertise, and notwithstanding the 
Respondent's objections relative to his Florida-related experience, he 
is currently an assistant professor teaching at a Florida Medical 
School. It may well be that the greatest and most significant aspect of 
Dr. Kennedy's opinion is that on the current record, it stands 
unrefuted. Thus, his opinion is the only expert opinion available for 
reliance in this action.\52\ 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.
---------------------------------------------------------------------------

    \51\ Tr. at 628.
    \52\ The Respondent did not testify on her own behalf.
---------------------------------------------------------------------------

The Analysis

    Pursuant to 21 U.S.C. Sec.  824(a)(4), the Deputy Administrator 
\53\ 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'':
---------------------------------------------------------------------------

    \53\ 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.

[[Page 19395]]

    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
21 U.S.C. 823(f).
    ``[T]hese factors are considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of 
factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Deputy Administrator may properly give each 
factor whatever weight she deems appropriate in determining whether an 
application for a registration should be denied. JLB, Inc., d/b/a Boyd 
Drugs, 53 FR 43945 (1988); England Pharmacy, 52 FR 1674 (1987); see 
also David H. Gillis, M.D., 58 FR 37507, 37508 (1993); Joy's Ideas, 70 
FR 33195, 33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422 
(1989). Moreover, the Deputy Administrator is ``not required to make 
findings as to all of the factors * * *.'' Hoxie v. DEA, 419 F.3d 477, 
482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (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.

[[Page 19396]]

Patrick W. Stodola, M.D., 74 FR 20727, 20730 (2009); Jayam Krishna-
Iyer, 74 FR at 461. It is well-established Agency precedent that a 
``state license is a necessary, but not a sufficient condition for 
registration.'' Leslie, 68 FR at 15230; John H. Kennedy, M.D., 71 FR 
35705, 35708 (2006). Even the reinstatement of a state medical license 
does not affect the DEA's independent responsibility to determine 
whether a registration is in the public interest. Mortimer B. Levin, 
D.O., 55 FR 9209, 8210 (1990). The ultimate responsibility to determine 
whether a registration is consistent with the public interest has been 
delegated exclusively to the DEA, not to entities within state 
government. Edmund Chein, M.D., 72 FR 6580, 6590 (2007), aff'd, Chein 
v. DEA, 533 F.3d 828 (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 his practice relative to prescribing and 
dispensing controlled substances and acts allegedly committed in 
connection with his practice at American Pain. Thus, it is analytically 
logical to consider public interest factors two, four and five 
together. That being said, factors two, four and five involve analysis 
of common and distinct considerations.
    Regarding Factor 2, the qualitative manner and the quantitative 
volume in which a registrant has engaged in the dispensing of 
controlled substances, and how long he has been in the business of 
doing so are factors to be evaluated in reaching a determination as to 
whether he should be entrusted with a DEA certificate. In some cases, 
viewing a registrant's actions against a backdrop of how he has 
performed activity within the scope of the certificate can provide a 
contextual lens to assist in a fair adjudication of whether continued 
registration is in the public interest.
    There are two principal considerations embedded within a 
consideration of this public interest factor. In considering a similar 
factor under the List I chemical context, the Agency has recognized 
that the level of experience held by those who will be charged with 
recognizing and taking steps to minimize diversion factors greatly in 
determining whether entrusting a COR will be in the public interest. 
See Volusia Wholesale, 69 FR 69409, 69410 (2004); Xtreme Enters., Inc., 
67 FR 76195, 76197-98 (2004); Prachi Enters., 69 FR 69407, 69409 
(2004); J&S Distribs., 69 FR 62089, 62090 (2004); K.V.M. Enters., 67 FR 
70968, 70969 (2002). The Agency has also recognized that evidence that 
a registrant may have conducted a significant level of sustained 
activity within the scope of the registration for a sustained period is 
a relevant and correct consideration, which must be accorded due 
weight. However, this factor can be outweighed by acts held to be 
inconsistent with the public interest. Experience which occurred prior 
and subsequent to proven allegations of malfeasance may be relevant. 
Evidence that precedes proven misconduct may add support to the 
contention that, even acknowledging the gravity of a particular 
registrant's transgressions, they are sufficiently isolated and/or 
attenuated that adverse action against its registration is not 
compelled by public interest concerns. Likewise, evidence presented by 
the Government that the proven allegations are consistent with a 
consistent past pattern of poor behavior can enhance the Government's 
case.
    In this case, the Respondent introduced no evidence regarding his 
level of knowledge and experience, or even the quality or length of his 
experience as a physician-registrant, but the Government has elected to 
do so.
    Regarding the Government's presentation, Agency precedent has long 
held that in DEA administrative proceedings that ``the parameters of 
the hearing are determined by the prehearing statements.'' CBS 
Wholesale Distribs., 74 FR 36746, 36750 (2009) (citing Darrel Risner, 
D.M.D., 61 FR 728, 730 (1996); see also Roy E. Berkowitz, M.D., 74 FR 
36758, 36759-60 (2009) (``pleadings in administrative proceedings are 
not judged by the standards applied to an indictment at common law'' 
and ``the rules governing DEA hearings do not require the formality of 
amending a show cause order to comply with the evidence''). That being 
said, however, the marked difference between the amount of evidence 
that the Government noticed in its OSC/ISO and the amount that it 
introduced at the hearing is striking. For example, contrary to its 
allegations, there was no evidence that the Respondent ``prescribe[d] 
and dispense[d] inordinate amounts of controlled substances,'' that the 
``majority'' of the Respondent's patients were ``from states other than 
Florida,'' and there was no evidence that American Pain patients were 
issued ``pre-signed prescriptions to obtain MRI[s],'' nor was there 
evidence that individuals positioned outside the American Pain building 
were there to ``monitor the activity of patients in the parking lot to 
prevent patients from selling their recently obtained controlled 
substances.'' Likewise, no evidence was introduced at the hearing that 
could support the allegations that ``employees of American Pain [] 
frequently ma[d]e announcements to patients in the clinic advising them 
on how to avoid being stopped by law enforcement upon departing the 
pain clinic'' and ``frequently ma[d]e announcements [] advising 
[patients], among other things, not to attempt to fill their 
prescriptions at out-of-state pharmacies and warning them against 
trying to fill their prescriptions at particular local retail 
pharmacies.'' ALJ Ex. 1 (emphasis supplied).
    In like fashion, the Government's prehearing statement proffered 
that SA Burt would testify to several of the items described but not 
established in the OSC/ISO. Among the list of allegations that were not 
supported by any evidence introduced at the hearing, were 
representations that SA Burt would testify concerning the following:

    Law enforcement in Florida and [other states that correspond to 
license plates seen in the American Pain parking lot] frequently 
arrest people for illegal possession and/or illegal distribution of 
controlled substances who have obtained the controlled substances 
from American Pain;
    American Pain hired individuals to ``roam'' the parking lot of 
the clinic to dissuade people from selling their recently obtained 
controlled substances on the property;

[[Page 19397]]

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

ALJ Ex. 6 at 3-9.
    To be clear, it is not that the evidence was introduced and 
discredited; no evidence to support these (and other) allegations was 
introduced at all. To the extent the Government had this evidence, it 
left it home. While the stunning disparity between the allegations 
proffered and those that were supported with any evidence does not 
raise due process concerns, it is worthy of noting, without deciding 
the issue, that Agency precedent has acknowledged the Supreme Court's 
recognition of the applicability of the res judicata doctrine in DEA 
administrative proceedings. Christopher Henry Lister, P.A., 75 FR 
28068, 28069 (2010) (citing Univ. of Tenn. v. Elliot, 478 U.S. 788, 
797-98 (1986) (``When an administrative agency is acting in a judicial 
capacity and resolves disputed issues of fact properly before it which 
the parties have had an adequate opportunity to litigate, the courts 
have not hesitated to apply res judicata[.]'')
    The evidence the Government did present raises issues regarding not 
only Factor 2 (experience dispensing \54\ controlled substances), but 
also Factors 4 (compliance with federal and state law relating to 
controlled substances) and 5 (other conduct which may threaten public 
health and safety). Succinctly put, the Government's evidence related 
to the manner in which the Respondent practiced, and whether his 
practice complied with the law and/or was a threat to the public.
---------------------------------------------------------------------------

    \54\ 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. Even apart from the 
unfortunate reality that one of the databases contained data that could 
not be directly tied to this Respondent as opposed to another with the 
same last name, without some insight into what types of results from 
these databases should be expected when compared to similarly-situated 
registrants engaged in acceptable prescribing practices, the raw data 
is without use. In short, there was no evidence elicited wherein the 
percentage of the Respondent's in-state to out-of-state patients could 
be assessed, and no reasonable measuring stick based on sound 
principles upon which to evaluate such data. Likewise, there was no 
reliable yardstick upon which to measure the amount of controlled 
substances reflected in the databases compared to what a reasonable 
regulator would expect to see regarding a compliant registrant. To the 
extent Langston possessed this information (and she well may have) it 
was not elicited from her. The same could be said of the allegation set 
forth in the Government's Prehearing Statement that alleges that from a 
given period the Respondent ``was the 8th largest practitioner 
purchaser of oxycodone in the United States.''\55\ 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.
---------------------------------------------------------------------------

    \55\ 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,\56\ or advising them to comply with vehicle and traffic laws,\57\ 
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.
---------------------------------------------------------------------------

    \56\ Tr. at 825.
    \57\ 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

[[Page 19398]]

apparently never explained to Burt,\58\ and that some patients were 
intentionally evading the American Pain urinalysis process. Sollie did 
not specifically name the Respondent or any physician as being 
connected with his allegations of misconduct. Tr. at 853. Thus, this 
tribunal is at something of a loss as to how the information, as 
presented, would tend to establish a fact relevant to whether the 
continuation of the Respondent's authorization to handle controlled 
substances is in the public interest.
---------------------------------------------------------------------------

    \58\ Tr. at 898.
---------------------------------------------------------------------------

    The Government's evidence targeted not only the Respondent's 
experience practicing under Factor 2, but also his compliance with 
applicable state and federal laws relating to controlled substances 
under Factor 4. To effectuate the dual goals of conquering drug abuse 
and controlling both legitimate and illegitimate traffic in controlled 
substances, ``Congress devised a closed regulatory system making it 
unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the CSA.'' 
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the 
maintenance of that closed regulatory system, subject to limited 
exceptions not relevant here, a controlled substance may only be 
dispensed upon a prescription issued by a practitioner, and such a 
prescription is unlawful unless it is ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 U.S.C. 829; 21 CFR 1306.04(a). Furthermore, 
``an order purporting to be a prescription issued not in the usual 
course of professional treatment * * * is not a prescription within the 
meaning and intent of [21 U.S.C. 829] and the person knowingly * * * 
issuing it, shall be subject to the penalties provided for violations 
of the provisions of law related to controlled substances.'' Id.
    A registered practitioner is authorized to dispense,\59\ which the 
CSA defines as ``to deliver a controlled substance to an ultimate user 
\60\ * * * by, or pursuant to the lawful order of a practitioner.'' 21 
U.S.C. 802(10); see also Rose Mary Jacinta Lewis, 72 FR 4035, 4040 
(2007). The prescription requirement is designed to ensure that 
controlled substances are used under the supervision of a doctor, as a 
bulwark against the risk of addiction and recreational abuse. Aycock, 
74 FR at 17541 (citing Gonzales v. Oregon, 546 U.S. 243, 274 (2006); 
United States v. Moore, 423 U.S. 122, 135, 142-43 (1975) (noting that 
evidence established that a physician exceeded the bounds of 
professional practice when he gave inadequate examinations or none at 
all, ignored the results of the tests he did 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).
---------------------------------------------------------------------------

    \59\ 21 U.S.C. 823(f).
    \60\ ``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,\61\ 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:
---------------------------------------------------------------------------

    \61\ 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.

[[Page 19399]]

    (4) All entries made into the medical records shall be 
accurately dated and timed. Late entries are permitted, but must be 
clearly and accurately noted as late entries and dated and timed 
accurately when they are entered in to the record * * *.

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

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

    Notwithstanding any other provision of law, a physician may 
prescribe or administer any controlled substance under Schedules II-
V * * * to a person for the treatment of intractable pain,\62\ 
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.
---------------------------------------------------------------------------

    \62\ 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,\63\ 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 
tenets 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.
---------------------------------------------------------------------------

    \63\ 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,'' \64\ resort must be had to an expert.
---------------------------------------------------------------------------

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

    \65\ 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

[[Page 19400]]

depending on the etiology of the pain and the extent to which the pain 
is associated with physical and psychosocial impairment.'' (emphasis 
supplied). Id.
    Another standard adopted by the Florida Board, under the subheading 
``Informed Consent and Agreement for Treatment,'' is the directive that

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

Id. at 9.003(3)(c).
    The Florida Standards contain a further requirement to periodically 
review ``the course of pain treatment and any new information about the 
etiology of the pain or the patient's state of health.'' Id. at 
9.013(3)(d). The Florida Standards explain the importance of periodic 
review in the following manner:

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

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

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

Id. at 9.003(3)(e).
    It is abundantly clear from the plain language of the Florida 
Standards that the Florida Board places critical emphasis on physician 
implementation of adequate safeguards in their practice to minimize 
diversion and the need to document the objective signs and rationale 
employed in the course of pain treatment utilizing the prescription of 
controlled substances. Conscientious documentation is repeatedly 
emphasized as not just a ministerial act, but a key treatment tool and 
a vital indicator to evaluate whether the physician's prescribing 
practices are ``within the usual course of professional practice.'' 
Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert 
opinion presented \66\ in these proceedings, reflects that the 
documentation he reviewed in the Respondent's patient charts reflected 
care that was markedly below the standard of care set by the Florida 
Medical Board. Dr. Kennedy's expert assessment was consistent with the 
state statutory and regulatory guidance. In Kennedy's view, the 
Respondent's charts demonstrated minimalistic, incomplete, and 
otherwise medically inadequate documentation of his contacts with 
patients, and the prescribing rationale for his issuance of controlled 
substance prescriptions to those patients for alleged pain management 
purposes. The boilerplate-style, ``one high-dosage controlled 
substances treatment plan fits all'' nature of nearly all of the 
patient medical records at issue, at least in the view of the 
uncontroverted expert, evidences a failure on the part of the 
Respondent to conduct his practice of medicine in a manner to minimize 
the potential of controlled substance abuse and diversion, and supports 
a conclusion that he failed to even substantially comply with the 
minimum obligations for professional practice imposed under the Florida 
Standards--and without ``good cause [] shown for such deviation.'' Id. 
at 9.013(1)(f).
---------------------------------------------------------------------------

    \66\ Respondent, in his brief, correctly points out that (for 
reasons not readily apparent) the Government elicited no testimony 
from Dr. Kennedy regarding any patient treated by the Respondent. 
Respt's Br. at 10-11.
---------------------------------------------------------------------------

    In his Post-Hearing Brief (Respondent's Brief), the Respondent's 
counsel has prepared and submitted a thoughtful and detailed review of 
one of the patient charts that was analyzed by Dr. Kennedy in his 
report. Respt's Br. at 22-26. While counsel argues that the patient 
chart entries were, at least by his interpretation of his client's 
obligations, satisfactory, the expert's opinion at the hearing remained 
unchanged. Even acknowledging, as this recommended decision does, that 
Dr. Kennedy's presentation was not without its deficiencies, its 
shortcomings do not render it so fundamentally defective as to 
completely undermine his credibility and viability as within the scope 
of what a litigant may depend upon.\67\ As recognized in the 
Respondent's Brief, ``the [G]overnment, like any party in a contested 
hearing, is free to hire an expert to advocate its position.'' Respt's 
Br. at 12. Unfortunately, counsel's analysis is the product of a lay 
evaluation of standards applicable to the nuanced and sophisticated 
science that is the practice of medicine. Where his opinion and that of 
the only accepted medical expert to provide an expert opinion conflict, 
his opinion cannot and will not be afforded controlling deference. 
Argument supplied by counsel (albeit a diligent and persuasive counsel) 
that the relevant standards were satisfactorily applied as evidenced by 
the protocols and procedures documented in the patient charts cannot 
supplant the unrefuted view of an accepted expert witness.
---------------------------------------------------------------------------

    \67\ Likewise, contrary to the position taken by the Respondent 
in his brief (Respt's Br. at 7), Dr. Kennedy's opinions are not 
invalidated by the size of the representative sample of files he 
reviewed or the manner in which they were selected. Firstly, SA 
Langston provided credible testimony regarding the selection 
process, which although admittedly not a paradigm of scientific 
sampling methodology, was likewise not designed to achieve a 
particular result. Secondly, contrary to the assertion in the 
Respondent's brief (Respt's Br. at 15), there is no baseline magic 
number of files or registrant actions that must be examined to 
support an expert opinion and ultimately an Agency determination as 
to whether a registrant has committed acts inconsistent with the 
public interest sufficient to merit adverse action relative to a DEA 
COR. See Krishna-Iyer, 74 FR at 464.
---------------------------------------------------------------------------

    The Respondent, who was in a unique position to conclusively refute 
Dr. Kennedy's views and explain the format and nuances of the reviewed 
documentation, elected not to testify in this matter. At a DEA 
administrative hearing, it is permissible to draw an adverse inference 
from the silence of the Respondent, even in the face of a Fifth 
Amendment invocation. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) 
(citing United States v. Hale, 422 U.S. 171, 176 (1975) (``silence 
gains more probative weight where it persists in the face of 
accusation, since it is assumed in such circumstances that the accused 
would be more likely than not to dispute an untrue accusation.'')); 
Joseph Baumstarck, M.D., 74 FR 17525, 17528, n.3 (2009) (citing Ohio 
Adult Parole Auth. v. Woodward, 523 U.S. 272, 286 (1998)). On the facts 
of this case, where the allegations are of a nature that a registrant 
would be more likely than not to dispute them if untrue, an adverse 
inference based on the Respondent's silence is appropriate. Where, as 
here,

[[Page 19401]]

the Government, through its expert, has alleged that the Respondent's 
charts do not reflect genuine analysis, but rather (at least in its 
view and the opinion of its expert), a sort of sham-by-check-box form 
designed specifically to present a false impression of a compliant 
registrant, it is precisely the type of allegation that would naturally 
all but oblige a registrant to spring to offer a contradictory account. 
The Respondent's choice to remain silent in the face of such 
allegations, where he could have related his version of his practice as 
a registrant, adds at least some additional credence to the factual and 
analytical views of the Government's expert in this regard.
    In the Social Security context, where an Administrative Law Judge 
has received expert medical opinions on the issue of the claimant's 
ability to work and they are not repudiated in any respect by 
substantial evidence, an adverse decision should be set aside as based 
on ``suspicion and speculation.'' Miracle v. Celebrezze, 351 F.2d 361, 
378 (6th Cir. 1965); see also Hall v. Celebrezze, 314 F.2d 686, 689-90 
(6th Cir. 1963); cf. Harris v. Heckler, 756 F.2d 431, 436 (6th Cir. 
1985) (improper to reject uncontroverted evidence supporting complaints 
of pain simply because of claimant's demeanor at hearing). When an 
administrative tribunal elects to disregard the uncontradicted opinion 
of an expert, it runs the risk of improperly declaring itself as an 
interpreter of medical knowledge. Ross v. Gardner, 365 F.2d 554 (6th 
Cir. 1966). While in this case it is ironically true, much like in the 
Social Security context, that the opinion of a treating physician 
should be afforded greater weight than the opinion of an expert whose 
opinion is limited to a review of the patient file, see Magallenes v. 
Bowen, 881 F.2d 747, 751 (9th Cir. 1989), the treating-source 
Respondent in this case offered no evidence, not even his own opinion, 
regarding the treatment rendered. Thus, in this adjudication, the 
record contains no dispute between experts to be resolved; instead, 
there is but one, unrefuted, uncontroverted, credible expert opinion. 
To ignore that expert opinion on this record and replace it with the 
opinion of this tribunal, Respondent's counsel, or any other lay source 
would be a dangerous course and more importantly, a plainly erroneous 
one.
    Accordingly, after carefully balancing the admitted evidence, the 
evidence establishes, by a preponderance, that the prescriptions the 
Respondent issued in Florida were not issued within ``the usual course 
of [the Respondent's] professional practice.'' 21 CFR 1306.04(a). 
Consideration of the evidence under the second and fourth factors 
support the COR revocation sought by the Government in this case.
    To the extent that the Respondent's prescribing practices fell 
below the requisite standard in Florida, that conduct also impacts upon 
the Fifth statutory factor. Under Factor 5, the Deputy Administrator is 
authorized to consider ``other conduct which may threaten the public 
health and safety.'' 21 U.S.C. 823(f)(5). Although this factor 
authorizes consideration of a somewhat broader range of conduct 
reaching beyond those activities typically associated with a 
registrant's practice, an adverse finding under this factor requires 
some showing that the relevant conduct actually constituted a threat to 
public safety. See Holloway Distrib., 72 FR 42118, 42126 (2007).
    The evidence establishes that the Respondent engaged in a course of 
practice wherein he prescribed controlled substances to patients 
irrespective of the patients' need for such medication and ignoring any 
and 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 his obligations as a DEA registrant, did not follow up in the face 
of multiple red flags. The Respondent's disregard of his obligations as 
a DEA registrant and Federal and state laws related to controlled 
substances militate in favor of revocation.
    By ignoring his responsibilities to monitor the controlled 
substance prescriptions he was authorizing to minimize diversion, and 
by participating in an insufficiently documented and thoughtful process 
for the issuance of potentially dangerous controlled substances, the 
Respondent created a significant potential conduit for the unchecked 
diversion of controlled substances. See Holloway Distrib., 72 FR at 
42124 (a policy of ``see no evil, hear no evil'' is fundamentally 
inconsistent with the obligations of a DEA registrant). Agency 
precedent has long recognized that ``[l]egally, there is absolutely no 
difference between the sale of an illicit drug on the street and the 
illicit dispensing of a licit drug by means of a physician's 
prescription.'' EZRX, LLC, 69 FR 63178, 63181 (1988); Floyd A. Santner, 
M.D., 55 FR 37581 (1988).
    Agency precedent has consistently held that where, as here, the 
Government has met its burden to establish a prima facie case that a 
registrant has committed acts demonstrating that continued registration 
is inconsistent with the public interest, acceptance of responsibility 
is a condition precedent to continued registration. Jeri Hassman, M.D., 
75 FR 8194, 8236 (2010); Medicine Shoppe, 73 FR at 387. The record 
contains no evidence that the Respondent has either acknowledged or 
accepted responsibility for the misconduct at issue in these 
proceedings.

Recommendation

    Based on the foregoing, the evidence supports a finding that the 
Government has established that the Respondent has committed acts that 
are inconsistent with the public interest. A balancing of the statutory 
public interest factors supports the revocation of the Respondent's 
Certificate of Registration and a denial of his application to renew. 
The Respondent has not accepted responsibility for his actions, 
expressed remorse for his conduct at any level, or presented evidence 
that could reasonably support a finding that the Deputy Administrator 
should continue to entrust him with a Certificate of Registration.
    Accordingly, the Respondent's Certificate of Registration should be 
revoked and any pending applications for renewal should be denied.

    Dated: August 10, 2010.
John J. Mulrooney, II,
U.S. Administrative Law Judge.
[FR Doc. 2011-8340 Filed 4-6-11; 8:45 am]
BILLING CODE 4410-09-P