Daily Rules, Proposed Rules, and Notices of the Federal Government
On October 27, 2011, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to T.J. McNichol, M.D. (Respondent), of Brandon, Florida. ALJ. Ex. 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration FM0624139, which authorizes him to dispense controlled substances in schedules II through V, as a practitioner, and the denial of any pending applications to renew or modify his registration, on the ground that his "continued registration is inconsistent with the public interest."
As support for the proposed action and the immediate suspension, the Show Cause Order alleged that "[o]n six separate occasions between approximately July 28 * * * and August 25, 2011, [Respondent] distributed controlled substances (oxycodone, a Schedule II controlled substance, and alprazolam, a schedule IV controlled substance) by issuing `prescriptions' to [four] undercover law enforcement officers [hereinafter, UC or UCs] for other than a legitimate medical purpose or outside the usual course of professional practice."
Next, the Show Cause Order alleged that on July 28, 2011, Respondent distributed 150 tablets of oxycodone 30mg and 90 tablets of alprazolam 1mg to UC2 on his initial visit, even though "UC2 provided no history of injury or illness that warranted the distribution of controlled substances" and that Respondent "conduct[ed] only a cursory physical examination" which lasted "approximately two minutes" and "despite the officer telling [Respondent] that he experienced little pain."
With respect to UC3, the Show Cause Order alleged that on August 25, 2011, Respondent distributed 180 tablets of oxycodone 30mg and 30 tablets of alprazolam 2mg to the UC at his first visit, "while conducting only a cursory physical examination and despite the officer not providing any information in his medical questionnaire about experiencing any pain."
Finally, with respect to UC4, the Show Cause Order alleged that on August 25, 2011, Respondent distributed 210 tablets of oxycodone 30mg and 60 tablets of alprazolam 2mg to the UC at his first visit.
Respondent requested a hearing on the allegations; the matter was placed on the docket of the Office of Administrative Law Judges and assigned to ALJ Timothy D. Wing. Following pre-hearing procedures, the ALJ conducted a hearing on January 17-18, as well as April 10-11, 2012.
On May 17, 2012, the ALJ issued his recommended decision. With respect to factor one--the recommendation of the state licensing board--the ALJ found "that Respondent currently holds a valid, unrestricted medical license in Florida and has never been disciplined by the Florida Department of Health." ALJ at 45. The ALJ thus found that, while this factor is not dispositive, it "weighs against a finding that Respondent's continued registration would be inconsistent with the public interest."
With respect to factor three--Respondent's conviction record under Federal or State laws related to the manufacture, distribution, or dispensing of controlled substances--the ALJ found that there was no evidence that Respondent has been convicted of such an offense.
Next, the ALJ considered factors two--Respondent's experience in dispensing controlled substances--and four--Respondent's compliance with applicable laws relating to controlled substances, together.
Reasoning that because "Respondent's prescribing practices with regard to the undercover patients visits [were] not remotely close to `outright drug deals,'" and that "the undercover patient visits objectively reflect that Respondent's prescribing practices included, to a degree, a documented medical history, physician examination, documented urinalysis testing, medical record release forms, and pharmacy prescribing profiles, * * * consistent with applicable Florida law," the ALJ explained that "any finding that Respondent's prescribing conduct * * * was not for a legitimate medical purpose and outside the usual course of professional practice under the Florida Standards or standards generally recognized and accepted in the medical community will significantly depend on the evidentiary weight" given to the opinion testimony of the Government's Expert.
The ALJ further stated that he found that the Expert's testimony included "inconsistencies, factual errors, vague or nonresponsive answers to basic questions, and an overall lack of interest or even curiosity in examining all available information relevant to Respondent's prescribing conduct."
Accordingly, based on what he deemed to be the absence of "credible medical opinion testimony," or other "credible evidence of misconduct by Respondent," the ALJ rejected the allegations that Respondent lacked a
With respect to factor five--such other conduct which may threaten public health and safety--the ALJ noted that Respondent, who had been called to testify by the Government, invoked his Fifth Amendment privilege and refused to testify. ALJ at 92. While the Government requested that the ALJ draw an adverse inference based on Respondent's refusal to testify, the ALJ declined to do so explaining that because the Government had failed to establish a
On June 5, 2012, the Government filed Exceptions to the ALJ's recommended decision. Thereafter, on June 14, 2012, the ALJ forwarded the record to me for Final Agency Action.
I have carefully considered the entire record including the ALJ's recommended decision and adopt his findings with respect to factors one and three. However, I reject his findings with respect to factors two and four because, with respect to many of the prescriptions (especially those for alprazolam) Respondent issued to the undercover officers, expert testimony was not necessary to prove that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing them. Indeed, with respect to one of the undercover officers, the ALJ ignored nearly all of the evidence of the conversation which occurred between Respondent and the officer which shows that Respondent knew the undercover officer was a drug abuser and that he engaged in an outright drug deal.
Likewise, with respect to the alprazolam prescriptions Respondent issued to three of the undercover officers, the ALJ entirely ignored relevant evidence and failed to discuss the evidence pertaining to these prescriptions. In other instances, the ALJ mischaracterized the evidence he cited. Finally, with respect to several issues, the ALJ failed to apply properly, or ignored entirely, precedents of both the Agency and federal courts.
Accordingly, as ultimate factfinder, I reject the ALJ's legal conclusion that the Government has not met its
I make the following
Respondent is the holder of DEA Certificate of Registration FM0624139, which prior to the issuance of the Order of Immediate Suspension, authorized him to dispense controlled substances in schedules II through V as a practitioner, at the registered location of Quality Care Medical Group (hereinafter, QCMG), 143 Oakfield Drive, Suite 102, Brandon, Florida. GX 1-2. Respondent's registration does not expire until January 31, 2014. GX 2.
Respondent is also the holder of an active medical license issued by the Florida Board of Medicine, which does not expire until January 31, 2014. ALJ at 45 n.76. There is no evidence that Respondent's state license has been the subject of any disciplinary proceedings.
QCMG first came to the attention of DEA in early 2010, when a Task Force Officer (TFO) received information from various sources including citizens, anonymous callers and a cooperating defendant regarding a QCMG clinic located in Bradenton, Florida. Tr. 50-53. The information included a report that persons were traveling to QCMG from out-of-state locations, that QCMG allowed sponsors to bring groups of people into the clinic, and that persons were presenting fraudulent MRIs and prescription profiles to obtain admission as patients.
In June 2011, DEA commenced undercover operations at the Bradenton location and sent in several undercover officers who presented MRIs and patient profiles and were able to see the doctor who worked at that location.
On some date not specified in the record but shortly before July 28, 2011, a Task Force Officer (TFO) using the undercover name of Robbie Payne went to the QCMG Bradenton clinic but was turned away because he did not have an appointment. Tr. 169-70. During a discussion following the operation, the investigators decided that the TFO would contact the Brandon clinic and make an appointment.
On July 28, the TFO went to the clinic, wearing a recording device, and brought an MRI and a profile purporting to show what prescriptions he had obtained; the latter showed that Payne had last received prescriptions for 210 tablets of oxycodone 30mg, 90 tablets of oxycodone 15mg, and 90 tablets of Xanax 2mg on April 10, more than three and a half months earlier.
The TFO did not, however, recall whether the questionnaire had any questions regarding whether he suffered from anxiety.
The TFO also testified that one of the forms had a picture of a human body and that he "deliberately" circled a part of the body that was different than his MRI "to disprove * * * the MRI."
The TFO was eventually summoned from the waiting room by Eddie Gomez, who identified himself as the office manager and Respondent's assistant.
Gomez then said that he was going to do a drug screen on the TFO and asked him when the last time was that he took his meds.
Gomez gave the TFO a cup for a urinalysis and the TFO provided a sample.
The TFO testified that Gomez did not ask him about the source of his pain, or whether he had any problems with anxiety or sleeplessness.
Gomez testified that after the information was entered into the EMR, "it was shredded."
Respondent entered the exam room and introduced himself. GX 14, at 9. Respondent noted that the TFO had been in pain management in south Florida but that "they went out of business."
Respondent reviewed the TFO's MRI, noting that it showed a "mild disc bulge" at "two levels, without significant central canal or neuro."
The TFO replied that "that's just what they prescribed, that's not what I actually took," and after Respondent said "okay," the TFO added: "So I didn't * * * I didn't, I can't * * * tell, you're the doctors, so I don't know * * * So that's just what they gave."
The TFO said "alright" and Respondent added: "Okay? Could, and * * * what you should get, and what you need, often sometimes is two different things cause if you've been on a certain number of pills, for a long time, if you don't get those number of pills, you're going to be sick."
During the physical exam, Respondent asked the TFO various questions regarding the location of his purported pain. GX 14, at 11. For example, Respondent asked the TFO if most of his pain was in his lower back.
Following an apparent test of the TFO's reflexes, Respondent asked him to stick his legs out and whether doing so caused pain; the TFO stated "not right now."
Following a discussion of the EMR system, Respondent asked the TFO if he had been getting Xanax.
After Respondent and the TFO discussed how the latter made his living, Respondent gave the TFO his "new patient talk," which included telling him to take his medication as prescribed, and that there is "no such thing in this clinic * * * of running out of medication.
Respondent added: "We're pretty strict here * * * but we do have fun also," a point which he reiterated.
The evidence shows that Respondent wrote the TFO a prescription for 150 tablets of oxycodone 30mg, and a prescription for 90 tablets of Xanax 1mg. GX 15, at 1. In the medical record for the visit, Respondent documented the TFO's pain level as a "3" and that it was of mild severity.
In the TFO's medical record, Respondent further recorded a diagnosis of "generalized anxiety disorder," which he deemed to be "active" and "chronic," notwithstanding that under the "psychiatric" section of the "review of systems" section, Respondent noted that "Patient denied problems with mood disturbance. No problems with anxiety." RX 1, at 27-28.
Likewise, under the "psychiatric" section of the physical examination, Respondent noted: "Oriented with normal memory. Mental status, judgment and affect are grossly intact and normal for age."
In addition, in the "Instructions" section of the medical record, Respondent wrote the following:
RX 1, at 29. At no point during this visit, however, did Respondent discuss with the TFO any of these instructions.
On August 25, the TFO, again wearing a recording device, returned to the Brandon clinic. Tr. 192. Upon his arrival, the TFO checked in with the receptionist and paid the fee for the visit. RX 4, at 21-22. Before even seeing Respondent, the receptionist gave the TFO an appointment for a follow-up visit.
After about twenty-five minutes, Eddie Gomez called the TFO back to the triage room and took his weight and blood pressure. GX 17, at 2-3. Gomez then told the TFO to return to the waiting room and that he would be called next.
Respondent entered the exam room and asked the TFO "what's going on"; the TFO replied: "How you doing?" GX 17, at 4. Respondent answered, "All right, what's up? How did your month go?"
Respondent then stated that he would "be feeling [the TFO's] lower back and get you going"; Respondent then asked: "[a]ny pain down in this areas here, how about here?"
The entire interaction between the TFO and Respondent lasted less than two minutes. GX 17. As the TFO wrote in his report for the visit:
Here again, evidence shows that Respondent made findings in the medical record notwithstanding that he never performed various tests. For example, the medical record for the visits noted that there was "no change" in the pain's "status," noted that it radiated into his "upper back," that the "timing" of the pain was "constantly, during the day and EVENING," and that its "quality" was "radiating and dull." The record further listed "sleep and physical activity" as "affected daily activities." RX 1, at 30.
Respondent also documented that he had done a neurologic examination, in which he found that the TFO had "[n]ormal and symmetrical deep tendon reflexes with no pathological reflexes." RX 1, at 31. Likewise, Respondent made findings that he had palpated the TFO's cervical spine and the surrounding areas, as well as that he had had the TFO perform various range of motion tests of various portions of his spine.
On July 27, 2011, a Special Agent, who used the name of Anthony Thompson, attempted to see a doctor at the QCMG clinic Bradenton. Tr. 240. While the Agent was turned away because he was not thirty years of age and his MRI could not be verified, a staff member advised him to go to the Brandon clinic because it was not "as strict as the Bradenton clinic."
The next day, the Agent, who was wearing a recording device, went to the Brandon clinic and presented an MRI
Mr. Gomez called the Agent and identified himself as the doctor's assistant. GX 7, at 3. Mr. Gomez proceeded to review the rules of the pain contract, told the Agent that the clinic reported doctor shoppers, asked if he was taking "any illegal substances," and what pain management clinic he was going to.
After taking the Agent's weight and blood pressure, Gomez asked him about his employment status, education level, marital status, and whether he had kids; whether he smoked, used alcohol or caffeine; whether he had any blood transfusions; whether he had body piercings or tattoos; whether he exercised; and whether he had any significant family history.
According to the Drug Urinalysis Test form, the Agent tested positive for benzodiazepines and oxycodone. RX 1, at 24. At the hearing, however, the Agent testified that he did not take either benzodiazepines or oxycodone; that in his position, he was subject to drug testing; and that he could not take these medications unless they were prescribed to him. Tr. 301. While Gomez insisted in his testimony that the Agent had tested positive for these
Following a discussion of the clinic's recordkeeping system, Gomez took the Agent to an exam room. GX 7, at 7. Respondent eventually entered the room, introduced himself, and proceeded to look at the Agent's MRI.
Respondent said "ok," and proceeded to conduct a physical exam which lasted less than two minutes.
The Agent then asked Respondent how long he had been at the clinic; Respondent said that he had been there since February and that when he started there, the doctors who had come before him "would basically give anything to anybody."
Respondent then told the Agent that his physical exam did not "one hundred percent correlate with [the] finding on your MRI," and that his "physical exam [wa]s a lot better than your MRI," but that "there is some stuff on your MRI that would justify you having pain."
Respondent replied that "that's very odd" because "the 30's and 15's are * * * both break through medications" and "do the same thing."
Respondent then told the Agent that based on the latter's MRI and physical exam, he would give him 180 tablets of oxycodone 30mg but not the 15s.
Next, Respondent said: "I take it you have some anxiety as well is that what's going on with you?"
Respondent then observed that "on July 1st[,] the law states now that if the patient has a psychiatric um problem along with being on pain management the law states we have refer you to psychiatry."
Respondent did not, however, provide the Agent with the name of any psychiatrist to see. Tr. 255. Moreover, in the psychiatric section of the "review of systems," Respondent noted: "Patient denies problems with mood disturbance. No problems with anxiety." RX 1, at 16. Likewise, in the psychiatric portion of the physical examination, Respondent documented: "Oriented with normal memory. Mental status, judgment and affect are grossly intact and normal for age."
Respondent then gave the Agent his "new patient speech" and the visit ended.
On August 25, 2011, the Agent returned to the clinic, and again wore a recording device. Tr. 256. The Agent met the receptionist, paid the fee for the visit and sat down in the waiting room. RX 4, at 10-11. After approximately thirty minutes, the Agent was called by Mr. Gomez for triage, who took his weight and blood pressure. GX 10, at 6; RX 4, at 11. Mr. Gomez did not, however, ask the Agent any questions regarding his health. GX 10, at 6; RX 4, at 11. The Agent then returned to the waiting room. RX 4, at 11. Moreover, the Agent testified that he did not recall filling out any forms at this visit. Tr. 295.
Shortly thereafter, Mr. Gomez called the Agent and took him to an exam room. Respondent entered the exam room, and after exchanging pleasantries, asked the Agent if the "medication is
Respondent then had the Agent stand up and explained that "[t]he state makes me do a physical exam each time."
The medical record for this visit indicates that the Agent presented with low back pain, with a severity which was "mild" and a "4 on the pain scale," that there was "no change" in the pain's status, and that the pain radiated into the Agent's "neck and upper back." RX 1, at 19. In the review of systems section, the record again states: "Patient denied problems with mood disturbance. No problems with anxiety."
The medical record further documents various tests as having been performed which clearly were not. For example, under the neurologic findings for the physical exam, the record states "normal and symmetrical deep tendon reflexes with no reflexes."
Likewise, with respect to the Agent's lumbar spine, the record states: "Full active ROM with rotation, Full active ROM with bending. Full active ROM with flexion and Full active ROM with extension." RX 1, at 21. And with respect to the Agent's thoracic spine, the record states: "Full active ROM with extension. Full active ROM with flexion. Full active ROM with bending. Full active ROM with Rotation."
On August 25, 2011, another Special Agent, using the name of Eric McMillen, saw Respondent at the Brandon Clinic. However, on July 21, 2011, the Agent had seen a Dr. Mosley at the QCMG Bradenton clinic. GX 20; Tr. 348-55. The Agent acknowledged that he had provided a pharmacy profile and MRI,
The Agent's medical record also includes a chart for his initial visit with Dr. Mosley. RX 1, at 60-61. While the chart lists Dr. Mosley's prescriptions to include "Xanax 2 mg qhs PRN Anxiety #30," notably the chart contains no findings pertinent to the Agent's having anxiety (or sleeping problems) and Mosley did not list anxiety as one of his diagnoses in the diagnosis/assessment section of the chart.
On August 25, 2011, the Agent, who wore a recording device, went to the Brandon clinic where he saw Respondent. Tr. 358-59, 363. While the Bradenton clinic was supposed to fax over the Agent's medical record, it had not done so; the Agent was subsequently required to fill out a medical questionnaire which asked about the location of the pain, how it had occurred, and what medications he was on.
The Agent was eventually called by Mr. Gomez, who asked how tall he was and took his weight and blood pressure.
After a short hiatus, Respondent entered the room, introduced himself, reviewed the Agent's paperwork, and began making entries on a touch screen computer monitor. RX4, at 44. Respondent asked if "[m]ost of the pain [wa]s in his lower back" and "[h]ow it all happened?" GX 22, at 7. The Agent replied that he "use [sic] to work in a warehouse lifting boxes and moving stuff" but didn't "remember the exact day."
Following a discussion of the EMR system, Respondent asked the Agent to lean forward, placed his stethoscope on the Agent's back and asked him to take a deep breath followed by a normal breath, and asked if the pain was "down here in your lower back?"
Respondent then asked: "How about over here?"
Respondent stated "okay" and that he had "just left [the Agent] on everything that you were on down there."
Respondent then stated: "Alright we have to have a plan at some point, okay? Cause you're not going to be able to be on these meds for the rest of your life. You know what I mean?"
The oxycodone prescription listed diagnoses of "[l]umbar lumbosacral disc degeneration" and "lumbar disc displacement." GX 23. The Xanax prescription listed a diagnosis of "GENERALIZED ANXIETY DISORDER."
However, in the psychiatric portion of the review of systems section of the medical record for the visit, Respondent wrote: "Patient denies problems with mood disturbance. No problems with anxiety." RX 4, at 41. Likewise, in the psychiatric portion of the physical examination section, Respondent noted: "Oriented with normal memory. Mental status, judgment and affect are grossly intact and normal for age."
On August 25, 2011, a TFO, using the name Michael Corleone, also visited Respondent at the Brandon clinic. Tr. 447, 464. The TFO had made two previous visits to the QCMG clinic in Bradenton (June 15 and July 20, 2011), and saw Dr. Mosley on each occasion. GX 25; RX 4, at 25 & 30.
At his first visit (to Bradenton), the TFO provided his driver's license, an MRI, and a prescription profile to the receptionist and was given several forms to complete including a patient questionnaire. RX 4, at 30-31. On the patient questionnaire, the TFO noted that he had "pain in the lower back and right shoulder," that his "[c]urrent pain level was at a two" and that his "average maximum pain level was at a five" on a one to ten scale, that the pain was "a sharp ache," which "occurs on a weekly basis," that it affected his "sleep and physical activity," and that "helpful treatments * * * included heat/ice and physical therapy."
Shortly after paying the $300 office visit fee, the TFO was summoned by a nurse, who questioned him about his driver's license which listed his address as being in Orlando.
Later, the nurse called the TFO to another room where he proceeded to take the TFO's vital signs, asked various personal questions, and then asked about the location of his pain, his previous clinic and his current medications.
Following a discussion of various non-medical subjects, Mosley asked the TFO where his pain was, with the TFO responding that it was in his lower back and right shoulder and that the pain was caused by playing softball.
Mosley returned to his desk and began completing paperwork. RX 4, at 34. Mosley then advised that he would not write the TFO prescriptions for 240 oxycodone and 90 alprazolam, which were the amounts the TFO had reported that he had previously received.
However, in the medical record for the TFO's initial visit, Dr. Mosley made no findings in the section for psychiatric history and did not check the line for anxiety. RX 1, at 5. In the family history section, which included a prompt for "mental health," Mosley wrote "none."
On July 20, 2011, the TFO returned to the Bradenton clinic and signed in. RX 4, at 25. After a short wait, the TFO was called by the receptionist, who collected the payment for the visit and gave him an appointment card for his next visit. RX 4, at 26. The receptionist also gave the TFO forms to complete, including one that asked about his current medications and pain level.
Thereafter, the TFO was called to a room by a nurse, who took his weight
After a patient left Dr. Mosley's office, Mosley told the TFO to enter his office and bring his file; the TFO did as instructed and gave his file to Mosley, who was seated at his desk facing a computer.
On August 25, 2011, the TFO went to the Brandon clinic and saw Respondent. Tr. 464. The TFO signed in, and after a short wait, was called by the receptionist who asked for his driver's license and current address, and collected payment for the visit; the receptionist then provided the TFO with an appointment card for a visit of September 22, 2011. RX 4, at 39. The TFO then took a seat in the waiting room.
Thereafter, the TFO was called by a male nurse to an exam room where he had his vital signs taken.
Respondent removed the TFO's file, entered the room, and introduced himself.
Next, Respondent asked the TFO if he had insurance; the TFO said "No."
Respondent then discussed the TFO's MRI, stating:
The TFO replied, "ok, gotcha, gotcha," Respondent stated "So, um," and the TFO stated: "Yeah, you guys get people in and out quick here. It's nice."
Respondent then asked to feel the TFO's "low back"; the TFO stood up, and Respondent pressed against the TFO's lower back in several locations, asking if it was painful.
The TFO was instructed to sit in a chair, and raise each leg separately and then simultaneously.