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On July 18, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to George Gowder, III, M.D., of Blairsville, Georgia (Respondent). OSC, at 1, 3. The OSC proposed the denial of Respondent's application for a DEA Certificate of Registration (registration), Control No. W22147308C, alleging that Respondent has been convicted of a felony relating to Federal controlled substance laws, and that he has been excluded from participation in Medicare, Medicaid, and all Federal health care programs. Id. at 1-2 (citing 21 U.S.C. 823(g)(1), 824(a)(2), 824(a)(5)).
A hearing was held before DEA Administrative Law Judge Teresa A. Wallbaum (ALJ), who, on December 1, 2023, issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or RD). The RD recommended that Respondent's application be granted with restrictions. RD, at 20-21. The Government filed Exceptions to the RD. Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the ALJ's rulings, credibility findings, findings of fact, and conclusions of law, and expands upon portions thereof herein. However, the Agency has determined based on Respondent's unequivocal acceptance of responsibility and his fulsome demonstration of remediation that Respondent can be trusted with an unencumbered registration for Schedules III through V.
The ALJ recommended that Respondent be required to submit to regular drug testing, refrain from taking controlled substances that are not lawfully prescribed, and hire a practice monitor to monitor his prescribing practices and submit regular reports to DEA. RD, at 20-21. The ALJ also recommended that Respondent's registration be limited to Schedules III through V. Id. As noted herein, Respondent only applied for authority in Schedules III through V.
The Agency adopts the ALJ's summary of each of the witnesses' testimonies as well as the ALJ's assessment of each of the witnesses' credibility. See RD, at 3-10. The Agency agrees with the ALJ that the testimony from the DEA Diversion Investigator (DI), which was primarily focused on the introduction of the Government's documentary evidence, was “sufficiently detailed, plausible, and internally consistent to be afforded full credibility.” Id. at 5.
I. Findings of Fact
A. Felony Conviction
On June 10, 2020, Respondent pled guilty to one count of “Dispensing Controlled Substances Outside Professional Practice” in violation of 21 U.S.C. 841(a) and 841(b)(1)(C), and he was sentenced to 18 months in prison. RX 2, at 1; RD, at 8; Tr. 8. After serving 15 months in prison, he was placed on two years of supervised release. RD, at 8; Tr. 89-91. Respondent served one year of supervised release, but was released from the second. RD, at 8; Tr. 91-92.
Respondent's Federal conviction was the culmination of more than a decade of diverting controlled substances for personal use. RD, at 5-6. Respondent testified that he began taking opioids in the early 2000s after they were lawfully prescribed for a back injury. Id. at 6; Tr. 55. Respondent testified that, after finishing that prescription, he would occasionally “reward” himself by taking an opiate sample from the emergency room where he worked. RD, at 6; Tr. 55-56, 59. He would take an opiate once a month, which then progressed to once every two weeks. RD, at 6; Tr. 58-59. Respondent testified that his progression “from a user to an addict” took at least two or three years. RD, at 6; Tr. 59-60. Respondent abused oxycodone and hydrocodone in pill form. Id. Respondent testified that when he became addicted to opiates, he “started doing things [he] would never ha[ve] thought [he] would do,” including forging prescriptions and stealing drugs from patients. RD, at 6; Tr. 60. Respondent explained that he forged prescriptions in two different ways. RD, at 7-8; Tr. 85. First, he wrote prescriptions for himself and forged another physician's name and DEA number. Id. Second, he wrote prescriptions purportedly for a homebound patient, went to the pharmacy to have the prescriptions filled, and used the drugs himself. RD, at 8; Tr. 85-86.
The Agency agrees with the ALJ that “Respondent testified clearly, candidly, and without hesitation,” notwithstanding that he “unarguably possesses . . . the greatest motivation to enhance, modify, or even fabricate his testimony.” RD, at 9. Respondent “did not shy away from difficult questions and his answers contained no caveats or attempts to minimize his behavior,” and in fact, the primary details regarding his fraudulent conduct came from Respondent's testimony and exhibits. Id. at 9-10. Therefore, the Agency agrees with the ALJ that Respondent's testimony should be “afforded full credibility.” Id. at 10.
Respondent's misconduct led to a series of arrests by local law enforcement in 2015 and 2016, which resulted in charges for prescription forgery. RD, at 6-7; Tr. 62-68. After the first arrest in April of 2015, Respondent entered a residential treatment center for three months, and has remained drug-free since. See supra III.B; RD, at 8; Tr. 93. While in recovery, local law enforcement referred his case to Federal law enforcement and Federal charges were brought. RD, at 7; Tr. 69-70. Respondent ultimately pled guilty and was federally convicted in June of 2020. RD, at 7; Tr. 64, 70, 79.
B. Exclusion From Medicare
The Department of Health and Human Services (HHS) notified Respondent by letter on October 29, 2021, that he would be “exclud[ed] from participation in all Federal health care programs . . . for a minimum period of [seven] years.” GX 3, at 1. The letter notified Respondent that the exclusion was a result of Respondent's “felony conviction . . . related to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.” Id. The letter also notified Respondent that his period of exclusion exceeded the minimum exclusion period of five years because his criminal sentence included prison time, and because the Georgia Composite Medical Board (Medical Board) had taken additional adverse action against Respondent by suspending his medical license. Id. HHS considered these factors to be “aggravating circumstances.” Id. The seven-year exclusion period became effective on November 18, 2021. Id.
Respondent regained his state medical license in October of 2022. RD, at 6; Tr. 53.
II. Discussion
The Government alleged two independent grounds for denial: (1) that Respondent has been convicted of a felony relating to controlled substances, 21 U.S.C. 824(a)(2), 823(g)(1), and (2) that Respondent has been excluded from participation in all Federal health care programs, id. sections 824(a)(5), 823(g)(1). OSC, at 1-2. Having reviewed the record and the RD, the Agency agrees with the ALJ, adopts the ALJ's analysis, and finds that the Government has satisfied its prima facie burden of demonstrating that both grounds for denial exist. Id. at 10-12.
A. Felony Conviction
Pursuant to 21 U.S.C. 824(a)(2), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (CSA) “upon a finding that the registrant . . . has been convicted of a felony . . . relating to any . . . controlled substance.” 21 U.S.C. 824(a)(2). The Agency has consistently held that it also may deny an application for a DEA registration upon finding that the registrant has been convicted of a felony relating to controlled substances. Arvinder Singh, M.D.,81 FR 8247, 8248 n.3 (2016) (quoting Kwan Bo Jin, M.D.,77 FR 35021, 35021 n.2 (2012)) (“[W]here a registration can be revoked under [21 U.S.C.] 824, it can, a fortiori, be denied under [21 U.S.C. ] 823 since the law would not require an agency to indulge in the useless act of granting a license on one day only to withdraw it on the next.”). Here, the undisputed and substantial record evidence demonstrates that Respondent has been convicted of a felony relating to controlled substances. OSC, at 10-11. RD, at 11; GX 2; RX 1, at 3-4; Tr. 87-88.
B. Exclusion From Medicare
Respondent's application also may be denied “upon a finding that the registrant . . . has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.” 21 U.S.C. 824(a)(5), 823(g)(1); Arvinder Singh,81 FR 8248 n.3. Here, the undisputed and substantial record evidence demonstrates that HHS mandatorily excluded Registrant from “all Federal health care programs” under 42 U.S.C. 1320a-7(a)(4). RD, at 11; GX 3; ALJX 14, at 2; Tr. 30-31.
III. Sanction
Where, as here, the Government has established sufficient grounds to deny a Respondent's application, the burden shifts to the registrant to show why he can be entrusted with the responsibility carried by a registration. Garret Howard Smith, M.D.,83 FR 18882, 18904 (2018). When a registrant has committed acts inconsistent with the public interest, he must both accept responsibility and demonstrate that he has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195,77 FR 62316, 62339 (2012). Trust is necessarily a fact-dependent determination based on individual circumstances; therefore, the Agency looks at factors such as the acceptance of responsibility, the credibility of that acceptance as it relates to the probability of repeat violations or behavior, the nature of the misconduct that forms the basis for sanction, and the Agency's interest in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D.,86 FR 33738, 33746 (2021).
A. Acceptance of Responsibility
Here, the Agency agrees with the ALJ that Respondent unequivocally accepted responsibility for his conduct. RD, at 12-14. Respondent took every opportunity to acknowledge that his conduct was wrong and he made no efforts to minimize it. Id. at 13. He admitted that he was guilty of dispensing controlled substances outside of his professional practice because he forged prescriptions and fraudulently filled his patients' prescriptions for his own use. RD, at 13; Tr. 84-85. Respondent testified that he did not want to defend or glorify his conduct, and stated that “it is a shameful, morally bad place to be.” RD, at 13; Tr. 56, 84-86. He also acknowledged that he “abused the public trust as a physician.” RD, at 13; Tr. 83. Respondent testified that he has “been completely honest” about his behavior and conduct “with every single person that [he has] spoken to whether it's law enforcement, whether in the legal system, [or] in treatment.” Tr. 89-90. Respondent testified that the judge presiding over his criminal sentencing hearing “spoke highly” of him, and noted his acceptance of responsibility and willingness to cooperate. RD, at 8; Tr. 80. Accordingly, the Agency agrees with the ALJ that Respondent unequivocally accepted responsibility for his misconduct, RD, at 12-14, and commends Respondent for his willingness to candidly reflect on his battle with addiction in a public forum.
Respondent's credible, unchallenged testimony regarding his acceptance of responsibility in his criminal proceedings weighs in his favor. See Michele L. Martinho, M.D., 86 FR 24012, 24020 n.*E (2021) (citing Mohammed Asgar,83 FR 29569, 29573 n.3 (2018)) (An AUSA or Judge's comments regarding a respondent's acceptance of responsibility during criminal proceedings are not binding on the Agency, but they are relevant evidence).
The Government seems to acknowledge in its Post-hearing Brief that Respondent accepted responsibility for his conduct. ALJX 23, at 25.
B. Remedial Measures
Having found that Respondent has unequivocally accepted responsibility for his conduct, the Agency considers whether Respondent has implemented sufficient remedial measures to demonstrate that he will not engage in future misconduct and can be trusted with a registration. Jayam Krishna-Iyer, M.D.,74 FR 459, 463 (2009). The Agency has acknowledged that “[i]n self-abuse cases, . . . successful rehabilitation efforts are an important consideration in determining whether a respondent can be trusted with a registration.” Trenton F. Horst, D.O.,80 FR 41079, 41091 (2015); see also Abbas E. Sina, M.D.,80 FR 53191, 53201 (2015) (“[T]he risk of relapse becomes critical in determining what steps are warranted when determining the public interest.”).
Respondent provided extensive testimony regarding his recovery and his efforts to remain sober. RD, at 15; Tr. 106-108, 109-110. After his first arrest in April of 2015, he entered a residential treatment center for three months. RD, at 8; Tr. 93. He went into treatment partially because he knew he would not be able to regain his medical license without receiving treatment. RD, at 8; Tr. 94-95. After completing residential treatment, Respondent entered a “Chemical Addiction Monitoring Agreement” with the Georgia Professional Health Program (PHP). RD, at 8-9; RX 2, at 1. The agreement required him to submit to random drug tests and attend self-help meetings, small-group counseling sessions, and meetings with other physicians in the PHP. RD, at 9; Tr. 96-97; RX 2, at 1-3. The initial agreement lasted for five years, and he completed it before entering Federal prison in July of 2020. RD, at 9; Tr. 107-09; RX 2, at 1. Respondent was not monitored by the PHP during his incarceration. RD, at 9; Tr. 108-109. Respondent entered a second agreement with the PHP in September of 2022, which required him to continue to attend various meetings and submit to random drug tests. RD, at 9; Tr. 107-08; RX 2, at 9-17. Respondent testified that he entered the new agreement because he wanted “to do whatever [the] Georgia PHP felt was needed for [him] to be a reliable physician,” but that he also had an “overwhelming desire not to fall back into addiction.” RD, at 15; Tr. 106. Because Respondent does “a good bit” more than is required by the Georgia PHP agreement, he was recently transitioned to a “senior monitoring agreement,” which still requires him to submit to random drug tests. RD, at 9, 15; Tr. 111-12.
Respondent testified that he plans to remain under the supervision of the Georgia PHP even if he is no longer required to do so to maintain his medical license. RD, at 15; Tr. 112. He also plans to continue taking random drug tests, because even though there is “no part of [him] that wants to take a drug[,] . . . the statistics [are] brutal on relapses,” so he “[cannot] imagine what would possess [him] to not continue to be accountable to a urine drug test.” RD, at 15-16; Tr. 112. Respondent testified that drug testing is one of the best tools to reduce the likelihood of remission. RD, at 16; Tr. 112. Respondent testified that he has taken hundreds of drug tests, and that there has only been one one-month period since April of 2015 that he has not been subject to random drug tests. Tr. 97. Respondent testified that he has never failed a drug test and that he has remained drug-free since entering treatment in April of 2015. Id.
Perhaps the most concrete remedial measure that Respondent has taken—which addresses both his addiction and the prescription forgery—is that he applied for a registration to dispense drugs only in Schedules III through V. Id. at 16; Tr. 37; 114-115; GX 4, at 1. Respondent testified that he does not want authority to prescribe Schedule II drugs because those are the drugs that he previously abused. RD, at 16; Tr. 85-86, 114-115.
Respondent believes that he can be trusted with a registration because of his understanding of addiction and his understanding of how doctors can abuse their power to write prescriptions. RD, at 16; Tr. 119. According to Respondent, with this knowledge, he is safer writing prescriptions than the majority of physicians. Id. Respondent requests authority to prescribe controlled substances in Schedules III through V so that he can work in an inpatient treatment facility that manages medical detoxification and treats patients with ongoing chronic illnesses, such as diabetes or mental health issues. RD, at 6; Tr. 58, 124. Respondent currently volunteers as a physician at a long-term recovery center where he is not required to possess a DEA registration. RD, at 5; Tr. 57, 123.
Analysis of Respondent's remedial measures is particularly complex. On one hand, the weight of the remedial evidence is reduced because the measures were not implemented until after Respondent was arrested, and many of these measures are mandatory under an agreement with the Medical Board. RD, at 15; Tr. 107. On the other hand, Respondent has made a sincere commitment to remaining drug-free for himself and for his family, and has gone above and beyond the Medical Board's requirements to ensure he does so. RD, at 15; Tr. 111. For example, Respondent's application seeks only to handle drugs in Schedules III through V to ensure that he does not have access to the Schedule II drugs that he abused in the past. RD, at 16; Tr. 85-86, 114-115. With these extensive remedial measures Respondent has remained sober for approximately nine years. Accordingly, the ALJ found, and the Agency agrees, that Respondent can be trusted with a DEA registration. RD, at 16.
The Agency has held that remedial measures are given “limited-to-no-weight” when they are implemented after enforcement begins. See, e.g., Morris & Dickson Co., LLC, 88 FR 34523, 34539-40 (2023) (citing Mireille Lalanne, M.D.,78 FR 47750, 47777 (2013) (“The Agency has recognized that a cessation of illegal behavior only when `DEA comes knocking at one's door,' can be afforded a diminished weight borne of its own opportunistic timing.”); Southwood Pharmaceuticals, Inc.,72 FR 36487, 36503 (2007) (giving no weight to respondent's “stroke-of-midnight decision” to cease supplying suspect pharmacies with controlled substances and to employ a compliance officer). This principle applies in even greater force here, where the remedial measures that Respondent has implemented appear to be mandatory under an agreement with the state medical board, rather than voluntary.
C. Deterrent Effect and Egregiousness
Acceptance of responsibility and remedial measures are assessed in the context of the “egregiousness of the violations and the [DEA's] interest in deterring similar misconduct by [the] Respondent in the future as well as on the part of others.” Daniel A. Glick, D.D.S.,80 FR 74800, 74810 (2015); OakmontScript Limited Partnership,87 FR 21516, 21545 (2022). Because these administrative proceedings are intended to be remedial, rather than punitive, the Agency has previously found that, under appropriate circumstances, “criminal convictions and sanctions by state licensing authorities can sufficiently deter physicians from engaging in misconduct, making the denial of an application . . . unnecessary to achieve the goal of general deterrence.” Gilbert Y. Kim, D.D.S.,87 FR 21139, 21145 (2022) (citing Kansky J. Delisma, M.D.,85 FR 23845, 23854 (2020)). The Agency has also held that, sometimes, “such punitive measures can suffice to deter the registrant or applicant from future misconduct, making revocation or denial of an application unnecessary to achieve specific deterrence.” Id.
Here, the Agency does not find that imposing a sanction is necessary to deter Respondent from engaging in future misconduct. Respondent has already faced significant legal consequences for his misconduct, including multiple arrests, jailtime, supervised release, and the loss of his state medical license and DEA registration. Respondent has also undergone significant monitoring to recover and maintain his state medical license, including taking hundreds of random drug tests and attending frequent substance abuse meetings. RD, at 9; Tr. 96-97; RX 2, at 1-3. Respondent testified that the consequences of his unlawful behavior have hurt him and his family. Tr. 131. Thus, the Agency finds that the punitive, remedial, and personal consequences that Respondent has suffered are sufficient to deter him from engaging in future misconduct, especially given Respondent's strong personal and professional commitment to remaining drug-free. Respondent's commitment to sobriety is a strong deterrent to future misconduct, as Respondent testified that the only reason that he engaged in the fraudulent conduct that led to the felony conviction and Medicare exclusion was to feed his personal addiction. RD, at 6; Tr. 60. Respondent's decision not to request authority to prescribe the Schedule II drugs that he previously abused is also a significant deterrent. RD, at 16; Tr. 85-86, 114-115. Moreover, there is no evidence that Respondent has committed any additional CSA violations since entering treatment in April of 2015, which bolsters the Agency's conclusion that Respondent has been sufficiently deterred from future violations.
The Agency also finds that the significant consequences that Respondent has faced are sufficient to deter the general registrant community from committing similar misconduct of forging prescriptions and diverting controlled substances for personal use. This Decision should signal to the registrant community that CSA violations are likely to result in serious legal consequences—as Respondent confronted a protracted legal battle with local and Federal law enforcement, state regulators, and DEA as a result of his misconduct. But this Decision should also demonstrate to registrants recovering from addiction that, by accepting responsibility, remediating their actions, demonstrating sustained success with sobriety and conveying a strong commitment to remaining sober, cooperating with state and Federal enforcers, and demonstrating candor during enforcement proceedings, they may be shown leniency.
Regarding egregiousness, there is no dispute that the conduct that led to Respondent's conviction and subsequent exclusion from all Federal health care programs was egregious. RD, at 17. Respondent admitted to using extra samples at the hospital where he worked, forging prescriptions using other physicians' DEA registrations, and writing prescriptions with his own DEA registration purportedly for home-bound patients. Id. Indeed, such cases of fraud and forgery are particularly egregious because Respondent used his knowledge as a DEA registrant to circumvent the closed system of distribution, and he diverted powerful Schedule II controlled substances. Id. “These are actions that strike at the very heart of the responsibilities entrusted to a DEA registrant . . . .” Id. (citing Jana Marjenhoff, D.O.,80 FR 29067, 29095 (2015)).
The Government argues in its Exceptions that “the egregiousness of Respondent's conduct supports denial and outweighs any acceptance of responsibility or proposed remedial measures.” Government's Exceptions, at 4. The Agency agrees with the Government that Respondent's conduct was egregious, but finds that other factors discussed throughout this Decision obviate the need for a sanction in this case.
However, the evidence overwhelmingly suggests that Respondent has unequivocally accepted responsibility, is remorseful for his conduct, has taken efforts to help others recover from addiction, and rehabilitated himself even before he was convicted and required to serve his time. He has also taken steps to reduce the likelihood of recurrence by limiting his application to drugs in Schedules III through V that he has never abused. In other words, Respondent has presented convincing evidence to demonstrate that the Agency can trust him with a registration. Therefore, the Agency will grant his application.
For all of the reasons set forth herein, the Agency finds that it can fully trust Respondent with a registration. The Agency therefore finds that the ALJ's recommended conditions on Respondent's registration are unnecessary. RD, at 20-21. However, the Agency's trust can be lost in the event of a relapse, so the Agency encourages Respondent to stick to his plan to continue taking random drug tests. As Respondent testified, “the statistics [are] brutal on relapses,” and drug testing is one of the best tools to reduce the likelihood of remission. RD, at 15-16; Tr. 112.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823 and 824, I hereby dismiss the Order to Show Cause issued to George Gowder, III, M.D., and grant Respondent's application number W22147308C in Schedules III through V. This Order is effective immediately.
Signing Authority
This document of the Drug Enforcement Administration was signed on September 11, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-21051 Filed 9-16-24; 8:45 am]
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