Dewey C. Mackay, M.D.; Revocation of Registration, 49956-49978 [2010-20211]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49956-49978]
From the Federal Register Online via the Government Printing 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 unde