John Qian, MD; Decision and Order

On May 3, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to John Qian, M.D., (Respondent) of San Diego, CA. OSC, at 1, 7. The OSC proposed the denial of Respondent's application for a DEA Certificate of Registration (Registration), Application Control No. W22061401C, alleging that the issuance of the registration would be inconsistent with the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1)).

A hearing was held before DEA Chief Administrative Law Judge John J. Mulrooney (the Chief ALJ), who, on October 19, 2023, issued his Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or RD), which recommended denial of Respondent's application. RD, at 27. Respondent did not file Exceptions to the RD. Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the entirety of the ALJ's rulings, findings of fact, conclusions of law, and recommended sanction as found in the RD and summarizes and expands upon portions thereof herein.

I. Findings of Fact

Respondent was previously registered with the DEA to prescribe controlled substances in California. John X. Qian, M.D. (“Qian I”),87 FR 8039, 8058 (2022). The Agency issued an OSC and Immediate Suspension of Registration to Respondent on November 18, 2019 (2019 OSC/ISO), recommending that his previous Registrations be revoked on the grounds that they were inconsistent with the public interest. RD, at 3 (citing 21 U.S.C. 824(a)(4)). Respondent's Registrations were immediately suspended because the Agency determined that there was an imminent danger to the public health or safety from continuing his Registrations during the pendency of the proceeding. RD, at 3 (citing 21 U.S.C. 824(d); 21 CFR 1301.36(e)). On February 11, 2022, following a hearing on the merits (2020 Hearing), the Agency revoked Respondent's previous Registrations. RD, at 3; Qian I, 87 FR at 8058.

Approximately three months later, on May 26, 2022, Respondent filed an application for a new registration. RD, at 3. The Agency issued an OSC on May 3, 2023, proposing that the application be denied based on the same conduct alleged in the 2019 OSC/ISO. Id. at 2. Following Respondent's request for a hearing, the Government filed a Partial Motion for Summary Disposition (the PMSD), arguing that the Agency's final order in Qian I satisfied the Government's prima facie case that it would be inconsistent with the public interest to grant Respondent's application. Id. at 2-3; ALJX 8, at 5-17. The Chief ALJ granted the Government's unopposed PMSD and found that the sole remaining issue to determine at the August 2023 Hearing (2023 Hearing) was whether Respondent could be entrusted with a registration. RD, at 2-3. The Chief ALJ also found that the Agency's factual findings, legal conclusions, and credibility determinations in Qian I should be afforded preclusive effect in this proceeding. The Agency agrees.

Because the Agency's factual findings in Qian I serve as the basis for the Government's prima facie case, they are briefly summarized here. In Qian I, the Agency found that Respondent had issued one-hundred and fifteen prescriptions to three patients from 2017 through 2019 in violation of federal and state law and beneath the standard of care for prescribing controlled substances in California. RD, at 4; Qian I,87 FR 8057. The Agency found that Respondent had issued these prescriptions without performing or documenting adequate physical examinations, developing or documenting adequate treatment plans, developing or documenting a justification for prescribing controlled substances, or resolving or documenting resolution of diversion red flags. RD, at 4-5; Qian I,87 FR 8039 n.1, 8040, 8045 n.27, 8050, 8055-57. The Agency also found that Respondent had repeatedly copied language verbatim throughout his medical records, which violated the California standard of care and significantly undermined the medical records' credibility. RD, at 5; Qian I,87 FR 8055. Respondent's recordkeeping errors were egregious; for example, in one medical record, Respondent copied forward his description of a physical examination verbatim over twenty-one visits for fifteen months without adding any new information. Id. at 8048. Respondent then added an additional eight physical tests to the description and copied forward the new description verbatim for an additional seventeen months. Id. Meanwhile, Respondent was prescribing this patient “astronomically high” dosages of opiates along with a long-acting benzodiazepine—a combination that poses a serious risk of death—without documenting whether safer methods had been tried or even what conditions he was treating with these controlled substances. Id. at 8046-48, 8057. The Agency found that Respondent's documentation was “so egregiously bad that it [was] difficult to determine what steps [he] was taking to ensure this patient's safety, or even why a particular controlled substance was being prescribed.” Id. at 8058. Respondent failed to accept responsibility for his recordkeeping violations, testifying that there may have been “some mistakes,” but “overall [his] charts [were] good” and “above average.” Id.

Respondent also failed to resolve red flags presented by his patients, including failing to adequately address an inconsistent urine drug screen that showed that the patient was taking two controlled substances that had not been prescribed and that posed serious risks when taken with the opioids prescribed by Respondent. Id. at 8051-52. Respondent's prescribing patterns were similar with all three patients and they were so dangerous that the Agency determined that Respondent's prescribing practices created a risk of death. RD, at 5-6; Qian I,87 FR 8047-53, 8057.

As discussed in more detail below ( see infra § II), the Agency found in Qian I that the Government had met its prima facie burden of demonstrating that Respondent's registration was inconsistent with the public interest under the Controlled Substances Act (CSA), and the burden shifted to Respondent to prove that he could be entrusted with a registration. Qian I,87 FR 8057-58. The Agency found that Respondent did not prove that he could be entrusted with a registration because he did not accept responsibility for his egregious conduct, and determined that the appropriate remedy was revocation. Id.

II. Discussion

A. The Five Public Interest Factors

Under the CSA, “[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 his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a). In making the public interest determination, the CSA requires consideration of the following factors:

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

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

(C) The [registrant's] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

(D) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(E) Such other conduct which may threaten the public health and safety.

21 U.S.C. 823(g)(1).

The Agency considers these public interest factors in the disjunctive. 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 proof in this proceeding. 21 CFR 1301.44. The Government satisfied its burden based on the Agency's findings in Qian I, which are binding in this case. In Qian I, the Agency considered all of the public interest factors in 21 U.S.C. 823(g)(1), and revoked Respondent's registration primarily based on evidence under Factors B and D (formerly Factors 2 and 4). 87 FR 8055-58; RD, at 21-22. Evidence is considered under Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances. See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022). The Agency found that Factors B and D weighed against Respondent's continued registration because Respondent had issued numerous controlled substance prescriptions in violation of state and federal law and beneath the standard of care in California. Qian I,87 FR 8055-57. Based on the Agency's findings in Qian I, the Agency finds that Respondent's continued registration is inconsistent with the public interest under 21 U.S.C. 823(g)(1). RD, at 21-22.

III. Sanction

Where, as here, the Government has established sufficient grounds to deny Respondent's Application, the burden shifts to Respondent 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 remedial 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).

At the 2020 Hearing in Qian I, Respondent explicitly denied responsibility for his misconduct, maintaining that his recordkeeping was “above average” and offering other incredulous and false testimony under oath. Qian I,87 FR 8052. The Agency found that some of his testimony was “self-serving to the point it denied belief.” Id. at 8042. For example, Respondent defended an inconsistent urine drug screen by suggesting that there might have been “liquid contamination” that caused the substance to show up in the screen without the patient having consumed the substance. Id. When asked what “liquid contamination” meant, Respondent suggested that the patient may have been in close proximity to someone else who was taking the drug, and that person may have dropped some of the substance into the patient's food, causing her to accidentally ingest it. Id. at 8051. This illogical testimony was discredited by the Government's expert. Id. at 8042. Another area where the Agency found that Respondent's testimony was untruthful was his suggestion that rather than mechanically copying forward the same description month-after-month in his medical records, he performed the same exact examination each month and made the same selections in the software, which generated an identical description. Id. The Agency called a representative from the software company to testify, who discredited Respondent's testimony and conclusively established that the medical records had been copied forward repeatedly. Id. at 8041. Respondent's lack of candor during the 2020 Hearing bolstered the Agency's conclusion that he could not be entrusted with a registration.

Although Respondent was more contrite at the 2023 Hearing, his acceptance of responsibility lacked the requisite remorse and sincerity to be considered unequivocal. During the course of his testimony, Respondent indicated that he accepted responsibility for several defects in his treatment of patients in Qian I, as well as defects in his treatment of patients identified in a January 31, 2020 probationary order by the Medical Board of California (MBC Order). For example, Respondent indicated that he accepted responsibility for failing to adequately monitor and assess the patients under his care taking opioids, Tr. 116, 125-27, 135-38, 150-53; failing to recognize signs of drug abuse in cases where some of his patients should have been referred to addictionologists, id. at 123-24; failing to adequately document his medication decisions, id. at 123-24, 131-132, 139-40, 142-46, 156-57; failing to consider the input of his patients' family members, id. at 136; failing to conduct adequate physical examinations, id. at 147-49, 156, 161; and failing to acquire sufficient patient histories, id. at 149. RD, at 13. Respondent also acknowledged that he failed to recognize the risks of concurrently prescribing opioids, benzodiazepines, and carisoprodol. RD, at 13; Tr. 116-22, 126, 134-35. Additionally, Respondent testified that he broadly accepted responsibility for the findings in Qian I. RD, at 14; Tr. 158.

However, many of Respondent's statements accepting responsibility were undermined by other portions of his testimony, particularly his explanations for why he committed the errors and omissions in Qian I. For example, he blamed his failure to comply with the standard of care on unspecified “guideline changes,” and referred to the pain management guidelines as “rapidly changing.” RD, at 14; Tr. 128; RX R, at 8. He testified that the guidelines had changed three times since he had been practicing, and that the changes were “always indicated for primary care physician,” but as a specialist he became “a little bit [ ] complacent.” Tr. 128. Respondent, however, did not explain what rules had changed, how those rules had changed, or why the rules were different for him as a specialist. This testimony is concerning because the deficiencies outlined in Qian I —such as failure to have a medical justification for the controlled substances prescribed, failure to warn about the dangers of concurrent prescriptions for opioids and benzodiazepines, failure to resolve red flags of abuse and diversion, and failure to maintain accurate medical records—are core failures that violated bedrock principles of the CSA.

Respondent also occasionally blamed others for his violations. For example, when asked why he failed to refer one of his patients to an addictionologist, he testified that he had made the referral, but it “never got carried out.” RD, at 13 n.37; Tr. 123. And while Respondent admitted to errors in his recordkeeping, he also explained that he was new to electronic medical records (EMRs), the copy forward feature was important for patient flow, and the physician's assistants who worked with him were complaining that the paperwork was arduous. RD, at 14; Tr. 130-33, 161, 163. Respondent also declined an opportunity to accept responsibility for falsifying his medical records. RD, at 14-15; Tr. 143-45. Although he conceded that he probably needed to conduct more detailed examinations, he testified that his examinations had been consistent with his training and that he thought they had been complete. Id.

Respondent was also evasive when asked to address the areas in Qian I where the Agency found that he had presented false testimony. Respondent initially explained that he was not lying to the prior ALJ and offered various explains for his testimony, including that he had been defensive, hypothetical, nervous, and speculative, and that he had misspoken. RD, at 14; Tr. 158-61, 163, 166-67. After returning from a recess requested by his counsel, Respondent reluctantly conceded that some of his statements were not accurate or truthful. RD, at 14; Tr. 158-61, 166-67). Respondent's testimony falls short of the unequivocal acceptance that is required from someone who previously lied under oath.

Respondent entered a proposed Corrective Action Plan (CAP) into the record, which contains additional statements that detract from his acceptance of responsibility and minimize the Agency's findings in Qian I. The CAP asserts that “the underlying reasons for the revocation of [Respondent's registration] did not involve patient harm.” RD, at 16; RX R, at 6. Although it is not necessary for the Agency to find patient harm to revoke a registration, and the Agency did not find specific evidence of patient harm in Qian I, the Agency found that Respondent's prescribing created a risk of death and that his “documentation [was] too deficient to conclusively determine that no harm occurred.” 87 FR 8057. Respondent's statement that Qian I did not involve patient harm indicates that he does not appreciate the dangers posed by his prescribing.

Further, in Qian I, the Agency noted that Respondent's “repeated and systematic violations of [his] obligations to document required elements of the standard of care when prescribing high dosages of opioids manifests a disturbing pattern of indifference.” 87 FR 8057. This indifference carried over into Respondent's testimony at the 2023 hearing. He testified that he had become complacent with some of his patients, particularly those who were medical practitioners or personal acquaintances. Tr. 127. For example, he testified, “often you have nurse practitioner, could be a little bit loose, a more combo.” Id. He also testified that he let his guard down with long-term patients and they became more like friends. Id. at 200. This testimony exhibits a lack of appreciation for medical ethics and the dangers of prescribing controlled substances, and Respondent's testimony did little to convince the Agency that he has been sufficiently rehabilitated to be trusted with a registration. Thus, the ALJ found, and the Agency agrees, that Respondent did not unequivocally accept responsibility for his misconduct. RD, at 24.

Although it is not necessary to consider Respondent's remedial measures if he has failed to unequivocally accept responsibility, Respondent presented very little evidence that can be fairly characterized as remedial measures, and most of these measures were either mandated by the MBC or lacked sufficient specificity to signal meaningful change. Id. at 24-25. First, Respondent submitted evidence of approximately 342 hours of continuing medical education (CME) courses from 2020 through 2022, approximately seventy-five of which arguably relate to remedial measures. ¹³ Id. at 19. However, most of these classes were either required by the MBC Order, or had also been previously completed by Respondent in 2013 and 2018 prior to issuing many of the prescriptions in this case. Id.; RX E-F; ALJX 15, app. at 118. The Agency has no reason to believe that Respondent would change his practices after taking these same courses again, and the fact that these courses were required by the MBC's Order detracts some from their weight as remedial measures.

Second, Respondent asserts that he has implemented a new EMR software that does not allow for patient examination records to be copied forward, but he did not supply any corroborating documentation confirming that the EMR lacks that feature. RD, at 17; Tr. 130. Even if it does, the implementation of a new EMR requires minimal effort and does not address the Agency's underlying concerns that Respondent does not fully appreciate his obligations under the CSA.

Third, as discussed in more detail supra, Respondent offered extensive testimony pledging to follow California's most recent Guidelines for Prescribing Controlled Substances for Pain. RD, at 20. To the extent that this testimony may be considered remedial in nature, the Agency agrees with the Chief ALJ that this testimony was not compelling, and it is unclear why the Agency should trust Respondent to comply with guidelines in the future that he declined to comply with previously. Id.

Finally, Respondent has been under mandatory monitoring by an MBC-appointed physician, Dr. Bitonte, since January 2021, and Respondent testified that he is willing to retain Dr. Bitonte as a monitor even if his probation with the MBC ends. However, neither Dr. Bitonte nor Respondent demonstrated in their testimony that Dr. Bitonte's monitoring has aided in remediating Respondent. Dr. Bitonte did not oversee Respondent's prescribing of controlled substances because Respondent did not possess a DEA registration while Dr. Bitonte monitored him (RD, at 12; Tr. 46, 56, 62, 73; ALJ Ex. 28, at 6). Dr. Bitonte also did not observe any of Respondent's encounters with his patients, which precluded him from addressing one of the Agency's primary concerns in Qian I, that Respondent's medical records did not accurately reflect what occurred during the patient encounters. RD, at 8-9. Additionally, Dr. Bitonte testified that he has not prescribed controlled substances since 2014 and is no longer comfortable doing so because opiate prescribing has become a specialty. RD, at 7; Tr. 83-84. This testimony suggests that Dr. Bitonte would not be the ideal candidate for monitoring Respondent's reinstated prescribing of controlled substances. Finally, Dr. Bitonte's opinions at the hearing and in his regular practice monitoring reports (PMRs) were conclusory and repetitive, which suggests that Dr. Bitonte's monitoring lacked the level of involvement necessary to help Respondent reform his recordkeeping practices, which are a vital component of the CSA's efforts to prevent diversion of controlled substances. Thus, the Agency agrees with the Chief ALJ that the potential remedial measures identified by Respondent are not sufficient to establish that Respondent can be trusted with a registration, especially in light of his failure to unequivocally accept responsibility for his actions. RD, at 19-21.

In addition to acceptance of responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction. Daniel A. Glick, D.D.S.,80 FR 74800, 74810 (2015). In this case, the Agency agrees with the Chief ALJ that Respondent's failure to fully acknowledge his wrongdoing suggests that these revocation proceedings have not sufficiently deterred him from future violations. RD, at 25-26. Although Respondent demonstrated some level of interest in complying with the applicable rules and regulations going forward, which suggests that the likelihood of recidivism may be reduced, on balance the considerations of specific deterrence do not support Respondent's application in this case. Id. Further, the Agency agrees with the Chief ALJ that the interests of general deterrence also support revocation. Id. at 26. A decision to grant Respondent's application now, despite Respondent's failure to fully accept responsibility for his misconduct, would send a message to the registrant community that lying to the Agency and prescribing controlled substances without conducting and documenting even the most basic examinations and mitigation measures can be overlooked or excused. Id.

Moreover, the Agency agrees with the Chief ALJ that Respondent's actions were egregious. Id. at 25. Respondent prescribed dangerous combinations of benzodiazepines and high-dose opioids while failing to conduct appropriate examinations, monitor for compliance, or maintain accurate medical records, leading the Agency to conclude that he had put his patients at risk of death. Id. Respondent also misled the tribunal in his first hearing and failed to adequately acknowledge the untruthful testimony in his second hearing. In this case, the Agency believes that denial of Respondent's application would encourage the general registrant community to exhibit candor when dealing with the Agency, conduct and document appropriate medical examinations, and monitor their patients carefully to ensure that the controlled substances that they prescribe do not harm their patients or fall into illegitimate channels where they can be abused or diverted.

In sum, Respondent has not offered any credible evidence on the record to rebut the Government's case for denial of his application and Respondent has not demonstrated that he can be entrusted with the responsibility of registration. Id. at 26-27. Accordingly, the Agency will order that Respondent's application be denied.

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny the pending application for a Certificate of Registration, Control Number W22061401C, submitted by John Qian, M.D., as well as any other pending application of John Qian, M.D., for additional registration in California. This Order is effective August 23, 2024.

Signing Authority

This document of the Drug Enforcement Administration was signed on July 16, 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 .