Daily Rules, Proposed Rules, and Notices of the Federal Government


Drug Enforcement Administration

[Docket No. 06-62]

Jeri Hassman, M.D.; Denial of Application

On June 1, 2006, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration issued an Order to Show Cause to Jeri Hassman, M.D. (Respondent), of Tucson, Arizona. The Show Cause Order proposed the denial of Respondent's application for a new DEA Certificate of Registration as a practitioner, authorizing her to dispense controlled substances in schedules II through V, on the grounds that the Respondent had "been convicted of a felony under the Controlled Substances Act, [had] materially falsified [her] application, and ha[d] committed such other acts as would render [her] registration under 21 U.S.C. 823 inconsistent with the public interest." ALJ Ex. 1, at 1 (citing 21 U.S.C. 824(a)(1)(2) and (4), 824(a) and 823).

More specifically, the Show Cause Order alleged that on November 1, 2002, DEA had immediately suspended Respondent's DEA registration on the ground that she "regularly engaged in the practice of prescribing excessive amounts of controlled substances * * * to patients for no legitimate medical purpose." 1-2. The Show Cause Order next alleged that patients to whom she had prescribed controlled substances had died of 2-3.

Next, the Show Cause Order alleged that Respondent "prescribed excessive quantities of controlled substances to patients, including frequent early refills" to a number of other 3. The Show Cause Order alleged that Respondent:

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." 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 4-6.

The Show Cause Order further alleged that on January 29, 2004, Respondent pled guilty to "four felony violations of 18 U.S.C. 3 involving controlled substances: Accessory After the Fact to Possession of Controlled Substances by Misrepresentation, Fraud, Forgery, Deception or Subterfuge, 21 U.S.C. 843(a)(3)." 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:


Finally, the Show Cause Order alleged that Respondent materially falsified her application, when, on January 28, 2005, Respondent applied for her DEA registration, she marked "no" to question 4(d), which "asked, in pertinent part, whether [Respondent] had ever had a State professional license revoked, suspended or placed upon probation."Id.

Respondent timely requested a hearing on the allegations, ALJ Ex. 2, and the matter was placed on the docket of the Agency's Administrative Law Judges (ALJ). Following pre-hearing procedures, a hearing was held on January 22-26, 2007 and February 27 to March 2, 2007, in Tucson, Arizona. Moreover, on March 13, 2007, the ALJ conducted a transcribed telephone conference at which Respondent gave her closing argument. Thereafter, both parties filed post-hearing briefs.

On October 9, 2008 the ALJ issued her Opinion and Recommended Decision (ALJ). With respect to factor one (the recommendation of the State licensing board), the ALJ noted that, while Respondent has twice been placed on probation and either censured or reprimanded, she currently holds an active, unrestricted medical license, and that this factor weighs in favor of her continued registration. ALJ at 147-48.

With respect to factor two (Respondent's experience in dispensing controlled substances) and factor four (Respondent's compliance with applicable laws relating to controlled substances), the ALJ concluded that the Government had established that Respondent issued prescriptions to two persons (H.T. and R.T.) which lacked a legitimate medical purpose. ALJ at 150. The ALJ reasoned, however, that these were "only two patients out of more than 900 whom Respondent was treating at that time," and thus the Government had not shown that "Respondent's overall medical practices [were] consistently lacking in legitimate purpose." 150.

The ALJ specifically rejected the evidence of the Government's Expert with respect to twenty-three other patients, noting that various physicians who testified on behalf of Respondent had disagreed with the conclusions of the Government's 151. According to the ALJ, this was "not to minimize the seriousness of the Respondent's cavalier attitude toward handling controlled substances during 2001 and 2002, but rather to demonstrate that it is not clear that her general treatment practices were lacking in medical purpose."Id.

In support of her conclusion, the ALJ cited various areas in which she maintained "that there was no clear consensus in the medical community regarding which practices were required to meet the standard of care during 2001 and 2002."Id.According to the ALJ, these areas included the role of physical examinations in treating chronic pain patients, the use of laboratory tests, the need to refer patients to other doctors as part of the course of treatment, appropriate dosage levels of controlled substances for treating chronic pain, and the propriety of prescribing both long and short-acting opioids simultaneously.Id.

The ALJ also rejected the Government's contention that Respondent's falsification of H.T.'s medical record (who performed multiple undercover visits and wore a recording device) justified the denial of her 153-55. While acknowledging that "[i]t is indeed disturbing that the Respondent apparently altered H.T.'s medical chart to include a physical examination thatwas not reflected in the recorded interaction between the Respondent and H.T.," 153, the ALJ concluded "that a single instance does not rise to the level of [a] pervasive pattern of falsification." 155. In this regard, the ALJ also noted that Respondent was working with another physician to improve her recordkeeping practices.1 155-56. The ALJ did not, however, expressly find whether the evidence under factors two and four satisfied the Government'sprima facieburden.

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.SS 823(f)(5);see also 158. While the ALJ found that Respondent's convictions "could * * * weigh in favor of denial of the * * * application," 158, she also did not address whether this factor established the Government'sprima faciecase.

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 161-62. The ALJ also found it significant that the State Board would conduct regular reviews of her medical charts and quarterly compliance 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." 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 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 aprima faciecase 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'sprima facieburden 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 Sokoloffv.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'sprima facieshowing 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.


Respondent graduated from New York University Medical School in 1981. Tr. 1346. She has been board-certified in physical medicine and rehabilitation since 1988, and she has practiced medicine in the State of Arizona since 1986.Id.Respondent practices as a physiatrist, a physician who specializes in physical medicine and rehabilitation.Id.

Respondent formerly held DEA registration BH1192359. ALJ Ex. 1, at 1. In August 2001, the Arizona Medical Board initiated an investigation of Respondent in response to two complaints from health care plans and one complaint from a pharmacy concerning Respondent's prescribing of controlled substances. GX 73, at 4. In July 2001, in response to complaints received from Tucson area pharmacists about Respondent's prescribing of controlled substances, DEA also initiated an investigation. GX 70, at 3. On May 16, 2002, DEA, along with law enforcement officers from other agencies, executed a search warrant at Respondent's registered location, Calmwood Medical in Tucson, 20-21. On November 1, 2002, my predecessor immediately suspended Respondent's DEA registration. ALJ Ex. 1, at 1.

On March 26, 2003, a Federal grand jury indicted Respondent, charging her with numerous violations of Federal law.SeeGX 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").SeeGX 73. In the consent agreement, the Board noted that its staff had reviewed twenty-three patient charts and that the Board's outside consultants had reviewed these charts and were critical of Respondent's practices in prescribing 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." 4.

The Board also found that in prescribing controlled substance medications, "Respondent [often] failed to maintain adequate records on the patients."Id.More specifically, the Board found that Respondent's "written notes often did not provide sufficient information to support the diagnoses, justify the treatments, accurately document the results and indicate advice and cautionary warnings provided to the patients."Id.The Board also found that Respondent "may have inappropriately prescribed higher than indicated doses of long- and short-acting opioid medication."Id.The Board further concluded that Respondent had engaged in "unprofessional conduct" under Arizona law for various reasons including,inter alia,that she had failed or refused to maintain adequate medical records and had engaged in conduct or practices "that is or might be harmful or dangerous to the health of the patient or the public." 6. Respondent was censured and placed on probation for two years with her office management and record-keeping practices under monitoring.Id.The Consent Agreement also provided for another two years of probation at the time that "her DEA Certificate is restored." 7. Respondent completed her initial probation on March 10, 2006. RX 30.

Respondent submitted a letter from the Arizona Medical Board, dated December 23, 2004, indicating that she was in compliance with the terms of the order and that Respondent "has the Board's support to pursue her DEA reinstatement." RX 53. The letter, however, also stated that "at no time [had Respondent] attempted to divert medications for non-medical purposes."Id. 3 She also submitted a letter from the Board dated January 8, 2007, which indicated that her probation terminated on March 10, 2006, but that new two-year probation would commence "when her DEA certificate is restored." RX 30. The letter indicated that Respondent's "license is currently active without restriction and she is off probation."Id.

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

Respondent applied for her DEA Certificate of Registration on January 28, 2005. ALJ Ex. 1, at 6.

Respondent's Prescribing PracticesThe 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. Hare6 ; Respondent's experts were Dr.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.SeeTr. 1137.8

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

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 158. As Dr. Hare testified, he would "be more cautious" in handling a patient with a "significant drug abuse history." 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 156-57.

Dr. Hare then performs a physical examination focusing on the area of the body where the pain is occurring, but which also involves a more general examination. Tr. 152-53. The examination includes "a neurologic examination, an examination for strength, an examination for reflexes, an examination for tenderness, changes in sensitivity of the skin, tenderness in muscles, a whole range of different things, again depending on the nature of what the pain complaint is." 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.10 154.

Dr. Schneider (Respondent's expert) testified that in her practice, she will not treat a patient absent "old records." Tr. 854. Dr. Schneider explained that the day before the initial visit, her office calls "to remind" patients that if they do not bring records with them, their physician will be called at the visit and asked to fax the records. Tr. 854-55. However, she noted that Respondent, as a physiatrist, would often have the first visit after an injury so that there would not be prior records of treatment of a particular injury and so "it's less essential to start out on day one with old records." Tr. 855.

Dr. Schneider likewise testified as to the importance of obtaining a patient's substance abuse history. According to Dr. Schneider, a patient who has a history of substance abuse can still be prescribed opioids for chronic pain, but the history is a "relative contraindication" for such treatment. Tr. 881. A physician thus needs to "get a careful history and * * * have much more stringent monitoring," but, depending on "the nature of the previous substance abuse, on how long it's been since the person last abused the substance and what kind of treatment they had for it," a physician could still safely prescribe controlled substances. Tr. 881-82.

Dr. Schneider testified that her initial appointment usually takes 45 minutes. Tr. 863-64. In that time, she goes through "the four As." Tr. 864. The first "A" isanalgesia,and Dr. Schneider asks for a pain rating on a scale of 1-10.Id.The second "A" isactivities 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" isadverse effects,such as side effects.Id.The fourth and final "A" isaberrant 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

At the first visit, the physician should create a treatment 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 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." 228. According to Dr. Hare, "[w]ithout the appropriate documentation it's inappropriate to prescribe the controlled substances." 229.

Titration of Dosing and Follow-up Visits

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

Moreover, both parties' expert were in agreement that when a patient is currently not on opioids they should be started at a low dose and titrated up slowly to achieve pain relief while minimizing the side effects such as nausea and sedation. Tr. 971-72;see also 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 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

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."15 876. Dr. Schneider further explained that if she gives a patient permission to increase his dose, she documents 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, 878; it may also involve writing very small prescriptions and having more frequent 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."17 163.

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.18 161; 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 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." 963. Dr. Schneider added that if the patient does it again, she "may discharge them." 964.

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." 1007. Moreover, she documents the incident in the patient 1008. Dr. Schneider also noted that it is especially "egregious" when a patient is buying drugs on the 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." 163. Dr Hare further explained that "[w]e do our refills on a 30-day basis," and we set "the dates that the refill is supposed to occur * * * so we have all of that information in our records" and that this allows for the physician "to quickly access * * * and determine when a refill is appropriate" and "when it's not." 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 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.

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." 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." 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." 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.SeeGX 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

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":

* 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." 2. She didnot "comment on the lack of patient compliance" when patients used controlled substances "in excess of the prescribed amounts."Id.Rather, she "usually increased the amount of the prescription to meet the patient's use of medication, rather than exercising any control over the patient's consumption."Id.

* Respondent switched from one controlled substance to another, "based on patient request, not on what was reasonable therapeutically."Id.

On cross-examination, Respondent admitted that she failed to take addiction histories. Tr. 2344. However, when asked whether she routinely failed to obtain prior medical records, she stated that "there is no obligation or rule that you have to get medical records."Id.; but seeGX 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 2345. She admitted that others might not always be able to "glean" her rationale for increasing opioid dosages from her 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" 2345-46. She indicated that she did not find doing frequent MRIs useful, that with chronic pain that was just a waste of medical 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 2347-48. She testified that she did not ignore that some patients had histories of addiction and that she did not ignore warning signs of addiction or 2348-49. She admitted that she was not in contact with primary care physicians in all cases, but she also justified that in the case of J.N., noting that her primary care physician wasn't practicing due to a licensing 2349. Respondent admitted that on occasion she failed to document the reason for increasing an opioid 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 2393-94. She compared the situation to one where a diabetic patient is not following his diabetic diet.Id.

Evidence Regarding Specific PatientsJ.N.

On September 11, 2000, J.N., who was then forty-three years old and who undergone a cervical fusion in 1994, started treating with Respondent. GX 9, at 1. She "had been sexually assaulted and suffered [a] cervical fracture and needed emergency surgery."Id.Her pain had recently worsened, and Respondent noted in her medical record that she "need[ed] another cervical fusion."Id.J.N. had been on disability since 1994.Id.

There is no indication in J.N.'s patient record that Respondent inquired about any history of substance abuse at the initial 1-2. At the first visit, Respondent performed a physical exam and diagnosed J.N. as having "[s]evere neck pain," "left upper extremity pain," and "signs of left cervical radiculopathy." 2. Respondent gave J.N. a free trial of 21 tablets of OxyContin 40 mg q8h22 (one tablet every eight hours), 50 tablets of Oxycodone IR "1-2 q4h PRN for breakthrough pain," and a prescription for 60 tablets of Xanax 0.5 mg twice a day, with one refill, although nothing in the patient record documented that J.N. experienced 2. Respondent was to "[r]echeck in 1 week."Id.

On September 15, Respondent noted that J.N. "is better on the OxyContin and Oxycodone. She feels less pain," yet Respondent increased the OxyContin prescription to 60 (160 mg.) tablets, with one tablet to be taken every eight hours, (a twenty-day supply), which was a four-fold increase in the dosage over the initial prescription.Id.Respondent also issued prescriptions for 50 milliliters of Oxyfast 20 mg/ml, "1-2 ml q4h PRN breakthrough pain," 360 tablets of MS Contin 100 mg., (4 tabs q8h), as well as 100 milliliters of morphine elixir "20 mg/ml 5 ml q6h PRN breakthrough pain." 2-3. Respondent noted that the latter two prescriptions were being issued in "[i]n case Pima insurance doesn't cover" the other medications.Id.Respondent also increased the dosage of Xanax four-fold to 2 mg. twice a day, again without any finding regarding anxiety.Id.

J.N. returned on October 5 and reported that she was "much better than she has been because of the MS Contin," and Respondent wrote prescriptions for MS Contin at the same dosing and also MSIR (morphine sulfate immediate release) "30 mg 6qh PRN breakthrough pain #120," to "recheck in one month." 3. Respondent also added a prescription for ten tablets of Dilaudid 4 mg., 1-2 four times a day.Id.On October 25, J.N. reported that the medications helped with her pain and with sleep and that she would like more Dilaudid.Id.She also reported having had an EMG/NCV with a Dr. L. on September 14, but did not know the 4. Respondent wrote prescriptions for Dilaudid, MS Contin, MSIR, as well as Fioricet for "headache."23 4. J.N. continued on Dilaudid, MS Contin, Xanax and Fioricet through June 14, 4-9.

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" 13. Continuing, the Summary stated that "she quit several years ago, but started using again one week ago because of increasing abdominal pain." 13-14. The Summary also noted that a urine toxicology screen was "positive for opiates, barbiturates, benzodiazepines, and marijuana." 15.

The Discharge Summary listed five medical problems J.N. had including "Chronic pain/narcotic addiction." 15-16. The Summary specifically noted that J.N. was "preoccupied with her pain medications, requesting p.r.n. medications frequently" and was "resistant to weaning attempts."Id.Moreover, while the hospital offered J.N. "drug abuse placement," she "refused," stating that "she was not an addict, and was only unable to get off Morphine due to her medical condition." 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 onDecember 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 6.

J.N.'s record contains no indication that Respondent attempted to monitor her use of controlled substances through drug screens and pill counts.See generally id.Moreover, the medical record contains no indication that Respondent questioned J.N. about her use of marijuana, heroin, or the barbiturate (which Respondent had not prescribed to her).

On subsequent visits, Respondent primarily prescribed 120 tablets of Dilaudid 4 mg. (QID--one tablet four times a day), 180 tablets of MS Contin 200 mg. (two tablets every eight hours), Xanax 2 mg. (BID -one tablet twice a day), and Restoril (temazepam) (two tablets at bed time).24 5-9. After J.N.'s hospitalization, all of the MS Contin prescriptions and all but two of the Dilaudid prescriptions were for a quantity equaling 30 days of dosing.See id.Approximately half of the Dilaudid and MS Contin prescriptions were refilled at least five days early, with some being refilled as early as eight or nine days before the previous prescription would have run out.See id.(Rxs for: 180 MS Contin on 12/18, 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14; for 120 Dilaudid on 1/11, 2/1, 2/26, 3/20, 4/19, and 5/14).

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 22. Yet there is no indication in J.N.'s medical record that Respondent ever noticed this.See generallyGX 9.

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. 921-22. 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 1154. Yet the Medical Examiner did not note any evidence of a heart attack.See generallyGX 8. Moreover, when Respondent asked her whether there are "any interactions between opiates, such as morphine, and * * * amitriptyline or cyclobenzaprine," the witness answered:

Tr. 1157. The expert's testimony does not make clear whether her answer as to the effect that would occur in an opioid-tolerant 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.

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 death--it just being a coincidence that syringes and crushed medication were found in the vicinity of her body--the 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 end" of the document but that the reference to J.N.'s heroin abuse was "buried in" the 1850 & 2367-68.27

The discharge summary was, however, only five pages in length (and the fifth page did not contain any medical information).SeeGX 9, at 13-17. Moreover, the reference to J.N.'s "history of IV heroin abuse" was on the bottom of the first page.See 1.

In her testimony, Respondent also maintained that that she was unaware that J.N. had crushed and injected her medication until she inferred it from a question DI Llenas asked her the day of the search warrant in May 2002. Tr. 2377. Yet other evidence indicated that J.N. had no veins and that it was difficult to draw blood from her, something which Respondent apparently never noticed.

With respect to J.N.'s initial visit, Dr. Hare concluded that Respondent "failed to obtain [an] adequate history * * * and [that] she did not obtain records from * * * the neurologist, by whom the patient had been evaluated," that she conducted a "minimal and inadequate physical examination," and that "the evaluation was inadequate to allow proper diagnosis and therefore the prescribing of controlled substances." GX 46, at 4. As to J.N.'s second visit, Dr. Hare's review of her patient record noted that her "already large dose ofOxyContin" was "dramatically increased" "six-fold"28 on September 15, 2000, "despite the patient's improvement."Id.He also noted that the strength of the alternative prescription that was written for MS Contin 100 mg. would "translate to about 8 times the original OxyContin [sic] dose."29 5.

Dr. Hare further noted that on January 11, 2001, the patient record "indicate[d] that the patient's [niece] died and that the patient was quite distressed."Id.He also remarked that "[t]his was the very first mention in the records of anxiety and depression, even though the patient had been treated with Xanax for a considerable period of time prior to this."Id.Dr. Hare also noted that on several occasions Respondent prescribed medications for J.N. that other doctors, in other specialties, had previously prescribed for J.N., without attempting to coordinate care with those physicians.Id.

Dr. Hare also observed that Respondent did not notice signs of abuse, did not acknowledge the Discharge Summary's information about J.N.'s current abuse and history of substance abuse, and failed to treat J.N. for depression or give a psychiatric referral.30 6. Dr. Hare thus concluded that Respondent's care of J.N. was "substandard" and "probably negligent." 6.

With respect to J.N. (as well as three other patients N.F., W.F., and C.O.), Dr. Schneider observed in her report that:

RX K-1, at 6.W.F.

W.F. first visited Respondent in September 2001. At that time he was a disabled 44-year-old veteran. GX 13, at 1. W.F. had been in a severe jeep accident in 1973 while in the Marine Corps, fracturing his pelvis, femur, right wrist and left mandible.Id.;Tr. 1958. He walked with crutches. GX 13, at 1.

At the first visit, W.F. brought in an impairment rating from the Veteran's Administration (VA) establishing that he was disabled.Id.Respondent did not, however, contact the VA to obtain copies of his treatment records.Id.Nor is there any indication in the patient record that Respondent inquired about W.F.'s substance abuse history at the initial visit, nor is there any indication that she asked for pain ratings.See id.Respondent's physical exam involved observing W.F. walk with his crutches, noting that he had "severe pain with lumbar range of motion," "tenderness over bilateral lumbar paraspinals," and "tenderness over [his] right wrist and pain with right wrist range of motion."Id.

W.F.'s patient file includes several letters which advised Respondent that he had a history of substance abuse. The first letter, which was dated January 8, 2002, was written by Dr. H.G., a psychiatrist with Cope Behavioral Health. GX 13, at 13. Therein, Dr. H.G. explained that W.F. was "currently under court ordered treatment by the Psychiatric Security Review Board which mandates that all [of] his medications are to be prescribed by either psychiatrists at Cope * * * or by the VA."Id.The letter further states that W.F.'s "case manager * * * has recently learned that [he] was receiving narcotics & psychotropics from your office; unfortunately, this history has repeated itself to poor outcomes in the past for [W.F.] (addiction issues)."Id.

On January 24, 2002, Dr. H.G. sent another letter to 15. Therein, he indicated that it was permissible for Respondent to prescribe for W.F. because he could not get an appointment at the VA until April. Dr. H.G. noted, however, that "[a]lthough he currently denies symptoms of abuse, please be aware he has had narcotics addiction problems in the past." 15.

Finally, on January 28, 2002, J.G., a case manager at Cope Behavioral Health, indicated that Cope had "received a phone call this afternoon from a family member of [W.F.], who is concerned that [W.F.] might be abusing his pain meds." 17.

The patient record contains some indication that on January 29, 2002, Respondent discussed addiction issues with W.F., as Respondent wrote: "[p]atient insists that the medications help with the pain, and he cannot function without the medications." 5. Respondent wrote prescriptions for 100 Methadone 10 mg. 1-2 QID (one to two tablets four times a day) and 100 Roxicodone 30 mg. q4h PRN (one tablet every four hours as needed for pain) 6. Respondent issued the same prescriptions on February 11, 2002. Respondent had also previously written prescriptions for temazepam with multiple refills on October 29, 2001, and December 17, 3, 5.

On February 24, 2002, W.F. was found dead. The Medical Examiner's report concluded that W.F. "died of undetermined cause. Possibilities include seizure related and drug intoxication." GX 11, at 2. A toxicology report found that W.F. had a temazepam level of 1148 ng/ml; 14, however, the Medical Examiner subsequently indicated in a letter to Respondent that this level of the drug "would not be expected to cause death." RX 52. The Medical Examiner also found that "[o]ther drugs identified in his body were in too low a concentration to allow me to come to the conclusion that death was likely the result of the combination of drugs, including Temazepam."Id.Relatedly, the toxicology tests found only a small amount of oxycodone and no presence of methadone in W.F. GX 11, at 9-15.

Dr. Hare observed that at the initial visit, Respondent did not obtain an adequate medical history and did not inquire about substance abuse issues. GX 46, at 3. Also, "the physical examination was minimal and inadequate to characterize various pain complaints."Id.Dr. Hare also faulted Respondent, who then knew of the history of substance abuse, for not limiting W.F.'s medication and not "requesting toxicology screens * * * to determine if he was using medications other than those she prescribed, or actually using the medication she was prescribing." 4. Dr. Hare further noted that the toxicology report done as part of the autopsy "was negative for opioids which he had been prescribed in sizable amounts" and that "[t]he lack of opioids would suggest that the patient was diverting significant portions or the entire prescriptions."Id. 31 He concluded that Respondent's care was "substandard and inappropriate regarding the controlled substance prescriptions."Id.

On cross-examination, Respondent testified that she had heeded the psychiatrist's warning about the past heroin addiction and also his "judgment" that pain medications were appropriate.32 Tr. 2382. She admitted that she never did an addiction history.Id.In her testimony, Respondent did not, however, respond to Dr. Hare's contention that her physical exam was minimal and inadequate.

The ALJ credited Respondent's testimony that oxycodone is a short-acting medication and that half of it is gone after two hours. ALJ at 82 (citing Tr. 2165). The ALJ also credited Respondent's testimony that it was "quite possible that a patient could take a level of less than five," and that this "doesn't mean that a person is not taking his or her oxycodone."Id.Respondent did not, however, address why there was no methadone, a medication with a much longer half-life than oxycodone, in W.F. at the time of his death.

W.F. was one of those patients about whom Dr. Schneider concluded that there was "evidence of `aberrant drug-related behaviors', which should have been pursued but weren't." RX K-1, at 6. Dr. Schneider further noted W.F. had "received early refills without adequate documentation and explanations," and that Respondent's charts indicated that Respondent "needed additional education about obtaining an addiction history, careful monitoring and review of the big picture."Id.

M.D. and S.R.

M.D. and S.R., who were both patients of Respondent, were unmarried but lived together. M.D. first visited Respondent on May 21, 2001, when he complained of having "fallen off a bicycle" and of a "back and leg injury." GX 17, at 1. M.D. further related that another physician had prescribed to him OxyContin 80 mg. (at a dosing of one tablet every twelve hours), Oxyfast, and methadone, but that the physician had left the office and that he had been off the drugs for several months.Id.Respondent did not, however, attempt to contact the other physician's office to verify the statement and/or to obtain treatment records.

Respondent's physical exam noted that M.D. was a "lethargic male in no acute distress with antalgic limp, favoring left lower extremity," "pain with range of motion of the left ankle," "tenderness over bilateral thoracic and lumbar paraspinals," and "decreased lumbar range of motion associated with pain."Id.Respondent did not, however, otherwise indicate how severe M.D's pain was.Id.Respondent also had M.D. sign a pain contract and issued him prescriptions for 60 OxyContin 80 mg. q12h, 30 milliliters of Oxyfast, and 30 tablets of Oxycodone 5 mg. PRN.Id.

Later the same day, Respondent documented having received a phone call (apparently from a pharmacy) reporting that M.D. was "known to forge prescriptions and was arrested." 2. Respondent notified the pharmacy where M.D. had indicated on the pain contract that he would fill his prescriptions not to fill them.Id.M.D., however, filled the OxyContin prescription at a Walgreen's pharmacy.Id.

On June 8, 2001, M.D. returned to Respondent seeking a new OxyContin prescription.Id.M.D. reported that he was taking double the dose of the OxyContin.Id.He also did not remember what had happened at the pharmacy which had reported him to Respondent.Id.Respondent refused to issue the prescription.Id.

There are no further visits recorded in M.D.'s patient record.Id.The record indicates, however, that on October 8, 2001, the patient pharmacy manager at Tucson Medical Center reported that M.D. had been admitted to the hospital in a coma seven days earlier and had in his possession methadone 40 mg. tablets which were contained in a prescription bottle; the label indicated that the prescription was for Dilaudid 4 mg. and had been issued by Respondent to S.R.33 Id.

S.R. first saw Respondent on August 3, 2001, complaining of abdominal and pelvic pain. GX 15, at 1. S.R. reported that she had a history of interstitial cystitis and active hepatitis C, but apparently she did not bring records about either condition with her.See id.S.R. indicated that she was taking Xanax and Vicodin, which she obtained from another doctor.Id.She also stated that she was taking her deceased husband's OxyContin and Dilaudid.34 Id.

Respondent's physical exam indicated that S.R. was "in moderate distress," that she had "pain with ambulation and limp," and had "tenderness over [her] abdomen."Id.Respondent diagnosed S.R. as having "interstitial cystitis and chronic pain," as well as Hepatitis C.Id.Respondent discussed the risks and benefits of long-acting opioids, including addiction and side effects, and prescribed Dilaudid 2 mg. "QID #30," OxyContin 10 mg. "q12h #30," and Xanax 0.5 mg. "TID PRN #90."Id.There is no indication that Respondent contacted the physician who had prescribed Vicodin and Xanax to her.See id.Moreover, there is no indication as to why she prescribed Xanax, an anti-anxiety drug. Nor did she counsel S.R. about the use of her deceased husband's medications. Tr. 2353.

S.R. returned seventeen days later, reported that she was out of Dilaudid and OxyContin, and asked for stronger medication. GX 15, at 1-2. Respondent found that S.R. had "pain with ambulation and limp" and "tenderness over [her] abdomen." 2. Respondent increased both the strength and quantity of the Dilaudid to 4 mg. "QID #60," and the strength of the OxyContin to 20 mg., with the same dosing and number of tablets ("q12h #30"). She also issued a new prescription for Xanax, 0.5 mg., TID PRN 2.

On September 4, 2001, S.R. again saw Respondent. Respondent noted that S.R.'s urologist had "diagnosed interstitial cystitis," and that she needed to "obtain records from Dr. [M]."Id.Respondent also noted that while S.R. "gets abdominal pain," "she is more comfortable."Id.Respondent again wrote prescriptions for Dilaudid and OxyContin, doubling the strength of the latter to 40 mg. with the same dosing instruction of "q12h."Id.

On September 18, S.R. complained of "continued pain" and wanted a higher dose of OxyContin even though she was "more comfortable."Id.Respondent doubled the strength of the OxyContin to 80 mg. "q12h #30" and also wrote a prescription for 60 Dilaudid 4 3. Respondent noted that she "sent another request for records from Dr. [M]."Id.

On October 2, Respondent discontinued OxyContin in favor of MS Contin, 100 mg. "q8h #100," which was "less expensive," and also wrote aprescription for Dilaudid.Id.She also issued S.R. a prescription for 100 Xanax (1 mg.), with two refills, which was double the strength of the previous prescription, after S.R. had claimed that "the pills got wet and they dissolved."Id.Respondent also noted that S.R. "has severe anxiety and needs the Xanax" and was complaining of abdominal pain.Id.The next day Respondent gave S.R. a prescription for 200 Methadone 10 mg. "3 tabs QID" for pain when S.R. returned, having not filled the MS Contin prescription due to its cost.Id.

On October 8, Respondent received the phone call described above reporting that M.D. had been admitted in a coma seven days 4. At S.R.'s next visit, which was on October 12, Respondent "explained to [her] that she must be very careful with her medications."Id.According to the patient record, S.R. "denie[d] that [M.D.] could have ever gotten his [sic] medications."Id.Respondent reported that S.R. was still complaining of abdominal pain and issued her a new prescription for 60 Dilaudid 4 mg.Id.Moreover, a week later, Respondent issued S.R. a new prescription for 200 Methadone 10 mg. Respondent did not institute any kind of monitoring on S.R.'s use of her medication.Id.

On November 2, S.R. returned "complaining of abdominal pain."Id.Respondent referred her to another physician "for interstitial cystitis treatment and work-up."Id.Respondent also wrote S.R. prescriptions for 60 Dilaudid 4 mg. and 200 Methadone 10 mg.Id.

On November 19, S.R. returned to obtain more "prescriptions, and [was] very irate that they weren't ready."Id.Respondent exp

Dated: February 2, 2010. Michele M. Leonhart, Deputy Administrator.
ACTION: 97I also take official notice of the findings of the SAMSHA Survey.