Federal Register: February 23, 2010 (Volume 75, Number 35)

DOCID: fr23fe10-167 FR Doc 2010-3305

DEPARTMENT OF JUSTICE

Treasury Department

Docket ID: [Docket No. 06-62]

NOTICE: Part II

DOCID: fr23fe10-167

SUBJECT CATEGORY:

Jeri Hassman, M.D.; Denial of Application

DOCUMENT SUMMARY:

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 12. The Show Cause Order next alleged that patients to whom she had prescribed controlled substances had died of overdoses. Id. at 23.

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 46.

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 prehearing procedures, a hearing was held on January 2226, 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 posthearing 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 14748.

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 twentythree 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 shortacting 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 15355. While acknowledging that ``[i]t is indeed disturbing that the Respondent apparently altered H.T.'s medical chart to include a physical examination that
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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 15556. The ALJ did not, however, expressly find whether the evidence under factors two and four satisfied the Government's prima facie burden.
\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 sheand not her medical licensehad 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.

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 16162. 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
\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 proceedingeven 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.

Respondent graduated from New York University Medical School in 1981. Tr. 1346. She has been boardcertified 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 2021. 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 twentythree 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 shortacting 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 recordkeeping 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 twoyear 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.
\3\ As explained below, the record in this matter establishes instances in which Respondent did divert for nonmedical purposes.

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\
\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.

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\
\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. 14445; GX 47. He is fellowshiptrained and boardcertified 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. 14748; see also GX 47.
\7\ Dr. Schneider is boardcertified 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 K1, at 1; RX 43, at 1. Respondent hired Dr. Schneider several months after the DEA executed its search warrant to mentor Respondent in recordkeeping 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.

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\
\9\ Respondent disputed the validity of Dr. Hare, who practiced in Utah, opining on the standard of care applicable to an Arizona practitioner. Tr. 142021. 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.

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 15657.

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. 15253. 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.
\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.

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. 85455. 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. 88182.

Dr. Schneider testified that her initial appointment usually takes 45 minutes. Tr. 86364. 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 110. 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\
\11\ Dr Schneider also testified that there is no lethal blood opioid level for nonopioidna[iuml]ve patients, and that insurance companies are often the reason why prescriptions may be written for high volume with low dosing. Tr. 904, 90911.
\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 followup 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.

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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 Followup Visits

Both Dr. Hare and Dr. Schneider testified that when any medication has been prescribed, there will be followup 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 followup 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. 97172; 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. 101213. 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 18788. I further note that the record contains a pain management agreement signed by a patient of Respondent in July 2001. See RX 72, at 34. 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 34. The agreement reads in relevant part:

I understand that if I break this Agreement, my doctor will stop prescribing these paincontrol 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 drugdependence 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 3a3b.

[[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 30day 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 20012002, 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 NonCancer 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 partlyused 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 20012002, urine drugs screens were difficult to interpret, in part because of the difference between opioids (which are semisynthetic 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 crossexamination, 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 234546. 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 234748. 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 234849. 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 239394. 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 fortythree 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 12. 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 ``12 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 40304.

    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 twentyday supply), which was a fourfold increase in the dosage over the initial prescription. Id. Respondent also issued prescriptions for 50 milliliters of Oxyfast 20 mg/ml, ``12 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 23. 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 fourfold 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., 12 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 49.
    \23\ The patient record also indicated that Respondent issued her a prescription for Amoxicillin, a noncontrolled 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 1314. 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 1516. 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. (QIDone 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 59. 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'' and that it was very hard to get blood from her. Id. at 22. Yet there is no indication in J.N.'s medical record that Respondent ever noticed this. See generally GX 9.
    \25\ According to the police report, twenty syringes were found, several of which had been opened. GX 8, at 1819. In addition to hydromorphone and morphine sulfate, the police found Duramorph, methocarbamol, Pancrease, Zyprexa, Naproxen, and Cimetidine. Id. at 18.

    The Medical Examiner determined that the cause of J.N.'s death was ``acute intoxication due to the combined effects of opiates, cyclobenzaprine, and amitriptyline.'' GX 8, at 2. Respondent disputed the Medical Examiner's conclusion. One of her experts (Dr. Schneider) maintained that it was not ``black and white that a morphine overdose was her cause of death,'' and indicated (in response to Respondent's question whether her opinion would change if J.N. had been on the same dose of extended release morphine for the previous ten months), that unless J.N. had ``suddenly taken a lot more'' of the drug, she would question whether J.N.'s death was caused by a morphine overdose. Tr. 92122. Dr. Schneider was not asked, however, whether her opinion would be different if J.N. had taken the drug intravenously.

    Relatedly, another of Respondent's experts (Dr. O'Connor) testified that J.N.'s taking of the cyclobenzaprine and amitriptyline (neither of which was prescribed by Respondent) would have ``certainly'' caused her to have a heart attack. Id. at 1154. Yet the Medical Examiner did not note any evidence of a heart attack. See generally GX 8. Moreover, when Respondent asked her whether there are ``any interactions between opiates, such as morphine, and * * * amitriptyline or

    cyclobenzaprine,'' the witness answered:

    Certainly in [an] opioidna[iuml]ve patient, if they took * * * Tylenol with codeine, and then they took some cyclobenzaprine or flexeril on top of that * * * they might get more sleepy. The same goes for amitriptyline or tricyclics. In an opioidtolerant patient, no.
    Tr. 1157. The expert's testimony does not make clear whether her answer as to the effect that would occur in an opioidtolerant patient applies to a patient taking opiates other than Tylenol with codeine, a drug which is far less potent than either MS Contin 200 mg. or Dilaudid. Furthermore, the Medical Examiner did not conclude that J.N.'s death was caused solely by her use of morphine, but rather, the combined effects of opiates and the other two drugs.\26\ GX 8, at 2. \26\ Respondent also introduced into evidence an article discussing a survey of blood levels of opiates in opioidtolerant patients. See RX 39. More specifically, Respondent pointed to a table which indicated that a patient with a Morphine SR blood level of 2837 ng/ml, a level which was higher than that found in JN (2374 ng/ml) following her death, was capable of functioning. Compare RX 39, at 4 with GX 8, at 10. Respondent did not, however, offer any evidence that she conducted blood tests of J.N. while she was alive to show what level she was functional act.

    In any event, it is not necessary to resolve the factual dispute. Even if J.N's intravenous use of either Dilaudid or MS Contin did not contribute to her deathit just being a coincidence that syringes and crushed medication were found in the vicinity of her bodythe evidence nonetheless clearly established that she was abusing drugs, that Respondent had reason to know that she was abusing drugs, and that Respondent failed to properly supervise her use of controlled substances.

    With respect to the discharge summary, which clearly indicated that J.N. was abusing drugs, Respondent testified that she failed to read the entire hospital discharge summary because it ``was a lot of pages.'' Tr. 2367. According to Respondent, she ``looked at the beginning'' and ``looked at the en

    SUMMARY:

    Justice Department, Drug Enforcement Administration

    DOCUMENT BODY 2:

    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 12. The Show Cause Order next alleged that patients to whom she had prescribed controlled substances had died of overdoses. Id. at 23.

    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 46.

    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 prehearing procedures, a hearing was held on January 2226, 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 posthearing 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 14748.

    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 twentythree 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 shortacting 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 15355. 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 15556. The ALJ did not, however, expressly find whether the evidence under factors two and four satisfied the Government's prima facie burden.
    \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 sheand not her medical licensehad 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.

    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 16162. 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.
    [[Page 8196]]
    Findings 2
    \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 proceedingeven 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.

    Respondent graduated from New York University Medical School in 1981. Tr. 1346. She has been boardcertified 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 2021. 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 twentythree 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 shortacting 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 recordkeeping 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 twoyear 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.
    \3\ As explained below, the record in this matter establishes instances in which Respondent did divert for nonmedical purposes.

    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\
    \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.

    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.
    [[Page 8197]]
    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\
    \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. 14445; GX 47. He is fellowshiptrained and boardcertified 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. 14748; see also GX 47.
    \7\ Dr. Schneider is boardcertified 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 K1, at 1; RX 43, at 1. Respondent hired Dr. Schneider several months after the DEA executed its search warrant to mentor Respondent in recordkeeping 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.

    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\
    \9\ Respondent disputed the validity of Dr. Hare, who practiced in Utah, opining on the standard of care applicable to an Arizona practitioner. Tr. 142021. 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.

    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 15657.

    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. 15253. 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.
    \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.

    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. 85455. 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. 88182.

    Dr. Schneider testified that her initial appointment usually takes 45 minutes. Tr. 86364. 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 110. 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\
    \11\ Dr Schneider also testified that there is no lethal blood opioid level for nonopioidna[iuml]ve patients, and that insurance companies are often the reason why prescriptions may be written for high volume with low dosing. Tr. 904, 90911.
    \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 followup 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 Followup Visits

    Both Dr. Hare and Dr. Schneider testified that when any medication has been prescribed, there will be followup 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 followup 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. 97172; 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. 101213. 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 18788. I further note that the record contains a pain management agreement signed by a patient of Respondent in July 2001. See RX 72, at 34. 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 34. The agreement reads in relevant part:

    I understand that if I break this Agreement, my doctor will stop prescribing these paincontrol 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 drugdependence 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 3a3b.

    [[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 30day 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 20012002, 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 NonCancer 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 partlyused 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 20012002, urine drugs screens were difficult to interpret, in part because of the difference between opioids (which are semisynthetic 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 crossexamination, 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 234546. 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 234748. 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 234849. 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 239394. 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 fortythree 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 12. 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 ``12 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 40304.

    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 twentyday supply), which was a fourfold increase in the dosage over the initial prescription. Id. Respondent also issued prescriptions for 50 milliliters of Oxyfast 20 mg/ml, ``12 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 23. 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 fourfold 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., 12 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 49.
    \23\ The patient record also indicated that Respondent issued her a prescription for Amoxicillin, a noncontrolled 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 1314. 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 1516. 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. (QIDone 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 59. 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'' and that it was very hard to get blood from her. Id. at 22. Yet there is no indication in J.N.'s medical record that Respondent ever noticed this. See generally GX 9.
    \25\ According to the police report, twenty syringes were found, several of which had been opened. GX 8, at 1819. In addition to hydromorphone and morphine sulfate, the police found Duramorph, methocarbamol, Pancrease, Zyprexa, Naproxen, and Cimetidine. Id. at 18.

    The Medical Examiner determined that the cause of J.N.'s death was ``acute intoxication due to the combined effects of opiates, cyclobenzaprine, and amitriptyline.'' GX 8, at 2. Respondent disputed the Medical Examiner's conclusion. One of her experts (Dr. Schneider) maintained that it was not ``black and white that a morphine overdose was her cause of death,'' and indicated (in response to Respondent's question whether her opinion would change if J.N. had been on the same dose of extended release morphine for the previous ten months), that unless J.N. had ``suddenly taken a lot more'' of the drug, she would question whether J.N.'s death was caused by a morphine overdose. Tr. 92122. Dr. Schneider was not asked, however, whether her opinion would be different if J.N. had taken the drug intravenously.

    Relatedly, another of Respondent's experts (Dr. O'Connor) testified that J.N.'s taking of the cyclobenzaprine and amitriptyline (neither of which was prescribed by Respondent) would have ``certainly'' caused her to have a heart attack. Id. at 1154. Yet the Medical Examiner did not note any evidence of a heart attack. See generally GX 8. Moreover, when Respondent asked her whether there are ``any interactions between opiates, such as morphine, and * * * amitriptyline or

    cyclobenzaprine,'' the witness answered:

    Certainly in [an] opioidna[iuml]ve patient, if they took * * * Tylenol with codeine, and then they took some cyclobenzaprine or flexeril on top of that * * * they might get more sleepy. The same goes for amitriptyline or tricyclics. In an opioidtolerant patient, no.
    Tr. 1157. The expert's testimony does not make clear whether her answer as to the effect that would occur in an opioidtolerant patient applies to a patient taking opiates other than Tylenol with codeine, a drug which is far less potent than either MS Contin 200 mg. or Dilaudid. Furthermore, the Medical Examiner did not conclude that J.N.'s death was caused solely by her use of morphine, but rather, the combined effects of opiates and the other two drugs.\26\ GX 8, at 2. \26\ Respondent also introduced into evidence an article discussing a survey of blood levels of opiates in opioidtolerant patients. See RX 39. More specifically, Respondent pointed to a table which indicated that a patient with a Morphine SR blood level of 2837 ng/ml, a level which was higher than that found in JN (2374 ng/ml) following her death, was capable of functioning. Compare RX 39, at 4 with GX 8, at 10. Respondent did not, however, offer any evidence that she conducted blood tests of J.N. while she was alive to show what level she was functional act.

    In any event, it is not necessary to resolve the factual dispute. Even if J.N's intravenous use of either Dilaudid or MS Contin did not contribute to her deathit just being a coincidence that syringes and crushed medication were found in the vicinity of her bodythe evidence nonetheless clearly established that she was abusing drugs, that Respondent had reason to know that she was abusing drugs, and that Respondent failed to properly supervise her use of controlled substances.

    With respect to the discharge summary, which clearly indicated that J.N. was abusing drugs, Respondent testified that she failed to read the entire hospital discharge summary because it ``was a lot of pages.'' Tr. 2367. According to Respondent, she ``looked at the beginning'' and ``looked at the en