Posted: 11 Apr 2017 08:41 PM PDT
By Andrew J. Hull –
Over the years, there have been a number of DEA administrative actions against physicians based on a recurrent theme of trading sex for drugs. Also, every prosecutor knows that these themes of sex, drugs, and rock and roll make for a lively case before a judge or jury. The DEA Acting Administrator (Administrator) issued a final order recently, denying the DEA registration application of Wesley Pope, M.D., that contained the first two ingredients. However, it is the Administrator’s discussion of current legal issues and agency precedent, and disagreement with the DEA Chief Administrative Law Judge, that provides the greatest interest in the 42-page decision in the Federal Register (an extraordinarily long decision for a practitioner case).
First: the obligatory sex and drugs allegations. The doctor in this case prescribed a number of prescriptions for controlled substances to a patient who complained of lower back pain. In May 2012, when police found the patient in a semiconscious and intoxicated state in a parked car in the center median of Interstate-35, they also discovered bottles of controlled substances prescribed by the doctor and evidence that the patient was illegally buying and selling drugs. Police also found text messages between the doctor and the patient regarding medical care and prescriptions, as well as sexually explicit messages between the two (the doctor was, at that time, also on probation for sexual misconduct with another patient). On May 14, 2012, the Oklahoma Medical Board suspended the doctor’s license, and he voluntarily surrendered his DEA registration on that same day.
The doctor served a four-month suspension until the medical board lifted the suspension in September 2012. He then applied for a new DEA registration in October 2012. It took DEA two years to review the application before issuing an order to show cause proposing the denial of the application. The doctor requested a hearing before the DEA Administrative Law Judges. The DEA Chief Administrative Law Judge (CALJ) issued a recommended ruling finding that, while the doctor had issued prescriptions outside of the “usual course of professional practice” in violation of 21 C.F.R. § 1306.04(a), his misconduct was a byproduct of “inattention to detail [and] not intentional diversion.” Final Order at 14,944. The CALJ found that the doctor was “irresponsible in continuing to prescribe to this patient in the face of red flags of diversion, and in failing to document or even possess the ability to persuasively convey a medically-based justification for prescribing new controlled medication.” Id. The CALJ concluded that while the government had met its prima facie burden, the doctor’s conduct was not egregious enough to warrant denial of the application despite the fact that he had not accepted responsibility or put forward evidence of remedial measures. However, it appears there were no allegations or findings that the physician was prescribing the drugs in exchange for sex, which would likely have resulted in a clear violation of prescribing for a non-legitimate medical purpose.
The Administrator rejected the CALJ’s recommended decision (over a year and seven months after issuance of the recommended decision) and denied the doctor’s application. In the lengthy final order, the Administrator took issue with several of the legal issues addressed by the CALJ, including the following.
Interpretation of Oklahoma Medical Board Standards: “Should” = “Must”
At the hearing, a government expert witness opined that the doctor’s recordkeeping deficiencies were violative of the Oklahoma Medical Board’s rules. The CALJ noted that the medical board’s use of the word “should” for certain requirements meant that those requirements were permissive and not mandatory. In support of this position, the CALJ referenced a prior version of the rule that used words such as “requires” and “must” to show that the medical board had made a thoughtful change in language.
The Administrator disagreed. In his view, the word “should” implies “obligation or duty,” not “permission.” Id. at 14,945. Thus, in interpreting state board rules, the Administrator’s position is that “‘must’ and ‘should’ have the same meaning: they impose mandatory obligations.” Id. at 14,946.
DEA has long maintained that it does not establish medical standards—that is the purview of the states. In this case, however, the Administrator imposed his own view of what is the applicable standard.
The Elements of 21 C.F.R. § 1306.04(a)
DEA’s rule for what constitutes a valid prescription for controlled substances is found in 21 C.F.R. § 1306.04(a):
The Combining of 21 U.S.C. § 823(f)’s Factor 2 and Factor 4
Of the five public interest factors that the Administrator must consider when determining whether to grant an application for DEA registration, Factor 2 looks to the “applicant’s experience in dispensing, or conducting research with respect to controlled substances,” and Factor 4 looks to the applicant’s “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. § 823(f)(2), (4). In the Administrator’s view, “experience” under Factor 2 is not meant to include a consideration of the quantitative volume of dispensing, and he disagreed with the CALJ’s assertion that DEA “has been engaged in a deliberate winnowing of the scope of Factor 2, to the extent that . . . it now largely mirrors the considerations found in Factor 4.” Final Order at 14,981.
According to the Administrator, the word “experience” has multiple meanings in the context of Factor 2, including:
The CALJ noted that, under existing agency precedent, “positive experience” analysis is banned in Factor 2 analysis, and he stated that DEA’s “ability to introduce alleged acts of malfeasance will warrant double consideration under Factor 2 and again under Factor 4, but respondents will remain unable to demonstrate that a transgression constituted an isolated occurrence when compared with even many years of compliant practice as a registrant.” Id. at 14,984. The Administrator dismissed these concerns, stating that parties may introduce evidence of lawful dispensing activities. Yet the Administrator has made clear that such evidence will not be considered under Factor 2 (or any of the other public interest factors). Simply allowing such evidence into the record is of no use to a respondent and fails to protect a respondent with years of positive experiencing who is now the recipient of an order to show cause for recordkeeping or other mistakes.
Acceptance of Responsibility
The Administrator explained that when DEA has met its burden of proving that “a practitioner . . . engaged in knowing or intentional diversion, [that practitioner] is not entitled to be registered (or maintain an existing registration) absent a credible acceptance of responsibility.” Id. Thus, because the Administrator agreed with the CALJ that the doctor had refused to accept responsibility for his conduct, the Administrator held as a matter of law that the doctor could not be granted a new registration.
In our opinion, the reasoning by the Administrator—that a respondent essentially has to apologize and admit bad behavior before the respondent can put on a remedial case—raises troubling due process concerns. At the administrative hearing, after DEA has presented its evidence before the ALJ, the respondent must make a choice: either attempt to refute the government’s theory or accept responsibility (whether rightly or wrongly). Historically, the ALJs in these cases have been reluctant to rule on motions by a respondent at the hearing before the respondent puts on its case on whether the DEA has met its prima facie burden. Thus, a respondent is left with a choice of having to admit to certain allegations or not being able to demonstrate remedial action. Thus, agency precedent on acceptance of responsibility puts respondents in an inappropriate position that hampers their ability to defend themselves.
We note that the recent amendment to the Controlled Substances Act that allows respondents to submit corrective action plans (and potentially show evidence of remedial action) was not in place at the time the physician in this case received the order to show cause.
Over the years, there have been a number of DEA administrative actions against physicians based on a recurrent theme of trading sex for drugs. Also, every prosecutor knows that these themes of sex, drugs, and rock and roll make for a lively case before a judge or jury. The DEA Acting Administrator (Administrator) issued a final order recently, denying the DEA registration application of Wesley Pope, M.D., that contained the first two ingredients. However, it is the Administrator’s discussion of current legal issues and agency precedent, and disagreement with the DEA Chief Administrative Law Judge, that provides the greatest interest in the 42-page decision in the Federal Register (an extraordinarily long decision for a practitioner case).
First: the obligatory sex and drugs allegations. The doctor in this case prescribed a number of prescriptions for controlled substances to a patient who complained of lower back pain. In May 2012, when police found the patient in a semiconscious and intoxicated state in a parked car in the center median of Interstate-35, they also discovered bottles of controlled substances prescribed by the doctor and evidence that the patient was illegally buying and selling drugs. Police also found text messages between the doctor and the patient regarding medical care and prescriptions, as well as sexually explicit messages between the two (the doctor was, at that time, also on probation for sexual misconduct with another patient). On May 14, 2012, the Oklahoma Medical Board suspended the doctor’s license, and he voluntarily surrendered his DEA registration on that same day.
The doctor served a four-month suspension until the medical board lifted the suspension in September 2012. He then applied for a new DEA registration in October 2012. It took DEA two years to review the application before issuing an order to show cause proposing the denial of the application. The doctor requested a hearing before the DEA Administrative Law Judges. The DEA Chief Administrative Law Judge (CALJ) issued a recommended ruling finding that, while the doctor had issued prescriptions outside of the “usual course of professional practice” in violation of 21 C.F.R. § 1306.04(a), his misconduct was a byproduct of “inattention to detail [and] not intentional diversion.” Final Order at 14,944. The CALJ found that the doctor was “irresponsible in continuing to prescribe to this patient in the face of red flags of diversion, and in failing to document or even possess the ability to persuasively convey a medically-based justification for prescribing new controlled medication.” Id. The CALJ concluded that while the government had met its prima facie burden, the doctor’s conduct was not egregious enough to warrant denial of the application despite the fact that he had not accepted responsibility or put forward evidence of remedial measures. However, it appears there were no allegations or findings that the physician was prescribing the drugs in exchange for sex, which would likely have resulted in a clear violation of prescribing for a non-legitimate medical purpose.
The Administrator rejected the CALJ’s recommended decision (over a year and seven months after issuance of the recommended decision) and denied the doctor’s application. In the lengthy final order, the Administrator took issue with several of the legal issues addressed by the CALJ, including the following.
Interpretation of Oklahoma Medical Board Standards: “Should” = “Must”
At the hearing, a government expert witness opined that the doctor’s recordkeeping deficiencies were violative of the Oklahoma Medical Board’s rules. The CALJ noted that the medical board’s use of the word “should” for certain requirements meant that those requirements were permissive and not mandatory. In support of this position, the CALJ referenced a prior version of the rule that used words such as “requires” and “must” to show that the medical board had made a thoughtful change in language.
The Administrator disagreed. In his view, the word “should” implies “obligation or duty,” not “permission.” Id. at 14,945. Thus, in interpreting state board rules, the Administrator’s position is that “‘must’ and ‘should’ have the same meaning: they impose mandatory obligations.” Id. at 14,946.
DEA has long maintained that it does not establish medical standards—that is the purview of the states. In this case, however, the Administrator imposed his own view of what is the applicable standard.
The Elements of 21 C.F.R. § 1306.04(a)
DEA’s rule for what constitutes a valid prescription for controlled substances is found in 21 C.F.R. § 1306.04(a):
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.While the CALJ looked at the “legitimate medical purpose” and “usual course of professional practice” phrases as separate elements (e.g., a physician could prescribe a controlled substance for a patient experiencing legitimate pain, but do so without performing a physical exam or noting the diagnosis in the patient chart), the Administrator held that “there is no material difference between the phrases.” Final Order at 14,967 n.38 (citing cases).
The Combining of 21 U.S.C. § 823(f)’s Factor 2 and Factor 4
Of the five public interest factors that the Administrator must consider when determining whether to grant an application for DEA registration, Factor 2 looks to the “applicant’s experience in dispensing, or conducting research with respect to controlled substances,” and Factor 4 looks to the applicant’s “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. § 823(f)(2), (4). In the Administrator’s view, “experience” under Factor 2 is not meant to include a consideration of the quantitative volume of dispensing, and he disagreed with the CALJ’s assertion that DEA “has been engaged in a deliberate winnowing of the scope of Factor 2, to the extent that . . . it now largely mirrors the considerations found in Factor 4.” Final Order at 14,981.
According to the Administrator, the word “experience” has multiple meanings in the context of Factor 2, including:
1) the “direct observation of or participation in events as a basis for knowledge,” 2) “the fact or state of having been affected by or gained knowledge through direct observation or participation,” 3) “practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity,” and 4) “the length of such participation.”Id. at 14,982 n.54.
The CALJ noted that, under existing agency precedent, “positive experience” analysis is banned in Factor 2 analysis, and he stated that DEA’s “ability to introduce alleged acts of malfeasance will warrant double consideration under Factor 2 and again under Factor 4, but respondents will remain unable to demonstrate that a transgression constituted an isolated occurrence when compared with even many years of compliant practice as a registrant.” Id. at 14,984. The Administrator dismissed these concerns, stating that parties may introduce evidence of lawful dispensing activities. Yet the Administrator has made clear that such evidence will not be considered under Factor 2 (or any of the other public interest factors). Simply allowing such evidence into the record is of no use to a respondent and fails to protect a respondent with years of positive experiencing who is now the recipient of an order to show cause for recordkeeping or other mistakes.
Acceptance of Responsibility
The Administrator explained that when DEA has met its burden of proving that “a practitioner . . . engaged in knowing or intentional diversion, [that practitioner] is not entitled to be registered (or maintain an existing registration) absent a credible acceptance of responsibility.” Id. Thus, because the Administrator agreed with the CALJ that the doctor had refused to accept responsibility for his conduct, the Administrator held as a matter of law that the doctor could not be granted a new registration.
In our opinion, the reasoning by the Administrator—that a respondent essentially has to apologize and admit bad behavior before the respondent can put on a remedial case—raises troubling due process concerns. At the administrative hearing, after DEA has presented its evidence before the ALJ, the respondent must make a choice: either attempt to refute the government’s theory or accept responsibility (whether rightly or wrongly). Historically, the ALJs in these cases have been reluctant to rule on motions by a respondent at the hearing before the respondent puts on its case on whether the DEA has met its prima facie burden. Thus, a respondent is left with a choice of having to admit to certain allegations or not being able to demonstrate remedial action. Thus, agency precedent on acceptance of responsibility puts respondents in an inappropriate position that hampers their ability to defend themselves.
We note that the recent amendment to the Controlled Substances Act that allows respondents to submit corrective action plans (and potentially show evidence of remedial action) was not in place at the time the physician in this case received the order to show cause.
* * *
The Pope decision is good reading for anyone wanting to understand the Agency’s current approach to the various legal issues surrounding practitioner application and revocation cases. Particularly, the discussion on Factor 2 experience and the acceptance of responsibility (whether correct or wrong) is a must-read for counsel to practitioners in receipt of DEA orders to show cause.
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