[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4962-4973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01797]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 13-21]


Ralph J. Chambers, M.D.; Decision and Order

    On February 11, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Ralph J. Chambers, M.D. (Applicant), of Sanford, Florida. 
GX 3. The Show Cause Order proposed the revocation of Applicant's DEA 
Certificate of Registration BC2172485, on the ground that his continued 
``registration would be inconsistent with the public interest.'' Id. at 
1 (citing 21 U.S.C. 823(f)). The Order also sought the denial of 
Applicant's June 2, 2010 pending application for a DEA registration at 
an address in Orange City, Florida.\1\ Id.
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    \1\ Notwithstanding this allegation, no evidence was put forward 
establishing that any such application is pending before the Agency.
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    The Show Cause Order alleged that, from June 2006 through January 
2009, Applicant ``inappropriately prescribed excessive quantities and 
combinations of controlled substances'' to eight confidential 
informants. Id. The Show Cause Order also alleged that a ``medical 
expert'' reviewed patient files seized from Applicant's practice and 
determined that ``for more than eighty patients, [he] inappropriately 
prescribed excessive quantities and combinations of controlled 
substances and failed to maintain proper medical documentation 
containing a legitimate medical purpose for [his] course of actions for 
those patients.'' Id. at 2.
    On March 11, 2013, Applicant filed a request for a hearing, and the 
matter was assigned to an Administrative Law Judge (ALJ). GX 4. 
However, on June 13, 2013, Applicant submitted a letter to the ALJ, 
wherein Applicant ``decided to waive [his] rights [sic] to a hearing 
regarding the revocation of my DEA Certificate.'' Id. at 2. The next 
day, the ALJ found that Applicant waived his request for a hearing and 
terminated the proceeding. Id. Subsequently, the Government forwarded 
the Investigative Record along with a Request for Final Agency Action 
to this Office, seeking the revocation of Applicant's DEA registration 
as well as the denial of any pending applications. Based on Applicant's 
letter of June 13, 2013, I find that he has waived his right to a 
hearing. 21 CFR 1301.43(d). I therefore issue this Decision and Final 
Order based on the record submitted by the Government and make the 
following findings of fact.

Applicant's Registration and Licensure Status

    On August 25, 2010, Applicant was issued DEA Certificate of 
Registration BC2172485, pursuant to which he was authorized to dispense 
controlled substances as a practitioner in schedules II through V; this 
registration's expiration date was August 25, 2013. GX 1. On August 1, 
2013, Applicant submitted a renewal application for this 
registration.\2\
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    \2\ I have taken official notice of the Agency's registration 
records which show that Applicant filed a renewal application on 
August 1, 2013. See 5 U.S.C. 556(e); 21 CFR 1316.59(e); Attorney 
General's Manual on the Administrative Procedure Act Sec.  7(d) 
(1947).
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    Under an Agency regulation applicable to those applicants who are 
subject to an Order to Show Cause:

    [i]n the event that an applicant for reregistration (who is 
doing business under a registration previously granted and not 
revoked or suspended) has applied for reregistration at least 45 
days before the date on which the existing registration is due to 
expire, and the Administrator has issued no order on the application 
on the date on which the existing registration is due to expire, the 
existing registration of the applicant shall automatically be 
extended and continue in effect until the date on which the 
Administrator so issues his/her order. The Administrator may extend 
any other existing registration under the circumstances contemplated 
in this section even though the Applicant failed to apply for 
reregistration at least 45 days before expiration of the existing 
registration, with or without request by the Applicant, if the 
Administrator finds that such extension is not inconsistent with the 
public health and safety.

    21 CFR 1301.36(i). Because Applicant had previously been served 
with an Order to Show Cause, and he did not apply to renew his 
registration until twenty-four days before it was due to expire, 
pursuant to the above regulation, I conclude that his registration 
expired on August 25, 2013. Having reviewed the record, I further 
conclude--for reasons explained below--that the extension of 
Applicant's registration during the pendency of this proceeding would 
be ``inconsistent with the public health and safety.'' Id. I therefore 
hold that Applicant's registration expired on August 25, 2013. See Paul 
H. Volkman, 73 FR 30630, 30641 (2008). However, I further hold that 
Applicant's renewal application remains pending before the agency. See 
id.
    Applicant is also the holder of a Florida state medical license, 
ME58544. However, he has been subjected to discipline by the Florida 
Board of Medicine on two occasions.
    Applicant's first brush with the Board occurred in 2001. GX 2, at 
1. That year, the Board filed an administrative complaint against 
Applicant, alleging, inter alia, that with respect to a patient, who 
had suffered a stroke, he ``fail[ed] to practice medicine with that 
level of care, skill, and treatment which is recognized by a reasonably 
prudent similar physician as being acceptable under similar conditions 
and circumstances,'' as well as that he ``failed to keep written 
medical records justifying the course of treatment'' for that patient. 
Id. at 9-10 (citing Fla. Stat. Sec.  458.331(1)(m)). Applicant did not 
dispute the facts, and following a hearing, he agreed to: (1) Pay a 
$5,000 fine, (2) pay $1,728, this sum being the Board's costs in the 
case, (3) complete twenty hours of continuing medical education, (4) 
complete a medical records course, and (5) submit to a Quality 
Assurance Review. Id. at 2.
    In 2010, the Board filed a new complaint, and in 2011, the Board 
filed two more complaints; these complaints culminated in a single 
final settlement order in 2012. Id. at 13. The 2010 complaint \3\ 
alleged that, between December 16, 2009 and May 27, 2010, Applicant 
``dispensed medicinal drugs

[[Page 4963]]

for human consumption for a fee or remuneration'' when he ``was not 
registered with the Board of Medicine to dispense medicinal drugs for 
human consumption,'' in violation of Fla. Stat. Sec.  465.0276(2). Id. 
at 76. The complaint also alleged that, by dispensing medication 
without a proper registration, Applicant violated Florida law by 
``practice[ing] beyond the scope permitted by law . . . .'' Id. at 78 
(citing Fla. Stat. Sec.  458.331(1)(v) (2013)).
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    \3\ State of Florida Department of Health Case number 2010-
03851.
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    The first 2011\4\ complaint made numerous factual allegations 
regarding Applicant's treatment of Patient J.D.\5\ Id. at 28-54. Count 
I of the complaint then alleged, inter alia, that over various periods, 
Applicant committed malpractice by prescribing controlled substances 
including Xanax, Lortab (hydrocodone), oxycodone, and Dilaudid 
(hydromorphone), ``in doses which were not medically justified.'' Id. 
at 55-56 (citing Fla. Stat. Sec.  458.331(1)(t)). Count II of the 
complaint alleged that the aforesaid prescribing constituted 
``inappropriate[] or excessive[] prescrib[ing] [of] medications.'' Id. 
at 57 (citing Fla. Stat. Sec.  458.331(1)(q)). Finally, Count III 
alleged that during the various periods, Applicant ``fail[ed] to 
document a justification for the prescription[s]'' of the four drugs, 
and that he also ``fail[ed] to document a specific examination of 
Patient J.D. from December 23, 2006, to August 16, 2010.'' Id. at 59-60 
(citing Fla. Stat. Sec.  458.331(1)(m)).
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    \4\ State of Florida Department of Health Case number 2009-
05877.
    \5\ These included that Applicant failed to document a patient's 
vital signs, failed to record the quantities of the controlled 
substances prescribed, and continued to increase the dosage amounts 
for Lortab and alprazolam for one patient despite continuously 
noting ``no change'' in that patient's medical record. See id. at 
28-52. In another instance, Applicant prescribed oxycodone, Lortab, 
and alprazolam to a patient who ``reported to Applicant that he had 
been getting Lortab off the street while waiting for his 
appointment.'' Id. at 36.
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    The second 2011 complaint \6\ made numerous factual allegations 
regarding Applicant's treatment of patient L.S. Id. at 63-68. Count I 
of the complaint then alleged that on three occasions, Applicant 
committed malpractice by: (1) Prescribing Xanax ``in doses which were 
not medically justified,'' or 2) ``[b]y authorizing . . . refills of 
the prescription of Xanax and Lortab,'' or 3) ``[b]y failing to refer . 
. . L.S. for a psychiatric consultation.'' Id. at 69-70 (citing Fla. 
Stat. Sec.  458.331(1)(t)). Count II alleged that the aforesaid 
prescribing of Xanax and Lortab constituted ``inappropriate[] and/or 
excessive[] prescribing [of] medications.'' Id. at 71 (citing Fla. 
Stat. Sec.  458.331(1)(q)). Finally, Count III alleged that Applicant 
``fail[ed] to document a justification for the prescription of the 
amount of Xanax'' on three occasions, and that he ``fail[ed] to 
document a physical examination or assessment of . . . L.S. on February 
10, 2007.'' Id. at 72 (citing Fla. Stat. Sec.  458.331(1)(m)).
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    \6\ State of Florida Department of Health Case number 2009-
20428.
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    On August 17, 2012, Applicant entered into a Settlement Agreement 
with the Board. Therein, ``Applicant neither admit[ted] nor denie[d] 
the allegations of fact contained in the Administrative Complaint [sic] 
for purposes of these proceedings only.'' Id. at 18. However, he did 
``admit[] that the facts alleged in the Administrative Complaint [sic], 
if proven, would constitute violations of Chapter 458, Florida 
Statutes, as alleged in the Administrative Complaint [sic].'' Id. 
Moreover, he further agreed that when the Agreement was presented to 
the Board, he would ``offer no evidence, testimony or argument that 
disputes any stipulated fact or conclusion of law.'' Id. at 24.
    Pursuant to the Agreement, Applicant was reprimanded and his 
medical license was suspended until he submitted to an evaluation by 
either a state program or Board-approved evaluation and appear before 
the Board's Probation Committee. Id. at 19. The Board also assessed an 
administrative fine of $60,000 against his license and required that he 
pay $15,910.65 to the Department of Health for its costs in 
investigating and prosecuting the matter. Id. at 19-20. Applicant also 
agreed to cease practicing if, within 105 days of the filing of the 
Board's final order, he did not receive written confirmation from the 
Board that it had received the full amount of both the fine and costs. 
Id. Finally, he agreed to take three courses: (1) A course in the 
``Legal and Ethical Implications in Medicine,'' (2) a course in 
prescribing controlled drugs, and (3) a course in quality medical 
recordkeeping. Id. at 21.
    On October 12, 2012, the Settlement Agreement was submitted to the 
Florida Board, and on October 24, 2012, the Board issued a final order 
approving the Agreement. Id. at 13-14. Applicant's license is currently 
classified as ``Obligations Active'' by the Florida Department of 
Health, which means that ``the licensed practitioner may practice his/
her profession in the State of Florida under the conditions specified 
by the licensing board or department.'' \7\
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    \7\ I have taken official notice of the status of Applicant's 
medical license by accessing the online database of all licensed 
providers maintained by Florida Department of Health. See http://ww2.doh.state.fl.us/IRM00PRAES/PRASLIST.ASP.
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The Investigations of Applicant

The 2005-2006 Investigation

    In 2005, the Florida Department of Law Enforcement (FDLE) notified 
a Sergeant with the Daytona Beach Police Department, who was then 
assigned to a Drug and Money Laundering Task Force, that a female who 
had been arrested for trafficking in hydrocodone and alprazolam might 
have information related to Applicant. GX 17, at 1. Subsequently, the 
Sergeant oversaw four undercover buys from Applicant, which were done 
by two confidential sources (CS1 and CS2); CS1 did the June 24, 2005 
visit, and CS2 did the May 30, 2006, June 27, 2006, and July 26, 2006 
visits. Id.
    During the operations, the police observed the CSs enter and exit 
Applicant's office; they also placed a recording device on the CSs. Id. 
However, during the last operation, the recording device did not work. 
Id. During each operation, the CSs obtained prescriptions for 
controlled substances, which they subsequently provided to the police. 
Id. Copies of these prescriptions were submitted in the record provided 
by the Government, as were the recordings and transcriptions for the 
three visits when the recording device functioned properly. See GX 9-
12.
    Following the buys on June 24, 2005, June 27, 2006 and July 26, 
2006, the confidential sources told the Sergeant that Applicant failed 
to perform any physical examination. Id. at 2. For the May 30, 2006 
undercover buy (which was CS2's first visit), the CS told the Sergeant 
that Applicant had briefly touched his back. Id.
    The recordings of the June 24, 2005 operation establish that the CS 
did not complain of any pain and that Applicant neither asked her any 
questions about her medical condition (indeed, nearly all of the 
interaction involved a discussion of the CS's family issues), nor 
performed a physical examination. GX 9. Applicant nonetheless gave CS1 
prescriptions for 60 tablets of OxyContin 20mg (oxycodone, sch. II), 90 
tablets of Lorcet 10/650 (hydrocodone/acetaminophen, sch. III), 90 
Xanax 1mg (sch. IV), and 90 Soma (carisoprodol, then unscheduled under 
federal law). Id. CS1 paid $65.00 in cash and then left. GX 9.
    As for the May 30, 2006 operation, the transcript of the operation 
corroborates the CS's hearsay statement that the Applicant physically 
touched him. GX 10, at Tr. 1, at 11-12. Yet there is no

[[Page 4964]]

other evidence establishing that Applicant's physical examination of 
the CS was inadequate.\8\ See David Ruben, 78 FR 38363, 38384 (2013). 
Moreover, the CS complained of pain, stating that he had strained his 
back lifting a fire extinguisher (weighing 40-60 pounds) and that he 
had pain ``all over,'' that his back was ``tender,'' and that when he 
woke up, his back ``cramps'' on him. Id. at 10. Applicant gave the CS a 
prescription for 60 Naprosen (a non-controlled drug) and 60 Lortab 10, 
a schedule III controlled substance containing hydrocodone.
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    \8\ As explained below, there is a lengthy report of an Expert 
regarding his review of numerous patient files. However, the Expert 
did not discuss these visits.
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    As for the June 27, 2006 operation, the prescriptions establish 
that the same CS, who made the previous visit, made this visit. The 
recording and transcript show that Applicant did not perform a physical 
examination. However, there is no evidence that the Government's Expert 
reviewed this encounter or the CS's patient file, and there is no 
evidence that under the standards of accepted medical practice, the 
performance of a physical exam was required at this visit.
    The recording and transcript do reflect that after Applicant and 
the CS greeted each other, a lengthy discussion ensued of such matters 
as Applicant's prior experience treating gunshot wounds as a trauma 
surgeon and critical care physician, his decision to move to Florida, 
and the skill required to perform cardiac and orthopedic surgery, the 
latter being ``just carpentry,'' which requires knowledge of ``some 
anatomy'' and ``patience.'' GX 11, Tr. Part 4, at 1-8. Applicant then 
asked the CS: ``What's going on with you?'' Id. at 8
    To this, the CS replied: ``Well . . . that . . . what you gave me 
last time. Made me feel really good. Ah . . . coming to see if I can 
get something a little stronger this time.'' Id. Applicant than asked 
the CS if he wanted something ``[s]tronger or just more'' of what he 
had previously gotten; the CS answered: ``[m]aybe more stronger.'' Id. 
Applicant then stated: ``Okay, no problem,'' and asked the CS if he was 
getting ``any therapy?'' Id. The CS replied that he was not. Id. 
Applicant then asked the CS, ``not into it?'' Id. The CS answered 
``[y]eah,'' and Applicant said ``fair enough.'' Id. Applicant then left 
the exam room and subsequently provided the CS with prescriptions for 
60 Ultram (tramadol, a non-controlled drug) and 120 oxycodone 15mg, a 
schedule II controlled substance.
    CS2 returned to Applicant on July 27, 2006. GX 12, at 5. However, 
as explained above, the recording device malfunctioned. In his 
affidavit, the Sergeant stated that the CS told him that Applicant did 
not perform a physical exam. GX 17, at 2. The CS also told the Sergeant 
that Applicant did not recognize him and did not remember what he was 
being treated for. Id. Most significantly, the CS told Applicant that 
he had ``previously pulled a muscle in his back, but was no longer in 
pain'' and that ``he just liked how the pain medication made him feel 
and wanted something stronger than the oxycodone 15mg tablets'' he 
obtained at the ``previous visit.'' Id. The CS also told the Sergeant 
that he received a prescription for 90 tablets of oxycodone 30mg. Id. 
Of note, the Sergeant's statement is corroborated by a copy of the 
prescription. GX 10, at 5.

The 2008-2009 Investigation

    Several years later, a DEA Diversion Investigator (DI), in 
conjunction with the Volusia County Florida Bureau of Investigation 
(VBI) and the Department of Health and Human Services Medicaid Fraud 
Control Unit (DHHS), conducted four undercover visits of Applicant. GX 
18, at 1. The visits were done on September 18, 2008, October 16, 2008, 
November 24, 2008, and January 15, 2009, and were performed by two 
different confidential sources (CS3 and CS4), who were equipped with a 
recording device,\9\ and after each visit the CSs were debriefed. Id.
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    \9\ DI Stocum's declaration states the date as November 25, 
2008. GX 18. The date on the issued prescriptions for that CS, 
however, is November 24, 2008. See GX 15.
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    According to the DI, after each of the visits, the confidential 
sources told her that Applicant did not perform a physical examination 
yet prescribed controlled substances to the CSs. Id. at 2. 
Subsequently, a search warrant was obtained from the Florida courts 
authorizing the search of Applicant's clinic, and was executed on 
October 1, 2009. Id. Pursuant to the warrant, Applicant's medical 
records were seized. Id. These records were turned over to Dr. Theodore 
Parran, an expert working for the Government, for review.\10\ Id.
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    \10\ The same day, the Investigators also interviewed Applicant. 
GX 5. Applicant admitted that his clinic did not accept insurance 
and was basically a cash clinic. Id. at 9. He also acknowledged that 
some pharmacies were refusing to fill his prescriptions, but did not 
follow-up with any of them because of their ``attitudes.'' Id. at 
37-38. When asked about the high volume of controlled substances he 
was prescribing, Applicant stated that he was ``not trying to 
overdose people but most of my chronic patients that I have never 
run out'' of medication. Id. Later, he acknowledged ``writ[ing] . . 
. a fair amount more than most doctors would'' and that ``every once 
in a while we have an overdose.'' Id. at 51.
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    On September 18, 2008, CS3 visited Applicant at his place of 
business. GX 13. After stating that ``I just can't move'' and ``I'm 
just so uncomfortable,'' Applicant asked ``[s]o what do we need to 
do?'' Id. at Tr. 1, at 7. CS3 then asked if she could ``get something 
for the discomfort that I have.'' Id. Applicant said ``okay'' and asked 
if she was no longer getting therapy. Id. at 8. CS3 said that she had 
not ``been able to fin[d] anybody that does this deep tissue,'' but 
that she was getting massages. Id. After CS3 made a further vague 
comment about her condition, Applicant stated that ``at one point I 
g[a]ve you some Percocets, at one point, I gave you some Lortab. I 
mean, do you want, did anything work for you?'' Id. CS3 replied: 
``Well, first, the, um . . . I guess the last one was the Percocet. 
That didn't work, but that helped with anti-inflammatory, too. I think 
you gave me something.'' Id.
    Applicant replied, ``[w]ell, now you saw me one time. You saw that 
other guy, the other guy gets it cheaper than this place.'' Id. CS3 
then denied that she had ``see[n] anybody in that office,'' an apparent 
reference to Applicant's former practice location, and Applicant noted 
that it has been ``like two (2) years ago.'' Id. CS3 again stated that 
she had not gone back to that office because it did not have a 
therapist and she ``didn't really care for his . . . chiropractic 
procedure.'' Id. at 9. Applicant said ``okay'' and asked the CS if she 
was ``tak[ing] something for pain, an anti-inflammatory?'' Id. The CS 
said ``yeah,'' after which CS and Applicant discussed various other 
matters, none of which related to the CS's medical condition. Id.
    Consistent with the DI's statement that the CSs had informed her 
that Applicant did not perform a physical exam, there is no evidence 
that Applicant performed a physical exam of CS3. Applicant nonetheless 
wrote CS3 a prescription for 180 tablets of Percocet 10/325mg. GX 13. 
CS3 paid $90.00 for the visit. Id. at 8.
    On October 16, 2008, CS3 returned to Applicant and paid $90.00 in 
cash. GX 14. After greeting each other and discussing how she could 
lose weight, CS3 asked Applicant if he could ``give [her] a little 
extra this time?'' Id. Tr. 1, at 10. Applicant answered, ``uh-hum,'' 
but never asked CS3 why she wanted or needed more medication. Id.
    CS3 then told Applicant that she had a friend who wanted to come in 
asked if he was seeing new patients. Id. at 11. Applicant said he was 
but he had rules and the CS's friend would have to bring documentation 
and that he would let the patient ``know beforehand what the rules are 
gonna be as far as what you get . . . cause somebody walks in here and 
wants strong pain medication and they've never had anything before, I 
say, `Let's start out with anti-inflammatories and muscle relaxers, 
first, and therapy, and let's see how things go.' So . . . I don't 
know.'' Id.
    CS3 then stated that she had ``shared a little bit [of her 
medications]'' with her

[[Page 4965]]

friend and did not ``know if that was the right thing to do.'' Id. 
Applicant replied that ``it's neither right or wrong, as far as I'm 
concerned, but you must understand, and, although, I don't think you 
can get in trouble for it, you both broke the law by doing that.'' Id. 
After CS3 replied ``I did?'' Applicant explained that ``[y]ou were 
dealing drugs and he was taking illegal medication; these are 
controlled substances.'' Id. at 12. After CS3 asked if it would ``be 
better now if I just get him an appointment,'' Applicant stated that 
``he can call,'' but that he would have to meet with his colleague and 
``bring in his documentation.'' Id.
    Applicant asked if the CS's friend ``had surgery before,'' but the 
CS did not know. Id. Applicant then explained that if ``he's had 
surgery before, then I just need to see some documentation . . . about 
the surgery.'' Id. After CS3 stated that she did not ``think it was 
that'' and that he may be ``going to a chiropractor,'' Applicant added 
that ``if he can show me that he's had therapy and things like that, 
that makes a difference.'' Id. at 12-13. Applicant then explained that 
``in other words, there are a lot of people who just want to walk in 
and say, `Give me pain medicine.' And I say, `You don't just get pain 
medicine without some documentation.''' Id. at 13. Applicant advised 
that if the CS's friend ``gets his medical records together and gets it 
to us . . . we'll get back to him.'' Id. Applicant then authorized the 
dispensing of 210 tablets of Percocet (oxycodone/apap) 10/325mg, for 
which the CS paid $200.\11\ Id.
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    \11\ The evidence shows that the drugs were dispensed by 
Applicant's clinic. GX 14.
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    On November 24, 2008, CS3 returned to Applicant's clinic and 
obtained 240 more tablets of Percocet 10/325mg. GX 15, at 2. However, 
as found above, the recording device malfunctioned. GX 18, at 2. In her 
affidavit, the DI stated that during the post-visit debriefing, the CS 
said that Applicant did not perform a physical exam and only took her 
weight and blood pressure. Id. While the DI's affidavit states that 
Applicant also required that CS3 sign a form in which she agreed not to 
share her medications and that she did not ask for an increase in her 
prescription, the affidavit offers no further information regarding the 
interaction between the CS and Applicant. Id.
    According to the DI, on January 15, 2009, CS4 visited 
Applicant.\12\ GX 16. After exchanging greetings and discussing the 
holidays, CS4 stated that he was ``feeling better though.'' Id., Tr. 1, 
at 5. After discussing whether CS4 needed his prescriptions ``split up 
the same way again,'' Applicant asked the CS, ``[h]ow's work?'' Id. The 
CS replied, ``[p]retty good, not too bad. Doing pretty good these days. 
My pain is getting better . . . that that makes it real good.'' Id. 
Applicant then asked the CS if he did ``anything for New Year's Eve''; 
the CS replied that he had gone to his uncle's party. Id. at 6-7. 
Shortly after that, the CS's encounter with Applicant ended. Id.
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    \12\ However, the transcript lists the date of the visit as 
January 5, 2009
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    CS4 filled his prescription at Applicant's clinic. As the evidence 
shows, Applicant dispensed 240 tablets of Oxycodone 15mg. Id.

The Government Expert's Analysis of the Seized Medical Records

    As found above, after the execution of the search warrant, the DI 
provided over 115 medical records to Dr. Theodore Parran for his 
review. GX 18, at 2. Dr. Parran, who has practiced medicine for thirty 
years, is a board-certified specialist in addiction medicine and 
internal medicine. GX 6. Dr. Parran is a member of the faculty at the 
Case Western Reserve University School of Medicine and developed the 
school's Addiction Fellowship Programs. Id. at 1, 13; GX 7. He is also 
the Medical Director for the Detoxification Unit at Huron Hospital in 
East Cleveland, Ohio, and the Medical Director for the Cleveland 
Treatment Center Methadone Maintenance Clinic. GX 6, at 14. He has also 
served as a reviewer for several professional journals on issues 
related to substance abuse, presented numerous lectures on substance 
abuse and controlled substance prescribing, and authored (or co-
authored) a large number of articles for professional journals and book 
chapters for treatises. Id. at 6-13.
    Following his review, Dr. Parran offered the following findings. 
Most significantly, Dr. Parran opined ``that there are many cases where 
the prescribing of controlled drugs appears to have been for other than 
[a] legitimate medical purpose and appears not to have taken place 
within the usual course of medical practice.'' GX 7, at 1.
    Dr. Parran then identified several ``general characteristics'' of 
Applicant's ``prescribing behaviors that are concerning and even 
alarming.'' Id. Specifically, he found that: (1) ``There [was] 
virtually always a very scant initial history and typically no 
documented evidence of a sufficient physical exam done on patients'' in 
the records; (2) there was a remarkable similarity in how Applicant 
treated each patient, suggesting a lack of individualized treatment; 
(3) there was typically no note in the patient chart to explain why 
Applicant started, increased, or changed a drug regimen; (4) there were 
very few, if any, referrals to alternative treatments (i.e., physical 
therapy) and specialists (i.e., psychiatry, rheumatology, neurology, 
orthopedics and neurosurgery); and (5) Applicant routinely ``provide[d] 
on-going supplies of multiple controlled drugs in an escalating 
pattern, typically culminating in quite high doses, in potentially 
dangerous combinations.'' Id. at 1-2. Dr. Parran thus opined that 
Applicant's ``pattern of relentlessly prescribing controlled drugs, 
with insufficient history and physical . . . and no clinical reasoning 
evident in progress notes what-so-ever, without initiating a clinical 
work-up or demonstrating evidence of an effort to obtain prior records, 
and in the face of non-compliance and often out of control behavior on 
the part of patients, is not consistent with the usual course of 
medical practice and constitutes prescribing of controlled drugs for 
other than [a] legitimate medical purpose.'' Id. at 2. A more detailed 
discussion of Dr. Parran's findings with respect to several of the 
patients follows.

K.B.

    At K.B.'s initial visit, she reported that she suffered from head 
and face trauma and seizures, and was taking undocumented dosages of 
Xanax, Dilantin and Naproxen. Id. at 4. The file included prior medical 
records from a neurology pain office several years earlier indicating 
that she had taken ``Oxy 40 BID [twice a day] and Roxi 5 and Xanax 2 
TID,'' three times a day. Id. Dr. Parran found that there was ``no 
evidence of a [physical exam] and little evidence of any history 
taking.'' Id.
    The next progress note in K.B.'s file is dated 6/6/06, sixteen 
months after K.B.'s initial visit, and states ``Duragesic does not seem 
to be effective for pain . . . refills.'' Id. Apparently, no 
explanation was provided as to when Applicant prescribed Duragesic 
(fentanyl), a schedule II controlled substance to her. Id.
    The next visit documented in K.B.'s record is dated 7/19/06; the 
progress notes states ``former WS pt. with chronic back pain/Lmyalgias/
HA/seizures and anxiety.'' Id. Dr. Parran again noted that there is 
``no evidence of a PE [physical exam] at all, or health history, or 
documentation of current RX or labs (to check Dilantin level, etc.) or 
studies, prior records, etc.'' Id. Yet Applicant prescribed 120 OC 30 
mg (oxycodone), 120 Oxy (also oxycodone)

[[Page 4966]]

40mg, 150 Xanax 2mg, Dilantin 300 mg/d, Naprosyn, and 90 Soma.
    On 8/16/06, Applicant added 120 Fiorinol to K.B.'s existing 
medications, without noting why in her record. Id. Dr. Parran opined 
that ``[a]dding a potent barbiturate or an existing barbiturate (soma) 
and a high dose very potent benzodiazepine and two CII opioids . . . is 
dangerous to health or even life of a patient and is clinically 
reckless.'' Id.
    K.B. received the same prescriptions the following month, but the 
visit note documents only the prescriptions. Id. Thereafter, there were 
no progress notes until February 2007, when the note stated that K.B. 
was going to a neurosurgeon and needed a new MRI, and the same 
prescriptions were provided. Id. Yet K.B. did not provide an MRI at 
either her April or May office visits, and in August 2007, the progress 
note stated that K.B. had complained that the ``pharmacist shorted me . 
. . so [she was] in bed almost all of last month.'' Id.
    Dr. Parran then noted that there was no evidence of a physical 
examination at any time in the past year except for a note regarding 
``spasm/tenderness in L/SP,'' and yet Applicant added a prescription 
for 60 MS XR (morphine sulfate extended release)--``a third CII opioid 
with no mention in the record at all!'' Id. Dr. Parran noted that K.B. 
received prescriptions that month for Soma 150, 150 OC 30 mg, 150 Xanax 
2mg, Dilantin, 120 Oxy 40mg, and had refills that were still active for 
Naproxen and Fioricet. Id. However, her chart included a note stating 
that: ``Medicaid refused Soma due to too high a dose and Oxy due to 
excessive quantity.'' Id.
    Next, Dr. Parran found that the progress note for 11/7/07 listed 
K.B.'s pain as 8/10, and that she reported she ``only got \1/2\ of meds 
from pharmacy this month.'' Id. Dr. Parran noted there were ``no 
studies, referrals, evidence of a PE, evidence of a neurological exam 
ever'' and yet Applicant wrote prescriptions were for 120 Fiorinal; 150 
Xanax 2mg; 120 MS XR 60mg QID (four times a day, notwithstanding that 
the drug is to be taken twice a day); 150 Soma; 150 OC 30mg; 60 Oxy 
80mg. Id.
    Dr. Parran further found that the February 2008 progress note 
stated that K.B. ``self-increases medication in cold weather.'' Id. 
Moreover, while the note of 3/27/08 states that K.B. ``will sched f/u 
with surgery;'' and the note dated 4/08 states, ``surgery next month''; 
the note of 5/22/08 states that she ``ran out early,'' with ``no 
mention of WD [withdrawal management],'' abstinence symptoms, nor 
mention of surgery. Id.
    Next, Dr. Parran observed that the 7/17/08 note stated: ``Hold RX 
until mother comes in with cash payment.'' Id. Applicant noted that he 
was providing an additional prescription of ``OC 15mg 300'' to 
K.B.'s medications, but did not document a justification for doing so. 
Id.
    The 8/14/08 progress note reported K.B.'s ``Pain 7/10.'' Id. 
Moreover, the note stated that K.B. received the following 
prescriptions: 150 OC 30mg; 300 Oxydose 15 mg; 120 Fiorinal; 150 Xanax 
2mg; 56 Oxycontin 80 mg. BID; 112 MS XR 60 mg QID; and 150 Soma. Id. 
Dr. Parran then explained that this provided K.B. with ``four CII 
opioids all at quite high dose and three sedative hypnotics!'' and was 
``[s]imply unbelievable.'' Id.
    As for K.B.'s 9/11/08 visit, the note listed her pain as ``7/10'' 
and stated that ``OC 15 mg's have helped smooth out pain well.'' Id. 
Dr. Parran then explained that this was ``inconsistent data in the 
medical record.'' Id.
    On 10/09/08 Applicant increased the prescription dosages to 180 OC 
30 mg; 120 MS; 60 Oxycontin; 180 Soma; 180 Xanax. Id. Yet 
notwithstanding the increases, the progress notes for her next month's 
visit stated that her pain was a ``7/10'' but that the ``meds [were] 
effective.'' Id.
    On February 5, 2009, Applicant again increased K.B.'s 
prescriptions. Id. These prescriptions provided K.B. with 300 OC 30 mg, 
180 OC 15 mg, 60 OxyContin 80 mg, Fiorinol 120 X3, 200 Xanax 2mg, and 
200 Soma, as well as two prescriptions for MS XR 60 mg, one for 94 
tablets and one for 56. Id
    In April 2009 the progress notes include ``pharmacy call re: 
Concern[s] about amounts of OC and too early refills.'' Id. In June 
2009, Applicant prescribed 30 OxyContin 80mg in addition to the 
existing 60 OxyContin 80mg; Dr. Parran found, however, that there was 
``no indication in PN [progress notes] as to why.'' Id. Dr. Parran then 
opined that:

    The prescribing of four and a half years of markedly escalating 
opioids and other controlled drugs to this patient with no 
evaluation, an insufficient H&P, non-existent work-up, lack of 
studies/consults/evaluation, up to exceedingly high doses of 
opioids, is inconsistent with the usual course of medical practice 
and was for other than a legitimate medical purpose.

Id.

D.B.

    Regarding D.B., Dr. Parran found that ``prior records recommend 
avoiding long-term narcotic medications.'' Id. at 5. D.B. reported 
``spinal and back pain'' and yet ``mark[ed] off in the patient self 
report[,] pain in each and every part of the body listed.'' Id. She 
also reported being on methadone 40mg, oxycodone 30 mg, Xanax 2mg, and 
Soma, but another note ``explicitly state[d] that the patient was not 
on any medications currently.'' Id. Applicant nonetheless prescribed 
120 OC 30mg and 60 Valium10mg at the initial office visit. Id. Dr. 
Parran concluded that ``this is clinically reckless and if taken as 
directed would result in patient harm and even an accidental 
potentially fatal OD.'' Id.
    At her next appointment (four weeks later), Applicant changed the 
prescriptions to 120 Percocet 10mg; 120 methadone 40 mg; 90 Xanax 2mg. 
Id. According to Dr. Parran, this was a ``massive increase,'' which was 
``even more clinically reckless, and in a patient who was not on any 
current medications just 4 weeks earlier, could and should have caused 
harm or even death if taken as directed.'' Id.
    Next, Dr. Parran found that the progress notes showed that the 
following month, asthma medications were added. Id. Dr. Parran reported 
that there was ``no discussion of asthma (a medical concern in the face 
of this huge amount of opioid and benzo prescribing), no evidence of a 
lung exam or evaluation of the severity of pulmonary function.'' Id.
    Over the next three months, D.B.'s patient file documents multiple 
increases in her prescriptions, such that by December, she was 
receiving 240 methadone 40mg, 120 Xanax 2mg, 120 Oxycodone 30mg, and 90 
Soma, ``with no indication in the medical record.'' Id. Dr. Parran 
explained that ``[t]his bears no resemblance to the usual course of 
medical practice.'' Id. Additional increases in Applicant's prescribing 
of oxycodone, as well as other drugs followed, notwithstanding that 
Applicant documented in D.B.'s file that the ``meds are working good.'' 
Id. Regarding the prescriptions, Dr. Parran explained that ``[t]he 
prescribing of three years of markedly escalating opioids and other 
controlled drugs to this patient with no evaluation, an insufficient 
[history and physical], non-existent work-up, lack of studies/consults/
evaluation, up to exceedingly high doses of opioids, is inconsistent 
with the usual course of medical practice and was for other than a 
legitimate medical purpose.'' Id.

J.H.

    Dr. Parran found that J.H.'s patient file indicated that during an 
initial office visit in January 2007, she complained of back pain from 
a motor vehicle accident in 1994, as well as anxiety from deaths

[[Page 4967]]

in the family. Id. at 16. J.H. also reported that she had not seen a 
doctor since 1994 and was not on any medications. Id. In the patient 
file, Applicant wrote that ``we would treat her for anxiety and not to 
expect any pain meds.'' Id. However, an additional note stated that 
J.H. was getting ``Percocets from her dad'' for back pain. Id.
    Dr. Parran found that there were ``no prior records/studies/
referrals/work-up'' or significant history and physical documented in 
her patient file. Id. Yet, at the initial visit, Applicant prescribed 
to J.H. 180 Percocet 5 mg. and 30 Xanax 2mg. Id. Dr. Parran explained 
that ``[t]his is completely unsupported by the medical record, [and] is 
inconsistent with the usual course of medical practice and lack [sic] 
legitimate medical purpose.'' Id.
    Dr. Parran found that at J.H.'s next visit (one month later), 
Applicant nearly tripled the oxycodone to 120 Oxy 15 mg, but made no 
mention of this in the progress note. Id. Dr. Parran then explained 
that if J.H. ``had not been on prior opioids . . . and she took it as 
prescribed . . . it could have resulted in [an] accidental OD 
[overdose] and even fatal accidental OD.'' Id.
    Dr. Parran observed that at J.H.'s next visit, Applicant added 180 
Percocet 5mg to her prescriptions for 120 Oxy 15mg and 30 Xanax 2mg and 
merely noted that these were refills. Id. Three months later, Applicant 
documented that the medications ``were working fine,'' even though he 
noted that she was ``doubling up on [her] meds'' and had been ``out of 
medications for one week.'' Id. Yet he did not document any withdrawal 
symptoms in J.H.'s record and did not change her prescriptions. Id.
    Two months later, he again increased her Oxycodone 15mg 
prescription and doubled her Xanax to 60 tablets. Id. The following 
month, he noted that J.H. had ``been doubling on Oxy 15s . . . would 
like increase''; Applicant increased the prescription to 120 Oxycodone 
30mg. Id. Within no more than a few days, J.H. claimed that she had 
been ``robbed at knife-point in [a] local store'' and that her 
prescriptions were stolen and she ``want[ed] more.'' Id. at 16-17. 
Applicant documented that he told her ``no,'' and that J.H. later 
``called back and reported maybe only half the RX was stolen and [that] 
she could probably make it to the next'' visit. Id. at 17. Yet at the 
next visit, J.H. reported being ``better'' and that ``all is well.'' 
Id. Applicant provided new prescriptions and did not document any 
discussion about J.H.'s claim that half of her medicine had been stolen 
or whether she actually ``only need[ed] half the medication.'' Id.
    By June 2008, Applicant had increased J.H.'s oxycodone prescription 
to 200 oxycodone 30mg. Id. That month, she also asked Applicant to 
increase the Xanax, and Applicant increased the prescription to 90 
tablets. Id. In November, he again increased her oxycodone prescription 
by 30 more tablets to 240,\13\ even though he noted that she was 
``fine'' and there were ``no new issues or complaints.'' Id.
---------------------------------------------------------------------------

    \13\ He had previously increased the prescription to 210 tablets 
in late July.
---------------------------------------------------------------------------

    Dr. Parran also noted that between February and May 2009, J.H.'s 
chart contained no indication of a visit or prescriptions. Id. Yet on 
May 15, 2009, Applicant ``restart[ed] all meds at [the] prior 
dosages.'' Id. Dr. Parran explained that ``[t]his is clinically 
reckless and demonstrated disregard for the health and safety of a 
patient.'' Id. He then opined that ``the prescribing of controlled 
drugs to this patient was done in a manner that is inconsistent with 
the usual course of medical practice, and appears to have been done for 
other than legitimate medical purpose.'' Id.

A.C.

    Reviewing the file for Patient A.C., who complained of back pain, 
Dr. Parran noted that the history forms were ``basically blank'' except 
for a notation of ``back pain'' and ``Xanax/Lortab/Oxy.'' Id. at 10. He 
further found that there was ``no evidence of a significant PE or neuro 
exam,'' that there was ``no imaging,'' and that there was ``no 
verification of prior RX.'' Id. Yet Applicant prescribed to A.C. 120 
oxycodone 30mg, 180 Lortab 10mg, and 30 Xanax 2mg. Id. Dr. Parran 
explained that ``[t]his is simply unbelievable and demonstrates 
reckless disregard for the health and safety of a patient.'' Id.
    Dr. Parran further found that while A.C.'s file indicated that he 
had suffered a back injury at work and had seen an orthopedist, 
Applicant never had A.C. sign a release for the records maintained by 
the orthopedist. Id. Moreover, A.C. missed several visits, showing up 
several days later, and that during one such late visit, A.C. said that 
he had been out of medications ``for two days.'' Id. Yet there was ``no 
evidence'' that A.C. went through withdrawal, although this ``should 
have been severe.'' Id. Dr. Parran also noted that Applicant did not 
perform a urine drug screen on A.C. Id. Finally, A.C.'s medical record 
showed that he had been simultaneously seeing another physician for six 
months. Id. Here again, Dr. Parran opined that Applicant acted outside 
of the usual course of professional practice and lacked a legitimate 
medical purpose in prescribing controlled substances to A.C.

S.H.

    Dr. Parran found that S.H. complained ``of coccyx/tail bone pain'' 
which Applicant documented as being ``sporadic.'' Id. at 17. Dr. Parran 
then found that there was ``virtually no HX [history] and no PE 
[physical exam]'' done at S.H.'s initial office visit and that ``all 
patient health history and registration paperwork is blank.'' Id. Dr. 
Parran further observed that while S.H. had been a patient at 
Applicant's previous clinic and there were patient notes for the period 
of June through September (which immediately preceded) S.H.'s first 
visit to Applicant's new clinic, there was ``basically no clinical 
information on them what so ever,'' again with ``virtually no'' history 
and ``nearly no PE performed.'' Id.
    Dr. Parran found that at the first visit (Oct. 2007), Applicant 
prescribed 200 oxycodone 30mg to S.H., who was driving from Tampa to 
Sanford, a distance of more than 100 miles. Id. at 18. Dr. Parran 
further found that over the following two years, the progress notes 
included notations that S.H. had run out of medications. Id.
    For example, two months after the first visit, Applicant noted that 
S.H. ``overtook medications--not strong enough--ran out,'' yet there 
was no indication that S.H. had withdrawal symptoms. Id. Moreover, even 
though this was ``contrary to [S.H.'s] Pain Agreement,'' Applicant 
increased S.H.'s oxycodone prescription to 240 tablets. Id.
    In April 2008, S.H. reported having undergone knee surgery and 
asked for more pain medication because the surgeon would not prescribe 
more to him. Id. Applicant did not obtain the records, nor was there a 
release in the file. Id. While it is unclear whether Applicant 
increased the medications at this visit, in May, he prescribed 300 
oxycodone 30mg. Id.
    In July 2008, S.H. claimed that he ``ran out of medications'' 
because he ``lost 50 in the water while fishing.'' Id. Here again, 
there was no discussion of whether S.H. had undergone withdrawal 
symptoms. Id. Yet Applicant issued another prescription. Id.
    In October 2008, S.H. reported that he had run ``out of medication 
10 days ago,'' but then changed his story ``to 5 days ago.'' Id. S.H. 
then claimed that he did ``not [have] enough medication'' and that he 
was ``stretch[ing] meds from prior visits.'' Id. Applicant than

[[Page 4968]]

increased the prescription to 360 oxycodone 30mg. Id.
    In December 2008, S.H. reported that he had been out of medication 
for two days. Id. According to Dr. Parran, S.H. should have had 
``horrendous'' withdrawal symptoms but there was no notation that he 
had undergone withdrawal. Id. Applicant then increased S.H.'s 
prescription to 390 oxycodone 30mg. Id. While at S.H.'s January 2009 
visit, he told Applicant that ``everything is okay'' and that he had 
``left over meds,'' Applicant nonetheless increased the prescription to 
400 oxycodone 30mg. Id.
    Dr. Parran also found that S.H. was seven days late for his March 
visit (at which he was prescribed a different drug--Morphine Sulfate 
Immediate Release) and nineteen days late for his April visit (at which 
Applicant returned to prescribing 400 oxycodone 30mg), and yet there 
was no mention of why S.H. had been late at either visit. Id. Dr. 
Parran opined that ``[t]his is dangerous and demonstrates clinically 
reckless disregard for the health and safety of the patient.'' Id.
    Finally, Dr. Parran noted that at S.H.'s last visit, there was ``no 
mention of anxiety/depression/sleep/muscle spasm issues and no mention 
of [benzodiazepines] at all, yet'' Applicant added a prescription for 
90 Xanax 2mg. to the prescription for 400 oxycodone 30mg. Id. Dr. 
Parran opined that this was also ``dangerous, and demonstrates 
clinically reckless disregard for the health and safety of the 
patient.'' Id. Dr. Parran then concluded that ``the prescribing of 
controlled drugs to this patient was done in a manner that is 
inconsistent with the usual course of medical practice, and appears to 
have been done for other than [a] legitimate medical purpose.'' Id.

D.F.

    Applicant treated D.F. from May 2008 through September 2009. Id. at 
14-15. During those sixteen months Applicant prescribed increasing 
amounts of oxycodone, Dilaudid, methadone and Soma.
    The records of the initial office visit showed that D.F. complained 
of ``fibromyalgia and chronic pain endorsing 31 symptoms in the patient 
self-report sheet and 12 of 15 pain descriptors--and pain everywhere in 
his body except hips.'' Id. at 14. The progress note then stated: 
``spoke with PT . . . he wants to get off methadone and use the 
Duragesic and other less expensive medications.'' Id. Regarding this, 
Dr. Parran opined that ``methadone is the least expensive'' of these 
drugs and that ``this is inconsistent!'' Id.
    The file also contained a letter indicating that D.F. had been on a 
methadone maintenance program at 70 mg/d since 12/07. Id. at 15. Dr. 
Parran noted that the file included prior records from a pain 
management specialist dated April 2007, a normal MRI, and that D.F. had 
been ``on Lyrica and Lidoderm (but no other controlled drugs).'' Id.
    Dr. Parran found that there was ``[b]asically no H&P [History and 
Physical]'' and yet Applicant started issuing prescriptions for 180 
Oxycodone 30mg, Duragesic 75mics, and 50 methadone 10mg. Id. Dr. Parran 
then found that at D.F.'s last visit (9/28/09) before the search of his 
clinic, Applicant had increased D.F.'s prescriptions to: 240 Oxycodone 
30mg; 150 Dilaudid 8mg; 240 Oxycodone 15mg; 300 Methadone 10mg; and 60 
Soma. Id.
    Dr. Parran found that throughout D.F.'s file, there were multiple 
notations that that she was running out early and yet Applicant 
increased the prescriptions. Id. More specifically, the note for D.F.'s 
second visit (June 2008) states ``doing good and ran out early''; 
Applicant then increased the prescriptions to 200 Oxy 30 mg. and 90 
methadone 10mg. Id. Moreover, when, in July 2008, D.F. ``asked about 
Soma,'' Applicant added a prescription for 28 Soma. Id.
    Next, Dr. Parran found that the 8/8/08 progress note again stated 
that D.F. ``ran out early,'' and that Applicant increased her 
prescriptions to 220 Oxy and 120 methadone. Id. Two months later (on 
10/8/08), Applicant noted that ``Pt. ran out one week ago (no W/D),'' 
and increased the ``Soma up to 60 and Oxy to 270.'' Id.
    Dr. Parran found that at D.F.'s November 2008 visit, Applicant 
noted that he was increasing the methadone prescription to 200 tablets 
and the Oxy 30mg to 300 tablets; he also noted that he was ceasing the 
Duragesic patches because they were ``not working well.'' Id. Dr. 
Parran then observed that ``this is totally contrary to the first OV 
notes and completely internally inconsistent.'' Id.
    Next, according to the February 2009 note, D.F. ``request[ed] more 
methadone'' and Applicant increased the prescription to 270 tablets; he 
also prescribed 300 tablets of Oxy 30mg. Id. At the April 2009 visit, 
Applicant added 120 Dilaudid 4mg to D.F.'s medications, which also 
included 240 Oxycodone 15mg, 180 Oxycodone 30mg, and 60 Soma. Id.
    The following month, Applicant changed D.F. from Dilaudid back to 
methadone, issuing prescriptions for 240 Methadone 10 mg, 240 Oxycodone 
15 mg, 180 Oxycodone 30 mg, and 60 Soma. Id. And in June, Applicant 
resumed prescribing 120 tablets of Dilaudid 4mg and again increased the 
methadone to 270 tablets, which he further increased to 300 tablets the 
next month. Id. Dr. Parran found Applicant's methadone prescribing 
remarkable given that this was for ``a patient who was supposedly being 
taken off a methadone program and [being given] other medications and 
patches!'' Id.
    Next, Dr. Parran found that the August 2009 progress note stated 
that D.F. had ``request[ed] 8 mg of Dilaudid'' and that Applicant 
``increase[d] [the] Dilaudid to 8mg 120.'' Id. Moreover, Dr. 
Parran found that the following month, Applicant increased the Dilaudid 
to 150 tablets (again of 8mg), and also prescribed 240 Oxycodone 30mg. 
Id. Finally, Dr. Parran found that at D.F.'s last visit before the 2009 
search, Applicant issued prescriptions for 240 Oxycodone 30mg, 240 
Oxycodone 15mg, 150 Dilaudid 8mg, 300 methadone 10mg, and 60 Soma. Id. 
According to Dr. Parran, ``[t]his is just plain dangerous.'' Id. Dr. 
Parran thus concluded that Applicant's ``prescribing of controlled 
drugs to this patient was done in a manner that is inconsistent with 
the usual course of medical practice, and appears to have been done for 
other than legitimate medical purpose.'' Id.

T.T.

    Reviewing T.T.'s file, Dr. Parran found that at the initial visit 
(2/8/06), she complained of chronic lower back pain, but reported 
taking ``no medications.'' Id. at 36. Dr. Parran observed that T.T. 
reported no prior doctor and that her file contained no studies, labs, 
or records and that there was ``virtually no'' history and physical 
documented ``with no neuro[logical] exam.'' Id. Applicant nonetheless 
diagnosed T.T. as having ``thoracic and Lumbar Myalgias'' and issued 
her a prescription for 90 tablets of Lortab (hydrocodone/apap) 5mg. Id.
    Dr. Parran than observed that at T.T.'s next visit (3/06), 
Applicant increased her prescription to 120 Lorcet 10mg, and thus 
nearly tripled the daily dose. Id. Next, Dr. Parran found that in late 
April, T.T. was provided an ``early [prescription] by 10 days.'' Id. 
Moreover, in late May, Applicant increased her Lortab prescription to 
150 tablets and yet seven days later (June 7), he gave her a 
prescription for another 120 tablets. Id. Later the same month, 
Applicant gave T.T. prescriptions for additional drugs including 60 
Valium 10mg, 30 Darvocet, and 60 Soma, and in October, he increased the 
Lorcet to 180

[[Page 4969]]

tablets. Id. Moreover, in November, Applicant added 90 oxycodone 30mg 
to her medications, and also prescribed 60 Valium 10mg, 180 Lortab 
10mg, and 60 Soma. Id. Dr. Parran then observed that there was no 
discussion in T.T.'s progress notes regarding the prescriptions. Id. 
Moreover, in January, Applicant further increased T.T.'s oxycodone 
prescription to 120 tablets. Id.
    On February 7, 2007, T.T., who did not have an appointment, 
obtained new prescriptions for all of the drugs, claiming that her 
brother was addicted to methamphetamine and had beaten her and taken 
all of her drugs. Id. Applicant again increased T.T.'s oxycodone 
prescriptions to 180 tablets. Id.
    Next, Dr. Parran found that while the May 2007 note stated that 
T.T. got tired a lot and did not take either the Valium or Soma, 
Applicant again prescribed both drugs. Id. Dr. Parran then noted an 
early refill for Valium (10/20/07), which was followed in November by a 
change to 60 Xanax 2mg (which doubled the dose), as well an increase to 
200 oxycodone 30mg which was further increased to 240 tablets in 
December, which was followed by an increase to 90 Xanax 2mg in January. 
Id.
    While in February, T.T. reported having doubled up on her 
medications and sought an early refill, Applicant did not grant her 
request. Id. However, in March, T.T. reported she was ``out of Xanax 
[and] asked for more,'' and Applicant obliged, increasing her 
prescription to 120 tablets. Id.
    Over the next several months, Applicant changed T.T.'s Lortab 
prescription to 90 oxycodone 15mg, and increased her Xanax prescription 
to 150 tablets (and also prescribed to her, both oxycodone 30mg and 
15mg, as well as Soma). Id. In October 2008, Applicant further 
increased her oxycodone 30mg prescription to 270 tablets, her oxycodone 
15mg prescription to 120 tablets, her Xanax 2mg prescription to 180 
tablets, and also prescribed 60 Soma. Id. Dr. Parran described this as 
``incredibly bizarre!'' Id. Yet at T.T.'s next visit, which occurred 
later that month on October 30th, Applicant further increased her 
prescriptions for oxycodone 15mg and Xanax to 150 and 200 tablets 
respectively, prompting Dr. Parran to opine that ``[t]here is no 
legitimate medical purpose for this prescribing.'' Id.
    Only two days later, T.T. reported that medications were stolen and 
Applicant gave her a prescription for 30 Xanax, which was followed only 
four days later with a prescription for 180 Xanax. Id. Later that 
month, T.T.'s sister called and asserted that T.T. was stealing her 
medications; the same day, T.T. called and claimed her medications had 
been stolen. Id. Moreover, in the middle of December, Applicant 
received a phone call from an apparent relative of T.T. stating that 
T.T. was getting addicted. Id. Yet at T.T.'s next visit, he again gave 
her a prescription for 180 Xanax, as well as increased her Soma 
prescription to 90 tablets. Id.
    Dr. Parran found that in February 2009, Applicant received a report 
that T.T. was ``seeing other doctors and selling her pills in the 
pharmacy parking lot.'' Id. He also found T.T.'s file included a March 
2009 fax from an addiction treatment program with a release for her 
records. Id.
    Dr. Parran further found that notwithstanding that T.T. had been 
undergoing treatment for addiction and had not seen Applicant for 
approximately three months, in June 2009, Applicant again saw her and 
prescribed both oxycodone 30mg and Xanax to her, prompting Dr. Parran 
to opine that ``[t]his is simply unbelievable.'' Id. Subsequently, in 
August, T.T. requested an early refill of her Xanax prescription, 
claiming that she had spilled the pills in the toilet. Id. While 
Applicant did not give her a refill, at her next office visit, he 
``wrote all'' of the prescriptions for her. Id. Dr. Parran thus 
concluded that ``the prescribing of controlled drugs to this patient 
was done in a manner that is inconsistent with the usual course of 
medical practice, and appears to have been done for other than 
legitimate medical purpose.'' Id.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
an application for a practitioner's registration may be denied ``if the 
Attorney General determines that the issuance of such registration . . 
. would be inconsistent with the public interest.'' 21 U.S.C. 823(f). 
In making the public interest determination, Congress directed that the 
following factors be considered:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id.
    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, 68 FR 15227, 15230 (2003). I ``may rely on any one or a 
combination of factors and may give each factor the weight . . . [I] 
deem[] appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id.; see also Kevin Dennis, 78 FR 
52787, 52794 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011).
    The Government has the burden of proving, by substantial evidence, 
that the requirements for a denial of an application, pursuant to 21 
U.S.C. Sec.  823(f), are met. 21 CFR 1301.44(e). This is so even in a 
non-contested case. Gabriel Sanchez, 78 FR 59060, 59063 (2013). Having 
considered all of the factors, I conclude that the Government's 
evidence with respect to factors two and four establishes, prima facie, 
that the issuance of a DEA certificate of registration to Applicant 
``would be inconsistent with the public interest.'' See 21 U.S.C. 
823(f).\14\
---------------------------------------------------------------------------

    \14\ The Attorney General has delegated this authority to the 
Administrator. See 28 CFR 0.100(b).
---------------------------------------------------------------------------

Factor One: Recommendation of the Appropriate State Licensing Board

    At the outset, it should be noted that the Board has not made a 
formal recommendation as to what action the Agency should take in this 
matter. However, ``DEA precedents have typically taken a broader view 
as to the scope of this factor.'' Tony T. Bui, M.D., 75 FR 49979, 49986 
(2010).
    The Government argues that the Florida Board of Medicine has found 
that Applicant ``prescribed controlled substances excessively and/or 
inappropriately'' to two patients (J.D. and L.S.) and that his 
``license was suspended.'' Request for Final Agency Action, at 6. The 
Government further argues that the Board's findings ``cannot be 
collaterally attacked in a DEA proceeding'' and that while his license 
has since been reinstated, this is not dispositive of the public 
interest inquiry.'' Id. at 7.
    It is well settled that while the possession of state authority to 
dispense controlled substance is a prerequisite for obtaining (and 
maintaining a registration), the possession of such authority is not 
dispositive of the public interest inquiry. See Jayam Krishna-Iyer, 74 
FR 459, 461 (2009) (quoting Mortimer B. Levin, 55 FR 8209, 8210 
(1990)). Thus, while Applicant currently holds an active medical 
license with the State, the Controlled Substances Act requires that the 
Agency make an independent determination from that made by the Florida 
Medical Board as to whether

[[Page 4970]]

granting controlled substance privileges to him would be in the public 
interest. See id.
    That being said, I do not rely on the findings of the Florida 
Medical Board regarding Applicant's prescribing of controlled 
substances to the two patients. While the state proceedings resulted in 
the assessment of substantial fines and costs, a suspension until he 
appeared before the Board's probation committee, and other conditions 
including that he take three courses, Applicant ``neither admit[ted] 
nor denie[d] the allegations of fact contained in the Administrative 
Complaint[s].'' GX 2, at 18. Moreover, there was no hearing in the 
matter, and while DEA has held that the findings of fact and legal 
conclusions that are made pursuant to a consent agreement or a 
stipulated settlement may be entitled to preclusive effect in an Agency 
proceeding, see David A. Ruben, 78 FR 38363, 38365 (2013),\15\ the 
settlement agreement between Applicant and the Board says nothing about 
whether Applicant would be estopped from challenging the findings in a 
subsequent proceeding brought by the Board (or other another state 
agency) against him. See id. at 38366-67 (giving preclusive effect to 
findings of state consent agreement which provided that physician could 
not ``contest the validity of the Findings of Fact . . . contained in 
the [o]rder in any present or future administrative proceedings before 
the Board,'' in a proceeding before ``any other state agency'' of the 
same State, and physician agreed not to challenge any portion of the 
order in state or federal court).\16\ Here, while Applicant agreed that 
he could not seek judicial review of the Agreement, the Government does 
not cite to any authority of the Florida courts holding that settlement 
agreements that contain similar wording as that in Applicant's, are 
entitled to preclusive effect. See also id. (noting that state courts 
gave preclusive effect to findings made in consent agreements).
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    \15\ See University of Tenn. v. Elliot, 478 U.S. 788, 797-98 
(1986) (``When an administrative agency is acting in a judicial 
capacity and resolves disputed issues of fact properly before it 
which the parties have had an adequate opportunity to litigate, the 
courts have not hesitated to apply res judicata[.]'') (internal 
quotations and citations omitted); Robert L. Dougherty, M.D., 76 FR 
16823, 16830 (2011).
    \16\ Of these clauses, only the latter is contained in 
Applicant's settlement agreement.
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    Accordingly, I do not rely on the Board's findings of fact and 
legal conclusions. Nor is there any need to do so given the extensive 
evidence which supports the conclusion that Applicant has repeatedly 
violated the CSA's prescription requirement.\17\
---------------------------------------------------------------------------

    \17\ I also place no weight on the findings of fact and legal 
conclusions of the 2001 Board Order. Those findings do not establish 
that Applicant committed any violations of controlled substance laws 
and regulations but only that he committed malpractice. As the 
Administrator has explained, ``the CSA and its case law `amply 
support the conclusion that Congress regulates medical practice 
insofar as it bars doctors from using their prescription-writing 
powers as a means to engage in illicit drug dealing and trafficking 
as conventionally understood. Beyond this, however, the statute 
manifests no intent to regulate the practice of medicine generally,' 
an authority which remains vested in the States.'' Bui, 75 FR 49988 
(quoting Gonzales v. Oregon, 546 U.S. 243, 270 (2006)).
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Factors Two and Four: Applicant's Experience in Dispensing Controlled 
Substances and Record of Compliance With Laws Relating to Controlled 
Substances

    To effectuate the dual goals of conquering drug abuse and 
controlling both the 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 the closed regulatory system, a controlled substance may 
only be dispensed upon a lawful prescription issued by a practitioner. 
Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011).
    Fundamental to the CSA's scheme is the Agency's longstanding 
regulation, which states that ``[a] prescription for a controlled 
substance [is not] effective [unless it is] issued for a legitimate 
medical purpose by an individual practitioner acting in the usual 
course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``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 issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' Id.
    As the Supreme Court has explained, ``the prescription requirement 
. . . ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), 
cert. denied, 574 U.S. 1113 (2006) (stating that the prescription 
requirement likewise stands as a proscription against doctors acting 
not ``as a healer[,] but as a seller of wares.'').
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a legitimate doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Paul H. Volkman, 73 
FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th 
Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence 
established that the physician exceeded the bounds of professional 
practice, when ``he gave inadequate physical examinations or none at 
all,'' ``ignored the results of the tests he did make,'' and ``took no 
precautions against . . . misuse and diversion''). The CSA, however, 
generally looks to state law to determine whether a doctor and patient 
have established a legitimate doctor-patient relationship. Volkman, 73 
FR 30642.
    In Florida, a physician is barred from ``prescribing, dispensing, 
administering, mixing, or otherwise preparing . . . any controlled 
substance, other than in the course of the physician's professional 
practice.'' Fla. Stat. Sec.  458.331(q). The statute further explains 
that ``prescribing, dispensing . . . or otherwise preparing . . . 
controlled 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.'' Id.; 
see also Fla. Stat. Sec.  893.05(1) (``A practitioner, in good faith 
and in the course of his or her professional practice only, may 
prescribe . . . a controlled substance[.]''). As such, when a physician 
acts outside the course of professional practice, he is shirking his 
``responsibility to dispense . . . controlled substances only in the 
course of [his] professional practice.'' Florida v. Toth, Case No. 80-
2309, 1981 WL 180354, at *8 (Fla. Div. of Admin. Hearings Mar. 31, 
1981).
    Moreover, prior to the conduct at issue here, the Florida Board of 
Medicine promulgated Standards for the Use of Controlled Substances for 
the Treatment of Pain, which were codified in the Florida 
Administrative Code. See Fla. Admin. Code R.64B8-9.013 (2003).\18\ 
Therein, the Board explained

[[Page 4971]]

that the ``standards are not intended to define complete or best 
practice, but rather to communicate what the Board considers to be 
within the boundaries of professional practice.'' Id. R.64B8-
9.013(1)(g).
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    \18\ The standards were first adopted on December 21, 1999, and 
subsequently amended on November 10, 2002 and October 19, 2003. New 
standards were promulgated on October 17, 2010; these standards 
substituted the word ``shall'' and thus made mandatory various 
provisions which had formerly used the word ``should'' in setting 
forth the scope of a physician's obligations.
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    Of particular significance here are the Board's standards 
pertaining to the ``Evaluation of the Patient'' and ``Medical 
Records.'' With respect to the former, the Board's standard provided 
that:

    A complete 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 substances.

Id. R.64B8-9.013(3)(a). And with respect to Medical Records, the 
Board's standard provided that:

    The physician is required to keep accurate and complete records 
to include, but not be 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. [D]iscussion of risks and benefits;
    6. Treatments;
    7. Medications (including date, type, dosage, and quantity 
prescribed);
    8. Instructions and agreements; and
    9. Periodic reviews. Records must remain current and be 
maintained in an accessible manner and readily available for review.

Id. R.64B8-9.013(3)(f).
    Here, there is substantial evidence to support the conclusion that 
on multiple occasions, Applicant acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose when he 
prescribed controlled substances. 21 CFR 1306.04(a). The evidence shows 
that notwithstanding that the Florida Board's standards clearly 
required that he perform a patient history and physical examination 
before prescribing to CS1, he did not ask the CS any questions about 
her medical condition nor performed a physical examination. Yet, he 
issued her prescriptions for 60 tablets of OxyContin (sch. II), 90 
tablets of Lorcet 10/650 (sch. III) and 90 tablets of Xanax 
(alprazolam, sch. IV), as well as carisoprodol.\19\ I thus conclude 
that Applicant violated 21 CFR 1306.04(a) in prescribing OxyContin, 
Lorcet and Xanax to CS1.
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    \19\ At the time, carisoprodol was not a controlled substance 
under federal law. However, in 2011, carisoprodol was placed in 
schedule IV, based, in part, on its abuse as part of cocktail of 
other controlled substances which included narcotics such as 
oxycodone or hydrocodone, and benzodiazepines, such as Valium 
(diazepam) and Xanax (alprazolam). See Schedules of Controlled 
Substances, Placement of Carisoprodol Into Schedule IV, 76 FR 77330 
(2011).
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    With respect to CS2, it is acknowledged that the evidence showed 
that he complained of pain and that Applicant performed a brief 
physical exam at his first visit. Moreover, there is no evidence 
establishing that under the standards of professional practice, the 
examination was inadequate. Nor is there any evidence that under the 
standards of professional practice, Applicant was required to perform a 
physical exam at CS2's subsequent visits.
    That being said, at CS2's second visit, Applicant made no inquiry 
into CS2's purported pain condition and CS2 made no mention of being in 
pain. To the contrary, CS2 made clear that he was seeking the 
controlled substances to abuse them as he told Applicant that the drug 
that was prescribed at the previous visit ``[m]ade [him] feel really 
good'' and that he had ``com[e] to see if [he] could get something a 
little stronger this time.'' After Applicant asked the CS if he wanted 
something ``stronger or just more'' of what he had gotten at the 
previous visit, the CS stated that he wanted something ``more 
stronger''; Applicant stated: ``Okay, no problem,'' after which the CS 
told Applicant that he was not doing ``any therapy'' and admitted that 
he was ``not into it.'' Applicant then gave the CS a prescription for 
120 oxycodone 15mg. As this conversation demonstrates, this was not a 
legitimate medical encounter between a doctor and his patient, but 
rather the negotiation of a drug deal, and thus, I hold that Applicant 
violated 21 CFR 1306.04(a) when he issued the prescription.
    As for CS2's final visit during which the recording device 
malfunctioned, according to the Sergeant, the CS related in the post-
operation debriefing that he told Applicant that he ``was no longer in 
pain,'' that ``he just liked how the pain medication made him feel,'' 
and that he wanted something stronger than oxycodone 15mg, which was 
what he had received at the previous visit. The CS also told the 
Sergeant that he received a prescription for oxycodone 30mg, which is 
corroborated by a copy of the prescription.
    Notwithstanding that the CS's statements are hearsay and unsworn, I 
find that they are reliable and entitled to weight given that several 
other of the CS's hearsay statements were corroborated by other 
evidence. More specifically, the CS's statement to the Sergeant 
regarding the scope of the physical exam which was performed by 
Applicant at the May 30, 2006 visit and the absence of any such exam at 
the June 27, 2006 visit were corroborated by the recordings. So too, 
the CS's statement that he received a prescription for oxycodone 30mg 
was corroborated by the prescription itself. In addition, the 
recordings of the other visits portray a physician who showed no real 
interest in determining whether his patients actually had medical 
conditions which warranted treatment. I therefore find that Applicant 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed 90 tablets of oxycodone 
30mg to the CS. See 21 CFR 1306.04(a).
    As for the September 18, 2008 visit, the recording establishes that 
Applicant had previously seen CS3 at least two years earlier and that 
he did not perform a physical exam of her. That being said, CS3 did 
complain of pain (``I just can't move'' and ``I'm just so 
uncomfortable'') and, while Florida's regulation requires a physical 
exam as part of the initial evaluation of a patient, the Government 
adduced no expert testimony as to whether it was within the usual 
course of professional practice to prescribe a controlled substance 
without performing a new physical exam.\20\ I therefore find that the 
Government has not proved that Applicant violated the prescription 
requirement when he prescribed 180 tablets of Percocet 10/325mg to CS3 
at this visit.
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    \20\ Nor do we know if Applicant performed at physical exam at 
the previous visit. That being said, it was the Government's burden 
to produce evidence that Applicant had not performed a physical exam 
at that visit.
---------------------------------------------------------------------------

    As for CS3's visit of October 16, 2008, the evidence shows that she 
asked Applicant if he could ``give [her] a little extra this time.'' 
Applicant, however, never asked CS3 why she wanted or needed more 
medication. Moreover, later in the encounter, CS3 told Applicant that 
she had a friend who wanted to see him and that she had ``shared a 
little bit [of] her medications'' with him, and that she did not ``know 
if this was the right thing to do.'' While Applicant told CS3 that she 
had broken the law and she was ``dealing drugs and he [her friend] was 
taking illegal medication'' because these ``are controlled 
substances,'' Applicant nonetheless gave her a new prescription, and 
increased the quantity

[[Page 4972]]

to 210 tablets of Percocet 10/325. Notably, at no time during this 
visit did Applicant ask CS3 any questions about her pain condition, how 
it affected her ability to function, and whether the medication was 
effective. Accordingly, I conclude that Applicant acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose when he issued this prescription to CS3. 21 CFR 1306.04(a).
    As for CS3's final visit, while there is evidence that Applicant 
further increased her prescription to 240 tablets, the recording device 
failed. While in her affidavit, the DI stated that during the 
debriefing, the CS said that Applicant did not perform a physical exam 
and only took her weight and blood pressure, here again, there is no 
evidence as to whether, under the standards of medical practice, 
Applicant was require to perform a physical exam and the scope of an 
appropriate exam. Nor is there any other evidence as to whether 
Applicant asked the CS whether she had pain, how the pain affected her 
ability to function, and how the medication was working. 
Notwithstanding my conclusion that the prescription issued at CS3's 
previous visit violated federal law, because the Government has the 
burden of proof, I conclude that it has not produced substantial 
evidence to support a finding that Applicant acted outside of the usual 
course of professional practice and lacked a legitimate medical purpose 
when he issued this prescription.
    As for CS4's January 2009 visit, the recording of the visit 
suggests that the CS had previously seen Applicant. The Government, 
however, produced no evidence as to when this previous visit occurred 
(or that there had been no such visit) and whether Applicant had 
performed a physical exam at this visit.
    To be sure, the recording establishes that Applicant did not 
perform a physical exam at the CS's January 2009 visit. However, here 
again, there is no evidence as to whether, under the standards of 
medical practice, a physical exam was required at this visit. Nor is 
there substantial evidence that, under the standards of medical 
practice, Applicant's evaluation was inadequate. Finally, the CS's 
statement that ``[m]y pain is getting better . . . and that [i.e., the 
oxycodone] makes it real good'' does not conclusively establish that 
the CS was seeking controlled substances for the purpose of abusing 
them or diverting them to others. Accordingly, I conclude that the 
Government has failed to prove that Applicant acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose when he prescribed oxycodone to CS4.
    By contrast, the Government did produce substantial evidence--in 
the form of the Expert's report--that Applicant acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose when he prescribed controlled substances to numerous patients. 
As found above, the Government's Expert reviewed the medical records of 
over one hundred and fifteen of Applicant's patients and found numerous 
instances in which Applicant acted outside of the usual course of 
professional practice and lacked a legitimate medical purpose in 
prescribing controlled substances. GX 6, at 1.
    As support for his conclusion, Dr. Parran identified several 
``general'' and ``alarming'' characteristics of Applicant's 
``prescribing behaviors.'' More specifically, he found that: (1) 
``there [was] virtually always a very scant initial history and 
typically no documented evidence of a sufficient physical exam done on 
patients'' in the records; (2) there was a remarkable similarity in how 
Applicant treated each patient, suggesting a lack of individualized 
treatment; (3) there was typically no note in the patient chart to 
explain why Applicant started, increased, or changed a drug regimen; 
(4) there were very few, if any, referrals to alternative treatments 
(i.e., physical therapy) and specialists (i.e., psychiatry, 
rheumatology, neurology, orthopedics and neurosurgery); and (5) 
Applicant routinely ``provide[d] on-going supplies of multiple 
controlled substances in an escalating pattern, typically culminating 
in quite high doses, in potentially dangerous combinations.'' GX 7, at 
1-2. Dr. Parran thus opined that:

    [Applicant's] pattern of relentlessly prescribing controlled 
drugs, with insufficient history and physical . . . and no clinical 
reasoning evident in progress notes . . . what-so-ever, without 
initiating a clinical work-up or demonstrating evidence of an effort 
to obtain prior records, and in the face of noncompliance and often 
out of control behavior on the part of patients, is not consistent 
with the usual course of medical practice and constitutes 
prescribing of controlled drugs for other than [a] legitimate 
medical purpose.

Id. at 2.
    Dr. Parran's conclusions are fully supported by the more detailed 
discussion he provided of Applicant's prescribing to various patients 
including K.B., D.B., J.H., A.C., S.H., D.F., and T.T., as well as 
others. As these findings show, Applicant repeatedly prescribed highly 
abused (and multiple) controlled substances including schedule II and 
III narcotics, as well as benzodiazepines to the patients, without 
doing a physical exam or doing an inadequate exam and having obtained 
little to no history; failed to obtain prior records; failed to refer 
patients to specialists; repeatedly increased both the quantity and 
strengths of medications or prescribed additional medications without 
any justification and frequently did so while noting that previous 
prescriptions were ``working good'' or the patient was doing ``better'' 
or ``fine''; prescribed large doses of controlled substances to 
patients even when presented with evidence that the patients were not 
currently on medications or had recently been in detoxification 
programs; prescribed controlled substances even in the face of evidence 
that the patients were doctor shopping, selling pills, or engaged in 
various scams (such as claiming that their medications were stolen or 
had been dropped into the toilet); and ignored evidence that patients 
did not go through withdrawal even when they reported having been out 
of drugs for several days.
    As these findings (as well as the recordings of several of the 
undercover visits) demonstrate, Applicant was not engaged in the 
legitimate practice of medicine with respect to many of his patients, 
but was engaged in outright drug dealing. See Jack A, Danton, 76 FR 
60900, 60917 (2011). I therefore find that the Government's evidence 
with respect to factors two and four establishes that the issuance of a 
new registration to Applicant ``would be inconsistent with the public 
interest.'' \21\ 21 U.S.C. 823(f). See also Eugene H.

[[Page 4973]]

Tapia, M.D., 52 FR 30458, 30459 (1987) (considering evidence that a 
physician did not perform physical exams and issued medically 
unnecessary prescriptions under factor two); Thomas Parker Elliott, 
D.O., 52 FR 36312, 36313 (1987) (adopting ALJ's conclusion that 
physician's ``experience in the handling [of] controlled substances 
clearly warrants finding that his continued registration is 
inconsistent with the public interest,'' based on the physician's 
having ``prescribed enormous quantities of highly addictive drugs to 
[ten] individuals'' without adequate medical justification).
---------------------------------------------------------------------------

    \21\ In its request for Final Agency Action, the Government 
alleges that Applicant lacked candor during the 2009 interview and 
that this conduct should be considered under factor five. While the 
Government cites to three pages of the interview transcript as 
support for its contention, it does not identify the specific 
questions posed by the Investigators to which it contends Applicant 
provided answers that lacked candor. Req. for Final Agency Action, 
at 9 (citing GX 5, at 38-39, 50). Indeed, many of the remarks of the 
various law enforcement personnel on these pages are not even 
properly characterized as questions. Thus, while ``[c]andor during 
DEA investigations properly is considered by the DEA to be an 
important factor when assessing whether a . . . registration is 
consistent with the public interest,'' Hoxie v. DEA, 419 F.3d 477, 
483 (6th Cir. 2005), because the Government does not identify the 
specific questions and false answers, I decline to make any findings 
on the issue.
     That being said, such findings are not necessary to support the 
sanction I have decided to impose, given the unrefuted evidence that 
Applicant diverted controlled substances and the lack of any 
evidence that he acknowledges his misconduct. There being no 
evidence in the record that Applicant has accepted responsibility 
for his actions, Applicant has failed to rebut the Government's 
prima facie showing that his registration would be ``inconsistent 
with the public interest.'' Medicine Shoppe, 73 FR 387 (citing 21 
U.S.C. 823(f)).
---------------------------------------------------------------------------

    Under agency precedent, ``where a registrant [or applicant] has 
committed acts inconsistent with the public interest, [he] must accept 
responsibility for his . . . actions and demonstrate that he . . . will 
not engage in future misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 463 
(2009); see also Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008). 
Here, because Applicant waived his right to a hearing (as well as his 
right to submit a written statement in lieu of a hearing), GX 4, at 2, 
the only evidence in the record to refute the conclusion that his 
continued registration is ``inconsistent with the public interest'' is 
that he apparently completed the courses required by the Florida Board 
of Medicine as evidenced by the fact that his medical license remains 
current and active.
    There is, however, no evidence that Applicant acknowledges his 
misconduct, which is egregious, and accepts responsibility for it. 
Indeed, the Expert's report identifies dozens of patients (beyond the 
seven specifically discussed above) to whom Applicant diverted 
controlled substances. Accordingly, Applicant's application will be 
denied.\22\ See Krishna-Iyer, 74 FR 464 (``[E]ven where the Agency's 
proof establishes that a practitioner has committed only a few acts of 
diversion, this Agency will not grant [an application for] registration 
unless he accepts responsibility for his misconduct.''); see also 
MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 2011) (sustaining agency 
order revoking practitioner's registration based on proof physician 
knowingly diverted drugs to two patients).
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    \22\ As found above, because Applicant did not submit his 
renewal application at least 45 days before the expiration of his 
registration, and had been served previously with the Order to Show 
Cause, pursuant to 21 CFR 1301.36(i), his registration expired on 
August 25, 2013. Had his registration not expired per the Agency's 
rule, I would have revoked it.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b) and 0.104, I order that the pending application of 
Ralph J. Chambers, M.D., for a DEA Certificate of Registration be, and 
it hereby is, denied. This Order is effective immediately.

    Dated: January 17, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-01797 Filed 1-29-14; 8:45 am]
BILLING CODE 4410-09-P