Jayam Krishna-Iyer, M.D.; Revocation of Registration, 52148-52159 [E6-14568]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Notices]
[Pages 52148-52159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14568]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 03-8]


Jayam Krishna-Iyer, M.D.; Revocation of Registration

Introduction and Procedural History

    On October 17, 2002, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Jayam Krishna-Iyer, M.D. (Respondent), of Clearwater, 
Florida. The Show Cause Order proposed to revoke Respondent's DEA 
certification of registration, No. AK2006648, as a practitioner on the 
grounds that Respondent had committed acts which rendered her continued 
registration inconsistent with the public interest. See 21 U.S.C. 
824(a)(4). The Show Cause Order also proposed to deny any applications 
for renewal or modification of her registration.
    The Show Cause Order alleged that between March 24, 1999, and June 
24, 1999, the Pinellas County, Florida, Sheriff's Office had conducted 
four undercover visits to Respondent's medical office. In essence, the 
Show Cause Order alleged that during three of the visits, Respondent 
had met with three different undercover operatives who had told her 
that they were not currently in pain but that they were users of 
various controlled substances such as Lorcet and Vicodin. See Show 
Cause Order at 2-3. The Show Cause Order further alleged that 
Respondent had issued prescriptions for controlled substances without 
performing a physical exam. See Id. The Show Cause Order alleged that 
Respondent had indicated in the patient records for each undercover 
operative that they had complained of pain when each had ``clearly 
stated that they were not in pain.'' Id. at 3. The Order also alleged 
that that Respondent had told the undercover operatives that she could 
offer them a detox program or could ``arrange an appropriate treatment 
plan.'' Id. at 3.
    The Show Cause Order further alleged that on the second visit of 
one of the undercover operatives, the operative had been seen by a 
nurse practitioner, Ben Mastridge. While Mastridge told him that 
Respondent would not prescribe narcotics if the operative was not in 
pain, he nonetheless issued him a prescription, which had been pre-
signed by Respondent, for Lorcet, Xanax, and Soma. See Id. at 2. The 
Order further alleged that Mastridge had offered ``to initiate 
Methadone

[[Page 52149]]

treatment, but the [operative] preferred simply to attempt to reduce 
his Lorcet addiction.'' Id.
    Based on the above, the Show Cause Order alleged that Respondent 
had ``prescribed controlled substances without a legitimate medical 
purpose in violation of Federal law.'' Id. at 4. The Show Cause Order 
further alleged that Respondent ``operated a narcotic treatment program 
without obtaining a separate registration for that purpose.'' Id.
    On January 26, 2000, a federal search warrant was executed at 
Respondent's office. During the search, the authorities seized the 
medical records for the undercover operatives.
    Thereafter, on June 21, 2000, a federal grand jury indicted 
Respondent on five counts of illegal distribution of various controlled 
substances in violation of 21 U.S.C. 841(a)(1). Resp. Ex. 110. These 
counts specifically alleged that Respondent had, on various dates, 
``knowingly and intentionally dispense[d] and distribute[d], outside 
the usual course of medical practice, and without a legitimate medical 
purpose,'' the drugs Lorcet, Vicodin and Vicodin ES (each being a 
Schedule III controlled substance), and Xanax (a Schedule IV controlled 
substance). Id. at 1-3. An additional count of the indictment alleged 
that Respondent had conspired to distribute Schedule III and Schedule 
IV controlled substances in violation of 21 U.S.C. 841(a)(1). See 21 
U.S.C. 846. See also Resp. Exh. 110, at 1.
    The United States Attorney offered Respondent pre-trial diversion. 
The agreement specifically provided that the period of supervision 
would last for no more than twelve (12) months, and that if Respondent 
fulfilled the conditions of the agreement, the charges would be 
dismissed. As part of the diversion agreement, Respondent also entered 
a medical supervision agreement. Under this agreement, Respondent was 
to submit the name of a monitoring physician for the approval of the 
United States Attorney; the monitoring physician was required to review 
twenty-five (25) percent of Respondent's patient records on a random 
basis and all records involving her prescribing of controlled 
substances to determine the appropriateness of the prescriptions. 
Respondent satisfactorily completed the supervision period and the 
indictment was dismissed.
    As stated above, on October 17, 2002, this proceeding was 
initiated. Respondent requested a hearing.\1\ The case was assigned to 
Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a 
hearing in Tampa, Florida, on July 1 and 2, and August 5 and 6, 2003. 
At the hearing, both the Government and Respondent called witnesses and 
introduced documentary evidence. Following the hearing, both the 
Government and Respondent submitted post-hearing briefs.
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    \1\ Respondent also sought to enjoin the proceeding. The 
district court, however, denied her motion for an injunction.
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    On April 15, 2005, the ALJ issued her recommended decision. The ALJ 
found that the Government had shown by a preponderance of the evidence 
that Respondent had, in each of the three instances involving the 
undercover operatives, prescribed controlled substances without a 
legitimate medical purpose and outside of the usual course of medical 
practice. See ALJ Dec. at 39-41. The ALJ further found that Respondent 
had ``unlawfully presigned prescriptions for controlled substances.'' 
Id. at 41. The ALJ also found that the Government had not proved by a 
preponderance of the evidence that Respondent had conducted a narcotic 
treatment program without the required registration. Id. Finally, the 
ALJ found that Respondent had refused to acknowledge her misconduct in 
prescribing the controlled substances, see id. at 43, and was 
``unwilling or unable to accept the responsibilities inherent in a DEA 
registration.'' Id. at 44. The ALJ thus recommended that Respondent's 
registration be revoked.
    Following the ALJ's decision, Respondent submitted an 87 page brief 
(Resp. Exceptions). Respondent's brief raised numerous challenges to 
the ALJ's findings of fact and conclusions of law. Respondent also 
claimed (1) That DEA's pursuit of this proceeding violates the pre-
trial diversion agreement, (2) that DEA should be estopped from 
contending that Respondent's continued registration is inconsistent 
with the public interest because of assertions the Government 
purportedly made in the criminal proceeding, and (3) that the DEA 
proceeding is a vindictive and retaliatory prosecution in violation of 
the Due Process Clause of the Constitution.
    Having considered the record as a whole, I hereby issue this 
decision and final order adopting the ALJ's findings of fact and 
conclusions of law except as expressly noted herein. I have also 
reviewed Respondent's various claims and find them to be without merit. 
For reasons set forth below, I concur with the ALJ's conclusion that 
Respondent's continued registration would be inconsistent with the 
public interest. I therefore adopt the ALJ's recommendation that 
Respondent's registration be revoked and that any pending applications 
for renewal or modification be denied.

Findings of Fact

    Respondent obtained her doctor of medicine degree in 1975 from 
Calicut University Medical College, in Kerala, India. Following a one 
year residency in New Delhi, Respondent attended the University Rene 
Descartes in Paris, France, from 1977 through 1981. There, she obtained 
additional training in anesthesia, critical care, and pain medicine. 
Respondent then moved to Pittsburgh, Pennsylvania, where she served a 
residency in anesthesia at Allegheny General Hospital from 1981 until 
1984. Because Respondent had already trained in anesthesia, she spent 
most of her time in pain management. Upon completion of her residency, 
Respondent moved to Clearwater, Florida, and took a position as an 
anesthesiologist at the Belleair Surgery Center (Belleair).\2\
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    \2\ Respondent is board certified in anesthesiology and pain 
management.
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    Respondent worked at Belleair from 1984 until 1999, and eventually 
became its medical director. While at Belleair, Respondent treated 
chronic pain patients and in 1994 or 1995, opened her own clinic. In 
1999, Respondent left Belleair to concentrate on her pain management 
practice. Respondent testified at the hearing that she had 
approximately 800 to 1000 recurring patients and saw around 3,000 
patients per year. Respondent has between fifteen and eighteen 
employees, and during the spring of 1999, employed Ben Mastridge, a 
Certified Addiction Registered Nurse. According to Respondent, 
Mastridge identified patients who were addicted to narcotics and helped 
patients address their mental health issues.

The Criminal Investigation

    In September 1998, Dale Carnell, a prescription fraud detective 
with the Pinellas County Sheriff's Office, contacted Ira Wald, a 
Diversion Investigator (DI) assigned to DEA's Tampa office. Detective 
Carnell told the DI that the Sheriff's Office had received ``numerous 
complaints'' about Dr. Iyer. Tr. 101-102. The DI proceeded to contact 
Walgreen's, a pharmacy chain, and obtained from it a printout of Dr. 
Iyer's controlled substance prescriptions for the previous twelve (12) 
months. Id. at 141. The DI testified that the printout

[[Page 52150]]

was ``the most voluminous'' he had seen in his twenty-three years as a 
DI, Id. at 102 & 142, that it ``was many hundreds of pages,'' Id. at 
140, and that it ``weighed five or six pounds.'' Id. at 141.
    Based on the printout, the DI and Detective Bernie McKenna of the 
Pinellas Sheriff's Office decided to conduct undercover visits to 
Respondent's office. The first visit was conducted by Mr. Chris Massey, 
an informant for the local authorities who was then on probation 
following his guilty plea for having obtaining hydrocodone 
prescriptions by fraud.

The First Undercover Visit

    On March 24, 1999, Massey went to Respondent's clinic and was seen 
by her. During the visit, Massey wore a wire; a transcript of his 
conversation with Respondent was admitted into evidence. According to 
the transcript, Respondent asked Massey who had sent him to see her. 
See GX-2, at 1. Massey told Respondent that he had been referred by a 
customer of his window tinting business. See id. Respondent then asked 
Massey, ``[w]here is your pain?'' Id. Massey answered: ``I'm not really 
in pain. He [the customer] said to come up. He said, you know, you're 
real understanding, just come up and be honest with you. I, uh, I had a 
shoulder surgery about 4\1/2\ years ago.'' Id.
    Respondent asked: ``[r]ight shoulder?'' Massey answered that ``the 
problem was more or less cured.'' Id. at 1-2. Massey then told 
Respondent that ``I was wanting to take Lorcet and Soma.'' Id. at 2. 
Massey also told Respondent that ``I have been taking it * * * [e]ver 
since then,'' an apparent reference to the surgery. Id. Massey added 
that he was ``sick of going to look for em.'' Id.
    Respondent then told Massey: ``Okay, look. We can, look, we can 
help you anyway.'' Id. In response, Massey then stated, ``I mean I'm 
being honest, I mean I'm not really in--I don't--I mean they make me 
feel good, make me get work done, I mean I'm not abusing them.'' Id. 
Following a discussion of how many pills Massey was taking per day, 
Respondent told Massey ``[w]e'll give you your medicine. The question 
for you is this--you can tell--you can tell me that you want to come 
out of drugs. We have intensive detox, we can help you.'' Id.
    Later in the conversation, Respondent asked Massey ``who gives you 
the medicine now?'' Id. at 3. Massey replied, ``I've been getting them 
from my girlfriend but me and her just split up.'' Id. Respondent then 
asked Massey what his job was and again asked about his shoulder. 
Massey told Respondent, ``I mean like I said, it's not, it doesn't 
bother me.'' Id.
    Respondent then asked Massey, ``what do you take, Lorcet 10?'' Id. 
at 4. After Massey told her that he took Lorcet 10/650, Respondent 
stated: ``Lorcet 10/650. See, this is a shame then that you have to 
take the medicine for the habit, you know.'' Id. Respondent once again 
asked Massey who had referred him. Massey told Respondent that his name 
was Bill and that he did not know Bill's last name, but that ``he's 
been going to you for a while you know, you're real understanding.'' 
Id. After stating that ``this is a pain center, you know,'' Respondent 
added: ``We don't want to give out drugs. So that's why we have to have 
a psychologist and a substance abuse counselor.'' Id. In response, 
Massey said ``Right.'' Respondent then added: ``We have massage 
therapist, physical therapist and everybody here, you know. But you are 
honest, you are telling the truth, and we are here to help you.'' Id. 
Massey replied: ``That's what he said, he said if you're honest with 
her, you know, go in there and tell her you're not in pain. This is 
your problem. You've been taking them.'' Id.
    Respondent then asked Massey how many Lorcets he was taking per 
day. Massey told her four. Respondent stated ``that's 124 a month'' and 
told him not to lose his medicine or run out of it because she would 
not call in a refill. Id. at 5. Massey then paid Respondent $175. Id. 
Respondent then told Massey, ``I'd be happy to see patients like you,'' 
and then told him that she could give him a refill on his SOMA 
prescription. She would not, however, give Massey a refill on the 
Lorcet. Respondent then gave Massey a prescription for 120 Lorcet 10 
with no refill and 60 SOMA with one refill.\3\ See Gov. Exh. 3.
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    \3\ The ALJ found that ``Respondent * * * said that she would 
give him sixty Soma, but would not list any refills on the 
prescription until she knew him better and knew that he was not 
abusing the medication.'' ALJ Dec. at 10. In light of the actual 
prescriptions written, I conclude that Respondent's statement that 
``Sorry there's no refill on it[,]'' was made in reference to the 
Lorcet.
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    The Government submitted into evidence the medical record which 
Respondent prepared for Massey's visit. Under the heading ``Chief 
Complaint,'' the History and Physical record states:

    Complains of neck and shoulder pain for the last several years. 
This began since he had surgery about 3-4 years ago. He complains of 
ongoing pain and has been taking Lorcet and Soma for a long time. He 
is having difficulty coming off of this and would like to get rid of 
the narcotics if he can. It is very difficult because of his daily 
activities etc. He has ongoing right shoulder pain and discomfort. 
Sometimes it is manageable and when the pain gets worse he has to 
take the medication as soon as possible.

Gov. Exh. 4, at 1.

    The second page of this document records the findings of a physical 
exam although Respondent admitted that she never performed one on 
Massey. See Tr. 495. Under the heading ``Musculoskeletal,'' the record 
states: ``Bilateral paracervical muscle spasms at the C6-7 area. 
Decreased range of motion of the right shoulder.'' Id. The record also 
includes the diagnosis of ``chronic right shoulder pain.'' Id.
    The medical records also include a questionnaire on which a patient 
indicates such information as the nature and source of his pain. The 
first question on this form is ``How long have you had this pain?'' 
Gov. Exh. 4, at 13. Massey left this blank. See id. Massey apparently 
did make a mark on both the front and back drawings of the human body 
in the area of the right shoulder. See id. Item 2 of this form directs 
the patient to ``circle all the words that best describe your pain'' 
and lists twenty-four adjectives that describe pain. Id. Massey did not 
circle any of these words. See id.
    Respondent testified that she understood the mark that Massey had 
made in the shoulder region to indicate that he was ``suffering from 
chronic pain injury'' and that the marks were ``the location area of 
the pain.'' Tr. 481. Respondent testified that Massey was not a typical 
pain patient as most of her patients ``have been to many doctors, many 
operations and had been through many treatments.'' Id. at 482. She 
further testified that she ``thought maybe he's suffering from chronic 
pain, something manageable that which may not have to be maintained on 
lots of oral narcotics'' because ``[i]t's not difficult pain for the 
patient.'' Id.
    Later on direct examination, Respondent was asked what she 
understood Massey's statement that ``I'm not really in pain'' meant. 
Id. at 483. Respondent answered that because Massey was ``already on 
medications[,] [m]aybe he doesn't have pain at that time when I see him 
in the office,'' but that if he wasn't taking the medication, ``[p]ain 
would be there.'' Id. Respondent further testified that she believed 
that Massey's statement that he had undergone shoulder surgery four and 
a half years earlier to mean that he had developed a calcification in 
his shoulder which leads to chronic pain even though the pain ``can be 
intermittent.'' Id. at 483-84. Later, however, Respondent testified 
that it was her impression that Massey had a

[[Page 52151]]

work-related shoulder sprain although she acknowledged that Massey 
``did not say that.'' Id. at 489. Respondent also testified that 
chronic pain patients may see her on days that they do not have pain. 
Id. at 490
    Respondent further testified that Massey's statement that ``the 
problem was more or less cured'' meant to her that the problem was 
``more or less cured for the surgeon, but the pain persists.'' Id. at 
484. Moreover, Respondent testified that Massey's comment that he had 
been taking Lorcet and Soma since the surgery meant that he was taking 
medications ``[t]o control the pain, so that they [the patient] can 
have a decent, normal life.'' Id. at 485. As for Massey's comment that 
he was being honest, that the drugs made him feel good and get work 
done, and that he was not abusing them, Respondent testified that 
``[e]ven today when people take narcotics they feel ashamed of 
themselves'' and that ``maybe he's ashamed of telling me he has to take 
pain medication to have a very active pace of living.'' Id. at 485-86. 
She then stated: ``he's not abusing, that he's not taking too many, 
that he's taking the [drugs] to control the daily activities of 
living.'' Id. at 486. Respondent added: ``Drug addicts don't take 
three, four [pills] a day to get work done. * * * Drug addicts take to 
get high and they don't do their job. They sit at home and watch TV.'' 
Id.
    Respondent testified that ``[o]ur job is to believe the patient.'' 
Id. at 491. Respondent was then asked what she meant when she told 
Massey, ``[t]his is a shame then that you have to take the medicine for 
the habit.'' Id. Respondent answered: ``See, whenever there is a pain, 
they take a pain pill to feel better. So, there are other habits we can 
create with them like the physical therapy, home exercises, so they 
don't have to depend on that habit of taking a pill for every little 
thing.'' Id.
    Respondent further testified that Massey appeared honest to her. 
Id. 494. When asked whether it was significant that Massey ``was honest 
with you and didn't exaggerate his symptoms or seek additional--more 
medication than he was taking,'' Respondent answered: ``Yes, he's not a 
drug-seeking person.'' Id.
    Respondent then admitted that she had not conducted a physical exam 
and that it was not ``proper'' to record the results of an exam that 
was never done. Id. at 496. When asked why she filled in the form, she 
answered that it was ``the end of the day when I was preparing--looking 
at the charts because the blanks, probably I filled in what I could 
have seen.'' Id. at 497. Respondent insisted, however, that the 
comments she entered on the record as Massey's ``Chief Complaint'' were 
based on what Massey told her. Id.
    The ALJ found disingenuous Respondent's testimony that she thought 
Massey had told her that he was not in pain because he was then taking 
medication. See ALJ Dec. at 40. I agree and note that the ALJ observed 
Respondent's testimony and was in the best position to evaluate her 
credibility on these issues of historical fact. See Universal Camera 
Corp. v. NLRB, 340 U.S. 474, 496 (1951). Indeed, Respondent's story is 
implausible and inconsistent. Respondent testified that Massey was not 
``a typical pain patient,'' and indeed, showed up without a referral. 
Given this, it is strange that Respondent proceeded to prescribe 
controlled substances without performing a physical exam and did so 
notwithstanding that Massey told Respondent numerous times that he was 
not in pain and that he was taking the drugs because they made him feel 
good. Indeed, in light of Respondent's testimony that she found Massey 
to be honest, and that it was her job ``to believe the patient,'' it is 
puzzling that she did not accept Massey's statements that he was not in 
pain and was taking the drugs because they made him feel good.
    Massey's statement that his girlfriend had been the source of his 
drugs begs the question of why, if he truly was in pain, he had 
obtained his drugs that way rather than through legitimate means. 
Furthermore, Respondent's statements that (1) ``[w]e'll give you your 
medicine * * * you can tell me that you want to come out of drugs,'' 
(2) that ``this is a shame * * * that you have to take the medicine for 
the habit,'' and (3) ``we don't want to give out drugs * * * that's why 
we have * * * a psychologist and a substance abuse counselor,'' 
demonstrate that Respondent understood that Massey was not seeking the 
prescription to treat pain, but rather to abuse them.
    Finally, the ALJ found that ``the descriptions of the alleged pain 
that Respondent wrote in [Massey's record was] not--by any stretch of 
the imagination--based on what [he] told her.'' ALJ Dec. 43. That is 
putting it charitably. The record was false. As Dr. Rafael Miguel (one 
of the Government's experts) explained, the record was likely created 
because Respondent knew exactly what she had done--prescribed a 
controlled substance without a legitimate medical purpose--and thus did 
so ``to justify the opioid prescriptions.'' Gov. Exh. 18, at 2.

The Second Undercover Visit

    On April 22, 1999, Massey returned to Respondent's office for a 
follow-up visit. Massey did not see Respondent during this visit. 
Instead, he saw Ben Mastridge, a Certified Addiction Registered Nurse. 
After Mastridge asked Massey how he was ``pain wise,'' Massey initially 
stated that ``it's into my joint there,'' that he had been put on 
Lorcet ``years ago for a shoulder surgery,'' but then added ``I'm not 
in no pain.'' Gov. Exh. 6, at 2. Massey used similar language several 
times to convey his condition to Mastridge. See id. at 2-3. 
Notwithstanding the double negative in Massey's statements, Mastridge 
clearly understood that Massey did not have pain. See id. at 3. 
(Mastridge stating ``if you're not having pain then you don't need'' 
narcotics.).
    Mastridge and Massey discussed what drugs the latter was taking; 
Mastridge suggested that ``I can give you like an Ativan \4\ or 
something.'' Id. Massey told Mastridge that ``I don't want no mind 
medication.'' Id. Massey also told Mastridge that he could ``function 
without'' the Lorcet, but that he took it ``to work and to get, you 
know to get chores done on work days.'' Id. Massey then suggested that 
if Mastridge put him ``on Xanax we could probably level me out a little 
bit.'' Id. Massey also told Mastridge that he took the Soma because he 
was ``so used to taking them'' and that he was not having muscle 
spasms. Id. at 4.
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    \4\ Ativan, or Lorazepam, is a Schedule IV controlled substance. 
21 CFR 1308.14(c).
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    Mastridge then told Massey that ``using narcotics when there is no 
pain isn't acceptable.'' Id. Mastridge added that ``just to prescribe * 
* * narcotics because you're physically dependent on it * * * that's, 
that's that's unacceptable.'' Id. Mastridge then suggested that ``we 
can come up with a plan [to] decrease by one pill every, one pill a day 
every two weeks * * * and see how you do.'' Id. at 5. Mastridge also 
suggested that he could put Massey on ``just methadone and decrease the 
Lorcet or we can * * * just decrease the Lorcet.'' Id. at 6. Massey 
told Mastridge that he was ``definitely not going to go without the 
Lorcet.'' Id.
    Later in the conversation, Massey again told Mastridge that his 
shoulder was ``cured,'' and added that he was ``over the cocaine and 
all the stuff I went through in my early days,'' but that ``these pills 
make me feel good.'' Id. at 8. Mastridge told Massey that he was going 
to give him a prescription for Xanax because it ``will help to take the 
edge off of bringing the coke down.'' Id. at 9. Mastridge further 
stated that ``we

[[Page 52152]]

are going to put down that you are starting the detox program and it 
will run over a period of fifty to ninety days'' and that Massey had 
agreed to start the program ``over the next 60 days.'' Id. at 10.
    Massey then told Mastridge that ``I don't have no physical 
problem'' and ``it's just I like these pills.'' Id. Mastridge replied 
that ``as far as the physical dependence on it goes * * * we can come 
up [with] other treatment options once we try some things here.'' Id. 
Mastridge then told Massey that he would be getting 105 Lorcet tablets, 
which he should take three times a day, 90 Soma, which he should take 
three times a day, and Xanax .5, which he should take twice a day. Id. 
at 10-11.
    Massey then asked whether ``oxycontin or dilaudid would be easier 
on my body?'' Id. at 11. Mastridge answered that ``it is not legal to 
prescribe narcotics long term if there is no pain,'' and that ``it's 
easier to take you down off the Lorcet than it would be off the 
oxycontin because of the types of doses.'' Id. When Massey suggested 
that oxycontin 10 tablets were available, Mastridge replied that ``the 
bottom line is you need to be off the narcotics.'' Id. at 11-12.
    Mastridge then gave Massey the prescriptions for Lorcet, Soma, and 
Xanax discussed above and a questionnaire, which he instructed him to 
complete in the waiting room. Id. at 12-13. Observing that the 
prescriptions were pre-signed, Massey asked Mastridge, ``So what do you 
do? You just fill these out and the doctor already signs them?'' Id. at 
13. Mastridge answered: ``Yes.'' Id. Massey then stated, ``I thought 
that the Doctor had to fill the prescriptions out and sign it.'' Id. 
Mastridge replied: ``Oh no, no * * * as long as she is in the building 
I am being supervised and as long as I'm being supervised, I can do 
anything that she can do because she signs her name to the treatment 
agreement, there's a place for her to sign it, too.'' Id.
    The Government entered into evidence the patient chart for Massey's 
April 22nd visit. The chart states that the patient ``report[s] no 
current pain.'' Gov. Ex. 4, at 3. The chart also states that Massey 
reported ``good sleep, appetite'' and that he had agreed to start 
outpatient ``detox over [the] next 60 days.'' Id. In addition, the 
questionnaire which Massey completed on this visit asked whether, 
``[d]uring the past month,'' he had ``been bothered by any illness, 
bodily disorder, pains, or fears about your health?'' Id. at 6. Massey 
checked the box for ``none of the time.'' Id.
    Mr. Mastridge did not testify in this proceeding. Respondent did, 
however, testify regarding this visit. In her testimony, Respondent 
acknowledged that at the time of the visit, Mr. Mastridge was not 
authorized under Florida law to dispense a controlled substance. Tr. 
641. Respondent attempted to justify her conduct testifying that she 
``was in the office,'' that Mastridge ``never saw the patient alone,'' 
and that ``I was right there.'' Id. at 641-42. Respondent admitted, 
however, that she was ``[n]ot in the same room'' when Mastridge issued 
the prescriptions for Lorcet, Soma, and a new drug Xanax. Id. at 642.

The Third Undercover Visit

    On May 12, 1999, Detective Jeff Esterline of the Pinellas Sheriff's 
Office went to Respondent's office to conduct an undercover visit. 
Using the name Jeff Scott, Esterline told Respondent that he had 
recently moved from Iowa and that he worked as an electrician's helper. 
Respondent asked Esterline what had happened to his back. See Gov. Ex. 
9, at 1. Esterline told Respondent that he had been referred by Chris 
Massey, that Massey had seen her before, and had ``said you were a good 
doctor to come to.'' Id. at 2. Respondent then told Esterline to 
``[t]ell me about your pain.'' Id. Esterline stated: ``I don't have any 
pain really, I didn't know if they would let me in to talk to you if I 
didn't tell them something, so I don't have any pain, really.'' Id. 
Esterline added that he was taking four to five Vicodin a day. Id. 
Respondent asked Esterline how he got his drugs. Esterline stated that 
he had been ``getting them from a friend.'' Id.
    Respondent then told Esterline that her clinic offered a detox 
program. Id. She then asked, ``you don't have pain but you are taking 
vicodin? Why were you taking vicodin?'' Id. After Respondent repeated 
her question, Esterline told her that he had ``started taking them 
quite a while ago'' and that he thought he ``function[ed] a lot better 
with them.'' Id. at 3. When Respondent asked if he got the drug from 
friends, Esterline answered in the affirmative. Id.
    Respondent then asked Esterline if he ``want[ed] to go to substance 
abuse program or do you want to be maintained on the vicodin?'' Id. 
Esterline answered that he would like to remain on drugs as he felt 
like he functioned ``real well'' while taking them. Id.
    Respondent then warned Esterline that narcotics ``are habit 
forming'' and can cause liver damage. Id. Esterline responded that he 
didn't think he had any problems and that he had started taking them 
when his mother had died a year and a half earlier. Id. He added that 
``I feel, just feel like I function real well with them'' and ``I don't 
abuse them.'' Id.
    Respondent then told Esterline: ``you don't have to start if you 
don't want to be on vicodin'' and ``there is no reason you should be on 
it.'' Id. at 4. Esterline responded that ``I feel like I, I function 
better,'' and that ``I don't think I'm not taking so many of them that 
I feel like I have a real problem, but I just function better, just 
keeps me even.'' Id.
    Respondent then stated that ``[i]f you didn't get vicodin, you 
know, you know it is okay, too, right?'' Id. She added that ``we don't 
want to start you on some narcotics that you don't have to be on it.'' 
Id. Esterline responded that Massey ``said that you know if I just was 
honest with you that you know, that that you'd helped him.'' Id. 
Respondent then stated that she thought she remembered Massey but 
didn't know. Id. Respondent also told Esterline that her assistant Ben 
Mastridge ``can help you to get off narcotics. He can do a methadone, 
whatever.'' Id.
    Esterline replied that he ``was just hoping to get'' Vicodin and 
again told Respondent that he took three or four a day. Id. Respondent 
advised Esterline that drugs could be toxic, that he could build up a 
tolerance to them and that ``the more you take the more you need,'' and 
then asked him if he was ``willing to take all these risks?'' Id. 
Esterline stated that he was and that the drug helped him to ``function 
better.'' Id. Respondent then referred to various potential causes of 
pain. Esterline once more stated that ``I don't really have any 
problem, I don't really have any pain,'' and again added that ``I feel 
like I function better'' when taking the drugs. Id.
    Respondent then asked Esterline if he ``would like to start on the 
vicodin?'' Id. at 5. Esterline told Respondent ``Yeah, that's what I 
was here for.'' Id. Respondent told Esterline to ``[s]tart with the 
four a day,'' and that her employee Ben Mastridge ``can counsel you 
with medication and narcotics and everything.'' Id.
    Later on, Respondent stated ``[s]o you don't want to come out to 
the narcotic clinic, you know this is for the people to come here so 
they don't do drugs, you know, and too, maybe I'm sympathetic to the 
people that allow themselves to slip into drugs.'' Id. Respondent then 
told Esterline that ``narcotics are good and bad,'' and that ``[y]ou 
don't want to get hooked on drugs.'' Id. Esterline again told 
Respondent that he did not think that he was addicted, that he went to

[[Page 52153]]

work every day, and that the drugs made him ``feel better.'' Id.
    Respondent then asked Esterline if he had been on vicodin ``for a 
while?'' Id. at 6. When Esterline answered ``yes,'' Respondent asked 
him if he could ``confirm it'' by bringing in ``left over 
[prescription] bottles'' he had gotten through other doctors. Id. 
Esterline told her that he had ``been having trouble getting them for 
so long'' and offered to look at home for the bottles. See Id. at 6. 
Respondent then again told Esterline that ``[y]ou don't want to make a 
new habit'' and get ``hooked on drugs.'' Id. Esterline reassured 
Respondent that he was not addicted. See Id.
    Respondent then stated that she would give him a prescription for 
60 Vicodin ES with two refills and that the drugs ``should easily last 
you for 1 month.'' Id. Respondent then suggested that Esterline make an 
appointment to see Mastridge. Id. She also told Esterline that her 
clinic had a massage therapist and a physical therapist and that ``you 
need to feel good-you're taking it just to feel good.'' Id. at 7. 
Esterline paid $180 for the visit. Gov. Ex. 10.
    The government entered into evidence various patient records 
pertaining to Detective Esterline's visit. Describing Esterline's chief 
complaint, the ``History and Physical'' record states: ``He has a 
terrible pain in his neck. This started 1\1/2\ years ago. Ever since 
his mother's death, he has had ongoing pain. He does a lot of 
construction work, wiring, etc., which makes the condition worse.'' 
Gov. Ex. 11, at 1. The entry for Esterline's Musculoskeletal system 
likewise states: ``chronic pain.'' Id.
    The records also include a questionnaire used by patients to report 
their symptoms and other information relevant in diagnosing and 
treating their condition. The first question on the form is ``How long 
have you had this pain?'' Id. at 2. Esterline wrote ``none.'' The form 
also lists twenty-four adjectives to describe pain and instructs the 
patient to ``circle all the words that best describe your pain.'' Id. 
Esterline did not circle any word. See Id.
    The form also contains front and back representations of the human 
body, on which patients are instructed to shade the area where they 
have pain. See Id. The forms have several small markings in the area of 
the neck. Id. Detective Esterline testified that he did not make the 
markings. Tr. 58. Respondent maintained that he did. Id. at 519.
    Respondent testified that she ``probably'' ``missed'' Detective 
Esterline's answer of ``none'' to the question ``How long have you had 
pain?'' Tr. 523. She further testified that Esterline was not typical 
of the pain patients she sees because ``[h]e has a soft tissue injury, 
neck pain. He didn't have any x-ray or MRI.'' Id. She added that a 
typical patient would be ``a construction worker, car accident patient 
who had an MRI x-ray workup'' and that Esterline hadn't ``had anything 
done.'' Id. at 524.
    Respondent's counsel then asked her about Esterline's statements 
that he didn't have any pain, that he had indicated he did because he 
did not think the office staff would let him in otherwise, that he was 
taking four to five Vicodin a day, and that he did so because he 
functioned better when he took them. Respondent testified that ``some 
patients are very reluctant to admit that they need Vicodin to control 
their pain,'' and that he was ``taking medications to be able to do his 
job.'' Id. at 526-27. Respondent also testified that she believed that 
Respondent had obtained his Vicodin through a lawful prescription. Id. 
at 528. Respondent further testified that she asked Esterline what type 
of work he did ``to find out whether he's having pain because of the 
type of job he does,'' and that electricians (the job Esterline said he 
had) commonly have neck pain. Id. at 529.
    When asked on direct what Esterline meant when he said ``I don't 
really have any pain,'' Respondent answered: ``He's contradicting 
himself[,]'' and that ``he is in pain, but when he takes medications he 
doesn't have any pain.'' Id. at 530. When asked whether Esterline had 
``in any way exaggerated his symptoms?,'' Respondent answered ``No''; 
when asked whether he appeared to be honest, Respondent answered 
``yes.'' Id. at 531. Respondent also testified that Esterline did not 
seek more medication than he was currently taking and that he seemed 
like a patient who was seeking treatment for chronic pain. Id. at 532.
    Respondent admitted on cross-examination that she did not conduct a 
physical examination on Esterline. Id. at 645. She also testified that 
her handwritten notes for the physical exam were based on what she 
``would have done with a patient'' with neck pain. Id. at 533-34. She 
further admitted that it was inappropriate to make these notations. Id. 
at 534. She testified, however, that she believed her prescribing of 
controlled substances to Esterline was within the standard of care. Id. 
at 537.
    Here, again, the ALJ, who personally observed Respondent testify, 
found disingenuous Respondent's testimony that she thought Esterline 
was not in pain because he was taking medication. See ALJ at 40. I 
agree and further note that it is strange that a patient who is 
``honest,'' does not ``exaggerate his symptoms,'' told Respondent 
multiple times that he did not have pain, and that he took the drugs 
because they helped him function better, would then be disbelieved as 
to why he was taking the drugs. Furthermore, while Respondent testified 
that she believed Esterline had obtained the drugs through a lawful 
prescription, Esterline told her at least twice that he had gotten them 
through friends and that he had also been ``having trouble getting them 
for so long.'' Finally, Respondent made several incriminating 
statements such as when she asked Esterline if he ``want[ed] to go to 
substance abuse program or do you want to be maintained on the 
vicodin?,'' and stated ``maybe I'm sympathetic to the people that allow 
themselves to slip into drugs.''

The Fourth Undercover Visit

    On June 24, 1999, Detective Randall Keys of the Tampa Police 
Department,\5\ using the name Ronald Briers, made an undercover visit 
to Respondent's office. Respondent asked him if he had abdominal pain. 
Gov. Ex. 12, at 1. Keys told Respondent that he did not have pain, but 
that he ``had to put something down on'' the form. Id. Keys then added 
that ``[a] friend of mine suggested that I come to talk to you about 
it.'' Id. Respondent asked: ``About what? Detox?'' Id. Keys told 
Respondent, ``I need some * * * vicodin.'' Id.
---------------------------------------------------------------------------

    \5\ Detective Keys was then assigned to a DEA task force. Tr. 
70.
---------------------------------------------------------------------------

    Respondent asked Keys why he needed vicodin. Id. Keys answered, 
``Well it, basically it makes me feel better. It just kind of takes the 
edge off.'' Id. After discussing Keys' job, Respondent stated: ``We do 
not give drugs out to people. And now, if you want to go to substance 
abuse program, we have Ben [Mastridge] here for you.'' Id. Denying that 
he was addicted, Keys stated again that the drug ``just kind of helps 
me. Just--it just takes the edge off.'' Id.
    After stating that she did not want ``to promote the intake of 
drugs,'' Respondent asked Keys who had sent him. Keys told her Chris 
Massey. Id. at 2. Respondent reiterated that ``We don't want to give 
drugs out to people, you know, and ruin our reputation.'' Id. 
Respondent then suggested that Keys try her acupuncture program. Id. 
Respondent declined, stating that he did not ``have any pain or 
anything like that'' and that he took the Vicodin because ``they just 
take the edge off.'' Id.
    Respondent and Keys discussed how many he took a day. Id. Keys said 
three.

[[Page 52154]]

Respondent then asked Keys where he got the drug. Id. At first, Keys 
said that he got it from a person, but when asked how much he paid for 
it, Keys said it was actually from ``like a family member who has a 
prescription.'' Id. at 3. Respondent then told Keys that ``[t]his is a 
real test for me'' and ``we don't want to give narcotics to like 
creating drug use.'' Id.
    Thereupon, Respondent apparently summoned Ben Mastridge to the 
examining room. After again discussing Chris Massey, Respondent briefed 
Mastridge on Keys' situation telling him that Keys took ``about 2 to 3 
vicodin a day'' and that ``now he's wondering whether we will be able 
to promote or support his pain with the 3 Vicodin a day.'' Id. After 
telling Mastridge that they had not discussed ``[t]he issue of people 
coming here asking for a drug,'' Respondent then told Keys that ``Ben 
is our AR and he does my detoxification for narcotics. He is the 
director for narcotics program.'' Id.
    Shortly thereafter, Mastridge asked Keys how many Vicodin he was 
taking and how long had he been taking the drug? Id. Keys answered that 
he usually took about three and had been doing it for six months. Id. 
Mastridge then asked Keys whether the Vicodin had been prescribed to 
him. Id. at 4. Keys answered ``no.'' Id. Respondent then told Keys that 
``we want to help people with pain,'' to which Keys responded 
``Right.'' Id. Respondent then stated that ``we don't want to promote a 
drug habit.'' Id. Keys responded: ``No, I understand.'' Id. Mastridge 
then told Keys ``[j]ust throwing pills at the situation, that's where 
people end up taking--if they are taking 3 Vicodin a day now, in 6 or 8 
or 12 months they're taking 15 of them a day.'' Id.
    After discussing the need to provide ``some sort of concurrent 
treatment to go along with [the vicodin] to address the source of the 
pain,'' Id., Mastridge asked ``is it muscle spasms that are actually 
going on here?'' Id. at 5. Respondent interjected, ``Pain, pain, you're 
right.'' Id. Mastridge continued stating: ``What, what's the source of 
the pain? I guess that's what the ultimate question is. And since you 
weren't diagnosed by anybody in primary care or anything.'' Id. 
Respondent replied: ``I guess he feels no pain, he just feels better.'' 
Id. Mastridge then asked Keys, ``You just feel better?'' Keys answered, 
``They just kind of mellow you out I guess * * * it makes me feel 
okay.'' Id.
    After discussing various treatments available at her clinic, 
Respondent told Keys that she was going to give him a prescription for 
60 vicodin, see Id, and Mastridge told Keys that they would discuss his 
condition and ``the best course of treatment'' during his next visit. 
Id. Respondent then explained the costs for the clinic's various 
services and added ``[i]t's a way of letting you know * * * we will not 
be supporting just a drug habit.'' Id. at 6. Respondent then told Keys 
that Ben ``will write the prescription for you too, He writes my 
prescriptions. When you see him, you don't have to see me.'' Id.
    The government entered into evidence various patient records 
pertaining to Detective Keys' visit. The History and Physical record 
describes the patient complaint as: ``Ronald Bryers presents to my 
office with low-back pain and anterior abdominal pain, which is 
ongoing. He works as an automobile detailer, getting under cars, etc., 
and the constant physical labor makes the pain worse. * * * He has had 
this pain for the past several years.'' Govt. Exh. 14, at 1.
    The document also reports the results of a physical exam. Under the 
musculoskeletal heading, the record states that ``[m]inimal paralumbar 
muscle spasm is noted, with minimal facet tenderness.'' Id. The report 
also contains a diagnosis of ``chronic low-back pain.'' Id. Respondent 
admitted, however, that she did not perform a physical exam on Keys, 
Tr. 647, and Keys testified that he did not believe that he had 
discussed his medical history with Respondent. Id. at 84.
    Respondent testified that Detective Keys was seeing her for 
abdominal and lower back pain but that ``[h]is history was kind of not 
clear to me.'' Id. at 541. Moreover, Keys was a ``very unusual'' 
patient. Id. Respondent explained: ``Patients come to me after being 
diagnosed, after being treated. * * * I wonder, what is he doing in my 
office without being diagnosed and we don't want to be a clinic where 
we give out medications for reasons not needed.'' Id. at 546.
    Respondent testified that because she ``didn't feel right,'' Id. at 
541, she sought out Mr. Mastridge to assist her in evaluating Keys 
because of Mastridge's knowledge of substance abuse and psychological 
problems. Respondent testified that she thought that Mastridge could 
help her diagnose whether Keys was ``taking medicine to control the 
pain or for any behavioral problems.'' Id. at 542.
    Respondent testified that Keys' statement that he took Vicodin 
because it took ``the edge off'' meant that the drug took the ``[e]dge 
off the pain,'' and that the term ``edge off'' is commonly used in the 
pain context. Id. at 544. As for Keys' statements that he didn't have 
pain, Respondent testified that she thought this was because he was 
``on pain medication,'' that ``people do not have to have the pain all 
the time,'' and that pain levels can fluctuate. Id. at 545. She further 
stated that even though Keys may not have had pain at the time of his 
visit, ``they wouldn't come to my pain clinic if [they] don't have the 
pain.'' Id.
    Respondent also testified that when she discussed with Mastridge 
doing narcotics detoxification, she meant ``medication reduction.'' Id. 
at 549. She further testified that when she told Keys that ``we want to 
help people with pain'' and that ``we don't want to promote a drug 
habit,'' she understood Keys' answers as meaning that he was in pain 
and was agreeing to her proposed treatment. Id.
    Respondent admitted that because she had not performed a physical 
exam, she should not have filled out the form as she did but maintained 
that the patient record's ``history part is true.'' Id. at 647. 
Respondent testified that the physical exam part of the record was 
``missing'' ``because I went and got Ben [Mastridge] because this 
patients [sic] were not my true pain patients,'' Id. at 647-48, and 
that she had made it up ``because of the confused cases brought to 
me.'' Id. at 648-49.
    Respondent added: ``I don't see patients like this at all in the 
office. These are like the strange weirdos coming to my office.'' Id. 
at 648. Respondent further testified that she was ``astonished to see 
patients like [Keys] in the pain clinic'' and that ``[t]hese are not my 
typical pain patients.'' Id.
    Respondent was then asked whether it was within the standard of 
care in the State of Florida to prescribe controlled substances without 
performing a physical exam. In response, Respondent testified: ``that's 
what we learn when we go to medical school. Take a history and physical 
examination. Chronic pain, these patients who are very difficult to 
evaluate. Physical examination is part of our job.'' Id. at 650. Upon 
further questioning Respondent added that performing a physical exam 
``is the standard of practice. That's our Rule No. 1.'' Id. at 651.
    Respondent then denied, however, that she had intentionally and 
knowingly dispensed controlled substances. See Id. at 652. She 
testified:

    Intentionally I did not dispense medication, I did not 
distribute outside of the usual course of medical practice. In the 
context of the clinical pain management, I knew the medication not 
to transfer, not to sell the drug to the street or anything. My 
intention here is believe the patient, give them the benefit of 
chronic pain, and

[[Page 52155]]

evaluate them, and do what is appropriate for them.

Id. at 652-53.
    As with the other undercover visits, the ALJ did not find credible 
Respondent's assertion that she prescribed Vicodin to Keys because she 
believed his use of the drug was the reason he was not in pain. See ALJ 
Dec. at 40. Again I agree. The transcript of the visit provides 
substantial evidence that Respondent knew that Keys was seeking drugs 
for illegitimate use. Not only did Keys state that he did not have pain 
and that the drug took the ``edge off,'' when Mastridge asked what the 
source of Key's pain was, Respondent stated: ``I guess he feels no 
pain, he just feels better.'' Shortly thereafter, Respondent explained 
the costs for the clinic's various services and added that ``we will 
not be supporting just a drug habit.'' Finally, I am perplexed as to 
why if a patient is a ``strange weirdo'' and causes astonishment 
because he is not a ``typical pain patient,'' a physician would then 
proceed to write a prescription for a controlled substance without 
performing a physical exam as required by ``Rule No. 1.'' \6\
---------------------------------------------------------------------------

    \6\ I acknowledge that in December 1999, the investigators 
attempted an additional undercover visit. Respondent's receptionist 
refused to admit the officer because he did not have a referral. See 
Resp. Ex. 46.
---------------------------------------------------------------------------

The Expert Testimony

    Both the Government and Respondent introduced expert opinion 
evidence on the subject of Respondent's prescribing practices. Dr. 
Daniel Frazier, M.D., of Tampa, Florida, a Board Certified Family 
Practice Physician with more than thirty years of experience, and an 
Assistant Clinical Professor of Family Practice at the University of 
South Florida (USF) College of Medicine, reviewed the tapes and 
transcriptions of the undercover visits. In a statement dated February 
1, 2001, Dr. Frazier declared that ``[i]t is inappropriate to prescribe 
pain medication in uncontrolled environments,'' and that ``[t]he 
physician must determine the level of pain that he/she is treating by 
means of examination and discussion with the patient.'' Gov. Exh. 16. 
Dr. Frazier further stated that ``the physician must closely monitor 
the patient to see that there is a medical need'' for a controlled 
substance. Id.
    Dr. Frazier concluded that Respondent ``was not in control of the 
patients; the patients were in control of'' her. Id. Moreover, ``[t]he 
patients actively sought pain pills for non-appropriate reasons and the 
patients were given the pain medication without examination or 
significant review of their symptoms. Such care on the part of the 
physician constitutes inappropriate medical treatment[,]'' and ``a 
failure to appropriately practice medicine within the acceptable 
standard of care.'' Id. I credit Dr. Frazier's statement.
    The government also submitted the statement of Rafael Miguel, M.D. 
At the time of his review, Dr. Miguel was a Professor and Interim 
Chairman of the Department of Anesthesiology, as well as the Director 
of the Pain Management Program at the USF College of Medicine. Dr. 
Miguel clearly states that he reviewed the medical records, transcripts 
of the undercover visits, and Respondent's pre-hearing statements. Gov. 
Exh. 18, at 1.\7\ Dr. Miguel stated that ``[t]here is no currently 
accepted therapeutic use of opioids but for the relief of pain. 
Administering opioids to patients with no pain is inappropriate and 
clearly constitutes practice below the standard of care.'' Gov. Exh. 
18, at 2.
---------------------------------------------------------------------------

    \7\ I note and reject Respondent's contention that the ALJ did 
not know what Dr. Miguel based his opinion on. See Resp. Br. 39-40. 
The factual basis for Dr. Miguel's opinion is clear from his 
statement. See Gov. Exh. 18, at 1. Moreover, Respondent could have 
sought to subpoena Dr. Miguel to testify if there was any dispute as 
to the factual basis of his opinion. 21 CFR 1316.52(d). She did not.
---------------------------------------------------------------------------

    Dr. Miguel observed that ``[i]f the concern was that patients were 
drug abusers and the intent was to wean them from opioids, this should 
have been done in an addiction treatment facility with trained 
personnel. * * * Addiction is a complex problem and physical dependence 
is a small part of the pathophysiology of the disease.'' Id. Dr. Miguel 
further explained that ``[p]rescribing opioids to known addicts is 
inappropriate and clearly constitutes practice below the standard of 
care.'' Id.
    Finally, Dr. Miguel discussed Respondent's failure to perform 
physical exams and record keeping practices. According to Dr. Miguel, 
``the documentation does not concur with the reported complaints. While 
the reported complaints did not include pain, high levels of pain 
interfering with daily life were documented. This was apparently done 
to justify the opioid prescriptions.'' Id. Dr. Miguel also stated that 
``[i]t does not appear that the patients were physically examined, yet 
there is documentation of heart and lung sounds, abdominal palpitation, 
even paracervical muscle spasms and decreased range of motion in joints 
impossible to assess without a physical exam.'' Id. Dr. Miguel 
concluded that ``[t]his may constitute medical fraud and is clearly 
practice below the standard of care.'' Id. I likewise credit Dr. 
Miguel's statement.
    Respondent introduced a statement of Walter E. Afield, M.D., a 
psychiatrist. Dr. Afield stated that he had reviewed Dr. Frazier's 
statement and was ``not in agreement.'' Resp. Ex. 55. He asserted that 
``based on statements made to the doctor, there are sufficient reasons 
for prescribing the medications in question.'' Id. In Dr. Afield's 
opinion, Respondent ``felt these patients were dependent on these 
medications to function and were functioning and that they needed to be 
placed in a medically supervised program to detoxify the patients and 
find alternative treatments for them.'' Id. Dr. Afield further stated 
that his ``[r]eview of the entire record of the patient indicates those 
medicines were given within the parameters of her specialty.'' Id.
    I agree with the ALJ's declination to credit Dr. Afield's statement 
for several reasons. First, while Dr. Afield has had a distinguished 
career in psychiatry, it is not clear what expertise he has in the area 
of pain management or the general diagnosis and treatment of physical 
injuries. If his opinion was offered as an expert in treating 
addiction, I note that Respondent maintained repeatedly that she 
prescribed the drugs to all three patients because she believed the 
patients were in pain and not because she was treating an addiction.
    Second, his opinion is vague and it is not clear whether he viewed 
Respondent's prescribing to be appropriate because the patients were in 
pain or because they were addicted. Indeed, to the extent Dr. Afield's 
statement that ``the patients were dependent on these medications to 
function'' and that the patients ``needed to be placed in a medically 
supervised program to detoxify them,'' was intended to suggest that 
Respondent's prescribing was appropriate because the patients were 
addicted, it is clearly wrong because the CSA prohibits the prescribing 
of controlled substances for this purpose. See 26 CFR 1306.04(c) (``A 
prescription may not be issued for the dispensing of narcotic drugs 
listed in any schedule for `detoxification treatment' or `maintenance 
treatment.' ''). DEA's regulations make clear that a physician who is 
not registered to conduct a narcotics treatment program may administer, 
but not prescribe, ``not more than one day's medication'' of narcotics 
for up to three days to a person suffering ``acute withdrawal systems 
when necessary while arrangements are being made for referral for 
treatment.'' 26 CFR 1306.07(b). A physician cannot,

[[Page 52156]]

however, issued a prescription for this purpose.
    Third, to the extent he believed that Respondent prescribing was 
appropriate because the undercover operatives were in pain, Dr. Afield 
stated that he ``review[ed] the entire record of the patient.'' Id. It 
is undisputed, however, that Respondent falsified the medical records 
of the three undercover operatives and there is nothing in the 
statement that suggests that Dr. Afield relied on non-falsified 
records. An expert opinion based on falsified records is obviously not 
probative of the issues.
    Fourth, Dr. Afield's statement does not address why it would be 
appropriate to prescribe a controlled substance without performing a 
physical exam. This is especially noteworthy in light of Respondent's 
acknowledgement that performing a physical exam is ``Rule 1.''
    Respondent also called as a witness Robert A Guskiewicz, M.D. Dr. 
Guskiewicz is the Director of the Pain Fellowship Program and a 
Clinical Assistant Professor in the Department of Anesthesiology, 
University of Florida College of Medicine. Resp. Exh. 57. Dr. 
Guskiewciz also served as the court monitor under the pre-trial 
diversion agreement.
    Dr. Guskiewicz testified that in his opinion Respondent had 
legitimately prescribed controlled substances to all three undercover 
visitors. Tr. 813. He further testified that his opinion was based on 
the indications of pain on the patient questionnaires that were 
completed by the undercover visitors. Id. at 814. Dr. Guskiewicz added 
that Massey had indicated that ``he did have pain in the past,'' and 
that the medications he had used had ``helped to improve his function 
in doing his job.'' Id. He also testified that the same was true for 
the patients portrayed by Detectives Esterline and Keys. Dr. Guskiewicz 
stated that while ``[t]here was some vagueness,'' he could determine 
that the medications had helped these patients improve their 
functionality. Id. at 815. Dr. Guskiewicz also testified that he 
teaches his students to ``give the patient the benefit of the doubt,'' 
Id. at 824, but to provide them with a ``limited supply of 
medications'' such as either a two-week or one-month supply, and to 
``do our due diligence.'' Id. at 825.
    On cross-examination, Dr. Guskiewicz was asked ``[w]hat is required 
of a physician who wanted to establish a course of treatment?'' Id. at 
818. Dr. Guskiewicz answered: ``[p]hysical examination, assessment and 
diagnosis.'' Id. Later in the cross-examination, Dr. Guskiewicz was 
asked a series of questions related to whether he knew that Respondent 
had made up the part of the record that supposedly were the findings of 
a physical exam. One of the questions was whether it was ``outside of 
the practice in the state of Florida'' to falsify a patient record. See 
Id. at 827. Dr. Guskiewicz testified that ``[n]ot performing the 
examination would not be outside the practice, but saying you performed 
the examination when you did not would be.'' Id. Dr. Guskiewicz 
acknowledged, however, that the assumption that a person comes to a 
pain management clinic because they are in pain does not relieve a 
physician from the responsibilities of performing a physical exam and 
inquiring into the patient's medical history. Id. at 829.
    The ALJ declined to credit Dr. Guskiewicz's opinion that Respondent 
had properly prescribed controlled substances. I likewise decline to 
credit Dr. Guskiewicsz's opinion on this point. As an initial matter, I 
note that Dr. Guskiewicsz's opinion was based, in part, on the fact 
that Massey had indicated that he had ``pain in the past.'' But Massey 
also stated that he had had shoulder surgery four and a half years ago 
and that the ``problem was more or less cured.'' Thus, Massey's 
statements do not provide an adequate basis for concluding that a 
patient is still in pain, or would be in pain but for the taking of a 
controlled substance.
    Indeed, I note that Respondent did not do ``due diligence'' by 
performing a physical exam even when she admitted that the undercover 
patients were ``not typical'' or were ``strange weirdos.'' Furthermore, 
Dr. Guskiewicz eventually, although apparently with some reluctance, 
conceded that it is essential to perform a physical exam before 
prescribing a controlled substance. Thus, Dr. Guskiewicz appears to 
have rendered his opinion on direct examination regarding Respondent's 
prescribing to the undercover patients without considering material 
facts.

Other Evidence

    I note that Respondent did comply with the terms of the pre-trial 
diversion agreement and that the United States Attorney dismissed the 
indictment. I also note that Respondent retained the services of a 
private investigation firm to review her patient records and determine 
which patients were likely substance abusers and should be discharged 
from her practice. I also note that the private investigation firm 
developed procedures to address, and trained Respondent's employees in, 
such matters as spotting drug abusers, doctor shopping, failed drug 
tests, claims of lost, stolen or destroyed medications, prescription 
fraud and forgery, and patients with a drug-related criminal history. 
The private investigation firm conducted criminal history checks on 
more than 500 people and interviewed nearly 280 patients and their 
associates. I further acknowledge that one of Respondent's private 
investigators testified that prescription drug abusers would target 
foreign doctors, that they would provide forged medical records such as 
MRI reports, and that most of the patients he interviewed admitted to 
lying to Respondent to obtain narcotics. I note, however, that none of 
the undercover operatives used false records to induce Respondent to 
prescribe to them and that none of them claimed to be in pain.
    Respondent testified that she had discharged or not accepted ``may 
be in the hundreds'' of patients. Id. at 426. She also testified that 
she stopped pre-signing prescriptions and that she was no longer 
accepting patients without a referral. Id. at 470.
    Finally, Respondent called several patients to testify on her 
behalf. In general, the patients testified that Respondent's treatments 
had greatly helped them to control their pain and had helped them 
improve their functionality. Respondent also submitted numerous letters 
from patients that were to similar effect.

Discussion

Respondent's Challenges to the Proceeding

    Before analyzing this case under the public interest factors, see 
21 U.S.C. 823(f), I note that Respondent has raised several challenges 
to DEA's authority to bring this proceeding. Therefore, I will address 
these claims to determine whether any of them have merit.
    Respondent's first contention is that this proceeding ``violates 
the plain terms, meaning and understanding of the'' pre-trial diversion 
agreement she entered into with the United States Attorney. Resp. Br. 
72. In particular, Respondent asserts that ``the Government agreed that 
it would dismiss the charges against [Respondent] (assuming [her] 
compliance with the [a]greement) and that she would continue to 
practice pain management including the prescribing of Schedule II-V 
controlled substances.'' Id. at 71. Respondent thus contends that this 
proceeding violates ``the understanding that Dr. Iyer would continue to 
practice pain management and to prescribe'' controlled substances.

[[Page 52157]]

    I disagre