Trenton F. Horst, D.O.; Decision and Order, 41079-41092 [2015-17309]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices The facts in Volkman pertaining to record keeping violations involved a doctor who ‘‘rapidly became the largest practitionerpurchaser in the nation of oxycodone’’ which included ordering ‘‘hundreds of thousands of dosage units of these drugs’’ over time periods as short as several months. Id. at 30,643. The facts in Volkman further reflected that no dispensing logs were maintained, at times exceeding an entire year. Id. at 30,645. Additionally, where a registrant has committed acts inconsistent with the public interest, a registrant must accept responsibility for his or her actions and demonstrate that he or she will not engage in future misconduct. Patrick W. Stodola, 74 FR 20,727 (DEA 2009). Also, ‘‘[c]onsideration of the deterrent effect of a potential sanction is supported by the CSA’s purpose of protecting the public interest.’’ Joseph Gaudio, 74 FR 10,083, 10,094 (DEA 2009). The Respondent testified in substance that she updated her new registration address with Texas authorities, made various efforts to do so with DEA including receiving correspondence, and therefore thought she had satisfied her obligation. (Tr. 161–63; ALJ Ex. 2.) Respondent’s explanation for record keeping violations is less specific. The Respondent’s testimony as a whole demonstrated that she understood the seriousness and importance of record keeping requirements, and testified that while at the temporary Collier street location ‘‘I didn’t have those little DEA 222s, so I really didn’t purchase any scheduled medications during that brief period of time.’’ (Tr. 197.) The Respondent also testified that she believed she ‘‘had very effective oversight’’ of controlled substances.’’ (Tr. 248.) This belief is contradicted by Respondent’s own testimony. Respondent also testified that she relied heavily on her staff with regard to inventory and maintenance of controlled substances, and that Respondent did very little herself. (Tr. 205.) The evidence of record does demonstrate, however, that Respondent’s errors were often due to lack of knowledge, omission or neglect, rather than a deliberate violation of the record keeping requirements. The alleged conduct supported by substantial evidence in this case centers on Respondent’s record keeping violations, which have been documented to be deficient over a relatively short period of time, as well as a failure to update her registered address, and improper acceptance and disposal of returned controlled substances from patients. The Government argues in its post-hearing brief that revocation is the appropriate remedy in this case. An agency’s choice of sanction will be upheld unless unwarranted in law or without justification in fact. A sanction must be rationally related to the evidence of record and proportionate to the error committed. See Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005) (sanction will be upheld unless unwarranted in law or without justification in fact). In support of its recommendation for revocation, the Government cites Paul H. Volkman, 73 FR 30,630, 30,644 (DEA 2008), which is significantly distinguishable from the facts of this case. Respondent’s conduct VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 in this case occurred over a comparatively short period of time, with substantially fewer controlled substances, and with no evidence of actual diversion of any controlled substances. The Government cites no other precedent to support a revocation sanction on facts similar to Respondent’s, nor does there appear to be any. The Respondent’s errors and conduct clearly were neglectful and serious during the relevant time period, and likely due in part to ongoing issues including eviction from her registered office, employee problems, and an office break-in and theft, among other factors. That said, a revocation penalty is simply not rationally related to the evidence of record established by substantial evidence or proportionate to Respondent’s misconduct. I find that Respondent’s testimony as a whole demonstrates that she has sufficiently accepted responsibility for her actions and omissions with regard to a revocation penalty, but Respondent’s explanation of past errors and demonstrated plan to avoid future violations is insufficient to support an unconditional registration. Accordingly, I recommend that Respondent’s COR BC0181999 as a practitioner not be revoked or a pending application denied, on the condition that Respondent: a) within a reasonable period of time as set forth in the agency’s final order in this matter, satisfy the appropriate DEA designee that Respondent has state authority to handle controlled substances in Texas, the state in which she is registered with DEA; 65 b) submit to the nearest Field Division Office of DEA no later than one (1) year after issuance of a DEA COR, documentation reflecting successful completion of accredited training at Respondent’s expense, in the proper maintenance, inventory, and record-keeping requirements for controlled substances, with such training to take place after the Agency issues a final order in this matter; and c) for one (1) year after the issuance of a COR, Respondent shall submit to the nearest Field Division Office of DEA, on a quarterly basis, a log of all controlled substances in Schedules II, III, IV and V received, maintained and dispensed by Respondent. Dated: October 26, 2010 s/ Timothy D. Wing, Administrative Law Judge [FR Doc. 2015–17310 Filed 7–13–15; 8:45 am] BILLING CODE 4410–09–P 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 U.S.C. 824(a)(3). citations to the Recommended Decision (R.D.) are to the ALJ’s slip opinion as originally issued. PO 00000 65 21 1 All Frm 00089 Fmt 4703 Sfmt 4703 41079 The Government filed Exceptions to the Recommended Decision. 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. 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 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. E:\FR\FM\14JYN1.SGM 14JYN1 41080 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 crossexamination, 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. 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 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 nofemale 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. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 thengirlfriend (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). PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 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. 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: 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. E:\FR\FM\14JYN1.SGM 14JYN1 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices . . . . 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: asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 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. 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. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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)). PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 41081 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 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 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 fourmonth 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. E:\FR\FM\14JYN1.SGM 14JYN1 41082 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 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 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). VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 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. 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]. 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 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. 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. E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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]. 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 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]. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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). 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 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. PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 41083 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 boardcertified 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 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]. E:\FR\FM\14JYN1.SGM 14JYN1 41084 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices physician at Accident Care and Treatment Center (‘‘ACTC’’). [Tr. 231]. 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]. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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]. 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 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]. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 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 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 [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]. 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 ‘‘[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. 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]. E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices for why marijuana and amphetamines were in his system. [Tr. 245]. 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 ´ Sante, 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 VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 41085 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. 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 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. E:\FR\FM\14JYN1.SGM 14JYN1 41086 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES 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: 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., 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]. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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]. 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 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]. PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 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. §§ 620 et seq., and specifically . . . § 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 Sante Center for ´ Healing (‘‘Sante’’) on October 12, 2011. [Tr. 208–09]. Respondent testified that ´ he paid for his time at Sante 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 Sante, 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 Sante $87,000. [Tr. 210]. Respondent described his experience ´ at Sante 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 Sante, Respondent was required to isolate E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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 ´ Sante by having a sexual relationship with a female patient.13 [Tr. 260–64]. In addition to his drug abuse therapy, Respondent completed a program at ´ Sante entitled ‘‘Maintaining Proper Boundaries,’’ which, according to a ´ letter from the medical director at Sante, 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 ´ Sante 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 Sante, 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 13 I admitted evidence of this relationship for impeachment purposes only. [Tr. 292–93]. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 12step 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]. 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. 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. PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 41087 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]. 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 16 DI Survovec described the PMP as ‘‘a real-time recording of controlled substance prescriptions that are issued.’’ [Tr. 40] E:\FR\FM\14JYN1.SGM 14JYN1 41088 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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]. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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]. VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 was not forthright in his testimony ´ about his experience at Sante. [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 E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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: (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 18 The Deputy Administrator has the authority to make such a determination pursuant to 28 CFR 0.100(b), 0.104 (2013). VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 ‘‘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. PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 41089 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 E:\FR\FM\14JYN1.SGM 14JYN1 41090 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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 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]. 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES Factor Three: Registrant’s Conviction Record Relating to Controlled Substances Pursuant to 21 U.S.C. § 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 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. 20 In order to follow agency precedent, I will take into consideration evidence of Respondent’s selfabuse 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. 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). VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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). 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 selfabuse 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 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 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 E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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 VerDate Sep<11>2014 19:09 Jul 13, 2015 Jkt 235001 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 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 41091 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 Sante’’ 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. 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 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 Sante. [Tr. 261–263]. However, because this subject was not disclosed prior to the hearing, I admitted the evidence for impeachment purposes only. [Tr. 293]. E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 41092 Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 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 VerDate Sep<11>2014 21:01 Jul 13, 2015 Jkt 235001 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 selfabused 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 selfabused 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 PO 00000 Frm 00102 Fmt 4703 Sfmt 9990 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 E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41079-41092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17309]


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 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.
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    \1\ All citations to the Recommended Decision (R.D.) are to the 
ALJ's slip opinion as originally issued.
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    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.
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    \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.
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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.
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    \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.
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    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.
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    \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).
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    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.
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    \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.
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    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\
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    \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.
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    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\
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    \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.
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    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\
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    \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).
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    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
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