80 FR 41079 - Trenton F. Horst, D.O.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 134 (July 14, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 134 (July 14, 2015)
| Page Range | 41079-41092 | |
| FR Document | 2015-17309 |
[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)] [Notices] [Pages 41079-41092] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17309] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 13-24] Trenton F. Horst, D.O.; Decision and Order On March 25, 2014, Administrative Law Judge Gail A. Randall (ALJ) issued the attached Recommended Decision.\1\ The Government filed Exceptions to the Recommended Decision. --------------------------------------------------------------------------- \1\ All citations to the Recommended Decision (R.D.) are to the ALJ's slip opinion as originally issued. --------------------------------------------------------------------------- Having reviewed the record in its entirety, I have decided to adopt the ALJ's findings of fact and conclusions of law.\2\ However, for reasons explained below, I respectfully amend the ALJ's recommended sanction because it is contrary to precedent and, in my opinion, gives insufficient weight to the Agency's interest in deterring intentional diversion, both on the part of Respondent and the community of registrants. See David A. Ruben, 78 FR 38363, 38386 (2013). A discussion of the Government's Exceptions follows. --------------------------------------------------------------------------- \2\ As ultimate factfinder, I am familiar with my obligations under the Administrative Procedure Act and the role of the ALJ's recommended decision. See Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951) (``The `substantial evidence' standard is not modified in any way when the Board and its examiner disagree . . . . The findings of the examiner are to be considered along with the consistency and inherent probability of testimony. The significance of his report, of course, depends largely on the importance of credibility in the particular case.'') (emphasis added). So too, the courts are quite familiar with the standard of review of an Agency decision. Accordingly, I decline to publish the ALJ's discussion of the substantial evidence test and the standard of review. --------------------------------------------------------------------------- The Government's Exceptions The Government raises two exceptions to the ALJ's recommended decision: First, it takes exception to the ALJ's finding that Respondent `` `has sufficiently accepted responsibility for his actions and instituted remedial measures to ensure that the misconduct will not reoccur.' '' Exceptions, at 2 (quoting R.D. 36). Second, it argues that the ALJ's recommended sanction is inconsistent with agency precedent. Exceptions, at 5-6. As for the first exception, the Government urges that I reject this finding, contending that Respondent ``continues to[] minimize the nature of his misconduct.'' Id. at 4-5. As support for its contention, the Government cites Respondent's testimony regarding his treatment at a rehabilitation center which it maintains was inconsistent with his conduct during his stay. More specifically, the Government notes Respondent's testimony that: it was a little bit difficult to acclimate myself for the first few weeks, probably six weeks. It took me a while to kind of get into the flow of things. Thereafter, I'd like to think I became a model participant. I spent seven months there. Tr. 210. The Government then notes that Respondent was subject to a ``no female contract'' during the initial four months of his treatment, and that he breached the contract when he had contact with another patient and engaged in sexual relations with her [[Page 41080]] approximately two months into his stay. Exceptions, at 2. The Government implies that his testimony was disingenuous because the incident occurred two weeks later than Respondent claimed it did. Id. The Government does not, however, explain why it matters whether the incident occurred six weeks or two months into his stay. The Government also maintains that Respondent engaged in a pattern of minimizing his misconduct, both during his time in treatment and in his testimony at the hearing. In support of this contention, it cites evidence showing that Respondent admitted his breach of the no-female contract to the treatment center staff only upon learning that he was going to be subject to a polygraph. As for his testimony, the Government argues that ``Respondent did not divulge that he broke [the] contract . . . on direct examination.'' Id. at 3. It then argues that even on cross-examination, Respondent failed to truthfully answer its questions because he did not admit to having sexual relations with the female patient until he was specifically asked if he had sex with female patients.\3\ However, when the Government specifically asked the question, he did answer it truthfully. --------------------------------------------------------------------------- \3\ The Government initially asked Respondent: ``How did you break that contract?'' Tr. 263. Respondent answered that he was ``a friendly person, and they would approach me, and it's kind of hard when people talk to you, to not talk to them, to completely ignore them.'' Id. While this may not have been the answer the Government was seeking, there is no evidence that Respondent's answer was untruthful. Following this, the Government asked Respondent: ``Did you do more than speaking with females?'' Id. Respondent answered: I had basically what could be called a girlfriend. She was very attentive to me, which I was appreciative of. My marriage was likely in ruins, and it was something that was--it was nice to have someone to talk to. And once that was--basically once that was discovered, I was placed on my no-female contract, and--well, actually I was on my no-female contract when that was discovered, and basically I got reprimanded and eventually I got my act together. Id. at 264. Here again, this may not have been the answer the Government was seeking, but there is no evidence that it was untruthful. --------------------------------------------------------------------------- Most significantly, to the extent the Government relies on this incident and Respondent's testimony regarding it to contend that he ``has consistently minimized his misconduct,'' Exceptions, at 5; its argument is misplaced. As the Government acknowledges, the incident and his testimony ``ha[ve] little or nothing to do with controlled substances.'' Id. at 2 (emphasis added). Nor does the Government cite to any case holding that an applicant's breach of the terms of a treatment contract, which does not involve a violation of the Controlled Substances Act or applicable state law (as would failing a drug test), constitutes conduct which may threaten public health or safety. Cf. Mark G. Medinnus, 78 FR 62683, 62684 (2013) (rejecting contention that violation of internal clinic operating policy, which did not otherwise violate CSA or state law, constituted conduct inconsistent with the public interest.). Because Respondent's breach of his no-female contract does not constitute actionable misconduct under the public interest standard, his testimony regarding the incident is not relevant in assessing whether he has accepted responsibility for his misconduct. While this evidence is arguably relevant in assessing Respondent's claim that he has been rehabilitated, it is undisputed that he successfully completed inpatient treatment, that he has been in compliance with his Oklahoma Health Professionals Program contract, and that he passed all of his random drug tests. RX 2. There is, however, evidence that supports the Government's contention that Respondent does not fully acknowledge his misconduct. As ultimate fact-finder, I am not bound by the Government's failure to cite this evidence which I conclude is properly considered in reviewing the Government's contention that the ALJ's recommended sanction is inconsistent with agency precedent. The ALJ found that Respondent not only abused methamphetamine, but that he also wrote prescriptions for controlled substances for A.B., his then-girlfriend (and fellow methamphetamine abuser), as well as for S.M. and Z.M., who were two of her friends. With respect to A.B., the evidence showed that between July 29, 2010 and September 12, 2011, Respondent issued her 15 prescriptions for Lortab 7.5mg and 10mg (then a schedule III controlled substance \4\ which combines hydrocodone and acetaminophen), as well as one prescription for both Xanax (alprazolam, a schedule IV drug) and promethazine with codeine cough syrup (schedule V). Moreover, the Lortab prescriptions, which ranged from 40 to 80 tablets, authorized 28 refills. In total, the prescriptions, with refills, provided A.B. with approximately 2,540 tablets of hydrocodone. --------------------------------------------------------------------------- \4\ Combination hydrocodone products have since been placed in schedule II of the Controlled Substances Act. See Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II, 79 FR 49661 (2014). --------------------------------------------------------------------------- With respect to S.M., at a minimum, the evidence showed that Respondent issued him a prescription for 60 tablets of hydrocodone/apap with three refills.\5\ See GX 13. As for Z.M., the evidence shows that Respondent issued him a prescription for 40 tablets of Lortab 7.5 with two refills. GX 14. --------------------------------------------------------------------------- \5\ The record includes three documents from Walgreens which have the caption: ``Audit/Board of Pharmacy Inspection Report.'' While each of the documents contains a copy of a prescription issued by Respondent on January 27, 2011, each document lists a different prescription number, a different store number, and a different sold date. GX 13. Thus, it is unclear whether two of the documents were simply refills of the original prescription or whether Respondent issued S.M. multiple prescriptions on the same date. --------------------------------------------------------------------------- Respondent did not dispute that he failed to perform a physical exam on A.B., S. M., and Z.M., or that the prescriptions were improper. Indeed, he testified that: ``[i]mproper, I think, is a weak word. I think it was stupid. I think you used the word `idiotic' earlier.'' Tr. 201 (testimony regarding prescriptions to A.B.); see also id. at 203 (admitting that the prescriptions to S.M. and Z.M. were ``very improper''). While Respondent also asserts that he received no monetary gain from writing these prescriptions, see Tr. 204, this is irrelevant. What is relevant is that Respondent knowingly and improperly diverted controlled substances to three individuals, including his girlfriend A.B., whom he knew was a drug abuser. Further, while Respondent acknowledged that the prescriptions were improper, he then maintained that he prescribed to A.B. ``out of compassion'' because ``[s]he was in pain.'' Id. at 252. And he further asserted that she did not ``use hydrocodone as a drug of choice, as far as recreational drugs'' because ``[s]he was a methamphetamine addict.'' Id. at 253. The ALJ rejected the Government's contention that Respondent's testimony was an attempt to minimize his misconduct. According to the ALJ, ``[w]hile the reasons Respondent gave for prescribing hydrocodone to A.B. certainly do not justify his improper methods of prescribing, they also do not represent an attempt to minimize or rationalize his behavior.'' R.D. at 35. In the ALJ's view, this was so because Respondent prefaced this testimony with ``his statement that `it was improper and I admit that.''' Id. (quoting Tr. 252). Read more broadly, however, his testimony most certainly was an attempt to minimize his misconduct. Indeed, on further questioning, Respondent testified that: [[Page 41081]] . . . . I'm exquisitely sorry that I ever prescribed these things, these medicines for these people. You know, I know that I did it improperly. I know I didn't have proper documentation. Deep down, when I was writing them, I knew better. Id. at 258 (emphasis added). Continuing, Respondent testified that: Deep down, whenever I was writing them, I knew better. I let my heart and my empathy get the best of me, more than my brain. I know better now. I've gone through extensive counseling, extensive instruction, boundaries course times two, to understand what my infractions were. Id. (emphasis added). Contrary to Respondent's assertion, this was not simply a matter of not having proper documentation to support the prescriptions. Notably, while the ALJ apparently credited his testimony that A.B. was in pain, noting that this testimony ``went unrebutted,'' see R.D. at 35, the evidence shows that while Respondent prescribed to A.B for more than one year, he made no claim that he ever conducted a physical exam on her or performed any diagnostic tests to determine whether she legitimately had pain or whether her pain warranted the prescribing of controlled substances. See Tr. 172-74 (testimony of Government's expert that the hydrocodone prescriptions lacked a legitimate medical purpose and were issued outside of the usual course of professional practice). As for his assertion that he prescribed ``out of compassion'' and ``empathy,'' this too is amply refuted by his failure--over the course of more than one year--to take appropriate steps to determine the source of her purported pain. And given his acknowledgement that he knew early in his relationship with A.B. that she was a meth addict, his claim that he prescribed to her ``out of compassion'' begs the question of why he did not usher her into treatment.\6\ --------------------------------------------------------------------------- \6\ Even assuming that the ALJ credited Respondent's testimony that A.B. was in pain, see R.D. at 33, because it was undisputed that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing the prescriptions to her, I decline to give this testimony any weight. Indeed, the ALJ later found that the prescriptions ``clearly constitute intentional diversion.'' Id. at 35. --------------------------------------------------------------------------- Respondent also justified A.B.'s hydrocodone prescriptions on the ground that she did not ``use hydrocodone as a drug of choice, as far as recreational drugs'' because ``[s]he was a methamphetamine addict.'' Id. at 253. Apparently the possibility that A.B. could also have been abusing hydrocodone to bring her down from the meth she abused or was selling the drug to support her meth addiction never dawned on him. Finally, Respondent attempted to rationalize his prescribing to A.B. on the ground that he did not understand the boundaries applicable to the practice of medicine. Id. However, this excuse does not explain his decision to prescribe controlled substances to both S.M. and Z.M. Indeed, it is unclear what his excuse is for prescribing to S.M. and Z.M. Thus, this does not strike me as an ``unequivocal acceptance of responsibility for his misconduct.'' R.D. at 36. I need not, however, reject the ALJ's finding that ``Respondent has sufficiently accepted responsibility for his actions'' because as the ALJ properly noted, ``[e]ven when a respondent is genuinely remorseful and has instituted sufficient remedial measures,'' DEA has ``impose[d] sanctions to deter egregious violations of the CSA'' and ``has placed special emphasis on the need to deter intentional diversion of controlled substances.'' Id. at 36 (citing David A. Ruben, 78 FR 38363, 38386-87 (2013); Joseph Gaudio, 74 FR 10083, 10094-95 (2009)). The ALJ noted that ``Respondent's improper prescriptions to A.B., S.M., and Z.M. clearly constitute intentional diversion.'' R.D. at 37. I agree. So too, she noted that while his ``improper prescribing practices were limited to A.B. and a few of her friends, under DEA precedent they clearly warrant sanctions to deter Respondent and others from repeating the practice.'' Id. Again, I agree. The ALJ also noted ``[w]here the respondent intentionally diverted controlled substances, the Agency required the respondents to periodically submit logs of all controlled substances they prescribe and suspended [their] registrations for a period of time commensurate with the severity of the misconduct.'' Id. at 38 (citing Ruben, also citing Michael S. Moore, 76 FR 45867, 45868 (2011), and Gregory D. Owens, 74 FR 36751, 36757-58 (2009)) (emphasis added). Yet notwithstanding that she found Respondent's prescriptions ``troubling to say the least,'' id. at 37, the ALJ recommended no period of suspension. The ALJ offered no explanation as for why she believed a period of outright suspension is unwarranted. To be sure, earlier in her decision, the ALJ opined that the Agency ``has granted registrations with restrictions to respondents whose misconduct was more egregious and/or lasted longer than the misconduct of Respondent here.'' Id. (citing Ruben, Owens, Moore, and Roger D. McAlpin, 62 FR 8038, 8040 (1997)). Yet in both Ruben and Moore, the Agency suspended each respondent's registration for a period of one year. As for the ALJ's assertion that the respective registrant's misconduct in each of these cases was more egregious than Respondent's, that is certainly true with respect to Ruben. But Respondent's misconduct in knowingly diverting controlled substances to three persons, including his girlfriend to whom he provided some 2,540 dosage units of hydrocodone and did so knowing that she was meth addict, is itself, sufficiently egregious to warrant a suspension for a period of one year. As for Moore, while the physician's misconduct in growing marijuana for his own and his wife's use was certainly egregious, there was inconclusive evidence as to whether he knowingly distributed it to others; thus, it is debatable whether his misconduct was more egregious than Respondent's. As for Owens, the ALJ asserted that the Agency ``grant[ed] a registration to a respondent who prescribed controlled substances for seven years based on an expired registration.'' R.D. at 37. However, the actual decision to grant a registration to Dr. Owens notwithstanding the above-described misconduct had been made in a proceeding which was resolved seven years earlier and there was no evidence that he was diverting controlled substances. See Gregory D. Owens, 67 FR 50461 (2002). So too, the misconduct which gave rise to the second Owens decision did not involve the diversion of controlled substances and was comparatively minor.\7\ --------------------------------------------------------------------------- \7\ As for the conduct which gave rise to the second Owens proceeding, Dr. Owens was found to have not complied with the 2002 order because he failed to file a quarterly drug activity log during a four-month period between September 3 and December 31, 2002, and failed to report a 2005 state board action. 74 FR at 36756-58. While Dr. Owens' misconduct was considerably less egregious than that involving the intentional diversion of controlled substances, the Agency nonetheless suspended his registration outright for a period of three months. Id. at 36758. --------------------------------------------------------------------------- Moreover, the 2002 Owens order predates the Agency's decision in Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007), which held for the first time that notwithstanding the remedial nature of proceedings under 21 U.S.C. 823 and 824, the Agency can consider the need to deter similar acts on the part of both the individual registrant/applicant and the community of registrants. Indeed, this Agency recently denied a physician's application for a new registration based, in substantial part, on his issuance of prescriptions after his registration had expired. See Anthony E. Wicks, 78 FR [[Page 41082]] 62676, 62678 (2013); see also Linda Sue Cheek, 76 FR 66972 (2011) (denying application based, in part, on physician's issuance of prescriptions without being registered). For the same reason, I respectfully disagree with the ALJ's reliance on McAlpin. Accordingly, notwithstanding that I do not reject the ALJ's finding that Respondent has ``sufficiently accepted responsibility for his actions'' and has produced evidence of his remedial efforts, R.D. at 36, I conclude that the ALJ's recommended order fails to give appropriate weight to the Agency's substantial interest in deterring the intentional diversion of controlled substances. While I will grant Respondent's application, consistent with similar cases, I will order that his registration be suspended outright for a period of one year. See Ruben, 78 FR at 38386 (imposing one-year suspension based on acts of intentional diversion notwithstanding ALJ's finding that registrant accepted responsibility for his misconduct and undertook remedial training); Gaudio, 74 FR at 10095 (imposing one-year suspension based on acts of intentional diversion and holding renewal application in abeyance pending registrant's acknowledgement of his misconduct); Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (imposing one-year suspension based on acts of intentional diversion where registrant acknowledged her misconduct).\8\ --------------------------------------------------------------------------- \8\ The scope of Respondent's unlawful prescribings far exceeds those of Dr. Krishna-Iyer, who wrote unlawful prescriptions during three undercover visits. See Jayam Krishna-Iyer, 71 FR 52148, 52158 (2006). Moreover, this Agency has held that proof of a single act of intentional diversion can support the denial of an application or the revocation of an existing registration. See Dewey C. MacKay, 75 FR 49956, 49977 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). --------------------------------------------------------------------------- Moreover, upon the completion of the suspension, Respondent's registration shall be subject to the following conditions for a period of two years: Respondent shall keep a log of all controlled substances he prescribes on a monthly basis for each calendar month. The log shall list each prescription in chronological order; the patient's name and address; the name, quantity, strength and dosing instructions for each drug prescribed; and the number of refills authorized. Respondent shall submit a copy of the log to the local DEA Field Office no later than five business days following the last day of each month. In the event Respondent opens his own practice, he shall consent to unannounced inspections of his registered location and waive his right to require DEA personnel to obtain an administrative inspection warrant prior to conducting an inspection. Respondent shall not prescribe any controlled substances to himself, a family member, or any person with whom he has or had a personal or romantic relationship. Respondent shall have no intentional contact with A.B., S.M., or Z.M. Respondent shall notify the local DEA Field Office of the results of any drug test he fails, no later than three business days after receiving notification of having failed any such test. This condition shall apply whether the test in conducted by the Oklahoma Board of Osteopathic Examiners, the Oklahoma Health Professions Program, any other licensing authority, any hospital at which he seeks or obtains privileges, or any other employer. Respondent shall further notify the local DEA Field Office in the event that the Oklahoma Board of Osteopathic Examiners or the Oklahoma Bureau of Narcotics and Dangerous Drug Control (or any other licensing authority) initiates any proceeding, or imposes sanctions against his medical license or state controlled substance registration respectively. Respondent shall make such notification no later than three business days upon being notified of any such action, regardless of whether he has been formally served with either a complaint or order issued by any such agency. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b), I order that the application of Trenton F. Horst, D.O., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, granted subject to the conditions set forth above. I further order that Respondent's Certificate of Registration be, and it hereby is, suspended for a period of one year. This Order is effective immediately. Dated: July 6, 2015. Chuck Rosenberg, Acting Administrator. Dedra S. Curteman, Esq., for the Government. Spencer B. Housley, Esq., for the Respondent. RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE I. INTRODUCTION Gail A. Randall, Administrative Law Judge. This proceeding is an adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 551 et seq., to determine whether the Drug Enforcement Administration (``DEA'' or ``Government'') should deny \1\ a physician's application for a DEA Certificate of Registration pursuant to 21 U.S.C. 823(f) (2006). Without his registration, the physician, Trenton F. Horst, D.O. (``Respondent'' or ``Dr. Horst''), would be unable to lawfully prescribe, dispense or otherwise handle controlled substances in the course of his medical practice. --------------------------------------------------------------------------- \1\ DEA regulations and precedent clearly establish that ``a registrant, who has been served with an Order to Show Cause, [must] file his renewal application at least 45 days before the expiration of his registration, in order for it to continue in effect past its expiration date and pending the issuance of a final order by the Agency.'' Paul Weir Battershell, N.P., 76 FR 44359, 44361 (DEA 2011) (citing Paul Volkman, 73 FR 30,630, 30,641 (DEA 2008)); 21 CFR 1301.36(i). Respondent's Certificate of Registration, Number BH9311604, expired by its own terms on October 31, 2013, about eight months after the Order to Show Cause was served, and Respondent did not apply for renewal until October 31, 2013. [ALJ Exh. 14]. Thus, Respondent's application for renewal will be considered an application for registration. See Battershell, 76 FR at 44,361 (holding that although the registration had expired, the renewal application may be considered). Accordingly, the issue in this case is whether DEA should grant Respondent's application, not whether DEA should revoke his registration. --------------------------------------------------------------------------- II. PROCEDURAL HISTORY The Deputy Assistant Administrator, Drug Enforcement Administration (``DEA'' or ``Government''), issued an Order to Show Cause (``Order'') dated February 27, 2013, proposing to revoke \2\ the DEA Certificate of Registration, No. BH9311604, of Respondent, as a practitioner, pursuant to 21 U.S.C. 824(a)(3)-(4), and deny any pending applications for renewal or modification of such registration because Respondent does not ``have authority to handle controlled substances in the State of Oklahoma'' and because the Respondent's continued registration would be inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). [Administrative Law Judge Exhibit (``ALJ Exh.'') 1 at 1]. --------------------------------------------------------------------------- \2\ As explained supra note 1, the issue is whether the DEA should grant Respondent's application, not whether his registration should be revoked, as the Order to Show Cause suggests. --------------------------------------------------------------------------- Specifically, the Order alleged that Respondent was ``registered with the DEA as a practitioner in Schedules II-V under DEA registration BH9311604 at St. Mary's Physician Associates, LLC, 330 South Fifth Street, Suite 103, Enid, Oklahoma 73701.'' [Id.]. The Order further alleged that Respondent was without authority to handle controlled substances in the state of Oklahoma, which is the state that listed on his DEA [[Page 41083]] Certificate Of Registration (``COR''), since his Oklahoma Bureau of Narcotics (``OBN'') registration expired on October 31, 2011. [Id.]. The Order further alleged that Respondent's state osteopathic license was suspended \3\ on June 21, 2012, for a period of five years, by the Oklahoma State Board of Osteopathic Examiners (``Oklahoma State Board''). [Id. at 2]. Thus, the Order stated that the DEA must revoke Respondent's DEA registration because he lacks authority to handle controlled substances in the state of Oklahoma. [Id. at 1]. --------------------------------------------------------------------------- \3\ I note here that the Oklahoma State Board of Osteopathic Examiners did not, in fact, suspend Respondent's license; rather, it placed the license on probation for five years. [Gov't Exh. 6 at 4]. --------------------------------------------------------------------------- On March 27, 2013, the Respondent, through counsel, timely filed a request for a hearing. [ALJ Exh. 2]. On April 3, 2013, the Government filed its Motion for Summary Disposition [ALJ Exh. 3]. On April 18, 2013, the Respondent, through his attorney, filed a timely Response to Motion for Summary Disposition. [ALJ Exh. 4]. On April 29, 2013, the Government filed a reply to the Respondent's Response to Motion for Summary Disposition, [ALJ Exh. 5], and on May 7, 2013, the Government filed a Renewed Motion for Summary Disposition, [ALJ Exh. 6]. On May 10, 2013, I issued my Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (``Summary Disposition''), recommending that the Administrator summarily revoke Respondent's DEA registration because Respondent was without state authority to dispense controlled substances and thus was ineligible for a DEA registration as a practitioner. [ALJ Exh. 7 at 9- 12]. On July 30, 2013, after my Summary Disposition was delivered to the Administrator, but before a final decision was rendered by the Administrator, Respondent filed a Notice to Court and Amended Motion to Reconsider. [See ALJ Exh. 8 at 1]. Therein, Respondent informed DEA that he had obtained an Oklahoma Board of Narcotics license which gave Respondent authority to handle controlled substances, so ``the fundamental facts of the case have now changed.'' [Id.]. Consequently, the Deputy Administrator ruled that ``the finding necessary to support the revocation of Respondent's registration under section 824(a)(3) can no longer be made.'' [Id.]. Noting that the Order to Show Cause also alleged that Respondent's continued DEA registration would be ``inconsistent with the public interest,'' the Deputy Administrator ordered the Government to notify his office as to whether the Government will seek a remand of the case to adjudicate that matter. [ALJ Exh. 10 at 2]. The Government requested a remand on August 6, 2013, [ALJ Exh. 9], which the Deputy Administrator granted on August 23, 2013, [ALJ Exh. 8]. The hearing in this case took place on December 17 through December 18, 2013, at the U.S. Tax Court in Oklahoma City, Oklahoma. [ALJ Exh. 13]. Respondent and the Government were each represented by counsel. At the hearing, the Government introduced documentary evidence and called six witnesses and Respondent introduced documentary evidence and called five witnesses, including himself. After the hearing, the Government and the Respondent submitted proposed findings of fact, conclusions of law and argument. III. ISSUE The issue in this proceeding is whether the record as a whole establishes by a preponderance of the evidence that the Drug Enforcement Administration (``DEA'' or ``Government'') should deny the application \4\ of Trenton F. Horst, D.O. (``Respondent''), as a practitioner, pursuant to 21 U.S.C. 824(a)(4), and deny any pending applications for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f), because his continued registration would be inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f). --------------------------------------------------------------------------- \4\ As explained supra note 1, the issue is whether the DEA should grant Respondent's application, not whether his registration should be revoked, as the Order to Show Cause suggests. --------------------------------------------------------------------------- IV. FINDINGS OF FACT A. Stipulated Facts The parties have stipulated to the following facts: 1. Respondent's DEA registration BH9311604, which authorized Respondent to handle controlled substances in Schedules II-V at St. Mary's Physician Associates, LLC, 330 South Fifth Street, Suite 103, Enid, Oklahoma 73701, expired by its terms on October 31, 2013. 2. Respondent submitted a renewal application for a DEA registration on October 31, 2013. 3. Respondent has an active and valid license to practice medicine in the State of Oklahoma. 4. Respondent has an active and valid license to handle controlled dangerous substances from the Oklahoma Bureau of Narcotics. 5. Respondent has not been charged with or convicted of any federal or state crimes relating to the manufacture, distribution, or dispensing of controlled substances. [ALJ Exh. 14]. B. Respondent's Background, Employment, Registration, and Licensure Respondent testified credibly regarding his medical background, employment, and training, facts which were undisputed at the hearing. [Tr. 182-192]. Respondent graduated from Oklahoma State University College of Osteopathic Medicine with honors in 1999. [Tr. 183]. Shortly thereafter, Respondent completed both an internship and residency at the Tulsa Regional Medical Center. [Tr. 184-85]. Upon completion of his internship and residency, Respondent was awarded a fellowship at the Scott & White Clinic and Memorial Hospital in Temple, Texas, where he learned the specialty of gastroenterology from 2002 to 2005. [Tr. 185- 86]. In 2005, Respondent began working in a private ``single-specialty group'' called Digestive Disease Specialists, Incorporated. [Tr. 187]. By 2007, Respondent was board-certified in both internal medicine and gastroenterology. [Tr. 186-87]. He began working for St. Mary's Hospital in Enid, Oklahoma ``on or about June 1, 2010'' in a hospital- owned clinic named Red Carpet Gastroenterology.\5\ [Gov't Exh. 6 at 2; Tr. 192]. As explained in further detail below, during his employment at St. Mary's, Respondent abused controlled substances, resulting in St. Mary's terminating his employment and the DEA issuing the Order to Show Cause. After completing therapy at an in-patient substance abuse rehabilitation facility, Respondent obtained employment as a delivery driver for Pizza Hut while he searched for employment as a physician. [Tr. 229; see also Tr. 33, 60-61]. Respondent later worked as a ``patient liaison'' at New Beginning Women's Healthcare from the fall of 2012 until April 2013, and then as a ``chart reviewer'' for Prairie View Hospice. [Tr. 230-31]. Since May 2013, Respondent has been employed as a [[Page 41084]] physician at Accident Care and Treatment Center (``ACTC''). [Tr. 231]. --------------------------------------------------------------------------- \5\ While Respondent was technically an employee of St. Mary's, he principally worked at Red Carpet, a clinic across the street from the hospital that at least one witness described as ``a private practice.'' [Tr. 78, 100, 130, 131, 150]. Respondent was the only physician working at Red Carpet, and he designed the clinic's name and logo. [Tr. 78, 130, 135-136, 150]. --------------------------------------------------------------------------- On June 29, 2005, Respondent was issued DEA Certificate of Registration (``COR'') Number BH9311604, which is the COR at issue in this case. [Gov't Exh. 22 at 3]. That COR expired by its terms on October 31, 2013. [Tr. 27, ALJ Exh. 14]. Respondent also holds an active, valid license to practice medicine in the State of Oklahoma and an active, valid license from the Oklahoma Bureau of Narcotics to handle controlled substances. [ALJ Exh. 14]. C. Respondent's Substance Abuse In 2009, while Respondent was employed at Digestive Disease Specialists, Respondent met and began an extra-marital relationship \6\ with A.B.,\7\ a medical assistant employed at the same location. [Tr. 78-79, 194-95, 250]. Respondent first became aware that A.B. was abusing controlled substances in November of 2010, when she called him and asked him to bail her out of jail after she was charged with possession of marijuana, a controlled substance. [Tr. 195-96]. Soon after that, in December 2010, Respondent began using illegal substances with A.B. and eventually moved in with A.B. on July 4th or 5th, 2011. [Tr. 195, 196, 198, 199]. --------------------------------------------------------------------------- \6\ Despite the Government's argument that Respondent speaking with co-workers about his relationship with A.B. is probative of Factor Five, I ruled at the hearing that the details of Respondent's romantic relationship with A.B. are not relevant to these proceedings. [Tr. 81, 86-87]. I now reaffirm that ruling, and only mention Respondent's relationship to give factual context to the events that led to Respondent's drug abuse and improper prescribing, which are, of course, relevant. In making my determinations about whether Respondent's registration is in the public interest, I assign no weight to Respondent's marital indiscretions. \7\ Before the hearing, I issued a Protective Order which protects the identities of third parties in these proceedings. [ALJ Exh. 12]. --------------------------------------------------------------------------- Respondent credibly testified, and the Government did not refute, that before moving in with A.B., Respondent had never taken amphetamines or methamphetamine. [Tr. 194-95]. Also, Respondent credibly testified, and the Government did not refute, that he has never been charged with or convicted of any crimes involving illegal substances. [Tr. 195; ALJ Exh. 14]. Several St. Mary's employees testified that they noticed ``red spots,'' ``boils,'' or ``lesions'' on Respondent's neck and elbow on at least two occasions. [Tr. 86; 119-122]. Although the reason for the Government soliciting testimony about the red spots is unclear, the insinuation seemed to be that the red spots were an indication of drug use. [Tr. 119. 121-22 (Government witness describing marks on the fleshy area of the elbow)]; 199 (Respondent counsel stating that ``[t]here's been insinuations at least by the Government that [Respondent was] IV drug-using'')]. Respondent denied ever using IV drugs, [Tr. 199], and, other than the red spots, the Government offered no evidence to the contrary. Indeed, a drug screen taken by Respondent in July of 2011 did not indicate any such use, and the witnesses who testified about the spots never explicitly linked the spots to drug use. In fact, the witness the Government used as an expert linked the spots to a bacteria, not to drug use. [Tr. 120-21]. While cross examining this expert, Respondent's attorney suggested that the explanation for the red spots was Respondent's cycstic acne. [Tr. 124- 25]. At that time, the Government's witness admitted that it was beyond the scope of her expertise to testify about such conditions. [Tr. 125]. The Government's witness also testified that the red spots ``appeared to be a boil, a bite,'' [Tr. 121], which is consistent with what Respondent told his receptionist when she inquired about the spots, [Tr. 86]. Given the thin evidence offered by the Government regarding the source of the red spots on Respondent's skin and Respondent's several explanations for the spots, I find that the Government failed to meet its burden of proof to show that Respondent used IV drugs or that the red spots on Respondent's elbow and neck were related to illicit drug use. Respondent's receptionist at Red Carpet, Brenda Martin, testified that Respondent told her that he had been present on at least one occasion while A.B. made a ``drug run.'' [Tr. 81-82; see also Gov't Exh. 19]. Ms. Martin noted, however, that Respondent pointed out he did not participate in the drug transactions; he stayed in the back seat of the car while the transaction was completed. [Tr. 81-82]. Ms. Martin also testified that in conversations she had with Respondent, he admitted to being present while A.B. and her associates were ``in the garage making meth,'' although Respondent also told Martin that he ``didn't have anything to do with it.'' [Tr. 85]. Several witnesses testified that at some point during his employment at St. Mary's, Respondent began coming to work tired and tardy on a regular basis.\8\ [Tr. 85, 94 (testimony of Brenda Martin); 104 (testimony of Michelle Lee Bays); 139 (testimony of Krista Ann Roberts); 241-44 (testimony of Respondent)]. Ms. Martin testified that Respondent's fatigue got so bad that he would take ``catnap[s]'' in his office between patient visits and had to reschedule several appointments after being late to work. [Tr. 83-84]. Staff members took special notice of Respondent's fatigue when they saw an incoherent notation written by Respondent on a patient's progress note that referenced the patient ``still having pain from right pink chair.'' [Tr. 85-86, 139; Gov't Exh. 17]. Respondent corrected the error by creating a new note from memory of the patient visit, and he admitted that he had trouble focusing the day he wrote the original note. [Tr. 136-140; Gov't Exh. 17]. --------------------------------------------------------------------------- \8\ The witnesses at the hearing did not all agree on the longevity of Respondent's fatigue and tardiness. Ms. Martin testified that for the first few months she worked for Respondent, Respondent was ``very efficient and punctual'' and that Respondent's fatigue began approximately one month before his termination. [Tr. 91, 93; Gov't Exh. 9]. Respondent himself also testified that ``[m]ost of my, quote, tiredness came during the month of July.'' [Tr. 243]. Michelle Bays, the St. Mary's employee in charge of overseeing day-to-day operations at hospital clinics, is the only witness who testified that Respondent's fatigue and tardiness lasted longer than a month. She testified that the fatigue and tardiness occurred for ``more than a month and a half'' and that ``[i]t was an issue for the time I--my whole time when I worked with him.'' [Tr. 100, 106]. Ms. Bays's recollection of the chronology of events, however, is not reliable for several reasons. First, as noted above, her testimony regarding the timing of Respondent's fatigue and tardiness conflicts with the testimony of two other witnesses. Second, she testified that she began overseeing Red Carpet in September 2009 and that Respondent ``was already there'' at that time, [Tr. 100], but it is clear from the record that Respondent did not begin working at Red Carpet until June 2010 [Gov't Exh. 6 at 2; Tr. 131]. Thus, while I find Ms. Bays to be generally credible, I find that her testimony regarding the timing of events in this case not credible. I also find that Respondent's tiredness and tardiness at work occurred approximately during the month immediately preceding his termination from St. Mary's. --------------------------------------------------------------------------- Respondent's staff at Red Carpet expressed their concerns about Respondent's tardiness, fatigue, and personal life to Michelle Bays, the practice administrator at St. Mary's. [Tr. 100, 104-105]. As a result of these reports, St. Mary's solicited a signed statement from Ms. Martin about her conversations with and observations of Respondent while at work. [Tr. 102-05; Gov't Exh. 19]. Respondent voluntarily submitted to a drug test, apparently requested by St. Mary's,\9\ on July 18, 2011. [Tr. 115-116, 205; Gov't Exh. 8]. The drug test came back positive for marijuana, methamphetamine, and amphetamines, and resulted in Respondent's termination from St. Mary's in August, 2011. [Tr. 118, 120, 131, 206, 245; Gov't Exh. 8]. Respondent admits to using methamphetamine, but at the hearing he offered explanations [[Page 41085]] for why marijuana and amphetamines were in his system. [Tr. 245]. --------------------------------------------------------------------------- \9\ The Government's witnesses did not explain who requested the drug test, but Respondent, when asked who initiated the test, testified that Michelle Bays ``escorted me to the facility where [the drug test] was done.'' [Tr. 205]. --------------------------------------------------------------------------- Regarding Respondent's methamphetamine use, Respondent credibly testified that he began using it in December 2010 and stopped around August of 2011. [Tr. 196-97]. Respondent testified that he used methamphetamine ``maybe twice a month'' before moving in with A.B. in July of 2011, and ``maybe once or twice a week at most'' after moving in with A.B. [Tr. 197]. Respondent also credibly testified that before becoming involved with A.B., he had never used methamphetamine or any other illicit drug. [Tr. 196]. The Government offered no evidence rebutting this testimony. With respect to the positive result for marijuana on the drug test, Respondent credibly testified that marijuana was in his system at the time of the drug screen because he was ``exposed'' to it while living with A.B., who regularly smoked marijuana with her associates. [Tr. 245]. Dr. Westcott, whom I certified at the hearing as an expert in addiction management, testified that second-hand marijuana smoke could cause a positive result on a drug screen if the subject were exposed to a concentrated amount, but also testified that positive results for marijuana on a drug screen normally mean the subject used the drug. [Tr. 379-82]. The Government, on the other hand, presented no evidence to rebut Respondent's explanation for the drug test's positive result for marijuana, opting instead to simply argue that Respondent's explanation was an ``attempt[] to minimize the significance of his failed drug screen.'' [Government Brief (``Gov't Br.'') at 33]. To be sure, Respondent has used marijuana in the past. At the Board hearing, Respondent testified that he had used marijuana with friends on a ``sporadic, recreational'' basis. [Gov't Exh. 21 at 11]. Furthermore, Respondent's discharge summary from Sant[eacute], appended to the Board hearing transcript, notes that Respondent had ``secondary'' issues with ``cannabis abuse.'' [Gov't Exh. 21, Attach. 1]. But none of this evidence contradicts Respondent's testimony at the hearing in these proceedings regarding his marijuana use. In these proceedings, Respondent never testified that he had never used marijuana; Respondent merely testified that the particular drug screen he failed was the result of exposure to marijuana rather than his personal use. [Tr. 245]. Indeed, the Government never asked Respondent generally whether he had ever used marijuana; it only asked whether the failed drug screen was the result of marijuana use. [Tr. 245]. In context, this testimony cannot be construed as a general denial by Respondent of any and all allegations of marijuana use. Thus, Respondent's testimony is not inconsistent with other evidence that proves Respondent has used marijuana in the past. I therefore find that Respondent's explanation for the positive marijuana result on the drug screen, which was corroborated by Dr. Westcott's testimony on cross examination and unrebutted by the Government, is credible. I also find that Respondent has used marijuana in the past, but that the frequency of such use is unclear from the record. In the absence of any evidence to rebut Respondent's credible testimony regarding the drug test, however, I find that the Government failed to establish that the positive result for marijuana on the drug test was the result of Respondent's personal use. With respect to the drug screen's positive result for amphetamines, Respondent testified that amphetamines were in his system due to a prescription drug he was taking called Vyvanse. Respondent and Dr. Westcott both testified that Vyvanse is a medication used to treat Attention Deficit Disorder (``ADD''), and that it is ``in the amphetamine class.'' [Tr. 246-48, 382-83]. Respondent testified that he was issued a valid prescription for Vyvanse in 2009, and began taking pills leftover from that prescription every day when ADD symptoms began to reoccur about a week and a half before he failed the drug screen at St. Mary's. [Tr. 246, 248-49]. This explanation is corroborated by two exhibits the Government itself introduced. First, the Board Order found that Respondent ``contacted the Board and confirmed that he had tested positive for . . . Vyvanse.'' [Gov't Exh. 6 at 2]. Second, at the Board hearing, Respondent testified to the same facts regarding his Vyvanse use as he did at the hearing in these proceedings. [Gov't Exh. 21 at 14-15]. Respondent and Dr. Westcott also testified that Vyvanse stays in the system for at least two days, and that in a drug test it would likely result in a positive result for amphetamines. [Tr. 248, 383]. Similar to its approach to the marijuana issue, the Government opted to not offer any evidence to rebut Respondent's explanation of the positive amphetamine result, instead arguing that ``Respondent would have the Court believe [his] less than plausible explanation in the face of unrefuted evidence that he tested positive at a time when he was dating a methamphetamine addict and living at her house where methamphetamine was manufactured.'' \10\ [Gov't Br. at 33]. This circumstantial evidence is not convincing in light of the credible testimony Respondent gave at the hearing in these proceedings, which was nearly identical to the testimony he gave at the Board hearing. I therefore find that the Government has failed to establish that Respondent improperly used amphetamines. --------------------------------------------------------------------------- \10\ The Government also suggested, without overtly accusing, that Respondent acted improperly by taking ``a two year-old prescription for which he did not seek the care of a doctor in a recent visit.'' [Gov't Br. at 33 (emphasis in original); Tr. at 246 (Government counsel asking Respondent, ``So you took it outside the usual course of professional practice[?]'')]. The Government, however, cites no regulation, and I can find none, that forbids the use of ``leftover'' prescription drugs. Further, the Government has offered no evidence to establish that the Respondent's prescription for Vyvanse restricted his use of the drug two years after the issuance of the prescription. I therefore find that the Government failed to establish any wrongdoing by Respondent regarding his consumption of Vyvanse. --------------------------------------------------------------------------- Respondent further testified that he never possessed or used illicit drugs while at work, and St. Mary's employees testified that they never concluded otherwise. [Tr. 123, 149, 200-01]. The Government refutes Respondent's assertion, arguing that Respondent's use of illicit drugs at work is evidenced by the fact that ``he tested positive for these drugs while on the job and commuted a great distance to his job.'' [Gov't Br. at 29-30]. Yet, Respondent's expert witness testified on cross examination that methamphetamine and amphetamines stay in the system for two to four days, and Respondent testified that it was ``widely known'' that marijuana can stay in your system for up to thirty days. [Tr. at 254, 382]. The Government failed to introduce any evidence to rebut this testimony, making considerably less plausible the suggestion that Respondent's drug use at home would wear off during his long commute. I therefore find that the Government failed to establish that Respondent used or possessed illicit drugs while at work. Within hours of his termination, which immediately followed his failed drug test, Respondent voluntarily reported himself to the State Board of Osteopathic Examiners (``State Board'' or ``Board'') and the Oklahoma Health Professional Program (``OHPP''). [Tr. 206-07; Gov't Exh. 6 at 2]. However, Respondent did not report himself to the DEA. [Tr. 273]. In fact, Respondent did not communicate with the DEA about his drug abuse until about a year later. [Tr. 274]. As a result of Respondent contacting the Board, the Board conducted an investigation and held a hearing on June 21, 2012, after Respondent returned [[Page 41086]] home from in-patient therapy.\11\ [Gov't Exh. 6 at 1; Tr. 207-208]. The same day as the hearing, the Board issued a Findings of Fact, Conclusions of Law, and Agreed Order of Probation (``Board Order''), which is pertinent to these proceedings and binding on this Court under the principles of collateral estoppel. [Gov't Exh. 6; Tr. 30]; David A. Ruben, 78 FR 38,363, 38,365 (DEA 2013); Robert L. Dougherty, M.D., 76 FR 16,823, 16,830 (DEA 2011). Specifically, in relation to Respondent's drug abuse, the Board found the following: --------------------------------------------------------------------------- \11\ As explained below, the hearing took place so long after Respondent's termination from St. Mary's because Respondent had checked into an in-patient rehabilitation center and his hearing was continued. [See Gov't Exh. 5]. 3. On or about August 2, 2011, St. Mary's Regional Medical Center (``Hospital'') in Enid, Oklahoma terminated Dr. Horst's employment at the Hospital. Dr. Horst had failed a drug screen and tested positive for marijuana, methamphetamine and another drug. 4. Dr. Horst contacted the Board and confirmed that he had tested positive for marijuana and a C-II medication Vyvanse for ADHD. Dr. Horst also confirmed that the Hospital had terminated his employment. [Gov't Exh. 6 at 2]. Respondent stipulated to and ``[did] not contest any of the factual allegations raised by the Board.'' [Gov't Exh. 6 at 2]. Respondent also testified at the hearing in the present proceedings that he agreed with the Board's findings. [Tr. 217]. D. Improper Prescriptions In addition to Respondent's illicit drug use, the Government proved, and Respondent admitted, that Respondent issued illegitimate prescriptions for purposes other than legitimate medical purposes. [Tr. 170-172, 201-04; Gov't Exhs. 9-14, 16]. Respondent wrote the prescriptions in question for three patients: A.B., Z.M., and S.M. [Tr. 170-172, 201-04; Gov't Exhs. 9-14, 16]. Patient A.B. was the same A.B. with which Respondent was romantically involved, and the other two were A.B.'s friends. [Tr. 201, 203]. Respondent admitted that he knew A.B. abused controlled substances when he issued her the improper prescriptions. [Tr. 196-97, 251-52]. To prove Respondent illegitimately issued the prescriptions in question, the Government offered Dr. Arthur Douglas Beacham, III as an expert witness in the area of osteopathic medicine with an emphasis in pain management. [Tr. 164; Gov't Exh. 15]. Dr. Beacham reviewed patient files and prescriptions written by Respondent for A.B., Z.M., and S.M., and testified that he could ``find no documentation that would support the legitimate medical purpose of controlled medications.'' [Tr. 170- 172; Gov't Exhs. 9-14, 16]. Specifically, Dr. Beacham testified that there was ``no documentation to support history or present illness or a physical exam or an assessment nor a plan.'' [Tr. 172-73]. Thus, Dr. Beacham concluded that, in his expert opinion, ``the prescriptions were written for a matter outside medical necessity.'' [Tr. 173-74]. Dr. Beacham also prepared a report containing these same conclusions, which was also admitted into evidence without objection. [Tr. 171; Gov't Exh. 16]. Respondent admitted to issuing the improper prescriptions and did not refute the testimony of the Government's expert witness. [Tr. 201- 04]. Respondent filed the patients' records of A.B., S.M., and Z.M. in his own desk rather than with Red Carpet's other patient files. The records were found by a St. Mary's employee \12\ in Respondent's desk drawer after Respondent's termination from St. Mary's, and Respondent admits that he should have filed those files with the rest of the clinic's records. [Tr. 131-36, 203; Gov't Exhs. 9-11]. --------------------------------------------------------------------------- \12\ There are no allegations of privacy invasions regarding the St. Mary's employee finding the files in Respondent's desk drawer. The St. Mary's employee who found the patient files in Respondent's desk, Krista Roberts, testified that she found the files after she offered to help Respondent clean out his desk and that Respondent consented to her help. [Tr. 132-33]. --------------------------------------------------------------------------- The Board Order included factual findings regarding Respondent's illegitimate prescriptions. These findings, as noted above, are binding on this court. Ruben, 78 FR at, 38,365; Dougherty, 76 FR at 16,830. Specifically, the Board found the following: 6. Upon Dr. Horst's termination of employment by [St. Mary's], staff at the [Red Carpet] Clinic discovered patient charts in Dr. Horst's office that were kept separate and apart from the Clinic's patient records. These separate charts represented patients never scheduled or seen by Clinic staff. They represent patients AB, SM, and ZM. 7. Patient AB's chart includes a patient registration and medical history, but no physical examination. Chart is on the Clinic's patient record forms. There are no prescribed medications or exam notes recorded. Beginning July 29, 2010 Dr. Horst issued to patient AB sixteen (16) prescriptions of controlled dangerous substances (CDS) with seventeen refills up until his termination by the Hospital. None of these prescriptions are charted. They include Hydrocodone, Promethazine with Codeine syrup, and Alprazolam. Dr. Horst admitted that he had an extramarital affair with patient AB. 8. Patient SM's chart includes a patient registration and medical history, but no physical examination. Chart is on the Clinic's patient record forms. There are no prescribed medications or exam notes recorded. Beginning January 27, 2011 Dr. Horst issued patient SM two (2) CDS prescriptions of Hydrocodone with one (1) refill. None of these prescriptions are charted. 9. Patient ZM's chart includes a medical history, but no patient registration and no physical examination. Chart is on the Clinic's patient record forms. There are no prescribed medications or exam notes. On November 29, 2010 Dr. Horst issued patient ZM one (1) CDS prescription of Hydrocodone with two (2) refills. This prescription is not charted. [Gov't Exh. 6 at 2-3]. As noted above, Respondent stipulated to all of these facts at the Board hearing and testified at the hearing in the present proceedings that he agreed with the Board's findings. [Gov't Exh. 6 at 2; Tr. 217]. Additionally, the Board concluded that Respondent's actions constituted ``a violation of the Oklahoma Osteopathic Medicine Act, 59 O.S. Sec. Sec. 620 et seq., and specifically . . . Sec. 637(A)(2)(f)(g)(12) and (13).'' [Gov't Exh. 6 at 4]. E. Respondent's Remedial Actions and Oversight of Respondent Upon suggestion by the former OHPP president, Respondent checked himself into an in-patient rehabilitation facility in Argyle, Texas, called Sant[eacute] Center for Healing (``Sant[eacute]'') on October 12, 2011. [Tr. 208-09]. Respondent testified that he paid for his time at Sant[eacute] by ``cash[ing] in everything we had as far as IRAs, 401(k)s, profit-sharing, anything that we'd saved up over the years.'' [Tr. 210]. Half of the money Respondent gathered went to Sant[eacute], and the other half ``went to sustaining [his] family while [he] was gone.'' [Tr. 210]. Respondent also testified that even after ``cashing out'' many of his assets, Respondent still owes Sant[eacute] $87,000. [Tr. 210]. Respondent described his experience at Sant[eacute] as ``intensive,'' especially in the beginning. [Tr. 209-210]. The staff there did various tests and evaluations on Respondent when he arrived, and the daily therapy regimen started early in the morning and lasted until 7:00 p.m., utilizing several different techniques such as group and one-on-one therapy. [Tr. 209-210]. While at Sant[eacute], Respondent was required to isolate [[Page 41087]] himself from those outside the treatment facility, and was not even permitted to discuss medical issues with other patients. [Tr. 214-15]. Respondent candidly admitted during direct examination that ``it was a little bit difficult to acclimate myself for the first few weeks, probably six weeks,'' but after the initial acclamation phase, he ``became a model participant.'' [Tr. 210; see also Tr. 258-260; but see Tr. 408; Gov't Exh. 21, Attach. 1]. On cross examination, Respondent also admitted that he broke a ``no female contract'' at Sant[eacute] by having a sexual relationship with a female patient.\13\ [Tr. 260-64]. --------------------------------------------------------------------------- \13\ I admitted evidence of this relationship for impeachment purposes only. [Tr. 292-93]. --------------------------------------------------------------------------- In addition to his drug abuse therapy, Respondent completed a program at Sant[eacute] entitled ``Maintaining Proper Boundaries,'' which, according to a letter from the medical director at Sant[eacute], is a comprehensive educational and experiential course designed to address the factors that lead to boundary violations, result from boundary violations and are required in the reparation and prevention of any further boundary issues. The course focuses particularly on sexual boundary issues: including sexual boundary transgressions and interpersonal sexual boundary violations, however also recognizes verbal, ethical, moral and legal boundary violations. [Resp't Exh.. 3; Tr. 212-13]. Respondent completed his time at Sant[eacute] on May 25, 2012, whereupon he received a ``certificate of sobriety.'' [Resp't Exh. 2; Tr. 213-14, 224]. Respondent testified that his ``sobriety date'' is October 12, 2011. [Tr. 208-09]. Respondent testified that in June 2012, after returning from seven months of therapy at Sant[eacute], he met with State Board members and investigators to discuss how he can ``make things right and get on with my life, and hopefully piece my career and life back together.'' [Tr. 217-18]. On June 21, 2012, the Board held a hearing for Respondent's case, which was attended by Respondent without counsel, and issued the Board Order the same day. [Gov't Exh. 6]. The Board Order, to which Respondent had previously agreed in his meeting with the Board members, placed Respondent's medical license on five years' probation and required that Respondent (1) enter into and comply with a contract with OHPP; (2) regularly attend counseling sessions with ``A Chance to Change'' and report to the Board on his progress in counseling; (3) have no contact with A.B.; (4) appear at the next regularly scheduled Board meeting and, when requested, at subsequent Board meetings; and (5) reimburse the Board for the costs it incurred in conducting its proceedings. [Gov't 6 at 4; Tr. 217-20]. Respondent's agreement with the OHPP required Respondent to submit to random bimonthly drug tests and attend at least 75 percent of the weekly ``Caduceus meetings'' conducted by OHPP. [Tr. 218-19; Resp't Exh. 1]. Caduceus meetings are similar to Alcoholics Anonymous meetings, but tailored specifically for physicians. [Tr. 351-52]. Dr. Robert Westcott, the president of the OHPP, testified that Caduceus meetings are a place where physicians can ``discuss issues about being in recovery and being a physician that you really can't talk about in just a regular open AA meeting.'' [Tr. 352]. Respondent testified that since entering into an agreement with OHPP, he has not failed any of his required drug tests and has 100 percent attendance at the weekly Caduceus meetings.\14\ [Tr. 219-21]. Respondent testified that the OHPP has also asked him to ``attend other 12-step type meetings,'' and that he normally attends those meetings two or three times per week. [Tr. 219]. Respondent also offered into evidence an attendance log which showed that between June 16, 2012, and September 12, 2013, Respondent attended Alcoholics Anonymous meetings almost every week, usually attending more than one meeting per week.\15\ [Resp't Exh. 4; Tr. 221- 23]. --------------------------------------------------------------------------- \14\ Although the letter from OHPP offered into evidence by Respondent reports slightly less than 100 percent attendance, [Resp't Exh. 1], Respondent credibly testified on direct examination that the reason for the discrepancy is that he was not aware of the sign-in procedures during the first few weeks he attended the meetings. [Tr. 219]. In any case, both the letter from the OHPP and Respondent's testimony verify that Respondent has been faithful to his contract with the OHPP regarding meeting attendance. \15\ The attendance logs indicated that Respondent did not attend OHPP meetings for the weeks of July 8-14, 2012, September 16- 22, 2012, October 21-27, 2012, October 28-November 3, 2012, January 13-19, 2013, and April 7-13, 2013. [Resp't Exh. 4]. However, the logs do not indicate whether meetings were scheduled during those weeks; they only list the meetings Respondent actually attended. Thus, it is impossible to tell from the logs alone what percentage of scheduled meetings Respondent attended. --------------------------------------------------------------------------- Dr. Westcott, the president of the OHPP, testified that Respondent has fully cooperated with his OHPP contract, that Respondent has ``done very well'' in his recovery, and that he has ``every reason to believe that [Respondent will] continue to do so.'' [Tr. 372, 377]. He also testified that under OHPP supervision, ``it would (be) very, very unusual for a person to be able to use and continue to use without being caught.'' [Tr. 369]. In fact, Dr. Westcott testified that the OHPP has a 90% success rate of helping physicians stay sober. [Tr. 367- 68]. The Government offered no evidence to refute that Respondent has been diligent in abiding by the terms of his probation. In addition to the conditions of Respondent's probation, the Board itself conducts a certain amount of oversight over physicians who have been disciplined. Most notably, at least every quarter, the Board uses the Prescription Monitoring Program (``PMP'') \16\ to review the prescriptions issued by disciplined physicians. [Tr. 370-71]. DEA investigators also have access to the PMP, and use it to monitor registrants suspected of misconduct. [See Tr. 39-40]. --------------------------------------------------------------------------- \16\ DI Survovec described the PMP as ``a real-time recording of controlled substance prescriptions that are issued.'' [Tr. 40] --------------------------------------------------------------------------- Respondent is also subject to oversight at his current place of employment, ACTC. [Tr. 422]. Dr. Richard Swenson, the medical director in charge of supervising the physicians at ACTC, testified that the ``locked cabinet or closet'' in which the controlled substances are stored at ACTC is ``under constant video surveillance'' and the drugs themselves are not dispensed by the physicians. [Tr. 418, 438]. Respondent is not permitted to issue prescriptions for controlled substances; he must obtain approval from a doctor with an unfettered license who personally meets and examines the patient before issuing the prescription. [Tr. 419, 437-38]. Although no formal procedures are in place for licensed physicians to review Respondent's charts, Dr. Swenson testified that almost all of the clinic's patients come in for multiple visits and see multiple doctors throughout the course of their treatment. As such, the charts for each patient are normally reviewed by multiple doctors. [Tr. 423- 24, 433]. Dr. Swenson also testified that ACTC has a ``no tolerance'' policy regarding diversion of controlled substances, meaning he would immediately report any concerns of diversion. [Tr. 424-25]. On cross examination, Dr. Swenson testified that ACTC does not conduct drug screens or enter into pain contracts before prescribing controlled substances known to be abused. [Tr. 433-36]. However, Dr. Swenson explained that such precautions are normally used only at ``chronic pain management clinics.'' [Tr. 434]. Even Group Supervisor John Kushnir, the Government's representative at counsel table at the hearing, testified that while ACTC had some minor bookkeeping [[Page 41088]] issues, the oversight ACTC conducts over controlled substances dispensing is ``good.'' [Tr. 335]. Notably, ACTC has experience with disciplined physicians because it works with the State Board to employ disciplined physicians. [Tr. 420- 21]. This practice began under the clinic's former medical director, who had himself experienced substance abuse problems and was ``interested in seeing what he could do to help other providers that found themselves in that same circumstance.'' [Tr. 421]. Other than Respondent, ACTC currently employs one other physician and one medical assistant with restricted licenses. [Tr. 420, 421]. Dr. Swenson testified that ACTC has a good track record of helping physicians remain sober and reestablish their professional careers. [Tr. 421-22]. F. DEA Investigations of Respondent DEA first interviewed Respondent in August of 2012, after learning that Dr. Horst's medical license had been put on probation by the State Board. [Tr. 26, 32]. In attendance at that interview were Diversion Investigator Mary Surovec, Group Supervisor John Kushnir, Respondent, and Dr. Robert Westcott. [Tr. 32]. Dr. Westcott attended the meeting at the request of Respondent. [Tr. 32, 275, 387]. Notably, DI Surovec testified that when asked about the allegations in the Board Order, Respondent ``didn't really deny anything.'' [Tr. 33]. DI Surovec and GS Kushnir also asked Respondent to surrender his DEA registration. [Tr. 32, 55, 226, 318]. Respondent asked what his options were, and he was told that he could either surrender his license or be served with an order to show cause. [Tr. 56, 227, 320]. Respondent told DI Surovec and GS Kushnir that ``he was going to think about surrendering.'' [Tr. 33; 227]. Respondent testified that he was hesitant to surrender his COR because other physicians had told him that after surrendering a DEA registration, ``you never get it back.'' [Tr. 276].\17\ Indeed, both DI Surovec and GS Kushnir testified that they did not recall making any indications to Respondent that he would be able to regain a surrendered COR through demonstrated compliance and rehabilitation. [Tr. 61-62]. --------------------------------------------------------------------------- \17\ The Government sought testimony from Dr. Westcott that, in fact, he was the one who advised Respondent to not surrender his registration, but Dr. Westcott credibly denied doing such. [Tr. 391- 392]. --------------------------------------------------------------------------- V. STATEMENT OF LAW AND DISCUSSION A. Positions of the Parties 1. Government's Position The Government timely filed Government's Proposed Findings of Fact and Conclusions of Law (``Government's Brief'') with this Court on January 31, 2014. In its brief, the Government set forth proposed findings of fact, conclusions of law, and arguments in favor of denying Respondent's COR. The Government argues that it met its burden of proving a prima facie case, primarily focusing on factors two, four, and five of the public interest analysis set forth in 21 U.S.C. 823(f). [Gov't Br. at 24, 28]. With respect to factors two and four, the Government points out that Respondent stipulated to the factual allegations in the Board Order regarding his positive drug test and improper issuing of prescriptions. [Id. at 25]. Moreover, the Government relies on its expert witness, who testified that Respondent's prescribing of controlled substances to A.B., S.M., and Z.M. were without a legitimate medical purpose. [Id. at 25-27]. Regarding factor five, the Government argues that Respondent's actions of prescribing controlled substances to A.B., someone he knew to be a drug abuser, were particularly harmful to the public health and safety given Respondent's ``practic[e] as a solo gastroenterologist in a small community.'' [Gov't Br. at 28-29]. The Government also argues that Respondent's admitted abuse of illicit and controlled substances also posed a threat to public health and safety. [Id. at 29]. Although Respondent insists that he never used or possessed illicit drugs at work, the Government argues that ``the sheer fact that he tested positive for these drugs while on the job and commuted a great distance to his job demonstrates that Respondent's behavior while he was employed as a physician caused a threat to the public health and safety.'' [Id. at 29-30]. The Government also argues that Respondent's remedial actions are not sufficient to entrust him with a DEA COR because Respondent has demonstrated a lack of candor with the DEA. The Government points out that (1) Respondent did not report to DEA the positive results of the drug test he took while working for St. Mary's, (2) Respondent ``could not admit that his self-abuse . . . contributed to his inability to perform as a doctor,'' (3) Respondent's testimony was ``rife with inconsistencies,'' and (4) Respondent was not forthright in his testimony about his experience at Sant[eacute]. [Gov't Br. at 32-33]. Finally, the Government argues that even if Respondent has shown sufficient remorse and instituted remedial measures, his actions were too egregious to warrant his registration. [Gov't Br. at 34-36]. Further, the Government argues that in light of the current prescription drug abuse epidemic, the need to deter improper prescribing weighs in favor of denying Respondent's registration. [Id. at 36]. 2. Respondent's Position Respondent timely filed Respondent's Proposed Findings of Fact, Conclusions of Law, and Argument (``Respondent's Brief'') on January 30, 2014. Therein, Respondent ``fully admits to writing improper prescriptions to three individuals'' and ``further admits to using methamphetamine, sometimes as often as twice a week.'' [Resp't Br. at 7]. Respondent also notes that the entirety of his impropriety was during a six month time period, but does not dispute that the Government has proved its prima facie case. [Id.]. Rather, Respondent argues that it has rebutted the case against him with evidence that he takes responsibility for his actions and has instituted sufficient remedial actions to justify his registration. Respondent argues that he has made ``significant, dramatic, and substantial efforts at rehabilitation and [has] demonstrated commitment to fully comply with any and all regulations placed upon him by state licensure boards.'' [Id. at 7]. In particular, he argues that his participation in (1) a seven-month inpatient substance abuse program, (2) boundaries training, (3) OHPP programs, (4) random drug testing, and (5) support groups demonstrate his commitment both to recovery from substance abuse and compliance with the Board's conditions of licensure. [Id.]. Respondent also argues that his substance abuse was short-lived, and that he has now been sober for over two years. [Id.]. Moreover, Respondent argues that his circumstances have ``changed drastically since the time of his misconduct''; he has reconciled with his wife, attended family counseling, ended his relationship with A.B., and even shortened his commute to work. [Id. at 9]. B. Statement of Law and Analysis Pursuant to 21 U.S.C. 823(f) (2011), the Deputy Administrator may deny an application for a DEA COR if he determines that such registration would be inconsistent with the public [[Page 41089]] interest.\18\ Similarly, pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator may revoke a DEA COR, if he determines that such registration would be inconsistent with the public interest. In determining the public interest, the following factors are considered: --------------------------------------------------------------------------- \18\ The Deputy Administrator has the authority to make such a determination pursuant to 28 CFR 0.100(b), 0.104 (2013). (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing, or conducting research with respect to 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) (2011). These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight he deems appropriate in determining whether a registration should be revoked or an application for registration be denied. See Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003) (citing Henry J. Schwartz, Jr. M.D., 54 FR 16,422, 16,424 (DEA 1989)). Moreover, the Deputy Administrator is ``not required to make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). Thus, ``this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor'' each party. Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (DEA 2009). ``Rather, it is an inquiry which focuses on protecting the public interest[.]'' Id. The Government bears the ultimate burden of proving that the requirements for registration are not satisfied. 21 CFR 1301.44(d) (2014). Specifically, the Government must show that Respondent has committed acts that are inconsistent with the public interest. 21 U.S.C. 823(f); Jeri Hassman, M.D., 75 FR 8,194, 8,227 (DEA 2010). However, where the Government has made out a prima facie case that Respondent's application would be ``inconsistent with the public interest,'' the burden of production shifts to the applicant to ``present[ ] sufficient mitigating evidence'' to show why he can be trusted with a new registration. See Medicine Shoppe--Jonesborough, 73 FR 364, 387 (DEA 2008). To this point, the Agency has repeatedly held that the ``registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.'' Id.; see also Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). The Respondent must produce sufficient evidence that he can be trusted with the authority that a registration provides by demonstrating that he accepts responsibility for his misconduct and that the misconduct will not reoccur. See id.; see also Samuel S. Jackson, D.D.S., 72 FR at 23,853. The DEA has consistently held the view that ``past performance is the best predictor of future performance.'' Alra Laboratories, 59 FR 50,620 (DEA 1994), aff'd Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 451 (7th Cir 1995). Factor One: Recommendation of Appropriate State Licensing Board Recommendations of state licensing boards are relevant, but not dispositive, in determining whether a respondent should be permitted to maintain a registration. See Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755 (DEA 2009); see also Martha Hernandez, M.D., 62 FR 61,145, 61,147 (DEA 1997). According to clear agency precedent, a ``state license is a necessary, but not a sufficient condition for registration.'' Robert A. Leslie, M.D., 68 FR at 15,230; John H. Kennedy, M.D., 71 FR 35,705, 35,708 (DEA 2006). DEA possesses ``a separate oversight responsibility with respect to the handling of controlled substances,'' which requires the Agency to make an ``independent determination as to whether the granting of [a registration] would be in the public interest.'' Mortimer B. Levin D.O., 55 FR 8,209, 8,210 (DEA 1990); see also Jayam Krishna-Iyer, M.D., 74 FR at 461. Even the reinstatement of a state medical license does not affect this Agency's independent responsibility to determine whether a DEA registration is in the public interest. Levin, 55 FR at 8,210. The ultimate responsibility to determine whether a registration is consistent with the public interest has been delegated exclusively to the DEA, not to entities within a state government. Edmund Chein, M.D., 72 FR 6,580, 6,590 (DEA 2007), aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Here, it is undisputed that Respondent holds a valid license to practice medicine in the state of Oklahoma. [Gov't Br. at 21; ALJ Exh. 14]. Because his licensure does not constitute a recommendation from the Board, however, I find that factor one weighs neither for nor against Respondent's registration. Factors Two and Four: Registrant's Experience with Controlled Substances and Registrant's Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances Respondent's experiences with handling controlled substances, as well as his compliance with laws related to controlled substances, are relevant considerations under the public interest analysis. Pursuant to the Controlled Substances Act, ``[p]ersons registered by the Attorney General under this subchapter to . . . dispense controlled substances . . . are authorized to possess . . . or dispense such substances . . . to the extent authorized by their registration and in conformity with the other provisions of this subchapter.'' 21 U.S.C. 822(b); Leonard E. Reaves, III, M.D., 63 FR 44,471, 44,473 (DEA 1998); see also 21 CFR 1301.13(a) (providing that ``[n]o person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.''). As such, the DEA properly considers practitioners' past compliance with CSA requirements and DEA regulations in determining whether registering such a practitioner would be in the public interest. The regulation applicable here is DEA's long-standing requirement that a prescription be issued for ``a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.'' Ralph J. Chambers, M.D., 79 FR 4,962, 4,970 (DEA 2014) (quoting 21 CFR 1306.04(a)). DEA precedent further establishes that ``a practitioner must establish and maintain a bona-fide doctor-patient relationship in order to be acting `in the usual course of . . . professional practice' and to issue a prescription for a `legitimate medical purpose.' '' Paul H. Volkman, 73 FR 30,630, 30,642 (DEA 2008). Whether a valid doctor-patient relationship was established is determined by looking to state law. Id. Here, Respondent issued prescriptions to A.B., S.M., and A.M. outside the usual course of his professional practice. The Government's expert credibly testified at the hearing that after reviewing the prescriptions and the patient files, he could ``find no documentation that would support the legitimate medical purpose of controlled [[Page 41090]] medications'' because there was ``no documentation to support history or present illness or a physical exam or an assessment nor a plan.'' [Tr. 170-173; Gov't Exhs. 9-14, 16]. Dr. Beacham's written report credibly reached these same conclusions. [Tr. 171; Gov't Exh. 16]. Respondent admitted to issuing the prescriptions improperly and did not refute the testimony of the Government's expert witness. [Tr. 201- 04].\19\ --------------------------------------------------------------------------- \19\ The Government also produced evidence, and Respondent admitted, that Respondent stored A.B.'s, S.M.'s, and Z.M.'s patient files in his own desk rather than with Red Carpet's other patient files. [Tr. 132-36, 203; Gov't Exhs. 9-11]. While this was certainly suspicious and Respondent admitted it was improper, I can find no regulation Respondent violated by storing the files in his desk, and the Government cites none. Indeed, the Government's argument section in its brief makes no mention of the location of the files. --------------------------------------------------------------------------- In addition to his issuing of improper prescriptions, Respondent's possession \20\ of methamphetamine violated federal law. Under the CSA, it is ``unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice.'' 21 U.S.C. 844(a). It is undisputed that Respondent possessed methamphetamine, which is a Schedule III controlled substance under 21 U.S.C. 812, without a prescription. [See Tr. 200; Resp't Br. at 3]. --------------------------------------------------------------------------- \20\ In order to follow agency precedent, I will take into consideration evidence of Respondent's self- abuse of illicit drugs under the fifth public interest factor. Tony T. Bui, M.D., 75 FR 49,979, 49,989 (DEA 2010). Thus, under factor four I only consider Respondent's possession of methamphetamine and not his use. --------------------------------------------------------------------------- I find that Respondent's possession of a controlled substance without a prescription, combined with his improper issuing of prescriptions to A.B., S.M., and Z.M., clearly weigh against Respondent's registration under factors two and four of the public interest analysis. Factor Three: Registrant's Conviction Record Relating to Controlled Substances Pursuant to 21 U.S.C. Sec. 823(f)(3), the Deputy Administrator may deny a pending application for a certificate of registration upon a finding that the applicant has been convicted \21\ of a felony related to controlled substances under state or federal law. See Thomas G. Easter II, M.D., 69 FR 5,579, 5,580 (DEA 2004); Barry H. Brooks, M.D., 66 FR 18,305, 18,307 (DEA 2001); John S. Noell, M.D., 56 FR 12,038, 12,039 (DEA 1991). --------------------------------------------------------------------------- \21\ The Administrator interprets the term ``conviction'' by affording it the ``broadest possible meaning.'' Donald Patsy Rocco, D.D.S., 50 FR 34,210, 34,211 (DEA 1985). Thus, evidence of a guilty plea is probative under the third factor of the public interest analysis. See e.g., Farmacia Ortiz, 61 FR 726, 728 (DEA 1996); Roger Pharmacy, 61 FR 65,079, 65,080 (DEA 1996). --------------------------------------------------------------------------- Here, the Government concedes that it ``did not introduce any evidence during this proceeding regarding a Federal or State conviction for Respondent relating to controlled substances.'' [Gov't Br. at 23]. Indeed, the parties stipulated that ``Respondent has not been charged with or convicted of any federal or state crimes relating to the manufacture, distribution, or dispensing of controlled substances.'' [ALJ Exh. 14]. However, the Government also correctly points out that under DEA precedent, factor three is not dispositive and ``is of considerably less consequence in the public interest inquiry.'' [Gov't Br. at 23 (quoting Ruben, 78 FR at 38,379 n.35]. I therefore find that this factor weighs neither for nor against Respondent's registration. Factor Five: Such Other Conduct Which May Threaten the Public Health and Safety Under the fifth public interest factor, the Agency considers ``[s]uch other conduct which may threaten the public health and safety.'' 21 U.S.C. 823(f)(5). The Administrator has clarified this language by reasoning that since Congress used the word ``may,'' factor five includes consideration of conduct ``which creates a probable or possible threat (and not an actual) threat [sic] to public health and safety.'' Roni Dreszer, M.D., 76 FR at 19,434; Michael J. Aruta, 76 FR 19,420, 19,420 (DEA 2011); Beau Boshers, M.D., 76 FR 19,401, 19,402 n.4 (DEA 2011); Jacobo Dreszer, M.D., 76 FR 19,386, 19,386 n.3 (DEA 2011). Taking into consideration Congress's clear statutory language and legislative intent under the CSA, misconduct considered under factor five also ``must be related to controlled substances.'' Terese, Inc. D/ B/A Peach Orchard Drugs, 76 FR 46,843, 46,848 n.11 (DEA 2011); Tony T. Bui, M.D., 75 FR at 49,989 (``In short, DEA has never held that a practitioner's prescribing practices with respect to non-controlled substances provide an independent basis for concluding that the practitioner has engaged in conduct which may threaten public health and safety and has thus committed acts inconsistent with the public interest.''). Long-standing agency precedent indicates that a ``practitioner's self-abuse of a controlled substance is a relevant consideration under factor five.'' Tony T. Bui, M.D., 75 FR at 49,989; Allan L. Gant, D.O., 59 FR 10,826, 10,827 (DEA 1994); David E. Trawick, D.D.S, 53 FR 5,326 (DEA 1988). This Agency has upheld such a position, ``even when there [was] no evidence that the registrant abused his prescription writing authority'' or when there was ``no evidence that the practitioner committed acts involving unlawful distribution to others.'' Tony T. Bui, M.D., 75 FR at 49,989. In determining the likelihood that a respondent's self-abuse would impair the public interest, the DEA may look to the duration of the drug abuse. See Roger D. McAlpin, D.M.D., 62 FR 8,038, 8,040 (DEA 1997) (finding ``serious questions regarding Respondent's fitness to possess a DEA registration'' because of ``his self-abuse of controlled substances from at least 1974 to 1990''). Here, it is undisputed that Respondent self-abused controlled substances. Respondent admitted at the hearing that he used methamphetamine with A.B. for about eight months and admitted at the Board hearing that he has sporadically used marijuana in the past. Under factor five of the public interest analysis, this self-abuse weighs against Respondent's registration. In addition to his self-abuse of drugs, other aspects of Respondent's behavior are also troubling under factor five. For example, Respondent continued prescribing hydrocodone, a highly abused drug, to A.B. despite knowing that A.B. regularly abused controlled substances such as methamphetamine and marijuana. Also, while Respondent did not personally take part in the sale or manufacturing of any illegal drugs, he was present or nearby while an illegal transaction took place and while methamphetamine was being manufactured. Taking into consideration these facts, combined with Respondent's self-abuse of controlled substances, I find that factor five weighs against Respondent's registration. Having found that factors two, four, and five weigh against Respondent, I find that the Government has met its burden to prove a prima facie case that Respondent's registration would not be in the public interest. I now turn to whether remedial measures instituted by Respondent show that he can be trusted with a DEA registration. Remedial Measures Where the Government has made out a prima facie case that Respondent's registration would be inconsistent with the public interest, the burden of production shifts to the applicant to ``present[ ] sufficient mitigating evidence'' to show why he can be trusted with a new registration. See [[Page 41091]] Medicine Shoppe--Jonesborough, 73 FR at 387. To this point, the Agency has repeatedly held that the registrant must ``accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct. Id.; see also Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). Specifically, to rebut the Government's prima facie case, the respondent is required ``to accept responsibility for [the established] misconduct, [and] also to demonstrate what corrective measures [have been] undertaken to prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010) (citing Jayam Krishna-Iyer, M.D., 74 FR 459, 464 n.8 (DEA 2009)). In determining whether a respondent has accepted responsibility and whether misconduct will reoccur, the Agency has historically looked to a number of considerations, including genuine remorse and admission of wrongdoing, Lawrence C. Hill, M.D., 64 FR 30,060, 30,062 (DEA 1999), lapse of time since the wrongdoing, Norman Alpert, M.D., 58 FR 67,420, 67,421 (DEA 1993), candor with the court and DEA investigators, Jeri Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010), and attempts to minimize misconduct, Ronald Lynch, M.D., 75 FR 78,745, 78,754 (DEA 2010). In self-abuse cases, the Agency has acknowledged that successful rehabilitation efforts are an important consideration in determining whether a respondent can be trusted with a registration. Steven M. Abbadessa, D.O., 74 FR 10,077, 10,082 (DEA 2009); Tony T. Bui, M.D., 75 FR 49,979, 49,990 (DEA 2010). At the hearing, Respondent stated several times that `` `regret' is not even a strong enough word. I'm very remorseful for my ever going down that pathway.'' [Tr. 197, 238]. He unequivocally stated that he accepts ``full responsibility'' for his misconduct and that he is ``appalled at [his] behavior.'' [Tr. 196, 238, 256, 257]. Respondent also testified, and the Government did not rebut, that he has been sober since October of 2011, confirming the effectiveness of his treatment and his commitment to remaining sober. [Tr. 259]. Most importantly, Respondent provided unrebutted evidence of his successful rehabilitation at an inpatient facility, where he received intensive therapy for about seven months. [Tr. 210 ; Resp't Exh. 2;]. Notably, Respondent displayed his genuine intent to become and remain sober by spending his own money--including retirement investments--to pay for his rehabilitation. [Tr. 210]. Moreover, Respondent provided evidence, largely unrebutted by the Government, that he faithfully attended support group meetings, passed random drug tests, and was otherwise successful in abiding by the terms of his probation. The Government argues that Respondent cannot be trusted with a COR because he was not candid with DEA investigators or this Court and that his testimony was ``rife with inconsistencies.'' [Gov't Br. at 33]. I disagree. The Government's first argument to this effect is that Respondent failed to self-report his failed drug screen to DEA, and that when Respondent first met with DEA investigators, he ``failed to admit . . . the fact that he issued illegal prescriptions to A.B., S.M., or Z.M., and did not admit his self-abuse of marijuana.'' [Gov't Br. at 32]. DI Surovec, however, testified that in her first meeting with Respondent, ``[w]e asked him about the allegation in the board order, and he really didn't deny anything.'' [Tr. 33]. The Board Order mentioned Respondent's improper prescribing and the positive result for marijuana on the drug screen. [Gov't Exh. 6 at 2, 3]. In that context, it can hardly be said that Respondent was attempting to conceal facts from the DEA that were contained in the very document about which the DEA was questioning him. Furthermore, Respondent's failure to self- report to the DEA does not show a lack of candor, given that he had already self-reported to the Board. [Tr. at 273-74]. Rather, Respondent's explanation that he did not know he needed to self-report is the more plausible explanation. [Tr. 273-74]. The Government also argues that Respondent was not candid because he ``could not admit that his self-abuse . . . contributed to his inability to perform as a doctor.'' [Gov't Br. at 32]. Respondent testified that he was tired at work because of his commute, heavy workload, and lack of sleep at A.B.'s house and that using methamphetamine, which is a stimulant, did not contribute to his fatigue. [Tr. 243-44, 249]. While this may seem like Respondent was trying to minimize the effects of his drug use, I find that this was merely Respondent's honest assessment of his situation at the time. Indeed, the Government elicited this testimony itself. [Tr. 243-44]. The Government similarly argues that Respondent minimized his misconduct by testifying that he prescribed hydrocodone to A.B., a known drug abuser, ``out of compassion [because] [s]he was in pain,'' and that ``hydrocodone was not her drug of choice.'' [Gov't Br. at 33]. Again, this testimony was specifically elicited by Government counsel and went unrebutted. While the reasons Respondent gave for prescribing hydrocodone to A.B. certainly do not justify his improper methods of prescribing, they also do not represent an attempt to minimize or rationalize his behavior. Indeed, Respondent's explanation for prescribing to A.B. was preceded by his statement that ``it was improper and I admit that.'' [Tr. 252] Additionally, the Government argues that Respondent's testimony was ``rife with inconsistencies.'' [Gov't Br. at 33]. For example, the Government points to Respondent's explanations as to why he tested positive for marijuana and amphetamine. As explained above, however, Respondent's explanation about these drug test results were credible and went unrebutted by the Government. The Government also argues that Respondent was not ``forthright regarding his treatment at Sant[eacute]'' because he failed on direct examination to disclose that he broke his ``no female contract'' at the treatment center. [Gov't Br. at 33]. The Government points out that on direct examination Respondent testified that he was a ``model patient,'' but that his breaking of the no-female contract contradicts that statement. [Gov't Br. at 33].\22\ The Government, however, ignores Respondent's testimony that directly precedes his ``model patient'' statement: ``[I]t was a little bit difficult to acclimate myself for the first few weeks, probably six weeks. It took me a while to kind of get into the flow of things. Thereafter, I'd like to think I became a model participant.'' [Tr. 210]. While Respondent did not divulge on direct examination every detail about his struggles in rehabilitation, his statement that he became a ``model participant'' was not an attempt to conceal anything. --------------------------------------------------------------------------- \22\ Over Respondent counsel's vehement objection at the hearing, I allowed the Government to introduce evidence of Respondent's relationship with a woman at Sant[eacute]. [Tr. 261- 263]. However, because this subject was not disclosed prior to the hearing, I admitted the evidence for impeachment purposes only. [Tr. 293]. --------------------------------------------------------------------------- I therefore find that Respondent has sufficiently accepted responsibility for his actions and instituted remedial measures to ensure that the misconduct will not reoccur. At the hearing, Respondent was consistent, sincere, and unequivocal in his acceptance of responsibility for his misconduct. The success of Respondent's rehabilitation is evidenced by his more than two years of sobriety and his faithful attendance at support group meetings since being discharged from therapy. His separation from A.B., the epicenter of most of his [[Page 41092]] problems, displays his commitment to avoiding influences that could lead to a relapse into abusing controlled substances or improperly issuing prescriptions. Even when a respondent is genuinely remorseful and has instituted sufficient remedial measures, however, the Agency sometimes imposes sanctions to deter egregious violations of the CSA. David A. Ruben, M.D., 78 FR 38,363, 38,386 (DEA 2013); Joseph Gaudio, M.D., 74 FR 10,083, 10,094-95 (DEA 2009). In light of the prescription drug epidemic, the Agency has placed special emphasis on the need to deter intentional diversion of controlled substances, which includes issuing prescriptions ``outside of the usual course of professional practice and [without] a legitimate medical purpose.'' David A. Ruben, M.D., 78 FR at 38,386-87; but see Tyson D. Quy, M.D., 78 FR 47,412, 47,412 n.2 (DEA 2013) (``Because there is no evidence that Respondent diverted controlled substances to others and this is a first offense, I conclude that consideration of the Agency's deterrence interests is not warranted.''). ``Indeed, this Agency has revoked a practitioner's registration upon proof of as few as two acts of intentional diversion and has further explained that proof of a single act of intentional diversion is sufficient to support the revocation of a registration.'' David A. Ruben, M.D., 78 FR at 38,386 (citing Dewey C. MacKay, M.D., 75 FR 49,956, 49,977 (DEA 2010)). Respondent's improper prescriptions to A.B., S.M., and Z.M. clearly constitute intentional diversion. He admits to improperly prescribing a highly abused drug, hydrocodone, to a known drug addict, A.B., and two of her friends, S.M. and Z.M.. While he only wrote one prescription each to S.M. and Z.M., he continued to prescribe controlled substances to A.B. for over a year, totaling fifty-four distributions of controlled substances, including refills. [Gov't Exhs. 12-14]. Thus, although Respondent's improper prescribing practices were limited to A.B. and a few of her friends, under DEA precedent they clearly warrant sanctions to deter Respondent and others from repeating the practice. I will not recommend, however, that the Agency deny Respondent's registration altogether. While Respondent's improper prescriptions are troubling to say the least, the DEA has granted registrations with restrictions to respondents whose misconduct was more egregious and/or lasted longer than the misconduct of Respondent here. David A. Ruben, M.D., 78 FR at 38,386 (granting a registration to a respondent who improperly prescribed drugs after being placed on probation by state board); Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755, 36,757-58 (DEA 2009) (granting a registration to a respondent who prescribed controlled substances for seven years based on an expired registration); Michael S. Moore, M.D., 76 FR 45,867, 45,868 (DEA 2011) (granting a registration to a respondent who was convicted of growing and distributing marijuana); Roger D. McAlpin, D.M.D., 62 FR 8,038, 8,040 (DEA 1997) (granting a registration to a respondent who self- abused controlled substances for sixteen years and forged a prescription to obtain controlled substances). In each of these cases, the DEA granted the respondents' registrations but also imposed restrictions, suspensions, or conditions. Where the respondent intentionally diverted controlled substances, the Agency required the respondents to periodically submit logs of all controlled substances they prescribe and suspended the respondents' registrations for periods of time commensurate with the severity of the misconduct. See Ruben, M.D., 78 FR at 38,387-88; Gregory D. Owens, D.D.S., 74 FR at 36,757-58; Moore, 76 FR at 45,869. Where the respondent self-abused controlled substances, the Agency required the respondent to submit to random drug tests. See Moore, 76 FR at 45,869; McAlpin, 62 FR at 8,040-41. Given that Respondent has a history of self-abuse and improper prescriptions, similar conditions are appropriate here. I also note that some of the oversight currently placed over Respondent may not be present if he is granted a DEA registration. Specifically, it is not clear from the record how much of the oversight of Respondent by ACTC would be conducted if Respondent had an unfettered DEA registration. Indeed, some of the oversight conducted by ACTC, such as approval from other doctors for prescriptions of controlled substances, is done precisely because Respondent has no DEA registration and thus is not authorized to dispense controlled substances. This part of oversight would presumably--though not necessarily--be lifted if Respondent were granted a DEA registration. Moreover, Respondent expressed at the hearing his desire to work as a gastroenterologist, so he may not be under ACTC supervision much longer. [Tr. 233]. Given Respondent's history of improper prescribing, DEA is justified in placing certain restrictions on Respondent's COR to ensure precise compliance with the CSA and DEA regulations in the event that ACTC no longer supervises Respondent's prescribing practices. VI. CONCLUSION AND RECOMMENDATION Therefore, given that Respondent has a history of both self-abuse and intentional diversion but has demonstrated genuine remorse and instituted significant remedial measures, I recommend that Respondent's registration be granted with the following conditions: (1) For six months following the publication of the Deputy Administrator's final order in this case, Respondent shall keep a log of all controlled substance prescriptions he issues. Said log shall be maintained in chronological order, and shall list each patient by name, and include the name of the drug prescribed, the number of refills authorized, the strength of the dosage unit, the quantity, and the dosing instruction. Not later than ten days following the end of each calendar month, Respondent shall provide the local DEA field office with a complete copy of the log for the preceding month. If during any month Respondent is required to maintain said logs he prescribes no controlled substances, he shall submit a letter declaring such to the local DEA field office no later than ten days following the end of that month. (2) Respondent shall agree to have no intentional contact with A.B., S.M., Z.M., or any other person with whom Respondent abused controlled substances. (3) Respondent shall comply with the terms of his probation instituted by the Board and shall comply with any other conditions the Board shall see fit to impose on his license or registration. (4) Respondent shall notify the local DEA field office if he fails any drug screen administered by any entity. I further recommend that Respondent's registration be suspended for six months following the effective date of his registration. Dated: March 25, 2014. Gail A. Randall, Administrative Law Judge. [FR Doc. 2015-17309 Filed 7-13-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41079
The facts in Volkman pertaining to record in this case occurred over a comparatively The Government filed Exceptions to the
keeping violations involved a doctor who short period of time, with substantially fewer Recommended Decision.
‘‘rapidly became the largest practitioner- controlled substances, and with no evidence Having reviewed the record in its
purchaser in the nation of oxycodone’’ which of actual diversion of any controlled entirety, I have decided to adopt the
included ordering ‘‘hundreds of thousands of substances. The Government cites no other ALJ’s findings of fact and conclusions of
dosage units of these drugs’’ over time precedent to support a revocation sanction
periods as short as several months. Id. at on facts similar to Respondent’s, nor does
law.2 However, for reasons explained
30,643. The facts in Volkman further there appear to be any. The Respondent’s below, I respectfully amend the ALJ’s
reflected that no dispensing logs were errors and conduct clearly were neglectful recommended sanction because it is
maintained, at times exceeding an entire and serious during the relevant time period, contrary to precedent and, in my
year. Id. at 30,645. and likely due in part to ongoing issues opinion, gives insufficient weight to the
Additionally, where a registrant has including eviction from her registered office, Agency’s interest in deterring
committed acts inconsistent with the public employee problems, and an office break-in intentional diversion, both on the part
interest, a registrant must accept and theft, among other factors. That said, a of Respondent and the community of
responsibility for his or her actions and revocation penalty is simply not rationally
demonstrate that he or she will not engage in
registrants. See David A. Ruben, 78 FR
related to the evidence of record established 38363, 38386 (2013). A discussion of the
future misconduct. Patrick W. Stodola, 74 FR by substantial evidence or proportionate to
20,727 (DEA 2009). Also, ‘‘[c]onsideration of Respondent’s misconduct.
Government’s Exceptions follows.
the deterrent effect of a potential sanction is I find that Respondent’s testimony as a The Government’s Exceptions
supported by the CSA’s purpose of protecting whole demonstrates that she has sufficiently
the public interest.’’ Joseph Gaudio, 74 FR accepted responsibility for her actions and The Government raises two
10,083, 10,094 (DEA 2009). omissions with regard to a revocation exceptions to the ALJ’s recommended
The Respondent testified in substance that penalty, but Respondent’s explanation of past decision: First, it takes exception to the
she updated her new registration address errors and demonstrated plan to avoid future ALJ’s finding that Respondent ‘‘ ‘has
with Texas authorities, made various efforts violations is insufficient to support an sufficiently accepted responsibility for
to do so with DEA including receiving unconditional registration. Accordingly, I his actions and instituted remedial
correspondence, and therefore thought she recommend that Respondent’s COR measures to ensure that the misconduct
had satisfied her obligation. (Tr. 161–63; ALJ BC0181999 as a practitioner not be revoked
Ex. 2.) Respondent’s explanation for record will not reoccur.’ ’’ Exceptions, at 2
or a pending application denied, on the
keeping violations is less specific. The (quoting R.D. 36). Second, it argues that
condition that Respondent: a) within a
Respondent’s testimony as a whole reasonable period of time as set forth in the
the ALJ’s recommended sanction is
demonstrated that she understood the agency’s final order in this matter, satisfy the inconsistent with agency precedent.
seriousness and importance of record appropriate DEA designee that Respondent Exceptions, at 5–6.
keeping requirements, and testified that has state authority to handle controlled As for the first exception, the
while at the temporary Collier street location substances in Texas, the state in which she Government urges that I reject this
‘‘I didn’t have those little DEA 222s, so I is registered with DEA; 65 b) submit to the finding, contending that Respondent
really didn’t purchase any scheduled nearest Field Division Office of DEA no later ‘‘continues to[] minimize the nature of
medications during that brief period of time.’’ than one (1) year after issuance of a DEA his misconduct.’’ Id. at 4–5. As support
(Tr. 197.) The Respondent also testified that COR, documentation reflecting successful for its contention, the Government cites
she believed she ‘‘had very effective completion of accredited training at
oversight’’ of controlled substances.’’ (Tr. Respondent’s testimony regarding his
Respondent’s expense, in the proper
248.) This belief is contradicted by treatment at a rehabilitation center
maintenance, inventory, and record-keeping
Respondent’s own testimony. Respondent requirements for controlled substances, with which it maintains was inconsistent
also testified that she relied heavily on her such training to take place after the Agency with his conduct during his stay. More
staff with regard to inventory and issues a final order in this matter; and c) for specifically, the Government notes
maintenance of controlled substances, and one (1) year after the issuance of a COR, Respondent’s testimony that:
that Respondent did very little herself. (Tr. Respondent shall submit to the nearest Field it was a little bit difficult to acclimate myself
205.) The evidence of record does Division Office of DEA, on a quarterly basis, for the first few weeks, probably six weeks.
demonstrate, however, that Respondent’s a log of all controlled substances in It took me a while to kind of get into the flow
errors were often due to lack of knowledge, Schedules II, III, IV and V received, of things. Thereafter, I’d like to think I
omission or neglect, rather than a deliberate maintained and dispensed by Respondent. became a model participant. I spent seven
violation of the record keeping requirements. months there.
Dated: October 26, 2010
The alleged conduct supported by
substantial evidence in this case centers on s/ Timothy D. Wing, Tr. 210. The Government then notes
Respondent’s record keeping violations, Administrative Law Judge that Respondent was subject to a ‘‘no
which have been documented to be deficient [FR Doc. 2015–17310 Filed 7–13–15; 8:45 am] female contract’’ during the initial four
over a relatively short period of time, as well BILLING CODE 4410–09–P months of his treatment, and that he
as a failure to update her registered address, breached the contract when he had
and improper acceptance and disposal of contact with another patient and
returned controlled substances from patients. DEPARTMENT OF JUSTICE
The Government argues in its post-hearing
engaged in sexual relations with her
brief that revocation is the appropriate Drug Enforcement Administration 2 As ultimate factfinder, I am familiar with my
remedy in this case. An agency’s choice of
obligations under the Administrative Procedure Act
sanction will be upheld unless unwarranted [Docket No. 13–24]
and the role of the ALJ’s recommended decision.
in law or without justification in fact. A See Universal Camera Corp. v. NLRB, 340 U.S. 474,
sanction must be rationally related to the Trenton F. Horst, D.O.; Decision and 496 (1951) (‘‘The ‘substantial evidence’ standard is
evidence of record and proportionate to the Order
asabaliauskas on DSK5VPTVN1PROD with NOTICES
not modified in any way when the Board and its
error committed. See Morall v. DEA, 412 F.3d examiner disagree . . . . The findings of the
165, 181 (D.C. Cir. 2005) (sanction will be On March 25, 2014, Administrative examiner are to be considered along with the
upheld unless unwarranted in law or without Law Judge Gail A. Randall (ALJ) issued consistency and inherent probability of testimony.
The significance of his report, of course, depends
justification in fact). the attached Recommended Decision.1 largely on the importance of credibility in the
In support of its recommendation for particular case.’’) (emphasis added). So too, the
revocation, the Government cites Paul H. 65 21
U.S.C. 824(a)(3). courts are quite familiar with the standard of review
Volkman, 73 FR 30,630, 30,644 (DEA 2008), 1 All
citations to the Recommended Decision of an Agency decision. Accordingly, I decline to
which is significantly distinguishable from (R.D.) are to the ALJ’s slip opinion as originally publish the ALJ’s discussion of the substantial
the facts of this case. Respondent’s conduct issued. evidence test and the standard of review.
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![41080 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
approximately two months into his stay. involve a violation of the Controlled With respect to S.M., at a minimum,
Exceptions, at 2. The Government Substances Act or applicable state law the evidence showed that Respondent
implies that his testimony was (as would failing a drug test), constitutes issued him a prescription for 60 tablets
disingenuous because the incident conduct which may threaten public of hydrocodone/apap with three refills.5
occurred two weeks later than health or safety. Cf. Mark G. Medinnus, See GX 13. As for Z.M., the evidence
Respondent claimed it did. Id. The 78 FR 62683, 62684 (2013) (rejecting shows that Respondent issued him a
Government does not, however, explain contention that violation of internal prescription for 40 tablets of Lortab 7.5
why it matters whether the incident clinic operating policy, which did not with two refills. GX 14.
occurred six weeks or two months into otherwise violate CSA or state law, Respondent did not dispute that he
his stay. constituted conduct inconsistent with failed to perform a physical exam on
The Government also maintains that the public interest.). A.B., S. M., and Z.M., or that the
Respondent engaged in a pattern of Because Respondent’s breach of his prescriptions were improper. Indeed, he
minimizing his misconduct, both during no-female contract does not constitute testified that: ‘‘[i]mproper, I think, is a
his time in treatment and in his actionable misconduct under the public weak word. I think it was stupid. I think
testimony at the hearing. In support of interest standard, his testimony you used the word ‘idiotic’ earlier.’’ Tr.
this contention, it cites evidence regarding the incident is not relevant in 201 (testimony regarding prescriptions
showing that Respondent admitted his assessing whether he has accepted to A.B.); see also id. at 203 (admitting
breach of the no-female contract to the responsibility for his misconduct. While that the prescriptions to S.M. and Z.M.
treatment center staff only upon this evidence is arguably relevant in were ‘‘very improper’’).
learning that he was going to be subject assessing Respondent’s claim that he While Respondent also asserts that he
to a polygraph. As for his testimony, the has been rehabilitated, it is undisputed received no monetary gain from writing
Government argues that ‘‘Respondent that he successfully completed inpatient these prescriptions, see Tr. 204, this is
did not divulge that he broke [the] treatment, that he has been in irrelevant. What is relevant is that
contract . . . on direct examination.’’ Id. compliance with his Oklahoma Health Respondent knowingly and improperly
at 3. It then argues that even on cross- Professionals Program contract, and that diverted controlled substances to three
examination, Respondent failed to he passed all of his random drug tests. individuals, including his girlfriend
truthfully answer its questions because RX 2. A.B., whom he knew was a drug abuser.
he did not admit to having sexual There is, however, evidence that Further, while Respondent
relations with the female patient until supports the Government’s contention acknowledged that the prescriptions
he was specifically asked if he had sex that Respondent does not fully were improper, he then maintained that
with female patients.3 However, when acknowledge his misconduct. As he prescribed to A.B. ‘‘out of
the Government specifically asked the ultimate fact-finder, I am not bound by compassion’’ because ‘‘[s]he was in
question, he did answer it truthfully. the Government’s failure to cite this pain.’’ Id. at 252. And he further
Most significantly, to the extent the evidence which I conclude is properly asserted that she did not ‘‘use
Government relies on this incident and considered in reviewing the hydrocodone as a drug of choice, as far
Respondent’s testimony regarding it to Government’s contention that the ALJ’s as recreational drugs’’ because ‘‘[s]he
contend that he ‘‘has consistently recommended sanction is inconsistent was a methamphetamine addict.’’ Id. at
minimized his misconduct,’’ with agency precedent. 253.
Exceptions, at 5; its argument is The ALJ found that Respondent not The ALJ rejected the Government’s
misplaced. As the Government only abused methamphetamine, but that contention that Respondent’s testimony
acknowledges, the incident and his he also wrote prescriptions for was an attempt to minimize his
testimony ‘‘ha[ve] little or nothing to do controlled substances for A.B., his then- misconduct. According to the ALJ,
with controlled substances.’’ Id. at 2 girlfriend (and fellow ‘‘[w]hile the reasons Respondent gave
(emphasis added). Nor does the methamphetamine abuser), as well as for prescribing hydrocodone to A.B.
Government cite to any case holding for S.M. and Z.M., who were two of her certainly do not justify his improper
that an applicant’s breach of the terms friends. With respect to A.B., the methods of prescribing, they also do not
of a treatment contract, which does not evidence showed that between July 29, represent an attempt to minimize or
3 The Government initially asked Respondent:
2010 and September 12, 2011, rationalize his behavior.’’ R.D. at 35. In
‘‘How did you break that contract?’’ Tr. 263.
Respondent issued her 15 prescriptions the ALJ’s view, this was so because
Respondent answered that he was ‘‘a friendly for Lortab 7.5mg and 10mg (then a Respondent prefaced this testimony
person, and they would approach me, and it’s kind schedule III controlled substance 4 with ‘‘his statement that ‘it was
of hard when people talk to you, to not talk to them, which combines hydrocodone and improper and I admit that.’’’ Id. (quoting
to completely ignore them.’’ Id. While this may not
have been the answer the Government was seeking,
acetaminophen), as well as one Tr. 252).
there is no evidence that Respondent’s answer was prescription for both Xanax (alprazolam, Read more broadly, however, his
untruthful. a schedule IV drug) and promethazine testimony most certainly was an attempt
Following this, the Government asked with codeine cough syrup (schedule V). to minimize his misconduct. Indeed, on
Respondent: ‘‘Did you do more than speaking with Moreover, the Lortab prescriptions, further questioning, Respondent
females?’’ Id. Respondent answered:
I had basically what could be called a girlfriend.
which ranged from 40 to 80 tablets, testified that:
She was very attentive to me, which I was authorized 28 refills. In total, the
appreciative of. My marriage was likely in ruins, prescriptions, with refills, provided A.B.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
5 The record includes three documents from
and it was something that was—it was nice to have with approximately 2,540 tablets of Walgreens which have the caption: ‘‘Audit/Board of
someone to talk to. And once that was—basically Pharmacy Inspection Report.’’ While each of the
once that was discovered, I was placed on my no-
hydrocodone.
documents contains a copy of a prescription issued
female contract, and—well, actually I was on my by Respondent on January 27, 2011, each document
no-female contract when that was discovered, and 4 Combination hydrocodone products have since lists a different prescription number, a different
basically I got reprimanded and eventually I got my been placed in schedule II of the Controlled store number, and a different sold date. GX 13.
act together. Substances Act. See Schedules of Controlled Thus, it is unclear whether two of the documents
Id. at 264. Here again, this may not have been the Substances: Rescheduling of Hydrocodone were simply refills of the original prescription or
answer the Government was seeking, but there is no Combination Products from Schedule III to whether Respondent issued S.M. multiple
evidence that it was untruthful. Schedule II, 79 FR 49661 (2014). prescriptions on the same date.
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![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41081
. . . . I’m exquisitely sorry that I ever Finally, Respondent attempted to Yet in both Ruben and Moore, the
prescribed these things, these medicines for rationalize his prescribing to A.B. on the Agency suspended each respondent’s
these people. You know, I know that I did ground that he did not understand the registration for a period of one year. As
it improperly. I know I didn’t have proper
boundaries applicable to the practice of for the ALJ’s assertion that the
documentation. Deep down, when I was
writing them, I knew better. medicine. Id. However, this excuse does respective registrant’s misconduct in
not explain his decision to prescribe each of these cases was more egregious
Id. at 258 (emphasis added). controlled substances to both S.M. and than Respondent’s, that is certainly true
Continuing, Respondent testified that: Z.M. Indeed, it is unclear what his with respect to Ruben. But Respondent’s
Deep down, whenever I was writing them, excuse is for prescribing to S.M. and misconduct in knowingly diverting
I knew better. I let my heart and my empathy Z.M. controlled substances to three persons,
get the best of me, more than my brain. I Thus, this does not strike me as an including his girlfriend to whom he
know better now. I’ve gone through extensive provided some 2,540 dosage units of
counseling, extensive instruction, boundaries ‘‘unequivocal acceptance of
course times two, to understand what my responsibility for his misconduct.’’ R.D. hydrocodone and did so knowing that
infractions were. at 36. I need not, however, reject the she was meth addict, is itself,
ALJ’s finding that ‘‘Respondent has sufficiently egregious to warrant a
Id. (emphasis added). suspension for a period of one year. As
sufficiently accepted responsibility for
Contrary to Respondent’s assertion, his actions’’ because as the ALJ properly for Moore, while the physician’s
this was not simply a matter of not noted, ‘‘[e]ven when a respondent is misconduct in growing marijuana for
having proper documentation to support his own and his wife’s use was certainly
genuinely remorseful and has instituted
the prescriptions. Notably, while the egregious, there was inconclusive
sufficient remedial measures,’’ DEA has
ALJ apparently credited his testimony evidence as to whether he knowingly
‘‘impose[d] sanctions to deter egregious
that A.B. was in pain, noting that this distributed it to others; thus, it is
violations of the CSA’’ and ‘‘has placed
testimony ‘‘went unrebutted,’’ see R.D. debatable whether his misconduct was
special emphasis on the need to deter
at 35, the evidence shows that while more egregious than Respondent’s.
intentional diversion of controlled
Respondent prescribed to A.B for more As for Owens, the ALJ asserted that
substances.’’ Id. at 36 (citing David A.
than one year, he made no claim that he the Agency ‘‘grant[ed] a registration to a
Ruben, 78 FR 38363, 38386–87 (2013);
ever conducted a physical exam on her respondent who prescribed controlled
Joseph Gaudio, 74 FR 10083, 10094–95
or performed any diagnostic tests to substances for seven years based on an
determine whether she legitimately had (2009)).
expired registration.’’ R.D. at 37.
pain or whether her pain warranted the The ALJ noted that ‘‘Respondent’s
However, the actual decision to grant a
prescribing of controlled substances. improper prescriptions to A.B., S.M.,
registration to Dr. Owens
See Tr. 172–74 (testimony of and Z.M. clearly constitute intentional
notwithstanding the above-described
Government’s expert that the diversion.’’ R.D. at 37. I agree. So too,
misconduct had been made in a
hydrocodone prescriptions lacked a she noted that while his ‘‘improper
proceeding which was resolved seven
legitimate medical purpose and were prescribing practices were limited to
years earlier and there was no evidence
issued outside of the usual course of A.B. and a few of her friends, under
that he was diverting controlled
professional practice). DEA precedent they clearly warrant
substances. See Gregory D. Owens, 67
As for his assertion that he prescribed sanctions to deter Respondent and
FR 50461 (2002). So too, the misconduct
‘‘out of compassion’’ and ‘‘empathy,’’ others from repeating the practice.’’ Id. which gave rise to the second Owens
this too is amply refuted by his failure— Again, I agree. decision did not involve the diversion
over the course of more than one year— The ALJ also noted ‘‘[w]here the of controlled substances and was
to take appropriate steps to determine respondent intentionally diverted comparatively minor.7
the source of her purported pain. And controlled substances, the Agency Moreover, the 2002 Owens order
given his acknowledgement that he required the respondents to periodically predates the Agency’s decision in
knew early in his relationship with A.B. submit logs of all controlled substances Southwood Pharmaceuticals, Inc., 72 FR
that she was a meth addict, his claim they prescribe and suspended [their] 36487, 36504 (2007), which held for the
that he prescribed to her ‘‘out of registrations for a period of time first time that notwithstanding the
compassion’’ begs the question of why commensurate with the severity of the remedial nature of proceedings under 21
he did not usher her into treatment.6 misconduct.’’ Id. at 38 (citing Ruben, U.S.C. 823 and 824, the Agency can
Respondent also justified A.B.’s also citing Michael S. Moore, 76 FR consider the need to deter similar acts
hydrocodone prescriptions on the 45867, 45868 (2011), and Gregory D. on the part of both the individual
ground that she did not ‘‘use Owens, 74 FR 36751, 36757–58 (2009)) registrant/applicant and the community
hydrocodone as a drug of choice, as far (emphasis added). Yet notwithstanding of registrants. Indeed, this Agency
as recreational drugs’’ because ‘‘[s]he that she found Respondent’s recently denied a physician’s
was a methamphetamine addict.’’ Id. at prescriptions ‘‘troubling to say the application for a new registration based,
253. Apparently the possibility that A.B. least,’’ id. at 37, the ALJ recommended in substantial part, on his issuance of
could also have been abusing no period of suspension. prescriptions after his registration had
hydrocodone to bring her down from The ALJ offered no explanation as for expired. See Anthony E. Wicks, 78 FR
the meth she abused or was selling the why she believed a period of outright
drug to support her meth addiction suspension is unwarranted. To be sure, 7 As for the conduct which gave rise to the second
never dawned on him. earlier in her decision, the ALJ opined
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Owens proceeding, Dr. Owens was found to have
that the Agency ‘‘has granted not complied with the 2002 order because he failed
6 Even assuming that the ALJ credited to file a quarterly drug activity log during a four-
registrations with restrictions to month period between September 3 and December
Respondent’s testimony that A.B. was in pain, see
R.D. at 33, because it was undisputed that he lacked respondents whose misconduct was 31, 2002, and failed to report a 2005 state board
a legitimate medical purpose and acted outside of more egregious and/or lasted longer action. 74 FR at 36756–58. While Dr. Owens’
the usual course of professional practice in issuing than the misconduct of Respondent misconduct was considerably less egregious than
the prescriptions to her, I decline to give this that involving the intentional diversion of
testimony any weight. Indeed, the ALJ later found
here.’’ Id. (citing Ruben, Owens, Moore, controlled substances, the Agency nonetheless
that the prescriptions ‘‘clearly constitute intentional and Roger D. McAlpin, 62 FR 8038, 8040 suspended his registration outright for a period of
diversion.’’ Id. at 35. (1997)). three months. Id. at 36758.
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![41082 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
62676, 62678 (2013); see also Linda Sue to require DEA personnel to obtain an adjudication pursuant to the
Cheek, 76 FR 66972 (2011) (denying administrative inspection warrant prior Administrative Procedure Act, 5 U.S.C.
application based, in part, on to conducting an inspection. 551 et seq., to determine whether the
physician’s issuance of prescriptions Respondent shall not prescribe any Drug Enforcement Administration
without being registered). For the same controlled substances to himself, a (‘‘DEA’’ or ‘‘Government’’) should
reason, I respectfully disagree with the family member, or any person with deny 1 a physician’s application for a
ALJ’s reliance on McAlpin. whom he has or had a personal or DEA Certificate of Registration pursuant
Accordingly, notwithstanding that I romantic relationship. to 21 U.S.C. 823(f) (2006). Without his
do not reject the ALJ’s finding that Respondent shall have no intentional registration, the physician, Trenton F.
Respondent has ‘‘sufficiently accepted contact with A.B., S.M., or Z.M. Horst, D.O. (‘‘Respondent’’ or ‘‘Dr.
responsibility for his actions’’ and has Respondent shall notify the local DEA Horst’’), would be unable to lawfully
produced evidence of his remedial Field Office of the results of any drug prescribe, dispense or otherwise handle
efforts, R.D. at 36, I conclude that the test he fails, no later than three business controlled substances in the course of
ALJ’s recommended order fails to give days after receiving notification of his medical practice.
appropriate weight to the Agency’s having failed any such test. This
substantial interest in deterring the II. PROCEDURAL HISTORY
condition shall apply whether the test
intentional diversion of controlled in conducted by the Oklahoma Board of The Deputy Assistant Administrator,
substances. While I will grant Osteopathic Examiners, the Oklahoma Drug Enforcement Administration
Respondent’s application, consistent Health Professions Program, any other (‘‘DEA’’ or ‘‘Government’’), issued an
with similar cases, I will order that his licensing authority, any hospital at Order to Show Cause (‘‘Order’’) dated
registration be suspended outright for a which he seeks or obtains privileges, or February 27, 2013, proposing to revoke 2
period of one year. See Ruben, 78 FR at any other employer. the DEA Certificate of Registration, No.
38386 (imposing one-year suspension Respondent shall further notify the BH9311604, of Respondent, as a
based on acts of intentional diversion local DEA Field Office in the event that practitioner, pursuant to 21 U.S.C.
notwithstanding ALJ’s finding that the Oklahoma Board of Osteopathic 824(a)(3)–(4), and deny any pending
registrant accepted responsibility for his Examiners or the Oklahoma Bureau of applications for renewal or modification
misconduct and undertook remedial Narcotics and Dangerous Drug Control of such registration because Respondent
training); Gaudio, 74 FR at 10095 (or any other licensing authority) does not ‘‘have authority to handle
(imposing one-year suspension based on initiates any proceeding, or imposes controlled substances in the State of
acts of intentional diversion and Oklahoma’’ and because the
sanctions against his medical license or
holding renewal application in Respondent’s continued registration
state controlled substance registration
abeyance pending registrant’s would be inconsistent with the public
respectively. Respondent shall make
acknowledgement of his misconduct); interest, as that term is used in 21 U.S.C.
such notification no later than three
Jayam Krishna-Iyer, 74 FR 459, 463 823(f). [Administrative Law Judge
business days upon being notified of
(2009) (imposing one-year suspension Exhibit (‘‘ALJ Exh.’’) 1 at 1].
any such action, regardless of whether Specifically, the Order alleged that
based on acts of intentional diversion he has been formally served with either
where registrant acknowledged her Respondent was ‘‘registered with the
a complaint or order issued by any such DEA as a practitioner in Schedules II–
misconduct).8 agency.
Moreover, upon the completion of the V under DEA registration BH9311604 at
suspension, Respondent’s registration Order St. Mary’s Physician Associates, LLC,
shall be subject to the following 330 South Fifth Street, Suite 103, Enid,
Pursuant to the authority vested in me
conditions for a period of two years: Oklahoma 73701.’’ [Id.]. The Order
by 21 U.S.C. 823(f), as well as 28 CFR
Respondent shall keep a log of all further alleged that Respondent was
0.100(b), I order that the application of
controlled substances he prescribes on a without authority to handle controlled
Trenton F. Horst, D.O., for a DEA
monthly basis for each calendar month. substances in the state of Oklahoma,
The log shall list each prescription in Certificate of Registration as a
which is the state that listed on his DEA
chronological order; the patient’s name practitioner, be, and it hereby is, granted
and address; the name, quantity, subject to the conditions set forth above. 1 DEA regulations and precedent clearly establish
strength and dosing instructions for I further order that Respondent’s that ‘‘a registrant, who has been served with an
each drug prescribed; and the number of Certificate of Registration be, and it Order to Show Cause, [must] file his renewal
hereby is, suspended for a period of one application at least 45 days before the expiration of
refills authorized. Respondent shall his registration, in order for it to continue in effect
submit a copy of the log to the local year. This Order is effective past its expiration date and pending the issuance of
DEA Field Office no later than five immediately. a final order by the Agency.’’ Paul Weir Battershell,
Dated: July 6, 2015. N.P., 76 FR 44359, 44361 (DEA 2011) (citing Paul
business days following the last day of Volkman, 73 FR 30,630, 30,641 (DEA 2008)); 21
each month. Chuck Rosenberg, CFR 1301.36(i). Respondent’s Certificate of
In the event Respondent opens his Acting Administrator. Registration, Number BH9311604, expired by its
own practice, he shall consent to own terms on October 31, 2013, about eight months
unannounced inspections of his Dedra S. Curteman, Esq., for the after the Order to Show Cause was served, and
Government. Respondent did not apply for renewal until October
registered location and waive his right 31, 2013. [ALJ Exh. 14]. Thus, Respondent’s
Spencer B. Housley, Esq., for the application for renewal will be considered an
Respondent. application for registration. See Battershell, 76 FR
asabaliauskas on DSK5VPTVN1PROD with NOTICES
8 The scope of Respondent’s unlawful
prescribings far exceeds those of Dr. Krishna-Iyer, at 44,361 (holding that although the registration had
who wrote unlawful prescriptions during three
RECOMMENDED RULINGS, FINDINGS expired, the renewal application may be
undercover visits. See Jayam Krishna-Iyer, 71 FR OF FACT, CONCLUSIONS OF LAW, considered). Accordingly, the issue in this case is
52148, 52158 (2006). Moreover, this Agency has AND DECISION OF THE whether DEA should grant Respondent’s
held that proof of a single act of intentional ADMINISTRATIVE LAW JUDGE application, not whether DEA should revoke his
diversion can support the denial of an application registration.
or the revocation of an existing registration. See I. INTRODUCTION 2 As explained supra note 1, the issue is whether
Dewey C. MacKay, 75 FR 49956, 49977 (2010), pet. the DEA should grant Respondent’s application, not
for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Gail A. Randall, Administrative Law whether his registration should be revoked, as the
Cir. 2011). Judge. This proceeding is an Order to Show Cause suggests.
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![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41083
Certificate Of Registration (‘‘COR’’), the public interest,’’ the Deputy dangerous substances from the
since his Oklahoma Bureau of Narcotics Administrator ordered the Government Oklahoma Bureau of Narcotics.
(‘‘OBN’’) registration expired on October to notify his office as to whether the 5. Respondent has not been charged
31, 2011. [Id.]. The Order further alleged Government will seek a remand of the with or convicted of any federal or
that Respondent’s state osteopathic case to adjudicate that matter. [ALJ Exh. state crimes relating to the
license was suspended 3 on June 21, 10 at 2]. The Government requested a manufacture, distribution, or
2012, for a period of five years, by the remand on August 6, 2013, [ALJ Exh. 9], dispensing of controlled substances.
Oklahoma State Board of Osteopathic which the Deputy Administrator
Examiners (‘‘Oklahoma State Board’’). granted on August 23, 2013, [ALJ Exh. [ALJ Exh. 14].
[Id. at 2]. Thus, the Order stated that the 8].
B. Respondent’s Background,
DEA must revoke Respondent’s DEA The hearing in this case took place on
Employment, Registration, and
registration because he lacks authority December 17 through December 18,
Licensure
to handle controlled substances in the 2013, at the U.S. Tax Court in Oklahoma
state of Oklahoma. [Id. at 1]. City, Oklahoma. [ALJ Exh. 13]. Respondent testified credibly
On March 27, 2013, the Respondent, Respondent and the Government were regarding his medical background,
through counsel, timely filed a request each represented by counsel. At the employment, and training, facts which
for a hearing. [ALJ Exh. 2]. hearing, the Government introduced were undisputed at the hearing. [Tr.
On April 3, 2013, the Government documentary evidence and called six 182–192]. Respondent graduated from
filed its Motion for Summary witnesses and Respondent introduced Oklahoma State University College of
Disposition [ALJ Exh. 3]. On April 18, documentary evidence and called five Osteopathic Medicine with honors in
2013, the Respondent, through his witnesses, including himself. 1999. [Tr. 183]. Shortly thereafter,
attorney, filed a timely Response to After the hearing, the Government Respondent completed both an
Motion for Summary Disposition. [ALJ and the Respondent submitted proposed internship and residency at the Tulsa
Exh. 4]. On April 29, 2013, the findings of fact, conclusions of law and Regional Medical Center. [Tr. 184–85].
Government filed a reply to the argument. Upon completion of his internship and
Respondent’s Response to Motion for III. ISSUE residency, Respondent was awarded a
Summary Disposition, [ALJ Exh. 5], and fellowship at the Scott & White Clinic
on May 7, 2013, the Government filed The issue in this proceeding is
and Memorial Hospital in Temple,
a Renewed Motion for Summary whether the record as a whole
Texas, where he learned the specialty of
Disposition, [ALJ Exh. 6]. establishes by a preponderance of the
gastroenterology from 2002 to 2005. [Tr.
On May 10, 2013, I issued my evidence that the Drug Enforcement
185–86]. In 2005, Respondent began
Recommended Rulings, Findings of Administration (‘‘DEA’’ or
working in a private ‘‘single-specialty
Fact, Conclusions of Law, and Decision ‘‘Government’’) should deny the
group’’ called Digestive Disease
of the Administrative Law Judge application 4 of Trenton F. Horst, D.O.
Specialists, Incorporated. [Tr. 187].
(‘‘Summary Disposition’’), (‘‘Respondent’’), as a practitioner,
recommending that the Administrator pursuant to 21 U.S.C. 824(a)(4), and By 2007, Respondent was board-
summarily revoke Respondent’s DEA deny any pending applications for certified in both internal medicine and
registration because Respondent was renewal or modification of such gastroenterology. [Tr. 186–87]. He began
without state authority to dispense registration, pursuant to 21 U.S.C. working for St. Mary’s Hospital in Enid,
controlled substances and thus was 823(f), because his continued Oklahoma ‘‘on or about June 1, 2010’’ in
ineligible for a DEA registration as a registration would be inconsistent with a hospital-owned clinic named Red
practitioner. [ALJ Exh. 7 at 9–12]. the public interest, as that term is Carpet Gastroenterology.5 [Gov’t Exh. 6
On July 30, 2013, after my Summary defined in 21 U.S.C. 823(f). at 2; Tr. 192]. As explained in further
Disposition was delivered to the detail below, during his employment at
IV. FINDINGS OF FACT St. Mary’s, Respondent abused
Administrator, but before a final
decision was rendered by the A. Stipulated Facts controlled substances, resulting in St.
Administrator, Respondent filed a The parties have stipulated to the Mary’s terminating his employment and
Notice to Court and Amended Motion to following facts: the DEA issuing the Order to Show
Reconsider. [See ALJ Exh. 8 at 1]. Cause. After completing therapy at an
1. Respondent’s DEA registration in-patient substance abuse rehabilitation
Therein, Respondent informed DEA that BH9311604, which authorized
he had obtained an Oklahoma Board of facility, Respondent obtained
Respondent to handle controlled employment as a delivery driver for
Narcotics license which gave substances in Schedules II–V at St.
Respondent authority to handle Pizza Hut while he searched for
Mary’s Physician Associates, LLC, employment as a physician. [Tr. 229;
controlled substances, so ‘‘the 330 South Fifth Street, Suite 103,
fundamental facts of the case have now see also Tr. 33, 60–61]. Respondent later
Enid, Oklahoma 73701, expired by worked as a ‘‘patient liaison’’ at New
changed.’’ [Id.]. Consequently, the its terms on October 31, 2013.
Deputy Administrator ruled that ‘‘the Beginning Women’s Healthcare from the
2. Respondent submitted a renewal
finding necessary to support the fall of 2012 until April 2013, and then
application for a DEA registration
revocation of Respondent’s registration as a ‘‘chart reviewer’’ for Prairie View
on October 31, 2013.
under section 824(a)(3) can no longer be 3. Respondent has an active and valid Hospice. [Tr. 230–31]. Since May 2013,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
made.’’ [Id.]. Noting that the Order to license to practice medicine in the Respondent has been employed as a
Show Cause also alleged that State of Oklahoma.
5 While Respondent was technically an employee
Respondent’s continued DEA 4. Respondent has an active and valid
of St. Mary’s, he principally worked at Red Carpet,
registration would be ‘‘inconsistent with license to handle controlled a clinic across the street from the hospital that at
least one witness described as ‘‘a private practice.’’
3 I note here that the Oklahoma State Board of 4 As explained supra note 1, the issue is whether [Tr. 78, 100, 130, 131, 150]. Respondent was the
Osteopathic Examiners did not, in fact, suspend the DEA should grant Respondent’s application, not only physician working at Red Carpet, and he
Respondent’s license; rather, it placed the license whether his registration should be revoked, as the designed the clinic’s name and logo. [Tr. 78, 130,
on probation for five years. [Gov’t Exh. 6 at 4]. Order to Show Cause suggests. 135–136, 150].
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physician at Accident Care and on the fleshy area of the elbow)]; 199 [Tr. 85, 94 (testimony of Brenda Martin);
Treatment Center (‘‘ACTC’’). [Tr. 231]. (Respondent counsel stating that 104 (testimony of Michelle Lee Bays);
On June 29, 2005, Respondent was ‘‘[t]here’s been insinuations at least by 139 (testimony of Krista Ann Roberts);
issued DEA Certificate of Registration the Government that [Respondent was] 241–44 (testimony of Respondent)]. Ms.
(‘‘COR’’) Number BH9311604, which is IV drug-using’’)]. Respondent denied Martin testified that Respondent’s
the COR at issue in this case. [Gov’t Exh. ever using IV drugs, [Tr. 199], and, other fatigue got so bad that he would take
22 at 3]. That COR expired by its terms than the red spots, the Government ‘‘catnap[s]’’ in his office between patient
on October 31, 2013. [Tr. 27, ALJ Exh. offered no evidence to the contrary. visits and had to reschedule several
14]. Respondent also holds an active, Indeed, a drug screen taken by appointments after being late to work.
valid license to practice medicine in the Respondent in July of 2011 did not [Tr. 83–84]. Staff members took special
State of Oklahoma and an active, valid indicate any such use, and the witnesses notice of Respondent’s fatigue when
license from the Oklahoma Bureau of who testified about the spots never they saw an incoherent notation written
Narcotics to handle controlled explicitly linked the spots to drug use. by Respondent on a patient’s progress
substances. [ALJ Exh. 14]. In fact, the witness the Government note that referenced the patient ‘‘still
C. Respondent’s Substance Abuse used as an expert linked the spots to a having pain from right pink chair.’’ [Tr.
bacteria, not to drug use. [Tr. 120–21]. 85–86, 139; Gov’t Exh. 17]. Respondent
In 2009, while Respondent was While cross examining this expert, corrected the error by creating a new
employed at Digestive Disease Respondent’s attorney suggested that note from memory of the patient visit,
Specialists, Respondent met and began the explanation for the red spots was and he admitted that he had trouble
an extra-marital relationship 6 with Respondent’s cycstic acne. [Tr. 124–25]. focusing the day he wrote the original
A.B.,7 a medical assistant employed at At that time, the Government’s witness note. [Tr. 136–140; Gov’t Exh. 17].
the same location. [Tr. 78–79, 194–95, admitted that it was beyond the scope Respondent’s staff at Red Carpet
250]. Respondent first became aware of her expertise to testify about such expressed their concerns about
that A.B. was abusing controlled conditions. [Tr. 125]. The Government’s Respondent’s tardiness, fatigue, and
substances in November of 2010, when witness also testified that the red spots personal life to Michelle Bays, the
she called him and asked him to bail her ‘‘appeared to be a boil, a bite,’’ [Tr. 121], practice administrator at St. Mary’s. [Tr.
out of jail after she was charged with which is consistent with what 100, 104–105]. As a result of these
possession of marijuana, a controlled Respondent told his receptionist when reports, St. Mary’s solicited a signed
substance. [Tr. 195–96]. Soon after that, she inquired about the spots, [Tr. 86]. statement from Ms. Martin about her
in December 2010, Respondent began Given the thin evidence offered by the conversations with and observations of
using illegal substances with A.B. and Government regarding the source of the Respondent while at work. [Tr. 102–05;
eventually moved in with A.B. on July red spots on Respondent’s skin and Gov’t Exh. 19]. Respondent voluntarily
4th or 5th, 2011. [Tr. 195, 196, 198, Respondent’s several explanations for submitted to a drug test, apparently
199]. the spots, I find that the Government requested by St. Mary’s,9 on July 18,
Respondent credibly testified, and the failed to meet its burden of proof to 2011. [Tr. 115–116, 205; Gov’t Exh. 8].
Government did not refute, that before show that Respondent used IV drugs or The drug test came back positive for
moving in with A.B., Respondent had that the red spots on Respondent’s marijuana, methamphetamine, and
never taken amphetamines or elbow and neck were related to illicit amphetamines, and resulted in
methamphetamine. [Tr. 194–95]. Also, drug use. Respondent’s termination from St.
Respondent credibly testified, and the Respondent’s receptionist at Red Mary’s in August, 2011. [Tr. 118, 120,
Government did not refute, that he has Carpet, Brenda Martin, testified that 131, 206, 245; Gov’t Exh. 8]. Respondent
never been charged with or convicted of Respondent told her that he had been admits to using methamphetamine, but
any crimes involving illegal substances. present on at least one occasion while at the hearing he offered explanations
[Tr. 195; ALJ Exh. 14]. A.B. made a ‘‘drug run.’’ [Tr. 81–82; see
Several St. Mary’s employees testified also Gov’t Exh. 19]. Ms. Martin noted, ‘‘[m]ost of my, quote, tiredness came during the
that they noticed ‘‘red spots,’’ ‘‘boils,’’ however, that Respondent pointed out
month of July.’’ [Tr. 243]. Michelle Bays, the St.
or ‘‘lesions’’ on Respondent’s neck and Mary’s employee in charge of overseeing day-to-day
he did not participate in the drug operations at hospital clinics, is the only witness
elbow on at least two occasions. [Tr. 86; transactions; he stayed in the back seat who testified that Respondent’s fatigue and
119–122]. Although the reason for the of the car while the transaction was tardiness lasted longer than a month. She testified
Government soliciting testimony about that the fatigue and tardiness occurred for ‘‘more
completed. [Tr. 81–82]. Ms. Martin also than a month and a half’’ and that ‘‘[i]t was an issue
the red spots is unclear, the insinuation testified that in conversations she had for the time I—my whole time when I worked with
seemed to be that the red spots were an with Respondent, he admitted to being him.’’ [Tr. 100, 106]. Ms. Bays’s recollection of the
indication of drug use. [Tr. 119. 121–22 present while A.B. and her associates
chronology of events, however, is not reliable for
(Government witness describing marks several reasons. First, as noted above, her testimony
were ‘‘in the garage making meth,’’ regarding the timing of Respondent’s fatigue and
6 Despite the Government’s argument that
although Respondent also told Martin tardiness conflicts with the testimony of two other
that he ‘‘didn’t have anything to do with witnesses. Second, she testified that she began
Respondent speaking with co-workers about his overseeing Red Carpet in September 2009 and that
relationship with A.B. is probative of Factor Five, it.’’ [Tr. 85]. Respondent ‘‘was already there’’ at that time, [Tr.
I ruled at the hearing that the details of Several witnesses testified that at 100], but it is clear from the record that Respondent
Respondent’s romantic relationship with A.B. are some point during his employment at did not begin working at Red Carpet until June 2010
not relevant to these proceedings. [Tr. 81, 86–87]. [Gov’t Exh. 6 at 2; Tr. 131]. Thus, while I find Ms.
I now reaffirm that ruling, and only mention
St. Mary’s, Respondent began coming to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Bays to be generally credible, I find that her
Respondent’s relationship to give factual context to work tired and tardy on a regular basis.8 testimony regarding the timing of events in this case
the events that led to Respondent’s drug abuse and not credible. I also find that Respondent’s tiredness
improper prescribing, which are, of course, 8 The witnesses at the hearing did not all agree and tardiness at work occurred approximately
relevant. In making my determinations about on the longevity of Respondent’s fatigue and during the month immediately preceding his
whether Respondent’s registration is in the public tardiness. Ms. Martin testified that for the first few termination from St. Mary’s.
interest, I assign no weight to Respondent’s marital months she worked for Respondent, Respondent 9 The Government’s witnesses did not explain
indiscretions. was ‘‘very efficient and punctual’’ and that who requested the drug test, but Respondent, when
7 Before the hearing, I issued a Protective Order Respondent’s fatigue began approximately one asked who initiated the test, testified that Michelle
which protects the identities of third parties in month before his termination. [Tr. 91, 93; Gov’t Bays ‘‘escorted me to the facility where [the drug
these proceedings. [ALJ Exh. 12]. Exh. 9]. Respondent himself also testified that test] was done.’’ [Tr. 205].
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![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41085
for why marijuana and amphetamines testimony cannot be construed as a manufactured.’’ 10 [Gov’t Br. at 33]. This
were in his system. [Tr. 245]. general denial by Respondent of any circumstantial evidence is not
Regarding Respondent’s and all allegations of marijuana use. convincing in light of the credible
methamphetamine use, Respondent Thus, Respondent’s testimony is not testimony Respondent gave at the
credibly testified that he began using it inconsistent with other evidence that hearing in these proceedings, which was
in December 2010 and stopped around proves Respondent has used marijuana nearly identical to the testimony he gave
August of 2011. [Tr. 196–97]. in the past. at the Board hearing. I therefore find
Respondent testified that he used I therefore find that Respondent’s that the Government has failed to
methamphetamine ‘‘maybe twice a explanation for the positive marijuana establish that Respondent improperly
month’’ before moving in with A.B. in result on the drug screen, which was used amphetamines.
July of 2011, and ‘‘maybe once or twice corroborated by Dr. Westcott’s Respondent further testified that he
a week at most’’ after moving in with testimony on cross examination and never possessed or used illicit drugs
A.B. [Tr. 197]. Respondent also credibly unrebutted by the Government, is while at work, and St. Mary’s employees
testified that before becoming involved credible. I also find that Respondent has testified that they never concluded
with A.B., he had never used used marijuana in the past, but that the otherwise. [Tr. 123, 149, 200–01]. The
methamphetamine or any other illicit frequency of such use is unclear from Government refutes Respondent’s
drug. [Tr. 196]. The Government offered the record. In the absence of any assertion, arguing that Respondent’s use
no evidence rebutting this testimony. evidence to rebut Respondent’s credible of illicit drugs at work is evidenced by
With respect to the positive result for testimony regarding the drug test, the fact that ‘‘he tested positive for these
marijuana on the drug test, Respondent however, I find that the Government drugs while on the job and commuted
credibly testified that marijuana was in failed to establish that the positive a great distance to his job.’’ [Gov’t Br. at
his system at the time of the drug screen result for marijuana on the drug test was 29–30]. Yet, Respondent’s expert
because he was ‘‘exposed’’ to it while the result of Respondent’s personal use. witness testified on cross examination
living with A.B., who regularly smoked With respect to the drug screen’s that methamphetamine and
marijuana with her associates. [Tr. 245]. positive result for amphetamines, amphetamines stay in the system for
Dr. Westcott, whom I certified at the Respondent testified that amphetamines two to four days, and Respondent
hearing as an expert in addiction were in his system due to a prescription testified that it was ‘‘widely known’’
management, testified that second-hand drug he was taking called Vyvanse. that marijuana can stay in your system
marijuana smoke could cause a positive Respondent and Dr. Westcott both for up to thirty days. [Tr. at 254, 382].
result on a drug screen if the subject testified that Vyvanse is a medication The Government failed to introduce any
were exposed to a concentrated amount, used to treat Attention Deficit Disorder evidence to rebut this testimony,
but also testified that positive results for (‘‘ADD’’), and that it is ‘‘in the making considerably less plausible the
marijuana on a drug screen normally suggestion that Respondent’s drug use at
amphetamine class.’’ [Tr. 246–48, 382–
mean the subject used the drug. [Tr. home would wear off during his long
83]. Respondent testified that he was
379–82]. The Government, on the other commute. I therefore find that the
issued a valid prescription for Vyvanse
hand, presented no evidence to rebut Government failed to establish that
in 2009, and began taking pills leftover
Respondent’s explanation for the drug Respondent used or possessed illicit
from that prescription every day when
test’s positive result for marijuana, drugs while at work.
ADD symptoms began to reoccur about
opting instead to simply argue that Within hours of his termination,
a week and a half before he failed the
Respondent’s explanation was an which immediately followed his failed
drug screen at St. Mary’s. [Tr. 246, 248–
‘‘attempt[] to minimize the significance drug test, Respondent voluntarily
49]. This explanation is corroborated by
of his failed drug screen.’’ [Government reported himself to the State Board of
Brief (‘‘Gov’t Br.’’) at 33]. two exhibits the Government itself Osteopathic Examiners (‘‘State Board’’
To be sure, Respondent has used introduced. First, the Board Order found or ‘‘Board’’) and the Oklahoma Health
marijuana in the past. At the Board that Respondent ‘‘contacted the Board Professional Program (‘‘OHPP’’). [Tr.
hearing, Respondent testified that he and confirmed that he had tested 206–07; Gov’t Exh. 6 at 2]. However,
had used marijuana with friends on a positive for . . . Vyvanse.’’ [Gov’t Exh. Respondent did not report himself to
‘‘sporadic, recreational’’ basis. [Gov’t 6 at 2]. Second, at the Board hearing, the DEA. [Tr. 273]. In fact, Respondent
Exh. 21 at 11]. Furthermore, Respondent testified to the same facts did not communicate with the DEA
Respondent’s discharge summary from regarding his Vyvanse use as he did at about his drug abuse until about a year
Santé, appended to the Board hearing the hearing in these proceedings. [Gov’t later. [Tr. 274].
transcript, notes that Respondent had Exh. 21 at 14–15]. Respondent and Dr. As a result of Respondent contacting
‘‘secondary’’ issues with ‘‘cannabis Westcott also testified that Vyvanse the Board, the Board conducted an
abuse.’’ [Gov’t Exh. 21, Attach. 1]. But stays in the system for at least two days, investigation and held a hearing on June
none of this evidence contradicts and that in a drug test it would likely 21, 2012, after Respondent returned
Respondent’s testimony at the hearing result in a positive result for
in these proceedings regarding his amphetamines. [Tr. 248, 383]. Similar to 10 The Government also suggested, without
marijuana use. In these proceedings, its approach to the marijuana issue, the overtly accusing, that Respondent acted improperly
Government opted to not offer any by taking ‘‘a two year-old prescription for which he
Respondent never testified that he had did not seek the care of a doctor in a recent visit.’’
never used marijuana; Respondent evidence to rebut Respondent’s [Gov’t Br. at 33 (emphasis in original); Tr. at 246
merely testified that the particular drug explanation of the positive
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(Government counsel asking Respondent, ‘‘So you
screen he failed was the result of amphetamine result, instead arguing took it outside the usual course of professional
that ‘‘Respondent would have the Court practice[?]’’)]. The Government, however, cites no
exposure to marijuana rather than his regulation, and I can find none, that forbids the use
personal use. [Tr. 245]. Indeed, the believe [his] less than plausible of ‘‘leftover’’ prescription drugs. Further, the
Government never asked Respondent explanation in the face of unrefuted Government has offered no evidence to establish
generally whether he had ever used evidence that he tested positive at a that the Respondent’s prescription for Vyvanse
time when he was dating a restricted his use of the drug two years after the
marijuana; it only asked whether the issuance of the prescription. I therefore find that the
failed drug screen was the result of methamphetamine addict and living at Government failed to establish any wrongdoing by
marijuana use. [Tr. 245]. In context, this her house where methamphetamine was Respondent regarding his consumption of Vyvanse.
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home from in-patient therapy.11 [Gov’t and testified that he could ‘‘find no include Hydrocodone, Promethazine
Exh. 6 at 1; Tr. 207–208]. The same day documentation that would support the with Codeine syrup, and Alprazolam.
as the hearing, the Board issued a legitimate medical purpose of controlled Dr. Horst admitted that he had an
Findings of Fact, Conclusions of Law, medications.’’ [Tr. 170–172; Gov’t Exhs. extramarital affair with patient AB.
and Agreed Order of Probation (‘‘Board 9–14, 16]. Specifically, Dr. Beacham 8. Patient SM’s chart includes a
Order’’), which is pertinent to these testified that there was ‘‘no patient registration and medical history,
proceedings and binding on this Court documentation to support history or but no physical examination. Chart is on
under the principles of collateral present illness or a physical exam or an the Clinic’s patient record forms. There
estoppel. [Gov’t Exh. 6; Tr. 30]; David A. assessment nor a plan.’’ [Tr. 172–73]. are no prescribed medications or exam
Ruben, 78 FR 38,363, 38,365 (DEA Thus, Dr. Beacham concluded that, in notes recorded. Beginning January 27,
2013); Robert L. Dougherty, M.D., 76 FR his expert opinion, ‘‘the prescriptions 2011 Dr. Horst issued patient SM two
16,823, 16,830 (DEA 2011). Specifically, were written for a matter outside (2) CDS prescriptions of Hydrocodone
in relation to Respondent’s drug abuse, medical necessity.’’ [Tr. 173–74]. Dr. with one (1) refill. None of these
the Board found the following: Beacham also prepared a report prescriptions are charted.
containing these same conclusions, 9. Patient ZM’s chart includes a
3. On or about August 2, 2011, St. medical history, but no patient
Mary’s Regional Medical Center which was also admitted into evidence
without objection. [Tr. 171; Gov’t Exh. registration and no physical
(‘‘Hospital’’) in Enid, Oklahoma examination. Chart is on the Clinic’s
terminated Dr. Horst’s employment at 16]. Respondent admitted to issuing the
improper prescriptions and did not patient record forms. There are no
the Hospital. Dr. Horst had failed a drug prescribed medications or exam notes.
screen and tested positive for marijuana, refute the testimony of the
Government’s expert witness. [Tr. 201– On November 29, 2010 Dr. Horst issued
methamphetamine and another drug. patient ZM one (1) CDS prescription of
4. Dr. Horst contacted the Board and 04].
Respondent filed the patients’ records Hydrocodone with two (2) refills. This
confirmed that he had tested positive for prescription is not charted.
marijuana and a C–II medication of A.B., S.M., and Z.M. in his own desk
rather than with Red Carpet’s other [Gov’t Exh. 6 at 2–3]. As noted above,
Vyvanse for ADHD. Dr. Horst also
patient files. The records were found by Respondent stipulated to all of these
confirmed that the Hospital had
a St. Mary’s employee 12 in facts at the Board hearing and testified
terminated his employment.
Respondent’s desk drawer after at the hearing in the present
[Gov’t Exh. 6 at 2]. Respondent proceedings that he agreed with the
stipulated to and ‘‘[did] not contest any Respondent’s termination from St.
Mary’s, and Respondent admits that he Board’s findings. [Gov’t Exh. 6 at 2; Tr.
of the factual allegations raised by the 217]. Additionally, the Board concluded
Board.’’ [Gov’t Exh. 6 at 2]. Respondent should have filed those files with the
rest of the clinic’s records. [Tr. 131–36, that Respondent’s actions constituted ‘‘a
also testified at the hearing in the violation of the Oklahoma Osteopathic
present proceedings that he agreed with 203; Gov’t Exhs. 9–11].
The Board Order included factual Medicine Act, 59 O.S. §§ 620 et seq.,
the Board’s findings. [Tr. 217]. and specifically . . .
findings regarding Respondent’s
D. Improper Prescriptions illegitimate prescriptions. These § 637(A)(2)(f)(g)(12) and (13).’’ [Gov’t
findings, as noted above, are binding on Exh. 6 at 4].
In addition to Respondent’s illicit
drug use, the Government proved, and this court. Ruben, 78 FR at, 38,365; E. Respondent’s Remedial Actions and
Respondent admitted, that Respondent Dougherty, 76 FR at 16,830. Specifically, Oversight of Respondent
issued illegitimate prescriptions for the Board found the following:
6. Upon Dr. Horst’s termination of Upon suggestion by the former OHPP
purposes other than legitimate medical president, Respondent checked himself
purposes. [Tr. 170–172, 201–04; Gov’t employment by [St. Mary’s], staff at the
[Red Carpet] Clinic discovered patient into an in-patient rehabilitation facility
Exhs. 9–14, 16]. Respondent wrote the in Argyle, Texas, called Santé Center for
prescriptions in question for three charts in Dr. Horst’s office that were
kept separate and apart from the Clinic’s Healing (‘‘Santé’’) on October 12, 2011.
patients: A.B., Z.M., and S.M. [Tr. 170– [Tr. 208–09]. Respondent testified that
172, 201–04; Gov’t Exhs. 9–14, 16]. patient records. These separate charts
represented patients never scheduled or he paid for his time at Santé by
Patient A.B. was the same A.B. with ‘‘cash[ing] in everything we had as far
which Respondent was romantically seen by Clinic staff. They represent
patients AB, SM, and ZM. as IRAs, 401(k)s, profit-sharing,
involved, and the other two were A.B.’s anything that we’d saved up over the
7. Patient AB’s chart includes a
friends. [Tr. 201, 203]. Respondent years.’’ [Tr. 210]. Half of the money
patient registration and medical history,
admitted that he knew A.B. abused Respondent gathered went to Santé, and
but no physical examination. Chart is on
controlled substances when he issued the other half ‘‘went to sustaining [his]
the Clinic’s patient record forms. There
her the improper prescriptions. [Tr. family while [he] was gone.’’ [Tr. 210].
are no prescribed medications or exam
196–97, 251–52]. Respondent also testified that even after
To prove Respondent illegitimately notes recorded. Beginning July 29, 2010
Dr. Horst issued to patient AB sixteen ‘‘cashing out’’ many of his assets,
issued the prescriptions in question, the Respondent still owes Santé $87,000.
Government offered Dr. Arthur Douglas (16) prescriptions of controlled
dangerous substances (CDS) with [Tr. 210].
Beacham, III as an expert witness in the Respondent described his experience
area of osteopathic medicine with an seventeen refills up until his
at Santé as ‘‘intensive,’’ especially in the
emphasis in pain management. [Tr. 164; termination by the Hospital. None of
beginning. [Tr. 209–210]. The staff there
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Gov’t Exh. 15]. Dr. Beacham reviewed these prescriptions are charted. They
did various tests and evaluations on
patient files and prescriptions written 12 There are no allegations of privacy invasions Respondent when he arrived, and the
by Respondent for A.B., Z.M., and S.M., regarding the St. Mary’s employee finding the files daily therapy regimen started early in
in Respondent’s desk drawer. The St. Mary’s the morning and lasted until 7:00 p.m.,
11 As explained below, the hearing took place so employee who found the patient files in utilizing several different techniques
long after Respondent’s termination from St. Mary’s Respondent’s desk, Krista Roberts, testified that she
because Respondent had checked into an in-patient found the files after she offered to help Respondent
such as group and one-on-one therapy.
rehabilitation center and his hearing was continued. clean out his desk and that Respondent consented [Tr. 209–210]. While at Santé,
[See Gov’t Exh. 5]. to her help. [Tr. 132–33]. Respondent was required to isolate
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himself from those outside the treatment subsequent Board meetings; and (5) Westcott testified that the OHPP has a
facility, and was not even permitted to reimburse the Board for the costs it 90% success rate of helping physicians
discuss medical issues with other incurred in conducting its proceedings. stay sober. [Tr. 367–68]. The
patients. [Tr. 214–15]. Respondent [Gov’t 6 at 4; Tr. 217–20]. Government offered no evidence to
candidly admitted during direct Respondent’s agreement with the refute that Respondent has been diligent
examination that ‘‘it was a little bit OHPP required Respondent to submit to in abiding by the terms of his probation.
difficult to acclimate myself for the first random bimonthly drug tests and attend In addition to the conditions of
few weeks, probably six weeks,’’ but at least 75 percent of the weekly Respondent’s probation, the Board itself
after the initial acclamation phase, he ‘‘Caduceus meetings’’ conducted by conducts a certain amount of oversight
‘‘became a model participant.’’ [Tr. 210; OHPP. [Tr. 218–19; Resp’t Exh. 1]. over physicians who have been
see also Tr. 258–260; but see Tr. 408; Caduceus meetings are similar to disciplined. Most notably, at least every
Gov’t Exh. 21, Attach. 1]. On cross Alcoholics Anonymous meetings, but quarter, the Board uses the Prescription
examination, Respondent also admitted tailored specifically for physicians. [Tr. Monitoring Program (‘‘PMP’’) 16 to
that he broke a ‘‘no female contract’’ at 351–52]. Dr. Robert Westcott, the review the prescriptions issued by
Santé by having a sexual relationship president of the OHPP, testified that disciplined physicians. [Tr. 370–71].
with a female patient.13 [Tr. 260–64]. Caduceus meetings are a place where DEA investigators also have access to
In addition to his drug abuse therapy, physicians can ‘‘discuss issues about the PMP, and use it to monitor
Respondent completed a program at being in recovery and being a physician registrants suspected of misconduct.
Santé entitled ‘‘Maintaining Proper that you really can’t talk about in just a [See Tr. 39–40].
Boundaries,’’ which, according to a regular open AA meeting.’’ [Tr. 352]. Respondent is also subject to
letter from the medical director at Santé, Respondent testified that since entering oversight at his current place of
is a comprehensive educational and into an agreement with OHPP, he has employment, ACTC. [Tr. 422]. Dr.
experiential course designed to address not failed any of his required drug tests Richard Swenson, the medical director
the factors that lead to boundary and has 100 percent attendance at the in charge of supervising the physicians
violations, result from boundary weekly Caduceus meetings.14 [Tr. 219– at ACTC, testified that the ‘‘locked
violations and are required in the 21]. Respondent testified that the OHPP cabinet or closet’’ in which the
reparation and prevention of any further has also asked him to ‘‘attend other 12- controlled substances are stored at
boundary issues. The course focuses step type meetings,’’ and that he ACTC is ‘‘under constant video
particularly on sexual boundary issues: normally attends those meetings two or surveillance’’ and the drugs themselves
including sexual boundary three times per week. [Tr. 219]. are not dispensed by the physicians. [Tr.
transgressions and interpersonal sexual Respondent also offered into evidence 418, 438]. Respondent is not permitted
boundary violations, however also an attendance log which showed that to issue prescriptions for controlled
recognizes verbal, ethical, moral and between June 16, 2012, and September substances; he must obtain approval
legal boundary violations. 12, 2013, Respondent attended from a doctor with an unfettered license
[Resp’t Exh.. 3; Tr. 212–13]. Alcoholics Anonymous meetings almost who personally meets and examines the
Respondent completed his time at every week, usually attending more than patient before issuing the prescription.
Santé on May 25, 2012, whereupon he one meeting per week.15 [Resp’t Exh. 4; [Tr. 419, 437–38].
received a ‘‘certificate of sobriety.’’ Tr. 221–23]. Although no formal procedures are in
[Resp’t Exh. 2; Tr. 213–14, 224]. Dr. Westcott, the president of the place for licensed physicians to review
Respondent testified that his ‘‘sobriety OHPP, testified that Respondent has Respondent’s charts, Dr. Swenson
date’’ is October 12, 2011. [Tr. 208–09]. fully cooperated with his OHPP testified that almost all of the clinic’s
Respondent testified that in June contract, that Respondent has ‘‘done patients come in for multiple visits and
2012, after returning from seven months very well’’ in his recovery, and that he see multiple doctors throughout the
of therapy at Santé, he met with State has ‘‘every reason to believe that course of their treatment. As such, the
Board members and investigators to [Respondent will] continue to do so.’’ charts for each patient are normally
discuss how he can ‘‘make things right [Tr. 372, 377]. He also testified that reviewed by multiple doctors. [Tr. 423–
and get on with my life, and hopefully under OHPP supervision, ‘‘it would (be) 24, 433]. Dr. Swenson also testified that
piece my career and life back together.’’ very, very unusual for a person to be ACTC has a ‘‘no tolerance’’ policy
[Tr. 217–18]. On June 21, 2012, the able to use and continue to use without regarding diversion of controlled
Board held a hearing for Respondent’s being caught.’’ [Tr. 369]. In fact, Dr. substances, meaning he would
case, which was attended by immediately report any concerns of
Respondent without counsel, and issued 14 Although the letter from OHPP offered into
diversion. [Tr. 424–25]. On cross
the Board Order the same day. [Gov’t evidence by Respondent reports slightly less than
100 percent attendance, [Resp’t Exh. 1], Respondent examination, Dr. Swenson testified that
Exh. 6]. The Board Order, to which credibly testified on direct examination that the ACTC does not conduct drug screens or
Respondent had previously agreed in reason for the discrepancy is that he was not aware enter into pain contracts before
his meeting with the Board members, of the sign-in procedures during the first few weeks
he attended the meetings. [Tr. 219]. In any case,
prescribing controlled substances
placed Respondent’s medical license on both the letter from the OHPP and Respondent’s known to be abused. [Tr. 433–36].
five years’ probation and required that testimony verify that Respondent has been faithful However, Dr. Swenson explained that
Respondent (1) enter into and comply to his contract with the OHPP regarding meeting such precautions are normally used
with a contract with OHPP; (2) regularly attendance.
only at ‘‘chronic pain management
asabaliauskas on DSK5VPTVN1PROD with NOTICES
15 The attendance logs indicated that Respondent
attend counseling sessions with ‘‘A clinics.’’ [Tr. 434]. Even Group
did not attend OHPP meetings for the weeks of July
Chance to Change’’ and report to the 8–14, 2012, September 16–22, 2012, October 21–27, Supervisor John Kushnir, the
Board on his progress in counseling; (3) 2012, October 28–November 3, 2012, January 13– Government’s representative at counsel
have no contact with A.B.; (4) appear at 19, 2013, and April 7–13, 2013. [Resp’t Exh. 4]. table at the hearing, testified that while
the next regularly scheduled Board However, the logs do not indicate whether meetings
were scheduled during those weeks; they only list ACTC had some minor bookkeeping
meeting and, when requested, at the meetings Respondent actually attended. Thus,
it is impossible to tell from the logs alone what 16 DI Survovec described the PMP as ‘‘a real-time
13 I
admitted evidence of this relationship for percentage of scheduled meetings Respondent recording of controlled substance prescriptions that
impeachment purposes only. [Tr. 292–93]. attended. are issued.’’ [Tr. 40]
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issues, the oversight ACTC conducts V. STATEMENT OF LAW AND was not forthright in his testimony
over controlled substances dispensing is DISCUSSION about his experience at Santé. [Gov’t Br.
‘‘good.’’ [Tr. 335]. A. Positions of the Parties at 32–33].
Finally, the Government argues that
Notably, ACTC has experience with 1. Government’s Position even if Respondent has shown sufficient
disciplined physicians because it works remorse and instituted remedial
with the State Board to employ The Government timely filed
Government’s Proposed Findings of Fact measures, his actions were too egregious
disciplined physicians. [Tr. 420–21]. to warrant his registration. [Gov’t Br. at
This practice began under the clinic’s and Conclusions of Law (‘‘Government’s
Brief’’) with this Court on January 31, 34–36]. Further, the Government argues
former medical director, who had that in light of the current prescription
himself experienced substance abuse 2014. In its brief, the Government set
forth proposed findings of fact, drug abuse epidemic, the need to deter
problems and was ‘‘interested in seeing improper prescribing weighs in favor of
conclusions of law, and arguments in
what he could do to help other denying Respondent’s registration. [Id.
favor of denying Respondent’s COR. The
providers that found themselves in that Government argues that it met its at 36].
same circumstance.’’ [Tr. 421]. Other burden of proving a prima facie case, 2. Respondent’s Position
than Respondent, ACTC currently primarily focusing on factors two, four,
employs one other physician and one Respondent timely filed Respondent’s
and five of the public interest analysis Proposed Findings of Fact, Conclusions
medical assistant with restricted set forth in 21 U.S.C. 823(f). [Gov’t Br.
licenses. [Tr. 420, 421]. Dr. Swenson of Law, and Argument (‘‘Respondent’s
at 24, 28]. Brief’’) on January 30, 2014. Therein,
testified that ACTC has a good track With respect to factors two and four, Respondent ‘‘fully admits to writing
record of helping physicians remain the Government points out that improper prescriptions to three
sober and reestablish their professional Respondent stipulated to the factual individuals’’ and ‘‘further admits to
careers. [Tr. 421–22]. allegations in the Board Order regarding using methamphetamine, sometimes as
his positive drug test and improper often as twice a week.’’ [Resp’t Br. at 7].
F. DEA Investigations of Respondent
issuing of prescriptions. [Id. at 25]. Respondent also notes that the entirety
DEA first interviewed Respondent in Moreover, the Government relies on its of his impropriety was during a six
August of 2012, after learning that Dr. expert witness, who testified that month time period, but does not dispute
Horst’s medical license had been put on Respondent’s prescribing of controlled that the Government has proved its
probation by the State Board. [Tr. 26, substances to A.B., S.M., and Z.M. were prima facie case. [Id.].
32]. In attendance at that interview were without a legitimate medical purpose. Rather, Respondent argues that it has
Diversion Investigator Mary Surovec, [Id. at 25–27]. rebutted the case against him with
Regarding factor five, the Government evidence that he takes responsibility for
Group Supervisor John Kushnir,
argues that Respondent’s actions of his actions and has instituted sufficient
Respondent, and Dr. Robert Westcott.
prescribing controlled substances to remedial actions to justify his
[Tr. 32]. Dr. Westcott attended the A.B., someone he knew to be a drug
meeting at the request of Respondent. registration. Respondent argues that he
abuser, were particularly harmful to the has made ‘‘significant, dramatic, and
[Tr. 32, 275, 387]. Notably, DI Surovec public health and safety given substantial efforts at rehabilitation and
testified that when asked about the Respondent’s ‘‘practic[e] as a solo [has] demonstrated commitment to fully
allegations in the Board Order, gastroenterologist in a small comply with any and all regulations
Respondent ‘‘didn’t really deny community.’’ [Gov’t Br. at 28–29]. The placed upon him by state licensure
anything.’’ [Tr. 33]. DI Surovec and GS Government also argues that boards.’’ [Id. at 7]. In particular, he
Kushnir also asked Respondent to Respondent’s admitted abuse of illicit argues that his participation in (1) a
surrender his DEA registration. [Tr. 32, and controlled substances also posed a seven-month inpatient substance abuse
55, 226, 318]. Respondent asked what threat to public health and safety. [Id. at program, (2) boundaries training, (3)
his options were, and he was told that 29]. Although Respondent insists that OHPP programs, (4) random drug
he could either surrender his license or he never used or possessed illicit drugs testing, and (5) support groups
be served with an order to show cause. at work, the Government argues that demonstrate his commitment both to
[Tr. 56, 227, 320]. Respondent told DI ‘‘the sheer fact that he tested positive for recovery from substance abuse and
Surovec and GS Kushnir that ‘‘he was these drugs while on the job and compliance with the Board’s conditions
going to think about surrendering.’’ [Tr. commuted a great distance to his job of licensure. [Id.]. Respondent also
33; 227]. Respondent testified that he demonstrates that Respondent’s argues that his substance abuse was
was hesitant to surrender his COR behavior while he was employed as a short-lived, and that he has now been
because other physicians had told him physician caused a threat to the public sober for over two years. [Id.]. Moreover,
that after surrendering a DEA health and safety.’’ [Id. at 29–30]. Respondent argues that his
registration, ‘‘you never get it back.’’ [Tr. The Government also argues that circumstances have ‘‘changed
276].17 Indeed, both DI Surovec and GS Respondent’s remedial actions are not drastically since the time of his
Kushnir testified that they did not recall sufficient to entrust him with a DEA misconduct’’; he has reconciled with his
COR because Respondent has wife, attended family counseling, ended
making any indications to Respondent
demonstrated a lack of candor with the his relationship with A.B., and even
that he would be able to regain a
DEA. The Government points out that
asabaliauskas on DSK5VPTVN1PROD with NOTICES
surrendered COR through demonstrated shortened his commute to work. [Id. at
(1) Respondent did not report to DEA 9].
compliance and rehabilitation. [Tr. 61– the positive results of the drug test he
62]. took while working for St. Mary’s, (2) B. Statement of Law and Analysis
Respondent ‘‘could not admit that his Pursuant to 21 U.S.C. 823(f) (2011),
17 The Government sought testimony from Dr. self-abuse . . . contributed to his the Deputy Administrator may deny an
Westcott that, in fact, he was the one who advised inability to perform as a doctor,’’ (3) application for a DEA COR if he
Respondent to not surrender his registration, but Dr. Respondent’s testimony was ‘‘rife with determines that such registration would
Westcott credibly denied doing such. [Tr. 391–392]. inconsistencies,’’ and (4) Respondent be inconsistent with the public
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interest.18 Similarly, pursuant to 21 ‘‘present[ ] sufficient mitigating 14]. Because his licensure does not
U.S.C. 824(a)(4), the Deputy evidence’’ to show why he can be constitute a recommendation from the
Administrator may revoke a DEA COR, trusted with a new registration. See Board, however, I find that factor one
if he determines that such registration Medicine Shoppe—Jonesborough, 73 FR weighs neither for nor against
would be inconsistent with the public 364, 387 (DEA 2008). To this point, the Respondent’s registration.
interest. In determining the public Agency has repeatedly held that the
Factors Two and Four: Registrant’s
interest, the following factors are ‘‘registrant must accept responsibility
Experience with Controlled Substances
considered: for [his] actions and demonstrate that
and Registrant’s Compliance with
(1) The recommendation of the [he] will not engage in future
Applicable State, Federal, or Local
appropriate State licensing board or misconduct.’’ Id.; see also Samuel S.
Laws Relating to Controlled Substances
professional disciplinary authority. Jackson, D.D.S., 72 FR 23,848, 23,853
(2) The applicant’s experience in (DEA 2007). The Respondent must Respondent’s experiences with
dispensing, or conducting research produce sufficient evidence that he can handling controlled substances, as well
with respect to controlled be trusted with the authority that a as his compliance with laws related to
substances. registration provides by demonstrating controlled substances, are relevant
(3) The applicant’s conviction record that he accepts responsibility for his considerations under the public interest
under Federal or State laws relating misconduct and that the misconduct analysis. Pursuant to the Controlled
to the manufacture, distribution, or will not reoccur. See id.; see also Substances Act, ‘‘[p]ersons registered by
dispensing of controlled substances. Samuel S. Jackson, D.D.S., 72 FR at the Attorney General under this
(4) Compliance with applicable State, 23,853. The DEA has consistently held subchapter to . . . dispense controlled
Federal, or local laws relating to the view that ‘‘past performance is the substances . . . are authorized to
controlled substances. best predictor of future performance.’’ possess . . . or dispense such
(5) Such other conduct which may Alra Laboratories, 59 FR 50,620 (DEA substances . . . to the extent authorized
threaten the public health and 1994), aff’d Alra Laboratories, Inc. v. by their registration and in conformity
safety. DEA, 54 F.3d 450, 451 (7th Cir 1995). with the other provisions of this
21 U.S.C. 823(f) (2011). subchapter.’’ 21 U.S.C. 822(b); Leonard
Factor One: Recommendation of E. Reaves, III, M.D., 63 FR 44,471,
These factors are to be considered in Appropriate State Licensing Board
the disjunctive; the Deputy 44,473 (DEA 1998); see also 21
Administrator may rely on any one or a Recommendations of state licensing CFR 1301.13(a) (providing that ‘‘[n]o
combination of factors and may give boards are relevant, but not dispositive, person required to be registered shall
each factor the weight he deems in determining whether a respondent engage in any activity for which
appropriate in determining whether a should be permitted to maintain a registration is required until the
registration should be revoked or an registration. See Gregory D. Owens, application for registration is granted
application for registration be denied. D.D.S., 74 FR 36,751, 36,755 (DEA and a Certificate of Registration is
See Robert A. Leslie, M.D., 68 FR 15,227, 2009); see also Martha Hernandez, M.D., issued by the Administrator to such
15,230 (DEA 2003) (citing Henry J. 62 FR 61,145, 61,147 (DEA 1997). person.’’). As such, the DEA properly
Schwartz, Jr. M.D., 54 FR 16,422, 16,424 According to clear agency precedent, a considers practitioners’ past compliance
(DEA 1989)). Moreover, the Deputy ‘‘state license is a necessary, but not a with CSA requirements and DEA
Administrator is ‘‘not required to make sufficient condition for registration.’’ regulations in determining whether
findings as to all of the factors.’’ Hoxie Robert A. Leslie, M.D., 68 FR at 15,230; registering such a practitioner would be
v. DEA, 419 F.3d 477, 482 (6th Cir. John H. Kennedy, M.D., 71 FR 35,705, in the public interest.
2005); see also Morall v. DEA, 412 F.3d 35,708 (DEA 2006). The regulation applicable here is
165, 173–74 (D.C. Cir. 2005). Thus, ‘‘this DEA possesses ‘‘a separate oversight DEA’s long-standing requirement that a
is not a contest in which score is kept; responsibility with respect to the prescription be issued for ‘‘a legitimate
the Agency is not required to handling of controlled substances,’’ medical purpose by an individual
mechanically count up the factors and which requires the Agency to make an practitioner acting in the usual course of
determine how many favor’’ each party. ‘‘independent determination as to his professional practice.’’ Ralph J.
Jayam Krishna-Iyer, M.D., 74 FR 459, whether the granting of [a registration] Chambers, M.D., 79 FR 4,962, 4,970
would be in the public interest.’’ (DEA 2014) (quoting 21 CFR 1306.04(a)).
462 (DEA 2009). ‘‘Rather, it is an inquiry
Mortimer B. Levin D.O., 55 FR 8,209, DEA precedent further establishes that
which focuses on protecting the public
8,210 (DEA 1990); see also Jayam ‘‘a practitioner must establish and
interest[.]’’ Id.
The Government bears the ultimate Krishna-Iyer, M.D., 74 FR at 461. Even maintain a bona-fide doctor-patient
burden of proving that the requirements the reinstatement of a state medical relationship in order to be acting ‘in the
for registration are not satisfied. 21 license does not affect this Agency’s usual course of . . . professional
CFR 1301.44(d) (2014). Specifically, the independent responsibility to determine practice’ and to issue a prescription for
Government must show that whether a DEA registration is in the a ‘legitimate medical purpose.’ ’’ Paul H.
Respondent has committed acts that are public interest. Levin, 55 FR at 8,210. Volkman, 73 FR 30,630, 30,642 (DEA
inconsistent with the public interest. 21 The ultimate responsibility to determine 2008). Whether a valid doctor-patient
U.S.C. 823(f); Jeri Hassman, M.D., 75 FR whether a registration is consistent with relationship was established is
8,194, 8,227 (DEA 2010). However, the public interest has been delegated determined by looking to state law. Id.
exclusively to the DEA, not to entities Here, Respondent issued
asabaliauskas on DSK5VPTVN1PROD with NOTICES
where the Government has made out a
prima facie case that Respondent’s within a state government. Edmund prescriptions to A.B., S.M., and A.M.
application would be ‘‘inconsistent with Chein, M.D., 72 FR 6,580, 6,590 (DEA outside the usual course of his
the public interest,’’ the burden of 2007), aff’d Chein v. DEA, 533 F.3d 828 professional practice. The Government’s
production shifts to the applicant to (D.C. Cir. 2008). expert credibly testified at the hearing
Here, it is undisputed that that after reviewing the prescriptions
18 The Deputy Administrator has the authority to Respondent holds a valid license to and the patient files, he could ‘‘find no
make such a determination pursuant to 28 CFR practice medicine in the state of documentation that would support the
0.100(b), 0.104 (2013). Oklahoma. [Gov’t Br. at 21; ALJ Exh. legitimate medical purpose of controlled
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medications’’ because there was ‘‘no under state or federal law. See Thomas 10,826, 10,827 (DEA 1994); David E.
documentation to support history or G. Easter II, M.D., 69 FR 5,579, 5,580 Trawick, D.D.S, 53 FR 5,326 (DEA
present illness or a physical exam or an (DEA 2004); Barry H. Brooks, M.D., 66 1988). This Agency has upheld such a
assessment nor a plan.’’ [Tr. 170–173; FR 18,305, 18,307 (DEA 2001); John S. position, ‘‘even when there [was] no
Gov’t Exhs. 9–14, 16]. Dr. Beacham’s Noell, M.D., 56 FR 12,038, 12,039 (DEA evidence that the registrant abused his
written report credibly reached these 1991). prescription writing authority’’ or when
same conclusions. [Tr. 171; Gov’t Exh. Here, the Government concedes that it there was ‘‘no evidence that the
16]. Respondent admitted to issuing the ‘‘did not introduce any evidence during practitioner committed acts involving
prescriptions improperly and did not this proceeding regarding a Federal or unlawful distribution to others.’’ Tony
refute the testimony of the State conviction for Respondent relating T. Bui, M.D., 75 FR at 49,989. In
Government’s expert witness. [Tr. 201– to controlled substances.’’ [Gov’t Br. at determining the likelihood that a
04].19 23]. Indeed, the parties stipulated that respondent’s self-abuse would impair
In addition to his issuing of improper ‘‘Respondent has not been charged with the public interest, the DEA may look to
prescriptions, Respondent’s or convicted of any federal or state the duration of the drug abuse. See
possession 20 of methamphetamine crimes relating to the manufacture, Roger D. McAlpin, D.M.D., 62 FR 8,038,
violated federal law. Under the CSA, it distribution, or dispensing of controlled 8,040 (DEA 1997) (finding ‘‘serious
is ‘‘unlawful for any person knowingly substances.’’ [ALJ Exh. 14]. However, questions regarding Respondent’s
or intentionally to possess a controlled the Government also correctly points fitness to possess a DEA registration’’
substance unless such substance was out that under DEA precedent, factor because of ‘‘his self-abuse of controlled
obtained directly, or pursuant to a valid three is not dispositive and ‘‘is of substances from at least 1974 to 1990’’).
prescription or order, from a considerably less consequence in the Here, it is undisputed that
practitioner, while acting in the course public interest inquiry.’’ [Gov’t Br. at 23 Respondent self-abused controlled
of his professional practice.’’ 21 U.S.C. (quoting Ruben, 78 FR at 38,379 n.35]. substances. Respondent admitted at the
844(a). It is undisputed that Respondent I therefore find that this factor weighs hearing that he used methamphetamine
possessed methamphetamine, which is neither for nor against Respondent’s with A.B. for about eight months and
a Schedule III controlled substance registration. admitted at the Board hearing that he
under 21 U.S.C. 812, without a has sporadically used marijuana in the
Factor Five: Such Other Conduct Which
prescription. [See Tr. 200; Resp’t Br. at past. Under factor five of the public
May Threaten the Public Health and
3]. interest analysis, this self-abuse weighs
I find that Respondent’s possession of Safety
against Respondent’s registration.
a controlled substance without a Under the fifth public interest factor, In addition to his self-abuse of drugs,
prescription, combined with his the Agency considers ‘‘[s]uch other other aspects of Respondent’s behavior
improper issuing of prescriptions to conduct which may threaten the public are also troubling under factor five. For
A.B., S.M., and Z.M., clearly weigh health and safety.’’ 21 U.S.C. 823(f)(5). example, Respondent continued
against Respondent’s registration under The Administrator has clarified this prescribing hydrocodone, a highly
factors two and four of the public language by reasoning that since abused drug, to A.B. despite knowing
interest analysis. Congress used the word ‘‘may,’’ factor that A.B. regularly abused controlled
five includes consideration of conduct substances such as methamphetamine
Factor Three: Registrant’s Conviction ‘‘which creates a probable or possible and marijuana. Also, while Respondent
Record Relating to Controlled threat (and not an actual) threat [sic] to did not personally take part in the sale
Substances public health and safety.’’ Roni Dreszer, or manufacturing of any illegal drugs, he
Pursuant to 21 U.S.C. § 823(f)(3), the M.D., 76 FR at 19,434; Michael J. Aruta, was present or nearby while an illegal
Deputy Administrator may deny a 76 FR 19,420, 19,420 (DEA 2011); Beau transaction took place and while
pending application for a certificate of Boshers, M.D., 76 FR 19,401, 19,402 n.4 methamphetamine was being
registration upon a finding that the (DEA 2011); Jacobo Dreszer, M.D., 76 FR manufactured. Taking into
applicant has been convicted 21 of a 19,386, 19,386 n.3 (DEA 2011). consideration these facts, combined
felony related to controlled substances Taking into consideration Congress’s with Respondent’s self-abuse of
clear statutory language and legislative controlled substances, I find that factor
19 The Government also produced evidence, and
intent under the CSA, misconduct five weighs against Respondent’s
Respondent admitted, that Respondent stored considered under factor five also ‘‘must
A.B.’s, S.M.’s, and Z.M.’s patient files in his own registration.
desk rather than with Red Carpet’s other patient be related to controlled substances.’’ Having found that factors two, four,
files. [Tr. 132–36, 203; Gov’t Exhs. 9–11]. While this Terese, Inc. D/B/A Peach Orchard and five weigh against Respondent, I
was certainly suspicious and Respondent admitted Drugs, 76 FR 46,843, 46,848 n.11 (DEA find that the Government has met its
it was improper, I can find no regulation
Respondent violated by storing the files in his desk,
2011); Tony T. Bui, M.D., 75 FR at burden to prove a prima facie case that
and the Government cites none. Indeed, the 49,989 (‘‘In short, DEA has never held Respondent’s registration would not be
Government’s argument section in its brief makes that a practitioner’s prescribing in the public interest. I now turn to
no mention of the location of the files. practices with respect to non-controlled whether remedial measures instituted
20 In order to follow agency precedent, I will take
substances provide an independent by Respondent show that he can be
into consideration evidence of Respondent’s self-
abuse of illicit drugs under the fifth public interest basis for concluding that the trusted with a DEA registration.
factor. Tony T. Bui, M.D., 75 FR 49,979, 49,989 practitioner has engaged in conduct
(DEA 2010). Thus, under factor four I only consider which may threaten public health and Remedial Measures
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Respondent’s possession of methamphetamine and Where the Government has made out
not his use.
safety and has thus committed acts
21 The Administrator interprets the term inconsistent with the public interest.’’). a prima facie case that Respondent’s
‘‘conviction’’ by affording it the ‘‘broadest possible Long-standing agency precedent registration would be inconsistent with
meaning.’’ Donald Patsy Rocco, D.D.S., 50 FR indicates that a ‘‘practitioner’s self- the public interest, the burden of
34,210, 34,211 (DEA 1985). Thus, evidence of a abuse of a controlled substance is a production shifts to the applicant to
guilty plea is probative under the third factor of the
public interest analysis. See e.g., Farmacia Ortiz, 61
relevant consideration under factor ‘‘present[ ] sufficient mitigating
FR 726, 728 (DEA 1996); Roger Pharmacy, 61 FR five.’’ Tony T. Bui, M.D., 75 FR at evidence’’ to show why he can be
65,079, 65,080 (DEA 1996). 49,989; Allan L. Gant, D.O., 59 FR trusted with a new registration. See
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![Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41091
Medicine Shoppe—Jonesborough, 73 FR unrebutted by the Government, that he Government counsel and went
at 387. To this point, the Agency has faithfully attended support group unrebutted. While the reasons
repeatedly held that the registrant must meetings, passed random drug tests, and Respondent gave for prescribing
‘‘accept responsibility for [his] actions was otherwise successful in abiding by hydrocodone to A.B. certainly do not
and demonstrate that [he] will not the terms of his probation. justify his improper methods of
engage in future misconduct. Id.; see The Government argues that prescribing, they also do not represent
also Samuel S. Jackson, D.D.S., 72 FR Respondent cannot be trusted with a an attempt to minimize or rationalize
23,848, 23,853 (DEA 2007). Specifically, COR because he was not candid with his behavior. Indeed, Respondent’s
to rebut the Government’s prima facie DEA investigators or this Court and that explanation for prescribing to A.B. was
case, the respondent is required ‘‘to his testimony was ‘‘rife with preceded by his statement that ‘‘it was
accept responsibility for [the inconsistencies.’’ [Gov’t Br. at 33]. I improper and I admit that.’’ [Tr. 252]
established] misconduct, [and] also to disagree. The Government’s first Additionally, the Government argues
demonstrate what corrective measures argument to this effect is that that Respondent’s testimony was ‘‘rife
[have been] undertaken to prevent the Respondent failed to self-report his with inconsistencies.’’ [Gov’t Br. at 33].
re-occurrence of similar acts.’’ Jeri failed drug screen to DEA, and that For example, the Government points to
Hassman, M.D., 75 FR 8,194, 8,236 when Respondent first met with DEA Respondent’s explanations as to why he
(DEA 2010) (citing Jayam Krishna-Iyer, investigators, he ‘‘failed to admit . . . the tested positive for marijuana and
M.D., 74 FR 459, 464 n.8 (DEA 2009)). fact that he issued illegal prescriptions amphetamine. As explained above,
In determining whether a respondent to A.B., S.M., or Z.M., and did not admit however, Respondent’s explanation
has accepted responsibility and whether his self-abuse of marijuana.’’ [Gov’t Br. about these drug test results were
misconduct will reoccur, the Agency at 32]. DI Surovec, however, testified credible and went unrebutted by the
has historically looked to a number of that in her first meeting with Government.
considerations, including genuine Respondent, ‘‘[w]e asked him about the The Government also argues that
remorse and admission of wrongdoing, allegation in the board order, and he Respondent was not ‘‘forthright
Lawrence C. Hill, M.D., 64 FR 30,060, really didn’t deny anything.’’ [Tr. 33]. regarding his treatment at Santé’’
30,062 (DEA 1999), lapse of time since The Board Order mentioned because he failed on direct examination
the wrongdoing, Norman Alpert, M.D., Respondent’s improper prescribing and to disclose that he broke his ‘‘no female
58 FR 67,420, 67,421 (DEA 1993), the positive result for marijuana on the contract’’ at the treatment center. [Gov’t
candor with the court and DEA drug screen. [Gov’t Exh. 6 at 2, 3]. In Br. at 33]. The Government points out
investigators, Jeri Hassman, M.D., 75 FR that context, it can hardly be said that that on direct examination Respondent
8,194, 8,236 (DEA 2010), and attempts Respondent was attempting to conceal testified that he was a ‘‘model patient,’’
to minimize misconduct, Ronald Lynch, facts from the DEA that were contained but that his breaking of the no-female
M.D., 75 FR 78,745, 78,754 (DEA 2010). in the very document about which the contract contradicts that statement.
In self-abuse cases, the Agency has DEA was questioning him. Furthermore, [Gov’t Br. at 33].22 The Government,
acknowledged that successful Respondent’s failure to self-report to the however, ignores Respondent’s
rehabilitation efforts are an important DEA does not show a lack of candor, testimony that directly precedes his
consideration in determining whether a given that he had already self-reported ‘‘model patient’’ statement: ‘‘[I]t was a
respondent can be trusted with a to the Board. [Tr. at 273–74]. Rather, little bit difficult to acclimate myself for
registration. Steven M. Abbadessa, D.O., Respondent’s explanation that he did the first few weeks, probably six weeks.
74 FR 10,077, 10,082 (DEA 2009); Tony not know he needed to self-report is the It took me a while to kind of get into the
T. Bui, M.D., 75 FR 49,979, 49,990 (DEA more plausible explanation. [Tr. 273– flow of things. Thereafter, I’d like to
2010). 74]. think I became a model participant.’’
At the hearing, Respondent stated The Government also argues that [Tr. 210]. While Respondent did not
several times that ‘‘ ‘regret’ is not even Respondent was not candid because he divulge on direct examination every
a strong enough word. I’m very ‘‘could not admit that his self-abuse . . . detail about his struggles in
remorseful for my ever going down that contributed to his inability to perform as rehabilitation, his statement that he
pathway.’’ [Tr. 197, 238]. He a doctor.’’ [Gov’t Br. at 32]. Respondent became a ‘‘model participant’’ was not
unequivocally stated that he accepts testified that he was tired at work an attempt to conceal anything.
‘‘full responsibility’’ for his misconduct because of his commute, heavy I therefore find that Respondent has
and that he is ‘‘appalled at [his] workload, and lack of sleep at A.B.’s sufficiently accepted responsibility for
behavior.’’ [Tr. 196, 238, 256, 257]. house and that using his actions and instituted remedial
Respondent also testified, and the methamphetamine, which is a measures to ensure that the misconduct
Government did not rebut, that he has stimulant, did not contribute to his will not reoccur. At the hearing,
been sober since October of 2011, fatigue. [Tr. 243–44, 249]. While this Respondent was consistent, sincere, and
confirming the effectiveness of his may seem like Respondent was trying to unequivocal in his acceptance of
treatment and his commitment to minimize the effects of his drug use, I responsibility for his misconduct. The
remaining sober. [Tr. 259]. Most find that this was merely Respondent’s success of Respondent’s rehabilitation is
importantly, Respondent provided honest assessment of his situation at the evidenced by his more than two years
unrebutted evidence of his successful time. Indeed, the Government elicited of sobriety and his faithful attendance at
rehabilitation at an inpatient facility, this testimony itself. [Tr. 243–44]. support group meetings since being
where he received intensive therapy for The Government similarly argues that
asabaliauskas on DSK5VPTVN1PROD with NOTICES
discharged from therapy. His separation
about seven months. [Tr. 210 ; Resp’t Respondent minimized his misconduct from A.B., the epicenter of most of his
Exh. 2;]. Notably, Respondent displayed by testifying that he prescribed
his genuine intent to become and hydrocodone to A.B., a known drug 22 Over Respondent counsel’s vehement objection
remain sober by spending his own abuser, ‘‘out of compassion [because] at the hearing, I allowed the Government to
money—including retirement [s]he was in pain,’’ and that introduce evidence of Respondent’s relationship
with a woman at Santé. [Tr. 261–263]. However,
investments—to pay for his ‘‘hydrocodone was not her drug of because this subject was not disclosed prior to the
rehabilitation. [Tr. 210]. Moreover, choice.’’ [Gov’t Br. at 33]. Again, this hearing, I admitted the evidence for impeachment
Respondent provided evidence, largely testimony was specifically elicited by purposes only. [Tr. 293].
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![41092 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
problems, displays his commitment to to a respondent who improperly longer supervises Respondent’s
avoiding influences that could lead to a prescribed drugs after being placed on prescribing practices.
relapse into abusing controlled probation by state board); Gregory D.
substances or improperly issuing Owens, D.D.S., 74 FR 36,751, 36,755, VI. CONCLUSION AND
prescriptions. 36,757–58 (DEA 2009) (granting a RECOMMENDATION
Even when a respondent is genuinely registration to a respondent who Therefore, given that Respondent has
remorseful and has instituted sufficient prescribed controlled substances for
remedial measures, however, the a history of both self-abuse and
seven years based on an expired
Agency sometimes imposes sanctions to intentional diversion but has
registration); Michael S. Moore, M.D., 76
deter egregious violations of the CSA. FR 45,867, 45,868 (DEA 2011) (granting demonstrated genuine remorse and
David A. Ruben, M.D., 78 FR 38,363, a registration to a respondent who was instituted significant remedial
38,386 (DEA 2013); Joseph Gaudio, convicted of growing and distributing measures, I recommend that
M.D., 74 FR 10,083, 10,094–95 (DEA marijuana); Roger D. McAlpin, D.M.D., Respondent’s registration be granted
2009). In light of the prescription drug 62 FR 8,038, 8,040 (DEA 1997) (granting with the following conditions:
epidemic, the Agency has placed special a registration to a respondent who self- (1) For six months following the
emphasis on the need to deter abused controlled substances for sixteen publication of the Deputy
intentional diversion of controlled years and forged a prescription to obtain Administrator’s final order in this
substances, which includes issuing controlled substances).
prescriptions ‘‘outside of the usual In each of these cases, the DEA case, Respondent shall keep a log of
course of professional practice and granted the respondents’ registrations all controlled substance
[without] a legitimate medical purpose.’’ but also imposed restrictions, prescriptions he issues. Said log
David A. Ruben, M.D., 78 FR at 38,386– suspensions, or conditions. Where the shall be maintained in
87; but see Tyson D. Quy, M.D., 78 FR respondent intentionally diverted chronological order, and shall list
47,412, 47,412 n.2 (DEA 2013) controlled substances, the Agency each patient by name, and include
(‘‘Because there is no evidence that required the respondents to periodically the name of the drug prescribed, the
Respondent diverted controlled submit logs of all controlled substances number of refills authorized, the
substances to others and this is a first they prescribe and suspended the strength of the dosage unit, the
offense, I conclude that consideration of respondents’ registrations for periods of quantity, and the dosing
the Agency’s deterrence interests is not time commensurate with the severity of instruction. Not later than ten days
warranted.’’). ‘‘Indeed, this Agency has the misconduct. See Ruben, M.D., 78 FR following the end of each calendar
revoked a practitioner’s registration at 38,387–88; Gregory D. Owens, D.D.S., month, Respondent shall provide
upon proof of as few as two acts of 74 FR at 36,757–58; Moore, 76 FR at the local DEA field office with a
intentional diversion and has further 45,869. Where the respondent self- complete copy of the log for the
explained that proof of a single act of abused controlled substances, the preceding month. If during any
intentional diversion is sufficient to Agency required the respondent to month Respondent is required to
support the revocation of a registration.’’ submit to random drug tests. See Moore, maintain said logs he prescribes no
David A. Ruben, M.D., 78 FR at 38,386 76 FR at 45,869; McAlpin, 62 FR at
controlled substances, he shall
(citing Dewey C. MacKay, M.D., 75 FR 8,040–41. Given that Respondent has a
submit a letter declaring such to the
49,956, 49,977 (DEA 2010)). history of self-abuse and improper
Respondent’s improper prescriptions prescriptions, similar conditions are local DEA field office no later than
to A.B., S.M., and Z.M. clearly appropriate here. ten days following the end of that
constitute intentional diversion. He I also note that some of the oversight month.
admits to improperly prescribing a currently placed over Respondent may (2) Respondent shall agree to have no
highly abused drug, hydrocodone, to a not be present if he is granted a DEA intentional contact with A.B., S.M.,
known drug addict, A.B., and two of her registration. Specifically, it is not clear Z.M., or any other person with
friends, S.M. and Z.M.. While he only from the record how much of the whom Respondent abused
wrote one prescription each to S.M. and oversight of Respondent by ACTC controlled substances.
Z.M., he continued to prescribe would be conducted if Respondent had
controlled substances to A.B. for over a an unfettered DEA registration. Indeed, (3) Respondent shall comply with the
year, totaling fifty-four distributions of some of the oversight conducted by terms of his probation instituted by
controlled substances, including refills. ACTC, such as approval from other the Board and shall comply with
[Gov’t Exhs. 12–14]. Thus, although doctors for prescriptions of controlled any other conditions the Board
Respondent’s improper prescribing substances, is done precisely because shall see fit to impose on his license
practices were limited to A.B. and a few Respondent has no DEA registration and or registration.
of her friends, under DEA precedent thus is not authorized to dispense (4) Respondent shall notify the local
they clearly warrant sanctions to deter controlled substances. This part of DEA field office if he fails any drug
Respondent and others from repeating oversight would presumably—though screen administered by any entity.
the practice. not necessarily—be lifted if Respondent
I will not recommend, however, that were granted a DEA registration. I further recommend that
the Agency deny Respondent’s Moreover, Respondent expressed at the Respondent’s registration be suspended
registration altogether. While hearing his desire to work as a for six months following the effective
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Respondent’s improper prescriptions gastroenterologist, so he may not be date of his registration.
are troubling to say the least, the DEA under ACTC supervision much longer. Dated: March 25, 2014.
has granted registrations with [Tr. 233]. Given Respondent’s history of Gail A. Randall,
restrictions to respondents whose improper prescribing, DEA is justified
Administrative Law Judge.
misconduct was more egregious and/or in placing certain restrictions on
lasted longer than the misconduct of Respondent’s COR to ensure precise [FR Doc. 2015–17309 Filed 7–13–15; 8:45 am]
Respondent here. David A. Ruben, M.D., compliance with the CSA and DEA BILLING CODE 4410–09–P
78 FR at 38,386 (granting a registration regulations in the event that ACTC no
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Document Created: 2018-02-23 09:19:51
Document Modified: 2018-02-23 09:19:51
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| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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