Michael T. Harris, M.D.; Decision and Order

On May 20, 2021, a former Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause (hereinafter, OSC), seeking to revoke the DEA Certificate of Registration, Control No. FH1510709, of Michael T. Harris, M.D. (hereinafter, Respondent) and deny any pending applications for renewal or modification of such registration, or for additional registrations, pursuant to 21 U.S.C. 824(a)(4). OSC, at 1. The Government alleges that Respondent's continued registration is inconsistent with the public interest, as defined in 21 U.S.C. 823(f). Id.

A hearing was held before an Administrative Law Judge (hereinafter, ALJ) on October 12, 2021. The ALJ issued Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (hereinafter, Recommended Decision or RD), which recommended that I revoke Respondent's registration and deny his pending application for renewal. RD, at 39. Respondent filed Exceptions to the RD on January 7, 2021, and the Government filed its Response on January 28, 2022.

I. Findings of Fact

A. Witness Credibility

The Government presented its case through the testimony of two witnesses, a DEA Diversion Investigator (hereinafter, DI), Tr. 16-58, 200-01, and Dr. L, a former colleague of Respondent, Tr. 60-80. The ALJ gave the DI and Dr. L's testimonies full weight and credit. RD, at 7, 9. I adopt her summary of their testimonies and credibility determinations. Id. at 5-9.

Respondent presented his case through two witnesses, Dr. R., who medically monitored Respondent's drug rehabilitation, Tr. 80-144, and Respondent, Tr. 144-190. The ALJ gave little weight to Dr. R's testimony—finding that Dr. R was a “combative and, at times, condescending witness,” who had a vested interest in Respondent retaining his DEA registration. RD, at 13-14. I agree with the ALJ's findings and adopt her credibility determination for Dr. R's testimony. Id.

I also agree with the ALJ's credibility findings regarding Respondent's testimony. The ALJ found that Respondent presented as generally credible to the extent he recounted his efforts at rehabilitation from his substance abuse disorder. RD, at 18. But, as the ALJ pointed out, Respondent's testimony was noteworthy for what it lacked—there was virtually no acknowledgement of the fraud Respondent committed or the numerous people he manipulated and harmed during the fraud. Id. at 18-19. The ALJ found, as a result, that “Respondent's testimony sounded rehearsed and his demeanor and body language in testifying was nonchalant. His testimony and demeanor sent the message that, while he had a substance abuse problem, he had successfully engaged in a rehabilitation program and that should be an end to the inquiry.” Id. at 19.

B. Respondent's Fraudulent Prescriptions and Criminal Indictment

Respondent is a Florida physician who holds a DEA registration to handle controlled substances in Schedules II-V. Stip. 6. From November 2015 through July 2016, Respondent issued twenty-four prescriptions for controlled substances using the DEA registration number of Dr. L. Tr. 27, GX 2. Respondent admitted that he did not have authorization or permission from Dr. L to issue the prescriptions using Dr. L's DEA registration number. Tr. 27, 65-72, 149. Respondent obtained the prescriptions, some signed and some unsigned, from a lockbox at their joint practice. Tr. 26, 149, 153-54. Respondent used the prescriptions, forging Dr. L's signature when necessary, to issue controlled substance prescriptions to himself and three family members. Id. Respondent filled the prescriptions for his personal use. Tr. 30, 191-92. Respondent deliberately filled prescriptions 30 days apart, rotated the names he used on the prescriptions, and rotated which pharmacy he would use in an effort to avoid detection. Tr. 88.

Dr. L first learned of Respondent's misuse of his prescription pad in August 2016. Tr. 74. Dr. L sent a letter to the Florida Board of Medicine stating that prescriptions were written under his name without his consent and confronted Respondent. Tr. 74-75.

On October 15, 2019, Respondent was indicted in the Northern District of Florida on one count of fraudulent acquisition of controlled substances in violation of 21 U.S.C. 843(a)(3) and (d)(1) and one count of unlawful use of another's DEA registration in violation of 18 U.S.C. 1028(a)(7) and (b)(3)(A). Stip. 12. As of the date of the hearing for this matter, Respondent was participating in a pretrial diversion program scheduled to end December 25, 2021. Tr. 178.

The DI twice asked Respondent to voluntarily surrender his DEA registration, once after an interview with Respondent in April of 2017 and once after Respondent's criminal indictment. Respondent declined both times. Tr. 31, 56-7.

C. Respondent's Rehabilitation

After Respondent was confronted by Dr. L about the fraudulent prescriptions, Respondent's wife, in conjunction with Dr. L, called the Florida Department of Health who referred them directly to the Professional Resources Network (hereinafter, PRN), which has a contract with the Florida Department of Health to “monitor physicians and nurses and other licensed practitioners in different fields for impairment issues.” Tr. 83, 100, 157, 159, 186. Respondent began a rehabilitation program on August 27, 2016, which he reports included inpatient detoxification, inpatient therapy, and constant monitoring. Tr. 157-58, 162-64. According to Respondent, he was discharged pursuant to a PRN monitoring contract, under which he had a PRN social worker or “case manager” to whom he reported regularly; weekly PRN meetings for impaired professionals; a licensed psychologist to ensure compliance; mandatory Alcoholics Anonymous (AA) meetings; meetings with an addictionologist (Dr. R); marriage counseling; and random, but regular, drug testing. Tr. 169. He must also regularly check in with his case manager and his practice manager (another physician who reviews his prescriptions and submits quarterly reports to PRN). Tr. 172, 195.

Respondent's PRN contract was scheduled to terminate on December 19, 2021. Tr. 168, 197. Once the contract ended, Respondent would no longer be required to participate in therapy or be subject to drug testing and practice monitoring. Tr. 197-98. When asked if he was planning on stopping all counseling and treatment at the expiration of the contract, Respondent replied that “there are several options that we considered, and that's something I would discuss with my wife” but did definitively testify that he would return to AA meetings. Tr. 183-84

II. Discussion

Section 304(a) of the Controlled Substances Act (hereinafter, CSA) provides that “[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In the case of a practitioner, the CSA requires the Agency consider the following factors in determining whether Respondent's registration would be inconsistent with the public interest:

(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

(2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.

(3) The [registrant'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). The DEA considers these public interest factors separately. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 (1993).

The Government has the burden of proving that the requirements for revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 CFR 1301.44(e). When the Government has met its prima facie case, the burden then shifts to the Respondent to show that revoking the registration would not be appropriate, given the totality of the facts and circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 387 (2008). Having reviewed the record and the ALJ's Recommended Decision, I agree with the ALJ that the Government has proven by substantial evidence that Respondent committed acts which render his continued registration inconsistent with the public interest.

While I have considered all of the public interest factors, the Government's case seeks the revocation of Respondent's registration based primarily on conduct most aptly considered under Public Interest Factors 2 and 4. Factors 2 and 4 are often analyzed together. See, e.g., Fred Samimi, M.D., 79 FR 18698, 18709 (2014). Under Factor 2, the DEA analyzes a registrant's “experience in dispensing . . . controlled substances.” 21 U.S.C. 823(f)(2). Factor 2 analysis focuses on a registrant's acts that are inconsistent with the public interest, rather than on a registrant's neutral or positive acts and experience. Randall L. Wolff, M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that “every registrant can undoubtedly point to an extensive body of legitimate prescribing over the course of [the registrant's] professional career”). Similarly, under Factor 4, the DEA analyzes a registrant's compliance with federal and state controlled substance laws. 21 U.S.C. 823(f)(4). Factor 4 analysis focuses on violations of state and federal laws and regulations. Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009).

Respondent clearly violated both federal and state law when he issued fraudulent prescriptions using Dr. L's DEA registration number and, in some instances, with Dr. L's forged signature. First, Respondent issued prescriptions for his own personal use to feed his addiction, not for a legitimate medical use. This violates 21 U.S.C. 844(a), which provides that: “[i]t shall be 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.” Respondent's actions also violate Florida law, which provides, consistent with the federal law, that

[a] person may not be in actual or constructive possession of a controlled substance unless such controlled substance was lawfully obtained from a practitioner or pursuant to a valid prescription or order of a practitioner while acting in the course of his or her professional practice or to be in actual or constructive possession of a controlled substance except as otherwise authorized by this chapter.

Fla. Stat. Ann. § 893.13(6)(a).

Second, Respondent violated federal and state law when he used Dr. L's DEA registration number to issue fraudulent prescriptions. It “shall be unlawful for any person knowingly or intentionally . . . to use for the purpose of acquiring or obtaining a controlled substance, a registration number which is . . . issued to another person.” 21 U.S.C. 843(a)(2). Moreover, it “shall be unlawful for any person knowingly or intentionally . . . to acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge.” Id. at (a)(3). Again, Florida law has a similar provision. Fla. Stat. Ann. § 893.13(7)(a)(9) (making it unlawful to “acquire or obtain, or attempt to acquire or obtain, possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge.”). Accordingly, Factors 2 and 4 weigh in favor of revocation.

III. Sanction

Where, as here, the Government has met its prima facie burden of showing that a respondent's continued registration is inconsistent with the public interest due to his violations pertaining to controlled substances, the burden shifts to the respondent to show why he can be entrusted with the responsibility carried by his registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018) (citing Samuel S. Jackson, 72 FR 23848, 23853 (2007)). DEA cases have repeatedly found that when a registrant has committed acts inconsistent with the public interest, “the Respondent is required not only to accept responsibility for [the established] misconduct, but also to demonstrate what corrective measures [have been] undertaken to prevent the reoccurrence of similar acts.” Holiday CVS LLC dba CVS Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012) (internal quotations omitted). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent; therefore, the Agency looks at factors, such as the acceptance of responsibility and the credibility of that acceptance as it relates to the probability of repeat violations or behavior and the nature of the misconduct that forms the basis for sanction, while also considering the Agency's interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR 8247, 8248 (2016).

I find, as the ALJ did, that Respondent has not unequivocally accepted responsibility for his misconduct. To begin, Respondent's testimony and overarching case strategy makes clear that he believes entering a rehabilitation program constitutes acceptance of responsibility. Tr. 175 (Q: “Did you take responsibility for your actions,” A: “Yes, I thought I had already showed that by going to rehab at that time.”). While rehabilitation is an essential pre-requisite for trusting a person with a substance use disorder with a registration, it does not address all of the misconduct here—the calculated fraud which involved a coherent strategy of deception achieved through the manipulation of multiple people and ended only because Respondent was caught. Cf. Noah David, P.A., 87 FR 21665, 21173-74 (2022) (Registrant manipulated relationships and engaged in intentional deceit to unlawfully obtain controlled substances). Respondent was conspicuously silent on this aspect of the case, providing minimal details about the fraud, minimizing the scope of his misconduct by characterizing the fraud as “improper prescribing,” and primarily ignoring that he manipulated a series of people, stole pre-signed prescriptions, and forged Dr. L's signature. RD, at 30. Respondent also violated his entrusted position as a DEA registrant by using his knowledge of the regulatory system to avoid detection, e.g., rotating the names on the prescriptions, rotating the pharmacies where he filled the prescriptions, and waiting thirty days before refilling a prescription. Id. at 30, 36.

Second, Respondent's decision to seek rehabilitation was not entirely voluntary; he did so only after he knew Dr. L had reported him to authorities. Respondent's attempt to characterize his rehabilitation efforts as voluntary further suggest that he has not truly accepted responsibility for his conduct, but is merely seeking to portray himself in the most favorable light in these proceedings. Id. at 30.

When a registrant fails to make the threshold showing of acceptance of responsibility, the Agency need not address the registrant's remedial measures. Ahuja, 84 FR at 5498 n.33; Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015); see also Jones Total Health Care Pharmacy, LLC, SND Healthcare, LLC, 881 F.3d 823, 833 (11th Cir. 2018) (upholding DEA's refusal to consider pharmacy's remedial measures given lack of acceptance). But even if I were to consider Respondent's remedial measures, they would not affect my ultimate decision in this matter. While I give Respondent credit for the rehabilitation he has pursued so far, it is significant that Respondent has never sustained his sobriety outside the context of a regulated drug program and has provided no documentary evidence corroborating his sobriety and remedial measures. I find it troubling that as of the date of the administrative hearing, he had no set plans for further treatment or other remedial measures once his PRN contract expired. Respondent's remedial measures also dealt only with his drug addiction, and he provided no evidence of remedial measures with respect to his fraudulent scheme aside from taking general, required courses on proper prescribing. Tr. 193-94. Thus, Respondent's remedial measures are inadequate given his lack of corroborating evidence of the measures he has already undertaken, his nonexistent plan for the future, and his failure to show any remedial measures related to his fraud.

In addition to acceptance of responsibility, the Agency looks to the egregiousness and extent of the misconduct, Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases), and gives consideration to both specific and general deterrence when determining an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (2015). Here, Respondent's fraud was egregious—he perpetrated a calculated, sophisticated scheme, manipulating those who trusted him, and using his knowledge as a DEA registrant to evade detection. See Jana Marjenhoff, D.O., 80 FR 29067, 29095 (2015). As for general deterrence, failing to impose a significant sanction against Respondent would send the wrong message to other registrants that the Agency does not take fraud seriously—especially a fraudulent scheme in which a registrant uses his knowledge of the controlled system of distribution to defeat it. Such a message would be inconsistent with past Agency precedent and the goals of the CSA. Id.

As for specific deterrence, the “Agency also looks to the nature of the crime in determining the likelihood of recidivism and the need for deterrence.” Jeffrey Stein, M.D., 84 FR 46968, 49973 (2019). The Agency has previously found that criminal convictions and sanctions by state licensing authorities can sufficiently deter physicians from engaging in misconduct, making the revocation of a registration unnecessary to achieve specific deterrence. Kansky J. Delisma, M.D., 85 FR 23845, 23854 (2020). Here, Respondent has not been criminally convicted and there is no evidence in the record that he has faced any sanctions by the state licensing authority. As a result, the interest of specific deterrence clearly favors the sanction of revocation.

As discussed above, to avoid sanction when grounds for revocation exist, a respondent must convince the Administrator that he can be entrusted with a registration. I find that Respondent has not met this burden. Accordingly, I shall order the sanctions the Government requested, as contained in the Order below.

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of Registration No. FH1510709 issued to Michael T. Harris, M.D. Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I further hereby deny any pending application to renew or modify this registration, as well as any other pending applications of Michael T. Harris, M.D. This Order is effective June 17, 2022.