19450 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

1All 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. 

2The ALJ found that there is ‘‘no evidence that 

the Respondent ‘prescribe[d] and dispense[d] 

inordinate amounts of controlled substances.’’ ALJ 

at 27. While there is no evidence as to the amounts 

Respondent may have dispensed directly, there is 

such evidence, which is unrefuted, with respect to 

her prescriptions. The Government’s Expert 

specifically found that Respondent ‘‘prescribed very 

high initial and subsequent doses of oxycodone and 

Xanax to [R.A.] excessively and inappropriately 

without adequate medical justification.’’ GX 55, at 

9 (emphasis added). The Government’s Expert 

further noted that ‘‘[t]he typical Xanax (alprazolam) 

starting dose is 0.25 to 0.5 mg. once to twice per 

day,’’ yet Respondent prescribed ‘‘high dose[s] of 

Xanax’’ 2 mg. ‘‘once to three times per day to 12 of 

the 13 ‘patients’ whose files [he] reviewed’’ without 

‘‘consider[ing] many important factors that cause 

anxiety’’ and any ‘‘previous medical evaluation’’; she 

also not refer these patients ‘‘to a mental health 

professional for evaluation.’’ Id. at 10. The Expert 

thus concluded that ‘‘[t]he treatment was with a 

very high dose of the controlled substance Xanax’’ 

and ‘‘was clearly not within the boundaries of 

professional practice.’’ Id. Finally, the Expert 

provided unrefuted evidence that Respondent 

prescribed ‘‘drug cocktails’’ of oxycodone and 

Xanax, which ‘‘were clearly not for any legitimate 

medical purpose.’’ Id. at 13. I thus reject the ALJ’s 

finding to the extent that it states that there was no 

evidence that Respondent prescribed inordinate 

amounts. 

3 I do not, however, adopt the ALJ’s discussion of 

the standards applied by the Agency in assessing 

a practitioner’s experience in dispensing controlled 

substances, which cites cases involving list 

chemical I distributors, a different category of 

registrant. See ALJ Dec. at 26–27. As the Agency has 

previously made clear, DEA can revoke based on a 

single act of intentional diversion and ‘‘evidence 

that a practitioner has treated thousands of patients’’ 

in circumstances that do not constitute diversion 

‘‘does not negate a prima facie showing that the 

practitioner has committed acts inconsistent with 

the public interest.’’ Jayam Krishna-Iyer, 74 FR 459, 

463 (2009). See also Dewey C. MacKay, 75 FR49956, 

49977 (2010); Medicine Shoppe-Jonesborough, 73 

FR 364, 386 & n.56 (noting that pharmacy ‘‘had 

17,000 patients,’’ but that ‘‘[n]o amount of legitimate 

dispensings can render * * * flagrant violations 

[acts which are] ‘consistent with the public 

interest’ ’’), aff’d, Medicine Shoppe-Jonesborough v. 

DEA, 300 Fed. Appx. 409 (6th Cir. 2008). As I 

further explained, ‘‘[w]hile such evidence may be 

[entitled to] some weight in assessing whether a 

practitioner has credibly shown that [he] has 

reformed his practices,’’ it is entitled to no weight 

where a practitioner fails to acknowledge her 

wrongdoing. Krishna-Iyer, 74 FR at 463. 

In any event, Respondent offered no evidence on 

the issue of his experience in dispensing controlled 

substances and the ALJ’s ultimate conclusion that 

Respondent violated the CSA’s prescription 

requirement because she dispensed controlled 

substance prescriptions that were not ‘‘within ‘the 

usual course of [her] professional practice,’ ’’ ALJ at 

39 (quoting 21 CFR 1306.04(a)), and that ‘‘the 

evidence under the [experience] * * * factor[] 

support[s]’’ the revocation of her registration, is 

consistent with Agency precedent. Id. at 40. 

With respect to factor five, ‘‘[s]uch other conduct 

which may threaten public health and safety,’’ 21 

U.S.C. 823(f)(5), the ALJ opined that ‘‘an adverse 

finding under this factor requires some showing 

that the relevant conduct actually constituted a 

threat to public safety.’’ ALJ at 40 (emphasis added). 

Contrary to the ALJ’s reasoning, Congress, by 

inserting the word ‘‘may’’ in factor five, clearly 

manifested its intent to grant the Agency authority 

to consider conduct which creates a probable or 

possible threat (and not only an actual) threat to 

public health and safety. See Webster’s Third New 

Int’l Dictionary 1396 (1976) (defining ‘‘may’’ in 

relevant part as to ‘‘be in some degree likely to’’); 

see also The Random House Dictionary of the 

English Language 1189 (1987) (defining ‘‘may’’ in 

relevant part as ‘‘used to express possibility’’). While 

the ALJ misstated the applicable standard, his 

conclusion that Respondent repeatedly ignored ‘‘red 

flags’’ indicative of likely diversion and thus 

‘‘created a significant potential conduit for the 

unchecked diversion of controlled substances’’ is 

clearly supported by substantial evidence and 

warrants an adverse finding under factor five. Id. at 

41. 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

21 U.S.C. 823(f)(5). Although this factor 

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein he prescribed 

controlled substances to patients 

irrespective of the patients’ need for 

such medication and ignoring any and 

red flags that could or did indicate 

likely paths of diversion. The testimony 

of Dr. Kennedy, the DEA regulations, 

and the Florida Standards make clear 

that physicians prescribing controlled 

substances do so under an obligation to 

monitor the process to minimize the risk 

of diversion. The patient charts reflect 

that the Respondent, contrary to his 

obligations as a DEA registrant, did not 

follow up in the face of multiple red 

flags. The Respondent’s disregard of his 

obligations as a DEA registrant and 

Federal and state laws related to 

controlled substances militate in favor 

of revocation. 

By ignoring his responsibilities to 

monitor the controlled substance 

prescriptions he was authorizing to 

minimize diversion, and by 

participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

Distrib., 72 FR at 42124 (a policy of ‘‘see 

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

long recognized that ‘‘[l]egally, there is 

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

EZRX, LLC, 69 FR 63178, 63181 (1988); 

Floyd A. Santner, M.D., 55 FR 37581 

(1988). 

Agency precedent has consistently 

held that where, as here, the 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

M.D., 75 FR 8194, 8236 (2010); Medicine 

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of his application to renew. 

The Respondent has not accepted 

responsibility for his actions, expressed 

remorse for his conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust him with a Certificate of 

Registration. Accordingly, the 

Respondent’s Certificate of Registration 

should be revoked and any pending 

applications for renewal should be 

denied. 

Dated: August 10, 2010. 

John J. Mulrooney, II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8345 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–34] 

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

Order 

On August 10, 2010, Administrative 

Law Judge (ALJ) John J. Mulrooney, II, 

issued the attached recommended 

decision.1 The Respondent did not file 

exceptions to the decision. 

Having reviewed the entire record 

including the ALJ’s recommended 

decision, I have decided to adopt the 

ALJ’s rulings, findings of fact,2

conclusions of law,3 and recommended 

Order. 

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The ALJ also opined that ‘‘[i]t is clear that in 

assessing whether the controlled substance 

prescribing practices of a Florida practitioner fall 

within the acceptable range of what constitutes 

being within the bounds of being ‘issued for a 

legitimate medical purpose by an individual 

practitioner acting in the usual course of his 

professional practice,’ resort must be had to an 

expert.’’ ALJ at 34 (quoting 21 CFR 1306.04(a)). 

While the ALJ properly noted the importance of 

expert testimony in this case, in which the 

Government primarily relied on a review of the 

medical charts, whether expert testimony is needed 

is necessarily dependent on the nature of the 

allegations and the other evidence in the case. 

Where, for example, the Government produces 

evidence of undercover visits showing that a 

physician knowingly engaged in outright drug 

deals, expert testimony adds little to the proof 

necessary to establish a violation of Federal law. 

4Pursuant to an order issued on April 15, 2010, 

the hearing in this matter was consolidated with the 

cases of four other registrants who were working at 

the same clinic as the Respondent and who were 

also issued OSC/ISOs on February 25, 2010, 

alleging similar and related conduct. 

5A schedule II controlled substance. 

6The majority of which are supported by no 

evidence introduced by the Government during the 

course of these proceedings. 

7A schedule IV controlled substance. 

8Although 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. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) and 824(a), as well 

as 21 CFR 0.100(b) and 0.104, I order 

that DEA Certificate of Registration, 

BC8112637, issued to Cynthia M. Cadet, 

M.D., be, and it hereby is revoked. I 

further order that any pending 

application of Cynthia M. Cadet, M.D., 

to renew or modify his registration, be, 

and it hereby is, denied. 

This Order is effective immediately. 

Dated: March 31, 2011. 

Michele M. Leonhart, 

Administrator. 

Larry P. Cote, Esq., for the 

Government. 

Glenn B. Kritzer, Esq., for the 

Respondent. 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

John J. Mulrooney, II, Administrative 

Law Judge. On February 25, 2010, the 

Deputy Administrator, Drug 

Enforcement Administration (DEA or 

Government), issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO), immediately 

suspending the DEA Certificate of 

Registration (COR), Number BC8112637, 

of Cynthia M. Cadet, M.D. (Respondent), 

as a practitioner, pursuant to 21 U.S.C. 

824(d), alleging that such registration 

constitutes an imminent danger to the 

public health and safety. The OSC/ISO 

also sought revocation of the 

Respondent’s registration, pursuant to 

21 U.S.C. 824(a)(4), and denial of any 

pending applications for renewal or 

modification of such registration, 

pursuant to 21 U.S.C. 823(f), alleging 

that the Respondent’s continued 

registration is inconsistent with the 

public interest, as that term is used in 

21 U.S.C. 823(f). On March 22, 2010, the 

Respondent timely requested a hearing, 

which, pursuant to a change of venue 

granted at her request, was conducted in 

Miami, Florida, on July 7, 2010 through 

July 9, 2010.4 The immediate 

suspension of the Respondent’s COR 

has remained in effect throughout these 

proceedings. 

The issue ultimately to be adjudicated 

by the Deputy Administrator, with the 

assistance of this recommended 

decision, is whether the record as a 

whole establishes by substantial 

evidence that Respondent’s registration 

with the DEA should be revoked as 

inconsistent with the public interest as 

that term is used in 21 U.S.C. §§ 823(f) 

and 824(a)(4). The Respondent’s DEA 

practitioner registration expires by its 

terms on August 31, 2011. 

After carefully considering the 

testimony elicited at the hearing, the 

admitted exhibits, the arguments of 

counsel, and the record as a whole, I 

have set forth my recommended 

findings of fact and conclusions below. 

The Evidence 

The OSC/ISO issued by the 

Government alleges that the 

Respondent, through the medical 

practice she had been participating in at 

American Pain, LLC (American Pain), 

has prescribed and dispensed inordinate 

amounts of controlled substances, 

primarily oxycodone,5 under 

circumstances where she knew, or 

should have known, that the 

prescriptions were not dispensed for a 

legitimate medical purpose. ALJ Ex. 1. 

The OSC/ISO further charges that these 

prescriptions were issued outside the 

usual course of professional practice 

based on a variety of circumstances 6

surrounding the manner in which 

American Pain had been operated and 

the manner in which its physicians, 

including Respondent, engaged in the 

practice of medicine. Id. The 

Government also alleges that 

Respondent’s former patients have 

apprised law enforcement personnel 

that ‘‘they were able to obtain 

prescriptions for controlled substances 

from [the Respondent] for other than a 

legitimate medical purpose and with 

little or no medical examination.’’ Id. 

Lastly, as an additional ground for the 

OSC/ISO, the Government cites the 

death of one of Respondent’s patients 

from an overdose of oxycodone and 

alprazolam 7 one day after obtaining 

prescriptions for those same controlled 

substances from a visit to the 

Respondent at American Pain, and notes 

that the investigation determined the 

deceased patient ‘‘frequently made trips 

from his home in Kentucky to Florida 

pain clinics with others for the purpose 

of acquiring controlled substances for 

other than a legitimate medical 

purpose.’’ Id. 

At the hearing, the Government 

presented the testimony of three 

witnesses, DEA Miami Field Division 

(MFD) Group Supervisor (GS) Susan 

Langston, DEA Special Agent (SA) 

Michael Burt, and L. Douglas Kennedy, 

M.D., D.A.B.P.M., Affiliate Clinical 

Assistant Professor at the University of 

Miami, Miller School of Medicine. 

GS Langston testified that the 

investigation of the American Pain 

Clinic had its origins on November 30, 

2009, during a routine inspection that 

she and a subordinate diversion 

investigator conducted at Appurtenance 

Biotechnology, LLC, a pharmacy doing 

business under the name Boca Drugs 

(Boca Drugs), and located a few blocks 

away from one of the former locations 

of American Pain. Tr. at 713, 717–20. 

According to Langston, an examination 

of the prescriptions seized from Boca 

Drugs revealed that the majority of those 

prescriptions were for oxycodone and 

alprazolam authorized over the 

signature of physicians associated with 

American Pain.8 Id. at 721. Under 

Langston’s supervision, DEA diversion 

investigators catalogued the 

prescriptions seized at Boca Drugs (Boca 

Drugs Prescription Log). Govt. Ex. 118. 

A review of the data relative to the 

Respondent on the Boca Drug 

Prescription Log reveals that from 

November 2, 2009 through November 

25, 2009, 151 controlled substance 

prescriptions issued over the 

Respondent’s signature, to seventy-eight 

patients, only seven of whom resided in 

Florida. The remainder of the patients 

had listed addresses in Kentucky, 

Tennessee, Ohio, Georgia, West 

Virginia, Indiana, and Missouri. The log 

also reflected that the Respondent wrote 

one non-controlled substance 

prescription to a patient for 

cyclobenzaprine, a muscle relaxant. 

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. 

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9Langston 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. 

10Although 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. 

11 GS Langston explained that through the 

ARCOS system, ‘‘[d]rug manufacturers and 

distributors are required to report the sale of certain 

controlled substances to DEA,’’ and the system 

‘‘shows the history of a drug from the point of 

manufacture through the distribution chain to the 

retail dispensing level.’’ Tr. at 685–86. 

12SA Burt described the pole cameras as ‘‘covert 

cameras that are installed to observe the activity in 

the clinic.’’ Tr. at 816. Burt testified that he was able 

to use a laptop to access the live video feed from 

the cameras after inputting a username and 

password. The camera video was also recorded to 

DVR. Id. at 821. 

13Tr. at 910. 

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 9 or OUTSIDE 

the STATE OF FLORIDA. 

Id. The final attachment to the 

composite sign bears the words ‘‘24 

Hour Camera Surveillance.’’ 

Id. A photograph of the composite 

sign was admitted into evidence. 

Langston also testified that while she 

was present in the American Pain 

offices, she noticed that each 

physician’s desk was equipped with a 

group of stamps, each of which depicted 

a controlled substance medication with 

a corresponding medication usage 

instruction (sig). Tr. at 738–39. A 

photograph of one set of prescription 

script stamps was admitted as an 

exhibit.10 Govt. Ex. 119 at 2. 

GS Langston also testified that a great 

number of medical charts were seized 

from the American Pain offices, and that 

she and her staff selected a number of 

these files to be analyzed by a medical 

expert procured by the Government. Tr. 

at 762. According to GS Langston, after 

the execution of the warrant, the charts 

from the entire office were placed into 

piles in alphabetical order, and not 

separated by physician. Langston 

testified that she and three of her 

diversion investigators reviewed the 

seized files with a view towards 

choosing approximately fifteen files for 

each doctor with the aspirational 

criteria that each would reflect at least 

three to four visits by that doctor with 

a patient. Each investigator was 

empowered to place a chart on the 

selected pile, and when the target 

number (or about that number) was 

reached for each physician, the 

selection effort relative to that physician 

was deemed accomplished. Id. at 765. 

Langston credibly testified that there 

was no effort to specially select files 

under some prosecution-enhancement 

or ‘‘cherry picking’’ purpose. Id. at 768. 

Langston also explained DEA’s 

Automated Record Consolidated 

Ordering System (ARCOS) 11 and 

testified that she generated an ARCOS 

report relative to the Respondent’s 

ordering of controlled substances from 

January 2009 through February 2010. 

Govt. Ex. 50. 

In the same fashion, Langston 

explained the purposes of and 

circumstances behind the generation of 

State prescription monitoring reports 

(PMPs) relative to the Respondent 

maintained by West Virginia, Kentucky, 

and Ohio. Govt. Exs. 51–53. Review of 

the PMP report data reflects that during 

the time period of February 1, 2006 

through February 11, 2010, pharmacies 

filled 166 controlled substance 

prescriptions issued over the 

Respondent’s signature to fifty patients 

located in West Virginia, 124 similar 

prescriptions provided to fifty-one 

Kentucky-based patients were filled 

between January 1, 2009 and April 4, 

2010, and fifty-five such prescriptions 

pertaining to twenty-eight patients 

located in Ohio were filled between 

April 1, 2008 and April 19, 2010. Id. 

No evidence was introduced at the 

hearing that would provide any reliable 

level of context regarding the raw data 

set forth in the databases received into 

evidence at the Government’s request. 

Other than the observations noted 

above, no witness who testified at the 

hearing ever explained the significance 

of the data set forth in any of these 

databases to any issue that must or 

should be considered in deciding the 

present case. 

GS Langston provided evidence that 

was sufficiently detailed, consistent and 

plausible to be deemed credible in this 

recommended decision. 

SA Michael Burt testified that he has 

been employed by DEA since March 

2004 and has been stationed with the 

Miami Field Division (MFD) since 

September 2004. Tr. at 813–14. Burt 

testified that he is the lead case agent for 

DEA in the investigation of American 

Pain Clinic and has participated in the 

investigation since the latter part of 

2008. According to Burt, American Pain, 

which was previously known by the 

name South Florida Pain, has conducted 

business at four different locations, and 

he surveilled the Boca Raton and Lake 

Worth locations both in person and by 

periodic live review of video captured 

via pole cameras 12 set up outside the 

clinic. Id. at 815–17. These pole 

cameras, which were in operation 

during a three week period from January 

to February 2010, were initially in 

operation on a 24 hour basis, but Burt 

testified that they were later activated 

only between the hours of 7:00 a.m. 

through 6:00 p.m. due to an observed 

lack of activity at the clinic outside of 

that time period. Id. at 820–21. The pole 

camera recordings were not offered into 

evidence at the hearing or made 

available to opposing counsel. 

Based on these surveillance efforts, 

SA Burt testified concerning various 

activities he observed occurring outside 

the Boca and Lake Worth clinic 

locations, which were open to the 

public from 8 a.m. to 5 p.m. At the Boca 

location, Burt stated that on any given 

day, beginning at 7 a.m. in the morning, 

automobiles could be seen pulling into 

the parking lot and approximately 

twenty to thirty people were routinely 

lined up outside of the clinic waiting to 

gain admittance. Additionally, there 

was a steady stream of automobile and 

foot traffic in and out of the clinic 

throughout the day. Id. at 817, 821. Burt 

testified that in his estimation, 

approximately 80–90 percent of the 

automobiles had out-of-State tags, 

predominantly from Kentucky, Ohio, 

West Virginia and Tennessee. Id. at 

817–18. Burt also observed security 

personnel with ‘‘staff’’ written on their 

shirts 13 riding around the exterior of the 

building in golf carts and who, in Burt’s 

assessment, appeared to be directing 

patients into the American Pain facility. 

Burt indicated his surveillance of the 

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14SA 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. 

15Later on cross-examination, SA Burt admitted 

that the clinic also accepted payment via credit 

card. Tr. at 916. 

16 Inasmuch as the Government provided no 

information from which any specific number of 

patients seen by any given clinic doctor on any day 

could be derived, or any expert testimony regarding 

a reasonable number of pain patients that could or 

should be seen per day, the value of providing the 

raw number of patients walking through the door 

at the clinic is negligible. 

17Burt 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). 

18Tr. at 1002–05. 

19The 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 crossexamination. Tr. at 900, 985. 20On cross-examination, Burt admitted the 

Respondent never worked at the South Florida Pain 

Clinic in Oakland Park, the facility where Sollie 

had previously been employed. Id. at 1027. 

21Although 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. 

22According 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. 

23See Tr. at 836–53 (addressing exclusion of 

Govt. Ex. 27 and associated testimony). 

24Although SA Burt testified that he requested 

‘‘the complete report’’ and ‘‘all the documents’’ 

relating to SM’s death from TFO Adams, id. at 860, 

Continued 

Lake Worth location yielded similar 

observations. Id. at 818. 

Based on his review of some (but not 

all) 14 of the audio and video tapes made 

by agents and informers sent into the 

clinic by the Government at various 

times, SA Burt also testified about his 

understanding of the process by which 

patients obtained controlled substance 

prescriptions at American Pain. 

According to Burt, after entering the 

clinic, a patient would meet with the 

receptionist, who would determine if 

the patient had an MRI. If not, the 

receptionist would issue that individual 

an MRI prescription in exchange for a 

$50 cash payment, and the patient 

‘‘would be directed to a place to obtain 

an MRI.’’ Id. at 822. Burt testified that 

one such MRI location was Faye 

Imaging, which was a mobile MRI trailer 

located behind a gentlemen’s club 

several miles away from American Pain. 

Id. at 822–23. The cost for the MRI was 

$250, and the patient could pay an 

additional fee ‘‘to have the MRI 

expedited and faxed over to American 

Pain.’’ Id. at 823–24. Once the MRI was 

procured and faxed to American Pain, 

the patient would return to the clinic 

and be seen by a doctor. According to 

Burt, the clinic accepted what he 

referred to as ‘‘predominantly cash 

only’’ 15 for these office visits, and the 

six doctors at the clinic saw ‘‘anywhere 

from 200 upward to 375 patients a 

day’’ 16 in this manner.17 Id. at 882–83 

(emphasis supplied). 

SA Burt also testified regarding his 

review of some 18 of the video and audio 

recordings made by an undercover agent 

(UC) who assumed the name Luis Lopez 

capturing activity inside of American 

Pain.19 In those recordings, Burt 

observed who he believed to be an 

American Pain employee inside the 

facility standing up in a waiting room 

full of patients and directing them ‘‘not 

to have their prescriptions filled out of 

State, not to go out into the parking lot 

and snort their pills,’’ and directing the 

patients to have their prescriptions 

filled ‘‘in house’’ (meaning at American 

Pain), at ‘‘a pharmacy they have in 

Orlando, Florida,’’ or at ‘‘a pharmacy 

they have down the street,’’ which, in 

Burt’s view, was a reference to Boca 

Drugs. Id. at 825–26. Burt further 

testified that the purported employee on 

the recording told the patients to ‘‘obey 

all the traffic laws; do not give the 

police a reason to pull you over.’’ Id. 

Although Burt testified as to the 

contents of these recordings, the 

physical recordings were not offered 

into evidence by the Government or 

made available to opposing counsel. 

SA Burt also testified that he received 

information from Dr. Eddie Sollie, a 

former physician employed during the 

time period American Pain was doing 

business as South Florida Pain, who 

terminated his employment at the 

Oakland Park clinic location in 

November or December 2008 after 

working there for approximately two 

and a half to three months.20 Id. at 827, 

898. During the course of an interview 

where Burt was present, Dr. Sollie 

related various ‘‘concerns about how the 

practice was being handled or 

managed.’’ Id. at 827–28. These concerns 

included medical records being, in his 

opinion, annotated inadequately by the 

doctors, and what he perceived as a lack 

of supervision during patient urinalysis 

testing, where patients would ‘‘go[] to 

the bathrooms together, bringing items 

with them to the bathrooms that could 

possibly disguise the urinalysis.’’ 

According to Burt, Sollie explained that 

he perceived that patients were 

substituting urine produced by other 

persons that contained the metabolites 

for controlled substances that the 

patients claimed to be legitimately 

taking, with a view towards falsely 

providing evidence to the American 

Pain doctors showing that they were 

actually taking prescribed medications 

and not diverting them. Id. at 828–29. 

During cross-examination, Burt 

explained that Dr. Sollie told him he 

had raised these concerns with 

Christopher George, the owner of 

American Pain, and that Burt had no 

evidence that the deficient practices that 

Sollie had objected to continued 

through 2010. Id. at 900, 906. Burt also 

acknowledged that he was aware Dr. 

Sollie had been involved in litigation 

with Mr. George and that their 

relationship was strained. Id. at 1009. 

Dr. Sollie was not called as a witness by 

either party. 

The Government also presented 

evidence through the testimony of SA 

Burt regarding the drug overdose deaths 

of TY and SM after obtaining controlled 

substances from American Pain.21 Burt’s 

record testimony indicates that DEA 

Task Force Officer 22 (TFO) Barry 

Adams informed him that a Kentucky 

resident named TY overdosed in 

Kentucky from oxycodone intoxication 

induced by medication procured at 

American Pain. Burt testified that this 

information was furnished pursuant to a 

working law enforcement relationship 

between the Kentucky State Police, 

Kentucky FBI, Kentucky DEA and 

Miami DEA aimed at addressing ‘‘the 

brunt of the pill problem’’ centered 

within the State of Kentucky relative to 

illegal use and resale of prescription 

pain medications. Id. at 833–35. 

However, in his testimony, Burt was 

unable to recall the name of the doctor 

from whom TY obtained his pills, and, 

thus, no admissible evidence was 

presented by the Government with 

respect to TY’s death.23

SA Burt also testified that TFO Adams 

notified him about the overdose death of 

SM, whose body was found at his 

Kentucky home. Id. at 854; Govt. Ex. 54 

at 1. SM’s death occurred on January 1, 

2009, the day after his first and only 

appointment with the Respondent. 

Govt. Ex. 69. Pursuant to Burt’s request, 

Adams provided him with a packet of 

various documents pertaining to SM’s 

death, including a narrative police 

report, medical examiner’s report and 

toxicology report, which were admitted 

into evidence. Govt. Ex. 54. Respondent, 

through counsel, introduced a more 

complete version of the report, obtained 

directly from the Rockcastle County 

Sherriff’s Office (RCSO), which was also 

admitted into evidence (RCSO 

Investigation).24 Respt. Ex. 1. 

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it was clear that the Government’s version omitted 

a discomforting number of pages that should have 

been included. Respt. Ex. 1; Tr. at 1041–43. The 

Government’s version included a toxicology report 

that was not present in the Respondent’s version. 

Govt. Ex. 54 at 4–7. 

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

26ALJ Ex. 6. 

27 Dr. Kennedy’s CV was admitted into evidence. 

Govt. Ex. 117. 

28Tr. at 17. 

29At the consolidated hearing in this matter, the 

Government elicited testimony from Dr. Kennedy 

regarding additional aspects of practice that he 

found deficient regarding the prescribing practices 

of other respondents. For example, Dr. Kennedy 

opined that the prescribing of 30 mg of oxycodone 

to an opioid naı ̈ve patient would, in his opinion, 

be dangerous and improper. Similarly, Dr. Kennedy 

provided his opinion that the practice of ordering 

of an MRI prior to a physician meeting with a 

patient would be improper. However, regarding the 

charts that Dr. Kennedy reviewed relative to this 

Respondent, the government adduced no 

testimonial evidence regarding issues such as 

opioid naı ̈vete ́ or the timing of MRI scripts, and it 

would be unfair, improper and illogical for an 

Administrative Law Judge to extrapolate the 

testimony elicited relative to the patients of other 

physician(s) to this Respondent. See Gregg & Son 

Distribs., 74 FR 17517 n.1 (2009) (data should be 

provided while record is open, and ‘‘[t]o make clear, 

it is the Government’s obligation as part of its 

burden of proof and not the ALJ’s responsibility to 

sift through the records and highlight that 

information which is probative of the issues in the 

proceeding’’) citing Southwood Pharms., Inc., 72 FR 

36487, 36503 n.25 (2007). The absence of 

testimonial support by Dr. Kennedy on these issues 

relative to this Respondent does not adversely affect 

the weight to be attached to the conclusions set 

forth in the reports he prepared in connection with 

this Respondent which were received into 

evidence. Govt. Exs. 28, 131. 

The certificate of death contained in 

the RCSO Investigation reflects the 

coroner’s finding of ‘‘acute Oxycodone 

and Alprazolam intoxication’’ as SM’s 

cause of death. Govt. Ex. 54 at 2; Respt. 

Ex. 1 at 7–8. The RCSO Investigation 

includes a narrative report, which states 

that the responding police officer 

reporting the incident procured various 

statements and paperwork from the 

decedent’s parents indicating he ‘‘had 

been going to a pain clinic in Ft. 

Lauderdale, FL [t]o receive pain 

medication,’’ copied said documents, 

and placed them in his case file. Id. at 

1. Record evidence of these copied 

materials, absent from the Government’s 

exhibit submission or Burt’s testimonial 

presentation, includes an American 

Pain business card listing ‘‘1/28’’ under 

the heading ‘‘next appointment,’’ and 

several prescription data printouts 

reflecting that on December 31, 2008, a 

prescription for oxycodone issued to SM 

by the Respondent was filled at Speedy 

Scripts Pharmacy in Fort Lauderdale. 

Respt. Ex. 1 at 21. The Respondent’s 

patient chart pertaining to SM reflects 

that on the date of their first and only 

encounter, she issued prescriptions for 

oxycodone (15 mg), Roxicodone (30 

mg), and Xanax (2 mg). Govt. Ex. 69 at 

16. This is consistent with patient 

receipts provided to RCSO personnel by 

SM’s mother. Respt. Ex. 1 at 17–22. 

Also absent from the Government’s 

version of the RCSO Investigation is that 

several prescription vials were found on 

SM’s body at the time of his death. One 

empty prescription vial indicates that it 

had once contained forty-five 

hydrocodone pills filled on December 2, 

2008 (twenty-eight days prior to his 

death and twenty-seven days prior to 

his first and only appointment with the 

Respondent), another empty 

hydrocodone vial indicates that it was 

filled on November 21, 2008 (forty-one 

days prior to his death and forty days 

prior to his first and only appointment 

with the Respondent), and a third vial 

of tizanidine (a non-controlled 

substance) was filled on November 19, 

2008 (forty-three days prior to his death 

and forty-two days prior to his first and 

only appointment with the Respondent). 

Also found on the Respondent was a 

vial with what appeared to be marijuana 

seeds, baggies and a scale of a type that 

is commonly used in connection with 

drug paraphernalia. Respt. Ex. 1 at 4. 

Statements of interviews contained in 

the RCSO Investigation reflect that SM’s 

friends and family were aware that he 

had a pain-killer addiction that had its 

origins in the treatment of pain 

symptoms from an automobile accident 

and that he abused marijuana. Id. at 5, 

25, 26. Witness statements also reflect 

that SM was emotionally upset by a 

recent break up with a girlfriend. Id. at 

4, 23–29. 

Although the coroner unambiguously 

concluded that ‘‘[a]cute Oxycodone and 

Alprazolam intoxication’’ was the cause 

of death,25 the autopsy also reflected 

evidence that SM had ingested other 

controlled substances, including 

marijuana and oxymorphone. Id. at 8; 

Govt. Ex. 54 at 4–7; Tr. at 1033–38. 

When viewed in its entirety, SA 

Burt’s record testimony was stunningly 

sparse when compared with his 

proposed testimony as noticed in the 

Government’s prehearing statement.26

Indeed, perhaps among the more 

striking aspects of SA Burt’s 

performance on the witness stand is the 

anticipated testimony which he did not 

provide. That certain information may 

be unavailable for reasons related to 

other litigation forums or other equally 

valid reasons are of no moment with 

respect to the evaluation that must be 

made at this administrative forum. 

Equally important, such considerations 

do not alter the burdens imposed upon 

the respective parties. Simply put, the 

admitted evidence must succeed or fail 

on its own merits, irrespective of 

extraneous considerations. 

Even apart from the marked contrast 

between the Burt testimony as proffered 

and as realized, his testimony was 

marred by periodic memory failures on 

significant issues and an inability to 

supply details to an extent that it could 

arguably have diminished the weight 

that could be fairly attached to those 

aspects of his own investigation that he 

did manage to recollect. During his 

testimony, SA Burt acknowledged his 

own marked lack of preparation and 

unfamiliarity with the investigation and 

confessed simply that ‘‘[t]here’s no 

excuse * * *.’’ Id. at 1003–05. 

Even acknowledging its obvious 

suboptimal aspects, SA Burt’s testimony 

had no apparent nefarious motivation or 

indicia of intentional deceit. Burt came 

across as an earnest and believable 

witness, who, regarding the aspects of 

the case that he did recall, was able to 

impart substantial information about the 

investigation and activities involving 

American Pain and its doctors. While 

frequently lacking in detail, his 

testimony was not internally 

inconsistent or facially implausible, and 

although the legal weight I have 

assigned to certain portions of Burt’s 

testimony varies given the issues 

described, I find his testimony to be 

credible overall. 

The Government presented the bulk 

of its case through the report and 

testimony of its expert, L. Douglas 

Kennedy, M.D., D.A.B.P.M., Affiliate 

Clinical Assistant Professor at the 

University of Miami, Miller School of 

Medicine.27 Dr. Kennedy, who testified 

that he is board certified by the 

American Board of Pain Medicine and 

the American Board of 

Anesthesiology,28 was offered and 

accepted as an expert in the field of pain 

medicine. Tr. at 39. 

Dr. Kennedy testified that after a 

review of a group of selected patient 

files from those seized at the 

Respondent’s practice that were to him 

provided by the Government, he 

concluded that the charts lacked the 

individualized treatment plans and the 

variety of diagnostic tools required to 

meet the minimally acceptable 

standards of practice in the State of 

Florida, that Respondent’s prescribing 

practices and the documentation 

present in those patient files fell below 

the standards fixed by the Florida State 

Medical Board, and that the controlled 

substance prescriptions contained in 

those files were not issued for a 

legitimate medical purpose.29 Id. at 384– 

90. 

At the hearing, Dr. Kennedy 

explained that he took professional 

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30Tr. at 542–44. 

31Tr. at 59. 

32Tr. at 74. 

33At 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. 

issue with several aspects of the 

Respondent’s patient care as reflected in 

the charts regarding the prescribing of 

controlled substances. It is apparent 

from his testimony that Dr. Kennedy’s 

analysis is restricted to those matters 

which can be gleaned from an 

examination of the written word in that 

subset of the Respondent’s patient 

charts provided by the Government for 

his review, and that limitation perforce 

circumscribes the breadth of his 

testimony. That being said, Dr. Kennedy 

highlighted numerous features in the 

Respondent’s chart documentation that 

he found wanting, or at least 

remarkable. 

Dr. Kennedy explained that there are 

basic elements to practicing pain 

medicine. The acquisition of a thorough 

history and physical examination is 

important. Id. at 41–42. He also stressed 

the vital importance of obtaining past 

medical records to evaluate what 

treatments, therapies, medications, and 

dosages have been utilized in the past 

so that correct current treatment 

decisions can be made. Id. at 45–46. 

Reliance upon the patient’s memory of 

these elements without the prior 

medical records, in Dr. Kennedy’s view 

is not reliable or acceptable. Id. at 46– 

47. Dr. Kennedy acknowledged that 

physicians customarily accept patients 

at their word, but on the subject of 

verifying a patient’s subjective 

complaint and medication history, Dr. 

Kennedy explained that 

[s]ometimes you have to help people 

understand why they’re suffering or what 

their problems are. A person with an 

addiction or drug abuse problem is no worse 

a human being than me. I’m not any better 

than them. But it’s your job as a doctor to sit 

down and find out what the truth is as well 

as you reasonably can under the 

circumstances. 

Id. at 357. 

In his testimony, Dr. Kennedy related 

that, in his expert opinion, although the 

information in the charts required a 

prudent physician to seek out prior 

medical records and/or input from prior 

medical providers, none of the 

Respondent’s charts reflected any 

attempt to do so. Id. at 525, 527–28. 

Kennedy also explained the 

importance of establishing a differential 

or working diagnosis on the first visit 

and modifying and reviewing that 

diagnosis as more information and 

results become available. Id. at 52. 

Similarly, a diagnostic plan is a 

systematic methodology of eliminating 

possible causes of symptoms to allow 

the treating physician to accurately 

determine what is causing them so that 

a successful treatment plan can be 

developed. Id. at 52–53. In other words, 

the diagnostic plan allows the treating 

doctor to eliminate or confirm items on 

the differential diagnosis. Id. at 54. In 

Kennedy’s view, the Respondent’s 

charts did not reflect an adequate, 

deliberative differential diagnosis 

process. Id. at 477–78. The ultimate 

diagnosis conclusion, at least in 

Kennedy’s view, appears assumed by 

the Respondent without supporting 

analysis. Id. at 478. 

In Kennedy’s view, the treatment 

plans in the Respondent’s chart were 

also infirm in that they were not 

sufficiently individualized. Id. at 386. 

Although, on cross examination, 

Kennedy conceded that at least one file 

recommended such things as yoga, 

stretching, vitamins and smoking 

cessation,30 his testimony supported the 

conclusion that every examined chart 

treated the patient primarily with 

controlled substances. Id. at 386, 472. 

Kennedy observed that comparing the 

patient charts, 

basically it’s the same. [The patients are] 

given high-dose oxycodone and two different 

strengths. The Roxicodone 15 milligrams is 

twice a day. The Roxicodone 30 looks like 

it’s been given six times a day in one case 

and eight times a day in another. Xanax is 

given at 2 miligrams. 

Id. at 482. 

Although Dr. Kennedy conceded that 

it is the judgment of the examining 

physician that is generally relied upon 

in determining the necessity and 

appropriateness of diagnostic testing,31

he also testified that the Respondent’s 

practice of routinely ordering magnetic 

resonance imaging (MRI) procedures 

before a physician meets with the 

patients was inappropriate because an 

MRI is not always required and not 

always appropriate. Id. at 71–73, 153– 

54. In Kennedy’s opinion, a physician 

has an obligation to meet with the 

patient before including this procedure 

as part of the utilized diagnostic tools. 

Id. Kennedy noted that the 

Respondent’s files reflected evidence 

that MRIs were the predominant 

diagnostic tool and were ordered prior 

to the patient’s first interaction with her 

at a clinic visit. Id. at 385. 

While acknowledging that some 

standardization and utilization of forms 

is not, standing alone, improper,32 Dr. 

Kennedy took issue with what he 

perceived as flaws in the forms utilized 

by the Respondent to document patient 

care. According to Dr. Kennedy, many 

of the forms used by the Respondent 

omitted too much. Id. at 472–73, 486. 

The error was not so much that every 

blank space was not filled in, but that 

‘‘important areas’’ such as the pain scale 

were left blank. Tr. at 486. 

Dr. Kennedy prepared two reports in 

connection with the Government’s case 

against the Respondent, which are dated 

April 28 and April 30, 2010, 

respectively, and both of which were 

admitted into evidence. Govt. Exs. 55, 

132; Tr. at 381–82. One of the reports 

describes a general analysis of thirteen 

charts that the Respondent maintained 

on as many patients, that were (selected 

by and) provided to Dr. Kennedy by the 

Government from among patient files 

seized pursuant to a criminal search 

warrant executed at the Respondent’s 

practice on March 3, 2010 (Patient 

Charts Analysis). Govt. Ex. 55. Although 

this report purports to describe practices 

common to all thirteen files reviewed by 

Dr. Kennedy, much of the analysis is 

directed toward a chart prepared in 

connection with RA,33 one of the 

Respondent’s patients. A second report 

(Supplemental Chart Analysis) prepared 

by Dr. Kennedy focuses on the chart of 

SM, the Kentucky-resident patient of the 

Respondent described in the RCSO 

Investigation who died from an 

overdose of the same variety of 

medications prescribed by the 

Respondent on the day after his first 

appointment with her. Govt. Ex. 132; 

Resp. Ex. 1; Tr. at 854–57. The 

Supplemental Chart Analysis notes that 

patient SM was seen by the Respondent 

at American Pain on December 31, 2008 

and indicates the presence of a note 

found in patient SM’s file stating 

‘‘Deceased 12/31/08/1–1–09 O.D.’’ Id. at 

2. 

Many of the observations and 

conclusions contained within the two 

reports are remarkably similar. Dr. 

Kennedy’s report makes it 

unambiguously clear that, at least in his 

opinion, all fourteen of the 

Respondent’s charts that he reviewed 

suffered from the same shortcomings. 

The Patient Charts Analysis states that 

the Respondent’s patient charts 

reviewed by Dr. Kennedy ‘‘are 

essentially the same with regard to 

review issues; as stated in the report of 

[RA] referenced and discussed in this 

report in detail, [and that] there were no 

significant differences that affected [his] 

conclusions and summary.’’ Govt. Ex. 55 

at 2. A like-worded proviso 

accompanies Dr. Kennedy’s analysis of 

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34Tr. at 470–74. 

35 Govt. Ex. 55 at 4. 

36 Govt. Ex. 55 at 4. In Dr. Kennedy’s opinion, the 

Respondent ‘‘prescribed, at the first visit, very high 

initial doses of controlled substance combinations 

despite not being within the standard of care for 

histories, physical examinations and/or absent past 

medical records [with] no apparent consideration 

given to patient safety with initial or subsequent 

prescription of controlled substance[s].’’ Id. at 7. 

37 Govt. Ex. 55 at 4. 

38As an example of the failure to adhere to the 

terms of the medication contract, Dr. Kennedy cites 

a contract term that provides notice that the 

physician may stop prescribing opioids or change 

treatment if pain or activity improvement is not 

demonstrated, and points out that pain and activity 

levels are routinely not documented in treatment 

notes. Govt. Ex. 55 at 4. Similarly, Dr. Kennedy 

references a medication contract warning that 

termination of services may result from failure to 

make regular follow-up appointments with primary 

care physicians, and notes that the American Pain 

charts contain no notes from primary care 

physicians or medical records generated by them. 

Id. 

39 Govt. Ex. 55 at 7. In Dr. Kennedy’s opinion, 

Respondent 

in effect, acted as a ‘barrier’ for [RA] to receive 

appropriate medical evaluation and treatment. In 

other words, the very potent, high doses of opioids 

(oxycodone) and benzodiazepine (Xanax) could 

cover up [RA’s] underlying disease process(s), 

making it more difficult to diagnose, and allowing 

the disease(s) to unnecessarily worsen. Without an 

accurate diagnosis, all [the Respondent] was doing 

was, again, masking or covering up the symptoms. 

Id. at 10. 

40 Govt. Ex. 55 at 7. 

41 Govt. Ex. 55 at 8. 

42 Govt. Ex. 55 at 7. 

43 Govt. Ex. 55 at 15. The only past medical 

record contained in RA’s chart was a report from 

an MRI conducted five months prior to the patient’s 

initial clinic visit with the Respondent. Id. at 8. 

44 Govt. Ex. 55 at 14. 

45 Govt. Ex. 55 at 15. 

46 Govt. Ex. 55 at 13. 

47 Govt. Ex. 55 at 8, 15. 

48 Govt. Ex. 55 at 16. 

SM’s patient chart in the Supplemental 

Chart Analysis. Govt. Ex. 132 at 1. 

When, on cross examination, Kennedy 

was directed to differences in exact 

wording, patient statements regarding 

chief complaints and dosage variations 

between patients,34 he explained that 

notwithstanding some variation 

between some details, his concern was 

that among all the files, at least in his 

view, ‘‘the process is the same.’’ Tr. at 

477. 

It is interesting to note that the SM 

patient chart contains no indication that 

the Respondent made any efforts to 

contact any prior doctors, pharmacists 

or family members. Likewise, there is no 

indication that any effort was made to 

query Kentucky PMP databases. A check 

to any of these sources could have 

informed the Respondent that another 

physician had recently prescribed 

oxycodone and other medications to 

SM, that SM was, at least in the opinion 

of his family and friends, addicted to 

pain medicine and was abusing 

marijuana, and that SM was emotionally 

labile due to the recent estrangement he 

had with his girlfriend. Unfortunately, 

because the Respondent made no efforts 

to reach out for any of that information, 

she merely talked to SM, prescribed 

controlled substances, and SM perished 

by an overdose of the same variety of 

medication she prescribed. 

In Dr. Kennedy’s opinion, the patient 

charts he reviewed that were prepared 

by the Respondent reflected care that 

fell below the applicable standard on 

multiple levels. In his report, Dr. 

Kennedy noted that the treatment notes 

in the charts: (1) Contained no 

typewritten clinical notes and were 

‘‘very brief, difficult to read (often 

impossible) and not within the standard 

of care due to their brevity and 

quality; 35’’ (2) reflected prescriptions, 

right from the initial patient visit, that 

‘‘were almost entirely for controlled 

substances, most often one or two 

immediate release oxycodone pills with 

Xanax,’’ and which were, in Dr. 

Kennedy’s view, inappropriate and 

more powerful than justified by the 

objective signs documented in the 

written notes; 36 (3) showed that ‘‘the 

same or very similar ‘drug cocktails’ 

were prescribed [among all patients in 

the reviewed files] in the same or very 

similar doses, [directions] * * * with a 

30-day supply,’’ and were affixed to the 

prescription scripts with a few prepared 

stamps utilized by all American Pain 

physicians that reflected ‘‘drug, dose, sig 

(directions) and quantity dispensed; 37’’ 

(4) contained medication contracts that 

were ‘‘not always signed’’ and ‘‘listed 

criteria that was not followed by the 

doctors at American Pain; 38 (5) failed to 

document the efficacy of the prescribed 

medication; (6) did not set forth a 

‘‘diagnostic plan, except to obtain an 

occasional MRI, the results of which 

made no difference in the 

‘treatment;’ ’’39 (7) reflected ‘‘no 

therapeutic plan, except to use 

controlled substances to ‘treat’ the 

subjective complaint of ‘pain’ which 

was inadequately described; 40 (8) did 

not reflect ‘‘real therapeutic goals * * * 

for improvement of quality of life 

(activities of daily living, work, sleep, 

mood); ’’41 (9) did not reflect 

‘‘consultations with other physicians or 

specialists outside the American Pain 

group [which] could have and in some 

cases should have included orthopedics, 

neurology, neurosurgery, psychiatry, 

addiction medicine and psychology; ’’42

(10) reflected ‘‘a gross lack of past 

medical records in all charts reviewed 

and in some cases none at all; 43’’ and, 

(11) demonstrated controlled substance 

patient monitoring practices that were 

‘‘not within the standard of care and 

outside the boundaries of professional 

practice.’’ 44

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, inoffice urine drug screen was frequently 

executed during the patients’ initial 

visit to the office but repeated only 

occasionally. Govt. Ex. 55 at 14. It was 

Dr. Kennedy’s observation that even a 

drug screen anomaly did not alter the 

seemingly inexorable continuation of 

controlled substance prescribing from 

the Respondent. Id. Dr. Kennedy also 

noted that the Respondent did not 

utilize out-of-office toxicology tests, or 

obtain out-of-State prescription 

monitoring program or outside 

pharmacy drug profiles. Furthermore, 

the charts contained only rare evidence 

of contact with primary care physicians, 

treating physicians, pharmacists, or 

other health care providers. Id. 

The identified shortcomings of 

controlled substance patient monitoring 

systems was of particular significance 

where Dr. Kennedy identified specific 

evidence that he identified as ‘‘red flags’’ 

of possible or likely diversion. In 

addition to providing incomplete and/or 

inconsistent information on his patient 

questionnaires, SM’s file reflected a 

positive urine screen test for the 

presence of benzodiazepines, opiates, 

and oxycodone, significant potential 

depression, and the failure to disclose 

information about his Kentucky-based 

primary care and orthopedics treating 

physicians, and his physical therapist. 

Govt. Exs. 69, 132 at 6. Other red flags 

noted by Dr. Kennedy in the reviewed 

charts included the relatively young age 

of the Respondent’s chronic pain 

patients,45 incomplete history 

information provided by the patients, 

periodically significant gaps between 

office visits,46 referrals from friends, 

relatives, or advertising, but not other 

physicians,47 and the fact that a 

relatively high number of patients were 

traveling significant distances to 

American Pain for pain treatment, 

although no physician employed at that 

facility had any specialized training in 

pain management.48

During the course of his testimony, 

Dr. Kennedy highlighted evidence in the 

chart of patient RA reflecting that 

although he disclosed to the Respondent 

that he was currently taking oxycodone 

and Xanax, and had last been prescribed 

a dosage that should have still been 

sufficient to supply him with 

medication on the day of his first office 

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49 Dr. Kennedy did not testify that a referral that 

emanated from a source other than a physician 

could or should be a basis for a diversion red flag 

on a given case. His opinion was limited to culling 

some manner of a trend or pattern. In view of the 

fact that the record contains no development of the 

numbers of files with non-physician referrals versus 

the total number of files, or even an acceptable 

metric upon which the issue could be evaluated, 

there is very little useful analysis that can come 

from Dr. Kennedy’s observation regarding the files 

he reviewed. 

visit, the urinalysis conducted on that 

day reflected negative results. Tr. at 

548–56; Govt. Ex. 57 at 5, 7, 10, 26. 

Notwithstanding this obvious anomaly, 

the Respondent issued prescriptions for 

Roxicodone in 15 and 30 mg doses and 

Xanax in a 2 mg dose. Govt. Ex. 57 at 

19. Furthermore, based on the disclosed 

prior prescription amount and date, the 

issuance of these new prescriptions was 

at an earlier time than the prior 

prescriptions should have run out. Id. at 

552–55. RA’s chart reflects no inquiry, 

analysis, or even notation of these clear 

red flags. Id. at 554–55. Failing to 

inquire about these issues, according to 

Dr. Kennedy, fell below the standard of 

care that the Respondent should have 

exercised. Id. at 555. 

Similarly, Dr. Kennedy explained that 

regarding RR’s patient chart, the 

paperwork generated at the time of the 

first visit with the Respondent reflected 

that he had been prescribed controlled 

substance medications that should have, 

but did not, yield positive urinalysis 

results. Id. at 556–60, 573–76; Govt. Ex. 

63 at 8, 14, 17, 34. Additionally, the 

patient examination form filled out by 

the Respondent based on her interview 

with RR reflected a chief complaint that 

included radicular symptoms extending 

to both legs, but the patient-completed 

questionnaire reflected that he did not 

have those symptoms. Tr. at 560–62; 

Govt. Ex. 63 at 8, 17. The chart did not 

contain additional inquiry regarding 

why the controlled substances were 

apparently not being taken by the 

patient or why the patient may not have 

had the symptoms the controlled 

substances were being prescribed to 

ameliorate. Dr. Kennedy testified that 

these discrepancies should have, but 

did not result in additional due 

diligence on the part of the physician. 

Tr. at 560–62. 

Although Dr. Kennedy agreed during 

cross examination that a possible 

explanation for a negative urinalysis 

could be that the medication was not 

taken within a few days of the 

urinalysis, Id. at 567, this inquiry misses 

the point. The question is not whether 

there could be a benign explanation 

from the patient, it is whether an 

explanation of any type was sought by 

the registrant. Here, the Respondent 

faced an obvious red flag of potential 

diversion and made no effort to resolve 

the conflict as best as can be divined 

from the patient file she kept. Dr. 

Kennedy reasonably characterized this 

type of discrepancy as ‘‘an inconsistency 

that should have been developed or 

should have been explored.’’ Id. at 571. 

Dr. Kennedy offered the following 

explanation regarding the nature of the 

due diligence that such inconsistencies 

should engender on the part of a 

physician: 

The duty was to talk with the—the first 

thing you do is talk with the person, the 

individual, the patient, and find out if they 

have an explanation for that; was it a 

misunderstanding? Did they mean what they 

wrote down? And find out exactly what’s 

going on and get their side, get their story, 

because your job is to advocate for them, and 

also, to help them from doing any harm to 

themselves. 

Id. at 573. 

In his report, Dr. Kennedy also found 

it remarkable that each American Pain 

patient file provided notice to its 

patients that American Pain did not 

accept any form of health care 

insurance. Govt. Ex. 55 at 3–4, 16. Dr. 

Kennedy’s report set forth his opinion 

that this practice was designed to 

‘‘effectively keep [the physicians at 

American Pain] ‘off the radar’ from 

monitoring by any private health care 

insurance company as well as all State 

and Federal agencies (Medicaid and 

Medicare respectively). Govt. Ex. 55 at 

16. Significantly, however, when asked, 

Dr. Kennedy acknowledged that he 

conducts his own current medical 

practice on a cash-only basis. Tr. at 151. 

Regarding the discomfiture that Dr. 

Kennedy expressed regarding nonphysician referrals in his report, during 

his testimony at the hearing, he clarified 

that it was not unusual for a physician 

to treat patients that have been referred 

by relatives and friends. Id. at 154. 

Further, Kennedy conceded while in the 

course of his own medical practice he 

has treated patients referred by family 

and friends, and that in his report he 

was focusing on what he perceived as a 

lack of any referrals by physicians in the 

files he reviewed, or what he perceived 

as ‘‘trends’’ or ‘‘patterns.’’ Id. at 154–55. 

Given Dr. Kennedy’s acknowledgement 

that such referrals are not unusual, 

coupled with the absence of any way to 

measure the relative percentage of 

physician referrals in the Respondent’s 

practice based on the record evidence, 

the observations regarding referral 

sources are of limited value here.49

Dr. Kennedy concluded his report 

regarding the Respondent’s prescribing 

practices with the following summary: 

[The Respondent] was not engaged in the 

practice of medicine, rather [s]he was 

engaged in an efficient, ‘‘[a]ssembly [l]ine’’ 

business. H[er] ‘‘patients’’ were revenue 

streams, not true patients. This business 

allowed h[er] to collect cas[h] for office visits 

as well as being a ‘‘[d]ispensing [p]hysician’’ 

for controlled substances. [Sh]e prescribed 

controlled substances so that ‘‘patients’’ 

would return to h[er] office on a regular 

basis, allowing h[er] to generate further 

revenue. [The Respondent’s] routine and 

excessive prescription of multiple controlled 

substances (oxycodone and Xanax) and lack 

of arriving at a valid medical diagnosis and 

treatment most likely caused harm to the 

‘‘patients’’ [s]he saw. Drug diversion most 

likely caused a ‘‘mushroom’’ effect of 

increased drug abuse, drug addiction, drug 

overdoses, serious bodily injury and death in 

those communities spread over several 

different states. [The Respondent’s] 

continued ability to prescribe controlled 

substances will only perpetuate the suffering 

and be a threat to the public. 

Govt. Ex. 55 at 16. 

On cross examination at the hearing, 

Dr. Kennedy’s attention was directed to 

what would seem, at least to a lay 

person, to present as including a 

significant level of detail set forth in the 

charts he reviewed relative to the 

Respondent’s patient documentation, 

including both subjective complaints of 

discomfort and objective signs of 

medical anomalies. Tr. at 497–98, 532– 

42. Undaunted, Dr. Kennedy (the sole 

expert to testify at the hearing), 

remained committed to his position that 

the manner in which the documentation 

was completed was fundamentally 

insufficient and too omission-plagued 

for a physician to adequately proceed to 

treat the patients with controlled 

substances. Id. at 473–74, 489, 522, 525. 

Dr. Kennedy, more than once, 

characterized the Respondent’s patient 

charts as demonstrating ‘‘gross errors of 

omission.’’ Id. at 522, 525. 

The Supplemental Chart Analysis 

focused exclusively on SM’s chart, 

which contained information assembled 

on the date of his first and only visit to 

the Respondent’s practice, which 

occurred on the day before he was 

pronounced dead of an overdose of the 

controlled substances prescribed to him 

by the Respondent. Govt. Exs. 69 at 10, 

132, 54; Respt. Ex. 1. Among the 

deficiencies noted by Dr. Kennedy 

regarding SM’s chart was an absence of 

any efforts to communicate with SM’s 

prior physician or obtain prior medical 

records, and SM’s failure to list any 

medications on the applicable portion of 

the medication contract. Govt. Ex. 132. 

Kennedy also opined that SM’s failure 

to provide any contact information 

regarding his prior physician, who, like 

SM was located in Kentucky, should 

have presented a red flag to the 

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50 The Government’s tactical decision to 

essentially unload a pile of charts that are explained 

only by the representations and generalizations in 

a report, with no attempt whatsoever to have its 

expert witness explain the applicable aspects of 

most charts to this tribunal or any future reviewing 

body is clearly at odds with the directive provided 

by the Deputy Administrator in Gregg & Son 

Distributors that ‘‘it is the Government’s obligation 

as part of its burden of proof and not the ALJ’s 

responsibility to sift through the records and 

highlight that information which is probative of the 

issues in the proceeding’’ 74 FR 17517 n.1. 

51Notably, however, there is no indication in the 

patient file that the patient sought or received 

replacement prescriptions from the Respondent. 

52Tr. at 628. 

53The Respondent did not testify on her own 

behalf. 54This authority has been delegated pursuant to 

28 CFR 0.100(b) and 0.104. 

Respondent. Id. at 6. In his report, 

Kennedy characterized the 

Respondent’s patient evaluation and 

treatment regarding SM as ‘‘very clearly 

not within the standard of medical 

care.’’ Id. at 7. 

A review of the fourteen patient 

files 50 that informed the analysis, 

findings and conclusions offered in Dr. 

Kennedy’s written report and testimony 

does reflect the presence of at least some 

of the red flag issues he identified 

therein, but there was not the unanimity 

among the files that he repeatedly urges. 

Contrary to Kennedy’s representations 

that the patients were all referred by 

friends, family, and advertising, patient 

JA’s file contains a representation by the 

patient that he was referred to the clinic 

by a doctor. Govt. Ex. 56 at 28. The 

significance of this anomaly is, 

however, diminished considerably by 

the fact that the doctor’s name is never 

furnished by JA or presented anywhere 

in the chart. 

Regarding Dr. Kennedy’s objections to 

what he perceives as a virtually uniform 

pattern in the Respondent’s therapeutic 

plans, the record is not without 

exception. For example, Respondent 

included notations in one patient’s 

records referring him to see an 

oncologist based on potential liver 

cancer concerns. Govt. Ex. 68 at 9. 

An examination of the reviewed 

patient charts does reveal the presence 

of other red flags that should have 

inspired additional diligence or inquiry 

on the part of the Respondent. GA’s 

patient file contains a notation about the 

patient getting Roxicodone, Xanax, and 

Percocet ‘‘off the street,’’ a patient 

comfort assessment guide where GA 

states that his current treatments or 

medicine include ‘‘street drugs,’’ a 

medication contract that is signed but 

does not list any current medications at 

all, along with an initial positive 

urinalysis screen for opiates and 

oxycodone, yet the Respondent decided 

to prescribe all three substances to GA 

during his initial and subsequent visits. 

Govt. Ex. 58 at 8–9, 11, 35; see also 

Govt. Exs. 64 at 2; 66 at 6; 67 at 22 

(similar notations involving other 

patients acquiring controlled substances 

‘‘off the street’’). 

Patient JA’s file also contains an 

indication that he had previously 

received pain medications ‘‘off the 

street,’’ along with a police incident 

report referring to the armed robbery of 

two ‘‘Roxycotin’’ (sic) prescriptions 

valued at $600 from the patient on 

12/31/09 (the same date on which the 

Respondent provided them to him), and 

which further contains a statement that 

‘‘[t]he victim completed a written 

statement affidavit, but refused to 

pursue criminal charges at this time.’’ 51

Govt. Ex. 56 at 2–3, 7. 

JA’s patient file also contains a form 

indicating a positive UDS for oxycodone 

and benzodiazepine from 10/7/09, yet 

on the same date, the patient comfort 

assessment guide and medication 

contract signed by JA are both blank in 

the section where a patient is supposed 

to list any medications he or she is 

currently taking. Govt. Ex. 56 at 13–14, 

30; see also Govt. Exs. 59 at 9–10, 24; 

61 at 7–8, 19; 66 at 11–12, 29 (similar 

issues). Patient RA’s 11/2/09 UDS 

indicates a negative test for all listed 

substances, yet on two different forms in 

his file which appear to be from the 

same date, he indicates he is currently 

taking oxycodone and Xanax. Govt. Ex. 

57 at 10–11, 26; see also Govt. Exs. 63 

at 14–15, 34; 67 at 9–10, 22 (similar 

issues). Patient RS’s UDS form, on the 

other hand, lists a positive test result for 

oxycodone and benzodiazepine on 10/5/ 

09, yet the patient states she is currently 

taking only oxycodone on a medication 

contract signed on the same date. Govt. 

Ex. 65 at 7, 18. 

The Government’s presentation of Dr. 

Kennedy’s testimony at the hearing was 

substantially consistent with the 

conclusions included in the Patient 

Charts Analysis, but Dr. Kennedy’s 

presentation was clearly not without its 

blemishes. Although he testified that he 

was familiar with prescribing practices 

in Florida, and that he utilized the 

medical standards applicable to Florida 

practice,52 he was unable to identify the 

documentation standard in the Florida 

Administrative code with any degree of 

particularity, he also acknowledged that 

he was not aware of what the standard 

is in Florida Medical Board 

administrative decisions regarding the 

overprescribing of medication or what 

constitutes an adequate medical history. 

Tr. at 149–51, 233, 304. While, overall, 

Kennedy presented testimony that 

appeared candid and knowledgeable, 

there were areas in his written report 

that rang of hyperbole and overembellishment. The reasoning behind 

some of the seemingly critical 

observations in the written report, such 

as the ‘‘cash basis’’ of the Respondent’s 

practice and the absence of doctor 

referrals among the reviewed patient 

files, did not well survive the crucible 

of cross examination at the hearing. 

However, overall, Dr. Kennedy’s 

testimony was sufficiently detailed, 

plausible, and internally consistent to 

be considered credible, and, consistent 

with his qualifications, he spoke 

persuasively and with authority on 

some relevant issues within his 

expertise, and notwithstanding the 

Respondent’s objections relative to his 

Florida-related experience, he is 

currently an assistant professor teaching 

at a Florida Medical School. It may well 

be that the greatest and most significant 

aspect of Dr. Kennedy’s opinion is that 

on the current record, it stands 

unrefuted. Thus, his opinion is the only 

expert opinion available for reliance in 

this action.53 Accordingly, Dr. 

Kennedy’s expert opinion that the 

Respondent’s controlled substance 

prescribing practices, at least as 

evidenced through his examination of 

the patient charts he reviewed, fell 

below the standards applicable in 

Florida, and that the controlled 

substance prescriptions contained in 

those files were not issued for a 

legitimate medical purpose is unrefuted 

on this record and (although by no 

means overwhelming) is sufficiently 

reliable to be accepted and relied upon 

in this recommended decision. 

The Analysis 

Pursuant to 21 U.S.C. 824(a)(4), the 

Deputy Administrator 54 may revoke a 

registrant’s DEA Certificate of 

Registration if persuaded that the 

registrant ‘‘has committed such acts that 

would render * * * registration under 

section 823 * * * inconsistent with the 

public interest * * *.’’ The following 

factors have been provided by Congress 

in determining ‘‘the public interest’’: 

(1) The recommendation of the 

appropriate State licensing board or 

professional disciplinary authority. 

(2) The applicant’s experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(3) The applicant’s conviction record 

under Federal or State laws relating to 

the manufacture, distribution, or 

dispensing of controlled substances. 

(4) Compliance with applicable State, 

Federal or local laws relating to 

controlled substances. 

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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19459 

(5) Such other conduct which may 

threaten the public health and safety. 

21 U.S.C. 823(f). 

‘‘[T]hese factors are considered in the 

disjunctive.’’ Robert A. Leslie, M.D., 68 

FR 15227, 15230 (2003). Any one or a 

combination of factors may be relied 

upon, and when exercising authority as 

an impartial adjudicator, the Deputy 

Administrator may properly give each 

factor whatever weight she deems 

appropriate in determining whether an 

application for a registration should be 

denied. JLB, Inc., d/b/a Boyd Drugs, 53 

FR 43945 (1988); England Pharmacy, 52 

FR 1674 (1987); see also David H. Gillis, 

M.D., 58 FR 37507, 37508 (1993); Joy’s 

Ideas, 70 FR 33195, 33197 (2005); Henry 

J. Schwarz, Jr., M.D., 54 FR 16422 

(1989). Moreover, the Deputy 

Administrator is ‘‘not required to make 

findings as to all of the factors * * *.’’ 

Hoxie v. DEA, 419 F.3d 477, 482 (6th 

Cir. 2005); see also Morall v. DEA, 412 

F.3d 165, 173–74 (DC Cir. 2005). The 

Deputy Administrator is not required to 

discuss consideration of each factor in 

equal detail, or even every factor in any 

given level of detail. Trawick v. DEA, 

861 F.2d 72, 76 (4th Cir. 1988) (the 

Administrator’s obligation to explain 

the decision rationale may be satisfied 

even if only minimal consideration is 

given to the relevant factors and remand 

is required only when it is unclear 

whether the relevant factors were 

considered at all). The balancing of the 

public interest factors ‘‘is not a contest 

in which score is kept; the Agency is not 

required to mechanically count up the 

factors and determine how many favor 

the Government and how many favor 

the registrant. Rather, it is an inquiry 

which focuses on protecting the public 

interest * * *.’’ Jayam Krishna-Iyer, 

M.D., 74 FR 459, 462 (2009). 

In an action to revoke a registrant’s 

DEA COR, the DEA has the burden of 

proving that the requirements for 

revocation are satisfied. 21 CFR 

1301.44(e). Once DEA has made its 

prima facie case for revocation of the 

registrant’s DEA Certificate of 

Registration, the burden of production 

then shifts to the Respondent to show 

that, given the totality of the facts and 

circumstances in the record, revoking 

the registrant’s registration would not be 

appropriate. Morall, 412 F.3d at 174; 

Humphreys v. DEA, 96 F.3d 658, 661 

(3d Cir. 1996); Shatz v. U.S. Dept. of 

Justice, 873 F.2d 1089, 1091 (8th Cir. 

1989); Thomas E. Johnston, 45 FR 72, 

311 (1980). Further, ‘‘to rebut the 

Government’s prima facie case, [the 

Respondent] is required not only to 

accept responsibility for [the 

established] misconduct, but also to 

demonstrate what corrective measures 

[have been] undertaken to prevent the 

reoccurrence of similar acts.’’ Jeri 

Hassman, M.D., 75 FR 8194, 8236 

(2010). 

Where the Government has sustained 

its burden and established that a 

registrant has committed acts 

inconsistent with the public interest, 

that registrant must present sufficient 

mitigating evidence to assure the 

Deputy Administrator that he or she can 

be entrusted with the responsibility 

commensurate with such a registration. 

Steven M. Abbadessa, D.O., 74 FR 10077 

(2009); Medicine Shoppe-Jonesborough, 

73 FR 364, 387 (2008); Samuel S. 

Jackson, D.D.S., 72 FR 23848, 23853 

(2007). Normal hardships to the 

practitioner, and even the surrounding 

community, that are attendant upon the 

lack of registration are not a relevant 

consideration. Abbadessa, 74 FR at 

10078; see also Gregory D. Owens, 

D.D.S., 74 FR 36751, 36757 (2009). 

The Agency’s conclusion that past 

performance is the best predictor of 

future performance has been sustained 

on review in the courts, Alra Labs. v. 

DEA, 54 F.3d 450, 452 (7th Cir. 1995), 

as has the Agency’s consistent policy of 

strongly weighing whether a registrant 

who has committed acts inconsistent 

with the public interest has accepted 

responsibility and demonstrated that he 

or she will not engage in future 

misconduct. Hoxie, 419 F.3d at 483; 

George C. Aycock, M.D., 74 FR 17529, 

17543 (2009); Abbadessa, 74 FR at 

10078; Krishna-Iyer, 74 FR at 463; 

Medicine Shoppe, 73 FR at 387. 

While the burden of proof at this 

administrative hearing is a 

preponderance-of-the-evidence 

standard, see Steadman v. SEC, 450 U.S. 

91, 100–01 (1981), the Deputy 

Administrator’s factual findings will be 

sustained on review to the extent they 

are supported by ‘‘substantial evidence.’’ 

Hoxie, 419 F.3d at 481. While ‘‘the 

possibility of drawing two inconsistent 

conclusions from the evidence’’ does not 

limit the Deputy Administrator’s ability 

to find facts on either side of the 

contested issues in the case, Shatz, 873 

F.2d at 1092; Trawick, 861 F.2d at 77, 

all ‘‘important aspect[s] of the problem,’’ 

such as a respondent’s defense or 

explanation that runs counter to the 

Government’s evidence, must be 

considered. Wedgewood Vill. Pharmacy 

v. DEA, 509 F.3d 541, 549 (DC Cir. 

2007); Humphreys, 96 F.3d at 663. The 

ultimate disposition of the case must be 

in accordance with the weight of the 

evidence, not simply supported by 

enough evidence to justify, if the trial 

were to a jury, a refusal to direct a 

verdict when the conclusion sought to 

be drawn from it is one of fact for the 

jury. Steadman, 450 U.S. at 99 (internal 

quotation marks omitted). 

Regarding the exercise of 

discretionary authority, the courts have 

recognized that gross deviations from 

past agency precedent must be 

adequately supported, Morall, 412 F.3d 

at 183, but mere unevenness in 

application does not, standing alone, 

render a particular discretionary action 

unwarranted. Chein v. DEA, 533 F.3d 

828, 835 (DC Cir. 2008) (citing Butz v. 

Glover Livestock Comm. Co., Inc., 411 

U.S. 182, 188 (1973)), cert. denied, __ 

U.S. __, 129 S.Ct. 1033 (2009). It is wellsettled that since the Administrative 

Law Judge has had the opportunity to 

observe the demeanor and conduct of 

hearing witnesses, the factual findings 

set forth in this recommended decision 

are entitled to significant deference, 

Universal Camera Corp. v. NLRB, 340 

U.S. 474, 496 (1951), and that this 

recommended decision constitutes an 

important part of the record that must 

be considered in the Deputy 

Administrator’s decision, Morall, 412 

F.3d at 179. However, any 

recommendations set forth herein 

regarding the exercise of discretion are 

by no means binding on the Deputy 

Administrator and do not limit the 

exercise of that discretion. 5 U.S.C. 

557(b); River Forest Pharmacy, Inc. v. 

DEA, 501 F.2d 1202, 1206 (7th Cir. 

1974); Attorney General’s Manual on the 

Administrative Procedure Act 8 (1947). 

Factors 1 and 3: The Recommendation 

of the Appropriate State Licensing 

Board or Professional Disciplinary 

Authority and Conviction Record 

Under Federal or State Laws Relating 

to the Manufacture, Distribution, or 

Dispensing of Controlled Substances 

In this case, it is undisputed that the 

Respondent holds a valid and current 

State license to practice medicine. The 

record contains no evidence of a 

recommendation regarding the 

Respondent’s medical privileges by any 

cognizant State licensing board or 

professional disciplinary authority. 

However, that a State has not acted 

against a registrant’s medical license is 

not dispositive in this administrative 

determination as to whether 

continuation of a registration is 

consistent with the public interest. 

Patrick W. Stodola, M.D., 74 FR 20727, 

20730 (2009); Jayam Krishna-Iyer, 74 FR 

at 461. It is well-established Agency 

precedent that a ‘‘state license is a 

necessary, but not a sufficient condition 

for registration.’’ Leslie, 68 FR at 15230; 

John H. Kennedy, M.D., 71 FR 35705, 

35708 (2006). Even the reinstatement of 

a State medical license does not affect 

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the DEA’s independent responsibility to 

determine whether a registration is in 

the public interest. Mortimer B. Levin, 

D.O., 55 FR 9209, 8210 (1990). The 

ultimate responsibility to determine 

whether a registration is consistent with 

the public interest has been delegated 

exclusively to the DEA, not to entities 

within State government. Edmund 

Chein, M.D., 72 FR 6580, 6590 (2007), 

aff’d, Chein v. DEA, 533 F.3d 828 (DC 

Cir. 2008), cert. denied, __ U.S. __, 129 

S.Ct. 1033 (2009). Congress vested 

authority to enforce the CSA in the 

Attorney General and not State officials. 

Stodola, 74 FR at 20375. Thus, on these 

facts, the fact that the record contains no 

evidence of a recommendation by a 

State licensing board does not weigh for 

or against a determination as to whether 

continuation of the Respondent’s DEA 

certification is consistent with the 

public interest. 

Similarly, regarding Factor 3, while 

testimony was received at the hearing 

that indicated that a criminal search 

warrant was executed regarding the 

Respondent and American Pain, the 

record contains no evidence that the 

Respondent has ever been convicted of 

any crime or even arrested in 

connection with any open criminal 

investigation. Thus, consideration of the 

record evidence under the first and 

third factors does not militate in favor 

of revocation. 

Factors 2, 4 and 5: The Respondent’s 

Experience in Dispensing Controlled 

Substances, Compliance With 

Applicable State, Federal or Local Laws 

Relating to Controlled Substances, and 

Such Other Conduct Which May 

Threaten the Public Health and Safety 

In this case, the gravamen of the 

allegations in the OSC/ISO, as well as 

the factual concentration of much of the 

evidence presented, share as a principal 

focus the manner in which the 

Respondent has managed that part of 

her practice relative to prescribing and 

dispensing controlled substances and 

acts allegedly committed in connection 

with her practice at American Pain. 

Thus, it is analytically logical to 

consider public interest factors two, four 

and five together. That being said, 

factors two, four and five involve 

analysis of common and distinct 

considerations. 

Regarding Factor 2, the qualitative 

manner and the quantitative volume in 

which a registrant has engaged in the 

dispensing of controlled substances, and 

how long she has been in the business 

of doing so are factors to be evaluated 

in reaching a determination as to 

whether she should be entrusted with a 

DEA certificate. In some cases, viewing 

a registrant’s actions against a backdrop 

of how she has performed activity 

within the scope of the certificate can 

provide a contextual lens to assist in a 

fair adjudication of whether continued 

registration is in the public interest. 

There are two principal 

considerations embedded within a 

consideration of this public interest 

factor. In considering a similar factor 

under the List I chemical context, the 

Agency has recognized that the level of 

experience held by those who will be 

charged with recognizing and taking 

steps to minimize diversion factors 

greatly in determining whether 

entrusting a COR will be in the public 

interest. See Volusia Wholesale, 69 FR 

69409, 69410 (2004); Xtreme Enters., 

Inc., 67 FR 76195, 76197–98 (2004); 

Prachi Enters., 69 FR 69407, 69409 

(2004); J&S Distribs., 69 FR 62089, 

62090 (2004); K.V.M. Enters., 67 FR 

70968, 70969 (2002). The Agency has 

also recognized that evidence that a 

registrant may have conducted a 

significant level of sustained activity 

within the scope of the registration for 

a sustained period is a relevant and 

correct consideration, which must be 

accorded due weight. However, this 

factor can be outweighed by acts held to 

be inconsistent with the public interest. 

Experience which occurred prior and 

subsequent to proven allegations of 

malfeasance may be relevant. Evidence 

that precedes proven misconduct may 

add support to the contention that, even 

acknowledging the gravity of a 

particular registrant’s transgressions, 

they are sufficiently isolated and/or 

attenuated that adverse action against its 

registration is not compelled by public 

interest concerns. Likewise, evidence 

presented by the Government that the 

proven allegations are consistent with a 

consistent past pattern of poor behavior 

can enhance the Government’s case. 

In this case, the Respondent 

introduced no evidence regarding her 

level of knowledge and experience, or 

even the quality or length of her 

experience as a physician-registrant, but 

the Government has elected to do so. 

Regarding the Government’s 

presentation, Agency precedent has long 

held that in DEA administrative 

proceedings ‘‘the parameters of the 

hearing are determined by the 

prehearing statements.’’ CBS Wholesale 

Distribs., 74 FR 36746, 36750 (2009) 

(citing Darrel Risner, D.M.D., 61 FR 728, 

730 (1996); see also Roy E. Berkowitz, 

M.D., 74 FR 36758, 36759–60 (2009) 

(‘‘pleadings in administrative 

proceedings are not judged by the 

standards applied to an indictment at 

common law’’ and ‘‘the rules governing 

DEA hearings do not require the 

formality of amending a show cause 

order to comply with the evidence’’). 

That being said, however, the marked 

difference between the amount of 

evidence that the Government noticed 

in its OSC/ISO and the amount that it 

introduced at the hearing is striking. For 

example, contrary to its allegations, 

there was no evidence that the 

Respondent ‘‘prescribe[d] and 

dispense[d] inordinate amounts of 

controlled substances,’’ that the 

‘‘majority’’ of the Respondent’s patients 

were ‘‘from states other than Florida,’’ 

and there was no evidence that 

American Pain patients were issued 

‘‘pre-signed prescriptions to obtain 

MRI[s],’’ nor was there evidence that 

individuals positioned outside the 

American Pain building were there to 

‘‘monitor the activity of patients in the 

parking lot to prevent patients from 

selling their recently obtained controlled 

substances.’’ Likewise, no evidence was 

introduced at the hearing that could 

support the allegations that ‘‘employees 

of American Pain [] frequently ma[d]e 

announcements to patients in the clinic 

advising them on how to avoid being 

stopped by law enforcement upon 

departing the pain clinic’’ and 

‘‘frequently ma[d]e announcements [] 

advising [patients], among other things, 

not to attempt to fill their prescriptions 

at out-of State pharmacies and warning 

them against trying to fill their 

prescriptions at particular local retail 

pharmacies.’’ ALJ Ex. 1 (emphasis 

supplied). 

In like fashion, the Government’s 

prehearing statement proffered that SA 

Burt would testify to several of the items 

described but not established in the 

OSC/ISO. Among the list of allegations 

that were not supported by any evidence 

introduced at the hearing, were 

representations that SA Burt would 

testify concerning the following: 

Law enforcement in Florida and [other 

states that correspond to license plates seen 

in the American Pain parking lot] frequently 

arrest people for illegal possession and/or 

illegal distribution of controlled substances 

who have obtained the controlled substances 

from American Pain; 

American Pain hired individuals to ‘‘roam’’ 

the parking lot of the clinic to dissuade 

people from selling their recently obtained 

controlled substances on the property; 

[The reason American Pain placed] signs 

within American Pain warning individuals 

not to have their prescriptions filled at 

Walgreens pharmacies [is] because Walgreens 

refuses to dispense the prescriptions; 

Walgreens has flagged all American Pain 

doctors and will not fill any of their 

prescriptions; 

[Physical exams at American Pain are] 

usually no more than a blood pressure check 

and some bending and stretching; 

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55The statutory definition of the term ‘‘dispense’’ 

includes the prescribing and administering of 

controlled substances. 21 U.S.C. 802(10). 56ALJ Ex. 6 at 11–12. 

57Tr. at 825. 

58Tr. at 826. 

59Tr. at 898. 

60Tr. at 1026–27. 

Dismissed patients would be routed to 

other doctors within the clinic; 

[There was] co-mingling of [American 

Pain] physician’s drugs; 

[American Pain maintained] no inventories 

of drugs dispensed; 

[Details surrounding] the death of 

[American Pain] patient OB [where] [t]he 

cause of death was determined to be drug 

intoxication—opiate and benzodiazepine; 

[Information] from a confidential source 

[who indicated] that she traveled to 

American Pain in order to obtain controlled 

substances that were later sold in Kentucky 

for $25 per pill[,] [that] [the American Pain 

physician she encountered] did not spend 

any significant time conducting a physical 

examination of [her] [,] [that she would 

simply ask questions regarding [her] well 

being and would then ‘‘stamp’’ a prescription 

for [controlled substances][,] * * * that on 

one visit [during a power failure a] security 

guard working for the clinic instructed 

everyone to be patient and that the doctors 

would be with them shortly to ‘‘get your fix.’’ 

ALJ Ex. 6 at 3–9. 

To be clear, it is not that the evidence 

was introduced and discredited; no 

evidence to support these (and other) 

allegations was introduced at all. To the 

extent the Government had this 

evidence, it left it home. While the 

stunning disparity between the 

allegations proffered and those that 

were supported with any evidence does 

not raise due process concerns, it is 

worthy of noting, without deciding the 

issue, that Agency precedent has 

acknowledged the Supreme Court’s 

recognition of the applicability of the 

res judicata doctrine in DEA 

administrative proceedings. Christopher 

Henry Lister, P.A., 75 FR 28068, 28069 

(2010) (citing University of Tennessee v. 

Elliot, 478 U.S. 788, 797–98 (1986) 

(‘‘When an administrative agency is 

acting in a judicial capacity and resolves 

disputed issues of fact properly before it 

which the parties have had an adequate 

opportunity to litigate, the courts have 

not hesitated to apply res judicata[.]’’) 

The evidence the Government did 

present raises issues regarding not only 

Factor 2 (experience dispensing 55

controlled substances), but also Factors 

4 (compliance with Federal and State 

law relating to controlled substances) 

and 5 (other conduct which may 

threaten public health and safety). 

Succinctly put, the Government’s 

evidence related to the manner in which 

the Respondent practiced, and whether 

her practice complied with the law and/ 

or was a threat to the public. 

While true that GS Langston 

convincingly testified about the course 

of her investigation and laid an 

adequate foundation for numerous 

database results, the Government 

provided no foundational context for 

any relevant uses for those database 

results. Without some insight into what 

types of results from these databases 

should be expected when compared to 

similarly-situated registrants engaged in 

acceptable prescribing practices, the raw 

data is without use. In short, there was 

no evidence elicited wherein the 

percentage of the Respondent’s in-State 

to out-of State patients could be 

assessed, and no reasonable measuring 

stick based on sound principles upon 

which to evaluate such data. Likewise, 

there was no reliable yardstick upon 

which to measure the amount of 

controlled substances reflected in the 

databases compared to what a 

reasonable regulator would expect to see 

regarding a compliant registrant. To the 

extent Langston possessed this 

information (and she well may have) it 

was not elicited from her. The same 

could be said of the allegation set forth 

in the Government’s Prehearing 

Statement that alleges that from a given 

period the Respondent ‘‘was the 12th 

largest practitioner purchaser of 

oxycodone in the United States.’’ 56 No 

evidence to support that allegation (or 

its relevance) was ever brought forth at 

the hearing. To the extent that fact may 

have been true or relevant, it was never 

developed. What’s more, the Florida 

Administrative Code specifically 

eschews pain medication prescribing 

analysis rooted only in evaluation of 

medication quantity. Fla. Admin. Code 

r. 64B8–9.013(g). Lastly, there was no 

indication that despite Langston’s 

obvious qualifications to do so, that she 

or anyone else ever conducted an audit 

of the controlled-substance-inventoryrelated recordkeeping practices at 

American Pain. 

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 outof-State license tags. This testimony 

arguably provides some support for the 

Government’s contention that out-ofState patients (or at least patients being 

dropped off by cars with out-of-State 

tags) were being seen at the clinic, but 

his testimony did not provide much else 

in terms of relevant information. In any 

event, recent Agency precedent holds 

that details such as ‘‘where [a 

registrant’s] patients were coming from,’’ 

without additional factual development, 

can support a ‘‘strong suspicion that [a] 

respondent was not engaged in a 

legitimate medical practice’’ but that 

‘‘under the substantial evidence test, the 

evidence must ‘do more than create a 

suspicion of the existence of the fact to 

be established.’ ’’ Alvin Darby, M.D., 75 

FR 26993, 26999, n.31 (2010) (citing 

NLRB v. Columbian Enameling & 

Stamping Co., 306 U.S. 292, 300 (1939). 

Likewise, without additional details 

or at least some context, Burt’s 

testimony that individuals with ‘‘staff’’ 

written on their shirts appeared to be 

directing patients into the clinic reveals 

virtually nothing about the 

Respondent’s prescribing practices. Tr. 

at 818, 910. Furthermore, that Burt 

observed an individual on a videotape, 

who he believed to be an American Pain 

employee, on a single occasion, instruct 

patients not to ‘‘snort [their] pills’’ in the 

parking lot,57 or advising them to 

comply with vehicle and traffic laws,58

does not shed illumination on the 

Respondent’s prescribing practices. 

There was no evidence that the 

Respondent knew that these isolated 

incidents occurred, nor was there 

contextual evidence from which the 

relevance to these proceedings could be 

gleaned. Even if this tribunal was 

inclined to engage in the unsupported 

assignment of motives to the actions of 

these employees, under these 

circumstances, such an exercise could 

not constitute substantial evidence that 

could be sustained at any level of 

appeal. 

Burt’s testimony regarding his 

conversations with Dr. Sollie, who was 

formerly employed by American Pain, 

was also not received in a manner that 

could meaningfully assist in the 

decision process. According to Burt, 

Sollie told him that some (unnamed) 

physicians at American Pain were 

inadequately documenting their patient 

charts in some manner that was 

apparently never explained to Burt,59

and that some patients were 

intentionally evading the American Pain 

urinalysis process. Also, as highlighted 

in Respondent’s Post-Hearing Brief 

(Respondent’s Brief), Sollie did not 

work at American Pain at the same time 

the Respondent did,60 and did not 

specifically name any physician as 

being connected with his allegations of 

misconduct. Respt’s Br. at 11. Thus, this 

tribunal is at something of a loss as to 

how the information, as presented, 

would tend to establish a fact relevant 

to whether the continuation of this 

Respondent’s authorization to handle 

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61 21 U.S.C. 823(f). 

62 ‘‘Ultimate user’’ is defined as ‘‘a person who has 

lawfully obtained, and who possesses, a controlled 

substance for his own use or for the use of a 

member of his household or for an animal owned 

by him or by a member of his household.’’ 21 U.S.C. 

802(27). 

63Rulemaking authority regarding the practice of 

medicine within the State of Florida has been 

delegated to the Florida Board of Medicine (Florida 

Board). Fla. Stat. § 458.309(1)(2009). 

controlled substances is in the public 

interest. 

The Government’s evidence targeted 

not only the Respondent’s experience 

practicing under Factor 2, but also her 

compliance with applicable State and 

Federal laws relating to controlled 

substances under Factor 4. To effectuate 

the dual goals of conquering drug abuse 

and controlling both legitimate and 

illegitimate traffic in controlled 

substances, ‘‘Congress devised a closed 

regulatory system making it unlawful to 

manufacture, distribute, dispense, or 

possess any controlled substance except 

in a manner authorized by the CSA.’’ 

Gonzales v. Raich, 545 U.S. 1, 13 (2005). 

Consistent with the maintenance of that 

closed regulatory system, subject to 

limited exceptions not relevant here, a 

controlled substance may only be 

dispensed upon a prescription issued by 

a practitioner, and such a prescription is 

unlawful unless it is ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of her professional 

practice.’’ 21 U.S.C. 829; 21 CFR 

1306.04(a). Furthermore, ‘‘an order 

purporting to be a prescription issued 

not in the usual course of professional 

treatment * * * is not a prescription 

within the meaning and intent of [21 

U.S.C. 829] and the person knowingly 

* * * issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id. 

A registered practitioner is authorized 

to dispense,61 which the CSA defines as 

‘‘to deliver a controlled substance to an 

ultimate user 62 * * * by, or pursuant to 

the lawful order of a practitioner.’’ 21 

U.S.C. 802(10); see also Rose Mary 

Jacinta Lewis, 72 FR 4035, 4040 (2007). 

The prescription requirement is 

designed to ensure that controlled 

substances are used under the 

supervision of a doctor, as a bulwark 

against the risk of addiction and 

recreational abuse. Aycock, 74 FR at 

17541 (citing Gonzales v. Oregon, 546 

U.S. 243, 274 (2006); United States v. 

Moore, 423 U.S. 122, 135, 142–43 (1975) 

(noting that evidence established that a 

physician exceeded the bounds of 

professional practice when she gave 

inadequate examinations or none at all, 

ignored the results of the tests she did 

make, and took no precautions against 

misuse and diversion)). The 

prescription requirement likewise 

stands as a proscription against doctors 

‘‘peddling to patients who crave the 

drugs for those prohibited uses.’’ Id. The 

courts have sustained criminal 

convictions based on the issuing of 

illegitimate prescriptions where 

physicians conducted no physical 

examinations or sham physical 

examinations. United States v. Alerre, 

430 F.3d 681, 690–91 (4th Cir. 2005), 

cert. denied, 574 U.S. 1113 (2006); 

United States v. Norris, 780 F.2d 1207, 

1209 (5th Cir. 1986). 

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. § 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. § 458.331(m). 

In exercising its rulemaking 

function,63 the Florida Board of 

Medicine (Florida Board) promulgated a 

regulation addressing ‘‘Standards for 

Adequacy of Medical Records’’ 

applicable to all physicians. Fla. Admin. 

Code r. 64B8–9.003 (2009). That 

regulation provides, in pertinent part: 

(2) A licensed physician shall maintain 

patient medical records in English, in a 

legible manner and with sufficient detail to 

clearly demonstrate why the course of 

treatment was undertaken. 

(3) The medical record shall contain 

sufficient information to identify the patient, 

support the diagnosis, justify the treatment 

and document the course and results of 

treatment accurately, by including, at a 

minimum, patient histories; examination 

results; test results; records of drugs 

prescribed, dispensed or administered; 

reports of consultations and hospitalizations; 

and copies of records or reports or other 

documentation obtained from other health 

care practitioners at the request of the 

physician and relied upon by the physician 

in determining the appropriate treatment of 

the patient. 

(4) All entries made into the medical 

records shall be accurately dated and timed. 

Late entries are permitted, but must be 

clearly and accurately noted as late entries 

and dated and timed accurately when they 

are entered in to the record * * *. 

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

With respect to defining the 

parameters of what constitutes 

‘‘professional practice’’ in the context of 

pain management prescribing, Florida 

State law provides: 

Notwithstanding any other provision of 

law, a physician may prescribe or administer 

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64Florida 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. § 458.326 (2009). 

65Pursuant 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. § 458.309(5) 

(2009). 66 21 CFR 1306.04(a). 

67The 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. 

any controlled substance under Schedules II– 

V * * * to a person for the treatment of 

intractable pain,64 provided the physician 

does so in accordance with that level of care, 

skill, and treatment recognized by a 

reasonably prudent physician under similar 

conditions and circumstances. 

Fla. Stat. § 458.326 (2009). Moreover, 

the Florida Board has adopted,65 albeit 

in modified version, the Model Policy 

for the Use of Controlled Substances for 

the Treatment of Pain (Model Policy), a 

document drafted by the Federation of 

State Medical Boards (FSMB) to provide 

professional guidelines for the treatment 

of pain with controlled substances. The 

standards adopted by Florida share the 

key tenants of the Model Policy’s 

standards for pain management 

prescribing, including the emphasis on 

diligent efforts by physicians to prevent 

drug diversion, prescribing based on 

clear documentation of unrelieved pain 

and thorough medical records, and 

compliance with applicable Federal and 

State law. 

Like the Model Policy, which was 

promulgated ‘‘to encourage the 

legitimate medical uses of controlled 

substances for the treatment of pain 

while stressing the need to safeguard 

against abuse and diversion,’’ Florida’s 

regulation providing ‘‘Standards for the 

Use of Controlled Substances for 

Treatment of Pain,’’ Fla. Admin. Code r. 

64B8–9.013 (2009) (Florida Standards), 

recognizes that ‘‘inappropriate 

prescribing of controlled substances 

* * * may lead to drug diversion and 

abuse by individuals who seek them for 

other than legitimate medical use.’’ The 

language employed by the regulation 

under the preamble section titled ‘‘Pain 

Management Principles’’ makes clear 

that the standards ‘‘are not intended to 

define complete or best practice, but 

rather to communicate what the [Florida 

Board] considers to be within the 

boundaries of professional practice’’ 

(emphasis supplied), id. at 9.013(1)(g); 

thus, the plain text supports an 

inference that the standards provide the 

minimum requirements for establishing 

conduct that comports with the 

professional practice of controlled 

substance-based pain management 

within the State. Likewise, the level of 

integral range of acceptable practice that 

is built into the regulation underscores 

the importance of seeking an expert 

professional opinion in reaching a 

correct adjudication of whether a 

registrant has met the applicable Florida 

standard. It is clear that in assessing 

whether the controlled substance 

prescribing practices of a Florida 

practitioner fall within the acceptable 

range of what constitutes being within 

the bounds of being ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice,’’ 66 resort must be had to an 

expert. 

The Florida Standards direct that 

‘‘[p]hysicians should be diligent in 

preventing the diversion of drugs for 

illegitimate purposes,’’ id. at 9.013(1)(d), 

and provide that the prescribing of 

controlled substances for pain will be 

considered 

to be for a legitimate medical purpose if 

based on accepted scientific knowledge of 

the treatment of pain or if based on sound 

clinical grounds. All such prescribing must 

be based on clear documentation of 

unrelieved pain and in compliance with 

applicable State or Federal law. 

Id. at 9.013(1)(e) (emphasis supplied). 

The Florida Standards further provide 

that the validity of prescribing will be 

judged ‘‘based on the physician’s 

treatment of the patient and on available 

documentation, rather than on the 

quantity and chronicity of prescribing’’ 

(emphasis supplied). Id. at 9.013(1)(g). 

Furthermore, the Standards advise that 

physicians should not fear disciplinary 

action for ‘‘prescribing controlled 

substances * * * for a legitimate 

medical purpose and that is supported 

by appropriate documentation 

establishing a valid medical need and 

treatment plan’’ (emphasis supplied), or 

‘‘for failing to adhere strictly to the 

provisions of these standards, if good 

cause is shown for such deviation’’ 

(emphasis supplied). Id. at 9.013(1)(b), 

(f). 

Although, as discussed above, the 

Florida Board instituted general 

guidance applicable to all physicians 

regarding medical records, it also 

promulgated a separate set of 

documentation requirements in the 

Florida Standards applicable 

specifically to those physicians who 

prescribe controlled substances in the 

pain-management context. The Florida 

Standards, under the subheading 

‘‘Medical Records,’’ state that ‘‘[t]he 

physician is required to keep accurate 

and complete records’’ (emphasis 

supplied) including, though not limited 

to: 

1. The medical history and physical 

examination, including history of drug abuse 

or dependence, as appropriate; 

2. Diagnostic, therapeutic, and laboratory 

results; 

3. Evaluations and consultations; 

4. Treatment objectives; 

5. Discussion of risks and benefits; 

6. Treatments; 

7. Medications (including date, type, 

dosage, and quantity prescribed); 

8. Instructions and agreements; and 

9. Periodic reviews. 

Id. at 9.013(3)(f). The same section 

directs that ‘‘[r]ecords must remain 

current and be maintained in an 

acceptable manner and readily available 

for review. Id. 

The Florida Standards similarly 

emphasize the need for proper 

documentation in the patient evaluation 

context by specifying: 

A complete 67 medical history and physical 

examination must be conducted and 

documented in the medical record. The 

medical record should document the nature 

and intensity of the pain, current and past 

treatments for pain, underlying or coexisting 

diseases or conditions, the effect of the pain 

on physical and psychological function, and 

history of substance abuse. The medical 

record also should document the presence of 

one or more recognized medical indications 

for the use of a controlled substance. 

Id. at 9.013(3)(a). 

Furthermore, the Florida Standards 

require a written treatment plan that 

‘‘should state objectives that will be 

used to determine treatment success, 

such as pain relief and improved 

physical and psychosocial function, and 

should indicate if any further diagnostic 

evaluations or other treatments are 

planned.’’ Id. at 9.013(3)(b). Subsequent 

to the initiation of treatment, ‘‘the 

physician should adjust drug therapy to 

the individual medical needs of each 

patient. Other treatment modalities or a 

rehabilitation program may be necessary 

depending on the etiology of the pain 

and the extent to which the pain is 

associated with physical and 

psychosocial impairment.’’ (emphasis 

supplied). Id. 

Another standard adopted by the 

Florida Board, under the subheading 

‘‘Informed Consent and Agreement for 

Treatment,’’ is the directive that 

[t]he physician should discuss the risks 

and benefits of the use of controlled 

substances with the patient, persons 

designated by the patient, or with the 

patient’s surrogate or guardian if the patient 

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is incompetent. The patient should receive 

prescriptions from one physician and one 

pharmacy where possible. If the patient is 

determined to be at high risk for medication 

abuse or have a history of substance abuse, 

the physician should employ the use of a 

written agreement between the physician and 

patient outlining patient responsibilities, 

including, but not limited to: 

1. Urine/serum medication levels screening 

when requested; 

2. Number and frequency of all 

prescription refills; and 

3. Reasons for which drug therapy may be 

discontinued (i.e., violation of agreement. 

Id. at 9.003(3)(c). 

The Florida Standards contain a 

further requirement to periodically 

review ‘‘the course of pain treatment and 

any new information about the etiology 

of the pain or the patient’s state of 

health.’’ Id. at 9.013(3)(d) The Florida 

Standards explain the importance of 

periodic review in the following 

manner: 

Continuation or modification of therapy 

depends on the physician’s evaluation of the 

patient’s progress. If treatment goals are not 

being achieved, despite medication 

adjustments, the physician should reevaluate 

the appropriateness of continued treatment. 

The physician should monitor patient 

compliance in medication usage and related 

treatment plans. 

Id. 

Under the subheading ‘‘Consultation,’’ 

the Florida Board promulgated the 

instruction that 

[t]he physician should be willing to refer 

the patient as necessary for additional 

evaluation and treatment in order to achieve 

treatment objectives. Special attention should 

be given to those pain patients who are at 

risk for misusing their medications and those 

whose living arrangements pose a risk for 

medication misuse or diversion. The 

management of pain in patients with a 

history of substance abuse or with a 

comorbid psychiatric disorder requires extra 

care, monitoring, and documentation, and 

may require consultation with or referral to 

an expert in the management of such 

patients. 

Id. at 9.003(3)(e). 

It is abundantly clear from the plain 

language of the Florida Standards that 

the Florida Board places critical 

emphasis on physician implementation 

of adequate safeguards in their practice 

to minimize diversion and the need to 

document the objective signs and 

rationale employed in the course of pain 

treatment utilizing the prescription of 

controlled substances. Conscientious 

documentation is repeatedly 

emphasized as not just a ministerial act, 

but a key treatment tool and a vital 

indicator to evaluate whether the 

physician’s prescribing practices are 

‘‘within the usual course of professional 

practice.’’ Here, the uncontroverted 

expert opinion of Dr. Kennedy, the only 

expert witness to testify at these 

proceedings, reflects that the 

documentation he reviewed in the 

Respondent’s patient charts reflected 

care that was markedly below the 

standard of care set by the Florida 

Medical Board. Dr. Kennedy’s expert 

assessment was consistent with the 

State statutory and regulatory guidance. 

In Kennedy’s view, the Respondent’s 

charts demonstrated minimalistic, 

incomplete, and otherwise medically 

inadequate documentation of her 

contacts with patients and the 

prescribing rationale for her issuance of 

controlled substance prescriptions to 

those patients for alleged pain 

management purposes. The boilerplatestyle, ‘‘one high-dosage controlled 

substances treatment plan fits all’’ 

nature of nearly all of the patient 

medical records at issue, at least in the 

view of the uncontroverted expert, 

evidences a failure on the part of the 

Respondent to conduct her practice of 

medicine in a manner to minimize the 

potential of controlled substance abuse 

and diversion, and supports a 

conclusion that she failed to even 

substantially comply with the minimum 

obligations for professional practice 

imposed under the Florida Standards— 

and without ‘‘good cause [] shown for 

such deviation.’’ Id. at 9.013(1)(f). The 

same can be said of the multiple ignored 

red flags of diversion risk, such as the 

seeking of premature controlled 

substance prescription refills and the 

urinalysis anomalies highlighted by Dr. 

Kennedy in his testimony. 

In his brief, the Respondent’s counsel 

has prepared and submitted a 

thoughtful and detailed review of the 

patient charts analyzed by Dr. Kennedy. 

Respt’s Br. at 5–10. While counsel 

argues that the patient chart entries 

were satisfactory, the expert’s opinion at 

the hearing remained unchanged. 

Unfortunately, counsel’s analysis is the 

product of a lay evaluation of standards 

applicable to the nuanced and 

sophisticated science that is the practice 

of medicine. An example of the problem 

encountered here can be seen where 

counsel urges that the medication 

contract clause requiring patients to 

follow-up with their primary care 

physicians was somehow satisfied by 

the patient following up with the 

Respondent. Id. at 7. Whether a pain 

specialist can serve as (or morph into) 

a primary care physician sufficiently to 

satisfy a medication contract term is 

beyond the expertise of this tribunal, 

and requires the input of an expert 

witness. Also illustrative of the 

potential risks of blurring the line 

between expert and lay opinion is 

counsel’s argument that regarding the 

reviewed charts, ‘‘[s]ections that were 

not filled in include details that are not 

necessarily indicated for [the 

Respondent’s] evaluation of a patient for 

chronic pain therapy.’’ Id. at 9. A lay 

person is simply not in a position to 

contradict otherwise reliable expert 

testimony regarding which details are 

‘‘necessarily indicated’’ for inclusion in 

the chart of a pain management 

specialist. Where the opinion of counsel 

offered through argument and the 

opinion of the only accepted medical 

expert to provide an expert opinion in 

these proceedings conflict, counsel’s 

opinion cannot and will not be afforded 

controlling deference. Argument 

supplied by counsel (albeit a diligent 

and persuasive counsel) that the 

relevant standards were satisfactorily 

applied as evidenced by the protocols 

and procedures documented in the 

patient charts cannot supplant the 

unrefuted view of an accepted expert 

witness. 

The Respondent, who was in a unique 

position to conclusively refute Dr. 

Kennedy’s views and explain the format 

and nuances of the reviewed 

documentation, elected not to testify in 

this matter. At a DEA administrative 

hearing, it is permissible to draw an 

adverse inference from the silence of the 

Respondent, even in the face of a Fifth 

Amendment invocation. Hoxie v. DEA, 

419 F.3d 477, 483 (6th Cir. 2005) (citing 

United States v. Hale, 422 U.S. 171, 176 

(1975) (‘‘silence gains more probative 

weight where it persists in the face of 

accusation, since it is assumed in such 

circumstances that the accused would 

be more likely than not to dispute an 

untrue accusation.’’)); Joseph 

Baumstarck, M.D., 74 FR 17525, 17528, 

n.3 (2009) (citing Ohio Adult Parole 

Auth. v. Woodward, 523 U.S. 272, 286 

(1998)). On the facts of this case, where 

the allegations are of a nature that a 

registrant would be more likely than not 

to dispute them if untrue, an adverse 

inference based on the Respondent’s 

silence is appropriate. Where, as here, 

the Government, through its expert, has 

alleged that the Respondent’s charts do 

not reflect genuine analysis, but rather 

(at least in its view and the opinion of 

its expert), a sort of sham-by-check-box 

form designed specifically to present a 

false impression of a compliant 

registrant, it is precisely the type of 

allegation that would naturally all but 

oblige a registrant to spring to offer a 

contradictory account. The 

Respondent’s choice to remain silent in 

the face of such allegations, where she 

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Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19465 

could have related her version of her 

practice as a registrant, adds at least 

some additional credence to the factual 

and analytical views of the 

Government’s expert in this regard. 

In the Social Security context, where 

an Administrative Law Judge has 

received expert medical opinions on the 

issue of the claimant’s ability to work 

and they are not repudiated in any 

respect by substantial evidence, an 

adverse decision should be set aside as 

based on ‘‘suspicion and speculation.’’ 

Miracle v. Celebrezze, 351 F.2d 361, 378 

(6th Cir. 1965); see also Hall v. 

Celebrezze, 314 F.2d 686, 689–90 (6th 

Cir. 1963); cf. Harris v. Heckler, 756 

F.2d 431, 436 (6th Cir. 1985) (improper 

to reject uncontroverted evidence 

supporting complaints of pain simply 

because of claimant’s demeanor at 

hearing). When an administrative 

tribunal elects to disregard the 

uncontradicted opinion of an expert, it 

runs the risk of improperly declaring 

itself as an interpreter of medical 

knowledge. Ross v. Gardner, 365 F.2d 

554 (6th Cir. 1966). While in this case 

it is ironically true, much like in the 

Social Security context, that the opinion 

of a treating physician should be 

afforded greater weight than the opinion 

of an expert whose opinion is limited to 

a review of the patient file, see 

Magallenes v. Bowen, 881 F.2d 747, 751 

(9th Cir. 1989), the treating-source 

Respondent in this case offered no 

evidence, not even her own opinion, 

regarding the treatment rendered. Thus, 

in this adjudication, the record contains 

no dispute between experts to be 

resolved; instead, there is but one, 

unrefuted, uncontroverted, credible 

expert opinion. To ignore that expert 

opinion on this record and replace it 

with the opinion of this tribunal, 

Respondent’s counsel, or any other lay 

source would be a dangerous course and 

more importantly, a plainly erroneous 

one. 

Accordingly, after carefully balancing 

the admitted evidence, the evidence 

establishes, by a preponderance of the 

evidence, that the prescriptions the 

Respondent issued in Florida were not 

issued within ‘‘the usual course of [the 

Respondent’s] professional practice.’’ 21 

CFR 1306.04(a). Consideration of the 

evidence under the second and fourth 

factors support the COR revocation 

sought by the Government in this case. 

To the extent that the Respondent’s 

prescribing practices fell below the 

requisite standard in Florida, that 

conduct also impacts upon the Fifth 

statutory factor. Under Factor 5, the 

Deputy Administrator is authorized to 

consider ‘‘other conduct which may 

threaten the public health and safety.’’ 

21 U.S.C. 823(f)(5). Although this factor 

authorizes consideration of a somewhat 

broader range of conduct reaching 

beyond those activities typically 

associated with a registrant’s practice, 

an adverse finding under this factor 

requires some showing that the relevant 

conduct actually constituted a threat to 

public safety. See Holloway Distrib., 72 

FR 42118, 42126 (2007). 

Although admittedly not argued in 

the Government’s brief, nowhere is the 

application of this fifth public interest 

factor more crystallized on this evidence 

than it is regarding the handling of SM. 

Inasmuch as there is no question that 

multiple controlled substances were 

identified in the decedent’s body at the 

moment of death that were prescribed 

by multiple physicians, it would be 

difficult-to-impossible to precisely 

discern whether there was a specific one 

that could be isolated as the sole cause 

of his demise. An analysis centered on 

which physician’s name appeared on 

the vial that produced the ultimately 

fatal dose misses the point. Even if it 

were conclusively established that a 

medication that was legitimately 

prescribed in the usual course of a 

professional practice resulted in an 

adverse consequence—even death—that 

fact alone would not necessarily decide 

the issue here. The practice of medicine 

has not yet developed to a condition of 

such mathematical precision that it is 

free of adverse consequences resulting 

from good-faith efforts on the part of 

treating physicians. The real focus of 

this aspect of this decision is not to 

conclusively divine which medication 

ultimately was the most lethal, or even 

which practitioner authorized it, but to 

evaluate whether the Respondent’s 

prescribing practices resulted in 

prescriptions which were not issued in 

the usual course of a professional 

practice and whether her prescribing 

practices contributed to SM’s death. The 

patient chart relative to SM reflected 

that no efforts were made to procure 

prior medical records, information from 

family or friends, or even to perform a 

Kentucky PMP database query. 

Performing the tasks that Dr. Kennedy 

opined were required by a prudent 

practitioner would have revealed, at a 

minimum, that SM had an addiction to 

pain killers, was abusing marijuana, was 

receiving controlled substance 

prescriptions from another physician 

and was in the midst of some manner 

of significant emotional-psychological 

event. None of that was done. In the 

case of SM, the Respondent did what 

she apparently routinely did: She 

prescribed controlled substances 

without performing the steps that were 

required to ensure that the prescriptions 

were being issued for a legitimate 

medical purpose. In the case of SM, 

while it is possible, even likely, that 

increased curiosity and professional 

attention and action on the 

Respondent’s part could have saved his 

life, that determination is not required 

for a disposition of this case. While 

experts could argue the point of which 

medication actually killed him, there 

seems very little room for argument that 

the Respondent’s poor prescribing 

practices were very problematic relative 

to this decedent and serve as a grave 

reminder of the potential consequences 

of failing to take the steps required by 

a prudent registrant to ensure the safety 

of the public. Consideration of the 

Respondent’s conduct under Factor 5 

balances significantly in favor of 

revocation. 

The evidence establishes that the 

Respondent engaged in a course of 

practice wherein she prescribed 

controlled substances to patients 

irrespective of the patients’ need for 

such medication and ignoring any and 

all red flags that could or did indicate 

likely paths of diversion. The testimony 

of Dr. Kennedy, the DEA regulations, 

and the Florida Standards make clear 

that physicians prescribing controlled 

substances do so under an obligation to 

monitor the process to minimize the risk 

of diversion. The patient charts reflect 

that the Respondent, contrary to her 

obligations as a DEA registrant, did not 

follow up in the face of multiple red 

flags. The Respondent’s disregard of her 

obligations as a DEA registrant and 

Federal and State laws related to 

controlled substances militate in favor 

of revocation. 

By ignoring her responsibilities to 

monitor the controlled substance 

prescriptions she was authorizing to 

minimize diversion, and by 

participating in an insufficiently 

documented and thoughtful process for 

the issuance of potentially dangerous 

controlled substances, the Respondent 

created a significant potential conduit 

for the unchecked diversion of 

controlled substances. See Holloway 

Distrib., 72 FR at 42124 (a policy of ‘‘see 

no evil, hear no evil’’ is fundamentally 

inconsistent with the obligations of a 

DEA registrant). Agency precedent has 

long recognized that ‘‘[l]egally, there is 

absolutely no difference between the 

sale of an illicit drug on the street and 

the illicit dispensing of a licit drug by 

means of a physician’s prescription.’’ 

EZRX, LLC, 69 FR 63178, 63181 (1988); 

Floyd A. Santner, M.D., 55 FR 37581 

(1988). 

Agency precedent has consistently 

held that where, as here, the 

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19466 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

Government has met its burden to 

establish a prima facie case that a 

registrant has committed acts 

demonstrating that continued 

registration is inconsistent with the 

public interest, acceptance of 

responsibility is a condition precedent 

to continued registration. Jeri Hassman, 

M.D., 75 FR 8194, 8236 (2010); Medicine 

Shoppe, 73 FR at 387. The record 

contains no evidence that the 

Respondent has either acknowledged or 

accepted responsibility for the 

misconduct at issue in these 

proceedings. 

Recommendation 

Based on the foregoing, the evidence 

supports a finding that the Government 

has established that the Respondent has 

committed acts that are inconsistent 

with the public interest. A balancing of 

the statutory public interest factors 

supports the revocation of the 

Respondent’s Certificate of Registration 

and a denial of her application to renew. 

The Respondent has not accepted 

responsibility for her actions, expressed 

remorse for her conduct at any level, or 

presented evidence that could 

reasonably support a finding that the 

Deputy Administrator should continue 

to entrust her with a Certificate of 

Registration. 

Accordingly, the Respondent’s 

Certificate of Registration should be 

revoked and any pending applications 

for renewal should be denied. 

Dated: August 10, 2010. 

John J. Mulrooney, II, 

U.S. Administrative Law Judge. 

[FR Doc. 2011–8342 Filed 4–6–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

[TA–W–71,287A; TA–W–71,287B] 

Masco Builder Cabinet Group 

Including On-Site Leased Workers 

From Reserves Network, Reliable 

Staffing, and Third Dimension Waverly, 

OH; Masco Builder Cabinet Group 

Including On-Site Leased Workers 

From Reserves Network, Reliable 

Staffing, and Third Dimension Seal 

Township, OH; Amended Certification 

Regarding Eligibility To Apply for 

Worker Adjustment Assistance 

In accordance with Section 223 of the 

Trade Act of 1974, as amended (‘‘Act’’), 

19 U.S.C. 2273, the Department of Labor 

issued a Certification of Eligibility to 

Apply for Worker Adjustment 

Assistance on October 16, 2009, 

applicable to workers of Masco Builder 

Cabinet Group including on-site leased 

workers from Reserves Network, 

Jackson, Ohio. The workers produce 

cabinets and cabinet frames. The notice 

was published in the Federal Register 

on December 11, 2009 (74 FR 65797). 

The notice was amended on December 

22, 2010 to include other company 

locations. The notice was published in 

the Federal Register on January 12, 

2011 (76 FR 2145). The notice was 

amended again February 24, 2011 to 

include on-site leased workers from 

Reserves Network and Reliable Staffing. 

The notice was published in the Federal 

Register on March 10, 2011 (76 FR 

13226–13227). 

At the request of the State agency, the 

Department reviewed the certification 

for workers and former workers of 

Masco Builder Cabinet Group, Waverly, 

Ohio (TA–W–71,287A) and Seal 

Township, Ohio (TA–W–71,287B). The 

company reports that workers leased 

from Third Dimension were employed 

at the Waverly, Ohio and Seal 

Township, Ohio locations of Masco 

Builder Cabinet Group. 

The Department has determined that 

these workers were sufficiently under 

the control of Masco Builder Cabinet 

Group to be considered leased workers. 

Based on these findings, the 

Department is amending this 

certification to include workers leased 

from Third Dimension working on-site 

at the Waverly, Ohio and Seal 

Township, Ohio locations of Masco 

Builder Cabinet Group. 

The amended notice applicable to 

TA–W–71,287A and TA–W–71,287B is 

hereby issued as follows: 

All workers of Masco Builder Cabinet 

Group, including on-site leased workers from 

Reserves Network, Reliable Staffing, and 

Third Dimension, Waverly, Ohio (TA–W– 

71,287A) and Seal Township, Ohio (TA–W– 

71,287B), who became totally or partially 

separated from employment on or after June 

11, 2008, through October 16, 2011, and all 

workers in the group threatened with total or 

partial separation from employment on the 

date of certification through two years from 

the date of certification, are eligible to apply 

for adjustment assistance under Chapter 2 of 

Title II of the Trade Act of 1974, as amended. 

Signed at Washington, DC this 29th day of 

March, 2011. 

Del Min Amy Chen, 

Certifying Officer, Office of Trade Adjustment 

Assistance. 

[FR Doc. 2011–8307 Filed 4–6–11; 8:45 am] 

BILLING CODE 4510–FN–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

[TA–W–74,895, et al.] 

Wellpoint, Inc. D/B/A/Anthem Blue 

Cross & Blue Shield, et al.; Amended 

Certification Regarding Eligibility To 

Apply for Worker Adjustment 

Assistance 

TA–W–74,895 

Wellpoint, Inc. D/B/A/Anthem Blue Cross 

& Blue Shield Enterprise Provider Data 

Management Team Including On-Site 

Leased Workers from Kelly Services and 

Jacobsen Group Indianapolis, Indiana 

TA–W–74,895A 

Wellpoint, Inc. D/B/A/Anthem Health 

Plans of Kentucky Enterprise Provider 

Data Management Team Louisville, 

Kentucky 

TA–W–74,895B 

Wellpoint, Inc. Enterprise Provider Data 

Management Team Saint Louis, Missouri 

TA–W–74,895C 

Wellpoint, Inc. D/B/A/Anthem Enterprise 

Provider Data Management Team 

(Pewaukee) Waukesha, Wisconsin 

TA–W–74,895D 

Wellpoint, Inc. D/B/A/Anthem Enterprise 

Provider Data Management Team 

Richmond, Virginia 

TA–W–74,895E 

Wellpoint, Inc. D/B/A/Anthem East 

Enterprise Provider Data Management 

Team North Haven, Connecticut 

TA–W–74,895F 

Wellpoint, Inc. D/B/A/Blue Cross Blue 

Shield of Georgia Enterprise Provider 

Data Management Team Atlanta, Georgia 

TA–W–74,895G 

Wellpoint, Inc. D/B/A/Blue Cross Blue 

Shield Of Georgia Enterprise Provider 

Data Management Team Columbus, 

Georgia 

TA–W–74,895H 

Wellpoint, Inc. D/B/A/Anthem East 

Enterprise Provider Data Management 

Team South Portland, Maine 

TA–W–74,895I 

Wellpoint, Inc. D/B/A/Anthem East 

Enterprise Provider Data Management 

Team Manchester, New Hempshire 

TA–W–74,895J 

Wellpoint, Inc. D/B/A/Empire Blue Cross 

and Blue Shield Enterprise Provider Data 

Management Team Albany, New York 

TA–W–74,895K 

Wellpoint, Inc. D/B/A/Empire Blue Cross 

and Blue Shield Enterprise Provider Data 

Management Team Brooklyn, New York 

TA–W–74,895L 

Wellpoint, Inc. D/B/A/Anthem Enterprise 

Provider Data Management Team Mason, 

Ohio 

In accordance with Section 223 of the 

Trade Act of 1974, as amended (‘‘Act’’), 

19 U.S.C. 2273, the Department of Labor 

issued a Certification of Eligibility to 

Apply for Worker Adjustment 

Assistance on January 12, 2011, 

applicable to workers of Wellpoint, Inc., 

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