Randall L. Wolff, M.D.; Decision and Order

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-20]

Randall L. Wolff, M.D.; Decision and Order

On July 25, 2011, Administrative Law Judge (ALJ) Timothy D. Wing issued the attached recommended decision (also cited as ALJ). Respondent filed Exceptions to the ALJ's decision.

Having considered the record in its entirety, as well as Respondent's Exceptions, I have decided to adopt the ALJ's recommended ruling, findings of fact and conclusions of law with respect to each of the five public interest factors excepted as discussed below. While I reject some of the ALJ's findings of fact and legal conclusions, I conclude that the record as a whole supports the ALJ's ultimate conclusion that Respondent's continued registration would be inconsistent with the public interest and thus will adopt his recommendation that Respondent's registrations be revoked and that any pending applications be denied.

The ALJ made extensive findings of fact and legal conclusions with respect to Respondent's prescribing of controlled substances to eleven undercover officers (UCs); Respondent saw three of the UCs at a clinic known as Commercial Medical Group (CMG) and the remaining eight at a clinic known as Coast to Coast Healthcare Management (CCHM).

See

ALJ at 10-38; 44-93. With respect to the undercover officers Respondent saw at Commercial Medical Group, the ALJ found that the Government had not proved by substantial evidence that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing oxycodone to Agents Miller and McClairie; with respect to Agent Bazile, the ALJ found that the Government had not proved that Respondent's prescription for oxycodone lacked a legitimate medical purpose but that a prescription he issued for Xanax did.

Id.

at 92.

With respect to the undercover officers Respondent saw at CCHM, the ALJ found that the Government had proved by substantial evidence that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing oxycodone to Agents Marshall, O'Neil, Doklean, Brigantty, Priymak, Zdrojewski, and Ryckeley.

See id.

at 44-92 (citing 21 CFR 1306.04(a)). Moreover, the ALJ also found that Respondent had violated various provisions of the State of Florida's Standards for the Use of Controlled Substances for the Treatment of Pain, Fla. Admin Code 64B8-9.013, in prescribing controlled substances to each of the aforementioned UCs.

See

ALJ at 44-92. However, with respect to Agent Saenz, the ALJ found that while the Government had proved that Respondent kept inaccurate records in violation of Florida's regulations, it had not proved that Respondent lacked a legitimate medical purpose in prescribing controlled substances to her.

Respondent filed Exceptions, most of which are variations on the same theme—that the ALJ erred in finding that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice. He argues that each of the UCs presented as being “[r]eal patients,” who “[c]omplain[ed] of chronic real pain,” which was “[b]ased on articulable causation.” Exceptions at 6. According to Respondent, the ALJ “fail[ed] to appropriately recognize or acknowledge that each of the [UCs] presented themselves with valid Florida driver's licenses, as well as authentic and verified MRI reports that articulated an objective finding that supported the claim of pain.”

Id.

at 6-7 (citing various portions of transcript). Respondent also maintains that he “believed that each [UC] was being truthful in their claim of real pain,” “that the Government failed to offer any evidence to rebut [his] testimony * * * concerning [his] basis for writing each of the prescriptions,” that he “exercised his good faith medical judgment that the prescriptions * * * were appropriate” and that “although presented as `credibility' findings[,] the [ALJ's decision] merely disagrees with his professional judgments [and] crosses outside of the boundary that limits DEA from substituting its judgment for that of a physician.”

Id.

at 7-9.

1

Having considered the exceptions, I reject them for the reasons explained below in my discussion of the evidence pertaining to the various undercover patients.

1

Respondent also contends that the Government's Expert “lacked qualifications or expertise and displayed a profound lack of knowledge concerning applicable Florida medical regulations, state and federal law, as well as the applicable standard of care.”

Id.

at 3. It is acknowledged that both the Expert report and testimony contained several factual inaccuracies and misstated the law and state standards on several issues.

The record shows that the Government's Expert is a Diplomate of both the American Board of Anesthesiology and the American Academy of Pain Management and has twenty years of experience in practicing pain management. Tr. Vol. 7, at 12. The ALJ thus properly held that he was qualified to testify as an expert.

Id.

at 41. I further conclude that the ALJ properly evaluated the Expert's testimony and report declining to give weight to both the testimony and the report when it was factually inaccurate; however, with respect to Agent Saenz, I conclude that notwithstanding the Expert's factual errors, other credible testimony supports the conclusion that Respondent violated 21 CFR 1306.04(a) when he prescribed Roxicodone and Xanax to her. In the individual patient findings I discuss in more detail those areas in which the ALJ erred in relying on the Expert's testimony regarding the requirements of federal and state rules.

The CCHM UC Patients

SA Marshall was seen by Respondent on two occasions: On April 7 and May 4, 2010. However, Respondent refused to prescribe to him on the first occasion, when Marshall stated that he was homeless and lived on the street, said his pain was “sometimes it's like a three or four * * * How does it need [to] be?” and added that a person in the lobby had filled out his intake forms. ALJ at 48 (citing GX 6, at 19-20; Tr. Vol. 4, at 62). Respondent asked “is this a test?” and stated that he thought it “must be”; he then asked Marshall what being homeless had to do with needing pain medicine. GX 6, at 19-20. Respondent then escorted Marshall to the reception area, maintaining that “we don't participate in such * * * folly” and told a staff member to discharge Marshall.

Id.

at 23. However, the staff member told Marshall that she would alter his chart and reschedule him to see another doctor the next day.

Id.

at 25-26. The staff member further told Marshall to “never, never say that you sell this, that, that on the street, ever. Because they think that you're an undercover, okay. And that you're trying to bust his nuts.” GX 6, at 26. Marshall returned the next day and obtained controlled substances from another doctor.

Id.

On May 4, 2010, Marshall made another visit to CCHM and saw Respondent. The interaction lasted less than three minutes. GX 6 (audio and DVD recordings). After asking Marshall about his age and birthdate, Respondent questioned him as to how everything was working out for him, whether he was working, whether the medicine was helping, whether he was having any complications, whether he was smoking, and if he was doing any exercises and staying limber; Marshall answered “no” to each question. GX 6, at 39-40. Respondent then listened to his breathing and asked him to place his hands out with his palms up, after which Respondent asked Marshall if he had any back pain.

Id.

at 40. When Marshall answered “no,” Respondent asked “Mostly in the Neck?” to which Marshall said “yes.”

Id.

Respondent then asked: “But overall you are doing

okay?”; Marshall answered: “Yeah.”

Id.

at 41. Respondent replied: “That's great,” and after apparently asking Marshall to confirm his date of birth (notwithstanding that he had already asked it), stated: “Alright, we got you all set.”

Id.

Respondent then issued Marshall a prescription for 120 dosage units of Roxicodone (oxycodone) 30mg, a schedule II controlled substance (for a daily dose of 120 mg), and 30 Xanax (alprazolam) 2mg, a schedule IV controlled substance.

It is true that the ALJ credited Respondent's testimony that he did not recognize Marshall notwithstanding the incident one month earlier. However, this provides no comfort to Respondent as there is ample evidence establishing that the prescriptions he issued lacked a legitimate medical purpose. For example, on the progress note for the May 4 visit, Respondent noted Marshall's pain level as a “5” with medication and apparently a “9” without it. GX 21, at 2. Yet there is no evidence that Respondent, during the brief encounter he had with Marshall, asked him to rate his pain either with or without medication.

Likewise, on the medical history form, Marshall checked “Yes” for whether he had emphysema/asthma, bipolar disorder, and recent depression.

Id.

21, at 10. Yet Respondent did not ask Marshall any questions about these conditions and the chart contained no evidence of a psychiatric consultation. Tr. Vol. 4, at 37; Vol. 7, at 67. As the Government's Expert explained: “It's very dangerous to treat people with depression or bipolar disorder with a combination of [an] opioid and [a] benzodiazepine, because they potentiate each other, and you could end up having a patient very, very depressed or even suicidal or even die accidentally from that combination.”

Id.

at 180.

The Government's Expert further noted that Marshall's file contained an MRI from two days before his first visit at the CCHM, yet there was no indication as to which physician had ordered it.

Id.

at 64;

see also

GX 21, at 27. Moreover, CCHM's Pain Assessment Form asked: “What

Current

medications have you been PRESCRIBED to help your pain?” GX 21, at 12. Marshall wrote that he was taking Roxicodone (oxycodone) 30mg, eight times a day; oxycodone 15mg, three times a day; and Xanax 2mg, two times a day.

Id.

However, nothing in the file indicates who had previously prescribed these drugs to Marshall nor documents how long he had been taking these drugs.

In addition, the Government's Expert noted that although the records for Marshall's first visit indicated that his cervical spine was “mildly painful to touch,” he was assessed as having “chronic severe back pain.”

Id.

at 6-7;

see also

Tr. Vo. 7, at 64. Moreover, with respect to Marshall's April 8 visit, the Expert observed that the progress note indicated “yes” for whether his pain was “under control,” yet also included the notation that “pain was not well controlled [on] present regimen.” Tr. Vol. 7, at 69-70; GX 21, at 4. The Expert further explained that “there were no objective findings * * * to really substantiate the level of pain” and that there was “also no mention about the activities that the patient is being precluded from doing.” Tr. Vo. 7, at 70.

According to the Government's Expert, “there is no legitimate reason[] why a physician would choose to treat a patient with such large doses of narcotics without going through other channels first, which would include the review of his prior medical records from wherever he was treated to other diagnostic tests that may have been performed to finding out what other drugs had been tried in the past and mentioning in the history of present illness how they were effective or not effective in treating this pain” and “getting more in the way of diagnostics such as x-rays, nerve conduction studies” and an orthopedic consult.

Id.

at 116. The Expert further explained that “[t]here [wa]s nothing * * * that warrants going to the `big guns' of narcotics so aggressively and bypassing the conservative treatment that is recommended in the majority of the places [that] practice safe medicine.”

2

Id.

2

It is noted that Respondent issued the same prescriptions as had Dr. C.N. on April 8, 2010, and that Dr. L.C. (another CCHM doctor) had prescribed 120 Oxycodone 15mg and 30 Xanax 2mg. The fact that these two physicians also prescribed both oxycodone and Xanax does not aid Respondent. As the Government's Expert testified, “it was incumbent upon [Respondent] to do his own assessment * * * and not just perpetuate narcotic prescriptions where there may have been other treatments that may have been warranted or may have actually diminished the patient's need for narcotics.” Tr. Vol. 9, at 93. The Government's Expert further explained it “would not be within the standard of care in Florida” for a physician to “perpetuate[] the issuance of controlled substances ordered by another doctor without first establishing his own valid doctor-patient relationship.”

Id.

at 135.

Based on the above, I agree with the ALJ's conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing oxycodone and Xanax to Agent Marshall. ALJ at 51-52. However, because there is no evidence that Respondent (as opposed to the doctors Marshall saw on his previous visits) completed the form (GX 21, at 8) in which various discussion items were checked off but which is neither dated nor signed, I reject the ALJ's finding that Respondent violated Fla. Admin Code r. 64B8-9.013(3) by failing to maintain accurate records.

Agent Saenz also visited CCHM on multiple occasions including twice on March 10, as well as on April 8 and May 4, 2010. GX 24. However, Agent Saenz did not see Respondent until May 4, 2010.

Id.

Agent Saenz testified that she first saw Dr. L.C. on March 10, but he declined to prescribe to her because “he didn't want [her] to be a drug addict” and “didn't think [she] needed it.” Tr. Vol. 2, at 300. However, her patient file contains no documentation of Dr. L.C.'s findings.

See

GX 24.

At her March 10 visit, Agent Saenz presented an MRI which showed that two posterior discs were bulging and that there was bilateral neural foraminal narrowing.

Id.

at 28-29. She also completed a medical history form in which she checked the “yes” box for whether she had recent depression,

id.

at 11; on a pain assessment form she submitted, Saenz wrote, with the coaching of a CCHM employee (Tr. Vol. 2, at 271), that her pain was a “9” on a scale of 0 to 10, and that she was currently being prescribed 240 tablets of Roxicodone 30mg (8 tablets per day), 40 tablets of oxycodone 15mg (3 tablets per day), and 60 tablets of Zanax[sic] 2mg (2 tablets a day).

Id.

at 13. However, the note for Saenz's second visit on March 10, which was with Dr. R.C., indicates that her pain did not “irradiate” [sic], that it did not interfere with her daily activities, that she did not need medication to function or work, and that her pain was in control.

Id.

at 6. In addition, the form noted the intensity of her “pain without meds” as a “3,” but that the intensity of her pain “arter[sic] taken meds” was “5-6.”

Id.

Finally, the note documents that Agent Saenz had not been taking opioids and “[n]o drugs” under toxic habits. At this visit, Dr. R.C. issued her prescriptions for 90 tablets of Vicodin 5/500mg, a schedule III control substance which combines hydrocodone and acetaminophen, and a 21-tablet Medrol dose pack (a non-controlled steroid) based on a diagnosis of LBP (lower back pain).

As the Government's Expert testified, the information in her file was “very inconsistent” and this is “a tip-off to a pain specialist that the patient isn't being forthright and may not be a suitable candidate for controlled substance prescriptions.” Tr. Vol. 7, at 133-34. The Expert further explained that “[w]hen somebody is changing their story, whatever it is, medication,

how much they're in pain, whether or not it affects them a certain way, it really * * * shows that they are not a reliable person, and they're not being truthful with their physician.”

Id.

at 134. According to the Expert, this “would make them a poor candidate to receive * * * controlled medication prescriptions.”

Id.

On April 8, Agent Saenz returned to CCHM and saw Dr. N., who noted that she was “still having moderate amount of lumbar pain” but with “no radiation.” GX 24, at 4; Tr. Vol. 2, at 283. Dr. N. also noted that Saenz had said that the Vicodin “didn't do `much for her.' ” GX 24, at 4. Dr. N. prescribed 90 oxycodone 30mg (one tablet every six hours as needed for a pain) and added 30 Xanax 2mg.

Id.

However, the note for the visit contains no indication as to Dr. N.'s justification for prescribing the Xanax.

See id.

On May 4, Agent Saenz returned to CCHM and saw Respondent. Agent Saenz testified that her entire encounter with Respondent lasted “no more than ten minutes,” during which Respondent asked her twice how she was doing (with Saenz responding that she was doing “fine”), what was bothering her, whether her current medications were helping, and whether she had a job.

3

Tr. Vol. 2, at 242, 244. Saenz replied that she worked at a day care center and that the prescriptions were helping; she then asked if she could take one more oxycodone 30mg pill a day which Respondent agreed to.

Id.

at 242-43. Respondent's physical examination was limited to listening to Saenz's heart with his stethoscope; he did not palpate her spine or require her to perform any movements.

Id.

at 245. Also, Respondent did not discuss Saenz's need for Xanax.

Id.

at 245-46. Respondent then issued Saenz prescriptions for 30 Xanax 2mg, indicating on the prescription that it was “for sleep,” and 120 Roxicodone 30mg “for pain.” GX 24, at 24.

3

Agent Saenz testified that while she was equipped with an audio recording device, the device failed to record the encounter. Tr. Vol. 2, at 231.

In the record for this visit, Respondent wrote that Saenz's pain level was a “7” out of 10 “with medication” and a “9” out of 10 “without medication.” GX 24, at 2. He also noted that the “Meds helping but not yet relieved @ present dose” and that Saenz was “sleeping better [on] Xanax.”

Id.

The ALJ did not specifically address whether Respondent's notations as to Saenz's pain level with and without medication and whether she was sleeping better were accurate representations of what occurred during the encounter.

4

Based on the testimony of Agent Saenz, which the ALJ found to be “fully credible,” ALJ at 9, I find that Respondent falsified the May 4 visit note with respect to the pain levels he documented and whether the Xanax was helping her sleep better.

4

The ALJ did, however, find that Respondent had documented having discussed various matters such an anti-inflammatory diet, yoga/stretching exercise, the use of fish oil/omega-3, and glucosamine/chondroitin even though Agent Saenz testified that no such discussion occurred. The ALJ found that Respondent violated the State's regulation by failing to maintain accurate records. ALJ at 54 (citing Fla. Admin. Code Ann. R. 64B8-9.013(3)(f)). However, because the evidence shows that Saenz saw other doctors at CCHM and the form on which the ALJ's finding was based on is neither signed, nor dated, and no other evidence establishes that he (as opposed to the other doctors) completed the form, once again, I reject his conclusion as not supported by substantial evidence.

While Respondent testified that Saenz had been seen previously by two other doctors who had prescribed medication without obtaining relief and had an MRI which showed abnormalities in her lower back, unlike the ALJ, I find that substantial evidence supports the conclusion that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing Roxicodone and Xanax to her. As the Government's Expert testified with respect to Agent Marshall, it “would not be within the standard of care in Florida” for a physician to “perpetuate[] the issuance of controlled substances ordered by another doctor without first establishing his own valid doctor-patient relationship.” Tr. Vol. 9, at 135. Thus, I find unavailing Respondent's attempt to justify his prescribing on the ground that he simply replicated what Dr. N. had prescribed to Agent Saenz.

See

Tr. Vol. 10, at 180. While it is true that Government's Expert misstated the evidence in attributing the April 8 prescriptions issued by Dr. N. to Respondent and by misreading a urine drug test as confirming the presence of various drugs when, in fact, they were not tested for,

see

ALJ at 21, this does not undermine the validity of the Expert's testimony regarding the obligation of a physician to establish “his own valid doctor-patient relationship” before prescribing large doses of narcotics. Tr. Vol. 9, at 135. In addition, the Expert explained that it was “below the standard of care to treat a patient with her pathologic findings on her MRI and her symptoms primarily only with narcotics and escalating narcotics and [to] not treat [her] with more conservative therapy [such as] physical therapy, anesthesia for nerve block treatments, * * * some other non-habituating medications, [and] behavior modification.” Tr. Vol. 7, at 143.

Also unavailing is Respondent's testimony that he relied on the truthfulness of the information contained in Saenz's patient file, and that if he had been aware of her misrepresentations, he would not have prescribed to her. Tr. Vol. 10, at 180. Given that Saenz's patient file contained numerous material inconsistencies, Respondent's testimony begs the question of which information he believed was truthful. For example, on the Pain Assessment Form, Saenz wrote that her pain was a “9” on a “0” to “10” scale and that she was currently being prescribed 240 Roxicodone 30mg (a daily dose of eight tablets or 240mg), along with 40 tablets of oxycodone 15mg (for a daily dose of 3 tablets), and 60 Xanax 2mg, with a daily dose of two tablets a day. GX 24, at 13. Yet there was no indication in the file of which physician was prescribing these drugs to her and the note for her first visit indicated that she had not seen another doctor, that she had not been taking opioids, and listed her pain levels as a “3” without meds and “5-6” with meds.

Id.

at 6. As found above, Respondent did not question Agent Saenz about any of these inconsistencies and falsified the record he created for the May 4 visit. Thus, I do not find credible Respondent's testimony that he believed Saenz to be a legitimate patient.

5

5

The ALJ also noted Respondent's testimony that the two strengths of oxycodone which Saenz listed on her Pain Assessment Form “might reasonably be prescribed together” for “breakthrough pain.” ALJ at 54-55. That may be true, yet as found above, Saenz's patient file contains no indication of who might have prescribed this to her and the note for her first visit indicates that she had not previously seen a doctor or taken opioids.

Agent O'Neil also visited CCHM on three occasions (March 10, April 7, and May 4, 2010), meeting with Respondent only at the last visit. GX 23. At the first visit, O'Neil wrote on the Pain Assessment Form that his “tummy” was the location of his pain and circled all of the numbers from 0 to 10 for his pain rating; he also wrote that OxyContin 30mg was being currently prescribed to him. GX 23, at 13. Yet the patient record for O'Neil's first visit documents that he complained of having low back pain for twelve years and that Respondent found that he had mild tenderness in his lumbosacral spine and that his right elbow was tender to palpation.

Id.

at 6-7. In addition, the record states that O'Neil was not seeing another doctor, that he drank six beers a day, that he had been taking opioids for twelve years and that it had been two weeks since his

last dose.

Id.

at 6. A urine test given on that date reported the presence of benzodiazepines.

Id.

at 27. The attending physician diagnosed O'Neil as having “severe” low back pain, as well “opiate tolerance” and “dependence.”

6

6

The chart also records that O'Neil had “HTN,” GX 23, at 8; an abbreviation for hypertension.

At the May 4 visit, Agent O'Neil arrived with three Agents and asked if they could be seen together. Tr. Vol. 3, at 305. During the triage procedure, a clinic employee asked him if he took the pills. GX 14, at 24. O'Neil answered “Nah,” to which the employee laughed and replied: “I know you don't take them.”

Id.

at 25. O'Neil asked: “How can you tell?” and the employee answered: “What you mean how can I tell? I'm stupid?”

7

Id.

7

As the ALJ explained, “[t]his conversation constitutes evidence that Respondent's staff in this instance possessed actual knowledge of diversion by patients. The staff's open indifference, if not encouragement, of patients seeking controlled substances for no legitimate medical purpose is inconsistent with Respondent's claim that he was unaware of the problems plaguing CCHM.” ALJ at 56. As the ALJ explained, “[e]pisodes such as this, while perhaps not on their own dispositive as to Respondent's specific knowledge of staff misconduct, * * * in the aggregate” support a finding that he was “willfully blind to the flagrant indications of diversion and abuse at” CCHM.

Id.

at 57.

I agree with the ALJ that while this incident by itself would not establish knowledge on the part of Respondent that the CCHM employees were facilitating diversion, the record here contains evidence establishing multiple incidents where employees knew that the undercover patients were seeking drugs either to abuse or sell. To make clear, where, such incidents are as pervasive as they were at CCHM, a registrant cannot reasonably claim ignorance of them.

Later, O'Neil was seen by Respondent and was asked how it was going, his age and birthdate, and “what have we got you on here today?”

Id.

at 26. O'Neil replied that he took the thirties; that he usually took about 180 fifteens, but the prescription was written “too low last time”; as well as Xanax 2mg “and sometimes Soma.”

Id.

Respondent stated: “Okay, last time he wrote you one-twenty thirties,” to which O'Neil interrupted him, stating: “Yeah, it was too low.”

Id.

at 26-27. Respondent continued to note the other drugs (oxycodone 15mg and Xanax 2mg) that had been prescribed at O'Neil's previous visit and asked if he was “[t]aking a blood pressure medicine?”

Id.

at 27. O'Neil answered “No,” and when asked “why,” said he “just never filled it.”

Id.

Respondent noted that O'Neil's blood pressure was “up again.”

Id.

Respondent then asked O'Neil if he had “been on medicine for a while?”; O'Neil stated: “Yeah.”

Id.

Respondent then asked what O'Neil had been “on when you got here?”

Id.

O'Neil stated 210 thirties and 180 fifteens.

Id.

O'Neil replied that Dr. C. (who had written O'Neil's previous prescriptions at his April visit) had said the day before: “start, and you can go up each time,” and that while Dr. C. only worked Wednesdays, “he said you'd gonna increase it.”

Id.

Respondent then asked how O'Neil was “doing on the present dose”; O'Neil said “[f]ine.”

Id.

Respondent followed by asking “so you're doing okay?”

Id.

at 28. O'Neil then stated: “No, no. I need more. But I don't need any less. The present dose is not * * * it would be better if it was more. It's not, you know, not making me feel worse.”

Id.

Respondent stated that he understood and added: “You ran out, or it wasn't enough?”

Id.

O'Neil answered: “Yeah, I ran out.”

Id.

After O'Neil and Respondent discussed the former's employment status, Respondent asked: “Where is most of your pain?”; O'Neil replied: “Lower back.”

Id.

at 29. Respondent asked “what happened?”; O'Neil said “[i]t was from football,” that he had had back pain since “98” and that Dr. C. “had it in my chart.”

Id.

After the two discussed whether O'Neil could see Respondent or Dr. C., Respondent conducted a physical exam.

Id.

During the exam, which lasted thirty-two seconds,

8

Respondent told O'Neil to take a deep breath and then breathe normally, to hold his arms up with his palms up and then put them down, and then had him raise each leg straight up.

Id.; see also

GX 14 (DVD, Excerpt 2). Upon completing the exam, Respondent stated that he could bump up O'Neil's medicine “a little” but rejected his request to give him 210 tablets, stating that he might do it “eventually” but could not do it “now.” GX 14, at 29-30 and DVD Excerpt 2. Of further note, at no point during the exam did O'Neil complain of pain.

8

This was from the moment Respondent got out of his chair (prior to asking O'Neil to breathe deeply) until he returned to it. The DVD also shows that Respondent had turned around and was returning to his chair when he told O'Neil to raise his other leg up.

See

GX 14 (DVD Excerpt 2).

O'Neil then told Respondent that he was also taking “the liquid drops,” a reference to a liquid form of OxyContin, which he had obtained from a friend. GX 14, at 30, Tr. Vol. 3, at 312. Respondent replied, “Don't even tell me that,”

9

and told him that it was “high abuse,” that it could be deadly, and “don't take it.”

Id.

Respondent further told O'Neil to take the oxycodone “just as it says on the bottle” and not to “take anyone else's medicine,” or to sell it or share it, noting that “[t]his is serious medicine” and was “not for experimentation.”

Id.

at 31. After a further discussion of the risks of taking someone else's medicine, Respondent added that when “[m]ost pain clinics * * * find out that * * * patients [are] taking other people's stuff,” they “instantly” discharge them.

Id.

at 32. Following a short discussion of the weather, O'Neil asked Respondent if he should just make his next appointment with Respondent, who replied “I'm here for you.”

Id.

at 33. O'Neill thanked Respondent, who replied: “Yeah. We got a bond now” and added that “the goal is not to get up to the highest number possible” but “to get pain relief.”

Id.

9

At the hearing, Respondent testified that he had made this statement, because he “was very disturbed that he would do such a thing” and what he meant was that “it hurt me to hear that because I don't like to hear patients using that because I think it's a dangerous product.” Tr. Vol. 10, at 155. The ALJ did not find Respondent's explanation credible. ALJ at 59. I agree with the ALJ's finding.

During the above conversation, Respondent printed out and signed prescriptions for 150 Roxicodone 30mg, 90 Roxicodone 15mg, and 30 Xanax 2mg, which he gave to O'Neil, notwithstanding the latter's statement about using liquid oxycodone which he had obtained from a friend.

See

GX 14, at 54. Moreover, as the ALJ found, Respondent noted on the record for this visit that there was “[n]o indication of substance abuse or diversion.” GX 23, at 2. In addition, Respondent noted on the chart that O'Neil's “pain level with medication [was] 7/10” and “without medication 9/10.”

Id.

at 4. Here again, this was a blatant falsification of O'Neil's record as there is no evidence that Respondent asked O'Neil either to rate his pain numerically or had any discussion regarding the intensity of his pain and whether it was affecting his ability to function.

Based on O'Neil's statement that he had been using liquid OxyContin which he obtained from a friend, and Respondent's response to it, the ALJ concluded that “Respondent's failure to reject SA O'Neil as a patient and his decision to issue him controlled substance[] prescriptions is inconsistent with state and federal law.” ALJ at 59 (citing and quoting Fla. Admin Code Ann. r. 64B8-9.013(1)(d) (“Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.”) and 21 CFR 1306.04(a)). As further support for his conclusion, the ALJ also cited Respondent's statement that “most pain clinics” would discharge a patient when they found out they were “taking other people's stuff” and reasoned that this “demonstrate[d] [his] awareness of the impropriety in the medical community about prescribing to a patient known to be diverting or abusing controlled substances.”

Id.

While I agree with the ALJ's ultimate conclusion that Respondent violated 21 CFR 1306.04(a) in prescribing to Agent O'Neil, I conclude that it is unnecessary to wade into the controversy within the medical community as to the propriety of prescribing controlled substances to a person who reports having obtained them illicitly. Instead, I conclude that the entire body of the evidence with respect to Agent O'Neil's prescriptions establishes that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing to him. 21 CFR 1306.04(a).

As previously held, Respondent is not excused from the obligation of establishing a valid doctor-patient relationship because O'Neil had previously received prescriptions from another doctor at the same clinic. As the Government's Expert testified, it “would not be within the standard of care in Florida” for a physician to “perpetuate[] the issuance of controlled substances ordered by another doctor without first establishing his own valid doctor-patient relationship.” Tr. Vol. 9, at 135. Notably, while O'Neil's record documented that he had been taking opioids for twelve years and had done so as recently as two weeks before his first visit to CCHM, there was no further documentation of how O'Neil had obtained the drugs, nor any history documenting any prior treatments for his injury and treating physicians. Moreover, more than two months had passed since O'Neil's initial visit to CCHM and yet none of O'Neil's medical records had been obtained.

Finally, as the Expert noted, during O'Neil's visit with Respondent, he did not complain of any pain or symptoms, Tr. Vol. 7, at 120; and Respondent neither asked O'Neil to rate his pain numerically nor questioned him regarding the nature and intensity of his pain. Nonetheless, Respondent falsified O'Neil's medical record by noting that his pain level was a “7/10” with medication and a “9/10” without medication. Similarly, as found above, Respondent's physical exam took all of thirty-two seconds during which O'Neil did not complain of any pain. Indeed, Respondent had already turned around and was in the process of returning to his chair when he told O'Neil to raise his other leg.

10

Given the totality of the evidence, it is clear that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing oxycodone and Xanax to Agent O'Neil.

11

21 CFR 1306.04(a).

10

As the Government's Expert also testified, it is “definitely below the standard of care to leave out a history and physical in a first-time patient that you're prescribing large doses of narcotics [to]. To not have a history and physical on the chart is absolutely below the standard of care.” Tr. Vol. 7, at 117.

11

Here again, the ALJ found that Respondent violated Florida's regulation requiring the maintenance of accurate records by checking off the boxes of a form which contain various discussion items.

See

ALJ at 60 & n. 62 (discussing GX 23, at 9). Once again, the form is neither signed, nor dated, and given that O'Neil had previously seen other doctors at the clinic, there is an insufficient basis to conclude that Respondent completed the form. However, it is clear that Respondent violated the regulation by falsely documenting O'Neil's pain levels on the record for the latter's May 4 visit.

Agent Priymak was also among the Agents who also visited CCHM on April 7, 2010 and May 4, 2010. Upon his arrival, Priymak presented his undercover driver's license and an MRI, paid for the visit and was given several forms to fill out. Tr. Vol. 2, at 319. On the Pain Assessment Form, Priymak did not circle any word to describe his pain and drew two circles around the numbers 2 and 3, and 3 and 4, on the pain scales. GX 22, at 10. Priymak also wrote that his pain was “between” being “occasional” and “continuous” and listed his current prescriptions as OxyContin 40mg, four times a day; Xanax, 2 times a day; and Soma, once per day.

Id.

He also circled “Yes” for whether he was having side effects from the medications and explained that “It Feels Good!”

Id.

On his Medical History Form, Priymak drew a squiggly line, which for the most part ran through the various “no” boxes for the listed conditions.

Id.

at 8. However, Priymak clearly checked the “yes” box for whether he drank alcohol and again listed his current medications as OxyContin, Soma, Xanax, and another drug which is indecipherable.

Id.

at 9. However, below this listing, Priymak did not check either the “yes” or “no” box for the questions: “Are all meds prescribed by a physician?”

Id.

Agent Priymak's file also contains a Drug Screen Result Form with the date of his first visit. GX 22, at 25. While this form indicates that opiates, oxycodone, and benzodiazepines were present in his urine specimen,

see id.,

Priymak testified that he was not taking these drugs and did not “recall taking a drug test.” Tr. Vol. 3, at 33-34, 37-38. Priymak did, however, recall that while being seen in the “triage room, the staff member checked something in his file and “indicate[d] that `Yes, you have drugs in your system.'” Tr. Vol. 3, at 37-38. I agree with the ALJ's finding that Respondent's staff falsified Agent Priymak's Drug Screen to document that he was taking drugs when he was not. ALJ at 75.

Priymak was called by Respondent who asked him if it was his first visit; Priymak said it was. GX 5, at 34. Respondent then stated “Let's see. We gonna help with your pain in your neck.”

Id.

Priymak replied “[y]eap” and then complained that his shoulder was “kind [of] tight” and that the pain had been going on “like * * * since 2001.”

Id.

After discussing Priymak's age and employment status (he was between jobs), Respondent asked him how he hurt his neck.

Id.

at 35. Priymak explained that he had “tweak[ed]” his neck “playing basketball,” and that “since then [he had] tightness in [his] neck.”

Id.

Priymak further stated that his pain was in the middle of his neck and when asked how bad it was, replied: “[w]ell[,] [i]t depends.”

Id.

Upon further questioning by Respondent, Priymak stated that his pain was a “two or three” if he did not take medication and that he currently was not taking any drugs.

Id.

Respondent then commented that Priymak's pain level didn't “sound too bad.”

Id.

at 36. Priymak replied that “for the last ten years or so,” he had been “taking medication on and off” because his shoulder got tight.

Id.

Respondent then asked Priymak what medicines he had “been taking.”

Id.

Priymak replied that he had been taking oxycodone 40mg, prompting Respondent to state: “for mild pain.”

Id.

Respondent and Priymak then discussed the location of the latter's condition.

Id.

Priymak stated that “it gives me like tightness between my shoulder blades and then goes to my shoulder” and complained that when he played basketball his shoulder got “really tight.”

Id.

Respondent then asked if Priymak's condition “mostly * * * affect[ed]” him when he was “playing basketball?”

Id.

Priymak stated that he also did construction, suggesting that his shoulder bothered him when he “lift[ed] it” and added that he was also “taking some Somas,” a non-controlled drug, but this drug was “not helping.”

Id.

at 37.

Respondent then stated “maybe we're not communicating,” emphasizing that Priymak had stated that his pain was “mild about two or three and mostly you * * * when you play basketball. Is that right?”

Id.

Priymak answered “yes,” and Respondent stated: “otherwise you're okay, I mean * * * otherwise you do pretty good?”

Id.

Priymak then stated: “No. I just * * * I need that * * * to get through the day.”

Id.

Respondent asked “why?” and Priymak answered, “because of the pain,” which prompted Respondent to ask: “I mean how bad is the pain?”

Id.

Priymak

answered: “[I]t depends. It comes, it comes and goes. Goes up and down.”

Id.

Respondent then asked: “from what to what? Two or three, maybe?”

Id.

Priymak answered that it “must be higher than that.”

Id.

Respondent replied: “I don't know. You tell me, I'm listening.”

Id.

Priymak stated: “Ah * * * five.”

Id.

Respondent then asked Priymak if he was “sleeping [o]kay?”

Id.

Priymak said “[n]o” and explained that he was waking up three or four times a night and that he had been taking between one half to two bars of Xanax.

Id.

However, at no point in the visit did Respondent ask how Priymak was getting the Xanax.

Respondent then questioned Priymak regarding various medical issues including whether he had “used intravenous drugs.”

Id.

at 38. Priymak stated he had “a long time ago,” and upon being asked how long ago, stated “like five or six years ago.”

Id.

Respondent then asked: “Is there any history of drug abuse or drug dependence?”

Id.

Priymak answered that he had been “taking Oxies for * * * a while.”

Id.

Respondent then asked how much oxycodone Priymak was taking; Priymak stated that it depended, that the drugs were “kind of expensive,” that he bought the forties and that he was taking up to four pills a day.

Id.

at 39;

see also

GX 5 (DVD). Respondent asked if Priymak had seen a doctor “lately?” GX 5, at 39. Priymak said “no,” and acknowledged that he was getting the drugs off the street.

Id.

Priymak also admitted that he drank three or four beers, three times a week, and emphasized that he was doing so because he did not have a job.

Id.

Respondent then asked Priymak what other drugs he was taking; Priymak said he was “taking Xanax and Soma sometimes to like relax me,” but added that he did not think it was helping him.

Id.

Respondent and Priymak discussed how much of each drug he was taking and why he was taking Xanax; Priymak said he was taking one half to one and a half Xanax and doing so “to sleep.”

Id.

at 40.

Respondent then conducted a physical exam, which lasted approximately one minute, during which he listened to Priymak breathe in and out, had him do several motions with his arms and turn his neck.

Id.

During the exam, Respondent asked him what drug he took intravenously (which Priymak did not answer) and whether he still played basketball (with Priymak saying that it was hard for him because his shoulder got tight).

Id.

Upon conclusion of the exam, Respondent told Priymak that he thought Priymak was “taking a lot of medicine for mild pain.”

Id.

Priymak asserted that he was big and that taking one pill did not “help” him.

Id.

Respondent replied that “we don't write OxyContin” and that “we write * * * what's appropriate.”

Id.

at 41. Respondent then added: “And sounds to me like your requirements for medication are way out of proportion for the degree of pain you have. I don't think I'm going to be able to help you.”

Id.

Priymak replied: “Are you serious Doc?” GX 5 (DVD).

12

Respondent answered: “Yeah. Your pain is way less than what would be indicated to be on what you're on. Does that make sense to you?” GX 5 (Tr. at 41). After Priymak answered “No,” Respondent explained that “somebody who has pain two or three doesn't need to be on one hundred and sixty milligrams of OxyContin. It's just way out of proportion.”

Id.

Priymak asked why it was “way out of proportion,” prompting Respondent to answer: “Because in my judgment it is.” Respondent then explained: “You're on way too much and I, I can't imagine that * * * I wouldn't even write anything for somebody who has pain at a two or three.”

Id.

Priymak reminded Respondent that they had talked about his “pain as five.”

Id.

Respondent replied: “Yeah, whatever it is. I just think that this is too many problems here * * * too many bottles of beer and * * * a history of * * * drug abuse.”

Id.

12

Having reviewed both the transcript and the DVD of this visit, I find that Priymak made this statement.

Priymak asked “what do you mean?”

Id.

Respondent answered: “I just don't think that I'm gonna be able to help you.”

Id.

at 42. Priymak then asked: “Can you help me with something less than that amount?”

Id.; see also

GX 5 (DVD). Respondent asked “Like?” and Priymak replied: “I won't be able to function, like thirties, like twenties.”

Id.

Respondent advised that “thirties is all we write,” and Priymak asked for thirties.

Id.

Respondent then stated: “I just don't see it for * * * what you have.”

Id.

Priymak asked: “Can you give me fifteens?” and Respondent stated: “You know, maybe I'll give you some fifteens.”

Id.

Priymak then thanked Respondent.

Id.

Next, Respondent told Priymak that he should go “to some sort of rehab facility and get on Suboxone.”

Id.

Priymak then maintained that he needed the drugs “to get through the day and work.”

Id.

Respondent stated that he understood but that it was still his “suggestion” that Priymak go to rehab.

Id.

However, Respondent then asked Priymak if he “want[ed] some Xanax?”

Id.

Priymak answered “yeah,” Respondent said “okay,” and then asked Priymak if he was “allergic to anything.”

13

Id.

13

Respondent and Priymak also discussed the latter's use of Soma (carisoprodol), a drug which is currently not controlled under federal law. GX 5, at 43. However, Respondent did not prescribe this drug.

Priymak also sought some Viagra, stating that he wanted to try it because he was going to a party and would like to try it. ALJ at 76 (discussing GX 5, at 43-44). Respondent asked Priymak if he had “some problems” for which the drug would be prescribed and whether it was “just for the party.”

Id.

at 44. After Priymak acknowledged that it was, Respondent said “good try” and did not prescribe the drug. Because Viagra is not a controlled substance and DEA is not a medical board, I do not adopt the ALJ discussion regarding the propriety of Respondent's decision.

See

ALJ at 77.

On the History and Physical Examination on which Respondent checked his diagnosis and plan, Respondent wrote that “PT has been on OxyContin 40 4x/day which is out of proportion to amt of pain. Will give Pt Rx for oxycodone 15 # 150 and refer to rehab. Rec. pt see MD for Suboxone.” GX 22, at 6. However, as found above, while Respondent did suggest that Priymak go to rehab, he did not refer him to any rehab center or a physician who is authorized to prescribe Suboxone to treat addiction. Instead, Respondent issued Priymak prescriptions for both 150 tablets of Roxicodone (oxycodone) 15mg and 30 Xanax 2mg. GX 22, at 24.

On May 4, 2010, Agent Priymak returned to CCHM and again saw Respondent. Tr. Vol. 2, at 237; GX 22, at 22. After paying for the visit and completing the triage procedure, Respondent called Priymak's name and the two went to the former's office. Tr. Vol. 2, at 328. According to Agent Priymak, “[i]t was a very short visit” during which Respondent asked him how he was, if he had any problems or complications, if the medication was helping, and if he was smoking.

Id.

at 328-29; GX 5, at 54-56.

Respondent then asked Priymak “[w]here is most of your pain?” GX 5, at 56. Priymak answered that it was on the “right side” of his “neck,” but that it was “going on and off[,] [k]ind of between my shoulders.

Id.

Respondent then asked: “Before you were having back[,] uh, neck pain?”

Id.

Priymak stated that back in 2000, 2001, he had “kind of like tweaked my neck roll.”

Id.

Respondent stated “yeah,” instructed Priymak to “take some breaths in and out,” had him do something with arms and hands,”

id.

at 56; and then “move [his] head from left to right.” Tr. Vol. 2, at 329-30. Priymak testified that he

completed the movements without showing pain,

id.

at 330, and the rest of the visit was spent discussing where Priymak was from (the Ukraine), the city of Kiev, and the time it took to travel to Kiev and Moscow. GX 5, at 57-58.

Respondent did not ask Priymak to rate his pain even though he documented on the form for the visit that Priymak's pain was a “5/10” with medication and “9/10” without it. GX 22, at 22. He also checked the box indicating that there was “[n]o indication of substance abuse or diversion,” notwithstanding the information he had obtained and documented at the first visit.

Id.

Moreover, Respondent did not engage in any further discussion with Priymak regarding the latter's entering rehab. Nonetheless, Respondent issued Priymak two more prescriptions for 150 tablets of Roxicodone 15mg and 30 tablets of Xanax 2mg.

Id.

at 338;

see also

GX 22, at 21.

Regarding the April prescriptions, Respondent testified that he had prescribed less than half the dosage of oxycodone that Priymak had told him he had been taking and that he made a “medical judgment based on [his] interpretation and assessment” as to the degree of pain Priymak had and that “he tr[ied] to correlate that with a commiserate[sic] dose of medication” which would be “more appropriate.” Tr. Vol. 10, at 108. Respondent further maintained that Priymak was “convinc[ing] and represented that he had significant pain.”

Id.

He also asserted that there had been a “considerable period of time” since Priymak had stated that he had used intravenous drugs,

id.

at 113, and that he “didn't want to totally cut [Priymak] off of medication and have him go into withdrawal, but thought it would be more appropriate that he be on a lower dose, something that I thought [was] more reasonable.”

Id.

at 128. Respondent also asserted that Priymak's MRI shows “a lot of changes * * * that would be consistent with a patient having significant neck pain.”

Id.

at 138.

With respect to Priymak's second visit, Respondent testified that “there was no immediate reason to refer him to rehab” or to even discuss the issue because Priymak “made no representation * * * that he had any withdrawal problems or that his pain was not sufficiently addressed by the dose” he had prescribed.

Id.

at 140-41. Respondent further justified his prescribing, stating that Priymak “was no longer having to get his medicine on the street” and that “he was in a more controlled environment” because he was being “taken care of by a doctor.”

Id.

at 141.

The ALJ addressed the credibility of only a part of Respondent's testimony, apparently finding credible that he prescribed at the first visit because did not want SA Priymak to suffer from withdrawal symptoms, while finding not credible his testimony regarding why, at the second visit, he did not discuss Priymak's entering rehab. ALJ at 77. While I agree with the ALJ's finding as to Respondent's testimony regarding the second visit, I do not find credible his testimony regarding his prescribing at the first visit because the transcript and recording of that visit make clear—in Respondent's own words—that Priymak complained only of “mild pain,” notwithstanding Respondent's successful efforts to coach him to eventually provide a higher pain level, and that Priymak's “requirements for medication [were] way out of proportion for the degree of pain” Priymak had. As Respondent further stated during the visit, “I wouldn't write anything for somebody who has pain at a two or three.” Thus, Respondent's own statements during Agent Priymak's visit manifest that his testimony—that he believed that Priymak “had significant pain” and made a medical judgment to prescribe something more appropriate to Priymak's pain level—is patently disingenuous. As for Respondent's testimony that he did not “want to totally cut [Priymak] off of medication and have him go into withdrawal,” even if this is credible, it provides no comfort to Respondent because federal law clearly prohibits prescribing a schedule II narcotic drug for this purpose.

See

21 CFR 1306.07.

14

14

To make clear, Respondent was not registered to provide maintenance or detoxification treatment under 21 U.S.C. 823(g). Under federal law, a practitioner who lacks such a registration is authorized only to administer (and not prescribe) a schedule II narcotic drug “to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral to treatment” and may administer no more than one day's dose of medication “at one time,” and do so for no more than three days.

See

21 CFR 1306.07(b).

Given the evidence of the undercover visits, expert testimony is hardly necessary to conclude that Respondent lacked a legitimate medical purpose in prescribing controlled substances to Agent Priymak. Nonetheless, it is further noted that the Government's Expert testified that Respondent's prescriptions to Priymak were not “warranted as [a] first-line, first-day treatment with this particular patient, who gave a history of being an intravenous drug abuser and purchasing drugs illicitly on the street.” Tr. Vol. 7, at 92. The Expert further explained that there were other forms of treatment including “physical therapy,” a “short course” of “anti-inflammatory medications,” and possibly “injection therapy” which were never discussed.

Id.

Finally, the Expert observed that there was no significant information documented in Priymak's patient file for his second visit to justify the additional prescriptions. I therefore conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing controlled substances to Agent Priymak at both visits.

15

21 CFR 1306.04(a).

15

I also do not adopt the ALJ's rumination that “Respondent's testimony that he didn't want SA Priymak to suffer from withdrawal symptoms and the fact that Respondent's prescription of oxycodone was less than half of the dosage that SA Priymak represented he was previously taking perhaps mitigate[s] in Respondent's favor.” ALJ at 77. As explained above, Priymak never complained of anything more than mild pain, which Respondent recognized did not warrant oxycodone, and clearly presented as a drug abuser. Thus, Respondent cannot credibly claim to have been duped by Priymak. In short, this was a blatant drug deal.

On July 23, 2010, Agent Doklean, along with nine other Agents, went as part of a “crew” to CCHM for the purpose of obtaining controlled substances. Tr. Vol. 1, at 179. Upon her arrival, Doklean paid a clinic employee $300 for the office visit and gave her an MRI report (of her lumbar spine) and her undercover driver's license.

Id.

at 186. Several minutes later, another Agent, who posed as the crew's ringleader and sponsor, discussed with a clinic employee what the charge would be to obtain expedited or VIP service; the Agent then told the other Agents to pay the clinic employee an additional $200 for VIP service.

Id.

at 187.

Agent Doklean testified that she had intentionally left blank various questions on the patient forms she had been given, and that subsequently, another clinic employee told her that she “needed to fill everything out.”

Id.

This employee also gave Doklean “examples of words to put on” the form.

Id.

Doklean also testified that following her visit with Respondent, she had a conversation with another CCHM employee, R.M.

Id.

at 188. R.M. related to Doklean that Respondent “had concern over the fact that we * * * were not putting the proper things [on] our paperwork, that we needed to say that we were in pain on the paperwork and that any other undercover that had not been seen yet * * * needed to make sure that they put on the paper work and * * * needed to tell the doctors

that they were in pain even if they were not.”

Id.

On her pain assessment form, Agent Doklean wrote that her pain was located in her “neck” and circled the words: “Tiring,” “Evening/Night,” and “Occasional.” GX 25, at 9. Doklean did not circle any number on the pain scale and wrote that she was not on any current medications.

Id.

On a separate medical history form, Doklean again noted her pain was located in her “Neck” and checked “Yes” for whether she drank alcohol and had “ever been treated for addiction.”

Id.

at 7-8.

Upon meeting Agent Doklean, Respondent asked her “what is your pain that we're going to help you with today?”; she answered: “over my neck.” GX 4, at 31. Respondent asked how long the pain had been going on; Doklean replied “six months.”

Id.

Respondent then asked if she had hurt herself; Doklean replied “No. I don't know where it came from.”

Id.

After again confirming with Doklean that she was having neck pain, Respondent asked, “what are we doing with an MRI of your back?”

Id.

Doklean answered: “That's what the other * * * you know, what a doctor prescribed for. So * * * that's what I went for.”

Id.

Respondent noted: “But your pain is in your neck.”

Id.

Doklean replied “Well, I mean it, it, it starts in the neck and towards the end of the day * * * it moves.”

Id.

Referring to her MRI, Doklean then asked: “Well, I mean, I don't know how to read that, what does that say?”

Id.

Respondent replied that “this just has to do with your back” and explained that the MRI was of Doklean's lower back.

Id.

at 31-32. Notably, Respondent did not ask for the name of the doctor who had ordered the MRI.

After taking a phone call, Respondent again asked Doklean if she had neck pain, and after she said “yes,” Respondent told her: “I guess I'm confused. You have pain in your neck but you have an MRI of your back.”

Id.

at 32. Doklean interrupted Respondent saying that she thought the pain “kind of radiates”; Respondent explained that there was a “disconnect” and that “we need to get an MRI of your neck.”

Id.

at 32-33. Doklean then explained that “[b]y the end of the night it goes up and down” and that “sometimes it goes all the way through” and she felt “stiffness * * * down at the bottom.”

Id.

at 33.

After asking Doklean about her employment status (she was unemployed), Respondent then confirmed that there was no trauma, with Doklean explaining that: “maybe, running after the kids” and that she had “two small kids.”

Id.

Respondent then asked her how bad her pain was on a scale of one to ten.

Id.

Doklean answered:

It fluctuates. Sometime is down, you know like a two or three, sometimes it goes up. I mean, it really depends on the day * * * sometimes I feel more than others if it's a cloudy day or if it's a rainy day it'll go up, if not, I'm running after the kids * * * if out running around, it, it fluctuates. Sometime, you know, it's getting to a point where * * * I can't even. Sometimes even * * * hang out with the kids or like do anything with them.

Id.

Respondent then asked Doklean if she was allergic to any medicines, with Doklean answering “no,” and how much she smoked, with Doklean stating that she did not.

Id.

However, upon being asked whether she drank, Doklean stated that she had been in rehab in November of the previous year (eight months earlier) but that she was now clean and sober.

Id.

at 33-34. However, Respondent did not inquire further as to where she had been treated and who were her physicians.

Id.

at 34;

see also

Tr. Vol. 1, at 204.

After a question about her medical history, Respondent asked Doklean if she had been taking medication. GX 4, at 34. Doklean stated that she would “take some Advils,” but added that “every now and then * * * I have a friend who would help me out a little bit with some of the blues” (a term which is street slang for oxycodone 30 mg,

see

Tr. Vol. 1, at 204) that seemed to help, so she decided to go “see a pain doctor.” GX 4, at 34. Respondent then asked Doklean “how long” she had “been taking the blues?”

Id.

Doklean stated that she had been taking them “on and off for like six months,” but it was “kind of hard” because “it's expensive.”

Id.

Next, Respondent asked Doklean if “you just take a few of those?”

Id.

Doklean answered that she did so “every couple of days, when thing get really bad” and that they seemed to help her.

Id.

Respondent then asked Doklean to “describe the pain.”

Id.

at 35. Doklean replied: “It radiates. I mean, sometimes I get like massive headaches * * * and it'll start up in my head and it'll go like from * * * here and towards in here and it'll go back down and then, that's why I say I feel it in the neck and it'll go, it'll shoot down.”

Id.

Respondent then proceeded to perform a physical exam (which took fifty seconds); the exam consisted of his placing his stethoscope on her back and instructing her to breathe in and out, as well as several range of motion exercises including having her move her arms, open her fingers and then make a fist, raise each of her legs straight up, then stand up and bend over.

Id.

at 35; GX 4 (recording of visit); Tr. Vol. 1, at 206-08. According to the credited testimony of Agent Doklean, she was able to completely bend over and touch the ground in “a swift maneuver,” which prompted Respondent “to chuckle.” Tr. Vol. 1, at 206.

Next, Respondent had Doklean turn her head both left and right as well as up and down. GX 4, at 35. Respondent asked if doing this caused her any pain; Doklean stated “not right now” and added that “[t]oday is a good day.”

Id.

Respondent stated “[t]hat's good,” and asked Doklean if she had pain “in [her] back occasionally?”

Id.

Doklean replied “Do I? Yeah, It goes, like I said, it, it radiates. It goes different ways. Sometimes it starts up from * * * I get * * * most I get the headaches and then it, it just goes all the way down.”

Id.

at 36. Respondent did not, however, palpate either her neck or lower back. Tr. Vol. 1, at 208.

Respondent then asked Doklean if she was “[t]aking anything now?” GX 4, at 36. Doklean said “No” and Respondent replied “[w]ell, let's just get you started on some medicine and see if we can't get you some relief” and instructed her to “[t]ake the medicine just as it says on the bottle,” and not to buy, sell or share it.

Id.

Doklean then asked: “Do I get some of the blues?”

Id.

Respondent answered: “Yeah. Let's * * * let me look at your chart, we'll see how we're gonna help you today” and told her to “[h]ave a seat out front. We'll * * * see what we can do for you.”

Id.

Subsequently, Respondent issued Doklean a prescription for 120 tablets of Roxicodone 30mg and a prescription for an MRI of her cervical spine. GX 4, at 59.

On the History and Physical Examination Form, Respondent noted that “upon questioning,” Doklean had reported that her pain was an “8 throughout the day, [with] flareups of * * * 10” on a scale of 0 to 10. GX 25, at 2. Respondent also put check marks indicating that her pain was “aggravated by” “lifting,” “twisting,” and “sitting or standing in one position too long.”

Id.

He also checked the “yes” box indicating that “the pain deplete[d] [her] energy/motivation,” that she was irritable and moody because of it, that it “affect[s] [her] relationship,” and that “it cause[d] problems at work.”

Id.

While Respondent noted that Doklean “has taken Roxi” and gotten drugs from friends and the street, he also wrote that she was “off any meds now and having great difficulty.”

Id.

As shown by the recording and transcript of her visit, Doklean never complained of having pain at the level Respondent documented and

Respondent never asked whether her pain was aggravated by any of the activities which he checked as doing so. Moreover, Respondent did not question her about whether the pain affected her energy, made her irritable and moody, affected her relationships and caused problems at work. Indeed, Doklean had told him that she was unemployed.

In addition, on pages two and three of the form, Respondent made numerous notations as to his purported findings of his physical examination. GX 25, at 3-4. As the Government's Expert observed, there were “extremely serious improprieties” as Respondent fabricated in the medical record “numerous findings, such as HEENT exam, heart exam, abdominal exam, cervical and lumbar spine exams, range of motion testing, reflex testing, sensory testing, peripheral pulses palpation, neurological testing [and the] presence of muscle spasm.” GX 32, at 18-19.

In his testimony, the Government's Expert further explained that Doklean “came in complaining of neck pain but had a lumbar MRI spine report, not a cervical MRI, so [Respondent] really was prescribing her medication prior to a definitive diagnosis of what was going on in her neck.” Tr. Vol. 7, at 148. Moreover, when Respondent questioned why her MRI was for her lower back and not her neck, the Expert observed that Doklean had “pointed to her entire spine, in a diffuse manner” and that “this is a common maneuver in a malinger patient.” GX 32, at 14. The Expert also noted “that while the patient also was complaining of `massive' headaches, he never performed a cranial evaluation, such as cranial nerve testing.”

Id.

at 17.

Additionally, the Expert testified that Doklean's “MRI shows just mild bulging of three disks in her lumbar spine, which is normally treated conservatively with non-steroidal anti-inflammatory medications and physical therapy.”

Id.

at 148-49. The Expert further observed that Doklean had “stated that her pain rating was a `2 or 3,' but could increase during the day and vary with the weather. Certainly this pain is not of the severity that usually requires high-dose narcotic therapy.” GX 32, at 14.

The ALJ found “dubious” Respondent's testimony that he interpreted Doklean's pain as actually being higher. ALJ at 63 (citing Tr. Vol. 10, at 190-91 & 201). I go a step further and find that it is not credible. In addition, the ALJ was not impressed by Respondent's testimony that he thought Doklean had gotten “controlled substances from friends because `she didn't have the money to see a doctor previously'” and that he would be “prescrib[ing] medication for her in a controlled way * * * [t]hat prevents diversion and prevents her from continuing to have to get medicine in an illegitimate way.”

Id.

at 64.

As the ALJ found, after Doklean's meeting with Respondent, R.M., a clinic employee, related that Respondent “had concern over the fact that we * * * were not putting the proper things [on] our paperwork, that we needed to say that we were in pain on the paperwork and that any other undercover that had not been seen yet * * * needed to make sure that they put on the paper work and * * * needed to tell the doctors that they were in pain even if they were not.” Tr. Vol. 1, at 188;

see also

ALJ, at 64. As this statement makes plain, Respondent's concern was not with prescribing only for legitimate medical purposes, but rather, with being able to justify illegitimate prescribing. In any event, even were I to give no weight to R.M.'s statement, there is overwhelming evidence that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing to Agent Doklean. 21 CFR 1306.04(a).

16

16

I also adopt the ALJ's finding that Respondent violated Florida's regulation by failing to maintain accurate records regarding Agent Doklean.

See

ALJ at 65. In addition, while the ALJ found that Respondent violated 21 CFR 1306.04(a) in prescribing to Agent Doklean, he also opined that the prescription “was not wholly without some indicia of medical purpose.” ALJ at 66. Because the ALJ provided no further explanation as to the meaning of this statement, and the basis for it, I do not adopt it.

Agent Zdrojewski was another member of the “crew” which visited CCHM on July 23, 2010. As with the other Agents, Zdrojewski testified that upon his arrival at the clinic he paid $300 for the visit and submitted an MRI and his undercover driver's license, that he received forms to fill out, and that another Agent, who posed as the ringleader, had a discussion with a clinic employee after which the ringleader told the other agents to pay over another $200 for VIP treatment, which Zdrojewski did. Tr. Vol. 3, at 72. Zdrojewski testified that after the Agents paid the additional fee for VIP treatment they joked around and made comments in front of clinic employees that they were not going to make any money off of the visit.

Id.

at 73. Agent Zdrojewski further testified that he was required to provide a urine sample, but was not supervised in doing so, and that when he turned over his sample, he told clinic employees that he had put water in his sample and was laughing about it, but that none of the employees said anything to him about this.

Id.

at 78-79.

On the pain assessment form, Agent Zdrojewski wrote that his head was the location of the pain and that his pain was “bothersome”; while he also circled that his pain was “Occasional,” he did not circle any of the other descriptors printed on the form. GX 28, at 9. On the numeric pain scale, Zdrojewski drew a single circle around the numbers “O” and “1” and wrote that “offshore boating” made his pain worse.

Id.

Zdrojewski listed his current medications as 90 OxyContin 80mg, 240 oxycodone 30mg, and Xanax, and indicated that he was not having any side effects from the medications.

Id.

Agent Zdrojewski also completed a medical history form. On this form, Zdrojewski checked the “yes” box indicating that he had high blood pressure, bipolar disorder,

17

and headaches. GX 28, at 7.

17

Zdrowjeski checked both the “yes” and “no” boxes for bipolar disorder. GX 28, at 7.

Upon meeting Respondent, Zdrojewski was asked if it was his first visit; Zdrojewski said it was and that he had gone to Tampa Bay Wellness, a clinic which was now closed. GX 8, at 11. Respondent then asked Zdrojewski where his pain was and how long it had been ongoing; Zdrojewski replied that he had “neck” pain and that it had been probably going on for “a year and a half.”

Id.

Respondent asked Zdrojewski about his employment status; the latter said he worked as a “charter captain.”

Id.

Next, Respondent asked Zdrojewski how he had hurt his neck.

Id.

Zdrojewski replied that he did not know and that “it just * * * over time * * * There's a bump here and its kind [of] in here and it goes up.”

Id.

at 12. Zdrojewski further explained “that this comes on. It's like, it doesn't always * * * If it moves a certain way it gets better.”

Id.

After stating that he had “gone through chiropractor stuff and traction,” Zdrojewski explained that “[t]he last doctor was giving me crazy amounts but I didn't even fill [all those]. Dude was giving me ninety count eighties.” Respondent confirmed with Zdrojewski that he had gotten eighties, with the latter adding that the clinic was “closed now. So, I put down on the sheet what I was getting. They were giving me sixty-two milligrams Xanax[,] and two hundred forty Thirties[,] and then ninety count eight[ies].”

Id.

Zdrojewski added that he didn't “need all that.”

Id.

Respondent then asked Zdrojewski to describe his pain; Zdrojewski replied that it “comes and goes” and was “intermittent” but “the word wasn't on there.”

Id.

Respondent then asked

Zdrojewski how his pain was on a one to ten scale with ten being severe, and added: “You got zero to one, is that right?”

Id.

Zdrojewski said “Oh,” and Respondent said “that means * * * you don't have pain.”

Id.

According to the credited testimony of Agent Zdrojewski, he then told Respondent to “top it” and Respondent circled the numbers 8 through 10 on the pain assessment form. Tr. Vol. 3, at 97.

Respondent then asked: “So the pain's been pretty bad?,” to which Zdrojewski said “[it] can be.” GX 8, at 12. Respondent asked if “it pretty much stays there on the neck?”

Id.

at 13. Zdrojewski said: “You can say stay.”

Id.

Upon further questioning, Zdrojewski stated that the pain did not go into his arms.

Id.

Respondent then asked how the pain affected his life, work and home.

Id.

Zdrowjewski stated that he “control[ed] it” and that he had “to function, so I function * * * I'm just not gonna sit around.”

Id.

Next, Respondent asked: “what makes you want to be on pain medicine?”

Id.

Zdrojewski answered that it “makes me feel better. It's not illegal like weed or something like that.”

Id.

Respondent then asked if when he took it before, it allowed him to function; Zdrojewski answered “Yeap.”

Id.

Respondent then said: “Meaning that without it you have difficulty functioning?”

Id.

Zdrojewski replied: “Without it, I've got pain.”

Id.

Upon questioning by Respondent, Zdrowjeski stated that he did not know of any allergies to medicines and that he had quit smoking six years earlier.

Id.

However, upon Respondent's questioning him about his use of alcohol, Zdrojewski said that on weekends, he drank a case of beer but that he was “trying to stay off the hard liquor.”

Id.

at 14. Respondent then asked him if he had “any medical problem” such as high blood pressure or diabetes and whether he had had any surgeries.

Id.

Zdrojewski stated that he had high blood pressure and was taking a drug for that; he also stated that he had had knee surgery and eye surgery when he “was a kid.”

Id.

Respondent then asked Zdrojewski if he used any recreational or IV drugs and if he had ever had any drug abuse or dependence problems.

Id.

Zdrojewski asked if “it's between us?” and when Respondent said “yeah,” stated that he used “marijuana.”

Id.

at 14-15. Respondent then asked him where had been going for his pain medicine, when he had last been there, and “[h]ow long were you over there?”

Id.

at 15. Zdrojewski again said that he had gone to Tampa Bay Wellness, that he had gone there for three or four months and that he had last been there “maybe” “two months ago.”

Id.

Respondent again asked what drugs they (Tampa Bay Wellness) had him on; Zdrojewski again said 90 count of 80 milligrams, 240 count of thirty milligrams, and 60 count of Xanax two milligrams.

Id.

Respondent then asked: “And you're not taking anything now?”

Id.

Zdrojewski replied that he did not “have anything,” and Respondent asked: “Then, how are you doing?”

Id.

Zdrojewski answered that he was “self-medicating,” and when asked what “with,” Zdrojewski asked if we can “wait till there is nobody in here?”

Id.

Respondent said “yeah,” and eventually, Zdrojewski again said marijuana.

Id.

Respondent then conducted a physical exam, which involved his listening to Zdrojewski's breathing, followed by various movements of his arms, legs, and fingers.

Id.

at 16. The exam lasted a total of 38 seconds. GX 8 (recording of visit). During the exam, Zdrojewski did not complain that any of the movements caused him pain.

Id.

at 16.

After the exam, Respondent asked Zdrojewski if anyone had ever reviewed his MRI with him; Zdrowjeski said “No.” Respondent then explained:

You've got a little inflammation going on in the joints between your vertebrae and your neck but it's very minimal. That they described it as trace. * * * [T]hat's what your MRI says. Other than that it's normal. There's no disc herniations, everything else is in place. So that's good. That there's nothing else going on.

Id

. at 16.

Zdrojewski then asked what was causing his headaches.

Id.

Respondent stated: “Oh, my God, there's nothing. I * * * I don't know. There's nothing around here that * * * explains that.”

Id.

Zdrojewski stated that “the last doctor said it radiated up and can cause it.”

Id.

Respondent stated: “[Y]es if you have significant problems in your neck, it then * * * it could do that, but I'm just saying, you[r] MRI doesn't show that.”

Id.

Respondent then asked Zdrojewski to stand up and apparently to bend over, but Zdrojewski stated that he could not do so.

Id.

Respondent then said: “Well * * * we have a little issue here. First of all your MRI doesn't show much of anything and secondly, drinking a case of beer is not compatible with taking a strong medicine like this.”

Id.

at 17. Zdrojewski asserted that he could “pull that off.”

Id.

Respondent then stated he was “not sure how you lived through all of this Oxy,” and Zdrojewski replied: “I told you I didn't take, I didn't take all of that.”

Id.

Respondent explained that he “would feel very uncomfortable prescribing all this strong medicine * * * when I have knowledge that beer is being consumed.”

Id.

Continuing, Respondent stated that beer “has alcohol and that coupled with OxyContin and oxycodone and Xanax is being [a] very bad combination, as in you need to worry about death.”

Id.

After Zdrojewski said “okay,” Respondent explained that he had some people who told him that they “drink three or drink four cans of beer and I say, `Listen, you need [to] drink or you take medicine.' They say, `Fine, I, I won't drink but it's going to be hard for me to give up a case of beer a weekend.' That's some serious drinking.”

Id.

After Zdrojewski said: “Well to make the headaches go away,” Respondent asked: “You understand what I'm saying?”

Id.

Zdrojewski said, “I get it” and that he would “stop drinking.”

Id.

Respondent then asked Zdrojewski: “So you rather take the medicine than to be drinking, is that right?”

Id.

Zdrojewski said “yup,” and Respondent said: “let me look at your chart to see what we can do to help you.”

Id.

Respondent then asked Zdrojewski what he was “taking the Xanax for?”

Id.

Zdrojewski answered: “they just gave them to me.”

Id.

Respondent then said: “You don't really need them,” to which Zdrojewski replied: “I'll take them.”

Id.

Respondent then said that if “you're not * * * riddled with anxiety and you're not having a * * * large amount of sleep problems, then we don't want to give you medicine you don't need.”

Id.

Zdrojewski replied: That'll work with me doc,” and Respondent stated “I just don't give you medicine just to write a prescription. So * * * so let me look at this.”

Id.

After Respondent told Zdrojewski to lock up his medicine in a safe place, the latter thanked him and the visit concluded.

Id.

Respondent then issued Zdrojewski a prescription for 150 tablets of Roxicodone 30mg. GX 28, at 19.

On the history and physical examination form documenting the visit, Respondent wrote that on a zero to ten scale, Zdrojewski's pain was an “8 throughout the day,” with “flare-ups of * * * 9-10.”

Id.

at 2. Respondent also wrote that Zdrojewski “was confused by pain scale on assessment form” and indicated that his pain was “aggravated by” lifting, bending and twisting.

Id.

Respondent also wrote that Zdrowjeski had “severe pain in neck” and that “at times pain [is] so severe he is unable to do his work” and that his pain was “sharp.”

Id.

Respondent also documented that he noted a muscle spasm in Zdrojewski's cervical area;

however, Zdrowjeski testified that Respondent never touched his neck. Tr. Vol. 3, at 107.

Under his treatment plan, Respondent wrote:

When pt returns pt will need to have seen NSG who will need to have concurred that pain meds are justified. During this visit pt expresses that pain was severe, so I Rx'ed meds sufficient to control his pain. He previously was on a much higher dose including OC. But in light of the MRI findings, I would not expect that pt would have such severe * * * therefore, must obtain referral [with] NSG and probably refer to bd cert pain mgmt before continuing care. Most likely will be D/C if * * * he doesn't follow above plan.

Id.

at 6.

In his testimony, Respondent explained that his plan was that “when patient returns, patient will need to have seen or will need to have seen neurosurgery who will need to have concurred that pain medicines are justified. So my plan was to send him to neurosurgery.”

18

There is, however, no evidence that Respondent even discussed with Agent Zdrojewski that he needed to be evaluated by a neurosurgeon, let alone referred him to one.

See

GX 8;

see also

Tr. Vol. 3, at 102.

18

Based on Respondent's testimony, I conclude that the abbreviation “NSG” refers to Neurosurgeon.

The Government's Expert observed that it was significant that Agent Zdrojewski represented that he smoked marijuana and engaged in “excessive alcohol use” and “was bipolar.” The Expert further testified that prescribing Roxicodone 30mg to someone who admitted to marijuana use was not an appropriate “first-line treatment” and was not within the standard of care in Florida. Tr. Vol. 7, at 176.

Notwithstanding that Respondent did not prescribe Xanax to Agent Zdrojewski, I conclude that the evidence as a whole supports a finding that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing Roxicodone to him. 21 CFR 1306.04(a). More specifically, Zdrojewski presented with vague complaints, completely altered his pain rating from one end of the scale to the other and yet at no point related other symptoms which would be consistent with severe pain, and represented that he abused both marijuana and alcohol. Moreover, Respondent acknowledged that Zdrojewski's MRI was not significant, and while he conducted a physical examination (which lasted all of 38 seconds), Respondent proceeded to falsify the medical record by documenting findings for which he clearly had no basis, as well as a referral which never occurred. Finally, the Expert gave unrebutted testimony (which the ALJ credited) that prescribing Roxicodone 30mg was not within the appropriate first-line treatment under the standard of care. I also adopt the ALJ finding that Respondent failed to maintain accurate records as required by Florida's regulation.

19

See

ALJ at 84.

19

The ALJ also found that “Respondent's failure to refer SA Zdrojewski to rehabilitation for his use of recreational and illicit controlled substances, and what may well have been his excessive use of licit controlled substances, is also inconsistent with Florida standards.” ALJ at 84-85 (citing Fla. Admin. Code Ann. R. 64B8-9.013(e) (prior to Nov. 28, 2010 amendment) (“The physician should be willing to refer the patient as necessary for additional evaluation and treatment. * * * Special attention should be given to those patients who are at risk for misusing their medications [or] * * * pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.”).

At its text make plain, this version of the rule—which was in effect at the time of the events at issue here—did not make such referrals mandatory. Most significantly, there is no evidence in this record establishing that the standard of care required that a patient presenting in the same manner as did SA Zdrojewski be referred at the first visit. Accordingly, I do not adopt the ALJ's finding.

Agent Ryckeley was another member of the “crew” which visited CCHM on July 23, 2010. Ryckeley likewise testified as to the monetary payments that were made for the office visit and to receive expedited service, and that he was given several forms to complete. Tr. Vol. 3, at 201.

On his pain assessment form, Agent Ryckeley wrote “back discomfort” as the location of his pain, put a question mark in the entry for the pain's duration. GX 27, at 9. Ryckeley also indicated that his pain was “occasional” and not “continuous,” and circled “2” on the numeric pain scale.

Id.

Finally, Ryckeley wrote that he was currently on 180 oxycodone 30mg, that he had no side effects, and that “fishing” made his pain worse.

Id.

On the medical history form, Agent Ryckeley did not indicate that he had any of the listed conditions or diseases.

Id.

at 7. However, in the “location of pain” block, he wrote “Back Discomfort”; he also indicated that he was not under the care of a physician for the condition, and that he drank alcohol.

Id.

at 7-8. Moreover, he then listed his current medications as “None.”

Id.

at 8.

Upon entering Respondent's office and exchanging pleasantries, Respondent asked Agent Ryckeley if it was his first visit (it was) and where his pain was. GX 7, at 18. Ryckeley said “back discomfort” and added: “I came in with * * * David Hays and all those guys.” GX 7, at 18. Respondent said “right,” and asked: “How long have you been having back pain?”

Id.

Ryckeley responded: “Uh, started in, uh, I got an MRI in May.”

Id.

Respondent again asked when the pain started; Ryckeley replied: “Mid May is when the * * * discomfort started” and added that “it was just before the date on the MRI.”

Id.

Respondent then asked: “And what have you done to yourself?”

Id.

Agent Ryckeley stated that he had been on a sport fishing charter and “caught a decent size albacore” which he “was trying to land.”

Id.

Respondent then asked: “And after that things started?”

Id.

Ryckeley stated that “what would happen after that” is that his girlfriend danced and “was taking some thirties,” and that he “took some of her thirties and * * * it put me in a state where, where I liked it, it made me feel better.”

Id.

Continuing, Ryckeley stated: “So I experimented with that, I know I probably shouldn't have done that * * * but * * * I liked how it made me feel and I said, `You know, best thing to do is come in and get evaluated by a doctor,' and * * * get your recommendation.”

Id.

at 20.

Respondent then asked Ryckeley how he would “describe the pain” and noted that he needed Ryckeley to fill out the Pain Assessment Form, saying the words “sharp, shooting, stabbing, throbbing, aching.”

Id.

Ryckeley stated: “It aches, I guess,” and when Respondent asked: “Anything else?” answered: “I'm not good with words.”

Id.

Respondent then told Ryckeley to “stand up, turn around, and show where the pain is.”

Id.

Ryckeley said “okay,” and apparently did not initially comply, as Respondent then said: “No, show it, I mean can you touch where it hurts?”

Id.

Ryckeley asked: “Oh, point?”; Respondent said “yeah,” and Ryckeley stated “it's in * * * my lower back area.”

Id.

Respondent then asked if “the pain is there all the time?”

Id.

Ryckeley replied: “[I]t comes and goes, mostly comes when I fish.”

Id.

Respondent then asked if the pain “stay[s] there or does it travel anywhere?”

Id.

Ryckeley answered: “Nope, it stays * * * in my back. Every, occasionally I get * * * headaches and stuff like that.”

Id.

at 21. Upon a further question by Respondent, Ryckeley stated that the pain did not go into his buttocks and legs.

Respondent then asked Ryckeley “how bad” his pain was, apparently noting that the latter had circled the

number 2 “on a scale of one to ten.”

Id.

Ryckeley said: “probably around two.”

Id.

Respondent asked: “A two?,” and Ryckeley said “Uh-huh.”

Id.

Respondent then asked Ryckeley if he had “ever tried anything else other than all of this fancy medicine?”; Ryckeley said “Oh, I really,” but did not complete his answer before Respondent noted, “A two here, here's the pain scale, I'm not sure, you maybe don't understand the pain scale.”

Id.

Ryckeley said “okay,” and Respondent stated: “a one and two is * * * just sort of * * * a very mild kind * * * of a problem, ten is where you're screaming.”

Id.

Ryckely replied “okay,” and Respondent asked “would you characterize it as mild? Which is about one or two, or moderate? You know, five or six, or is it pretty severe, like eight or nine or ten.”

Id.

Ryckeley stated: “Well, I guess it, it could be moderate, I would imagine * * * middle of the road.”

Id.

Respondent stated “see,” and Ryckeley explained: “like I said, I took my girl's pills and it made me feel good * * * so I never, I've really never thought about it after that.”

Id.

at 22. Ryckeley added that he was no longer taking the pills because he was applying for a new job and had to take a urinalysis and that if he was “taking something, [and] didn't have a prescription,” he “might not get the job.”

Id.

Ryckeley then told Respondent that he had been taking the pills “about six times a day.”

Id.

Respondent asked Ryckeley: “How's [the pain] affected your life, your work, your home, has it?”

Id.

Ryckeley stated: “not, not really no. Especially now since I've been on * * * my girl's medication.”

Id.

Respondent then asked Ryckeley about when he was not “on medication.”

Id.

Ryckeley answered: “it makes it more difficult to fish.”

Id.

Respondent laughed and said: “You're underwhelming me,” and added “you're sort of telling me, you do okay.”

Id.

at 22-23. Respondent then told Ryckeley to “just listen” and added:

If I came to you and I wanted pain medicine right? Cause I have pain. And I told you that, `Um, it's just like a one or a two and it only bothers me when I fish and it hasn't affected my life.' You think that would be an appropriate patient for pain medicine?

Id.

at 23. Ryckeley replied: “[W]ell, it bothers me.”

Id.

Respondent then stated: “You're, you're like telling me that's there's nothing going on.”

Id.

Ryckeley attempted to interject, but Respondent continued, stating: “I'm writing you the strongest medicine available. So I'm like, I'm thinking * * * what are we doing here?”

Id.

Ryckeley stated “yea, I think I missed,” and Respondent replied: “You're, I think, either I'm missing the point or you're missing the point.”

Id.

Ryckeley said: “I think I'm missing the point.”

Id.

Respondent then added: “[B]ut you [are] telling me that the pain is a two and it doesn't affect you very often and you're doing fine.”

Id.

After Ryckeley interjected that he was “talking on medication,” Respondent asked: “it means to me * * * you know what that means to me?”

Id.

at 24. Ryckeley replied “No,” and Respondent said: “You should just take Tylenol * * * Because* * * You don't have anything wrong, I don't get it.”

Id.

Respondent asked: “What are you doing here?” and Ryckeley again insisted his pain level was “a two on the medication.”

Id.

Respondent and Ryckeley then discussed the latter's employment as a charter boat captain, followed by how long he had taken his girlfriend's medicine.

Id.

at 24-25. Ryckeley mentioned that he had broken up with his girlfriend and added that “sometimes people gave me two at the club and stuff like that.”

Id.

at 25.

Respondent then asked Ryckeley if the pain depleted his energy, with the latter stating that it made him “less willing to do what I like to do” because he was “in discomfort.”

Id.

Next, Respondent asked Ryckeley if he was “irritable or moody because of the pain?” Ryckeley answered: “Yeah, I guess I would cause I feel a lot better on the pills than I'm at, a lot better mood when I'm not in a discomfort.”

Id.

Respondent followed this by asking if it affected his relationship in “any way.”

Id.

Ryckeley answered: “I think it makes it better, the medicine.”

Id.

Respondent then asked Ryckeley: “[D]o they cause you problems at work?”

Id.

Ryckeley said “Nope,” prompting Respondent to ask: “I mean, you're able to work with the pain?”

Id.

at 26. Ryckeley replied: “with the medicine, I misunderstood that question. I'm able to work with, * * * with the medicine.”

Id.

Respondent then asked: “But you're now without the medicine, are you able to work without the medicine now?”

Id.

Ryckeley replied: “It makes it more difficult. Significantly more difficult.”

Id.

Respondent then asked Ryckeley whether he was allergic to any medicine (Ryckeley answering that he was not aware of any), whether he smoked (answering “no”), and whether he drank, with Ryckeley stating he was a social drinker.

Id.

Respondent then discussed with Ryckeley the danger of mixing alcohol with oxycodone, with the former saying “I'm not sure you yet have * * * an appreciation of how strong this medicine is, but medicine and alcohol, this medicine and alcohol is not to be mixed.”

Id.

at 27.

Next, Respondent asked Ryckeley if he had any medical problems or surgeries; Ryckeley answered in the negative except for his having broken his nose three times.

Id.

Respondent then asked if he had ever “seen a doctor for this?”

Id.

Ryckeley said “no.”

Respondent then asked: “But the thirties seem to work good for you?”

Id.

at 28. Ryckeley answered: “Yeah, I like them,” leading Respondent to ask: “You like them?”

Id.

Ryckeley stated: “Well, which I mean, I think they, they work good.”

Id.

Respondent replied: “You know, you're killing me, I can't even believe I'm having this conversation.”

Id.

Ryckeley maintained that he had “never been [an] educated man,” prompting Respondent to state: “killing me.”

Id.

Respondent then proceeded to perform a physical examination, telling Ryckeley to perform various movements including raising his arms and legs, standing up, and walking across the room.

Id.

at 28. He also told Ryckeley to have a seat and to show him where he was sore.

Id.

In total, the exam took less than one minute.

Id.; see also

GX 7 (audio recording).

Respondent again asked Ryckeley whether he was on any medicines “right now” and how bad his pain was “right now.” GX 7, at 29. Ryckeley now claimed that it was “a five or seven * * * after you explained the chart to me” and asserted that there were “a lot [of] words” on the forms that he “didn't understand.”

Id.

Respondent expressed his understanding, and asked “[w]hat makes you hurt the most?”

Id.

Ryckeley replied that in charter fishing there was “running lines” and “a lot of standing out there.”

Id.

After a short discussion of sport fishing, Respondent said: “Alright * * * let's * * * get you started on some medicine, we'll see how you do.”

Id.

at 30. Respondent then proceeded to discuss Ryckeley's MRI, which showed a bulging disc with “some inflammation” at L-3, and another bulging disc between L-5 and S-1.

Id.

at 30-31. Respondent then told Ryckeley not to take the medication other than as it said on the bottle; not to buy, sell or share them; and to keep his medicine locked up.

Id.

at 31. Respondent also said that it was serious medicine, and that “if you don't need it[,] I don't want you to take it but if your pain is such that * * * you can't function without it then * * * that's a reasonable indication.”

Id.

at 32. Respondent then asked Ryckeley if his

work was slow, and the visit ended.

Id.

at 32-33.

Regarding the discussion with Respondent as to his pain level, Agent Ryckeley testified that he believed Respondent was coaching him to increase his pain level to justify prescribing oxycodone 30mg. Tr. Vol. 3, at 209, 269. Agent Ryckeley also testified that Respondent “was a box-checker * * * and he was going through and checking the boxes and making sure [there was] every element to justify writing me * * * one of the strongest pain level—pain medicines available. He wanted to make sure all his Is were dotted and his Ts were crossed.”

Id.

at 209-10. Respondent maintained, however, that Ryckeley presented as a person who “was not very educated” and “had difficulty in * * * grasping his description of his pain, his degree [of] pain.” Tr. Vol. 10, at 229. Respondent further testified that he “spent the time to try to explain to him the pain scale and * * * give[] him an opportunity to express himself fully so that * * * we were communicating.”

Id.

Respondent further maintained that he “had every indication he was a real patient with pain.”

Id.

Although it is not entirely clear, the ALJ apparently credited Agent Ryckeley's testimony.

See

ALJ at 87. In any event, as ultimate factfinder, I find that the transcript of the visit—in particular Respondent's statements to Ryckeley that the latter was “underwhelming him,” his asking Ryckeley “if I came to you and I wanted pain medicine” and “it's just like a one or a two * * * You think that would be an appropriate patient for pain medicine?,” and his further statements that “you're like telling me that there's nothing going on” and “I think either I'm missing the point or you're missing the point”—fully support Ryckeley's interpretation of the conversation and demonstrates the utter implausibility of Respondent's testimony.

I therefore find that Respondent coached Agent Ryckeley to provide a pain level sufficient to justify prescribing oxycodone. This finding provides reason alone to conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he prescribed oxycodone to Agent Ryckeley.

20

21 CFR 1306.04(a).

20

As the Government's Expert also testified, Agent Ryckeley “'had stated he had received these drugs from a girlfriend, so he was not receiving them appropriately,” Tr. Vol. 7, at 166, and told Respondent that the drugs “put me in a state were, were I liked it, it made me feel better” and he liked how the drugs made him feel. GX 7, at 19-20. Agent Ryckeley clearly presented as a drug-seeking patient, as Respondent himself recognized in his note for the visit in which he wrote: “I want to make sure pt is legitimate pain patient with chance of diversion.” GX 27, at 6.

Moreover, in light of the clear evidence that Respondent coached Ryckeley to justify his prescribing, and the latter's presentation of as a substance abuser, I do not find that Respondent's discussion of the risks of combining alcohol and oxycodone mitigates his misconduct. I do, however, adopt the ALJ's finding that Respondent failed to maintain accurate records as required by State regulations.

See

ALJ at 90.

SA Brigantty also visited CCHM on July 23, 2010. However, in contrast to the other undercover patients, Agent Brigantty's complaint was generally neither vague nor inconsistent and he presented an MRI which reported that he had three bulging disks in his lumbar spine. GX 26, at 22.

Respondent asked Agent Brigantty where his pain was (Brigantty answering “his lower back”), how long it had been going on (Brigantty answering “about fifteen years”), how he hurt his back (“lifting heavy objects”), and whether he had been in an accident or fallen off a scaffold (“No”). GX 9, at 35-36. When asked to describe his pain, Brigantty initially complained that his back was “very stiff,” but then added that “right now, it's going down * * * my leg, sometimes in on my [U/I], but for the most part, the left side hurts.” GX 9, at 36. Upon questioning by Respondent as to whether his pain was “sharp,” “shooting,” “aching,” “throbbing,” or stabbing,” Brigantty answered: “It depends on what's happening. Most of the time it's sharp.”

Id.

at 36-37.

Moreover, when asked to rate his pain on the numeric scale, Brigantty stated that with the shooting it was “about six,” and that “[i]f it's the other pain, it's going to debilitate for a little while, it's pretty f---ing bad.”

Id.

at 37. After being told by Respondent that he would have to figure out what number corresponded to that, Brigantty again related that it could be “pretty f—ing bad” and that the pain went down his left leg although it was more like “on the lower back but towards” his buttocks.

Id.

Brigantty then related that he felt the pain “sometimes even in the middle back, [and] you feel like someone just punched you in the stomach and you can't breath for a little while.”

Id.

After being interrupted by an unidentified female, Respondent then asked Brigantty what the pain felt like when it went down his leg.

Id.

at 38.

Brigantty replied “it feels like electricity, I guess.”

Id.

Respondent then asked how the pain interfered with his work and life; Brigantty explained that he did odd jobs and that the pain interfered with his work (“Yeah, of course it does”) and with the kids.

Id.

at 38-39. Respondent then explained that Brigantty had several bulging disks and that “when the disk is bulging, it means it's pushed back here, pushed back into the nerve,” and “[t]hat's what gives you the pain.”

Id.

at 39.

Agent Brigantty asked Respondent if there was “anything you can do for that?”

Id.

Respondent replied that other than surgery, “there's nothing you can do to push the disk back.”

Id.

at 40. Brigantty then asked how successful the surgeries are; Respondent answered that “if you have severe disease that * * * you know, [is] affecting you or giving you severe numbness or not letting you perform your work * * * then they can do the surgery,” but “[n]obody will give you a guarantee.”

Id.

Next, Respondent asked Brigantty if he smoked (with Brigantty answering “No”), drank (“occasionally”), was using either IV drugs (“No”) or recreational drugs (“No”), as well as whether he had “any medical problems.”

Id.

Brigantty said that the “girl told me my blood pressure was high today.”

Id.

Respondent then stated that Brigantty's blood pressure was “very high” and asked if this was the first time he had been told this.

Id.

at 41. Brigantty answered: “They mentioned it in the past, but, I feel fine.”

Id.

Respondent then asked Brigantty where he had gone previously for pain medicine; Brigantty replied that he went to Jacksonville, but “didn't like that experience” and “for the most part,” he purchased them on the street.

Id.

When asked what he had been taking and how often, Brigantty said that he took Oxy thirties, but not often because “they are pretty expensive” and that someone had given him “a Xanie bar.”

Id.

Respondent then asked how long Brigantty had been taking the medicine; Brigantty said for about two to three years.

Id.

at 42. Respondent then asked if the oxycodone seemed to help him; Brigantty replied: “Yeah, I was feeling good.”

Id.

Respondent then told Brigantty that his blood pressure was high and that he needed to get himself re-evaluated.

Id.

Respondent further explained: “Meaning you need to find a regular medical doctor as soon as possible and have that re-checked.”

Id.

Brigantty asked, “Is that bad?”; Respondent said “yes.”

Id.

Brigantty then asked if the condition was “life threatening bad?”

Id.

Respondent answered: “It could be if this persists, it can give you a stroke, heart attack, so it must be re-checked, if it remains at this level you probably need to be on medication.”

Id.

Respondent added that “[i]t sounds like other people have mentioned it to you

but you haven't taken it too seriously.”

Id.

Brigantty answered “yeah” and Respondent added that “it's very serious. It's a serious problem.”

Id.

at 43.

After a further discussion of Agent Brigantty's blood pressure, Respondent performed a physical examination during which he had Brigantty breathe in and out and perform various exercises.

Id.

During the course of the examination, Respondent asked: “[a]nd the pain * * * just goes down that * * * that left leg?”

Id.

Brigantty answered: “Yeap.”

Id.

Brigantty then asked if “[t]his can get worse?”

Id.

Respondent said it could, and when asked if there were “things you could do,” replied that Brigantty “could do some stretching exercises to try to * * * increase your muscle strength.”

Id.

at 44. He then added that there was no “medicine to like move those discs back in place.”

Id.

Respondent then asked Brigantty what he had been given in Jacksonville; the latter again said “Oxy Thirties, a while ago,” but that the “place was * * * disgusting.”

Id.

Respondent asked if Brigantty “use[sic] to go to American?”

Id.

Brigantty stated:

Well they wanted me to * * * they wanted * * * the girls outside told me they want a physician that I was seeing, and I'm like, “I'm not seeing a physician.” Then they went, “You need to write something.” Someone said American, I was like, “F—it, I'll put American.” But I don't see doctors, doc. I can't afford constantly going to the doctor. I barely could come in here today.

Id.

Respondent acknowledged this statement, and Brigantty added that “that's the only reason I put that down, cause * * * I didn't even know that I had high blood pressures. You know?”

Id.

at 45. Respondent replied that he “want[ed] to make sure that you get that under control,” and asked if Brigantty was “sleeping ok?”

Id.

Once again, Brigantty represented that he had pain, stating, “It hurts, you know what I mean?”

Id.

Respondent replied, “Right, but if the pain is under control you'd sleep better.”

Id.

Brigantty said that he thought so and “absolutely.”

Id.

Respondent then stated: “Well, we'll get you started on some medicine and we'll see how you do? You're not on anything now?”

Id.

Brigantty said he was not.

Id.

Respondent then prepared a prescription for 150 Roxicodone 30mg, which he gave to Brigantty, telling him to take the medicine as it was prescribed and adding: “Don't buy it, sell it, share it, keep it locked up in a safe place.”

Id.

at 46; GX 26, at 19.

Citing “numerous violations of applicable standards and regulations,” the ALJ concluded that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescription to Agent Brigantty. ALJ at 72-73. More specifically, the ALJ noted that “[g]iven SA Brigantty's confessed illicit use of controlled substances, Respondent failed to `refer the patient as necessary for additional evaluation and treatment,' notwithstanding the Florida regulations provided that `[s]pecial attention should be given to those pain patients who are at risk for misusing their medication' or who `pose a risk for medication misuse or diversion. * * *” ALJ at 68 (quoting Fla. Admin Code Ann. R. 64B8-9.013(3)(e)).

The ALJ further noted that “[t]he record reveals interactions between Respondent and SA Brigantty that reflect poorly both as to Respondent's standard of care as a physician and as to Respondent's knowledge of operations at CCHM.”

Id.

at 68-69. Among other things, the ALJ faulted Respondent because he “did not offer to prescribe blood pressure medication or perform any diagnostic testing for blood pressure,”

id.

at 68-69; and “did not refer SA Brigantty to any particular `regular doctor,'” which the ALJ concluded “is inconsistent with the referral standard contained in Fla. Admin Code Ann. R64B8-.013(3).”

Id.

at 70. The ALJ further found that Respondent gave inconsistent testimony as to why he did not prescribe blood pressure medication, noting that Respondent initially testified he “didn't want to prescribe medication for people I was only going to see one time,” ALJ at 69 (citing Tr. Vol. 2, at 169, 214-15), yet later testified that his goal was to put Brigantty “on a therapeutic trial of” pain medication, and that “I was going to see him back in a month” and see how he did. Tr. Vol. 2, at 177-78; 215 (cited at ALJ 69-70).

As for the ALJ's various criticisms of Respondent's handling of Brigantty's high blood pressure, there is no evidence in this record establishing that prescribing oxycodone is contraindicated for a patient with this condition. Moreover, even if Respondent's failure to treat Brigantty's blood pressure

21

constitutes civil negligence—and there is no evidence that it does—this alone does not establish a violation of the CSA's prescription requirement.

See Laurence T. McKinney,

73 FR 43260, 43266 (2008) (citing cases). Nor is the ALJ's conclusion that Respondent's failure to refer Brigantty “to any particular `regular doctor' * * * is inconsistent with the referral standard” of the Florida pain regulation, ALJ at 70 (citing Fla. Admin. Code Ann. R.64B8-9.013(3)), supported by either the Expert's testimony or citation to any decision of the Florida courts or Board of Medicine.

21

As for the ALJ's criticism that Respondent did not “perform any diagnostic testing for blood pressure,” ALJ at 69, here again, the record is devoid of any evidence establishing what tests are required under the standard of care, and in any event, the issue of the adequacy of Respondent's evaluation and treatment of Agent Brigantty's blood pressure is for the state medical board and not this Agency.

To be sure, Respondent's prescribing of oxycodone to a patient who told him he had obtained the drug on the street and whom he did not expect to see again, raises the issue of how he would effectively monitor his patient. However, while the Government's Expert acknowledged on cross-examination that controlled substances can be prescribed to a patient who presents with a history of drug abuse if it is done “very carefully with proper monitoring in place,” Tr. Vol. 8, at 68; the Expert did not further explain what measures are required to properly monitor a patient under the standard of professional practice nor testify that it exceeds the bounds of professional practice to a prescribe to a person under these circumstances.

Indeed, with respect to Agent Brigantty (as opposed to the other patients), the testimony of the Government's Expert was not particularly illuminating on the ultimate issue of whether Respondent complied with 21 CFR 1306.04(a) in prescribing Roxicodone to him.

See

Tr. Vol. 7, at 157-162. When asked by Government counsel what information “was significant in considering whether controlled substances should have been * * * prescribed,” the Expert noted that Brigantty “saw [Respondent] complaining of sharp, shooting pain in his lower back with radiation into his left leg and buttock. Pain is severe.”

Id.

at 157. While the Expert observed that “the physical exam portion * * * is a lot of check marks involving various portions of the fill-in places for the physical exam,” the Expert offered no further testimony to the effect that the Respondent's physical exam did not support the findings and diagnosis that were documented. Likewise, the Expert testified that Respondent noted “bony tenderness being present from L1 to L5 over the entire lumbar spine into the buttock,” yet offered no testimony that this finding could not have been made based on the physical exam that was performed.

Id.

at 158. Moreover, Agent Brigantty did not remember if

Respondent had palpated his back. Tr. Vol. 2, at 41.

Later, Government Counsel asked the Expert “what, if any, information did [Agent] Brigantty give to [Respondent] that's of significant importance?” Tr. Vol. 7, at 159-60. The Expert replied:

Well, he stated he had low back pain for 15 years duration. He wasn't sure of the cause. It may have occurred lifting at work. He noted it shooting down into his leg, into the left leg and buttock, and stated it was severe. He rated the pain as six throughout the day and with flare-ups a ten, aggravated by lifting, bending, twisting, relieved by resting.

Id.

at 160.

Subsequently, the Government asked the Expert if he saw in Agent Brigantty's Patient File “any significant medical information that justifies the issuance of controlled substances prescriptions?”

Id.

at 162. The Expert answered, “I do not” and provided no further explanation as to why the information he had previously related regarding Brigantty's complaint, history and physical exam did not support Respondent's diagnosis and the prescription.

Id.

Indeed, the Expert did not even acknowledge the MRI report Brigantty presented, let alone explain why the MRI's findings combined with the other information, did not justify the diagnosis and the issuance of the prescription.

22

In short, substantial evidence does not support a finding that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing to Agent Brigantty.

22

The ALJ also cited the Government's Expert testimony “that a patient who is illegally buying drugs on the street, and who requests that the same drug be prescribed, should be precluded from receiving prescriptions for controlled substances.” ALJ at 72 (citing Tr. Vol. 7, at 161). However, even assuming that the Expert's testimony reflects the accepted standards of professional practice, neither the transcript, nor the DVD of Agent Brigantty's visit, provide evidence that the Agent requested that Respondent prescribe Roxicodone 30mg to him.

The Government and the ALJ also noted that there was no evidence that Respondent discussed the risks and benefits of controlled substances notwithstanding that he documented in the medical record that he did so. While this may constitute a violation of the State's regulations (which require both that he do so and document having done so), as well as some evidence that a practitioner exceeded the bounds of professional practice, by itself it is not conclusive proof that a prescription was issued as part of a drug deal.

Finally, the ALJ found it significant that Respondent prescribed to Agent Brigantty notwithstanding that he had told Respondent that he had falsified his medical record by listing on his history that he had gone to a clinic to which he had not gone.

See

ALJ at 71. According to the ALJ, “[a]pplicable Florida regulations are clear about the mandatory weight of the recordkeeping guideline: `The physician is required to keep accurate and complete records' before prescribing controlled substances.'”

Id.

(citing Fla. Admin. Code Ann. r. 64B8-9.013(f)). The ALJ then reasoned that “Respondent's acquiescence in recordkeeping inaccuracies weighs heavily against [his] continued registration.”

Id.

While I agree that there are numerous other apparent violation of the State's regulations (including with respect to Agency Brigantty by documenting having discussed various items which he did not do),

see

ALJ at 71-72, I do not rely on the above discussion. As the evidence shows, on the history and physical examination form, Respondent documented that Brigantty's “Past history of Pain Management” included “Jacksonville and then the street.” This was an accurate statement of what Agent Brigantty had told Respondent.

Accordingly, with the exception of the visit of Agent Brigantty, I reject Respondent's Exceptions to the ALJ's findings that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to Agents Marshall, O'Neill, Doklean, Priymak, Zdrojewski and Ryckeley and thus violated both federal and state law. 21 CFR 1306.04(a), 21 U.S.C. 841(a)(1); Fla. Stat. Ann. § 458.331(1)(q). I further find that substantial evidence supports a finding that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to Agent Saenz.

See id; see also

5 U.S.C. 557(b) (“On appeal from or review of the initial decision, the agency has all the powers which it would have in making the initial decision. * * *”). I also adopt the ALJ's findings and legal conclusions with respect to each of the Agents who saw Respondent at Commercial Medical Group, including his finding that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Xanax to Agent Bazile.

See

ALJ at 92 (citing 21 CFR 1306.04(a)). In addition, substantial evidence also supports the ALJ's numerous findings that Respondent failed to maintain accurate records in violation of Florida's regulations,

see

ALJ at 93 (citing Fla. Admin. Code r.64B8-9.013(3)(f)), and that he falsified numerous patient records to support the prescribing of controlled substances.

23

23

In his Exceptions, Respondent argues that “[t]he Government successfully prevented Dr. Wolff from inquiring whether undercover patients had made subsequent visits to the clinic and whether [they] had been unsuccessful in acquiring controlled substances from Dr. Wolff.”

Id.

at 12. In his Exceptions, Respondent does not identify which of the Agents the ALJ precluded him from asking whether they had returned to the clinic. Upon reviewing the record, it is noted that while the ALJ sustained the Government's objection to Respondent's asking this question on cross-examination of two of the Agents, he did so on the ground that the question was beyond the scope of the direct examination.

See

Tr. Vol. 3, at 183, 276-77. Respondent does not contend, however, that he sought to subpoena the Agents to ask this question of them. In addition, the patient files contain no evidence that any of the eight Agents made undercover visits after the dates to which they testified as having obtained controlled substances on from Respondent. I thus reject this Exception.

In his Exceptions, Respondent further contends that he “was denied the opportunity to review and produce files of patients that he had discharged from the clinic” which “had been seized by [the Agency] pursuant to a federal search warrant.” Exceptions at 9-10. Respondent contends that “[t]he discharge files evidence [his] compliance with Florida Standards of Care, Florida Medical Regulations, as well as state and federal law.”

Id.

at 10. He further contends that the files “would also permit [him] to [show his] methodology in determining whether or not to write prescriptions for persons claiming to have pain” and “that he would not automatically write prescriptions merely because individuals claimed to be suffering from pain.”

Id.

As for the contention that these files would permit him to show his methodology in determining whether to write prescriptions and that he would not automatically write prescriptions merely because a person complained of pain, these files are not relevant in assessing Respondent's compliance with federal and state standards in prescribing to the undercover CCHM patients. With respect to these patients, Respondent had ample opportunity to testify as to his methodology in determining whether to prescribe to the Agents as he was provided with the files of each of the Agents whose prescriptions form the bulk of the Government's case against him.

24

24

It is acknowledged that the Government did not turn over the patient file for Agent Bazile, who saw Respondent at CMG. However, the ALJ's finding that Respondent violated 21 CFR 1306.04(a) when he prescribed Xanax to her was based on Agent Bazile's credited testimony. More specifically, Agent Bazile testified that she asked Respondent for something to help her sleep. Tr. Vol. 6, at 23. Respondent then asked if she had trouble sleeping, and Agent Bazile replied “sometimes,” prompting Respondent to remark that she was “not very convincing.”

Id.

at 23-24. At the hearing, Respondent testified that he could not provide the reason he prescribed Xanax to Agent Bazile without having the opportunity to see her patient file. Tr. Vol. 10, at 53. I adopt the ALJ's finding noting that Respondent had ample opportunity to cross-examine her regarding the circumstances surrounding her obtaining of the Xanax prescription and yet did not ask her a single question about this prescription.

See

Tr. Vol. 6, at 30-61. I thus find her testimony credible as did the ALJ. ALJ at 9.

As for the contention that the discharged patient files would show his compliance with applicable standards, I will credit his testimony that he has discharged hundreds of patients. Tr.

Vol. 9, at 272. Accordingly, the files were not necessary to prove his assertion and Respondent cannot claim prejudice.

Cf.

5 U.S.C. 706 (“due account shall be taken of the rule of prejudicial error”).

However, that Respondent discharged hundreds of other patients does not render the prescriptions he issued to Agents Marshall, O'Neill, Doklean, Priymak, Zdrojewski, Ryckeley, Saenz and Bazile any less unlawful.

See Dewey C. MacKay,

75 FR 49956, 49977 (2010) (quoting

Jayam Krishna-Iyer,

74 FR 459, 463 (2009) (holding that a physician's lawful “prescribings to thousands of other patients [does] not * * * render [his] prescribings to undercover officers any less unlawful, or any less acts which `are inconsistent with the public interest'”)). Indeed, with respect to these patients, the evidence is clear that Respondent was not duped and that he intentionally diverted controlled substances.

25

See

ALJ at 95. Thus, the Government has made out a

prima facie

case that Respondent “has committed such acts as would render his registration * * * inconsistent with the public interest.”

26

21 U.S.C. 824(a)(4).

25

As I have previously explained,

Under the CSA, a practitioner is not entitled to a registration unless [he] “is authorized to dispense * * * controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because under law, registration is limited to those who have authority to dispense controlled substances in the course of professional practice, and patients with legitimate medical conditions routinely seek treatment from licensed medical professionals, every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of [his] professional career.

Jayam Krishna-Iyer,

74 FR 459, 463 (2009).

In

Krishna-Iyer,

I further explained that in past cases, this Agency has given no more than nominal weight to a practitioner's evidence that he has dispensed controlled substances to thousands of patients in circumstances which did not involve diversion.

Id. See also MacKay,

75 FR at 49977;

Paul J. Caragine,

63 FR 51592, 51599 (1998) (“[T]he Government does not dispute that during Respondent's 20 years in

practice he has seen over 15,000 patients. At issue in this proceeding is Respondent's controlled substance prescribing to 18 patients.”);

id.

at 51600 (“[E]ven though the patients at issue are only a small portion of Respondent's patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.”).

While in

Caragine,

my predecessor did consider “that the patients at issue ma[de] up a very small percentage of Respondent's total patient population,” he also noted—in contrast to most of the prescriptions at issue here—“that [those] patients had legitimate medical problems that warranted some form of treatment.”

Id.

at 51601. Moreover, in contrast to this case, in

Caragine,

there was no evidence that the practitioner had intentionally diverted.

Id. See also Medicine Shoppe—Jonesborough,

73 FR 364, 386 & n.56 (2008) (noting that pharmacy “had 17,000 patients,” but that “[n]o amount of legitimate dispensings can render * * * flagrant violations [acts which are] `consistent with the public interest.' ”),

aff'd, Medicine Shoppe-Jonesborough

v.

DEA,

300 Fed. Appx. 409 (6th Cir. 2008).

Indeed, DEA has revoked other practitioners' registrations for committing as few as two acts of diversion, and “can revoke based on a single act of diversion” absent a credible showing by the registrant that he accepts responsibility for his misconduct.

MacKay,

75 FR at 49977.

See also Alan H. Olefsky,

57 FR 928, 928-29 (1992) (revoking registration based on physician's presentation of two fraudulent prescriptions to pharmacy and noting that the respondent “refuses to accept responsibility for his actions and does not even acknowledge the criminality of his behavior”);

Sokoloff

v.

Saxbe,

501 F.2d 571, 576 (2d Cir. 1974) (upholding revocation of practitioner's registration based on

nolo contendere

plea to three counts of unlawful distribution).

Accordingly, evidence that a practitioner has treated thousands of patients does not negate a

prima facie

showing that the practitioner has committed acts inconsistent with the public interest. While such evidence may be of some weight in assessing whether a practitioner has credibly shown that he has reformed his practices, where a practitioner commits intentional acts of diversion and insists he did nothing wrong, such evidence is entitled to no weight.

Krishna-Iyer,

74 FR at 463.

26

As the ALJ explained, the public interest factors are “considered in the disjunctive. [I] may properly rely on any one or a combination of those factors, and give each factor the weight [I] deem appropriate, in determining whether a registration should be revoked or an application for registration should be denied.” ALJ at 43 (citing cases);

see also Hoxie

v.

DEA,

419 F.3d, 477, 482 (6th Cir. 2005). Nor am I required to make findings as to all of the factors.

Hoxie,

419 F.3d at 482. Moreover, whether conduct is considered under factor two—the experience factor, or factor four—the compliance factor, or both factors, is of no legal consequence because the fundamental question is whether the registrant “has committed such acts as would render [his] registration * * * inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Thus, as both the Agency and various courts of appeals have recognized, findings under a single factor are sufficient to support the revocation of a registration, especially where the proven misconduct involves egregious acts.

See Hoxie,

419 F.3d at 482;

Morall

v.

DEA,

412 F.3d 165, 173-74 (DC Cir. 2005);

Krishna-Iyer,

74 FR at 462.

That said, I have considered the ALJ's findings with respect to each of the factors and adopt them except as noted herein.

As the ALJ explained, under longstanding Agency precedent, where, as here, “the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must `present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.' ”

Medicine Shoppe,

73 FR at 387 (quoting

Samuel S. Jackson,

72 FR 23848, 23853 (2007) (quoting

Leo R. Miller,

53 FR 21931, 21932 (1988))). “Moreover, because `past performance is the best predictor of future performance,'

ALRA Labs, Inc.

v.

DEA,

54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.”

Medicine Shoppe,

73 FR at 387;

see also Jackson,

72 FR at 23853;

John H. Kennedy,

71 FR 35705, 35709 (2006);

Prince George Daniels,

60 FR 62884, 62887 (1995).

See also Hoxie

v.

DEA,

419 F.3d 477, 483 (6th Cir. 2008) (“admitting fault” is “properly consider[ed]” by DEA to be an “important factor[]” in the public interest determination). In addition, DEA has held that a registrant's candor is an important factor in the public interest determination.

See Satinder Dang,

76 FR 51424 (2011);

Alan H. Olefsky,

76 FR 20025 (2011);

The Lawsons, Inc.,

72 FR 74334 (2007).

See also Hoxie,

419 F.3d at 483.

It is acknowledged that Respondent testified that he had fired several clinic employees after he purchased CCHM and that he brought in a risk manager to assess the clinic's procedures and to create a policy and procedures manual. However, as the ALJ found, “Respondent's testimony * * * repeatedly demonstrated [his] belief that he had engaged in no past misconduct and was in full compliance with existing laws and regulations,” as well as “a remarkable lack of acknowledgment and recognition of the risks of diversion.” ALJ at 97-98. In addition, the ALJ found that “Respondent's testimony in numerous instances was not credible and reflected an overall lack of admission of past misconduct, let alone acceptance of responsibility.”

Id.

at 98. Indeed, much of his testimony regarding the CCHM patients was patently disingenuous. Accordingly, I adopt the ALJ's conclusion that Respondent has “fail[ed] to accept responsibility for his misconduct and demonstrate that he will not engage in future misconduct,” ALJ at 98, and therefore hold that he has not rebutted the Government's

prima facie

case. Given the egregiousness of his misconduct, I further adopt the ALJ's recommendation that Respondent's registrations be revoked and that any pending application for renewal or modification of his registrations be denied.

Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233, and BW0601446, issued to Randall L. Wolff, M.D., be, and they hereby are, revoked. I also order that any pending application of Randall L. Wolff, M.D., to renew or modify these registrations, as well as any pending

application for a new registration, be, and they hereby are denied. This order is effective immediately.

27

27

For the same reasons that I ordered the immediate suspension of Respondent's registrations, I conclude that the public interest requires that his order be effective immediately. 21 CFR 1316.67.

Dated: January 19, 2012.

Michele M. Leonhart,

Administrator.

Theresa Krause, Esq.,

for the Government

Bruce A. Zimet, Esq.,

for the Respondent

Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of the Administrative Law Judge

I. Introduction

A. The Order to Show Cause and Immediate Suspension of Registration

Timothy D. Wing, Administrative Law Judge. This proceeding is an adjudication pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 551

et seq.,

to determine whether the Drug Enforcement Administration (DEA or Government) should revoke a physician's DEA Certificates of Registration (CORs) as a practitioner pursuant to 21 U.S.C. 824(a)(4) and deny, pursuant to 21 U.S.C. 823(f), any pending applications for renewal or modification thereof and any application for a new COR. Without these registrations, Respondent Randall L. Wolff, M.D. (Respondent), of the State of Florida, would be unable to lawfully prescribe, dispense or otherwise handle controlled substances in the course of his practice.

On December 16, 2010,

1

the Deputy Administrator, DEA, served an Order to Show Cause and Immediate Suspension of Registration (OSC/IS) upon Respondent, dated December 14, 2010. The OSC/IS immediately suspended Respondent's nine (9) DEA CORs as a practitioner, and also provided notice to Respondent of an opportunity to show cause as to why the DEA should not revoke Respondent's CORs, pursuant to 21 U.S.C. 824(a)(4), and deny, pursuant to 21 U.S.C. 823(f), any pending applications for renewal or modification thereof and any applications for a new COR, alleging that Respondent's continued registration is inconsistent with the public interest as that term is defined in 21 U.S.C. 823(f).

1

The Government's Notice of Service of Order to Show Cause and Immediate Suspension of Registration states that “Service was completed on December 16, 2010.” (Notice of Service at 1.) In his hearing request, Respondent states that “Dr. Wolff was served on December 17, 2010. * * *” (Hg. Req. at 2.) Respondent subsequently stipulated that service occurred on December 16, 2010.

The OSC/IS alleges that Respondent is registered as a practitioner in Schedules II through V under DEA registration numbers FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and BW0601446, and that on or about August 12, 2010, Respondent submitted an application for registration, assigned Control Number W10053115C, as a practitioner in Schedules II through V. (Administrative Law Judge (ALJ) Ex. 1 at 1-2.)

The OSC/IS further alleges that between approximately March 5, 2010, and July 23, 2010, Respondent distributed controlled substances (to include oxycodone and alprazolam) by issuing prescriptions to at least eleven undercover law enforcement officers for other than a legitimate medical purpose or outside the usual course of professional practice. In particular, the OSC/IS alleges that on March 5, 2010, Respondent distributed to three undercover law enforcement officers various quantities of controlled substances after conducting little or no physical examination, among other deficiencies.

In addition, the OSC/IS alleges that from April 7, 2010, through July 23, 2010, Respondent distributed oxycodone and alprazolam tablets to at least eight undercover law enforcement officers under circumstances similar to those noted above, to include little or no physical examination, no diagnosis warranting the prescription for controlled substances and under circumstances which Respondent knew or should have known that prescribing controlled substances was for other than a legitimate medical purpose.

Finally, the OSC/IS alleges that Respondent's registered location associated with DEA COR FW1453757 is the location of Coast to Coast Healthcare Management Pain Clinic (CCHM) and the location where the vast majority of the undercover activity occurred; that from approximately July 30, 2009, through December 29, 2009, Respondent ordered approximately 249,000 dosage units of oxycodone that were delivered to this location; and that from approximately January 4, 2010, through September 1, 2010, Respondent ordered approximately 267,000 dosage units of oxycodone that were delivered to this location.

In addition to the OSC/IS, the Government also noticed and alleged additional information in its initial and supplemental prehearing statements to include Automation of Reports and Consolidated Orders System (ARCOS) data pertaining to Respondent, along with medical expert opinion regarding Respondent's prescribing and recordkeeping practices.

Following prehearing procedures, a hearing was held in Ft. Lauderdale, Florida between February 15, 2011, and February 18, 2011, and in Miami, Florida between March 8, 2011, and March 17, 2011,

2

with the Government represented by counsel and Respondent represented by counsel. Both parties called witnesses to testify and introduced documentary evidence. After the hearing, both parties filed proposed findings of fact, conclusions of law and argument. All of the evidence and post-hearing submissions have been considered, and to the extent the parties' proposed findings of fact have been adopted, they are substantively incorporated into those set forth below.

2

Hearing was recessed over the weekend of March 12-13, 2011.

II. Issue

Whether the record establishes that Respondent's DEA CORs FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and BW0601446 as a practitioner should be revoked and any pending applications for renewal or modification thereof and any applications for a new COR, to include application WI0053115C, should be denied, on the grounds that Respondent's continued registration would be inconsistent with the public interest as that term is used in 21 U.S.C. 824(a)(4) and 823(f).

III. Evidence and Incorporated Findings of Fact

3

3

In addition to the evidence discussed in this Section, additional evidence and findings of fact are discussed in later Sections of this Recommended Decision.

I find, by a preponderance of the evidence, the following facts:

A. Stipulated Facts

4

4

(

See

ALJ Ex. 8;

see also

Tr. vol. 5, at 4-5.)

1. Respondent is registered with DEA as a practitioner in Schedules II through V under DEA registration numbers FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and BW0601446 at 328 East Hillsboro Blvd., Deerfield Beach, Florida 33441; Delray Beach Fire Dept., 501 W. Atlantic Avenue, Delray Beach Florida 33444; Palm Beach Fire Rescue, 300 N. County Road, Palm Beach, Florida 33480; West Palm Beach Fire Dept., 500 North Dixie, West Palm Beach, Florida 33401; Wycliffe Golf & Country Club, 4160 Wycliffe Country Club Drive,

Wellington, Florida 33449; Public Safety Fire Department, 560 US Highway 1, North Palm Beach, Florida 33408-4902; Greenacres City Public Safety, 2995 Jog Road, Greenacres City, Florida 33467; 10985 Blue Palm Street, Plantation, Florida 33324-8234 and Lake Worth Fire Dept., 1020 Lucerne Ave., Lake Worth, Florida 33460, respectively.

2. Respondent's DEA registration numbers FW1453757, BW3918440, BW4448571, AW2065058, FW1338690, BW4362935, AW2654639, AW8594233 and BW0601446 expire by their terms on May 31, 2012, May 31, 2012, May 31, 2013, May 31, 2012, May 31, 2012, May 31, 2013, May 31, 2012, May 31, 2012 and May 31, 2011, respectively.

3. On or about August 12, 2010, Respondent filed an application with DEA for a DEA COR as a practitioner to handle controlled substances in Schedules II through V at 8609 Forest City Road, Orlando, Florida 32809; this application was assigned DEA Control Number W10053115C. Respondent's application is pending.

4. On December 16, 2010, a federal criminal search warrant was executed at 328 East Hillsboro Blvd., Deerfield Beach, Florida 33441, one of Respondent's registered locations. Respondent was simultaneously served with the DEA OSC/IS.

5. Oxycodone is a Schedule II controlled substance pursuant to 21 CFR 1308.12(b)(1)(xiii).

6. OxyContin is a brand of oxycodone, a Schedule II narcotic controlled substance pursuant to 21 CFR 1308.12(b)(1)(xiii).

7. Roxicodone is a brand of oxycodone, a Schedule II narcotic controlled substance pursuant to 21 CFR 1308.12(b)(1)(xiii).

8. Alprazolam is a Schedule IV controlled substance pursuant to 21 CFR 1308.14(c)(1).

9. Xanax is a brand of alprazolam, a Schedule IV narcotic controlled substance pursuant to 21 CFR 1308.14(c)(1).

10. Vicodin is a brand of hydrocodone combination product, a Schedule III narcotic controlled substance pursuant to 21 CFR 1308.13(e)(1)(iv).

11. Soma is a brand of carisoprodol, a non-controlled

5

muscle relaxant.

5

Although not pertinent to the instant proceeding, I note that because of its potential for abuse, DEA has initiated a proceeding to place carisoprodol into Schedule IV under the Controlled Substances Act.

See

74 FR 59,108, 59,109 (DEA 2009).

B. Introduction

Respondent completed his internship and residency in the field of internal medicine in 1980, subsequently working in emergency medicine as well as completing a fellowship in pulmonary/critical care. (Tr. vol. 9, at 211.) Respondent worked in Florida as an emergency department physician at JFK Medical Center beginning in 1982, later becoming Deputy Medical Director, and eventually Medical Director from 1995 to 2001. (Tr. vol. 9, at 214.) Respondent next worked as a regional medical director for three hospitals in California for a little more than a year, before returning to Florida to work in several different emergency departments. (Tr. vol. 9, at 216-17.) Respondent began a clinic in Delray Beach, Florida, and also worked as medical director for various municipal and community fire and emergency departments. (Tr. vol. 9, at 217.)

In July 2009 Respondent accepted a position at Commercial Medical Group (CMG),

6

a pain management clinic in Fort Lauderdale, Florida. Respondent's employment at CMG ended in February or March 2010 due to a conflict between Respondent and the owner, Mr. Vincent Colangelo. (Tr. vol. 9, at 220.)

6

Respondent testified that CMG had previously been called Seaside Pain Management Clinic, but that the name was changed in or about August or September 2009. (Tr. vol. 11, at 95.)

Respondent next worked for another clinic known as American Pain for approximately one week, before the clinic was closed down.

7

(Tr. vol. 9, at 235.) In April 2010, Respondent began working for another pain clinic, CCHM, initially working there with three or four other doctors until October 2010, when Respondent's role changed from independent contractor to owner of the clinic. (Tr. vol. 9, at 221.) Respondent remained at CCHM as owner and practicing doctor from October 2010 until mid-December 2010, when the clinic was closed by DEA. (Tr. vol. 9, at 222.)

7

Respondent testified on cross-examination that the only pain clinics he worked at were CMG and CCHM, except that he also worked “for a brief time in Orlando” but did not remember the name of the clinic. (Tr. vol. 11, at 76.)

C. Evidence

1. Background

The Government's evidence included testimony from seventeen witnesses, including Respondent and a pain management expert, Dr. Scott A. Berger, M.D. Three witnesses were undercover law enforcement officers who posed as patients and received treatment from Respondent at CMG: DEA Special Agent (SA) Mark McClarie (SA McClarie); SA Rochelle E. Burnett Bazile (SA Bazile); and SA Kirk Miller (SA Miller). Eight witnesses were undercover law enforcement officers who posed as patients and received treatment from Respondent at CCHM: SA Nicholas Priymak (SA Priymak); SA Jeffrey K. O'Neil (SA O'Neil); SA Julia Saenz de Viteri (SA Saenz); SA Marc A. Marshall (SA Marshall); DEA Task Force Officer (TFO) Dana G. Doklean (TFO Doklean); SA Louis J. Ryckeley (SA Ryckeley); SA Brian M. Zdrojewski (SA Zdrojewski); and SA Edwin Brigantty (SA Brigantty). Mr. Kyle J. Wright, Unit Chief, DEA Office of Diversion Control, testified regarding ARCOS data pertaining to Respondent.

8

DEA Diversion Investigator (DI) Barbara Boggess (DI Boggess) testified regarding Respondent's DEA certificates of registration. Finally, the evidence included testimony from DEA TFO Robbie R. Weir (TFO Weir), “case agent” for the investigation of CCHM, and SA Joseph Gill (SA Gill), “case agent” for the investigation of CMG.

8

The ARCOS evidence shows trends in Respondent's prescribing of controlled substances over time as well as absolute numbers of dosage units prescribed. (

See

Tr. vol. 1, at 100-169;

see also

Gov't Exs. 13 & 30.) Mr. Wright could not testify as to the causes of the trends other than to identify that the trends existed. (

E.g.,

Tr. vol. 1, at 148.) The Government concedes, correctly, that “[s]tanding alone this ARCOS data is not persuasive * * *.” (Gov't Br. at 8.) The Government argues, however, that in conjunction with evidence of Respondent's prescribing practices, the “ARCOS data * * * reveals * * * the impact that the Respondent's illegal conduct had on the health and safety of the public.” (Gov't Br. at 8.) To the contrary, in the form it was offered, the ARCOS evidence provides little insight into whether Respondent's conduct was consistent or inconsistent with the public interest.

See Gregg & Son Distribs.,

74 FR 17,517, 17,517 n.1 (DEA 2009) (“To make clear, it is the Government's obligation as part of its burden of proof and not the ALJ's responsibility to sift through the records and highlight that information which is probative of the issues in the proceeding.”)

The Government's evidence also included various audio and video recordings of undercover meetings that occurred at CMG and CCHM, along with transcripts of portions of the various recordings.

9

Additionally, the evidence included eight patient files associated with undercover visits to CCHM. No patient files were offered with regard to undercover visits to CMG.

9

No recording was made of the meeting between SA Bazile and Respondent at CMG, or SA Saenz and Respondent at CCHM, due to recording failures.

Respondent's evidence included testimony from four witnesses, including Respondent. Three witnesses provided testimony related to three of Respondent's registered locations: Phil Webb, Fire Chief, West Palm Beach Fire Department; Mark Pure, EMS Chief, Greenacres City Department of Public Safety; and David Dyal, Assistant Fire Chief, Stuart, Florida. Respondent testified regarding his education and professional background, as well as his

prescribing practices. Respondent's evidence also included eight patient files associated with undercover visits to CCHM,

10

along with six other patient files reflecting prior treatment by Respondent. (Resp't Exs. 1-8; 11, 13, 15-17 & 19.)

10

Respondent argued at hearing that use of separate copies of patient files for the eight undercover visits to CCHM was necessary because the source of the files, and arguably content, varied from those presented by the Government. In the absence of an objection by the Government, the patient files, which are substantially identical to those offered by the Government, were admitted. (Tr. vol. 10, at 86-88; Tr. vol. 11, at 46.)

With the exception of Respondent and Dr. Berger, I find all of the witnesses at hearing to be fully credible in that the testimony was generally internally consistent and evidenced a reasonable level of memory for past events. Each witness presented testimony in a professional manner and the material portions of the testimony was consistent with other credible evidence of record. Respondent's testimony was presented in a professional and serious manner, but as more fully explained in the discussion section below, I find it to be only partially credible. Dr. Berger's testimony was generally credible, but was diminished in several respects by various factual errors, as more fully explained below.

2. Expert Testimony and Report

The Government presented the testimony of Dr. Scott A. Berger, M.D., along with a written report prepared by Dr. Berger (Gov't Ex. 32), pertaining to his review of various DEA reports of investigation and eight patient files related to DEA undercover visits to CCHM between April 7, 2010, and July 23, 2010. Dr. Berger did not review or offer any testimony related to three undercover patient visits to CMG.

The Government offered Dr. Berger as an expert in the legitimate and illegitimate use of narcotic controlled substances related to pain management. (Tr. vol. 7, at 38.) Dr. Berger testified that he has over twenty years of experience in treating chronic pain patients and is certified by the American Board of Anesthesiology, as well as the American Academy of Pain Management. (Tr. vol. 7, at 11;

see

Gov't Ex. 20 at 3.) Dr. Berger further testified that the American Academy of Pain Management is not a board, but rather a peer review organization, which predated the American Board of Pain Management. Dr. Berger testified that he is not board certified by the American Board of Pain Management. (Tr. vol. at 7, at 26.) Based on his experience, education, and training, I accepted Dr. Berger as an expert within the field of pain medicine.

Consistent with his testimony, Dr. Berger stated in his report that the patient files for undercover special agents Brigantty, Zdrojewski and Ryckeley reflected “extremely superficial physical examinations, which were essentially memorialized in the record as a series of checkboxes, which did not truly indicate what was done.” (Gov't Ex. 32 at 113.) Dr. Berger's report further indicated that the three patient files reflected referrals to a neurosurgeon in two instances, and an interventional anesthesiologist in the third, but “these were just words, and never actually occurred.” (Gov't Ex. 32 at 114.)

Dr. Berger opined that with regard to his review of eight undercover patient files, and related information, Respondent “fell well below the standard of care in many if not all the standards as they relate to the prescribing of controlled substances in the State of Florida.” (Tr. vol. 7, at 177.) Dr. Berger explained the basis for his opinion to include the fact that evaluations of patients were incomplete, lacked review of prior patient records, and Respondent was “essentially taking [patients] at their word for a lot of their stories.” (Tr. vol. 7, at 178.) Dr. Berger further explained that Respondent's treatment plans were just checked boxes, and Respondent had not made actual referrals to other healthcare providers. Dr. Berger also testified that it is very dangerous to treat people with depression or bipolar disorder with a combination of opioids and benzodiazepine. (Tr. vol. 7, at 180.)

3. Commercial Medical Group (CMG)

SA Gill testified in substance to having approximately seven years of law enforcement experience with DEA. SA Gill testified that he was primarily involved in the investigation of CMG, which began in September of 2009. (Tr. vol. 5, at 203.) SA Gill testified that he was the “case agent” and learned from a confidential source that a Mr. Vincent Colangelo was the owner of several pain clinics, including CMG. (Tr. vol. 5, at 203.) CMG was determined to be a cash-only business open usually six days per week, with lines of patients outside the door. (Tr. vol. 5, at 205.) SA Gill was also aware that Respondent worked as a physician at CMG. (Tr. vol. 5, at 204.) SA Gill further testified that weekly surveillance which revealed vehicles from the states of Kentucky, Tennessee, the Carolinas and Ohio, among others, raised DEA agents' suspicions. (Tr. vol. 5, at 205.)

SA Gill further testified that based on information from various confidential sources, CMG saw approximately forty to one hundred patients a day. (Tr. vol. 5, at 207-08.) SA Gill testified that Mr. Colangelo had a well-known formula that would generate the most amount of money for the clinic, keep patients happy and generate a lot of money for the pharmacy. (Tr. vol. 5, at 214.) The formula was “240 oxycodone 30-milligram tablets, 90 oxycodone 15-milligram tablets, and, then, 90 Xanax, 2-milligram bars.” (Tr. vol. 5, at 214.)

SA Gill testified that as part of the investigation of CMG, three undercover law enforcement officers posing as patients visited CMG in early 2010

11

with the goal of meeting one-on-one with a doctor to determine if there was any level of criminal behavior or if inappropriate prescriptions were being written. (Tr. vol. 5, at 206.) SA Gill further testified on direct examination that in January 2011, he instructed that law enforcement officers go to CMG with release forms and attempt to recover patient files related to three undercover law enforcement visits to CMG in 2010.

12

(Tr. vol. 5, at 215.) SA Gill testified on direct examination that he was unsuccessful in obtaining the undercover patient files from CMG.

11

The witness did not recall the exact date, but thought it was “January or so.” (Tr. vol. 5, at 205.) The testimony of the undercover officers and other uncontroverted evidence of record places the date at March 5, 2010.

12

Special Agents Miller, Bazile and McClarie.

On cross-examination, over Government counsel's objection,

13

SA Gill testified that he had recovered the patient files for at least two of the three undercover officers that met with Respondent at CMG. (Tr. vol. 5, at 218.) The files were recovered at a storage warehouse. (Tr. vol. 5, at 219.) SA Gill also testified the “Colangelo formula” had been reduced due to law enforcement and media attention, and the formula was not consistent with every patient. (Tr. vol. 5, at 227.) SA Gill further testified on cross-examination that he was aware Respondent had quit CMG, but did not know the reason. (Tr. vol. 5, at 237-38.)

13

As a cautionary note, although Agency precedent relieves the Government of a duty to disclose “potentially exculpatory information” to a respondent, there remains, of course, an ongoing duty to ensure that material evidence and argument made to a fact-finder is not knowingly contradicted by other material evidence in the Government's possession, but not otherwise disclosed.

See, e.g., Richard A. Cole, M.D.,

57 FR 8677, 8677 (DEA 1992) (after hearing, Government filed Request for

In Camera

Inspection of Information advising that one of Government's witnesses at hearing failed to disclose information in response to certain questions asked during cross-examination).

(a) SA Miller, March 5, 2010 Undercover Visit to CMG

SA Miller testified in substance to having approximately fourteen years of law enforcement experience, including an assignment to a DEA Tactical Diversion Squad for the past three years. SA Miller testified that he met Respondent on March 5, 2010, at CMG while working in an undercover capacity and posing as a patient. Upon arriving at CMG he observed the waiting area to be very crowded and disorganized, with a long line of people. (Tr. vol. 5, at 13.) After waiting in line, SA Miller was handed a clipboard with paperwork and told the cost of the visit was $250, for which he gave the receptionist $300.

14

(Tr. vol. 5, at 14.) SA Miller completed the paperwork, noting left knee discomfort and nothing on the pain scale, among other information. (

E.g.,

Tr. vol. 5, at 16.) SA Miller also provided CMG staff a copy of an MRI report which was an actual report of SA Miller's knee using his undercover name. (Tr. vol. 5, at 29;

see

Gov't Ex. 12 at 13.) After returning the forms to the receptionist, SA Miller waited approximately two hours, noticing that other patients arriving after him had already been seen by a doctor. (Tr. vol. 5, at 17.) SA Miller approached the receptionist and gave her a $100 tip to speed things along, and waited another two hours before being called to triage. (Tr. vol. 5, at 17.) In triage, SA Miller's blood pressure was taken and he was asked the purpose of the visit. SA Miller also submitted to a urinalysis test. (Tr. vol. 5, at 18.)

14

The receptionist indicated she did not have any change and SA Miller told her to keep the difference, which she did. (Tr. vol. 5, at 14.)

SA Miller next testified that before he went to the triage area, Mr. Vincent Colangelo arrived and appeared agitated, questioning why so many people were waiting, and indicated that the doctor was not then seeing anyone. (Tr. vol. 5, at 20.) After triage, SA Miller overheard Mr. Colangelo speaking on the phone about prices charged for out-of-state patients. (Tr. vol. 5, at 20.)

SA Miller continued to wait, and eventually Respondent called SA Miller to come back and see him. (Tr. vol. 5, at 23.) SA Miller met with Respondent in an examination room, with the visit lasting a total of approximately five minutes. (Tr. vol. 5, at 23.) SA Miller explained his knee issue, noting that he had seen a family practice doctor in Colorado, but had not seen a doctor in approximately one month. (Tr. vol. 5, at 24.) SA Miller also told Respondent he was taking Vicodin. (Tr. vol. 5, at 26.) Upon questioning by Respondent, SA Miller stated his pain was a five on a one-to-ten scale. (Tr. vol. 5, at 24.) Respondent next asked SA Miller to stand, raise his arms, touch his toes, and Respondent also placed a stethoscope on SA Miller's chest and back. (Tr. vol. 5, at 25.) Respondent next issued SA Miller a prescription for 60 Roxicodone 15 mg tablets.

15

(Tr. vol. 5, at 26; Gov't Ex. 12 at 14.)

15

The evidence also included a partial transcript of the undercover meeting. Neither party produced a patient file.

Respondent testified in substance that review of the patient file for SA Miller, including the MRI report, was critical to his ability to respond to the Government's allegations, and would have assisted him with testimony. (Tr. vol. 10, at 13-16.) Respondent understood SA Miller's representation of pain to be a five located in the knee, with pain lasting for eighteen months. (Tr. vol. 10, at 18.) Respondent further testified to the importance he places on listening to patients with regard to prescribing medication. (Tr. vol. 10, at 22.) Having patients perform range-of-motion exercises included checking for track marks. (Tr. vol. 10, at 23.) Respondent testified he believed SA Miller was being honest, expressing reports of pain that were real and significant. (Tr. vol. 10, at 26-27.)

Respondent also testified that part of his plan in treating SA Miller was to assess in a follow-up appointment whether the medication had relieved the pain. (Tr. vol. 10, at 29.) Respondent testified that he “would not have prescribed medication unless a patient presents a convincing story of pain and has a legitimate medical purpose for receiving medication.” (Tr. vol. 10, at 30.)

(b) SA McClarie, March 5, 2010 Undercover Visit to CMG

SA McClarie testified in substance to having approximately thirteen years of law enforcement experience, including an assignment to a DEA Tactical Diversion Group for the past few years. (Tr. vol. 5, at 94-95.) SA McClarie testified to meeting Respondent on March 5, 2010, at CMG while working in an undercover capacity and posing as a patient. (Tr. vol. 5, at 95-96.) SA McClarie testified that upon arriving at approximately 1:30 p.m., he observed approximately fifty people inside the clinic. (Tr. vol. 5, at 97.) While waiting in line, SA McClarie overheard one person state that he was from New York and “was down here to get prescription medication.” (Tr. vol. 5, at 98.) SA McClarie further testified to observing a male who appeared to be in the company of four or five people, and the male went to the front desk, paid cash for all of the people with him and obtained clipboards and forms for the group to fill out. (Tr. vol. 5, at 99.)

SA McClarie next testified that when he reached the front counter he was charged $350 for the visit and another $100 for “VIP” expedited service, all paid in cash. (Tr. vol. 5, at 111-12.) The receptionist gave SA McClarie forms to fill out including a pain scale, on which he circled all the numbers with one large circle. (Tr. vol. 5, at 112-13.) SA McClarie also informed CMG staff that he had an MRI done but did not have the MRI report with him, to which the staff indicated they would have it faxed over. (Tr. vol. 5, at 113-14.) SA McClarie next completed a triage procedure

16

and after an additional wait, met with Respondent.

16

The triage procedure at CMG generally consisted of an inquiry regarding the purpose of the visit, medications, and the measurement of biometric data such as height, weight, blood pressure and urinalysis testing.

SA McClarie testified that Respondent told him that the MRI of his knee was not very impressive. (Tr. vol. 5, at 117 & 119.) SA McClarie also informed Respondent he was having issues with his back. (Tr. vol. 5, at 117.) Respondent asked SA McClarie about his blood pressure and whether he was allergic to anything, listened to SA McClarie's heart with a stethoscope and had SA McClarie perform a series of basic movements such as standing and bending, among others. (Tr. vol. 5, at 121.) SA McClarie completed the range-of-motion test without difficulty. (Tr. vol. 5, at 121.) Respondent asked SA McClarie how the over-the-counter medications were working, to which SA McClarie said they were doing nothing. (Tr. vol. 5, at

This text is long and has been trimmed here. Open the source document for the complete record.