[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49956-49978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20211]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-28]


Dewey C. Mackay, M.D.; Revocation of Registration

    On February 26, 2009, I, the Deputy Administrator of the Drug 
Enforcement Administration (DEA), issued an Order to Show Cause and 
Immediate Suspension of Registration to Dewey C. MacKay, M.D. 
(Respondent), of Brigham City, Utah. The Show Cause Order proposed the 
revocation of Respondent's DEA Certificate of Registration, AM9742380, 
which authorizes him to dispense controlled substances as a 
practitioner, as well as the denial of any pending applications to 
renew or modify the registration, on the ground that his ``continued 
registration is inconsistent with the public interest, as that term is 
defined in 21 U.S.C. 823(f) and 824(a)(4).'' ALJ Ex. 1, at 1. The Order 
also immediately suspended Respondent's registration on the ground that 
his continued registration during the pendency of the proceeding 
``constitutes an imminent danger to public health and safety.'' Id.
    The Show Cause Order alleged that ``[f]rom June 2005 to the 
present,'' Respondent ``issued numerous purported prescriptions for 
controlled substances without a legitimate medical purpose and outside 
the usual course of professional practice.'' Id. at 1-2. As evidence of 
his allegedly ``unlawful prescribing practices,'' the Order alleged 
that: (1) On four occasions, M.R., a patient of his who cooperated with 
the DEA, visited Respondent and, while she ``did not exhibit any 
verifiable medical indication warranting the prescribing of controlled 
substances,'' Respondent ``issued prescriptions for controlled 
substances to her'' and did so even after

[[Page 49957]]

M.R. told him that ``she shared her controlled substances with another 
person''; (2) Respondent issued prescriptions for opioids ``to at least 
four patients after engaging in unwelcome and inappropriate sexual 
activity * * * and without conducting any type of reasonable physical 
evaluation,'' that ``this prescribing pattern indicates'' that he 
issued ``prescriptions for controlled substances in exchange for 
receiving sexual favors'' and that the prescriptions were ``without a 
legitimate medical purpose and outside the scope of professional 
practice''; (3) a ``qualified medical expert'' reviewed M.R.'s medical 
file and concluded that Respondent's ``evaluation of M.R. was 
inadequate to justify the prescribing of controlled substances for her 
conditions,'' and that the expert had also reviewed nine of 
Respondent's patient files ``selected at random'' and concluded that 
his ``actions encouraged the abuse of controlled substances and allowed 
their misuse''; (4) the same expert ``determined that, with respect to 
four patients who died while under [his] care, the controlled 
substances [Respondent] prescribed were present in their systems and 
contributed to their deaths'' and that ``there was no justification for 
[his] long-term prescribing of controlled substances to these 
individuals''; and (5) since the execution of a search warrant at his 
office on June 5, 2008, Respondent had ``continued to prescribe opioids 
in extraordinarily large amounts,'' which was ``consistent with 
[Respondent's] prior practice of prescribing controlled substances 
without a legitimate medical purpose and outside the usual course of 
professional conduct.'' Id. at 2.
    By letter of March 6, 2008, counsel for Respondent timely requested 
an expedited hearing in the matter, ALJ Ex. 2, at 1; and the matter was 
placed on the docket of the Agency's Administrative Law Judges (ALJ). 
Thereafter, Respondent objected to the Government's having scheduled 
the hearing to be held in Arlington, Virginia on April 28, 2009, on the 
ground that it would deny him Due Process; he also moved to have the 
venue of the hearing changed to Utah. ALJ Ex. 12. While the Government 
had initially argued against changing the location, ALJ Ex. 33, at 1; 
following Respondent's filing of his motion, it retreated from its 
earlier position and withdrew its objection to holding the hearing in 
Salt Lake City, Utah. ALJ Ex. 17. However, the ALJ denied Respondent's 
motion on the ground that he had failed to provide ``sufficient 
justification'' to change the location of the hearing. ALJ Ex. 18, at 
5. Thereafter, Respondent also moved for the ALJ to recuse himself on 
the ground that he had ``demonstrated partiality and bias against both 
[him] and [his] counsel'' based, in part, on his pre-hearing rulings 
and several exchanges which occurred during two conference calls. ALJ 
Ex. 19, at 7-8. On March 30, 2009, the ALJ denied both motions. ALJ Ex. 
18, at 2, 5-6; ALJ Ex. 20.
    Thereafter, on April 7, 2009, the United States District Court for 
the District of Utah set aside the Order of Immediate Suspension, and 
further ordered that the hearing be held in the District of Utah. ALJ 
Ex. 33, at 1. The hearing was then rescheduled for April 28-30, 2009. 
Id. at 2. The District Court also rejected Respondent's request for an 
Order that the ALJ recuse himself. ALJ Dec. at 2.
    Following additional procedures, the ALJ conducted a hearing in 
Salt Lake City, Utah, from April 28, 2009 through May 1, 2009. At the 
hearing, both parties elicited testimony and introduced documentary 
evidence for the record. The Government also introduced audio-
recordings into the record. Following the hearing, both parties 
submitted briefs detailing their proposed findings of fact, conclusions 
of law, and argument.
    On July 31, 2009, the ALJ issued his recommended decision (ALJ). 
With respect to the first of the five public interest factors, see 21 
U.S.C. 823(f), (the recommendation of the appropriate State licensing 
board or professional disciplinary authority), the ALJ found that the 
record contained no evidence of a recommendation of any such licensing 
board or disciplinary authority and thus concluded that this factor 
``does not weigh for or against a determination as to whether 
continuation of the Respondent's DEA certification is consistent with 
the public interest.'' ALJ at 94. As to the third factor (Respondent's 
conviction record under Federal or State laws relating to the 
manufacture, distribution or dispensing of controlled substances), the 
ALJ noted that the record ``contains no evidence that the Respondent 
has ever been convicted of any crime related to the manufacture, 
distribution, or dispensing of controlled substances'' and concluded 
that this ``weighs in the Respondent's favor.'' Id. at 96. The ALJ 
noted, however, that the ``probative value'' of this finding is 
``somewhat diminished by the myriad of considerations that are factored 
into a decision to initiate, pursue, and dispose of criminal 
proceedings by Federal, State, and local prosecution authorities.'' Id.
    The ALJ then considered together factors two (Respondent's 
experience in dispensing controlled substances), four (Respondent's 
compliance with applicable State, Federal or local laws relating to 
controlled substances), and five (such other conduct which may threaten 
the public health and safety). Id. More specifically, the ALJ concluded 
that Respondent violated numerous provisions of Utah State law.
    First, the ALJ concluded that Respondent met with K.D. and wrote 
her controlled substance prescriptions after ``touching her in 
inappropriate, intimate, even sexual ways,'' thereby violating Utah 
Code Ann. Sec.  58-1-501(2)(k), which makes sexual abuse and 
exploitation ``unprofessional conduct.'' Id. at 101. Next, with respect 
to patients K.D., M.R. and M.P., the ALJ concluded that Respondent 
``routinely'' violated Utah Code Ann. Sec.  58-1-501(2)(m)(i) in that 
he ``routinely issued prescriptions without first obtaining information 
`sufficient to establish a diagnosis, to identify conditions, and to 
identify contraindications to the proposed treatment.' '' Id. He 
further found that ``Respondent's recordkeeping was not merely sloppy 
or scant, [but that] the records reflect things that never happened, do 
not monitor medication efficacy, and do not comply with the 
documentation levels even minimally required by Utah Admin. Code R156-
37-602(1)\1\ and/or the Model Policy, which has been incorporated into 
Utah law by Utah Administrative Code R156-1-502.''\2\ Id. at 104.
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    \1\ This provision provides, in pertinent part:
    Records of * * * prescribing * * * controlled substances shall 
be kept according to State and Federal law. Prescribing 
practitioners shall keep records reflecting the examination, 
evaluation and treatment of all patients. Patient medical records 
shall accurately reflect the prescription or administration of 
controlled substances in the treatment of the patient, the purpose 
for which the controlled substance is utilized and information upon 
which the diagnosis is based.
    \2\ Under a regulation of the Utah Division of Occupation and 
Professional Licensing, it is ``unprofessional conduct'' for a 
``prescribing practitioner'' to ``fail[] * * * to follow the Model 
Policy for the Use of Controlled Substances for the Treatment of 
Pain, 2004, established by the Federation of State Medical Boards.'' 
Utah Admin. Code R156-1-502(6).
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    Next, with respect to K.D., the ALJ found that Respondent had 
continued to prescribe controlled substances to her ``after she 
confided her concerns that she felt she was addicted to prescription 
drugs and wanted treatment,'' and that doing so violated Utah's 
regulation which prohibits ``knowingly prescribing controlled 
substances to a drug-dependent person.'' Id. at 104-05 (citing Utah 
Admin. Code R156-37-502(6)). The ALJ also found that even if Respondent 
considered himself to be prescribing narcotics for maintenance

[[Page 49958]]

purposes to K.D., he violated 21 CFR 1306.07, as Respondent lacked the 
``requisite special registration'' to so prescribe controlled 
substances. Id. at 105.
    The ALJ further found that ``[b]ecause the controlled substance 
prescriptions that * * * Respondent wrote were not preceded by even 
cursory physical examinations or even the minimum level of treatment 
and progress information,'' he violated 21 CFR 1306.04(a). Id. Finally, 
the ALJ determined that ``[b]ecause * * * Respondent routinely ignored 
obvious indications of abuse of controlled substances by his patients 
and took no real steps to address that abuse,'' Respondent violated his 
``obligations to guard against and provide effective controls against 
the diversion of controlled substances in accordance with 21 CFR 
1301.71(a) and Utah Administrative Code R156-37-502(2).'' Id. The ALJ 
thus concluded that ``under the Fourth public interest factor, 
consideration of the Respondent's disregard of State and Federal laws 
related to controlled substances in the course of his controlled 
substance prescribing practices militates in favor of the revocation of 
his Certificate of Registration.'' Id.\3\
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    \3\ The ALJ also apparently considered this conduct relevant in 
assessing Respondent's experience in dispensing control substances 
(which it is) although he did not explicitly state as much.
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    As for the fifth factor, the ALJ indicated that ``Respondent's 
trading of physical intimacy for controlled substance prescriptions 
with K.D., the abysmal and misleading character of his patient-care 
documentation, the virtual ignoring of blatant indications of diversion 
exhibited by some of his patients, his practice of prescribing 
controlled substances without examining or even minimally questioning 
his patients beyond ascertaining which controlled substances they 
desired * * * are [all] practices that impact upon the public health 
and safety.'' Id. at 106. The ALJ also cited Respondent's repeated 
requests of K.D. during her undercover visits as to whether she was 
wearing a wire and working for DEA. Id. at 107. As he noted, ``these 
repeated inquiries'' not only ``reflect[] * * * Respondent's poor 
judgment and naivet[eacute],'' they also ``demonstrate consciousness of 
guilt.'' Id. Furthermore, the ALJ determined that ``Respondent's 
persistence in conducting his practice in this manner [in trying to 
ascertain whether the patient was working for DEA instead of asking the 
appropriate medical questions to formulate a basis for prescribing the 
controlled substances which he prescribed] reflects an astounding 
absence of any kind of remorse or acceptance of responsibility.'' Id. 
at 108.
    The ALJ also found that Respondent's ``unprofessional conduct'' in 
not following the documentation requirements imposed by the Model 
Policy ``constitutes sufficient justification, even standing alone, to 
support a revocation of the Respondent's DEA registration as contrary 
to the public interest.'' Id. at 108-09. Moreover, the ALJ further 
found that Respondent's failure ``to react to multiple `red flags' of 
drug abuse and/or misuse demonstrated by his patients'' violated Utah 
Administrative Code R156-37-502 by ```fail[ing] to maintain controls 
over controlled substances which would be considered by a prudent 
practitioner to be effective against diversion * * * of controlled 
substances.''' Id. at 109.
    The ALJ thus concluded that ``the Government ha[d] established that 
the Respondent has committed acts that are inconsistent with the public 
interest.'' Id. at 114. Because Respondent ``has not accepted 
responsibility for his actions, expressed remorse for his conduct at 
any level, or presented evidence that could reasonably support a 
finding that the Deputy Administrator should continue to entrust him 
with a registration,'' the ALJ recommended that I revoke Respondent's 
registration and deny any pending applications to renew his 
registration. Id.
    On August 24, 2009, Respondent filed Exceptions to the ALJ's 
decision. Therein, Respondent argues that the record lacks substantial 
evidence to support the allegations that nine patients were 
``improperly treated,'' that he engaged in ``sexual impropriety,'' and 
that his ``care caused the death of a patient.'' Resp. Exceptions, at 
2. Respondent also contends that ``the ALJ disregard[ed] reliable 
testimony of [Respondent's] witnesses and afford[ed] the Petitioner's 
(or `DEA') witnesses an unsupportable amount of deference,'' that he 
engaged in ``a one sided assessment of the evidence rather than 
weighing disputed evidence offered in response by [Respondent], and * * 
* ignore[d] evidence that [was] not disputed, that [was] supportive of 
[Respondent],'' and that the ``recommended decision [was] rife with 
bias and written in the tone of an advocate rather than an impartial 
ALJ.'' Id. at 2-3. Respondent further claims that the ALJ did not, in 
fact, ``weigh'' the statutory factors. Id. at 7-8.
    On August 25, 2009, the ALJ forwarded the record to me for final 
agency action. Having carefully reviewed the record as whole, as well 
as Respondent's Exceptions,\4\ I concur with the ALJ's ultimate 
conclusion that Respondent has committed acts which render his 
continued registration inconsistent with the public interest and that 
he has failed to provide evidence sufficient to establish why he can be 
entrusted with a registration. Accordingly, I will adopt the ALJ's 
recommendation, revoke Respondent's registration and deny any pending 
applications to renew his registration.
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    \4\ I have carefully considered Respondent's exceptions 
pertaining to the ALJ's evaluation of the evidence in making my 
factual findings.
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    However, before proceeding to make my factual findings, the record 
in this matter contains a motion to recuse the ALJ, which is 
accompanied by the affidavits of Respondent's two counsels. See ALJ Ex. 
19. Under 5 U.S.C. 556(b)(3), ``[o]n the filing in good faith of a 
timely and sufficient affidavit of personal bias or other 
disqualification of a presiding or participating employee, the agency 
shall determine the matter as a part of the record and decision in the 
case.''
    Respondent's motion is based largely on exchanges that occurred 
during what appears to have been a somewhat heated conference call, the 
ALJ's having rejected several of his motions, and the Government's 
alleged tainting of the ALJ by sending him a letter which references an 
allegation of sexual impropriety on Respondent's part. ALJ Ex. 19, at 
1-9; see also ALJ Ex. 10, at 1. I conclude, however, that Respondent's 
affidavits are insufficient to establish that the ALJ was personally 
biased against Respondent or his counsels.
    As for the ALJ's conduct of the conference call, the allegations 
that he cut off one of the lawyers and asked him if he had ever 
practiced administrative law (which, according to the ALJ, happened 
when he attempted to explain to Respondent's lawyers the limited scope 
of discovery in the proceeding, see ALJ at 3 n.3.), is hardly so far 
outside of the norms of judicial conduct as to overcome the presumption 
of impartiality that attaches to the ALJ's conduct of the proceeding. 
See Liteky v. United States, 510 U.S. 540, 555-556 (1994) (``Not 
establishing bias or partiality * * * are expressions of impatience, 
dissatisfaction, annoyance, and even anger, that are within the bounds 
of what imperfect men and women, even after having been confirmed as 
Federal judges sometimes display. A judge's ordinary efforts at 
courtroom administration--even a stern and short-tempered judge's 
ordinary

[[Page 49959]]

efforts at courtroom administration-remain immune.'').\5\
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    \5\ To make clear, having reviewed the transcript, there is no 
evidence that the ALJ conducted himself with anything other than the 
temperament which is expected of a judicial officer.
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    Nor is the contention made persuasive by the ALJ's having ruled 
against Respondent on several issues. As the Supreme Court has further 
explained, ``judicial rulings alone almost never constitute a valid 
basis for a bias or partiality motion.'' Id. at 555 (citing United 
States v. Grinnell Corp., 384 U.S. 563, 583 (1966)). Notably, 
Respondent did not challenge any of these rulings in his exceptions. 
Finally, the allegation that the ALJ was impermissibly tainted because 
the Government sent a letter to the ALJ seeking a subpoena which set 
forth that a patient had ``alleged that [he] subjected her to 
inappropriate sexual activity,'' ALJ Ex. 10, ignores that in every case 
an ALJ is required to read the Order to Show Cause and the allegations 
contained therein (as well as other documents such as pre-hearing 
statements which disclose what a potential witness may testify to). A 
judge, however, is presumptively able to distinguish between what is an 
allegation and what has been proved with evidence.
    I therefore hold that the ALJ properly denied Respondent's recusal 
motion. I further note that when Respondent sought injunctive relief on 
the same issue in the District Court, the Court denied the motion.

Findings of Fact

    Respondent currently holds DEA Certificate of Registration 
AM9742380, which authorizes him to dispense controlled substances in 
schedules II though V as a practitioner.\6\ ALJ Ex. 6, at 10. While 
Respondent's registration was to expire on January 31, 2008, on 
December 18, 2007, Respondent filed a renewal application. Because 
Respondent's renewal application was timely filed, in accordance with 
the Administrative Procedure Act, I find that Respondent's registration 
has remained in effect pending the issuance of this Decision and Final 
Order. See 5 U.S.C. 558(c).
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    \6\ In accordance with 5 U.S.C. 556(e), I have taken official 
notice of the registration records of the Agency pertaining to 
Respondent. In accordance with this provision and DEA's regulation, 
Respondent ``is entitled * * * to an opportunity to show the 
contrary'' by filing a motion for reconsideration within twenty (20) 
days of the date this order is served by being placed in the mail.
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    Respondent holds a physician's license issued by the State of Utah 
and is a board-certified orthopedic surgeon. RX 12. Sometime around 
2001, Respondent underwent cardiac bypass surgery, which apparently 
resulted in damage to his hand. Tr. 1307. Thereafter, Respondent 
gradually reduced the number of surgeries he performed, and in 2006, 
ceased performing surgeries altogether. Id. at 1308-09. As his surgical 
practice decreased, Respondent commenced seeing chronic pain patients, 
id., and by February 2007, eighty-five percent of his practice involved 
pain patients. Id. at 504, 1307.
    According to P.E., his former office manager, who had worked for 
him from March 1986 until February 2007, Respondent, as a pain 
management doctor, was seeing an average of 90 to 100 patients a day, 
and he would see the patients for three to five minutes each. Id. at 
506-07. See also id. at 1583 (testimony of Investigator that T.S., an 
employee of Respondent stated during an interview that Respondent ``saw 
between 85 and 90 patients per day'' and that he ``did not perform any 
physical examinations'' because he was a pain management doctor). By 
contrast, Dr. Perry Fine, who testified for Respondent as an expert in 
pain management, stated that in an eight-hour day (with a 30-minute 
lunch break), he could see ``maybe 24, 30 patients at the most.'' Id. 
at 782. P.E. further testified that it ``was not part of the routine 
procedure'' to take the patient's vital signs ``on each visit'' and 
that when there was ``a lull in the patient flow,'' Respondent would 
``pick up the charts and write the prescriptions before the patients 
arrived.'' Id. at 513; see also id. at 538 & 542 (testimony of former 
employee J.N.).
    DEA initiated an investigation of Respondent upon receiving 
information from the Box Elder Narcotics Strike Force, which had, in 
its own investigation, interviewed several individuals, conducted 
several undercover operations, and determined that Respondent was 
issuing unlawful controlled substance prescriptions. Id. at 940-41; see 
also 21 CFR 1306.04(a). In addition to interviewing several former 
patients of Respondent, DEA executed search warrants on or about June 
5, 2008, and on January 22, 2009, when it obtained various patient 
records. Tr. 1065. DEA also obtained the cooperation of two persons 
(M.R. and K.D.), who agreed to perform undercover visits with 
Respondent. Id. at 942, 944.
    The four undercover visits of M.R. occurred on October 9, November 
27, December 24, 2007 and January 29, 2008. The four undercover visits 
of K.D. occurred on November 3, November 24, December 1, and December 
22, 2008. In addition there was a recorded telephone conversation 
between K.D. and Respondent on November 20, 2008. During the course of 
the investigations, DEA Investigators obtained various patient records 
which were entered into evidence. Before proceeding to analyze the 
evidence pertaining to the specific patients, a review of the parties' 
evidence regarding what practices satisfy the longstanding requirement 
of Federal law that a prescription ``must be issued for a legitimate 
medical purpose by an individual practitioner acting in the usual 
course of his professional practice,'' 21 CFR 1306.04(a), is warranted.

The Parties Evidence Regarding the ``Usual Course of Professional 
Practice''

    Both parties put on extensive evidence on the issue of whether 
Respondent's prescriptions were issued in the usual course of 
professional practice and were for a legitimate medical purpose. Dr. 
Bradford D. Hare testified for the Government, and Dr. Perry Fine for 
Respondent.\7\ Both Drs. Hare and Fine also submitted written 
affidavits, regarding their reviews of the medical files of additional 
patients as well as the requirements for writing legitimate 
prescriptions for controlled substances under Federal and State law.
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    \7\ Dr. Lynn Webster, although qualified as an expert witness in 
medicine and pain medicine, did not present substantial testimony on 
pain medicine and testified only about the death of Respondent's 
patient D.W.
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    Dr. Bradford D. Hare, who has practiced medicine since 1975, is an 
anesthesiologist who is board-certified in pain medicine and has nearly 
thirty years of experience in the specialty of pain management. Tr. 34-
35. Dr. Hare holds both an M.D. and a Ph.D. in pharmacology, which he 
received from the University of Utah. Id. at 35; GX 23, at 1. At the 
time of the hearing, Dr. Hare practiced pain management at the 
University of Utah's Pain Treatment Center, where he is also the 
Director of the Fellowship Program at the University's Pain Management 
Center.\8\ Tr. 37; GX 23, at 2. He also holds the positions of Vice 
Chairman of Pain Management Services, Department of Anesthesiology, and 
Associate Professor of Anesthesiology and Pharmacology, both at the 
University of Utah. GX 23, at 2. Dr. Hare has published extensively in 
professional journals and in book chapters, and has made numerous 
presentations on pain management. GX 23, at 12-25. He also serves as a 
consultant to the Utah Division of

[[Page 49960]]

Professional Licensing (DOPL) and currently is a member of its 
Diversion Committee. Id. at 2-3. Dr. Hare was qualified as expert 
witness in pain management practice in Utah and in prescribing 
controlled substances in pain management practice. Id. at 40-41.
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    \8\ Dr. Hare continues to see patients two days a week and also 
teaches on the clinical staff of the University of Utah Operating 
Room Anesthesiology Staff. GX 23, at 5; Tr. 37.
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    Dr. Hare testified that Utah has adopted the Federation of State 
Medical Boards May 2004 Model Policy for the Use of Controlled 
Substances for the Treatment of Pain (hereinafter, Model Policy), the 
essential provisions of which are set forth below.\9\ Dr. Hare 
testified that in the usual course of professional practice, prior to 
prescribing a controlled substance for treating pain, a patient 
presents a medical complaint which the physician then evaluates. Id. at 
43-44. According to Dr. Hare, the evaluation and proper diagnosis 
requires both taking a medical history and performing a physical 
examination. Id. at 44.
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    \9\ The Model Policy states that:
    The Board will consider prescribing * * * controlled substances 
for pain to be for a legitimate medical purpose if based on sound 
clinical judgment. All such prescribing must be based on clear 
documentation of unrelieved pain. To be within the usual course of 
professional practice, a physician-patient relationship must exist 
and the prescribing should be based on a diagnosis and documentation 
of unrelieved pain.
    GX 9, at 3. The Model Policy then states that ``[t]he Board will 
judge the validity of the physician's treatment of the patient based 
on available documentation, rather than solely on the quantity and 
duration of medication administration.'' Id.
    With respect to evaluation of a patient, the Model Policy 
provides that:
    A medical history and physical examination must be obtained, 
evaluated, 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 pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.
    Id.
    As for the physician's treatment plan, the Model Policy states:
    The written treatment plan should state objectives that will be 
used to determine treatment success, such as pain relief and 
improved physical and psychosocial function, and should indicate if 
any further diagnostic evaluations or other treatments are planned. 
After treatment begins, the physician should adjust drug therapy to 
the individual medical needs of each patient. Other treatment 
modalities or a rehabilitation program may be necessary depending on 
the etiology of the pain and the extent to which the pain is 
associated with physical and psychosocial impairment.
    Id. at 4.
    The Model Policy also states that ``[t]he physician should 
periodically review the course of pain treatment and any new 
information about the etiology of the pain or the patient's state of 
health.'' Id. Continuing, the Model Policy states that ``[o]bjective 
evidence of improved or diminished function should be monitored * * 
*. If the patient's progress is unsatisfactory, the physician should 
assess the appropriateness of continued use of the current treatment 
plan and consider the use of other therapeutic modalities.'' Id.
    Finally, the Model Policy states that ``[t]he physician should 
keep accurate and complete records to include[:] 1. the medical 
history and physical examination, 2. diagnostic, therapeutic and 
laboratory results, 3. evaluations and consultations, 4. treatment 
objectives, 5. discussion of risks and benefits, 6. informed 
consent, 7. treatments, 8. medications (including date, type, dosage 
and quantity prescribed), 9. instructions and agreements and 10. 
periodic reviews.'' Id.
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    Taking the medical history includes asking the patient questions 
about what causes the pain, when did it occur, what treatments the 
patient has had, and what things alleviate or increase the pain. Id. 
The history should also include the patient's ``medication history'' 
and any ``history of substance abuse'' as required by the Model Policy. 
Id. at 54. Moreover, the patient's medical records should be obtained 
and reviewed. Id. at 46.
    Dr. Hare testified that the physical examination includes taking 
the patient's vital signs, blood pressure, temperature, and heart rate; 
listening to the patient's heart and lungs; performing a neurological 
examination, which ``involves checking reflexes * * * [and] the 
sensation particularly from one side of the body to the other'' and 
which merges into the musculoskeletal examination; and a 
musculoskeletal examination, which is used to determine the patient's 
strength and whether he/she has lost strength due to the complaint. Id. 
at 49-51. Dr. Hare further testified that even if a patient brings her 
medical records to the initial visit, and those records show that 
another physician has recently performed a physical exam, a physician 
should still conduct his own examination because he might make 
different findings than the previous physician or find that a new 
problem has developed. Id. at 52. However, the physician need not 
repeat diagnostic tests such as x-rays, MRIs and labs. Id. at 53.
    The diagnosis ``dictate[s] the type of treatment that [was] most 
appropriate.'' Id. at 44-45. For instance, there are various types of 
pain such a neuropathic, diabetic neuropathic, and musculoskeletal. Id. 
While ``there are some types of pain where opioid medications are a 
primary type of treatment[,] [t]here are other types of pain [such] as 
neuropathic pain * * * where one would not start with * * * opioids.'' 
Id. Moreover, musculoskeletal pain ``responds best to physical therapy 
* * * better than pain medicine.'' Id.
    Dr. Hare stressed that the Model Policy requires certain 
documentation for using controlled substances to treat pain with 
controlled substances, such as a proper medical history which includes 
a patient's history of substance abuse and information regarding prior 
medications. Id. at 54. Dr. Hare also testified that in the ``usual 
course of professional practice for pain management,'' a physician must 
document in the patient's medical record the steps discussed above 
``prior to issuing a controlled substance prescription.'' Id. at 55. He 
further testified that the ``usual course of professional practice'' 
includes establishing a treatment plan at the first visit, as well as 
asking the patient for a pain rating which is typically done using ``a 
zero to ten scale'' and which is repeated at subsequent visits. Id. at 
56-57.
    To evaluate the effectiveness and appropriateness of the treatment 
plan, at follow-up visits, the physician should ask whether the 
prescribed treatment, including any medications, helped, and whether 
the medication is causing side effects. Id. at 56-58. A physician 
should document the patient's response to these questions; if the 
physician decides to change the medication, the reason for the change 
should be documented. Id. at 58-59. Moreover, if the patient develops 
additional problems such as anxiety or the inability to sleep, the 
physician should document the problem, the treatment plan for the 
particular problem, and the reason for prescribing any additional drug. 
Id. at 59. While Dr. Hare testified that it is ``never appropriate 
under * * * any circumstances'' for a physician to touch a patient in a 
sexual manner, he then added that ``there could be the situations where 
there's a romantic involvement, but * * * just like in any other 
professional setting, if something like that would occur, it has to be 
put out in public.'' Id. at 60.
    Dr. Perry Fine is a physician who is board-certified in 
anesthesiology, and holds subspecialty certifications in pain 
management as well as hospice and palliative care. Id. at 614; RX 11, 
at 1. Dr. Fine is a professor of anesthesiology at the University of 
Utah and is also on the faculty of its Pain Research Center. Tr. 610. 
After completing a residency in anesthesiology at the University of 
Utah and a pain medicine fellowship at the University of Toronto, he 
joined the faculty of the University of Utah. Id. at 611. At the time 
of the hearing, Dr. Fine served on the Board of Directors of both the 
American Academy of Pain Medicine and the American Pain Foundation. Id. 
at 615. He has also published extensively on pain management and 
anesthesiology and has done numerous presentations. RX 11, at 9-57. Dr. 
Fine was also qualified

[[Page 49961]]

as an expert in pain management practice and prescribing. Tr. 611-12.
    Based on some of the records he reviewed, Dr. Fine maintained that 
Respondent's ``prescribing practices * * * were done in the usual and 
customary routine of a physician-patient relationship,'' id. at 622, 
whatever that means. Dr. Fine testified that, based on the evidence he 
reviewed, Respondent ``saw these patients * * * in a professional 
medical environment. He'd established a relationship with them, with 
recurrent visits and follow-up appointments, to evaluate the effective 
therapy, and to fulfill the obligations of prescribing controlled 
substances.'' Id. He also maintained that in several of the cases he 
reviewed, Respondent had consulted with other clinicians and that his 
``interpretation of that is that certainly met with approval within 
that local community standard.'' Id. at 624. Dr. Fine also testified 
that there is ``no'' test for pain, and that ``[t]here are really only 
two ways to evaluate whether a patient has pain or not. One is what 
they tell you, and the other is by behaviors.'' Id. at 627-28. Dr. Fine 
then explained that there are ``a number of tools we use to try and 
have patients rate their pain intensity,'' including ``verbal 
descriptor scales, numerical scales, [and] pictorial scales.'' Id. at 
628.\10\ He also maintained that what a patient tells a physician is 
``certainly a large component of what constitutes * * * at least on a 
first-run basis, what we would consider to be the most valid or 
reliable indicator of a patient's pain experience.'' Id.
---------------------------------------------------------------------------

    \10\ According to Dr. Fine, behaviors are used to assess pain in 
``pre-verbal children or mentally incapable children or adults, or 
in patients with advanced dementing illness who can't verbally 
report.'' Tr. 628.
---------------------------------------------------------------------------

    On cross-examination, Dr. Fine acknowledged that in the ``usual 
course of professional practice'' in pain management, ``the patient 
presents with * * * an essentially, a compelling case, based upon their 
history and physical findings, and whatever corroborating laboratory or 
imaging studies may be required, depending upon the patient's 
circumstances.'' Id. at 704. Moreover, ``within the course of their 
professional conduct,'' the physician must make ``a reasonable effort 
to * * * try and understand what risks there might be of misuse, abuse, 
diversion, addiction, tolerance, dependence, all the various 
pharmacological and sort of social responsibility issues that come with 
prescribing.'' Id. at 704-05. A treatment plan is then initiated which 
``is appropriate to the level of risk, and monitors that patient 
accordingly.'' Id. at 705.
    While Dr. Fine acknowledged that obtaining and documenting a 
patient's history is part of the usual course of professional practice 
for prescribing a controlled substance, he then maintained that ``in 
the usual course of medical education, the details of the pain history 
are not spelled out under law, so much as spelled out under best 
practices.'' Id. at 706. Continuing, he maintained that ``what we hope, 
of course, is that best practices become standard over the course of 
time'' but then claimed that ``for physicians'' in the middle of their 
careers, ``the opportunity to inculcate that level of skill or 
expertise simply has been lacking.'' Id. He then asserted that while 
``ideally, and under best practices,'' the ``usual course of 
professional practice'' requires that ``a medical history documents 
activities that [the patient reports] exacerbate or mitigate the 
pain,'' this is ``not necessarily so.'' Id. at 707. He then maintained 
that in a medical record, ``you would rarely see a line item that said 
what exacerbates the pain, what relieves the pain.'' Id. at 708.
    Continuing his answer, Dr. Fine then stated that physicians ``might 
describe the pain in other ways. They may give it a numerical score. 
They may just say the patient has pain; they may not even say that.'' 
Id. When then asked if the usual course of professional practice 
requires documenting the frequency and intensity of the reported pain, 
he responded, ``That's highly desirable. I teach that; I wish everybody 
did it * * * . It's simply not yet the standard of care.'' Id.
    As to Utah's adoption of the Model Policy as part of its 
regulations, Dr. Fine opined that ``I think it holds up a standard that 
would be desirable * * *. But very few physicians in the State would 
make that grade.'' Id. at 708-09. When asked whether the CSA's ``usual 
course of professional practice'' standard is an objective standard or 
what most physicians do, Dr. Fine answered:

    I think it's a desirable standard that's been put forth for very 
good reason, and supported by people who have expertise in pain 
medicine and want to both optimize the health and well-being of 
individual patients, and limit the * * * adverse consequence of 
problematic prescribing. But I daresay that in terms of in practice, 
how it's actualized, we could not call that standard in the way * * 
* [i]n a tort sense, what constitutes a standard of practice in the 
community, in the region, in the nation.

Id. at 709.

    However, when asked whether it would be in the usual course of 
professional practice ``if most physicians prescribe controlled 
substances without ever performing a physical exam,'' \11\ Dr. Fine 
answered that ``it is certainly a requirement, in terms of meeting 
reasonable standards of practice and standards of care, that some form 
of physical examination in proportion to or pursuant to the problem in 
front of the physician'' be done. Id. at 710-11. Dr. Fine then 
acknowledged that documenting the findings of a physical exam is part 
of the usual course of professional practice. Id. at 712. However, he 
then maintained that, notwithstanding the Model Policy's statement that 
``the effect of pain on physical and psychological function'' should be 
documented, this is only ``a highly desirable evaluative point. But not 
necessarily what most people do most of the time.'' Id. He then 
asserted that the ``usual course of professional practice'' standard 
does not ``get[] to that granular a level.'' Id. at 713.
---------------------------------------------------------------------------

    \11\ While this question is not very clear, Dr. Fine's answer 
was clear.
---------------------------------------------------------------------------

    When asked whether the ``usual course of professional practice'' 
required documenting a patient's history of substance abuse, Dr. Fine 
acknowledged that ``a history of substance abuse, active addiction, * * 
* chemical dependency, or known diversion is highly problematic'' and 
that there is ``a professional obligation to at least acknowledge 
[that] and have a plan that manages that.'' Id. at 713-14. He also 
acknowledged that the ``usual course of professional practice'' 
requires that a physician document in a patient's medical record one or 
more recognized medical indications for prescribing a controlled 
substance. Id. at 714.
    Dr. Fine further testified that a physician's recitation of a 
patient's complaint does not, by itself, constitute a diagnosis. Id. at 
725. While he then acknowledged that the usual course of professional 
practice requires that a physician document a diagnosis before 
prescribing a controlled substance, he then maintained that ``chronic 
pain is a legitimate diagnosis, for which there is no corroborative 
test other than what the patient says'' and that a physician ``is under 
absolutely no obligation to rule out every single potential cause of 
that problem.'' Id. In his affidavit, Dr. Fine further stated, ``[i]n 
large part, chronic pain diagnosis and treatment relies on a patient's 
self-reporting to the physician, and a doctor is absolutely entitled to 
rely on the patient's self-report of pain.'' RX 36, at 3. He also 
stated:

    It is my medical opinion that an experienced orthopaedic 
surgeon, such as [Respondent], who had seen a patient routinely over 
a period of time, would not necessarily need to conduct a 
comprehensive

[[Page 49962]]

physical examination or exhaustive work-up on every visit from the 
patient during the maintenance phase of treatment. Much of the 
diagnosis and treatment of chronic pain involves observational 
analysis by the physician including affect and pain related behavior 
during interview, watching the patients' [sic] gait, ability to sit 
down, ability to get up, ability to ambulate, etc.

Id.

    Dr. Fine also testified that with chronic pain, ``the diagnosis * * 
* oftentimes sound[s] like it came out of the patient's mouth.'' Tr. 
726. He maintained that this is justified because the ``International 
Classification of Diagnoses'' \12\ includes a code for ``arm pain'' 
even though ``there could be a hundred different causes of arm pain.'' 
Id. However, Dr. Fine then admitted that while ``arm pain'' could be a 
diagnosis, the physician would have to do a physical exam and, in his 
own words, ``before you do that, you take more history'' before 
prescribing a controlled substance. Id. at 726-27.
---------------------------------------------------------------------------

    \12\ Apparently, Dr. Fine was referring to the International 
Classification of Diseases, a publication of the World Health 
Organization.
---------------------------------------------------------------------------

    As to the usual course of professional practice for follow-up 
visits, Dr. Fine testified that in his own practice, he utilizes ``the 
four As'' to evaluate his patients and that this is ``what we teach'' 
to doctors around the country. Id. at 764-67. He further testified that 
these guidelines were published some four to five years earlier, id. at 
767, and they were now ``very commonly used.'' Id. at 764. ``The four 
As'' stand for ``analgesia, activities, adverse effect, [and] aberrant 
drug-related behaviors.'' Id. at 765. Dr. Fine clarified that 
``analgesia'' means ``analgesic efficacy''; that ``activities'' is 
``really about [a patient's] functional capacities''; that ``adverse 
effects'' are the effects caused by taking a controlled substance; and 
``aberrant behavior * * * would include anything that indicated misuse, 
abuse, drug-seeking behavior, * * * missed appointments * * * not 
following through with recommendations for physical therapy, behavioral 
therapy, [and] referrals.'' Id. at 765-66.
    When then asked whether it is ``the usual course of practice to 
fail to ask a patient about the efficacy of [an] opioid that is being 
prescribed over a period of four months, when [the physician] see[s] 
that patient each month?''; Dr. Fine answered: ``I can't speak to DEA 
requirements. I would say that it certainly would be a reasonable 
expectation in the course of conventional medical practice.'' Id. at 
768-69. He then acknowledged that during at least one of the follow-up 
visits, he would expect the physician to ask his patient if the 
medicine was helping, if her pain had worsened, if there were any 
activities which increased her pain, and if anything reduced her 
pain.\13\ Id. at 769.
---------------------------------------------------------------------------

    \13\ Dr. Fine testified that a physician is not obligated to see 
a patient every time that he writes a controlled substance 
prescription for her. Id. at 757.
---------------------------------------------------------------------------

    As to whether the ``usual course of professional practice'' 
included documenting a change to an existing controlled-substance 
prescription, Dr. Fine testified that ``[i]t's recommended'' and that 
``it would be a good practice.'' Id. at 722. However, he indicated that 
he would ``have trouble elevating [that] to an absolute requirement or 
necessity.'' Id.
    As to whether, when a patient presents a new pain complaint, the 
``usual course of professional practice'' requires obtaining the 
history of the injury and performing a physical exam on that area, Dr. 
Fine stated that ``[t]aking * * * a reasonable history and examination 
of any new problem would be considered a reasonable practice * * * 
[t]hat's necessary * * * to do a professional job as a doctor.'' Id. at 
724. However, the physician could ``refer the patient to someone else 
if [the condition is] beyond [his] expertise.'' Id. Here again, the 
evaluation should ``include a history, physical examination and 
laboratory tests or imaging studies,'' although Dr. Fine maintained 
that the ``obligation is not to do any of those * * * with any rigor 
outside of the necessity of making that which is necessary to make a 
reasonable diagnosis.'' Id. at 724-25.
    After acknowledging that it would be a ``sign of doctor-shopping'' 
if a pharmacy called and reported that a patient had filled ``the same 
exact prescription for Oxycontin from two other doctors in the last 
week,'' Dr. Fine stated that ``in our practice, we run'' DOPL (State 
prescription monitoring) reports ``as a matter of course,'' and do so 
even if there is no concern that a particular patient is seeking drugs 
from other physicians. Id. at 718-19. Dr. Fine testified that if a 
report showed that a patient is getting a controlled substance from 
multiple physicians, it ``may be'' an indication of doctor shopping, 
but the report ``doesn't signal a diagnosis or a conclusion in and of 
itself.'' Id. at 719. He later testified that checking the DOPL 
database when regularly prescribing large amounts of opioid analgesics 
would ``reflect best practices, but a minority, a small minority of 
practitioners * * * were using the database on a regular basis.'' Id. 
at 813.
    As to whether ``it is in [the] usual course of professional 
practice'' to discuss with a patient why she is seeking a refill before 
a prior prescription should have run out, Dr. Fine testified that a 
physician should ``inquire, to try and understand the motivation for 
that.'' Id. at 721. He also acknowledged that if a patient routinely 
seeks early refills with no explanation, this is a ``red flag'' for 
diversion or abuse. Id. He also acknowledged that if a physician 
obtains information that a patient is sharing controlled substances 
with others, the ``usual course of professional practice'' requires the 
physician to address the issue with the patient. Id. at 721-22.
    Dr. Fine agreed that the ``usual course of professional practice'' 
included, in the event of a documented history of overdose, that the 
physician should be ``taking certain steps to ensure that narcotics are 
not going to be * * * abused.'' Id. at 738. However, he also indicated 
that where the documented history indicated an overdose from methadone, 
it would not necessarily signal an addiction but could instead be 
simple misuse of medication or an accident: ``Again, it's a 
differential diagnosis.'' Id. at 737. He did agree that, if a physician 
knew of an overdose event and did not include it anywhere in the 
patient's medical record, this would not be in the ``usual course of 
professional practice.'' Id. at 745-46.
    The Government then asked Dr. Fine several hypothetical questions 
regarding the propriety of a physician prescribing to a patient with 
whom he engages in sexual relations. Dr. Fine testified that it is not 
within the ``usual course of professional practice'' for a physician to 
``invite a patient to a motel room for a topless massage,'' and after 
giving her a topless massage, to issue her a prescription for a 
controlled substance. Id. at 751. Although he initially answered ``no'' 
to the question whether it would be outside of the course of 
professional practice to go to the home of his patient, have her take 
off her clothes, digitally penetrate her vagina, and then issue her a 
controlled substance prescription, Dr. Fine eventually acknowledged 
that it is also not within the usual course of professional practice to 
continue to issue controlled substances to this person. Id. at 753.
    As a follow-up, the Government asked Dr. Fine whether, if it was 
true that Respondent had engaged in the above described acts, this 
would change his opinion as to whether Respondent's ``prescribing of 
controlled substances was in the usual course of professional 
practice?'' Id. at 762-63. While Dr. Fine

[[Page 49963]]

answered ``yes,'' he then stated: ``[b]eyond that, it would require far 
more granularities towards understanding the relationship.'' Id. at 
763. While Dr. Fine did not have ``much favorable'' to say ``about 
sexual impropriety,'' he then stated ``my personal opinions are not 
what matters. What matters is what really happened, and what the 
standards are as viewed by the Code of Ethical Conduct within the 
jurisdiction. And that would not be viewed as within the Code of 
Ethical Conduct.'' Id. Dr. Fine then acknowledged that he would change 
his opinion about the propriety of Respondent's prescribing of 
controlled substances to the person he had met at a hotel room and 
given the topless massage to (and on another occasion, digitally 
penetrated) if these events did, in fact, occur. Id. at 763-64.
    While the ALJ acknowledged his ``impressive credentials,'' the ALJ 
found that ``Dr. Fine's testimony was marked by a significant level of 
consistent equivocation regarding the appropriate standards.'' ALJ at 
83. More specifically, the ALJ observed that although Dr. Fine 
``acknowledg[ed] that State law and regulations inform[ed] his expert 
opinions, [his] testimony reflected a persistent, intentional 
reluctance to explain the correct standard of care and patient file 
documentation.'' Id. The ALJ further noted that while Dr. Fine was 
``repeatedly and directly queried about the correct practices in clear 
and concise terms, [he] consistently declined to provide direct 
answers.'' Id. at 87. Continuing, the ALJ explained that ``[f]or hours 
on the witness stand, Dr. Fine adhered to the logically inconsistent 
position that although he teaches correct standards of care and has 
even created mnemonic tools to assist practitioners in remembering 
them, these standards are * * * only some sort of best-practices 
guidelines based on his anecdotal awareness that some practitioners may 
fall below the proper standard.'' Id. Relatedly, the ALJ found that 
``[w]hen repeatedly queried about the proper standard [for] prescribing 
medications and documenting patient files, he persistently answered 
with variations upon a theme that there are substandard physicians 
practicing medicine who do not adhere to the correct standard.'' Id. at 
88-89.
    As the ALJ also noted, when asked to give an opinion (based on his 
review of the transcripts of the undercover visits) as to the propriety 
of Respondent's prescribing during these visits, Dr. Fine testified 
that he ``discounted them as not being particularly useful,'' and that 
without video recordings of the visit, he really could not compare what 
happened with ``what was documented [in the patient's record] as 
supposedly occurring on that date''; and he therefore could not draw 
any ``further conclusions.'' Id. at 878-79.
    As the ALJ found, Dr. Fine ``intentionally avoid[ed] direct answers 
that did not favor the Respondent's position.'' ALJ at 88. Moreover, 
the ALJ found that Dr. Fine's testimony was ``evasive'' and ``bias[ed] 
in favor of assuming the correctness of the actions of any doctor.'' 
Id. at 90. Having personally observed Dr. Fine's testimony, the ALJ 
findings are entitled to substantial deference. See Universal Camera 
Corp. v. NLRB, 340 U.S. 474 (1951). His conclusion that Dr. Fine's 
testimony should be given less weight than Dr. Hare's is well supported 
by the record. ALJ at 90.

The Patient Specific Evidence

 M.R.
    M.R. was a patient of Respondent from May 2004 through January 29, 
2008. GX 25, at 21, 34. At her initial visit, M.R., who was then 
twenty-three years old, presented with ``wrist pain.'' Id. at 34. Under 
the heading ``PHYSICAL EXAM,'' the record reads as follows: ``She has 
wrist pain. Neurologically intact.'' \14\ Id. According to the M.R.'s 
record, at this visit Respondent recommended that she use ibuprofen. 
Id.
---------------------------------------------------------------------------

    \14\ Respondent frequently employed the phrase ``neurologically 
intact'' in his patients' progress notes. According to Dr. Fine this 
means that Respondent could have performed a number of types of 
tests or alternatively made some rather casual observations to make 
this determination:
     In the most specific sense of the word, you would do a very 
detailed examination of the cranial nerves. Motor findings, for 
which there are many, many different tests. Anything from gross 
muscle-strength testing to electromyography.
    Sensory examination, which in fact may include multiple 
modalities. And coordination. Those would be the main * * * 
contributors.
     On the other--that's at the most micro-level. At the macro-
level, it simply might be the observation--for instance, my standing 
here observing you, and having interacted with you, saying to the 
best of my ability, you are neurologically intact.
    Tr. 732.
---------------------------------------------------------------------------

    At the hearing, M.R. testified that the wrist pain she reported was 
false and that she simply went to Respondent to obtain prescriptions 
for Lortab (a schedule III controlled substance which contains 
hydrocodone and acetaminophen, see 21 CFR 1308.13), which she had used 
recreationally ``off and on,'' because she liked ``the buzz'' and ``the 
high'' and wanted to ``have that high all the time.'' Tr. 272-74. M.R. 
had previously received Lortab prescriptions from a Dr. D. of Logan, 
Utah. Id. at 274. She apparently obtained prescriptions from Dr. D. and 
Respondent at the same time and was ultimately discharged from Dr. D.'s 
practice for doctor-shopping. Id.
    According to M.R., Respondent's initial physical examination of her 
consisted solely of his grabbing both of her wrists and holding them 
for about ten seconds, after which he handed her a prescription. Id. at 
272. M.R. indicated that Respondent did not ask about the severity of 
her pain or do any further examination such as a range-of-motion test 
or take an x-ray. Id. at 273. As noted above, the medical record for 
the visit indicates only that she would use ibuprofen, a non-controlled 
drug. GX 25, at 34. However, the medical record indicates that at 
M.R.'s second visit (June 23, 2004), Respondent diagnosed her as having 
``BILATERAL WRIST PAIN,'' with his physical examination finding that 
she had ``diffuse tenderness over the dorsum of the wrist'' and also 
``low back pain where she had an epidural.'' Id. On this date, although 
the current medication is listed as ibuprofen, the ``PLAN'' indicated 
that M.R. ``was given a refill of LORTAB 7.5 (60).'' Id. (emphasis 
added).
    M.R. testified that Respondent never discussed alternative 
treatments to the use of opioids, although the record of the initial 
visit and every visit thereafter, indicates that M.R. was to ``continue 
conservative treatment.'' Id. at 275; GX 25, at 21-34. M.R. also 
testified that, while she complained of wrist pain two or three times, 
she ``never really'' had to ``mention anything, just walk in and he'd 
give [me] a refill. He didn't ask.'' Tr. 277. M.R. further testified 
that a bit later she complained of back pain to Respondent, but this 
pain was also a feigned condition; M.R. also admitted that she was 
engaged in drug-seeking behavior. Id. at 277, 282. At the time, 
Respondent had her stand, bend over, and then stand up straight again, 
in a sequence that perhaps lasted ten seconds. Id. at 277. At the third 
visit, however, Respondent increased both the strength and quantity of 
the Lortab to 90 tablets of 10 mg. strength. GX 25, at 34.
    In M.R.'s medical record, bilateral wrist pain was reported as the 
diagnosis through September 20, 2006. GX 25, 26-34. In this period, 
Respondent prescribed Lortab, as well as both Xanax (alprazolam) and 
Valium (diazepam), which are schedule IV controlled substances (see 21 
CFR 1308.14(c)); the progress notes for the visits, however, contain no 
indication of a new medical complaint or diagnosis which supported 
prescribing either Xanax or Valium. See id. at 26-29.
    The entry for October 18, 2006, indicated that M.R.'s chief 
complaint

[[Page 49964]]

was ``bilateral wrist pain.'' Id. at 26. Under the Physical Exam 
heading, Respondent indicated only that ``she continues to have 
bilateral wrist pain and chronic low back pain. She is having low back 
pain.'' Id. Respondent indicated his ``IMPRESSION'' as both Bilateral 
Wrist Pain and Low Back Pain and issued a refill for Lortab 10 mg. He 
also prescribed Valium. Id. at 26. Respondent also indicated that he 
would get ``x-rays of the low back on her return.'' Id.
    The entry for the next appointment (November 20, 2006), replicated 
verbatim the entry for the previous visit with the exception of the 
statement regarding x-rays, which was not included. Id. However, there 
is no indication that x-rays were obtained. See id. The entry for 
M.R.'s December 20, 2006 visit was identical to that of November 20 
except for the notation that Respondent would no longer prescribe 
Valium. Id.
    The entry for the following visit, January 15, 2007, listed both 
wrist pain and low back pain under ``IMPRESSIONS,'' and under 
``PHYSICAL EXAM,'' noted that ``[s]he continues to have low back pain. 
She has diffuse tenderness L4 to S1. She is also having wrist pain.'' 
Id. at 25. However, the entry for M.R.'s next visit, February 12, 2007, 
completely omitted all mention of wrist pain. Id. Moreover, it repeated 
verbatim the notation under the physical exam section of January 15, 
adding only the adjective ``chronic'' before ``low back pain'' in both 
the diagnosis and physical exam sections. Id. The same complaint, 
physical exam, and impression are repeated for subsequent visits until 
March 29, 2007, when Respondent added to the physical exam findings 
that M.R. was ``neurologically intact'' and indicated as his impression 
both ``CHRONIC LOW BACK PAIN'' and ``DEGENERATIVE DISC DISEASE 
LUMBOSACRAL SPINE.'' Id. at 24. At this visit, Respondent also resumed 
prescribing Valium for M.R. Id.
    Between March 29, 2007, and January 29, 2008, M.R. saw Respondent 
eight times. The progress notes for these visits contain the same 
complaint, history, physical exam findings (although the last three 
visits also added ``degenerative disc disease'' to this section), 
impressions, and treatment plan (invariably 90 tablets of Lortab 10 
with one refill and ``she will continue conservative treatment'' and 
``will follow up as needed'').\15\ Id. at 21-24.
---------------------------------------------------------------------------

    \15\ Under the entry for M.R.'s last visit (January 29, 2008), 
there is a handwritten notation which states: ``5-25-08 I will no 
longer see pt. DCM'').
---------------------------------------------------------------------------

    M.R.'s medical record contains two signed Controlled Substance 
Contracts, one dated March 29 (with no year indicated) and another 
dated December 10, 2005. Id. at 4, 19. Although not identical, both 
contracts stated that controlled substances ``have a high potential for 
misuse, addiction, and are closely controlled by the State and Federal 
government.'' Id. Both contracts also included a paragraph stating that 
the patient understands that if she violates the contract, ``treatment 
may be terminated'' and that the violation ``may also be reported to 
other physicians, medical facilities and legal authorities.'' Id. The 
contracts also included a clause by which the patient promised to 
``help'' herself through ``better health habits such as exercise, 
weight control, minimal use of alcohol and to stop smoking.'' Id. The 
record also contained entries in the progress notes to the effect that 
Respondent asked M.R. if she was obtaining controlled substances from 
other physicians on three occasions, February 27 and April 3, 2006, and 
also February 12, 2007. Id. at 25, 28, 29.
    M.R. estimated that at 95% of her appointments with Respondent, he 
just issued her a prescription without any discussion of her medical 
condition. Tr. 286. With respect to her purported back condition, M.R. 
testified that ``I just told him that my back hurt.'' Id. at 279. When 
asked whether Respondent had physically examined her back, M.R. 
answered: ``One time he did have me stand up and then just bend over, 
and I was standing straight back up again. That was it. Nothing more 
than that ever.'' Id. M.R. further explained that the exam lasted 
``[n]o longer than 10 seconds. Long enough to stand up, bend over, and 
stand back up again.'' Id. Moreover, Respondent took neither x-rays nor 
ordered other diagnostic tests of her back. Id. at 280. Indeed, M.R. 
testified that she ``didn't really need to complain'' to Respondent 
about having back pain, ``because he didn't ask if you were in pain.'' 
Id.
    As for the Valium prescriptions, M.R. testified that ``[t]he first 
time I got them, I'm sure I asked for them. But after that he just 
asked if I needed a refill and I'd say yes and I'd get my refill. That 
was it.'' Tr. 285.
    At the time that M.R. agreed to wear a wire on undercover visits 
for DEA, she had been charged with six felony counts of obtaining 
prescriptions under false pretenses. Id. at 302-03. M.R. acknowledged 
that she had worn the wire hoping to reduce the charges, which were 
eventually dismissed. Id. at 291-92. The ALJ found M.R.'s testimony 
``credible insofar as it describes the manner in which Respondent 
interacted with her during their treatment relationship and during the 
times he prescribed controlled substances to her.'' ALJ at 13. Here 
again, the ALJ personally observed M.R. testify and was in the best 
position to observe her demeanor. Moreover, having reviewed the 
recordings and transcripts of M.R.'s undercover visits, I find that 
they support her credibility. Accordingly, I adopt the ALJ's 
credibility findings with respect to M.R.\16\
---------------------------------------------------------------------------

    \16\ In his exceptions, Respondent argues that I should reject 
M.R.'s testimony (and the ALJ's credibility finding with respect to 
her) because: (1) She violated her controlled substance contract in 
which she agreed not to seek drugs from other doctors, (2) ``she 
could not remember specifics from'' an undercover visit which had 
occurred only one year earlier but could remember whether he had 
performed physicals exams at visits which occurred four years 
previously, (3) that she had been charged with six felony counts, 
and that after she assisted the investigations, the charges were 
dismissed and that she ``has everything to gain by testifying for 
the DEA, and motive to falsely implicate'' him, and (4) that she 
admitted under oath that she lied to Respondent about being in pain 
in order to obtain narcotics. See Resp. Exceptions at 11-16.
    Respondent's contentions ignore that the ALJ observed M.R. 
testify and was thus able to observe her demeanor. In any event, his 
first and fourth reasons beg the question of what one would expect a 
drug-seeking patient to do. More importantly, as discussed in my 
legal conclusions, it is clear that at a certain point Respondent 
clearly knew that M.R. was not a legitimate patient and cannot claim 
to have been duped.
     As for the contention that she could not recall ``specifics''--
a reference to whether Respondent asked her a particular question at 
one of the undercover visits--that a witness does not remember every 
single aspect of a year-old conversation does not render her entire 
testimony incredible. Finally, as for the contention that M.R. had 
reason to lie about Respondent because she was facing six felony 
counts, similar arguments are made to the factfinder (whether judge 
or jury) in nearly every criminal case and appellate courts rarely 
find them reviewable, let alone persuasive. In addition, much of her 
testimony is supported by the transcripts of the undercover visits. 
I thus reject his exceptions to M.R.'s testimony.
---------------------------------------------------------------------------

M.R.'s Undercover Visits
    On October 9, 2007, M.R. made her first undercover visit to 
Respondent, and brought along a DEA undercover officer (UC) who used 
the cover name of ``Rebecca.'' See GX 10, at 10. The visit began with 
M.R. asking Respondent to ``see'' Rebecca. Id. Respondent said he would 
require a referral from Rebecca's ``regular doctor'' and that he would 
also require ``old records.'' Id. However, after declining to see her, 
he asked, ``what do you need to come in for?'' Id. at 10-11. The UC 
stated that a Dr. Stack had been giving her medications in May or June 
but that she ``can't get it from him anymore,'' that she couldn't 
``function without'' the medication, and that at present she has ``been 
just having to kinda rely on friends to help [her] out.'' Id. at 11. 
After the UC stated that she

[[Page 49965]]

had gotten Lortab and OxyContin from Dr. Stack, Respondent asked her 
whether she had insurance and whether she had a job. Id. Respondent 
then stated that because the UC did not ``fit the * * * rules,'' she 
was not his ``first choice'' as a patient. Id. Continuing, he stated 
that he was ``not a hundred percent opposed trying to help'' the UC and 
added that ``there's no way [the UC] can afford OxyContin'' without a 
job or insurance. Id. at 11-12. Respondent told the UC to get a job, 
``then give us a call, and we'll see if we can help.'' Id. at 12. A bit 
later he commented that without the UC having a job or insurance, it 
would be ``irresponsible'' for him to prescribe OxyContin. Id. at 12-
13.
    Immediately thereafter, the UC said, ``I do have money today. Could 
you do a Lortab for me today?'' Id. After doing an apparent double-
take, Respondent insisted that the UC needed to make an appointment, 
get a referral and bring her records before he could prescribe for her. 
Id.
    Although M.R. had no interaction with Respondent other than in her 
effort to refer Rebecca, she emerged from the appointment with a 
prescription for ninety Lortab 10mg. GX 14, at 1. Her medical record 
for that date indicates the Lortab prescription, with one refill. GX 
25, at 22. While the record also bears the previously noted refrain 
used by Respondent for his physical examination findings--``She has 
chronic low back pain. She has diffuse tenderness L4-S1. Neurologically 
intact''--nothing in the transcripts or recording indicates that 
Respondent conducted a physical examination of her back that would 
reveal tenderness. See id. Moreover, the recording and transcripts make 
clear that Respondent never asked about M.R.'s pain level, medical 
condition, side effects from the medication or whether M.R. was 
continuing with whatever ``conservative treatment'' he had noted in the 
numerous progress notes.\17\
---------------------------------------------------------------------------

    \17\ As his treatment ``PLAN,'' the record for this visit reads 
(as many entries do), that M.R. ``will continue conservative 
treatment'' and that she ``will follow up as needed.'' GX 25, at 22.
---------------------------------------------------------------------------

    At the second undercover visit (November 27, 2007), Respondent 
asked M.R., ``How are you today?'' GX 11, at 3. M.R. replied, ``Good. 
How are you?'' Id. Respondent did not inquire about M.R.'s pain, and 
there is no evidence that he performed a physical examination although 
he indicated having done so in M.R.'s medical record. GX 25, at 22. 
Respondent asked M.R., ``You want a refill again?''; she replied: 
``Yeah.'' GX 11, at 3. M.R. then mentioned her friend Rebecca and asked 
whether, if she provided information on her job and insurance, 
Respondent could issue a prescription for her. Id. at 3-4. Respondent 
declined, saying that ``[t]he law requires her to have a face-to-face 
with the doctor.'' Id. at 4.
    M.R. then stated that she ``ended up having to share a little bit 
with [Rebecca] last time my prescription.'' Id. After M.R. asked 
whether that was ``okay to do?''; Respondent answered: ``It's against 
the law.'' Id. M.R. then asked, ``Oh, is it?'' Respondent replied: 
``Just don't, uh, don't tell me about it.'' Id.
    M.R. again asked for a prescription for Rebecca, this time offering 
$140, but Respondent stated: ``No, it's * * * not a money thing, it's 
the law thing.'' Id. at 5. Later, Respondent said that he ``wouldn't 
mind seeing'' the UC, but then he remembered that she had gone to Dr. 
Stack, who ``poisoned a lot of people [and is] in jail.'' Id. at 6-7. 
Respondent commented that ``anybody that's * * * been coming from that 
office, we've been staying away from.'' Id. at 7. Again, without any 
discussion of M.R.'s medical condition or any apparent physical 
examination, M.R. emerged from the appointment with a prescription for 
ninety Lortab 10mg. GX 14, at 2.
    At M.R.'s third undercover visit (on December 24, 2007), Respondent 
opened the visit by noting that she was in after only one month, but 
that after this visit, he wanted her to not come back for two months 
because he was giving her a prescription plus a refill. GX 12, at 3, 9. 
Respondent then asked, ``Lortab ten?'' and M.R. answered, ``Yeah.'' Id. 
After the sound of paper tearing from a pad, Respondent asked, ``You 
been doing okay?'' Id. M.R. replied, ``Yeah. I'm doing good.'' Id. at 
4, 9. After Respondent and M.R. exchanged Christmas greetings, 
Respondent concluded the visit and told M.R. to ``[t]ake care.'' Id. at 
4, 9-10. Once again, without any meaningful inquiry regarding her pain, 
Respondent issued M.R. a prescription for ninety Lortab 10mg., with one 
refill. GX 14, at 3. M.R.'s patient record does not record a visit for 
December 24, but an entry for December 20, 2007 carried over the 
information from the prior visit verbatim, including the description of 
a physical exam. GX 25, at 22.
    On the fourth undercover visit (January 29, 2008), Respondent began 
the appointment by asking, ``How are you today?'' GX 13, at 8. M.R. 
answered, ``Good. How are you?'' Id. Respondent said, ``Good,'' then 
asked ``Lortab, ten 90?'' and ``You want a refill on it?'' Id. 
Respondent inquired whether M.R. was ``getting pills from any other 
doctor'' and whether she was ``abusing them, selling them, [or] buying 
them?'' Id. When M.R. responded in the negative, Respondent further 
asked whether M.R. was ``doing anything illegal?''; she answered, 
``No.'' Id. at 9. Respondent never inquired about her pain level, about 
side effects, or about her functional capacity, and the recording does 
not indicate that a physical examination was performed, yet M.R. 
emerged from the visit with another prescription for ninety Lortab 10s 
and one refill. GX 14, at 4. Respondent also never mentioned that M.R. 
was back a month earlier than he had indicated for her, yet he wrote 
another prescription for a controlled substance with one refill. M.R.'s 
medical record for that date again repeats verbatim the record from the 
prior visit, including a physical exam that found ``diffuse tenderness 
L4 to S1.'' GX 25, at 21.
    Dr. Hare reviewed both M.R.'s medical record and the transcripts of 
the visits; his opinion was set forth in a letter which was entered 
into evidence. See GX 44. Dr. Hare noted that at M.R.'s initial visit, 
``[n]o history was obtained at that time, even in regards to the 
occurrence of the wrist pain and its characterization.'' GX 44, at 1. 
He also noted that ``[n]o further tests were ordered and the physical 
examination was only that she was `neurologically intact,' no details 
of any neurological exam were listed.'' Id. Dr. Hare remarked that 
about one month after the initial Lortab 7.5 prescription, Respondent 
increased M.R.'s prescription from 60 to 90 tablets and the strength to 
Lortab 10mg. ``with no indication of benefit from the prior 
prescriptions.'' Id. Moreover, ``[e]ven though the pain apparently 
persisted unchanged, no further tests were ordered.'' Id. According to 
Dr. Hare, while the note indicated that M.R. was ``told to continue 
`conservative treatment' * * * this was not initiated by [Respondent] 
nor described by him, i.e. immobilization, ice, etc.'' Id.
    With respect to M.R.'s February 27, 2006 visit, Dr. Hare found that 
``the note for bilateral wrist pain is essentially the same with the 
exception that the patient is said to be on Valium 5 mg. but [there] is 
no indication that she had been previously prescribed this medication 
by Dr. MacKay. At the time of this visit though, she was given a 
prescription for Valium 5 mg. tablets.'' Id. Moreover, at the next 
visit, Respondent indicated that M.R. was taking Valium 10 mg. and gave 
her a prescription for this strength of the drug. Id. at 2.
    Dr. Hare then observed that on May 24, Respondent switched M.R. 
``from Valium to Xanax, even though there was no description of the 
reasons for the

[[Page 49966]]

Valium previously.\18\ There was no follow up as to efficacy and there 
was no reason for switching to Xanax.'' Id. Dr. Hare then noted that 
M.R. ``remained on Lortab and Xanax throughout the next several visits 
but then was switched back to Valium on August 30, 2006 for reasons 
that aren't described and no diagnosis is included.'' Id.
---------------------------------------------------------------------------

    \18\ In testimony, Dr. Hare indicated that Valium was an anti-
anxiety drug which could be used as a muscle-relaxant for a few days 
to a week. Tr. 146. Xanax is also an anti-anxiety drug but a 
``shorter acting, shorter lasting drug than Valium.'' Id. at 147.
---------------------------------------------------------------------------

    Next, Dr. Hare noted that on January 15, 2007, M.R.'s chief 
complaint changed from wrist pain to low back pain, and on subsequent 
visits the wrist pain (which she had purportedly complained of for 
nearly three years at that point) was no longer a problem. Id. As for 
M.R.'s complaint of back pain, Dr. Hare observed that:

there is no additional physical examination other than describing 
``tenderness'' to define this problem nor were there any other tests 
such as x-rays, MRI's, or other diagnostic tests done to better 
understand this complaint. The patient was just treated with 
continuing doses of Lortab as had been previously prescribed for 
wrist pain. With the substitution of Low Back Pain, the notes 
otherwise seem to be largely the same as they were when the patient 
had wrist pain.

Id.

    Dr. Hare then explained that the March 29, 2007 ``note indicated 
that the patient has `degenerative disc disease, lumbosicral [sic] 
spine' and yet there is no physical exam or other diagnostic tests done 
to identify this as a problem. This diagnosis remains in his notes 
throughout the remainder of his care for her.'' Id. Dr. Hare also 
observed that ``[f]rom March 29, 2007 through January 29, 2008 the 
clinic notes are almost identical, verbatim. There is no apparent 
change in her condition and there is no indication that she is getting 
any benefit from [Respondent's] treatment. There is no further testing 
of any sort done nor are any consultations sought despite the 
persistence of pain.'' Id.
    Dr. Hare concluded that neither M.R's. complaint of bilateral wrist 
pain or low back pain ``was adequately evaluated.'' Id. He further 
explained that ``[n]o history was obtained, inadequate physical 
examination was done, no tests were ordered to better understand these 
problems and despite the lack of information [Respondent] chose to 
treat these problems aggressively with controlled substances.'' Id. at 
2-3. Dr. Hare concluded that ``the continuing prescriptions of 
controlled substances were not warranted.'' Id. at 3.
    As for Respondent's recordkeeping, Dr. Hare observed that:

[Respondent's] clinic notes appear to be computer generated, 
basically ``rubber stamped,'' or ``fill in a blank,'' type notes 
that do not really reflect the patients [sic] change in condition. 
There is no indication that the patient was getting any benefit from 
[Respondent's] treatment [and] there is no indication of updated 
physical examinations or further evaluations for the above described 
problems. Without some indication that the patient has improved with 
treatment, there is not justification for the continued prescribing 
of controlled substances. The clinic notes reflect a number of 
inaccuracies in terms of current medications and previous 
prescriptions, another indication that these notes were computer 
generated and did not necessarily reflect the patient's current 
status.

Id. (emphasis added).

    Ultimately, Dr. Hare concluded that Respondent's evaluation of M.R. 
``was inadequate to justify the prescribing of controlled substances 
for her conditions.'' Id. Noting that there was no medical 
justification in M.R.'s chart for the benzodiazepines (Valium and 
Xanax) Respondent prescribed, Dr. Hare observed that ``that there can 
be dangerous and detrimental interactions between Benzodiazepines and 
Opioid medications'' such that, absent any description that would 
``justify the prescribing of Valium and Xanax,'' Dr. Hare concluded 
that Respondent's prescribing was ``below the standard of care for the 
evaluation of the patient for the above described medical conditions 
and the treatment he prescribed.'' Id.
    In his testimony, Dr. Hare explained that in the usual course of 
professional practice, a physician documents the reasons for a change 
from one benzodiazepine to another (e.g., a switch from Valium to 
Xanax, or vice versa), yet M.R.'s patient record has no such 
documentation. Tr. 148. He also testified that the physical examination 
and history were not consistent with the usual course of professional 
practice, which requires more detail. Id. at 157. He further noted that 
there was a DOPL report in M.R.'s file for January to April 2007, which 
showed that she was also receiving hydrocodone (Lortab) from Dr. D. (as 
found above), yet Respondent apparently did not alter his prescribing 
practice for her. Id. at 161-63. He testified that he ``did not believe 
the medical records support the long-term prescribing of controlled 
substances to this patient'' and that there was ``insufficient 
evaluation for both her wrists and her low-back problems to allow such 
prescribing.'' Id. at 164.
    Dr. Fine did not offer any testimony specific to M.R. even though 
he reviewed her patient file and the transcripts of her undercover 
visits. Tr. 619 & 872. As found above, Dr. Fine was unwilling to 
express an opinion on the validity of Respondent's prescribing to M.R. 
during the undercover visits because he was unable to view ``a full 
audiovisual recording of these visits [and] compare them to the 
[patient] records.'' Id. at 878-79. He indicated that without knowing 
the context of the physician-patient relationship he just couldn't 
``make sense out of'' the transcripts. Id. at 875.
    I conclude that Dr. Fine's testimony is patently disingenuous. As 
did the ALJ, I find credible Dr. Hare's testimony regarding 
Respondent's prescribing to M.R.

K.D.

    K.D. first saw Respondent in November 2004, complaining of a neck 
injury that was caused by a July 2003 auto accident.\19\ GX 26, at 118. 
Previously, a Dr. M. had diagnosed her as having cervical spine disease 
and a pinched nerve. Tr. 345. K.D. testified that at her initial visit, 
Respondent did not take her heart rate, blood pressure, or weigh her, 
and he performed no physical examination beyond looking at her neck. 
Id. at 349; 345-46. Moreover, he did not ask about the severity of her 
pain or order diagnostic tests such as x-rays. Id. at 346, 348. 
According to K.D.'s records, Respondent found that ``[s]he has diffuse 
pain in the neck areas, into the shoulders and headaches[,] * * * 
diffuse tenderness in the cervical spine C3 to C7[,] * * * tenderness 
in the trapezius area[,]'' and that she was ``neurologically intact.'' 
GX 26, at 118.
---------------------------------------------------------------------------

    \19\ On cross-examination, K.D. clarified that she had 
experienced more than three months of pain prior to consulting 
Respondent. Tr. 441.
---------------------------------------------------------------------------

    In contrast to K.D.'s testimony, Respondent noted in her record 
that ``[x]-rays of the cervical spine taken are essentially normal with 
some straightening and loss of the lordotic curve.'' Id. He then 
diagnosed her as having ``cervical strain July 2003 motor vehicle 
accident with flare up residuals.'' Id. Respondent indicated that 
K.D.'s treatment plan would include ``physical therapy''; he also 
prescribed 60 Lortab 7.5 mg. (hydrocodone), 60 Soma, 60 Fioricet, and 
indicated that she would ``continue conservative treatment'' with a 
``follow up in three weeks.''\20\
---------------------------------------------------------------------------

    \20\ The progress notes for K.D's first three visits list her 
name as ``Terri'' rather than Kerri, the name which is used 
throughout the rest of this voluminous record. See generally GX 26. 
It is further noted that the cover of the file is labeled with the 
type-written name of Terri, with the letter K handwritten over the 
T. No argument has been raised that these progress notes were for a 
different patient.

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

[[Page 49967]]

    As early as her third visit, K.D. reported that ``her prescriptions 
and purse [were] stolen.'' Id. at 117. Respondent then gave her a new 
prescription for 60 Lortab. Id.
    Respondent treated K.D. with various narcotics which, over the 
course of his prescribing to her, were of increasing strength and 
quantities. More specifically, through September 2006, Respondent 
usually prescribed Lortab; however, at some visits he prescribed 
Percocet 5 mg., or Percocet 10 mg., which are schedule II controlled 
substance containing oxycodone. GX 26, at 113-118. However, on November 
6, 2006, Respondent gave her a prescription for sixty tablets of 
OxyContin 40 mg.; he also noted that ``[t]he METHADONE made her itch to 
the point that she could not tolerate it over the weekend.'' Id. at 
108. Yet there is no indication in her record that he had previously 
prescribed methadone for her.
    At the next visit, Respondent refilled her OxyContin 40 mg. 
prescription and gave her a prescription for Lortab 10. Id. at 107. 
Subsequently, he wrote more prescriptions for OxyContin 40 mg. and 
Percocet 10 mg., although at times he indicated that the latter was for 
hydrocodone 10/325, a different controlled substance. Id. at 105-06. 
Subsequently, on March 9, 2007, Respondent stopped writing Percocet 
prescriptions and started issuing prescriptions for oxycodone 15 mg. 
(as well as OxyContin 40 mg.). Id. at 104. This prescribing pattern 
generally continued through the course of K.D.'s visits with 
Respondent. Id. at 91-105. However, in July 2007, Respondent gave her a 
prescription for Demerol, another schedule II controlled substance. Id. 
at 102. Moreover, in November 2007, Respondent again increased the 
quantity of oxycodone IR (from 120 tablets of 15 mg. strength to 90 
tablets of 30 mg. strength, which was eventually increased to 120 
tablets). On various occasions, he also gave her prescriptions for 
Lortab. In addition, Respondent prescribed several schedule IV 
controlled substances to K.D. including Ambien, Xanax and Valium. Id. 
at 91-98, 100-01; Tr. 348.
    K.D. testified that Respondent did not ask her about her pain at 
every visit and that, if her pain was discussed, it was because she 
raised the subject and not because Respondent asked her about her pain 
or its severity. Id. at 348-49. She further testified that Respondent 
never performed physical examinations at subsequent visits and that she 
received at least one controlled substance prescription per visit. Id. 
at 349.
    At an appointment in the summer of 2006, K.D. asked Respondent 
about getting a referral to a physical therapy practice with a masseuse 
on its staff. Id. at 360. Respondent asked K.D. if she ``would like a 
massage'' and then asked for her cell phone number. Id. at 350. He then 
stated that he would get a motel room in another town, and call for 
her. Id. Several weeks later, Respondent called K.D. and told her where 
to meet him. Id.
    On or about September 23, 2006, K.D. met Respondent at the motel 
and, after entering his room, removed both her top and bra. Id. 
Respondent massaged her for 30-45 minutes. Id. at 351. After K.D. put 
on her clothes, Respondent explained that because he had diabetes he 
was unable ``to perform certain sexual activities.'' Id. at 351. He 
then took out his prescription pad and asked her ``what prescriptions 
[she] needed.'' Id. Respondent then gave her a prescription for ninety 
tablets of Percocet 7.5 mg., a schedule II controlled substance. Id.; 
see also GX 39 (prescription signed by Respondent dated September ``9-
25-06'').\21\ Not surprisingly, K.D. and Respondent did not discuss her 
pain or medical condition. Id. at 353.\22\
---------------------------------------------------------------------------

    \21\ The label attached by the dispensing pharmacy indicates, 
however, that the prescription was actually filled on September 23, 
2006. GX 39.
     The Government also entered into evidence a confirmation 
receipt, which showed that Respondent took a room at the Bestrest 
Inn, a motel in Ogden, Utah, on September 23, 2006, see GX 16; motel 
personnel told a DEA Investigator that Respondent had purchased the 
room for that night. Tr. 1146. An Investigator further testified 
that K.D. had provided investigators with an account of the visit 
that was generally consistent with the layout of the motel. Id. at 
1019. The Government also entered into evidence a floor plan of the 
hotel, on which K.D. identified the room she had been in with 
Respondent as one of four rooms. GX 15; Tr. 1019-21.
    \22\ K.D.'s medical record has entries for September 22, 24, and 
25, 2006. The September 22 entry indicates that a prescription for 
ten Lortab 10s was called in to a pharmacy. GX 25, at 109. The 
September 24 entry indicates that K.D. ``called over the weekend 
needing more medication. She was given a prescription for PERCOCET 
7.5/500 mg. (90), AMBIEN 10 mg. (30) and FIORCET (60).'' Id. The 
entry for September 25 indicates that ``[p]atient failed to show for 
appointment.'' Id. A DOPL report for KD for the period shows only 
that she filled a prescription from Respondent for hydrocodone 10 
mg/APAP on September 22 and a prescription from Respondent for 
Endocet 7.5 on September 23, a drug which is the same formulation as 
Percocet. GX 37, at 3.
---------------------------------------------------------------------------

    K.D. also met Respondent on four or five other occasions ``at a 
friend's house.'' Id. at 354. During each encounter, Respondent again 
gave her a massage and afterward, gave her a controlled substance 
prescription. Id. at 354, 355. Prior to one of these encounters, which 
occurred in March 2008, K.D. called Respondent to tell him that she was 
back in town and wanted more drugs. Id. at 355. Respondent agreed to 
meet K.D. at her friend's house after he got off from work, and upon 
meeting her, asked her if she ``would like a full body massage.'' Id. 
K.D. agreed and removed all of her clothes and laid down on a bed. Id.
    After massaging her upper body and legs, Respondent rubbed her 
vaginal area and digitally penetrated her. Id. at 356. After five 
minutes or so of this latter activity, K.D. faked an orgasm to end the 
session. Id. K.D. got dressed, and Respondent then gave her a 
prescription for oxycodone IR 30 mg., as well as $75 to $100 ``to 
fill'' her prescription. Id. at 357; GX 38, at 1 (signed RX). K.D. then 
filled the prescription. Id. at 358. During the encounter (as well as 
the others that occurred outside of Respondent's office), there was no 
discussion of her condition or her pain. Id. at 361.
    K.D. testified that she agreed to the March 2008 meeting so she 
``would get [her] pain medication.'' Id. at 396. She also stated that, 
while she had regular appointments at which she obtained medications, 
she agreed to meet Respondent outside of his office to obtain 
additional narcotics. Id.
    K.D.'s medical record does not reflect either an office visit or 
the issuance of a prescription as having occurred on March 10, 2008, 
the date of the prescription. Rather, her record contains an entry for 
January 31, 2008, during which K.D. reported that she was ``moving out 
of state to take care of her mother'' and ``will not be coming back,'' 
and at which Respondent indicated that his physical exam found that 
``[s]he has chronic low back pain'' with ``diffuse tenderness L4 to 
S1,'' ``degenerative disc disease'' and was ``[n]eurologically 
intact.'' GX 26, at 98. Respondent gave her prescriptions for both 150 
oxycodone IR (30 mg.) and Ambien. Id. K.D.'s record then contains an 
entry for an office visit which occurred on April 9, 2008, during which 
Respondent again found that she had ``chronic low back pain'' and 
``diffuse tenderness L4 to S1.'' Id. at 97. At the visit, Respondent 
gave her prescriptions for sixty tablets of OxyContin 40 mg., 120 
tablets of oxycodone IR (30 mg.), 30 tablets of Ambien, and Fioricet. 
Id. at 97.
    K.D.'s medical record contains a letter from Respondent to her, 
dated December 20, 2007, which stated that she had told Respondent that 
her insurance company would not approve her OxyContin prescription. GX 
26, at 50. Respondent wrote that ``we gave you

[[Page 49968]]

Methadone to try and help you,'' \23\ but the ``State of Utah reported 
that [the OxyContin prescription] was indeed filled at WalMart Pharmacy 
in Harrisville.'' Id. Respondent wrote, ``This represents an abuse 
situation and I will no longer be able to see you.'' Id. However, as 
found above, Respondent continued to prescribe controlled substances to 
K.D. notwithstanding this incident and did so on numerous occasions 
thereafter.\24\
---------------------------------------------------------------------------

    \23\ This prescription is reflected in an entry of December 13, 
2007, in which Respondent wrote, ``That prescription was torn up by 
a pharmacist instead she was given methadone, 10 mgs.'' GX 26, at 
55, 99. K.D. testified that she had used up her OxyContin too 
quickly so Respondent was going to give her methadone; she had not 
reported to Respondent that the prescription was torn up by the 
pharmacist. Tr. 377.
    \24\ K.D. testified that Respondent never told her that he was 
dismissing her from his practice; rather, he told her that she must 
use just one doctor. Tr. 379.
---------------------------------------------------------------------------

    K.D.'s medical record also contains a January 23, 2008 fax from the 
Box Elder Narcotics Task Force. Id. at 43-49. The fax included a 
document, which stated that K.D. was obtaining controlled substances 
from five prescribers (and twelve different pharmacies), as well as a 
DOPL report for the period of December 20, 2006 to December 20, 2007, 
which showed the same. Id. at 43, 46-49. In another fax, which is dated 
January 25, 2008, Respondent wrote to the Box Elder Narcotics Strike 
Force that: ``We talked about her. I did talk to her as per our 
conversation. She promises 1 doctor, 1 pharmacy, as of the first part 
of Jan. Let's monitor her closely for [indecipherable].'' Id. at 
42.\25\
---------------------------------------------------------------------------

    \25\ Another DOPL report, dated April 8, 2008, showed that K.D. 
filled a prescription from Respondent for various controlled 
substances from Respondent including oxycodone on March 10, 2008, as 
well as for Ambien (Zolpidem), which was written by another 
physician. GX 26, at 41.
---------------------------------------------------------------------------

    K.D.'s medical record contains a signed Controlled Substances 
Contract, which is dated September 23, 2005. Id. at 36. While one of 
the terms of the contract was that Respondent would not replace a 
prescription which was ``lost, misplaced, stolen or * * * use[d] up 
sooner than prescribed,'' id., K.D. testified that on May 12, 2008, 
where the medical record indicated that her medications had been 
stolen, Respondent restricted her to using one pharmacy. Id. at 380; GX 
26, at 97. According to K.D., ``I had run out of my medication early, 
and I called [Respondent] and told him. And he instructed me to make a 
false police report, and tell the police that my medication had been 
stolen, and to bring that.'' Tr. 381; see GX 43 (police report of May 
12, 2008).\26\
---------------------------------------------------------------------------

    \26\ K.D.'s medical record also indicates that Respondent 
discussed with her whether she was getting narcotics from other 
physicians and/or more than one pharmacy on six occasions: August 
24, 2005; February 1 and November 6, 2006; February 5 and March 5, 
2007; and January 16, 2008. Id. at 54, 61, 63, 65, 69-70, 72. 
However, given the numerous instances in which Respondent falsified 
records, these notations are of questionable accuracy.
---------------------------------------------------------------------------

    In addition, K.D. testified that there were several falsifications 
in her medical record. While an entry for July 11, 2008, indicates that 
K.D. was having a ``right knee scope by a physician in Ogden'' and that 
she received another thirty tablets of oxycodone 30 mg. IR from 
Respondent, K.D. testified that she never had arthroscopic surgery on 
her right knee and that she had neither knee problems nor complained of 
such. Tr. 375-76. Moreover, while many of the notes for her visits list 
her chief complaint as ``chronic low back pain,'' GX 26, K.D. testified 
that she has never suffered from chronic low back pain and never told 
Respondent that she did. Tr. 374. While K.D. maintained that some of 
the prescriptions she obtained from Respondent were necessary to treat 
her pain, she maintained that she used a ``huge percentage'' of them 
``for recreational use.'' Id. at 391-92.
    K.D. became addicted to pain medication, id. at 392, and asked 
Respondent to take her off of OxyContin and give her methadone instead. 
Id. at 393. Respondent, however, told her that methadone hurts people, 
and he continued to write her prescriptions for OxyContin. Id.
    On four occasions in November and December 2008, K.D., who had 
agreed to cooperate with DEA Investigators, visited Respondent while 
wearing a recording device. With regard to these activities, K.D. 
testified that nothing was promised her in exchange for her testimony, 
and that, at the time of the hearing, she was incarcerated in a county 
jail for violating her probation which had been imposed because she had 
violated a protective order involving her ex-husband. Id. at 390-91.
    Moreover, while K.D. was generally required to give the 
Investigators the prescriptions she obtained, after the first 
undercover visit (November 7, 2008), the Investigator had her go into a 
pharmacy and fill a prescription for oxycodone 40 mg. Tr. 1064. The 
pharmacy, however, only partially filled the prescription. Id. While 
K.D. turned over the drugs to the Investigators, she later went back 
and filled the rest of the prescription without telling them. Id.
    K.D. also admitted that in November 2008, she had sold on the 
street seventy tablets of OxyContin for $2400, which she had obtained 
using a prescription issued by Respondent.\27\ Id. Moreover, on cross-
examination, K.D. admitted that after the visit on December 22, 2008 
(during which she received a prescription for 120 tablets of oxycodone 
IR 30 mg.), she called Respondent's office, told them she had lost the 
prescription, and obtained a replacement which she then filled.\28\ Id. 
at 408; see GX 37 (DOPL report), at 9. K.D. stated that she considered 
this prescription to be ``legitimate,'' because she was having pain 
that day. Tr. 406. The following week, K.D. was given a drug test which 
she flunked. Id. at 1171. She was re-incarcerated and DEA stopped using 
her as an informant.\29\ Id.
---------------------------------------------------------------------------

    \27\ DEA learned of this in January 2009, apparently from K.D. 
Tr. 1142. As of the hearing, the matter had not been further 
investigated or referred to either Federal or State prosecutors. Id. 
at 1142-43.
    \28\ K.D. was then residing in a work-release facility. Tr. 
1141.
    \29\ The ALJ provided an extensive explanation for why he found 
K.D.'s testimony credible. ALJ at 28-31. Among other things, the ALJ 
noted that other evidence corroborated her testimony regarding the 
March 2008 encounter at the motel.
     It is disturbing that K.D. was able to obtain an extra 
prescription from Respondent which she apparently sold on the street 
while she was cooperating with the investigation. However, K.D. 
freely admitted having done so during her testimony. Again, the ALJ 
personally observed K.D.'s testimony and found her testimony to 
generally be credible. I find no reason to reject this finding. See 
Resp. Exceptions at 26.
---------------------------------------------------------------------------

    K.D.'s undercover visits were recorded; the recordings along with 
transcripts for three of the visits were admitted into evidence by the 
Government. On November 3, 2008, after an initial discussion regarding 
a domestic violence incident with her ex-husband, Respondent asked 
K.D.: ``Now, are you getting pills from other doctors?'' GX 19, at 6. 
K.D. answered, ``No, I've been in Kansas.'' Id. She indicated that for 
the past two months she had ``been in a lot of pain.'' Id. at 7. After 
replying ``I'll bet you have,'' Respondent asked, ``What do you want to 
do?'' Id. K.D. said, ``I want my, all my--I need all my meds. I need my 
oxycontin, my [roxicet], my juraset.'' After a brief discussion of 
whether her insurance company had approved the OxyContin, Respondent 
asked: ``Okay, so you want--got you down for 40 mg., 90 of them?'' Id. 
K.D. answered affirmatively. Id. Respondent than asked: ``And then what 
else?'' Id. at 8. K.D. told him 120 Roxicet 30 mg., 60 Fioricet, and 
Ambien. Id. at 8. Continuing, K.D. complained that ``I can't believe 
you forgot this, this is just not cool * * * You forgot what I take.'' 
Id. Respondent asserted that, to the contrary, ``I make the patient 
tell me, to make sure they understand what they're

[[Page 49969]]

getting,'' and added that ``[i]t's just my little trick.'' Id.
    Respondent then asked K.D. if she was ``a plant from the police or 
the DEA?''; a lengthy conversation ensued in which Respondent 
complained that his office had been under investigation for sixteen 
months. Id. at 9-12. During this part of the conversation, K.D. asked 
if she was going to get in trouble, and Respondent answered: ``Just as 
long as you're not abusing drugs. You're not getting narcotics from any 
other doctor?'' Id. at 10. He also complained that DEA had ``actually 
sent people in with wires'' and had interviewed 100 of his patients to 
find out if he was ``selling pills to them.'' Id. at 11-12. Respondent 
further asserted that his former partner had ``turned'' him ``in,'' id. 
at 12, because he ``sued me, and then to cover up this lawsuit he had 
filed against me, * * * he called the DEA in on me.'' Id. at 13. After 
venting about the lawyers involved in the suit, id. at 13-14, 
Respondent complained that the Government had seized all of his records 
and various assets and labeled him a terrorist. Id. at 16. After a 
discussion regarding K.D.'s mother, who had been put in an `` `old 
folks' home,'' id. at 20-23, the visit ended. During the visit, 
Respondent gave prescriptions for 90 tablets of OxyContin 40 mg., 120 
tablets of oxycodone IR 30 mg., 30 tablets of Ambien, and 60 tablets of 
Fioricet. GX 17, at 1-4. As is clear from the transcript and recording, 
Respondent did not physically examine K.D. and did not ask about her 
pain level, the efficacy of the previously prescribed medications, 
possible side effects, or her functional capacities.
    K.D.'s patient record for November 3, 2008, states, however, that 
Respondent conducted a physical examination during which he found: 
``She has chronic low back pain. She has degenerative disc disease and 
diffuse tenderness L4 to S1.'' GX 26, at 92. The record also states 
that K.D. ``stated that she has been suffering.'' Id. Finally, the 
record states that K.D. ``will continue conservative treatment'' 
although neither the recording nor the transcript contain evidence that 
her continuation of such treatments was discussed. Id.
    K.D.'s next undercover visit occurred on November 24, 2008. GX 20. 
K.D.'s meeting with Respondent began with a discussion of her insurance 
and whether the insurer had approved a full prescription. GX 20, at 4. 
K.D. complained that she had ``bought twenty at first, and then, yeah--
they, they held it back first, `cause they only approved that twenty. 
And then, I had to go back and call and--twenty a year--which is 
complete bulls* * *'' Id. Respondent then asked whether she had gotten 
the full prescription; K.D. answered, ``yes.'' Id. Respondent stated 
that he could not write a refill in ``less than four weeks'' so that it 
would be the first of December before he could again write the 
prescription. Id. K.D. insisted, ``I just need my meds.'' Id. 
Respondent replied that he could give her sixty oxycodone tablets 
instead to carry her through Thanksgiving, and that she could then come 
back and he would not charge her for the new prescription. Id. at 4-5.
    Respondent then asked: ``And you're not working with the DEA, or 
wearing a wire, right?'' Id. at 5. K.D. answered, ``no,'' and 
Respondent complained about the ``pressure'' DEA was applying. Id. 
Respondent explained that it was this pressure ``that's why I, I just 
can't do it. 'Cause the * * * law says * * * four weeks.'' Id. K.D. 
then replied: ``Does that mean you're not seeing me no more, either?'' 
Id. Respondent asked, ``What?'' and K.D. repeated, ``That means you're 
not seeing me no more, either? You can't see me no more? Can't talk to 
me no more? I can't believe you!'' Id. Respondent replied, ``I can't, I 
can't, yeah. It's * * * crazy.'' Id. at 6. K.D. said, ``That's--this is 
insane to me,'' and Respondent replied, ``Yeah.'' Id. K.D. stated 
``you'll be okay, though. I think''; Respondent answered, ``I think 
so'' plus some inaudible comment. Id.
    Next, K.D. asked when she had to come back and whether Respondent 
would charge her. Id. Respondent stated that while he would bill K.D.'s 
insurance he would not charge her a co-pay. Id. Respondent and K.D. 
then agreed that her next visit would be ``next Monday,'' which was 
December 1. Id.; see also id. at 9. Respondent then affirmed that he 
would not charge her the co-pay and added, ``I'll give you sixty of the 
oxy 30s to get by and we'll * * * fill everything next week.'' Id. at 
7.
    The conversation turned to Respondent's dispute with his former 
partner and the latter's purported motivation for reporting him to the 
Agency. Id. K.D. then made an appointment with Respondent's office 
assistant for an appointment on December 1, 2008. Id. at 9. At the 
visit, Respondent gave K.D. a prescription for sixty tablets of 
oxycodone IR 30 mg. GX 17, at 5.
    Once again, K.D.'s medical record indicates that Respondent 
performed a physical exam at this visit, during which he found that 
``[S]he has chronic low back pain. She has degenerative disc disease 
and diffuse tenderness L4 to S1.'' GX 26, at 92. However, neither the 
transcript nor the recording of the visit contain any evidence 
suggesting that a physical exam was performed. In addition, the 
progress note states that K.D. ``denie[d] getting narcotics from any 
other physician'' although neither the transcript nor the recording 
indicate that Respondent asked her anything of the sort. Id. The 
progress note also states that K.D. ``will continue conservative 
treatment'' although no alternative form of treatment was discussed in 
the course of the visit. Id.
    K.D.'s third undercover visit took place on December 1, 2009. After 
a few inaudible exchanges between them, Respondent asked K.D., ``today, 
what do you need?'' GX 21, at 5. K.D. responded: ``Everything. My 
Oxycontin, my Roxicet, my Fioricet, my Ambien, and I have been so 
stressed out, so I was going to see if I could get some Xanax, too. I 
don't know if I can do that with the Ambien, or if I have to substitute 
them.'' Id. Respondent made an inaudible comment, and K.D. indicated 
that she was ``going through some sh-t.'' Id. Respondent then asked 
her, ``how many Ambien, or, uh, Xanax do you want?'' Id. They settled 
on thirty. Id. Respondent then warned K.D. that with Xanax, Ambien, 
Klonopin and Soma, she would ``run the risk of over sedating.'' Id.
    After K.D. stated that the Christmas holidays stressed her out, 
Respondent asked her how she was doing at her job. Id. at 6. K.D. 
replied: ``I'm not making any money. I just barely went back to work, 
and I am just * * * freaking out * * * I have no more--I have--I'm just 
stressed out.'' Id. To this Respondent replied, ``I told you about all 
my money, didn't I?'' Id. He then stated: ``They took * * * over a 
million dollars from me. And they haven't said anything, or given it 
back, or done anything.'' Id. When K.D. asked, ``So I--I can't get 
Christmas help from you this year?''; Respondent offered to ``give 
[her] every dollar in my wallet, but it's only three dollars.'' Id.
    A bit later, Respondent asked K.D. for her ``newest phone number'' 
and stated that ``if anything goes better for me, I'll * * * give you a 
call.'' Id. at 7. K.D. then complained that the back of her neck was 
swollen and stated, ``I need a massage.'' Id. Respondent replied, 
``Right through there, yeah,'' and K.D. responded, ``That means no more 
massages? No more help--at all?'' Id. Respondent laughed. Id. A bit 
later, Respondent said, ``Well, let's see if things get any better for 
us here.'' Id. at 8.
    After Respondent assured K.D. that he would call her if things got 
better for him, she asked if one of his employees ``get[s] mad that I 
close the door?'' Id. Respondent answered: ``She does. She

[[Page 49970]]

thinks your [sic] doing nasty things in here.'' Id. K.D. replied: ``no, 
I would never do that * * * Well, not in the office. That's why she 
gets all--yeah, I can tell she does not like that. But I don't like to 
talk about my, and your personal business in front--yeah, I mean like 
[inaudible.]'' Id. Respondent's reply was inaudible. Id. K.D. then 
stated that when she closed the door, the employee ``kind of gave [her] 
a dirty look'' and didn't like her ``at all.'' Id. at 9. Respondent 
said that his employee did not ``trust'' K.D. and that his ``mother 
said never trust anybody with a tattoo.'' Id. K.D. then acknowledged 
that she has two tattoos. Id.
    Respondent inquired whether K.D. ``still live[d] in that same 
place?'' Id. K.D. answered, ``yeah,'' and added that she was going to 
be kicked out because the house was being foreclosed on. Id. She then 
explained that while her ``stuff'' was still at the house she was 
actually ``living at one of those little Budget Inn places.'' Id. at 9-
10. After K.D. and Respondent discussed that neither of them had gone 
shopping due to money problems, Respondent said, ``I am going to give 
you all the money I have * * * My three dollars.'' Id. at 11. K.D. 
noted that this would allow her to get ``two gallons'' of gas and 
thanked Respondent, who apparently again complained about the 
investigation. Id. K.D. said, ``So you better * * * call me,'' and 
Respondent replied, ``We'll win.'' Id. After K.D. told Respondent that 
he was ``a friend,'' the two exchanged farewell wishes. Id. at 11-12.
    At the visit, Respondent gave K.D. prescriptions for 90 tablets of 
OxyContin 40 mg., 120 tablets of oxycodone 30 mg., 30 tablets of Xanax, 
and 60 tablets of Fioricet. GX 17, at 6-7. The progress note for this 
visit again states that K.D. ``comes in for follow up of chronic low 
back pain,'' and that Respondent had performed a physical examination 
and found that that K.D. ``has degenerative disc disease and diffuse 
tenderness L4 to S1,'' GX 26, at 91, although neither the transcript 
nor the recording suggests that Respondent performed even a perfunctory 
physical examination. Moreover, the note states that K.D. ``denies 
getting narcotics from any other physician'' and that she ``stated that 
this controls her pain well'' although neither the transcript nor the 
recording provides any evidence that Respondent and K.D. discussed 
either issue during this visit. Id. The record also states that K.D. 
``will continue conservative treatment'' although no discussion of such 
treatments took place in the course of the visit. Id.
    On either December 18 or 22, 2008, K.D. made a fourth undercover 
visit; an audio recording of the visit was entered into evidence. GX 
48.\30\ The ALJ found that this visit shared many of the same 
characteristics of the other three visits. ALJ at 24. Respondent asked 
K.D. to tell him what she needed, and K.D. requested several controlled 
substances. GX 48. K.D. took the opportunity to thank Respondent for a 
$250.00 gift.\31\ Id. During the visit, Respondent agreed to postdate 
prescriptions for K.D. because of an issue related to her insurance. 
Id. The visit ended with Respondent again bemoaning the investigation. 
Id.
---------------------------------------------------------------------------

    \30\ While the prescriptions Respondent gave K.D. are dated 12-
22-08, on two of them the date of 12-18-08 was crossed out. GX 17, 
at 8 & 11. Other evidence suggests that the visit occurred on 
December 18, including the discussion of the need to post-date the 
prescriptions and K.D.'s patient record. See GX 26, at 91. The 
transcript was not entered into evidence. ALJ at 24 n. 41.
    \31\ In discussing this visit, the ALJ found that ``[i]n the 
Respondent's version of the transcript, K.D. alludes to swelling on 
her neck, says she is [in] pain, and makes something of an effort to 
induce the Respondent to provide a massage.'' ALJ at 24 (citing RX 
13, at 5). It is not clear why the ALJ cited RX 13 as evidence of 
the December 22 visit, as he had previously noted that it was a 
transcript of the December 1 visit. See id. at n.40. Moreover, 
having carefully read RX 13, it is noted that it tracks verbatim, 
with only minor differences, the Government's transcript of the 
December 1 visit. Compare RX 13 with GX 21. Furthermore, while the 
ALJ noted that in the recording of the December 22 visit, K.D. 
thanked Respondent for a $250 gift, RX 13 contains no such 
discussion. I thus find that RX 13 is a transcript of the December 
1st, and not the December 22nd, visit.
---------------------------------------------------------------------------

    K.D.'s patient record contains no entry for December 22, 2008. See 
generally GX 26. An entry for December 18, 2008, however, shares many 
of the features of the other entries, such as a Physical Exam section 
that reads: ``She has chronic low back pain. She has degenerative disc 
disease and diffuse tenderness L4 to S1. Neurologically intact.'' GX 
26, at 91. Consistent with the other undercover visits, the audio 
recording reflects no indication that any tests were conducted that 
would support any of the findings set forth in the treatment notes. The 
note also indicates that K.D. ``denies getting narcotics from any other 
physician'' and ``stated this controlled her pain well.'' Id. Again, 
however, the recording contains no indication that Respondent and K.D. 
discussed how the prescriptions were affecting her pain level and 
functionality.
    At the visit, K.D. ``was given OXYCONTIN 40 (90), OXYCODONE 30 mg. 
IR (120), FIORCET [sic] (60) and XANAX 1 mg. (30).'' Id.; see also GX 
17, at 8 (RX for 120 oxycodone IR 30 mg.), 9 (RX for 90 OxyContin 40 
mg.), 10 (RX for 30 Xanax 1 mg.), and 11 (RX for 60 Fioricet). The note 
also states that ``She will continue conservative treatment.'' Id.
    An addendum of the same date states that Respondent wrote ``all 
four'' prescriptions for K.D., but that she returned ``stating that she 
did not get the ROXICET prescription.'' Id. Respondent wrote, ``I will 
give her the benefit of the doubt this time and rewrite the ROXICET. I 
will check a DOPL in a few weeks to see if she doubled her prescription 
refill.'' Id. As found above, K.D. admitted in testimony that on that 
day, she had returned to Respondent's office without telling her DEA 
handlers, obtained an additional prescription, which she then filled at 
a drugstore across the street from Respondent's practice. Tr. 408.
    In a letter of March 25, 2009, Dr. Hare provided an extensive 
analysis of Respondent's prescribings to K.D. GX 46. Therein, Dr. Hare 
found that Respondent's initial evaluation of K.D. for neck pain 
``consisted of a very brief history and a rather superficial 
examination,'' in which he stated that she was ``neurologically 
intact'' without providing ``details as would be expected of the 
neurologic exam (reflexes sensory and strength examination).'' Id. 
Respondent prescribed Lortab 7.5 and Soma, as well as Fioricet, which 
the patient was reportedly taking. Id.
    Dr. Hare noted that at K.D.'s third visit (December 17, 2004), 
``the patient reported that her medications were stolen and 
[Respondent] promptly reissued her medications.'' Id. Dr. Hare observed 
that Respondent saw K.D. at two to three week intervals, yet he 
prescribed in a way that would ``suggest one month medication 
supplies.'' Id. Next, Dr. Hare observed that in May 2005, K.D. reported 
that she had been assaulted by her husband and brought a police report 
(GX 26, at 81-82), which indicated that K.D. had a problem with 
substance abuse, and yet, despite this and the ``early refills,'' 
Respondent ``did not seem fazed and continued to prescribe for her 
without concern.'' Id. Moreover, ``the next year [Respondent] gradually 
escalated her doses and sometime changed from Lortab to Percocet with 
no explanation.'' Id.
    Next, Dr. Hare observed that on September 11, 2006, K.D.'s chief 
complaint changed to low back pain and that ``there is no mention of 
her neck pain any longer.'' Id. He also noted that in Respondent's 
physical exam findings, ``tenderness in the back [was] substituted for 
cervical tenderness.'' Id. He further noted that while oxycodone 15 mg. 
was substituted for her previous medications because they (Lortab and 
Percocet) were upsetting her stomach, shortly thereafter she was 
``again

[[Page 49971]]

receiving Lortab and then * * * Percocet.'' Id. at 2.
    Dr. Hare noted that the following month (October 20, 2006), a 
handwritten note signed by one of Respondent's staff stated that a 
pharmacy had called and reported that K.D. was ``getting multiple 
prescriptions from multiple doctors.'' Id. Dr. Hare observed that the 
entry for the November 1, 2006 visit indicates that Respondent 
discussed the matter with the patient and that K.D. ``claimed this was 
a matter of identity theft by a roommate,'' and that on November 6, 
2006, Respondent reportedly ``set up a plan for `one physician 
prescribing and one pharmacy for refills.' '' Id. Dr. Hare noted, 
however, that Respondent ``[i]mmediately began prescribing a 
significantly larger dose [sic] the pain medication for her,'' which 
``consisted of OxyContin 40'' mg. Id. Dr. Hare also noted that K.D.'s 
record stated that methadone was causing side effects but that ``there 
is no indication in her notes that she had ever received [m]ethadone 
from'' Respondent. Id. Dr. Hare also observed that K.D. saw Respondent 
``approximately every three weeks for refills of what were apparently 
30 day prescriptions for'' narcotic controlled substances and that 
``there were continued incidents of her over using her medications or 
early refills for various reasons.'' Id
    Dr. Hare next noted that in March 2007, despite K.D's. having 
reported re-injuring her neck in a recent motor vehicle accident, the 
chief complaint is still listed as low back pain, and there is no 
mention of neck pain. Id. On March 9 and 27, Respondent indicated his 
concern that K.D. had run out of Percocet early, and, in mid-April, 
when K.D. again complained of back pain and that because of an `` 
`awful week' '' and `` `extreme pain' '' she had overused her 
medication, Respondent gave her new prescriptions which `` `must last 
four weeks.' '' Ten days later, K.D. reported her medication as stolen, 
and Respondent, indicating that there had been problems in the past, 
placed her on probation. Id. Dr. Hare observed that Respondent had also 
placed K.D. on probation in November 2006 ``but he does not seem to 
recall those past problems.'' Id.
    In June 2007, Respondent began to list degenerative disc disease as 
a diagnosis ``but he had not done any further evaluation of her that 
could confirm such a diagnosis.'' Id. Although K.D. ``complained of 
some neck pain, numbness, tingling, and weakness in her arms for about 
a two week period, [Respondent] did not perform any additional 
neurologic examination which would be appropriate in diagnosing a new 
neurologic issue.'' Id. The following month ``there apparently is no 
longer any problem with her neck or any neurologic issues.'' Id. Dr. 
Hare noted that Respondent had prescribed various drugs including 
Demerol (also a schedule II controlled substance) and opined that 
``there is really no explanation for these prescriptions in terms of 
trying to address a specific problem.'' Id.
    Next, Dr. Hare noted that in October 2007, K.D. had again run ``out 
of her medications early after about two weeks.'' Id. at 2. Dr. Hare 
again observed that an October 11 note referred to refilling a 
methadone prescription, but that her record contains ``no indication * 
* * that she ha[d] ever been prescribed this medication before and 
certainly not in the immediate past.'' Id. at 3. Dr. Hare further noted 
that Respondent gave her a prescription for Valium but that ``there was 
no explanation for'' this. Id.
    Dr. Hare found that in December 2007, K.D. told Respondent that her 
insurance company would not cover OxyContin, that a pharmacist had torn 
up the prescription, and that she ``need[ed] a different medication.'' 
Id. Dr. Hare noted that a DOPL report a few weeks later indicated that 
K.D. had, in fact, filled that prescription. Id. Dr. Hare noted that in 
January 2008, the medical record states that `` `the patient denies 
getting refills from other doctors but she has been using several 
pharmacies,' '' yet Respondent ``again remark[ed] about putting her on 
probation with one doctor and one pharmacy handling her 
prescriptions.'' Id. Dr. Hare then observed that ``[t]his is at least 
the third or fourth time she is put on probation with no consequence.'' 
Id.
    Next, Dr. Hare observed that an entry for late January indicated 
that K.D. ``was moving out of state and * * * will not be coming back 
for treatment at his office.'' Id. However, ``[h]e continued to 
prescribe for her'' and actually increased the amount of oxycodone and 
gave ``no explanation.'' Id. Dr. Hare further noted that Respondent 
``was aware of the patient's deception in filling the OxyContin 
prescription in December and yet he continued to prescribe for her.'' 
Id. Dr. Hare also noted that while Respondent sent K.D. a letter on 
December 20, 2007, in which he described an ``abuse situation,'' he 
continued to see K.D. and prescribed controlled substances to her at 
three separate visits in January 2008.
    Next, Dr. Hare observed that ``[e]venthough [sic] his records would 
indicate that he terminated care with her in January,'' in March 2008, 
Respondent again prescribed to K.D. Id. Dr. Hare noted that ``[t]here 
are no clinical records for this visit'' (in fact, this prescription 
was issued after one of the massage encounters).
    Id. Dr. Hare noted that on May 23, 2008, only eleven days after 
receiving new prescriptions, K.D. reported that she had run out of her 
medications early, and Respondent gave her new prescriptions. Id. Dr. 
Hare noted that on May 29, 2008, K.D. again claimed that her 
medications were stolen and that Respondent ``state[d] he will see her 
early and refill her medications for a month[,] but that they will need 
to last that full time.'' The record indicates ``she will not come in 
earlier than 30 days or I will not see her again.'' Id. Dr. Hare noted, 
however, that there were still more early refills including one for 
OxyContin, which occurred only ``17 days after her last prescription.'' 
Id. at 4.
    Dr. Hare then summarized the numerous problems he found with 
respect to Respondent's prescribing practices. Id. More specifically, 
``[t]here is an inadequate history and physical evaluation to justify 
prescribing chronic controlled substance prescriptions and particularly 
in escalating amounts.'' Id. Relatedly, when Respondent made a major 
diagnosis change from cervical spine pain to low back pain, ``there was 
no significant additional evaluation done to try to delineate the 
problem or other means for treatment suggested.'' Id.
    Moreover, there was frequently no justification in her chart for 
prescribing particular drugs and/or Respondent's changing K.D.'s 
medications. Id. Nor was there ``documentation or indication of patient 
improvement even with dramatic increases in the medications, such as 
OxyContin and Oxycodone.'' Id.
    Next, there were ``many signs and outright indications'' of overuse 
and abuse such as K.D.'s ``reports of stolen medications and other 
excuses for early refills on many occasions.'' Id. Moreover, even 
though Respondent documented an ``abuse situation,'' he ``ignored these 
overt signs of problems * * * and continued prescribing to her without 
any apparent concern.'' Id. In addition, Respondent never performed 
toxicology screens on K.D. Id. He also never enforced his rule that 
``one doctor [was] to prescribe and one pharmacy [was] to fill'' the 
prescriptions. Id.
    Dr. Hare observed that while Respondent had indicated that K.D. 
would ``continue conservative treatment,'' there was no evidence (such 
as notes from a physical therapist) that such treatments ``ever 
occurred.'' Id. Dr. Hare also found that the progress ``notes are 
remarkably identical from visit to

[[Page 49972]]

visit for long periods of time even with inaccuracies, i.e.[,] the 
current medications which are listed as Hydrocodone and Fioricet for 
many, many months even when the patient has not been on these 
medications.'' Id. Moreover, the ``notes do not contain any new 
information, such as the response to treatment of the side effects to 
the medications, or other important issues.'' Id. Dr. Hare opined that 
``[t]his would be consistent with record falsification.'' Id.
    In an addendum, Dr. Hare noted that he had reviewed the transcripts 
and recordings of K.D.'s undercover visits. Id. at 5. Dr. Hare found 
that during these visits, K.D. ``requested medications which for the 
most part were granted as written prescriptions.'' Id. Moreover, 
``during those visits,'' ``[n]o medical history was obtained [and] no 
physical examination was done. The conversations were almost entirely 
social [with] little pertaining to patient care.'' Id. Continuing, Dr. 
Hare opined that ``[a]s the chart notes for these visits indicate a 
physical exam the same as the other notes, this raises the question as 
to whether physical exams were ever performed. The notes corresponding 
to the recordings are falsified. It is likely the other[] clinic notes 
were also falsified.'' Id.
    In summary, Dr. Hare concluded that that Respondent's care for K.D. 
``was deficient in many parameters,'' that his prescribing of 
controlled substances for her was ``done poorly and in a substandard 
fashion,'' and his prescribing ``encouraged overuse of medications and 
possible diversion of these medications.'' Id. at 4-5. Dr. Hare also 
found that ``[t]here was [a] clear indication that the patient was 
overusing and likely abusing her medications and yet this never seemed 
to deter [Respondent] in his prescribing.'' Id. Finally, Dr. Hare 
concluded that, although he ``assume[d]'' Respondent was paid for his 
services, ``a deviation from standard care such as this would suggest 
other `rewards' for [him] such as drugs or sexual favors.'' \32\ Id.
---------------------------------------------------------------------------

    \32\ Dr. Hare also opined that the conversations with K.D. 
``became inappropriately personal with her personal phone number and 
place of residence given to Respondent'' and that ``[o]n one 
occasion he gave her $250 in cash.'' GX 46, at 5. Dr. Hare explained 
that ``[t]his would appear to cross the line of professional 
behavior and suggest an inappropriate relationship with a patient 
receiving controlled substances.'' Id.
---------------------------------------------------------------------------

    Based on his review of K.D.'s medical record and the transcripts 
and recordings of her four undercover visits as well as her numerous 
early refills, lost prescriptions, and stolen prescriptions, Dr. Hare 
testified that he was concerned that she was abusing her medications. 
Tr. 165-66. He also testified that several times Respondent obtained a 
DOPL report which showed that K.D. was using multiple doctors to obtain 
controlled substances, and yet in each instance, Respondent reacted as 
if it were ``the first time it ever happened, and the whole process 
start[ed] over again.'' Id. at 168. Dr. Hare testified that K.D.'s 
medical records ``were really quite superficial on the initial 
evaluation, very little in the way of history or physical exam was 
done,'' there was ``essentially nothing to follow-up to chart her 
progress,'' and ``nothing to explain changes in medication.'' Id. at 
169. When asked whether the prescriptions were issued ``within the 
usual course of professional practice and for a legitimate medical 
purpose,'' Dr. Hare testified that ``the evaluation * * * and the 
record don't support the long-term prescribing of controlled 
substances'' and that ``the records indicate an ongoing problem of drug 
misuse, abuse.'' Id.
    With respect to the undercover visits, Dr. Hare testified that the 
findings of the physical exams were repeated ``verbatim'' and that 
there was no indication that Respondent actually performed a physical 
examination at ``any of those visits.'' Id. at 173. He also opined that 
the long term prescribing of controlled substances was not supported by 
a legitimate medical purpose. Id. at 174. He further testified that in 
the usual course of professional practice, a physician engaged in pain 
management would have done ``an adequate evaluation of the patient to 
set the base'' and would have to ``closely monitor the patients'' when 
there are ``multiple indications of abuse'' such as in K.D.'s case. Id. 
at 175. Moreover, he then opined that if ``the patient didn't comply to 
[sic] the plan, then the patient should be discharged from care.'' Id. 
at 176.
    Although Dr. Fine testified that he had reviewed both K.D.'s 
medical record and a letter by Dr. Hare regarding his review of K.D.'s 
medical record, Id. at 618, Dr. Fine offered no testimony on direct 
examination about his review of K.D.'s record. As he did with M.R., on 
cross-examination, Dr. Fine declined to offer an opinion about the 
transcripts of the undercover visits claiming he needed a video 
recording to put the visit in context. Id. at 873-74. However, in 
response to the Government's hypothetical questions regarding the 
propriety of prescribing controlled substances to a patient with whom 
he had a sexual relationship, he acknowledged that this conduct was 
unethical and outside of the usual course of professional practice. Id. 
at 763-64.

Other Evidence

    Dr. Hare also reviewed the files of ten additional patients of 
Respondent--D.W. (GX 47), P.A. (GX 28), J.B. (GX 29), T.D (GX 30), S.G. 
(GX 31), J.H. (GX 32), S.J., A.M. (GX 33), S.N. (GX 34), and W.S. (GX 
36)--and provided a letter summarizing his review. GX 45. Dr. Hare also 
testified about several of these patients individually. Dr. Fine 
similarly reviewed Respondent's medical records for these patients, 
provided an affidavit that was entered into evidence, and testified 
about the results of his review. See RX 36. Moreover, several of the 
patients either submitted affidavits in support of Respondent or 
testified on his behalf. However, for reasons explained in the 
DISCUSSION section of this decision, in light of my findings with 
respect to M.R. and K.D., I find it unnecessary to make findings 
regarding these patients.
    Respondent also submitted nineteen affidavits from fellow 
physicians within his community in support of his continued 
registration. RX 9. Three of these individuals--Dr. Carlos Dribble, Dr. 
Thomas Matthews, and Dr. Richard Dunn--also testified, offering their 
opinion that it is in the ``best interest'' of the local community that 
Respondent retain his registration. See, e.g., Tr. 1215 (Dr. Dibble); 
id. at 1229 (Dr. Matthews); id. at 1246 (Dr. Dunn). However, while 
several of the physicians who provided affidavits and two of the 
physicians who testified had family members who had been patients of 
Respondent, only one, Dr. Beard, had been a patient of Respondent, and 
this was years earlier for fractures, and not pain management. RX 9N, 
at 28. While these individuals stated that they had referred patients 
in the past and would continue to refer patients in the future, none of 
their testimony was based on personal knowledge of Respondent's 
prescribing practices with respect to M.R. and K.D.
    Finally, I further note that Respondent did not testify in this 
proceeding.

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance * * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). With respect to a practitioner, the Act requires the 
consideration of the

[[Page 49973]]

following factors in making the public interest determination:

    (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. Sec.  823(f).

    ``These factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 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 a registration should be 
revoked.'' Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009). While I must consider each factor, I am ``not required to make 
findings as to all of the factors.'' Volkman, 567 F.3d at 222; see also 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).\33\
---------------------------------------------------------------------------

    \33\ As I recently explained, ``this is not a contest in which 
score is kept; the Agency is not required to mechanically count up 
the factors and determine how many favor the Government and how many 
favor the registrant. Rather, it is an inquiry which focuses on 
protecting the public interest,'' and thus, ``what matters is the 
seriousness of the registrant's misconduct,'' Jayam Krishna-Iyer, 74 
FR 459, 462 (2009); and whether he has demonstrated that the 
continuation of his registration is consistent with the public 
interest.
---------------------------------------------------------------------------

    The Government has the burden of proof. See 21 CFR 1301.44. 
However, once the Government's establishes its prima facie case that 
the registrant has committed acts which render his registration 
inconsistent with the public interest, the burden shifts to the 
Respondent to show why the continuation of his registration is 
consistent with the public interest. See Medicine Shoppe-Jonesborough, 
73 FR 364, 387 (2008) (citing cases).
    Having considered all of the factors, I acknowledge that Respondent 
holds a valid medical license from the State of Utah and that there is 
no ``recommendation'' one way or the other from the State Board as to 
whether Respondent should retain his registration (factor one). 
Moreover, it is also undisputed that Respondent had not been convicted 
of an offense related to controlled substances under either Federal or 
State law (factor three).
    In enacting the CSA, Congress vested this Agency with ``a separate 
oversight responsibility [apart from that which exists in State 
authorities] with respect to the handling of controlled substances.'' 
Mortimer B. Levin, 55 FR 8209, 8210 (1990). DEA has therefore long 
recognized that it has ``a statutory obligation to make its independent 
determination as to whether the granting of [a registration] would be 
in the public interest.'' Id. Accordingly, ``DEA has long held * * * 
that a State's failure to take action against a registrant's medical 
license is not dispositive in determining whether the continuation of a 
registration is in the public interest.'' Jayam Krishna-Iyer, 74 FR 
459, 461 (2009); see also Levin, 55 FR at 8210 (holding that 
practitioner's reinstatement by State board ``is not dispositive'' in 
public interest inquiry). Thus, that the Utah Department of 
Professional Licensing has taken no action with respect to Respondent's 
medical license is of no consequence in determining whether his 
continued registration is consistent with the public interest.
    Likewise, while a history of criminal convictions for offenses 
involving the distribution or dispensing of controlled substances is a 
highly relevant consideration, there are any number of reasons why a 
registrant may not have been convicted of such an offense, and thus, 
the absence of such a conviction is of considerably less consequence in 
the public interest inquiry. Krishna-Iyer, 74 FR at 461; Edmund Chein, 
72 FR 6580, 6593 n.22 (2007). Accordingly, that Respondent has not been 
convicted of an offense related to the distribution or dispensing of 
controlled substances is not dispositive of whether the continuation of 
his registration is consistent with the public interest.
    The primary focus of this proceeding is--as the Government 
alleged--his unlawful controlled substance prescribing practices under 
both Federal and State law, see 21 CFR 1306.04(a), and whether he 
engaged in various practices which ``encouraged the abuse of controlled 
substances and allowed their misuse.'' Show Cause Order at 2. This 
conduct is clearly relevant in assessing Respondent's experience in 
dispensing controlled substances (factor two), his compliance with 
applicable laws related to controlled substances (factor four), and 
whether he engaged in ``other conduct which may threaten public health 
and safety'' (factor five). 21 U.S.C. 823(f). Accordingly, I turn to 
whether the evidence relevant under these factors establishes that 
Respondent has committed acts which render his ``registration 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    Under a longstanding DEA regulation, 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 related to controlled 
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term 
``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added).
    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)).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a bonafide doctor-patient relationship in order to act 
``in the usual course of * * * professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 
142-43 (noting that evidence established that 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''). Consistent with the CSA's recognition of the State's 
primary role in regulating the practice of medicine, the Act generally 
looks to State law and standards of medical practice to determine 
whether a doctor and patient have established (and are maintaining) a 
bonafide doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 
54931, 54935 (2007); United Prescription Services, Inc., 72 FR 50397, 
50407

[[Page 49974]]

(2007); see also Volkman, 567 F.3d at 223. But see 21 U.S.C. 829(e) 
(requiring in-person examination by physician in order for pharmacy to 
lawfully dispense controlled substances through the Internet).
    Except for in circumstances not relevant here, under Utah law it is 
``unprofessional conduct'' for a licensed physician to issue ``an order 
or prescription for a drug * * * without first obtaining information in 
the usual course of professional practice, that is sufficient to 
establish a diagnosis, to identify conditions, and to identify 
contraindications to the proposed treatments[.]'' Utah Code Ann. Sec.  
58-1-501(2)(m). Under Utah law, it is also ``unprofessional conduct'' 
for a licensed physician to ``sexually abus[e] or exploit[] any person 
through conduct connected with the licensee's practice under this title 
or otherwise facilitated by the licensee's license.'' Id. Sec.  58-1-
501(2)(k).
    The rules promulgated under the Utah Controlled Substances Act 
further define ``[u]nprofessional conduct'' to include:

    (2) Violating any Federal or State law relating to controlled 
substances;
* * *
    (4) failing to maintain controls over controlled substances 
which would be considered by a prudent practitioner to be effective 
against diversion, theft, or shortage of controlled substances;
* * *
    (6) knowingly prescribing, selling, giving away, or 
administering, directly or indirectly, or offering to prescribe, 
sell, furnish, give away, or administer any controlled substance to 
a drug dependent person, as defined in Subsection 58-37-2(s), except 
for legitimate medical purposes as permitted by law[.] \34\
---------------------------------------------------------------------------

    \34\ Under Utah law, the term ``[d]rug dependent person means 
any individual who unlawfully or habitually uses any controlled 
substance to endanger the public morals, health, safety, or welfare, 
or who is so dependent upon the use of controlled substances as to 
have lost the power of self-control with reference to the 
individual's dependency.'' Utah Code Ann. Sec.  58-37-2(s).

Utah Admin. Code r.156-37-502. See also id. r.156-67-502 (Utah Medical 
Practice Act Rule) (`` `Unprofessional conduct' includes * * * 
knowingly prescribing * * * any controlled substance as defined in 
Title 58, Chapter 37 to a drug dependent person, * * * unless permitted 
by law and when it its prescribed, dispensed or administered according 
to a proper medical diagnosis and for a condition indicating the use of 
that controlled substance is appropriate.'').
    In addition, the Utah Controlled Substance Rules require that 
``[p]rescribing practitioners shall keep accurate records reflecting 
the examination, evaluation and treatment of all patients. Patient 
medical records shall accurately reflect the prescription or 
administration of controlled substances in the treatment of the 
patient, the purpose for which the controlled substance is utilized and 
information upon which the diagnosis is based.'' Id. r.156-37-602(1). 
The rule also requires that ``[a] practitioner shall not prescribe or 
administer a controlled substance without taking into account the 
drug's potential for abuse, the possibility the drug may lead to 
dependence, the possibility the patient will obtain the drug for a 
nontherapeutic use or to distribute to others, and the possibility of 
an illicit market for the drug.'' Id. r.156-37-603(2).
    Finally, under the ``General Rule'' of the Utah DOPL, `` 
`[u]nprofessional conduct' '' also includes ``failing, as a prescribing 
practitioner, to follow the `Model Policy for the Use of Controlled 
Substances for the Treatment of Pain', 2004, established by the 
Federation of State Medical Boards, which is hereby adopted and 
incorporated by reference.'' Id. r.156-1-502(6). As noted above, with 
respect to the evaluation of a patient, the Model Policy provides that:

    A medical history and physical examination must be obtained, 
evaluated, 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 pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

GX 9, at 3.

    With respect to the physician's treatment plan, the Model Policy 
provides that:

    The written treatment plan should state objectives that will be 
used to determine treatment success, such as pain relief and 
improved physical and psychosocial function, and should indicate if 
any further diagnostic evaluations or other treatments are planned. 
After treatment begins, the physician should adjust drug therapy to 
the individual medical needs of each patient. Other treatment 
modalities or a rehabilitation program may be necessary depending on 
the etiology of the pain and the extent to which the pain and the 
extent to which the pain is associated with physical and 
psychosocial impairment.

Id. at 4.

    With respect to the physician's monitoring and supervision of his 
patient, the Model Policy states that ``[t]he physician should 
periodically review the course of pain treatment and any new 
information about the etiology of the pain or the patient's state of 
health.'' Id. Continuing, the policy provides that ``[o]bjective 
evidence of improved or diminished function should be monitored * * * 
If the patient's progress is unsatisfactory, the physician should 
assess the appropriateness of continued use of the current treatment 
plan and consider the use of other therapeutic modalities.'' Id.
    Finally, the Model Policy states that ``[t]he physician should keep 
accurate and complete records to include[:] 1. the medical history and 
physical examination, 2. diagnostic, therapeutic and laboratory 
results, 3. evaluations and consultations, 4. treatment objectives, 5. 
discussion of risks and benefits, 6. informed consent, 7. treatments, 
8. medications (including date, type, dosage and quantity prescribed), 
9. instructions and agreements and 10. periodic reviews.'' Id.
    Applying these standards, the record clearly establishes numerous 
violations of both the CSA's prescription requirement and State law. 
More specifically, while the evidentiary standard applicable in this 
proceeding is the preponderance standard, Steadman v. SEC, 450 U.S. 91, 
100-01 (1981), there is clear and convincing evidence that Respondent 
engaged in the knowing or intentional diversion of controlled 
substances.\35\
---------------------------------------------------------------------------

    \35\ As numerous courts have noted with respect to whether a 
violation of the prescription requirement constitutes an act of 
intentional diversion, there must be ``proof that the practitioner's 
conduct went `beyond the bounds of any legitimate medical practice, 
including that which would constitute civil negligence.' '' United 
States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006) (quoted in 
Laurence T. McKinney, 73 FR 43260, 43266 (2008)). As the Fourth 
Circuit further explained, ``the scope of unlawful conduct under 
Sec.  841(a)(1) [requires proof that a physician] used `his 
authority to prescribe controlled substances * * * not for treatment 
of a patient, but for the purpose of assisting another in the 
maintenance of a drug habit' or some other illegitimate purposes, 
such as his own `personal profit.' '' Id. (quoted at 73 FR at 
43266). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th 
Cir. 2006) (``[T]he Moore Court based its decision not merely on the 
fact that the doctor had committed malpractice, or even intentional 
malpractice, but rather on the fact that his actions betrayed any 
semblance of legitimate medical treatment.'').
     To make clear, this is not a criminal trial, but rather, a 
proceeding brought under sections 303 and 304 of CSA to protect the 
public interest. While proof of intentional or knowing diversion is 
highly consequential in these proceedings, the Agency's authority to 
act is not limited to those instances in which a practitioner is 
shown to have engaged in such acts. See Paul J. Caragine, Jr., 63 FR 
51592, 51601 (1998) (``Just because misconduct is unintentional, 
innocent or devoid of improper motivation, does not preclude 
revocation or denial [of a registration]. Careless or negligent 
handling of controlled substances creates the opportunity for 
diversion and could justify revocation or denial.''). Accordingly, 
under the public interest standard, DEA has authority to consider 
those prescribing practices of a physician, which, while not rising 
to the level of intentional or knowing misconduct, nonetheless 
create a substantial risk of diversion.

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

[[Page 49975]]

    Among the patients to whom he intentionally diverted controlled 
substances are M.R. and K.D. M.R. testified that her complaints of 
wrist and back pain were false and were done so in order to obtain 
controlled substance prescriptions. While a physician is entitled to 
believe a patient's complaint, he still must comply with the 
fundamental requirements necessary to establish a legitimate doctor-
patient relationship and properly diagnose his patient.
    As the medical records show and as Dr. Hare testified, at the 
initial visit, Respondent did not obtain a history ``even in regards to 
the occurrence of the wrist pain and its characterization,'' his 
physical exam was limited to finding that M.R. was neurologically 
intact and grabbing her wrist, and no further tests were ordered. Thus, 
from the outset, Respondent did not comply with the Model Policy's and 
Utah's requirement for obtaining, evaluating and documenting M.R.'s 
medical history and physical examination, which mandates that the 
medical record ``document the nature and intensity of the pain, current 
and past treatment for pain, underlying or coexisting disease or 
conditions, the effect of pain on physical and psychological function'' 
and substance abuse history. While it is true that he did not prescribe 
Lortab to her until the second visit (which occurred a month later), 
the only additional finding related to her wrist pain made at the 
second visit was that she had ``diffuse tenderness over the dorsum of 
the wrist.''
    When M.R. also complained of back-pain, which too was a feigned 
complaint, Respondent's physical exam lasted all of ten seconds and was 
limited to having her stand up, bend over, and then stand up straight 
again. Respondent nonetheless prescribed Lortab to her. As Dr. Hare 
observed, Respondent's evaluation of M.R.'s pain complaints ``was 
inadequate to justify the prescribing of controlled substances for her 
conditions.'' It is thus clear that Respondent did not comply with 
Utah's standards for prescribing controlled substances for pain and 
that he lacked a legitimate medical purpose and acted outside of the 
usual course of professional practice and violated the CSA's 
prescription requirement. 21 CFR 1306.04(a).
    There is ample evidence to infer that Respondent knew full well 
that M.R. was not a legitimate pain patient. More specifically, she 
testified that she ``never really'' had to mention anything to get a 
refill, and that she ``didn't really need to complain'' about being in 
pain ``because he didn't ask if you were in pain.'' She further 
testified that at 95% of her appointments, he just issued her a 
prescription whether for Lortab or either Valium or Xanax without 
discussing her medical condition. Moreover, Respondent issued her 
numerous prescriptions for Valium and Xanax which are unsupported by 
any documentation of a medical purpose. In addition, M.R.'s patient 
file contains a DOPL report which indicated that M.R. was obtaining 
controlled substances from another physician at the same time she was 
actively seeing him.
    Then there is the evidence pertaining to M.R.'s undercover visits. 
For example, while at the first of these visits Respondent refused to 
prescribe to an undercover Agent whom M.R. introduced to him, he 
nonetheless gave M.R. a refill for 90 tablets of Lortab 10 without 
doing something as basic as asking her about her pain level. The 
transcript further shows that Respondent did not perform even a 
perfunctory physical exam, and yet he fabricated M.R.'s patient record 
to indicate that he had conducted a physical examination in which he 
found that she ``has diffuse tenderness L4-S1'' and was 
``neurologically intact.''
    At the second undercover visit, his inquiry was limited to asking 
M.R., ``how are you today?'' Again, Respondent made no inquiry 
regarding her pain level and once again fabricated the patient record 
to indicate that he had performed a physical exam when he had not. 
Moreover, during the visit M.R. told him that she had shared some of 
her drugs with the Agent who had accompanied her at the previous visit 
and asked him if this was ``okay.'' While Respondent initially told 
M.R. that this was ``against the law,'' he then stated, ``Just * * * 
don't tell me about it.'' Thus, Respondent was clearly aware that M.R. 
was diverting drugs, and yet he gave her another prescription for 90 
Lortab. He also made clear that his reason for declining to see the 
undercover Agent was because she had stated that she had previously 
gone to another physician who had been jailed for drug dealing and that 
he was ``staying away from'' persons who had gone to that physician.
    It is thus clear that Respondent knew that M.R. was not a 
legitimate pain patient and that she was seeking the controlled 
substances for illicit purposes (whether to self-abuse or sell to 
others is irrelevant). Yet he continued to prescribe to her. And even 
following these two visits, when it cannot be disputed that he knew 
that she was not a legitimate pain patient, he wrote her additional 
prescriptions at both her third and fourth undercover visits for 90 
Lortab, each of which also authorized a refill.
    With respect to M.R., Dr. Fine (Respondent's expert) offered only 
the disingenuous testimony that he could not opine on the validity of 
Respondent's prescribings during the undercover visits without ``a full 
audiovisual recording of these visits'' and that, without knowing the 
context of the physician-patient relationship, he couldn't ``make sense 
out of'' the transcripts. Contrary to Dr. Fine's testimony, it is 
possible to make sense out of the transcripts. What they manifest is 
that Respondent's prescribings to M.R. ``betrayed any semblance of 
legitimate medical treatment,'' Feingold, 454 F.3d at 1010, were well 
outside of the usual course of professional practice, and lacked a 
legitimate medical purpose. In short, Respondent knowingly and 
intentionally dealt drugs to M.R. and violated Federal law in doing so. 
21 U.S.C. 841(a)(1).
    As for K.D., while she testified that she had a legitimate pain 
condition, she also acknowledged that a ``huge percentage'' of the 
prescriptions she obtained from Respondent were ``for recreational 
use.'' Moreover, even if is true that she was still suffering pain at 
the time of her initial visit, Dr. Hare noted that ``there is an 
inadequate history and physical evaluation to justify prescribing 
chronic controlled substance prescriptions and particularly in 
escalating amounts.'' Indeed, as K.D. testified, Respondent's physical 
exam was limited to looking at her neck; he did not order diagnostic 
tests such as x-rays and did not even ask her about the severity of her 
pain. Moreover, as Dr. Hare noted, when Respondent changed his 
diagnosis from cervical spine pain to low back pain, ``there was no 
significant additional evaluation done to try to delineate the problem 
or other means for treatment suggested.''
    Beyond this, throughout the course of his prescribing to her, 
Respondent escalated the prescriptions from Lortab 7.5 mg, a schedule 
III controlled substance, to OxyContin 40 mg., a schedule II controlled 
substance; he also frequently prescribed either more Lortab or Percocet 
simultaneously with these prescriptions. Yet, as Dr. Hare explained, 
there was no ``documentation or indication of patient improvement even 
with [the] dramatic increase in the medications, such as OxyContin and 
Oxycodone.''

[[Page 49976]]

    Moreover, as Dr. Hare observed, Respondent escalated his 
prescribing notwithstanding that there were ``many signs and outright 
indications'' of overuse and abuse. These include K.D.'s claims that 
her medications were stolen (which occurred as early as her third 
visit); a police report for a domestic disturbance in May 2005, which 
indicated that she had a problem with substance abuse; a December 2007 
letter in which Respondent recounted that he would no longer see her 
because she had claimed that her insurance would not pay to fill an 
OxyContin prescription and needed a prescription for another drug, but 
then filled the OxyContin prescription; a report from a local narcotics 
task force, which included a DOPL report, showing that she was getting 
controlled substances from five different prescribers; K.D.'s seeking 
early refills (which he provided) even after he received the DOPL 
report; and K.D.'s continuing to see him even after she had reported 
that she was moving out of state. Notwithstanding each of these 
incidents, Respondent continued to prescribe to K.D.
    To make clear, this is not a case of doctor who was merely 
indifferent to the warning signs that his patient was abusing or 
selling drugs. Rather, the record demonstrates that Respondent 
continued to prescribe to K.D. even after he was aware of some of these 
incidents, because he was using his prescribing authority to receive 
sexual favors from her.
    As the evidence shows, on multiple occasions beginning in September 
2006 and lasting through March 2008, Respondent engaged in sexual 
activities with K.D., which included giving her topless massages and 
digitally penetrating her, in exchange for controlled substance 
prescriptions. As even Dr. Fine acknowledged, Respondent's conduct 
``would not be viewed as within the Code of Ethical Conduct,'' and it 
would not be within the usual course of professional practice for a 
physician, who had engaged in such conduct, to issue controlled 
substance prescriptions to that person. Tr. 763-64. Indeed, the conduct 
is so far outside the bounds of professional practice as to constitute 
evidence of intentional diversion.
    K.D. also made several undercover visits. While at the first of 
these visits (Nov. 2008), Respondent asked her if she was getting pills 
from other doctors, he was then already aware that he was under 
investigation, complained that DEA had ``actually sent people in with 
wires,'' and also asked her if she was ``a plant from the police or the 
DEA.'' Given the context of the conversation (as well as all the other 
evidence regarding his relationship with her), it is reasonable to 
conclude that Respondent's reason for asking K.D. whether she was 
getting pills from other doctors was not because he was concerned that 
she was a drug abuser or drug dealer, but rather, that he would be 
caught.
    While K.D. stated at this visit that she had ``been in a lot of 
pain,'' his response was limited to stating, ``I'll bet you have,'' 
with no further inquiry as to her pain level and how it was affecting 
her ability to function, the efficacy of what Respondent had previously 
prescribed, and any side effects. In addition, Respondent fabricated 
K.D.'s medical record to indicate that he had performed a physical exam 
when he did not. Respondent nonetheless gave her prescriptions for 90 
tablets of OxyContin 40 mg., 120 tablets of oxycodone IR 30 mg., and 30 
tablets of Ambien.
    At the next undercover visit, Respondent again asked K.D. if she 
was ``working with the DEA, or wearing a wire?'' This, of course, is 
not the type of conversation one would expect to occur in the usual 
course of an office visit involving a legitimate patient and doctor. 
While at this visit, Respondent stated that he could not refill one of 
her previous prescriptions (likely the OxyContin 40) because it was 
``less than four weeks,'' he then gave her a prescription for 60 
tablets of oxycodone IR 30 mg. (also a schedule II drug, which is 
nearly as potent as OxyContin 40 mg.) to supply her until the following 
week. At this visit, Respondent did not ask her a single question about 
her purported medical condition and K.D. made no statements about being 
in pain. Moreover, once again Respondent falsified her medical record 
to indicate that he had performed a physical exam when he had not done 
so.
    At the next undercover visit, Respondent asked K.D. what she needed 
and she replied with a shopping list of drugs including ``My OxyContin, 
my Roxicet, my Fioricet, my Ambien, and I have been so stressed out, so 
I was going to see if I could get some Xanax too.'' While K.D. 
complained that she was going though some ``sh-t,'' Respondent asked 
how many Xanax she wanted, a question not typically asked of a patient 
by a physician in the usual course of professional practice but one 
which is consistent with drug dealing. While there was no discussion of 
how the previously prescribed drugs affected her pain level, functional 
capacities, and whether she had experienced any side effects, 
Respondent gave her new prescriptions for 90 OxyContin 40 mg., 120 
Oxycodone 30 mg., and 30 Xanax. And again, K.D.'s record indicates that 
at this visit Respondent performed a physical exam although the 
transcript contains no evidence that he did so.
    As for K.D.'s final undercover visit which likely occurred on 
December 18 (only 17 days after the previous visit), the recording 
contains no indication that Respondent performed a physical exam on her 
although he indicated in her record that he had done so. There is also 
no indication in the recording that K.D. and Respondent discussed how 
the prescriptions were affecting her pain level and functionality 
although he indicated in her medical record that the prescriptions 
controlled her pain well. Once again, Respondent asked K.D. what she 
needed, and K.D. requested several controlled substances. Respondent 
then gave her prescriptions for 90 OxyContin 40 mg. (so much for the 
law which he had previously stated required four weeks between 
prescriptions) as well as 120 oxycodone 30 mg. and 30 Xanax.\36\
---------------------------------------------------------------------------

    \36\ In his exceptions, Respondent argues that K.D. testified 
that ``she was in fact in real pain during the final undercover 
visit, [and] she felt the prescription was legitimate because she 
had legitimate pain.'' Resp. Exc. at 27. Even if K.D. was in pain, 
this does not make the prescriptions Respondent issued at this visit 
lawful because he did not ask K.D. a single question about the 
nature and intensity of her pain and thus had no clinical basis for 
concluding that the prescriptions, which were for multiple drugs, 
were medically necessary to treat her pain. In addition, at this 
visit, Respondent also gave K.D. a prescription for Xanax. Yet K.D. 
did not testify that she had anxiety, the medical condition which 
Xanax is typically prescribed for. In sum, at this visit, K.D. 
presented a shopping list of drugs and in issuing the prescriptions, 
Respondent abdicated his role as a physician. I thus reject 
Respondent's contention.
---------------------------------------------------------------------------

    As Dr. Hare opined, in the usual course of professional practice, a 
physician engaged in pain management would have adequately evaluated 
his patient ``to set the base,'' which Respondent did not do. Moreover, 
when, as in K.D.'s case, there are ``multiple indications'' that a 
patient is abusing controlled substances, a physician must ``closely 
monitor the patient[],'' and discharge a patient who did not comply 
with the plan.
    Of course, Respondent did none of these things in the course of his 
prescribing to K.D. I thus agree with Dr. Hare's conclusion that 
Respondent issued to K.D. numerous prescriptions which were not 
``within the usual course of professional practice and for a legitimate 
medical purpose.'' 21 CFR 1306.04(a). And I further conclude that the 
totality of the evidence with respect to K.D. not only establishes that 
Respondent violated the CSA's prescription requirement, but also that 
he did so knowingly and intentionally. 21 U.S.C. 841(a)(1).

[[Page 49977]]

    Consistent with DEA precedent, my findings that Respondent 
intentionally diverted to M.R. and K.D. and did so on multiple 
occasions are sufficient to hold that the Government has made a prima 
facie showing that Respondent has committed acts which render his 
registration inconsistent with the public interest. As I have 
previously noted, the Agency has revoked other practitioner's 
registration for committing as few as two acts of diversion, see 
Krishna-Iyer, 74 FR at 463 (citing Alan H. OIefsky, 57 FR 928, 928-29 
(1992)), and the Agency can revoke based on a single act of intentional 
diversion. Accordingly, there is no need to make findings regarding the 
other patients.
    In his post-hearing brief, Respondent argues that he presented the 
testimony of three physicians (as well as the affidavits of sixteen 
others) to the effect that he should be allowed to keep his 
registration because of the benefit he provides to his local community. 
Resp. Summation Br. at 26. Respondent also cites an unpublished 
decision of the Eleventh Circuit, which vacated my Decision and Order 
in Jayam Krishna-Iyer, M.D., 71 FR 52148 (2006), on the ground that I 
``did not consider any of Petitioner's positive experience in 
dispensing controlled substances.'' Id. (quoting Krishna-Iyer v. DEA, 
249 Fed. Appx. 159, 160 (11th Cir. 2007)). According to Respondent, 
``[a] better assessment of [his] medical practice and habits can be 
ascertained from [his] numerous positive experiences in prescribing 
controlled substances, some of which were recounted by the patients 
themselves * * * at the hearing.'' Id. at 3.
    However, as I noted in my Decision on remand in Krishna-Iyer, the 
Eleventh Circuit ``did not cite to any decision of either this Agency 
or another court defining the term `positive experience.' Nor did the 
Court offer any guidance as to the meaning of this term, which is not 
to be found in the'' CSA. 74 FR at 460. Accordingly, in Krishna-Iyer, I 
assumed that the physician's controlled-substance prescribings to every 
other patient in the course of her medical career ``constitute[d] 
`positive experience,' '' whatever that means. Id. at 461. However, as 
I noted therein, ``[h]er prescribings to thousands of other patients 
[did] not * * * render her prescribings to the undercover officers any 
less unlawful, or any less acts which `are inconsistent with the public 
interest.' '' Id. at 463. See also Medicine Shoppe-Jonesborough, 73 FR 
364, 386 & n.56 (2008) (noting that pharmacy ``had 17,000 patients,'' 
but that ``[n]o amount of legitimate dispensings can render * * * 
flagrant violations [acts which are] `consistent with the public 
interest.' ''), aff'd, Medicine Shoppe-Jonesborough v. DEA, 300 Fed. 
Appx. 409 (6th Cir. 2008).
    This is so because under the CSA, ``registration is limited to 
those who have authority to dispense controlled substances in the 
course of professional practice.'' Krishna-Iyer, 74 FR at 463. Because 
``patients with legitimate medical conditions routinely seek treatment 
from licensed medical professionals, every registrant can undoubtedly 
point to an extensive body of legitimate prescribing over the course of 
[his] professional career.'' Id.
    In Krishna-Iyer, I further explained that ``evidence that a 
practitioner has treated thousands of patients [without violating the 
CSA] does not negate a prima facie showing that a practitioner has 
committed acts inconsistent with the public interest. While such 
evidence may be of some weight in assessing whether a practitioner has 
credibly shown that she has reformed her practices, where a 
practitioner commits intentional acts of diversion and insists she did 
nothing wrong, such evidence is entitled to no weight.'' Id.
    Accordingly, even assuming, without deciding, that Respondent's 
prescribing practices to all of his other patients (including those 
whose medical records were reviewed by the Government's expert) fully 
complied with the CSA and Utah law, these prescribings do not refute 
the evidence showing that he intentionally diverted to M.R. and K.D. in 
violation of both the CSA and Utah law.\37\ I thus reject Respondent's 
arguments and conclude that the Government has established a prima 
facie case that his continued registration is ``inconsistent with the 
public interest.''\38\ 21 U.S.C. 823(f).
---------------------------------------------------------------------------

    \37\ As for the evidence provided by Respondent's fellow 
practitioners, none of them have personal knowledge of his 
prescribing practices with respect to M.R. and K.D. The evidence is 
thus not probative of whether he violated the CSA and Utah law in 
prescribing controlled substances to them.
    \38\ In light of my findings under factors two and four, I 
conclude that it is not necessary to make findings under factor 
five.
---------------------------------------------------------------------------

Sanction

    Under Agency precedent, where, as here, ``the Government has proved 
that a registrant has committed acts inconsistent with the public 
interest, a registrant must `present[] sufficient mitigating evidence 
to assure the Administrator that [he] can be entrusted with the 
responsibility carried by such a registration.' '' Medicine Shoppe-
Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, 72 FR 23848, 
23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). 
Moreover, because ``past performance is the best predictor of future 
performance, ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), 
[DEA] has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also 
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); 
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. 
DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).
    As noted above, Respondent did not testify in this proceeding. It 
has long been settled, however, that the Fifth Amendment privilege does 
not preclude the Agency from drawing an adverse inference based on a 
registrant's failure to testify in a proceeding under sections 303 and 
304 of the Act. Cf. Baxter v. Palmigiano, 425 U.S. 308, 318-20 (1976); 
see also The Lawsons, Inc., 72 FR 74334, 74339 (2007); United 
Prescription Services, Inc., 72 FR 50397, 50409 n.31 (2007). Based on 
Respondent's failure to testify, I further conclude that Respondent 
does not accept responsibility for his misconduct, and therefore, he 
has not rebutted the Government's prima facie showing that his 
continued registration is inconsistent with the public interest. See 
Krishna-Iyer, 74 FR at 464.
    Respondent nonetheless argues that the revocation of his 
``registration is an extreme penalty and a limited restriction of his 
DEA registration is likely more appropriate.'' Resp. Summation Br. 
Findings at 31. As support for his contention, Respondent cites several 
agency decisions which granted a restricted registration to a 
practitioner. See id. at 31-32. None of these cases support Respondent.
    In Larry L. Kompus, 55 FR 30990, 30991-92 (1990), the physician's 
misconduct, which involved trading controlled substances for sexual 
favors, had occurred ``more than ten years'' earlier. Moreover, in 
contrast to Respondent, the physician ``acknowledged the wrongfulness 
of his actions and ha[d] shown remorse for them.'' Id.
    Likewise, in William P. Jerome, 61 FR 11867, 11867-68 (1996), there 
was extensive evidence of the physician's misconduct which also 
involved trading controlled substances (both samples and prescriptions) 
for sexual favors and trading controlled substances for other 
controlled substances and/or cash. Id.

[[Page 49978]]

However, the physician had committed the acts at least six years 
earlier. Id. Most importantly, in addition to presenting evidence of 
his rehabilitation, the physician admitted that he had violated Federal 
law and ``testified as to his remorse for his past misconduct and his 
determination that he [would] not engage in such conduct in the 
future.'' Id. at 11870. The case thus provides no comfort to 
Respondent.
    In another portion of his brief, Respondent cites three additional 
cases in which the Agency granted a restricted registration to a 
practitioner. See Resp. Summation Br. at 26-27 (citing Karen A. Kruger, 
69 FR 7016 (2004); Wesley G. Harline, 65 FR 5665 (2000); Paul J. 
Caragine, Jr., 63 FR 51592 (1998)). However, none of these cases 
support granting Respondent a restricted registration.
    In Caragine, unlike here, there was no evidence of intentional 
diversion and the physician testified that he had undergone training to 
help him better identify and manage drug-seeking patients.\39\ See 63 
FR at 51601. Likewise, in Harline, there was no evidence of intentional 
diversion. Indeed, the Agency specifically held that the prescriptions 
in dispute were issued for a legitimate medical purpose and thus did 
not violate the CSA. See 65 FR at 5671. Furthermore, the practitioner 
admitted that he had violated State law and gave assurance that he 
would not do so in the future. Id. Finally, Kruger involved a 
practitioner who wrote fraudulent prescriptions to obtain drugs for 
self-abuse and not to divert to others. The practitioner, however, 
readily admitted her misconduct and provided evidence that she had 
undergone treatment.
---------------------------------------------------------------------------

    \39\ In Krishna-Iyer, I made clear that while there may be a few 
isolated decisions that suggest that a practitioner who has 
committed only a few acts of diversion may regain his registration 
``without having to accept responsibility for his misconduct, the 
great weight of the Agency's decisions is to the contrary.'' 74 FR 
at 464 (citation omitted). I explained that ``[b]ecause of the grave 
and increasing harm to public health and safety caused by the 
diversion of prescription controlled substances, even where the 
Agency's proof establishes that a practitioner has committed only a 
few acts of diversion, this Agency will not grant or continue the 
practitioner's registration unless he accepts responsibility for his 
misconduct.'' Id. I further held that to the extent any decision of 
this Agency suggests otherwise, it is overruled. Id. at n.9. Thus, 
were a case to present facts similar to those of Caragine, I would 
likely deny the practitioner's application.
    As I also noted in Krishna-Iyer: ``The diversion of controlled 
substances has become an increasingly grave threat to this nation's 
public health and safety. According to The National Center on 
Addiction and Substance Abuse (CASA), `[t]he number of people who 
admit abusing controlled prescription drugs increased from 7.8 
million in 1992 to 15.1 million in 2003.' '' 74 FR at 463 (quoting 
National Center on Addiction and Substance Abuse, Under the Counter: 
The Diversion and Abuse of Controlled Prescription Drugs in the U.S. 
3 (2005) [hereinafter, Under the Counter]). CASA also found that 
``[a]pproximately six percent of the U.S. population (15.1 million 
people) admitted abusing controlled prescription drugs in 2003, 23 
percent more than the combined number abusing cocaine (5.9 million), 
hallucinogens (4.0 million), inhalants (2.1 million) and heroin 
(328,000).'' Id. (quoting Under the Counter at 3). Finally, CASA 
found that ``[b]etween 1992 and 2003, there has been a * * * 140.5 
percent increase in the self-reported abuse of prescription 
opioids,'' and in the same period, the ``abuse of controlled 
prescription drugs has been growing at a rate twice that of 
marijuana abuse, five times greater than cocaine abuse and 60 times 
greater than heroin abuse.'' Id. (quoting Under the Counter at 4).
---------------------------------------------------------------------------

    In contrast to these cases, Respondent does not remotely meet the 
Agency's standards for obtaining a restricted registration. His failure 
to testify precludes a finding that he has accepted responsibility for 
his misconduct. His misconduct is egregious; that he continued to 
provide unlawful prescriptions even when he knew he was under 
investigation renders it especially so. Thus, even if Respondent 
provided treatment to some legitimate patients and those patients 
benefitted from his treatment of them, the evidence with respect to 
M.R. and K.D. establishes that he is still a drug dealer.
    In short, Respondent has not rebutted the Government's prima facie 
case that he has committed acts which ``render his registration * * * 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). 
Accordingly, I conclude that the public interest requires that his 
registration be revoked and his pending application be denied. And 
because of the egregiousness of his misconduct, I conclude that the 
public interest requires that his Order be effective immediately. See 
21 CFR 1316.67.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA 
Certificate of Registration, AM9742380, issued to Dewey C. MacKay, 
M.D., be, and it hereby is, revoked. I further order that any pending 
application to renew or modify the registration be, and it hereby is, 
denied. This Order is effective immediately.

    Dated: August 3, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20211 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P