Daily Rules, Proposed Rules, and Notices of the Federal Government
On September 27, 2011, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Henri Wetselaar, M.D. (Respondent), of Las Vegas, Nevada. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration as a practitioner, and the denial of any application to renew or modify his registration, on the ground that Respondent's "continued registration is inconsistent with the public interest." Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
The Show Cause Order alleged that from April through August 2010, law
The Show Cause Order further alleged that a medical expert had "reviewed more than 200 patient files obtained from [Respondent's] office" and found that he "consistently prescribed large amounts of oxycodone and alprazolam without adequate examination and documentation to support such prescribing."
On September 29, 2011, the Order, which also notified Respondent of his right to request a hearing on the allegations, or to submit a written statement in lieu of a hearing, the procedures for electing either option (including that he file his request for a hearing or his written statement within 30 days of receipt of the Order), and the consequences for failing to do either, was served on him.
Thereafter, the Government moved to terminate the proceeding on the grounds that Respondent had neither requested a hearing nor timely filed a request for an extension to request a hearing. GX 5, at 1. The Government also argued that Respondent had not established "good cause" for his untimely filing.
Upon reviewing the motion, the ALJ ordered Respondent to respond to the Government's motion. GX 6. Thereafter, Respondent's counsel submitted a letter stating that he "ha[d] voluntarily chosen to forego his right to file a Request for a Hearing" and respond to the Show Cause Order. GX 7. The ALJ then found that Respondent had withdrawn his request for a hearing, granted the Government's motion and ordered that the proceeding be terminated. GX 8, at 1-2. Several months later, the Government forwarded the investigative record to this office with its request for Final Agency Action.
Having reviewed the record, I adopt the ALJ's finding that Respondent has withdrawn his request for a hearing. I further hold that the evidence with respect to factors two and four supports a finding that Respondent has committed acts which render his registration "inconsistent with the public interest." 21 U.S.C. 824(a)(4). I make the following factual findings.
Respondent is the holder of DEA Certificate of Registration BW5180372, which, prior to the issuance of the Order of Immediate Suspension, authorized him to dispense controlled substances in schedules II through V at the registered location of New Amsterdam Medical Group, 4525 S. Sandhill Road, Suite 107, Las Vegas, Nevada. GX 1. Respondent's registration was due to expire on May 31, 2011.
On April 6, 2010, a DEA Task Force Officer (TFO 1) visited Respondent complaining of pain in his right shin which occurred only when he ran but that he had for six months. GX 11, at 59. During the visit, Respondent asked TFO 1 what he thought caused the pain ("probably running") and TFO 1's vital signs were taken.
Respondent then asked the TFO what medications worked best for his pain; the TFO replied that he "would like to get, if I could get Percocet or Oxy."
Respondent's assistant asked the TFO if there was any other medication he took "for anxiety or Xanax."
The TFO then asked if he could get some testosterone cream.
The TFO subsequently asked Respondent: "I ain't pushing my luck, but there's no way I could get oxycodone or Oxy?"
Respondent's assistant then suggested that the TFO might be able to get oxycodone at his next visit if "it's not quite enough."
On May 4, 2010, TFO 1 again saw Respondent. GX 12. The TFO asserted that the Percocet was not helping and that Respondent had "said if it didn't work," he could get "something better" and asked if it was "possible" to "get OxyContin."
Respondent noted that the TFO had just "started with us"; the TFO replied that he "was referred to you guys."
Respondent's assistant then asked how much the TFO had paid at the previous visit; the TFO said "200" and added that "you said it would be an extra hundred if," to which the assistant interjected: "yeah cause Oxycodone."
Next, the TFO complained about the cost of the Viagra, and ultimately said he did not need more of it.
After discussing with Respondent and his assistant how he could get Viagra for cheaper,
On June 1, 2010, TFO 1 made a third visit to Respondent. Respondent noted that he had seen the TFO on May 4 and asked him where he was filling his prescriptions. GX 13, at 3. Respondent's assistant took the TFO's vitals and listened to his lungs.
Respondent then noted that the TFO was "on 180" and "we could increase the number of tabs per day" and "do that" as "the first step," but that he didn't want to go from oxycodone to OxyContin.
Respondent's assistant then suggested that the TFO's prescription be "increase[d] to 220 and then we can step up?"
The TFO then asked what strength of Xanax he was taking; Respondent stated it was two milligrams and that this "is pretty powerful."
Respondent then discussed what drugs the TFO had gotten at the previous visit, and the TFO replied that he had not gotten Viagra because it was "too much money."
Notably, the progress note for this visit now listed the TFO's chief complaint as "more pain in lower lumbar spine," and noted diagnoses of "chronic lbp,"
On June 29, 2010, TFO 1 made a fourth visit to Respondent. Upon meeting, Respondent asked the TFO "how's that going for you?" GX 14, at 8. The TFO replied that "[i]t could be better I guess."
Following a discussion of the whereabouts of the assistant who had been at the TFO's previous appointments, the TFO's vital signs were taken.
Respondent then asked the TFO how he took the Xanax. The TFO stated that he took a whole one at night to help him sleep, a whole one in the morning, and that he sometimes took a third tablet if he "need[ed] it," but "not all the time."
Next, the TFO and Respondent discussed the latter's recommendation that he use a particular pharmacy.
On August 10, 2010, TFO 1 made a final visit to Respondent. After Respondent's assistant called his name, the TFO stated that he had been there "five times," asked if he could "get Oxy 80s please, please," and offered to pay $400 for the visit. GX 15, at 12. However, the assistant replied that "[i]t doesn't matter to me how much you pay," that he was "not going to jail just because you need something," and that he could "go somewhere else."
Respondent then told the TFO to "come on in," and upon noting that it had been "a little over a month" since his last visit, asked him if there were any "major changes."
Respondent then asked the TFO if he would like Xanax, and the TFO asked if he could get 100 Xanax.
Respondent subsequently asked the TFO to explain what he had in mind with the prescriptions and "what we could do for you other than what we are doing here," stating that he "didn't quite follow with the prescriptions."
A second TFO made three undercover visits. The first of these occurred on June 1, 2010. After Respondent's assistant took the TFO's vitals and listened to her lungs, Respondent asked the TFO if she had pain. GX 16, at 6. The TFO responded that she had pain in her "left arm."
Next, Respondent asked the TFO what medications she had been using for her pain; the TFO stated Lortab and Soma,
Respondent stated that "the Lortab you have tried is not quite strong enough. You need to go a step further."
The TFO replied "okay," and Respondent asked her if she would "also like some Soma as well then?"
Next, the TFO asked Respondent if he would "mind if I ask for something for stress?"
The progress note for this visit lists Respondent's diagnoses as "chronic L forearm pain" but does not document the TFO's past history. GX 19. As for Respondent's plan, the note lists the three prescriptions which were discussed during the TFO's meeting with Respondent and his assistant but no diagnostic testing. GX 19. The record also contains a copy of a prescription form, which is dated June 1, 2010, and which lists prescriptions for 30 Xanax 2mg, 90 Percocet 10/325mg, and 60 Soma 350mg. GX 21.
On July 2, TFO 2 returned to Respondent's clinic. GX 17. The TFO met with Respondent's assistant, who upon determining her name, asked: "Percocet and the uh * * * Soma? * * * Xanax?"
Of note, the TFO did not see Respondent on this date, and according to the progress note for the visit, Respondent was "out of town/Las Vegas." GX 19. The progress note states that "authorization of refill of medication has been authorized by" Respondent.
On August 10, 2010, the TFO made a final visit to Respondent. On the progress note, Respondent listed the diagnosis as "as previous," and issued prescriptions for the same three drugs as before but increased the TFO's Percocet prescription to 120 tablets, adding "PRN pain/back." GX 19;
The Government also submitted a declaration of a Diversion Investigator regarding a conference call she and other law enforcement personnel did with a physician who had reviewed 200 patient files which were seized from Respondent pursuant to a search warrant in August 2010. GX 9, at 1. According to the affidavit, the physician provided his "overall impressions of [Respondent's] prescribing habits, recordkeeping, and standard of patient care [and] stated that there is no question that [Respondent's] standard of care fell below the civil standard for [various] reasons," including that there were "no appropriate exams in many cases; no diagnoses were given, particularly when [Respondent] prescribed Xanax (alprazolam, Schedule IV); high doses were routinely prescribed; and doses were increased without good reason."
There is, however, no similar tradition of courts holding affidavits relating the substance of telephone interviews of physicians to be inherently reliable. Thus, the DI's affidavit stands on a fundamentally different footing than that of a physician's written report. It is, however, unnecessary to decide whether the doctor's opinions, as related in this affidavit, can constitute substantial evidence, notwithstanding that they are hearsay within hearsay, because they are simply generalities regarding his review of some 200 files.
Moreover, the legitimacy of Respondent's prescribing to these 200 patients is not before the Agency. Rather, the Government has submitted evidence regarding Respondent's prescribing to the two TFOs. While in its Request for Final Agency Action, the Government asserts that the physician reviewed the files of the two TFOs, nothing in the DI's affidavit (or any other exhibit) establishes this as a fact. Nor does anything in the affidavit reflect that the physician offered opinions specific to the prescriptions Respondent issued to the TFOs. In short, this affidavit has no probative value in determining whether Respondent violated federal law in issuing prescriptions to the TFOs.
Section 304(a) of the Controlled Substances Act provides that a "registration pursuant to section 823 of this title to * * * dispense a controlled substance * * * may be suspended or revoked by the Attorney General upon
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
21 U.S.C. 823(f). In addition, pursuant to 21 U.S.C. 824(d), "[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to public health or safety."
The public interest factors are considered in the disjunctive.
The Government has "the burden of proving that the requirements for * * * revocation or suspension pursuant to section 304(a) * * * are satisfied." 21 CFR 1301.44(e);
Having considered all of the factors, I conclude that the Government's evidence pertinent to factors two (Respondent's experience in dispensing controlled substances) and four (Respondent's compliance with applicable laws related to controlled substances), establishes that Respondent has committed acts which render his registration "inconsistent with the public interest." 21 U.S.C. 824(a)(4).
Under a longstanding DEA regulation, to be effective, "[a] prescription for a controlled substance * * * must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a). As the Supreme Court has explained, "the prescription requirement * * * ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses."
Under the CSA, it is fundamental that a practitioner must establish and maintain a bonafide doctor-patient relationship in order to act "in the usual course of * * * professional practice" and to issue a prescription for a "legitimate medical purpose."
By regulation, the Nevada State Board of Medical Examiners has adopted by reference the Federation of State Medical Boards of the United States, Inc.'s, 2004
Section II of the
Finally, under a Nevada Board regulation, "[a] person who is licensed
As found above, at TFO 1's first visit, Respondent prescribed to him both Percocet 10 and Xanax. At this visit, the TFO unequivocally complained of pain even if he stated that it occurred only when he ran. Moreover, Respondent's assistant clearly performed a physical examination, and while the Government asserts that this was "a cursory examination," Req. for Final Agency Action at 4, it offered nothing bordering on substantial evidence to support this contention.
However, even if Respondent's evaluation of TFO 1 was sufficient to support his prescribing of Percocet, other evidence establishes that Respondent was not engaged in the legitimate practice of medicine but was dealing drugs. More specifically, Respondent, without solicitation by the TFO, asked him if there was any other medication he took for anxiety or Xanax. While the TFO replied he was "always stressed" but was not currently taking anything, Respondent made no effort to determine the extent of the TFO's symptoms and whether they warranted a diagnosis of anxiety. Moreover, when Respondent's assistant asked the TFO if Xanax helped him, the TFO replied, laughing no less, that "everything helps. Can I get some Xanax?" Respondent then said "yeah, but that's why he mentioned it. We'd be happy to write some Xanax for you,
Expert testimony is unnecessary to determine that controlled substances are not prescribed because patients like them, but rather to treat a legitimate medical condition. I therefore conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing Xanax to TFO 1, and therefore violated 21 CFR 1306.04(a).
Moreover, at various points in this visit, TFO 1 provided additional indication that he was a drug-seeking patient as he sought various other controlled substances such as testosterone cream and Adderall. In addition, even after Respondent had agreed to write a Percocet prescription (which contains oxycodone) for him, the TFO asked if he was pushing his luck but then said he would like to get oxycodone or Oxy. While Respondent said "no," and that "it has to be medically indicated," his assistant then suggested that he might be able to get it at his next visit if the Percocet was "not quite enough."
Following this, the TFO stated he had already made his next appointment and added that he "would like to get oxycodone" at it. Respondent's assistant then advised the TFO that the fee would be $300 rather than $200 for an oxycodone visit because the drug was more potent than Percocet and the TFO offered to pay $300 "right now if [he] could get" oxycodone. Thus, the TFO provide ample indication that he was a drug-seeking patient. Moreover, the statement of Respondent's assistant begs the question of why Respondent's charge would be $100 more if a stronger narcotic was prescribed.
At TFO 1's second visit, the TFO sought "something better" and asked if he could get OxyContin 80mg, which he claimed to have "tried . . . before" and that "they helped big time." While Respondent said "no," the TFO's comment did not prompt any questioning as to his source for the OxyContin. And while the TFO claimed that the Percocet was not helping, neither the transcript of the visit nor the progress note for it indicate that Respondent asked the TFO about "the nature and intensity of the pain" and its effect "on [his] physical and psychological function" as mandated by the Nevada rule.
Nonetheless, Respondent offered to prescribe oxycodone 30mg, a drug three times more potent than the Percocet the TFO had previously obtained. Moreover, he then prescribed 180 pills, thus giving the TFO a prescription for six times the amount of oxycodone he had prescribed at the previous visit. In addition, as further evidence of the TFO's drug seeking behavior, he then asked for more Xanax and if he could try some Norco, the latter being a schedule III narcotic combining hydrocodone with acetaminophen. While Respondent did not prescribe Norco (because the TFO was already getting 180 oxycodone 30mg), he did prescribe another 90 Xanax 2mg to the TFO.
I conclude that both the oxycodone 30mg and Xanax prescriptions lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. As for the oxycodone, even if Respondent's initial prescription for Percocet was medically justified, there was no justification for a six-fold increase in the amount of oxycodone that he prescribed.
At TFO 1's third visit, he once again sought "something stronger" than oxycodone 30mg, claiming they didn't "work well." While Respondent stated that he did not want to go from oxycodone to OxyContin, because the latter was "top of the line," Respondent increased the TFO's prescription, this time to 240 tablets of oxycodone 30mg. Here again, there was no discussion of the nature and intensity of the TFO's pain and how it was affecting his ability to function. Nor, notwithstanding that the previous prescription represented a six-fold increase in dosage, was there any discussion (other than the TFO's assertion that the drug did not "work well") as to the effectiveness of the previous prescription. Finally, Respondent wrote in the progress note a new and different diagnosis of chronic lower back pain even though there is no indication in the transcript of the visit that the TFO complained of having any back pain. Accordingly, I find that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing the oxycodone prescription. 21 CFR 1306.04(a).
Moreover, in discussing the Xanax prescription, the TFO disagreed with Respondent's statement that the strength he was taking was "pretty powerful" and added that he "just [didn't] feel them." Once again, there was no discussion of any symptoms the TFO had which would warrant the prescribing of Xanax. Accordingly, I conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in prescribing Xanax to the TFO. 21 CFR 1306.04(a).
At his fourth visit, TFO 1 again complained that the oxycodone was "not working very well" and Respondent asked if he actually wanted OxyContin. While the TFO replied that he thought that OxyContin "would work better for [his] pain," once again the transcript of the visit shows that Respondent made no inquiry as to the nature and intensity of the TFO's pain and its effect on his ability to function. While Respondent did not prescribe OxyContin (because the TFO "would first have to go to 300 tablets" of
At his final visit, TFO 1 again asked if he could get OxyContin and offered to pay $400 for the visit. Manifesting his awareness that the TFO was not a legitimate pain patient but was engaged in drug-seeking, Respondent's assistant replied that "[i]t doesn't matter to me how much you pay" and that he was "not going to jail just because you need something." Moreover, while Respondent asked the TFO if there had been any "major changes" since his last visit, the TFO said no but that he "was going to see if I could get the Oxys 80," but "if not, the Roxies work fine for me." After noting that the TFO had been getting oxycodone (the same drug as Roxicodone), Respondent asked the TFO, "is that what you would like?" and whether 300 pills "works for you?"
Notably, at no point did the TFO complain of pain, and other than Respondent's question whether there had been any "major changes" since his last visit, neither Respondent nor his assistant questioned the TFO about the nature and intensity of his pain, and its effect on his ability to function. Moreover, Respondent then asked the TFO if he would like Xanax and the TFO asked if he could get 100 tablets. Manifesting that he knew the TFO was a drug abuser, Respondent expressed his concern that he could get in trouble because the "Xanax is so powerful" if "they found [the TFO] on the street unconscious" with Respondent's name on the bottle in his pocket. Notwithstanding that there was no legitimate purpose for either prescription, Respondent prescribed 300 oxycodone 30mg and 90 Xanax 2mg to the TFO, in violation of 21 CFR 1306.04(a).
As found above, at TFO 2's first visit, she represented that she had pain in her left arm, that the pain was related to her former work as a cocktail waitress, and that she had had the pain for over six months. However, Respondent made no further inquiry into whether the TFO had suffered an injury, the nature and intensity of her pain, its effect on her physical and psychological function, and whether she had previously been treated for it. Moreover, while the TFO stated that she had used Lortab and Soma for her pain, Respondent made no inquiry as to the TFO's source for these drugs. Furthermore, the TFO then asked Respondent if he would mind if she "ask[ed] for something for stress?" While Respondent stated that he thought the TFO would "sleep better" if she was relaxed, he conducted no inquiry into what symptoms the TFO had that would warrant prescribing Xanax. Respondent then prescribed 90 Percocet 10/325, 30 Xanax 2mg, as well as Soma. Based on Respondent's clear lack of compliance with the Nevada Board's
Moreover, at her second visit, Respondent was not present and the TFO was seen by his assistant, who either called or faxed in prescriptions for 90 Percocet and 30 Xanax. While the TFO had stated that she was "feeling better and everything," Respondent's assistant conducted no inquiry into the nature and intensity of her pain and its effect on her physical and psychological functioning. Nor did Respondent's assistant discuss with the TFO her use of Xanax and whether she even needed a refill. As noted above, while Respondent was not present at his clinic, the TFO's chart noted that he authorized the prescriptions. Accordingly, I conclude that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice in authorizing the prescriptions for Percocet and Xanax and therefore violated 21 CFR 1306.04(a).
Based on the numerous controlled substance prescriptions which Respondent issued in violation of 21 CFR 1306.04(a), I conclude that the evidence relevant to factors two and four supports a finding that he has "committed such acts as would render his registration . . . inconsistent with the public interest." 21 U.S.C. 824(a)(4). I further conclude that Respondent's conduct is sufficiently egregious as to warrant the revocation of his registration and the denial of his application to renew his registration. Accordingly, I will order that Respondent's registration be revoked and that his pending application be denied.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration BW5180372, issued to Henri Wetselaar, M.D., be, and it hereby is, revoked. I further order that any pending application of Henri Wetselaar, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.