Daily Rules, Proposed Rules, and Notices of the Federal Government
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."
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.
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."
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)."
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."
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."
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."
The ALJ specifically rejected the evidence of the Government's Expert with respect to twenty-three other patients, noting that various physicians who testified on behalf of Respondent had disagreed with the conclusions of the Government's Expert.
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."
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.
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."
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.
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
First, it is inconsistent with Agency precedent, which holds that proof of as few as two acts of diversion satisfies the Government's
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.
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
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.
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.
On March 26, 2003, a Federal grand jury indicted Respondent, charging her with numerous violations of Federal law.
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").
The Board also found that in prescribing controlled substance medications, "Respondent [often] failed to maintain adequate records on the patients."
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."
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."
Respondent applied for her DEA Certificate of Registration on January 28, 2005. ALJ Ex. 1, at 6.
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.
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 (
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.
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."
Dr. Schneider (Respondent's expert) testified that in her practice, she will not treat a patient absent "old records." Tr. 854. Dr. Schneider explained that the day before the initial visit, her office calls "to remind" patients that if they do not bring records with them, their physician will be called at the visit and asked to fax the records. Tr. 854-55. However, she noted that Respondent, as a physiatrist, would often have the first visit after an injury so that there would not be prior records of treatment of a particular injury and so "it's less essential to start out on day one with old records." Tr. 855.
Dr. Schneider likewise testified as to the importance of obtaining a patient's substance abuse history. According to Dr. Schneider, a patient who has a history of substance abuse can still be prescribed opioids for chronic pain, but the history is a "relative contraindication" for such treatment. Tr. 881. A physician thus needs to "get a careful history and * * * have much more stringent monitoring," but, depending on "the nature of the previous substance abuse, on how long it's been since the person last abused the substance and what kind of treatment they had for it," a physician could still safely prescribe controlled substances. Tr. 881-82.
Dr. Schneider testified that her initial appointment usually takes 45 minutes. Tr. 863-64. In that time, she goes through "the four As." Tr. 864. The first "A" is
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."
At the first visit, the physician should create a treatment plan.
It was undisputed, however, that "the appropriateness of prescribing [controlled substance] medications * * * depends on the level of medical documentation."
Both Dr. Hare and Dr. Schneider testified that when any medication has been prescribed, there will be follow-up visits at which the physician questions the patient about whether there has been improvement in his pain level and functionality, whether there have been side effects, and the continuing benefits of taking the medication.
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;
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.
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."
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.
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."
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."
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.
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."
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."
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.
At the request of the DEA Investigators, Dr. Hare reviewed the medical records of Respondent's patients.
* 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."
* Despite the fact that "[t]he information in [Respondent's] records was insufficient to make a proper diagnosis," Respondent "prescribed Controlled Substances."
* Respondent "did not properly track the use of medications."
* Respondent switched from one controlled substance to another, "based on patient request, not on what was reasonable therapeutically."
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."
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.
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.
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."
There is no indication in J.N.'s patient record that Respondent inquired about any history of substance abuse at the initial visit.
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.
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."
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".
The Discharge Summary listed five medical problems J.N. had including "Chronic pain/narcotic addiction."
While the patient record indicates that Respondent was notified on
J.N.'s record contains no indication that Respondent attempted to monitor her use of controlled substances through drug screens and pill counts.
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).
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.
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 attack.
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 report.
The discharge summary was, however, only five pages in length (and the fifth page did not contain any medical information).
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 of
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."
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.
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:
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.
At the first visit, W.F. brought in an impairment rating from the Veteran's Administration (VA) establishing that he was disabled.
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."
On January 24, 2002, Dr. H.G. sent another letter to Respondent.
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."
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."
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;
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."
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.
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."
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."
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.
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."
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."
On June 8, 2001, M.D. returned to Respondent seeking a new OxyContin prescription.
There are no further visits recorded in M.D.'s patient record.
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.
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."
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."
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]."
On September 18, S.R. complained of "continued pain" and wanted a higher dose of OxyContin even though she was "more comfortable."
On October 2, Respondent discontinued OxyContin in favor of MS Contin, 100 mg. "q8h #100," which was "less expensive," and also wrote a
On October 8, Respondent received the phone call described above reporting that M.D. had been admitted in a coma seven days earlier.
On November 2, S.R. returned "complaining of abdominal pain."
On November 19, S.R. returned to obtain more "prescriptions, and [was] very irate that they weren't ready."