Jeri Hassman, M.D.; Denial of Application, 8194-8237 [2010-3305]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8194-8237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3305]



[[Page 8193]]

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Part II





Department of Justice





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Drug Enforcement Administration



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Jeri Hassman, M.D.; Denial of Application; Notice

Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / 
Notices

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 06-62]


Jeri Hassman, M.D.; Denial of Application

    On June 1, 2006, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration issued an Order to 
Show Cause to Jeri Hassman, M.D. (Respondent), of Tucson, Arizona. The 
Show Cause Order proposed the denial of Respondent's application for a 
new DEA Certificate of Registration as a practitioner, authorizing her 
to dispense controlled substances in schedules II through V, on the 
grounds that the Respondent had ``been convicted of a felony under the 
Controlled Substances Act, [had] materially falsified [her] 
application, and ha[d] committed such other acts as would render [her] 
registration under 21 U.S.C. 823 inconsistent with the public 
interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 824(a)(1)(2) and (4), 
824(a) and 823).
    More specifically, the Show Cause Order alleged that on November 1, 
2002, DEA had immediately suspended Respondent's DEA registration on 
the ground that she ``regularly engaged in the practice of prescribing 
excessive amounts of controlled substances * * * to patients for no 
legitimate medical purpose.'' Id. at 1-2. The Show Cause Order next 
alleged that patients to whom she had prescribed controlled substances 
had died of overdoses. Id. at 2-3.
    Next, the Show Cause Order alleged that Respondent ``prescribed 
excessive quantities of controlled substances to patients, including 
frequent early refills'' to a number of other patients. Id. at 3. The 
Show Cause Order alleged that Respondent:

generally failed to adequately evaluate patients, failed to conduct 
complete physical examinations, failed to obtain adequate histories, 
failed to include pain ratings, failed to determine the exact 
location or character of the pain, failed to obtain information 
concerning previous treatment from other physicians or medication 
used.

    Id. In addition, the Show Cause Order stated that ``[d]espite these 
inadequate evaluations, [Respondent] immediately prescribed controlled 
substances to these patients.'' Id.
    The Order to Show Cause also alleged that Respondent was ``made 
aware of possible diversion incidents but continued to prescribe 
controlled substances for patients who were engaged in diversion.'' Id. 
at 4. The Show Cause Order related five known incidents involving (1) 
F.L. and his son B.L., both patients of Respondent; (2) & (3) J.O. and 
her husband W.O., both patients of Respondent; (4) M.H., P.H., and 
A.B., a mother and two ``daughters'', all patients of Respondent; and 
(5) S.R., a patient of Respondent. Id. at 4-6.
    The Show Cause Order further alleged that on January 29, 2004, 
Respondent pled guilty to ``four felony violations of 18 U.S.C. 3 
involving controlled substances: Accessory After the Fact to Possession 
of Controlled Substances by Misrepresentation, Fraud, Forgery, 
Deception or Subterfuge, 21 U.S.C. 843(a)(3).'' Id. at 6.
    Next, the Show Cause Order alleged that on March 10, 2004, 
Respondent ``entered into a Consent Agreement with the Arizona Medical 
Board (the Board), in which the Board found that [Respondent] failed in 
many ways to properly care for [her] patients, including the 
prescribing of excessive amounts of controlled substances.'' Id. 
According to the Show Cause Order:

    The Board also found that [Respondent] failed to conduct 
physical examinations, failed to obtain adequate patient histories 
and failed to obtain prior medical records. The Board also found 
that [her] patient notes often did not provide sufficient 
information to support the diagnoses, justify the treatments, 
accurately document the results, or indicate advice and cautionary 
warnings provided to the patients.
    * * * Under the Consent Agreement the Board found [Respondent] 
guilty of unprofessional conduct and placed [Respondent's] Arizona 
medical license on probation for two years from the effective date 
of the Consent Agreement.

Id.
    Finally, the Show Cause Order alleged that Respondent materially 
falsified her application, when, on January 28, 2005, Respondent 
applied for her DEA registration, she marked ``no'' to question 4(d), 
which ``asked, in pertinent part, whether [Respondent] had ever had a 
State professional license revoked, suspended or placed upon 
probation.'' Id.
    Respondent timely requested a hearing on the allegations, ALJ Ex. 
2, and the matter was placed on the docket of the Agency's 
Administrative Law Judges (ALJ). Following pre-hearing procedures, a 
hearing was held on January 22-26, 2007 and February 27 to March 2, 
2007, in Tucson, Arizona. Moreover, on March 13, 2007, the ALJ 
conducted a transcribed telephone conference at which Respondent gave 
her closing argument. Thereafter, both parties filed post-hearing 
briefs.
    On October 9, 2008 the ALJ issued her Opinion and Recommended 
Decision (ALJ). With respect to factor one (the recommendation of the 
State licensing board), the ALJ noted that, while Respondent has twice 
been placed on probation and either censured or reprimanded, she 
currently holds an active, unrestricted medical license, and that this 
factor weighs in favor of her continued registration. ALJ at 147-48.
    With respect to factor two (Respondent's experience in dispensing 
controlled substances) and factor four (Respondent's compliance with 
applicable laws relating to controlled substances), the ALJ concluded 
that the Government had established that Respondent issued 
prescriptions to two persons (H.T. and R.T.) which lacked a legitimate 
medical purpose. ALJ at 150. The ALJ reasoned, however, that these were 
``only two patients out of more than 900 whom Respondent was treating 
at that time,'' and thus the Government had not shown that 
``Respondent's overall medical practices [were] consistently lacking in 
legitimate purpose.'' Id. at 150.
    The ALJ specifically rejected the evidence of the Government's 
Expert with respect to twenty-three other patients, noting that various 
physicians who testified on behalf of Respondent had disagreed with the 
conclusions of the Government's Expert. Id. at 151. According to the 
ALJ, this was ``not to minimize the seriousness of the Respondent's 
cavalier attitude toward handling controlled substances during 2001 and 
2002, but rather to demonstrate that it is not clear that her general 
treatment practices were lacking in medical purpose.'' Id.
    In support of her conclusion, the ALJ cited various areas in which 
she maintained ``that there was no clear consensus in the medical 
community regarding which practices were required to meet the standard 
of care during 2001 and 2002.'' Id. According to the ALJ, these areas 
included the role of physical examinations in treating chronic pain 
patients, the use of laboratory tests, the need to refer patients to 
other doctors as part of the course of treatment, appropriate dosage 
levels of controlled substances for treating chronic pain, and the 
propriety of prescribing both long and short-acting opioids 
simultaneously. Id.
    The ALJ also rejected the Government's contention that Respondent's 
falsification of H.T.'s medical record (who performed multiple 
undercover visits and wore a recording device) justified the denial of 
her application. Id. at 153-55. While acknowledging that ``[i]t is 
indeed disturbing that the Respondent apparently altered H.T.'s medical 
chart to include a physical examination that

[[Page 8195]]

was not reflected in the recorded interaction between the Respondent 
and H.T.,'' id. at 153, the ALJ concluded ``that a single instance does 
not rise to the level of [a] pervasive pattern of falsification.'' Id. 
at 155. In this regard, the ALJ also noted that Respondent was working 
with another physician to improve her recordkeeping practices.\1\ Id. 
at 155-56. The ALJ did not, however, expressly find whether the 
evidence under factors two and four satisfied the Government's prima 
facie burden.
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    \1\ The ALJ also noted that a 2002 DEA Audit of controlled 
substances which Respondent physically dispensed had found that 
Respondent was unable to account for 150 dosage units out of a total 
of 7,560 dosage units which were on hand. Id. at 153. DEA 
Investigators also found that Respondent had failed to keep 
receiving records for samples of controlled substances which her 
office received, that the records did not contain all of the 
information required by regulations, and that some records may have 
been missing because Respondent was not aware that she was required 
to keep them for two years. Id. I agree with the ALJ that these 
deficiencies are not sufficient by themselves to justify denying her 
application.
     Finally, the ALJ rejected the Government's contention that 
Respondent had materially falsified her application because she 
answered ``no'' to the question whether her State license had ever 
been sanctioned. Id. at 160. The ALJ found that Respondent had 
attached to her application a letter from the Arizona Medical Board 
which indicated that she would ``continue to be monitored every six 
months until the end of her probation in March 2007.'' Id. (quoting 
GX 3, at 4). According to Respondent, based on the wording of the 
letter she believed that she--and not her medical license--had been 
placed on probation by the Board. Id. In light of Respondent's 
having provided the letter with her application, as well as her 
having truthfully answered the other questions on the application, I 
agree with the ALJ that she ``lacked the intent to deceive the'' 
Agency. Id. at 161.
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    The ALJ further found that Respondent had been convicted of four 
counts of the felony offense of ``Accessory After the Fact to 
Possession of Controlled Substances by Misrepresentation, Fraud, 
Forgery Deception or Subterfuge,'' and that the convictions could be 
considered as either an offense ``under Federal * * * laws relating to 
the * * * dispensing of controlled substances,'' 21 U.S.C. 823(f)(4), 
or as ``[s]uch other conduct which may threaten the public health and 
safety.'' Id. Sec.  823(f)(5); see also id. at 158. While the ALJ found 
that Respondent's convictions ``could * * * weigh in favor of denial of 
the * * * application,'' id. at 158, she also did not address whether 
this factor established the Government's prima facie case.
    The ALJ further found that Respondent had ``engaged in extensive 
remedial training,'' that she has ``improved skills now available to 
her, including the use of risk assessment tools and [the] collection of 
extensive addiction histories on each patient,'' and that she would 
continue to consult with another pain management expert. Id. at 161-62. 
The ALJ also found it significant that the State Board would conduct 
regular reviews of her medical charts and quarterly compliance reports. 
Id. at 162. Finally, the ALJ found that ``Respondent's willingness to 
admit her past mistakes, accept responsibility for her actions, and 
remedy her professional deficiencies should weigh heavily in favor of 
granting her application.'' Id. at 162. The ALJ thus recommended that I 
grant Respondent a new registration subject to the conditions that she 
continue her mentoring arrangement with a pain management specialist 
for a period of three years and also submit the quarterly reports 
required by the State Board to the Agency. Id. at 163.
    On November 3, 2008, the Government filed its exceptions to the 
ALJ's decision; and on November 28, 2008, Respondent submitted her 
response to the Government's exceptions. On December 22, 2008, the ALJ 
forwarded the record to me for final agency action.
    Having considered the entire record in this matter, including the 
ALJ's decision and the parties' briefs, I adopt the ALJ's conclusion of 
law with respect to the allegations of material falsification. I also 
agree with the ALJ that Respondent's prescriptions for H.T. lacked a 
legitimate medical purpose. I reject, however, the ALJ's conclusions 
with respect to factors two and four.
    The ALJ's failure to acknowledge that the Government established a 
prima facie case for denying the application was largely based on her 
conclusion that the Government had only proved that Respondent issued 
unlawful prescriptions to two patients and that it had not shown that 
her ``other medical practices [were] consistently lacking in legitimate 
purpose.'' The ALJ's reasoning is erroneous for several reasons.
    First, it is inconsistent with Agency precedent, which holds that 
proof of as few as two acts of diversion satisfies the Government's 
prima facie burden under the public interest standard and supports the 
revocation of a practitioner's registration when she fails to accept 
responsibility for her misconduct. See Alan H. Olefsky, 57 FR 928, 928-
29 (1992); see also Sokoloff v. Saxbe, 501 F.2d 571, 576 (2d Cir. 
1974). The record here, however, supports the conclusion that 
Respondent knowingly issued multiple prescriptions to H.T. which lacked 
a legitimate medical purpose and violated Federal law. Moreover, while 
the ALJ stated that she had made extensive findings to place 
Respondent's treatment of various patients in context, ALJ at 151 n.34, 
she nonetheless frequently ignored relevant evidence establishing 
numerous other instances in which Respondent issued prescriptions which 
clearly violated the prescription requirement of Federal law. 21 CFR 
1306.04(a).
    Second, the ALJ's reasoning ignores longstanding precedent that the 
Agency's authority to revoke a registration or deny an application is 
not limited to those instances in which a practitioner intentionally 
diverts. Rather, a practitioner who ignores the warning signs that her 
patients are either personally abusing or diverting to others, commits 
acts inconsistent with the public interest even if her conduct is 
merely reckless or negligent. See Paul J. Caragine, Jr., 63 FR 51592 
(1998). My review of the patient records establishes numerous instances 
in which Respondent ignored obvious warning signs that her patients 
were either personally abusing or diverting. Relatedly, the ALJ did not 
make detailed findings regarding the frequency of Respondent's issuance 
of new prescriptions even though this was one of the significant issues 
in this matter. Moreover, I reject the ALJ's conclusion that Respondent 
only falsified H.T.'s patient record once and conclude that substantial 
evidence supports the finding that on six different occasions she 
falsified his patient record to indicate that she had performed a 
physical exam when she had not.
    While I acknowledge that Respondent has undertaken some measures to 
improve her practice, I am compelled to reject the ALJ's findings that 
she has willingly ``admit[ted] her past mistakes,'' and ``accepted 
responsibility for her actions.'' ALJ at 162. As explained more fully 
below, with respect to the prescriptions she issued to H.T., Respondent 
continues to deny that she did anything wrong. Moreover, in her 
testimony, Respondent maintained that there is nothing wrong with 
persons using a controlled substance that has not been prescribed to 
them but to family members and that she did not know what the term 
``early refill'' meant even though this was one of the central issues 
in this case. Accordingly, I conclude that Respondent has not rebutted 
the Government's prima facie showing that granting her a registration 
would be ``inconsistent with the public interest.'' 21 U.S.C. 823(f). 
Respondent's application will therefore be denied. As ultimate 
factfinder, I make the following findings.

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Findings 2
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    \2\ In this document I take official notice of several material 
facts because the record is unclear. Under the Administrative 
Procedure Act (APA), an agency ``may take official notice of facts 
at any stage in a proceeding--even in the final decision.'' U.S. 
Dept. of Justice, Attorney General's Manual on the Administrative 
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). 
In accordance with the APA and DEA's regulations, Respondent is 
``entitled on timely request to an opportunity to show to the 
contrary.'' 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow 
Respondent the opportunity to refute the facts of which I take 
official notice, Respondent may file a motion for reconsideration 
within fifteen days of service of this order which shall commence 
with the mailing of the order.
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    Respondent graduated from New York University Medical School in 
1981. Tr. 1346. She has been board-certified in physical medicine and 
rehabilitation since 1988, and she has practiced medicine in the State 
of Arizona since 1986. Id. Respondent practices as a physiatrist, a 
physician who specializes in physical medicine and rehabilitation. Id.
    Respondent formerly held DEA registration BH1192359. ALJ Ex. 1, at 
1. In August 2001, the Arizona Medical Board initiated an investigation 
of Respondent in response to two complaints from health care plans and 
one complaint from a pharmacy concerning Respondent's prescribing of 
controlled substances. GX 73, at 4. In July 2001, in response to 
complaints received from Tucson area pharmacists about Respondent's 
prescribing of controlled substances, DEA also initiated an 
investigation. GX 70, at 3. On May 16, 2002, DEA, along with law 
enforcement officers from other agencies, executed a search warrant at 
Respondent's registered location, Calmwood Medical in Tucson, Arizona. 
Id. at 20-21. On November 1, 2002, my predecessor immediately suspended 
Respondent's DEA registration. ALJ Ex. 1, at 1.
    On March 26, 2003, a Federal grand jury indicted Respondent, 
charging her with numerous violations of Federal law. See GX 5. 
Thereafter, Respondent and the Government agreed to a plea bargain; and 
on January 29, 2004, Respondent pled guilty to four counts of Accessory 
After the Fact to Possession of Controlled Substances by 
Misrepresentation, Fraud, Forgery, Deception, or Subterfuge. GX 6, at 
1.

The Consent Agreement With the Arizona Medical Board

    On March 10, 2004, following the entry of the plea agreement on 
January 29, 2004, Respondent entered into a Consent Agreement For 
Decree of Censure And Probation with the Arizona Medical Board (``the 
Board''). See GX 73. In the consent agreement, the Board noted that its 
staff had reviewed twenty-three patient charts and that the Board's 
outside consultants had reviewed these charts and were critical of 
Respondent's practices in prescribing opioids. Id. at 4. The Board 
specifically found that: (1) Respondent ``often failed to obtain 
adequate medical histories or perform adequate physical examinations'' 
before prescribing controlled substances to the patients, (2) that much 
of her ``medical histories came from information provided by the 
patients themselves,'' (3) that in some cases she ``failed to further 
substantiate actual diagnoses and physical findings with prior medical 
records,'' and (4) that sometimes she ``failed to obtain histories of 
previous drug abuse or monitor for signs of current drug abuse.'' Id. 
at 4.
    The Board also found that in prescribing controlled substance 
medications, ``Respondent [often] failed to maintain adequate records 
on the patients.'' Id. More specifically, the Board found that 
Respondent's ``written notes often did not provide sufficient 
information to support the diagnoses, justify the treatments, 
accurately document the results and indicate advice and cautionary 
warnings provided to the patients.'' Id. The Board also found that 
Respondent ``may have inappropriately prescribed higher than indicated 
doses of long- and short-acting opioid medication.'' Id. The Board 
further concluded that Respondent had engaged in ``unprofessional 
conduct'' under Arizona law for various reasons including, inter alia, 
that she had failed or refused to maintain adequate medical records and 
had engaged in conduct or practices ``that is or might be harmful or 
dangerous to the health of the patient or the public.'' Id. at 6. 
Respondent was censured and placed on probation for two years with her 
office management and record-keeping practices under monitoring. Id. 
The Consent Agreement also provided for another two years of probation 
at the time that ``her DEA Certificate is restored.'' Id. at 7. 
Respondent completed her initial probation on March 10, 2006. RX 30.
    Respondent submitted a letter from the Arizona Medical Board, dated 
December 23, 2004, indicating that she was in compliance with the terms 
of the order and that Respondent ``has the Board's support to pursue 
her DEA reinstatement.'' RX 53. The letter, however, also stated that 
``at no time [had Respondent] attempted to divert medications for non-
medical purposes.'' Id.\3\ She also submitted a letter from the Board 
dated January 8, 2007, which indicated that her probation terminated on 
March 10, 2006, but that new two-year probation would commence ``when 
her DEA certificate is restored.'' RX 30. The letter indicated that 
Respondent's ``license is currently active without restriction and she 
is off probation.'' Id.
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    \3\ As explained below, the record in this matter establishes 
instances in which Respondent did divert for non-medical purposes.
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    The Consent Agreement also had required Respondent to complete ten 
hours of Continuing Medical Education (CME) in ``the principles and 
practices of pain management or addiction medicine'' before applying 
for a new DEA registration. GX 73, at 7. Respondent completed twelve 
hours of the required CME by April 2004. RX 53. ``Since January 2004, 
she has also acquired 51.25 hours in a wide range of topics relating to 
pain management.'' Id.\4\
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    \4\ In June 2006, the Arizona Medical Board also reprimanded 
Respondent and placed her on probation for two years for performing 
``excessive joint and soft tissue injections without adequate 
indications and for inadequate documentation of the quantities of 
pharmaceuticals injected.'' GX 7, at 12.
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    Respondent applied for her DEA Certificate of Registration on 
January 28, 2005. ALJ Ex. 1, at 6.

Respondent's Prescribing Practices

The Expert Testimony

    Both parties put on extensive testimony relevant to the issue of 
whether Respondent's prescriptions were issued in the usual course of 
professional practice and were for a legitimate medical purpose.\5\ The 
Government's expert was Dr. Bradford D. Hare \6\; Respondent's experts 
were Dr.

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Jennifer Schneider,\7\ who testified as an expert in pain management, 
and Marylee O'Connor, a Doctor of Pharmacy, who testified as both a 
fact witness and expert witness on pharmacy although she was not 
formally qualified as such. See Tr. 1137.\8\
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    \5\ While much of the testimony of both parties' experts was 
couched as to what practices were required to meet the standard of 
care, numerous courts have recognized that such testimony is 
relevant in determining whether a physician acted in the usual 
course of professional practice and for a legitimate medical purpose 
in prescribing a controlled substance. See United States v. 
Feingold, 454 F.3d 1001, 1012 n.3 (9th Cir. 2006) (in criminal case, 
jury can appropriately ``consider the practitioner's behavior 
against the benchmark of acceptable and accepted medical 
practice''); see also United States v. Alerre, 430 F.3d 681, 691 
(4th Cir. 2005) (in criminal case, ``evidence that a physician's 
performance has consistently departed from accepted professional 
standards supports the proposition that the physician was not 
practicing medicine, but was instead cloaking drug deals under the 
guise of a professional medical practice'').
    \6\ Dr. Hare is an associate professor of anesthesiology and 
pharmacology at the University of Utah School of Medicine, where he 
is also the director of the pain management fellowship and the vice 
president of the Department of Pain Management Services. Tr. 144-45; 
GX 47. He is fellowship-trained and board-certified in pain 
management. Tr. 145. He has an M.D., special certifications from the 
Board of Anesthesiology and Pain Management, and a Ph.D. in 
pharmacology. Id.; see also GX 47. He has performed research in pain 
management and is currently engaged in the practice of pain 
management. Tr. 147-48; see also GX 47.
    \7\ Dr. Schneider is board-certified in internal medicine, is 
certified by the American Society of Addiction Medicine, and is a 
diplomate of the American Academy of Pain Management. Tr. 807; see 
also RX K-1, at 1; RX 43, at 1. Respondent hired Dr. Schneider 
several months after the DEA executed its search warrant to mentor 
Respondent in record-keeping and in pain management. Tr. 808.
    \8\ Respondent also introduced a written report from Dr. Sharon 
Weinstein, an Associate Professor of Anesthesiology, Neurology and 
Oncology at the University of Utah and the Director of Pain Medicine 
and Palliative Care at the University of Utah's Huntsman Cancer 
Institute. RX 32, at 1. Dr. Weinstein did not, however, testify at 
the hearing.
     In her report, Dr. Weinstein criticized ``Dr. Hare's judgment 
of [Respondent's] pain management practices [as] appear[ing] to be 
based at least in part upon * * * assumptions that are erroneous as 
stated,'' and than listed what she attributed as being his 
assumptions. Id. at 2. It is unclear, however, the extent to which 
Dr. Weinstein has accurately characterized Dr. Hare's assumptions, 
and in any event, many of her criticisms rely on snippets taken from 
his opinions and ignore extensive other evidence in the patient 
files that he relied upon.
    Dr. Weinstein also opined ``that the prescriptions by 
[Respondent] were written in the usual course of professional 
practice and for legitimate medical purposes.'' Id. at 1. Because 
Dr. Weinstein did not testify and was thus not subject to cross-
examination, her opinion lacks probative force.
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    In her decision, the ALJ concluded ``that there was no clear 
consensus in the medical community regarding what practices were 
required to meet the standard of care during 2001 and 2002.'' ALJ at 
151. The ALJ's finding paints with too broad a brush. While it is true 
that there were some issues on which the parties' experts disagreed 
(e.g., the scope of an appropriate physical examination, the need to 
order diagnostic testing, appropriate dosing levels), there was 
substantial agreement as to what practices are necessary to meet the 
standard of care.\9\
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    \9\ Respondent disputed the validity of Dr. Hare, who practiced 
in Utah, opining on the standard of care applicable to an Arizona 
practitioner. Tr. 1420-21. Even if the standard of care varies from 
one State to another (rather than simply between competing schools 
of thought within a medical practice specialty), Dr. Hare and Dr. 
Schneider (who practices in Arizona) had significant areas of 
agreement.
     Respondent also disputed whether her prescribing practices 
should be evaluated under the standard of care applicable to a pain 
management specialist rather than the standard applicable to a 
physiatrist. Resp. Br. at 195. In her brief, Respondent apparently 
contends that the standard of care applicable to a physiatrist did 
not require her to obtain other provider's medical records or to 
obtain addiction histories on her patients prior to prescribing 
controlled substances. See id. The short answer to this contention 
is that the Arizona Medical Board specifically found that 
``Respondent failed to further substantiate actual diagnoses and 
physical findings with prior medical records,'' and ``failed to 
obtain adequate histories of previous drug abuse.'' GX 73, at 4. The 
Board further cited these findings as evidence that Respondent had 
engaged in unprofessional conduct under Arizona law. Id. at 6. 
Respondent's contention is therefore meritless.
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Initial Visit

    Dr. Hare testified that at the initial visit, he asks the patient 
to characterize the pain and rate it on a scale of 1 to 10. Tr. 155. 
Dr. Hare also obtains the patient's medical history and ``drug 
history''; as part of the latter, Dr. Hare gathers information on the 
patient's history of substance abuse including the use of both 
prescription and illicit drugs. Id. at 158. As Dr. Hare testified, he 
would ``be more cautious'' in handling a patient with a ``significant 
drug abuse history.'' Id. at 158. Dr. Hare also explained that he tries 
to get records from other physicians who have treated the patient, as 
well as the results of diagnostic studies. Id. at 156-57.
    Dr. Hare then performs a physical examination focusing on the area 
of the body where the pain is occurring, but which also involves a more 
general examination. Tr. 152-53. The examination includes ``a 
neurologic examination, an examination for strength, an examination for 
reflexes, an examination for tenderness, changes in sensitivity of the 
skin, tenderness in muscles, a whole range of different things, again 
depending on the nature of what the pain complaint is.'' Id. at 153. 
Moreover, his examination would include ``the vital signs, in other 
words[,] blood pressure, respiratory rate, heart rate, comments about 
just general appearance of the patient.'' Id. Also, as part of his 
physical examination, Dr. Hare checks a patient's heart, chest and 
abdomen.\10\ Id. at 154.
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    \10\ Dr. Hare proceeded to distinguish different types of pain 
and the treatments appropriate to them. For instance, myofascial 
pain, characterized by ``tender spots in the muscles'' and which is 
usually the result of ``an injury of some sort,'' does not respond 
well to opioid medication although opioid medication may take the 
``edge off a bit.'' Id. at 159. Dr. Hare also discussed neuropathic 
pain, ``pain that's due to nerve injury,'' and stated that it ``is a 
type of pain again that is first treated not with opioids but * * * 
with drugs like tricyclic antidepressants or the anticonvulsive 
agents.'' Id. at 160.
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    Dr. Schneider (Respondent's expert) testified that in her practice, 
she will not treat a patient absent ``old records.'' Tr. 854. Dr. 
Schneider explained that the day before the initial visit, her office 
calls ``to remind'' patients that if they do not bring records with 
them, their physician will be called at the visit and asked to fax the 
records. Tr. 854-55. However, she noted that Respondent, as a 
physiatrist, would often have the first visit after an injury so that 
there would not be prior records of treatment of a particular injury 
and so ``it's less essential to start out on day one with old 
records.'' Tr. 855.
    Dr. Schneider likewise testified as to the importance of obtaining 
a patient's substance abuse history. According to Dr. Schneider, a 
patient who has a history of substance abuse can still be prescribed 
opioids for chronic pain, but the history is a ``relative 
contraindication'' for such treatment. Tr. 881. A physician thus needs 
to ``get a careful history and * * * have much more stringent 
monitoring,'' but, depending on ``the nature of the previous substance 
abuse, on how long it's been since the person last abused the substance 
and what kind of treatment they had for it,'' a physician could still 
safely prescribe controlled substances. Tr. 881-82.
    Dr. Schneider testified that her initial appointment usually takes 
45 minutes. Tr. 863-64. In that time, she goes through ``the four As.'' 
Tr. 864. The first ``A'' is analgesia, and Dr. Schneider asks for a 
pain rating on a scale of 1-10. Id. The second ``A'' is activities of 
daily living, about how the patient is functioning, as ``treating 
chronic pain is a lot about function, at least as much as about pain 
relief.'' Id. The third ``A'' is adverse effects, such as side effects. 
Id. The fourth and final ``A'' is aberrant drug related behaviors, 
which is ``anything that's out of the ordinary, like if they say I need 
an early refill.'' Tr. 865.
    Dr. Schneider also testified that it is medically appropriate for a 
physician to prescribe based on a ``focused physical exam.'' Tr. 870. 
According to Dr. Schneider, when a physician sees ``somebody for a 
particular problem, and this is not just in pain, but this is in any 
field, you limit your exam to that part.'' Id. The exam is ``called a 
focused physical exam because it is limited to the part of the body 
that the person is having trouble with.'' Id.\11\ While the parties 
thus disagree as to the proper scope of a physical exam, I assume 
without deciding that a focused physical exam is adequate to diagnose a 
patient.\12\
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    \11\ Dr Schneider also testified that there is no lethal blood 
opioid level for non-opioid-na[iuml]ve patients, and that insurance 
companies are often the reason why prescriptions may be written for 
high volume with low dosing. Tr. 904, 909-11.
    \12\ As one of the grounds for her finding that ``there was no 
clear consensus'' regarding what was required to meet the standard 
of care, the ALJ noted that ``Dr. Hare concluded that the 
Respondent's failure to always perform physical examinations or 
order tests to verify symptoms constituted inadequate treatment of 
the patient for whom she prescribed controlled substances. Yet, Dr. 
Weinstein found that Dr. Hare's conclusion rested on the erroneous 
assumption that all painful conditions would be objectively 
verifiable by a physical exam or test results.'' ALJ at 52.
     It is unclear, however, whether the ALJ was referring to Dr. 
Hare's testimony regarding the need for the initial exam or for 
follow-up exams when patients report new symptoms. If the ALJ's 
comment was referring to whether a patient should be physically 
examined at the initial visit, even Dr. Schneider indicated that the 
exam is part of the standard of medical practice. To the extent the 
ALJ was referring to the need for a physician to perform a physical 
exam on a subsequent visit when a patient reports new symptoms, 
obviously the necessity of performing a further physical exam 
depends upon the patient's symptoms and complaint. Accordingly, 
whether an exam was required to meet the accepted standard of 
medical practice cannot be evaluated outside of the context of a 
specific patient.

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

[[Page 8198]]

    At the first visit, the physician should create a treatment plan. 
Id. at 170. According to Dr. Hare, he ``[t]ypically'' does not 
prescribe opioids on the first visit because he lacks other physicians' 
records, test results, and the opportunity to consult with other 
members in his practice group. Id. at 164. However, it appears this may 
be also because Dr. Hare and the other physicians in his practice 
``oftentimes see the patient as a group,'' and after evaluating the 
patient, discuss among themselves whether they ``have something to 
offer that patient.'' Id. Accordingly, to the extent Dr. Hare's 
testimony suggests that is outside of the course of professional 
practice to prescribe a controlled substance at a patient's first 
visit, it is not conclusive.
    It was undisputed, however, that ``the appropriateness of 
prescribing [controlled substance] medications * * * depends on the 
level of medical documentation.'' Id. at 228. According to Dr. Hare, 
``[w]ithout the appropriate documentation it's inappropriate to 
prescribe the controlled substances.'' Id. at 229.

Titration of Dosing and Follow-up Visits

    Both Dr. Hare and Dr. Schneider testified that when any medication 
has been prescribed, there will be follow-up visits at which the 
physician questions the patient about whether there has been 
improvement in his pain level and functionality, whether there have 
been side effects, and the continuing benefits of taking the 
medication. Id. at 172 & 181 (testimony of Dr. Hare); id. at 864 & 949 
(Dr. Schneider's testimony that she reviews the four ``A''s with her 
patients at every visit). At follow-up visits, the physician should 
question the patient as to whether he is using the medication 
appropriately.\13\ Id. The physician should document the patient's 
response to medication, functionality, and adverse effects in the 
patient chart. Id. at 173; id. at 865 & 951.
---------------------------------------------------------------------------

    \13\ Dr. Hare also testified that he asks his patients about 
their mood and sleep as chronic pain patients ``almost uniformly * * 
* have problems with anxiety and depression.'' Tr. 172. He indicated 
that the failure to monitor sleep and mood could cause a physician 
to ``miss the boat'' in medicating with opioids. Id. at 182.
---------------------------------------------------------------------------

    Moreover, both parties' expert were in agreement that when a 
patient is currently not on opioids they should be started at a low 
dose and titrated up slowly to achieve pain relief while minimizing the 
side effects such as nausea and sedation. Tr. 971-72; see also id. at 
177 (testimony of Dr. Hare that ``you don't want to increase too 
quickly for fear of overshooting and getting the patient in trouble'' 
by causing ``dangerous side effects'').
    Dr. Hare noted that in the event that the medication is increased, 
the usual increase is in the amount of 50 percent of the prior dosage. 
Id. at 176. However, according Dr. O'Connor, it is acceptable to 
titrate at a rate of ``no more than 50% to 100% every 5 or more days'' 
so long as the increase in the dose does not cause adverse effects. RX 
8, at 2. Moreover, because people respond differently to opioids, there 
can be great variability as to the dose necessary to alleviate a 
patient's pain. Tr. 972. In treating unrelieved pain, ``there is no 
dose which is too high unless the patient has toxicity or side 
effects.'' RX 9, at 2.\14\
---------------------------------------------------------------------------

    \14\ According to Dr. Hare, if a patient states that the 
medications are not working well, ``then we'd have to decide whether 
we've just undershot the prescribing or we're dealing with a pain 
problem that isn't going to respond to pain medicine.'' Id. at 174. 
In the latter case, he would ``make plans to back off on these 
opioids and look at other ways to manage the pain.'' Id. While this 
testimony suggests the existence of a dispute over the maximum 
dosage levels, it is not necessary to resolve this dispute.
---------------------------------------------------------------------------

Managing Patients Who Are Receiving Controlled Substances

    Both Drs. Hare and Schneider testified as to the importance of 
setting boundaries with patients who are receiving controlled 
substances through the use of written agreements. Tr. 161. As Dr. 
Schneider testified: ``I have all my patients sign an agreement [which] 
lays down the rules and it says that they're [the patients] not to make 
any changes in their medications without first consulting me.'' \15\ 
Id. at 876. Dr. Schneider further explained that if she gives a patient 
permission to increase his dose, she documents it. Id. at 877.\16\ If a 
patient comes in reporting that he took more medication than 
prescribed, Dr. Schneider asks why and if the response is not 
reasonable, her ``reaction is * * * to build more structure around 
them.'' Id. Sometimes this involves having a family member administer 
the medication, id. at 878; it may also involve writing very small 
prescriptions and having more frequent visits. Id. at 879. Similarly, 
Dr. Hare noted that ``if a patient has overused medication,'' a 
physician needs to find out why, and if the patient does not offer a 
``good reason, the physician should counsel the patient to use his 
medication as prescribed and ``hold them to it.'' \17\ Id. at 163.
---------------------------------------------------------------------------

    \15\ Dr. Schneider further explained that there is a ``loss of 
control thing that is part of addiction [and] an addict who wants 
more medication is not going to be willing to call me in the office 
and leave a message and have me call him back four hours later to 
tell him that yes, you can take another pill because you're having 
more pain.'' Id. at 876.
    \16\ Subsequently, Dr. Schneider testified that ``three'' to 
``five years'' ago, a lot of people were not aware of pain 
agreements and were not using them. Tr. 1012-13. Dr. Hare, however, 
testified that the agreements had been in use for as ``as long as'' 
he could remember and in excess of fifteen years. Id. at 187-88. I 
further note that the record contains a pain management agreement 
signed by a patient of Respondent in July 2001. See RX 72, at 3-4. 
Whether or not the usual course of professional practice requires 
that the physician enter into a written agreement setting forth her 
expectations and what rules her patient must follow while being 
treated, it is undisputed that a physician must carefully monitor 
her patients' use of controlled substances.
    \17\ The record contains a copy of a pain management agreement 
Respondent used in treating R.T. GX 72, at 3-4. The agreement reads 
in relevant part:
    I understand that if I break this Agreement, my doctor will stop 
prescribing these pain-control medicines.
    In this case, my doctor will taper off the medicine over a 
period of several days, as necessary, to avoid withdrawal symptoms. 
Also, a drug-dependence treatment program may be recommended.
    I will communicate fully with my doctor about the character and 
intensity of my pain, the effect of pain on my daily life, and how 
well the medicine is helping to relieve the pain.
    I will not use any illegal controlled substances, including 
marijuana, cocaine, etc.
    I will not share, sell or trade my medication with anyone.
    I will not attempt to obtain any controlled substances, 
including opioid pain medicines, controlled stimulants, or 
antianxiety medications from any other doctor.
    I will safeguard my pain medicine from loss or theft. Lost or 
stolen medicines will only be replaced at the doctor's discretion.
    * * *
    I agree to use -------- Pharmacy, located at ------------, 
Telephone number ------------, for filling prescriptions for all my 
pain medicine.
    * * *
    I agree that I will submit to a blood or urine test if requested 
by my doctor to determine my compliance with my program of pain 
control medicine.
    I agree that I will use my medicine at a rate no greater than 
the prescribed rate and that use of my medicine at a greater rate 
will result in my being without medication for a period of time.
    I will bring all unused medicine to every office visit.
    GX 72, at 3a-3b.

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

[[Page 8199]]

    Both Drs. Hare and Schneider testified that they require their 
patients to agree to obtain their medications only from themselves and 
not from other physicians.\18\ Id. at 161; id. at 963. Dr. Schneider 
testified that if she found out that a patient was obtaining drugs from 
another source, she would question the patient and determine the 
circumstances. Id. at 962. Moreover, if the patient was obtaining the 
drugs from another physician, she would call the physician and remind 
him that ``the patient has a contract with'' her, which the other 
physician knows about because she sends reports to him, and that she 
tells the other physician that he ``cannot be prescribing for the 
patient.'' Id. at 963. Dr. Schneider added that if the patient does it 
again, she ``may discharge them.'' Id. at 964.
---------------------------------------------------------------------------

    \18\ Dr. Hare further explained that his agreement provides the 
patients with instructions for obtaining refills and also 
establishes rules for dealing with a patient's claim that his 
medication was lost or stolen. Id. at 161. According to Dr. Hare, 
the agreement ``makes it clear that we may or may not choose to 
refill the medications under those circumstances.'' Id. Continuing, 
he explained that his practice is ``usually pretty flexible'' the 
first time a patient reports that his medication has been lost or 
stolen and will issue a new prescription while counseling the 
patient. Id. at 162. If, however, it happens again, it raises a 
concern that the patient is ``overusing their medicine'' and 
``perhaps diverting them.'' Id.
---------------------------------------------------------------------------

    Dr. Schneider further testified that if a patient is giving drugs 
to a family member, she counsels them that this is a felony offense and 
she is ``certainly not going to replace a pill that [a patient] ha[s] 
one less of because [she] gave it to a family member.'' Id. at 1007. 
Moreover, she documents the incident in the patient record. Id. at 
1008. Dr. Schneider also noted that it is especially ``egregious'' when 
a patient is buying drugs on the street. Id. at 1006.
    With respect to requests for early refills, Dr. Hare testified that 
``we try to come up with a plan that's going to meet the patient's 
needs until the time of the next visit,'' including ``a reasonable type 
of medicine,'' and ``a reasonable amount of medication.'' Id. at 163. 
Dr Hare further explained that ``[w]e do our refills on a 30-day 
basis,'' and we set ``the dates that the refill is supposed to occur * 
* * so we have all of that information in our records'' and that this 
allows for the physician ``to quickly access * * * and determine when a 
refill is appropriate'' and ``when it's not.'' Id. at 164.
    To similar effect, Dr. Schneider testified that when a patient ask 
for early refills, she discusses with the patient why the refill is 
needed and documents this in the patient record. Id. at 949. Moreover, 
Dr. Schneider may decline to refill the prescription. She also noted 
that she has a page in her charts in which every prescription and the 
date of its issuance is recorded so that a refill request can be 
properly evaluated to determine whether it is too early.\19\ Id.
---------------------------------------------------------------------------

    \19\ Dr. Schneider also testified that many doctors ``simply 
write down the prescription they wrote that day in the body of the 
records, meaning that the next time the patient comes, they've got 
to be rifling back through to see what was the last one.'' Tr. 1001.
---------------------------------------------------------------------------

    Dr. Schneider testified that when an anonymous phone call is 
received which indicates that a patient is either selling or abusing a 
drug, ``[y]ou have to look into it * * * You have to pursue all these 
angles.'' Id. at 830. According to Dr. Schneider, ``there are some 
times when the information has a lot of validity and you have to follow 
it, and when the doctor doesn't that's a bad scene.'' Id. As to a 
patient using ``somebody's prescription that happened to be around the 
house because they had a bad headache or whatever,'' Schneider 
testified that ``counseling them, and advising them, and warning them 
and so forth may be enough.'' Id. at 836. However, if in truth it is a 
situation of ``an active addiction problem,'' the physician needs to 
inform the patient that the addiction will interfere with the 
prescribing and ``that they need to get some help with their addiction 
problem.'' Id.
    Dr. Schneider further testified that there are ``many sets of tools 
on the Internet to help pain specialists assess their patients for a 
history of addiction and for addiction issues and on how to monitor 
them and how to follow them.'' Id. at 824. In addition, a physician 
should use such measures as pill counts (i.e., requiring patients to 
bring in their prescriptions to determine whether they are taking them 
as prescribed) and random drug screening through either blood or urine 
tests to determine whether the patient is taking the prescribed 
medication and/or taking illicit drugs. See GX 72, at 4 (requiring that 
Respondent's patients agree to ``submit to a blood or urine test * * * 
to determine my compliance with my program of pain control medicine'' 
and that they ``bring all unused pain medicine to every office 
visit'').\20\
---------------------------------------------------------------------------

    \20\ In her testimony, Dr. Schneider vaguely suggested that in 
2001-2002, the use of urine drugs screens was not generally accepted 
as required by the standard of care. Tr. 1013. In August 1998, 
however, Dr. Schneider published an article in which she noted that 
required her patients to ``obtain urine drug screens when asked. 
This feature of the contract prevents any refusals from the patient 
and lets me request a urine screen at any suspicion of drug 
addiction problems.'' Jennifer P. Schneider, Management of Chronic 
Non-Cancer Pain: A Guide To Appropriate Use Of Opioids, 4 J. Care 
Mgmt. 10, 18 (Aug. 1998). Therein, Dr. Schneider also noted the role 
of asking a patient ``to bring in partly-used medication containers 
for a pill count'' in assessing whether the patient has lost control 
over his/her drug use. Id. at 13. In accordance with 5 U.S.C. 
556(e), I take official note of Dr. Schneider's article and reject 
her suggestion that urine drug screens were not required to meet the 
standard of care in prescribing controlled substances by a pain 
specialist. Moreover, the Arizona Board found that Respondent had 
failed to monitor her patients for signs of current drug abuse. GX 
73, at 4.
     Dr. Schneider also contended that in 2001-2002, urine drugs 
screens were difficult to interpret, in part because of the 
difference between opioids (which are semi-synthetic or synthetic) 
and opiates (which are derivatives of morphine), and that the 
opioids would not show up on a standard urine drug screen and that 
the physician had to specifically request that the lab test for 
them. Tr. 892. Putting aside whether a competent physician should 
have known the difference between opioids and opiates and how to 
properly screen for them, in her article she also noted that urine 
drugs screens were useful in determining whether a patient is 
abusing illicit drugs. Were it the case that Respondent required her 
patients to undergo urine drug screens and mistakenly failed to 
request the correct test, it would be a relevant consideration. 
However, Respondent rarely required her patients to undergo urine 
drug screens.
---------------------------------------------------------------------------

    Dr. Schneider testified that it is important for a doctor to 
communicate with other doctors. Tr. 853. Dr. Schneider sends a copy of 
her notes on ``every visit'' to the primary care physician. Id. If she 
knows of a patient's ``ongoing relationship with some other specialist 
related to their pain problem,'' she also sends a copy of the notes 
from every visit. Id. After making a referral to a specialist, she also 
requests ``a copy of that report and of imaging studies.'' Id.

Alleged General Practices

    At the request of the DEA Investigators, Dr. Hare reviewed the 
medical records of Respondent's patients.\21\ GX 46. In his first 
report (January 15, 2003), Dr. Hare indicated that he had reviewed the 
records of eight patients and found that Respondent's care exhibited 
the following ``general problems'':
---------------------------------------------------------------------------

    \21\ In a subsequent report, Dr. Hare reviewed the medical 
records for an additional seven patients. See GX 46A.
---------------------------------------------------------------------------

     Respondent ``failed to adequately evaluate'' patients by 
not obtaining an adequate ``pain history'' and by not ``obtaining[ing] 
information from previous treatment such as records of treating 
physicians and the previous medications used.'' GX 46, at 1. These 
would ``have allowed [Respondent] to determine if there had been 
problems with medications or patient compliance.'' Id.
     Despite the fact that ``[t]he information in 
[Respondent's] records was insufficient to make a proper diagnosis,'' 
Respondent ``prescribed Controlled Substances.'' Id.
     Respondent ``did not properly track the use of 
medications.'' Id. at 2. She did

[[Page 8200]]

not ``comment on the lack of patient compliance'' when patients used 
controlled substances ``in excess of the prescribed amounts.'' Id. 
Rather, she ``usually increased the amount of the prescription to meet 
the patient's use of medication, rather than exercising any control 
over the patient's consumption.'' Id.
     Respondent switched from one controlled substance to 
another, ``based on patient request, not on what was reasonable 
therapeutically.'' Id.
    On cross-examination, Respondent admitted that she failed to take 
addiction histories. Tr. 2344. However, when asked whether she 
routinely failed to obtain prior medical records, she stated that 
``there is no obligation or rule that you have to get medical 
records.'' Id.; but see GX 73, at 4 (State Board's finding that 
``Respondent failed to further substantiate actual diagnoses and 
physical findings with prior medical records.''). She stated that in 
many cases she did get parts of medical records. Id. at 2345. She 
admitted that others might not always be able to ``glean'' her 
rationale for increasing opioid dosages from her records. Id. at 2346. 
When asked whether she often issued early refills on controlled 
substance prescriptions without documenting the reason in her medical 
records, Respondent said that she did not know what the term ``early 
refill'' meant. Id. at 2345-46. She indicated that she did not find 
doing frequent MRIs useful, that with chronic pain that was just a 
waste of medical resources. Id. at 1381.
    Respondent testified that she always did an evaluation on new 
injury cases, that there was always a physical examination, and that it 
was always documented. Id. at 2347-48. She testified that she did not 
ignore that some patients had histories of addiction and that she did 
not ignore warning signs of addiction or abuse. Id. at 2348-49. She 
admitted that she was not in contact with primary care physicians in 
all cases, but she also justified that in the case of J.N., noting that 
her primary care physician wasn't practicing due to a licensing issue. 
Id. at 2349. Respondent admitted that on occasion she failed to 
document the reason for increasing an opioid dose. Id. at 2351.
    Respondent also stated that she did not believe in reprimanding 
patients when she found out that they were giving their controlled 
substances to another person. Id. at 2393-94. She compared the 
situation to one where a diabetic patient is not following his diabetic 
diet. Id.

Evidence Regarding Specific Patients

J.N.
    On September 11, 2000, J.N., who was then forty-three years old and 
who undergone a cervical fusion in 1994, started treating with 
Respondent. GX 9, at 1. She ``had been sexually assaulted and suffered 
[a] cervical fracture and needed emergency surgery.'' Id. Her pain had 
recently worsened, and Respondent noted in her medical record that she 
``need[ed] another cervical fusion.'' Id. J.N. had been on disability 
since 1994. Id.
    There is no indication in J.N.'s patient record that Respondent 
inquired about any history of substance abuse at the initial visit. Id. 
at 1-2. At the first visit, Respondent performed a physical exam and 
diagnosed J.N. as having ``[s]evere neck pain,'' ``left upper extremity 
pain,'' and ``signs of left cervical radiculopathy.'' Id. at 2. 
Respondent gave J.N. a free trial of 21 tablets of OxyContin 40 mg q8h 
\22\ (one tablet every eight hours), 50 tablets of Oxycodone IR ``1-2 
q4h PRN for breakthrough pain,'' and a prescription for 60 tablets of 
Xanax 0.5 mg twice a day, with one refill, although nothing in the 
patient record documented that J.N. experienced anxiety. Id. at 2. 
Respondent was to ``[r]echeck in 1 week.'' Id.
---------------------------------------------------------------------------

    \22\ The record establishes that ``q'' means every, and that 
``h'' means hour(s), and ``hs'' at bedtime. See Tr. 1122 & RX L, at 
6; Tr. 1151 & GX 9, at 8; Tr. 1165 & GX 13, at 6; Tr. 1175. Thus, 
``q4h'' means every four hours, ``q6h'' means every six hours, 
``q8h'' means every eight hours, and ``q12h'' means every twelve 
hours. See Tr. 1122 & RX L, at 6; Tr. 1175; id. at 1151 & GX 9, at 
8. In addition, the abbreviation ``BID'' means ``twice a day,'' Tr. 
355 & RX 13, at 1; ``TID'' means ``three times a day,'' Tr. 403 & RX 
13, at 1; and ``QID'' means ``four times a day.'' Id. at 358 & GX 
22, at 18. The abbreviation ``PRN'' means ``as needed.'' Id. at 
1174. It is also undisputed that prescribing in excess of 4 grams or 
4000 mg. per day of drugs containing acetaminophen risks liver 
toxicity. See id. at 403-04.
---------------------------------------------------------------------------

    On September 15, Respondent noted that J.N. ``is better on the 
OxyContin and Oxycodone. She feels less pain,'' yet Respondent 
increased the OxyContin prescription to 60 (160 mg.) tablets, with one 
tablet to be taken every eight hours, (a twenty-day supply), which was 
a four-fold increase in the dosage over the initial prescription. Id. 
Respondent also issued prescriptions for 50 milliliters of Oxyfast 20 
mg/ml, ``1-2 ml q4h PRN breakthrough pain,'' 360 tablets of MS Contin 
100 mg., (4 tabs q8h), as well as 100 milliliters of morphine elixir 
``20 mg/ml 5 ml q6h PRN breakthrough pain.'' Id. at 2-3. Respondent 
noted that the latter two prescriptions were being issued in ``[i]n 
case Pima insurance doesn't cover'' the other medications. Id. 
Respondent also increased the dosage of Xanax four-fold to 2 mg. twice 
a day, again without any finding regarding anxiety. Id.
    J.N. returned on October 5 and reported that she was ``much better 
than she has been because of the MS Contin,'' and Respondent wrote 
prescriptions for MS Contin at the same dosing and also MSIR (morphine 
sulfate immediate release) ``30 mg 6qh PRN breakthrough pain 
120,'' to ``recheck in one month.'' Id. at 3. Respondent also 
added a prescription for ten tablets of Dilaudid 4 mg., 1-2 four times 
a day. Id. On October 25, J.N. reported that the medications helped 
with her pain and with sleep and that she would like more Dilaudid. Id. 
She also reported having had an EMG/NCV with a Dr. L. on September 14, 
but did not know the results. Id. at 4. Respondent wrote prescriptions 
for Dilaudid, MS Contin, MSIR, as well as Fioricet for ``headache.'' 
\23\ Id. at 4. J.N. continued on Dilaudid, MS Contin, Xanax and 
Fioricet through June 14, 2001. Id. at 4-9.
---------------------------------------------------------------------------

    \23\ The patient record also indicated that Respondent issued 
her a prescription for Amoxicillin, a non-controlled drug.
---------------------------------------------------------------------------

    J.N.'s patient record includes a Discharge Summary from University 
Medical Center in Tucson, Arizona, which was faxed to Respondent on 
January 16, 2001. Notably, the first page states that JN had a 
``history of IV heroin abuse''. Id. at 13. Continuing, the Summary 
stated that ``she quit several years ago, but started using again one 
week ago because of increasing abdominal pain.'' Id. at 13-14. The 
Summary also noted that a urine toxicology screen was ``positive for 
opiates, barbiturates, benzodiazepines, and marijuana.'' Id. at 15.
    The Discharge Summary listed five medical problems J.N. had 
including ``Chronic pain/narcotic addiction.'' Id. at 15-16. The 
Summary specifically noted that J.N. was ``preoccupied with her pain 
medications, requesting p.r.n. medications frequently'' and was 
``resistant to weaning attempts.'' Id. Moreover, while the hospital 
offered J.N. ``drug abuse placement,'' she ``refused,'' stating that 
``she was not an addict, and was only unable to get off Morphine due to 
her medical condition.'' Id. at 16. The Summary also noted that on 
discharge, J.N. was given MS Contin, Dilaudid and Xanax in the doses 
that she had been receiving from Respondent and in quantities that 
would last until she could see her pain specialist. Id.
    While the patient record indicates that Respondent was notified on

[[Page 8201]]

December 4, 2000 that J.N. had been hospitalized, GX 9, at 5, she did 
not obtain the Discharge Summary for another month. Moreover, J.N.'s 
medical record contains a note dated January 24, 2001, that Respondent 
``received records from UMC and discharge diagnosis was sludge in 
gallbladder''; the note contains no mention of either the results of 
the drug screen done by the hospital or of J.N's statement to the 
hospital staff that she had recently started using heroin again. Id. at 
6.
    J.N.'s record contains no indication that Respondent attempted to 
monitor her use of controlled substances through drug screens and pill 
counts. See generally id. Moreover, the medical record contains no 
indication that Respondent questioned J.N. about her use of marijuana, 
heroin, or the barbiturate (which Respondent had not prescribed to 
her).
    On subsequent visits, Respondent primarily prescribed 120 tablets 
of Dilaudid 4 mg. (QID--one tablet four times a day), 180 tablets of MS 
Contin 200 mg. (two tablets every eight hours), Xanax 2 mg. (BID -one 
tablet twice a day), and Restoril (temazepam) (two tablets at bed 
time).\24\ Id. at 5-9. After J.N.'s hospitalization, all of the MS 
Contin prescriptions and all but two of the Dilaudid prescriptions were 
for a quantity equaling 30 days of dosing. See id. Approximately half 
of the Dilaudid and MS Contin prescriptions were refilled at least five 
days early, with some being refilled as early as eight or nine days 
before the previous prescription would have run out. See id. (Rxs for: 
180 MS Contin on 12/18, 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14; for 120 
Dilaudid on 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14).
---------------------------------------------------------------------------

    \24\ Both Xanax (alprazolam) and Restoril (temazepam) are 
benzodiazepines and schedule IV depressants. See 21 CFR 1308.14(c).
---------------------------------------------------------------------------

    J.N. died of an overdose on June 18, 2001. According to a police 
report, ``several syringes were found at the scene,'' as well as 
various drugs including hydromorphone and morphine sulfate.\25\ GX 8, 
at 18. The police also found a white powder in the living room and were 
told by J.N.'s boyfriend that the two of them would mix ``her 
prescription medication with water and inject it using the used 
syringes.'' GX 8, at 19. Moreover, in an interview with investigators, 
J.N.'s boyfriend stated that she would crush up the Dilaudid 
(hydromorphone) she obtained from Respondent and inject it. GX 43, at 
11. J.N.'s boyfriend also related that ``[s]he didn't have veins'' a