False Medical Board Accusations in California
The Medical Board of California can file a false Accusation and when it does the physician is harmed even if he wins. In this blog we review the Accusation filed on September 28, 2023 against Dr. David Bockoff (Beverley Hills). Physician Lawyer Daniel Horowitz reviews all the board Accusations as they are filed. Once in a while he finds one that is so outrageous that he has comment on it.
The board sends e-mail blasts that included the Medical Board Accusation filed against Dr. Bockoff. In the same e-mail blast by the Medical Board included notice of the dismissal of an Accusation filed against Dr. Jeffrey Max of San Diego. That was a small footnote to what must undoubtedly have been a terrible ordeal for Dr. Max.
So the first rule is this - Beware reading too much into an Accusation. Our office has also had Accusations dismissed even though as you read the Accusation it looked onerous.
Lack of Checks & Balances to Protect the Doctor
Understanding Dr. Bockoff’s Accusation:
Dr. Bockoff’s accusation serves as a stark warning to other physicians that actions taken by the DEA can lead to filings by the Medical Board. DEA actions are primarily law enforcement focused, often lacking fairness and balance. Despite the Medical Board having some decent checks and balances to protect physicians, they can easily piggyback on a law enforcement investigation and unjustly target an innocent doctor.
Key Points in the Bockoff Allegation:
The board states that: "Respondent is subject to disciplinary action under sections 141 and 2305 of the Code because the United States Drug Enforcement Administration (DEA) suspended Respondent's Certificate of Registration. Suspension of Respondent's DEA Certificate of Registration constitutes grounds for discipline in California, as a violation of federal or state laws regulating dangerous drugs or controlled substances, pursuant to Code section 2238."
This highlights how the Medical Board can discipline a physician based on DEA actions, despite a lack of intrinsic checks and balances to ensure fairness.
Politics vs. Medicine
There is a huge medical battle right now between the opioids are evil and if only I had been told how addictive they were I would never prescribe them group and doctors who treat chronic pain with opiates when nothing else works. The board and the DEA were absolutely slamming the prescribe opiate doctors but recently the Medical Board of California admitted that the strict enforcement policy had caused patients unnecessary pain. States make millions suing big pharma and individual physicians are collateral damage.
Daniel Horowitz: Your Defense Against Unfounded Medical Board Accusations
The Accusation is NUTS on its Face
When facing a Medical Board Accusation, you need an attorney who will protect your rights and challenge unfounded claims. Daniel Horowitz is that attorney.
Questionable Expert Review
The patient files were reviewed by a board “expert” whose summaries and descriptions reveal a lack of true expertise.
Example of Unfounded Accusation
One patient cited by the board was described as follows:
- On February 23, 2021, Respondent prescribed a 15-day supply of oxycodone 15 mg (60 tablets) to be taken every six to eight hours as needed for severe pain.
- On March 12, 2021, Respondent prescribed a 15-day supply of oxycodone 20 mg (60 tablets) to be taken every six to eight hours as needed for severe pain.
- On March 16, 2021, Respondent prescribed a 15-day supply of oxycodone 20 mg (60 tablets) to be taken every six to eight hours as needed for severe pain.
Depending on the patient, this is not outrageous and could be necessary. However, the board alleges:
Patient 6’s prior medical records indicate that she drinks 1 1/2 alcoholic beverages per month. Respondent does not document the patient’s alcohol use or discuss the risks of using alcohol with opioids prior to and while prescribing oxycodone to Patient 6. This is an extreme departure from the standard of care.
To our lawyers, this statement is NUTS. One and a half drinks per month is practically teetotaling. Even if it were 1 ½ drinks per day, it might warrant checking for safety, potentiation, and overdose issues, but 1 ½ per month? This accusation shows a complete lack of judgment.
Another Example of Misjudgment
Regarding Patient 5:
- On October 7, 2019, Respondent documented under “Personal History - Social History - Habits” that “[t]he patient states that he does not smoke cigarettes, drinks alcoholic beverages rarely, and does not use any street drugs.”
Patient 5’s prior medical records in Respondent’s office reflect that he drinks beer 1-2 times a week. Despite this, Respondent continued to prescribe substantial amounts of opioids to Patient 5, which the board claims is an extreme departure from the standard of care.
In other words, someone who does not smoke, does not use street drugs, and drinks beer 1-2 times per week should not be prescribed opiates? This is absurd.
Contact Daniel Horowitz
If you are facing similar unfounded accusations, contact Daniel Horowitz. He will protect your rights and provide the strong defense you need.
Bottom line. Honest doctors can be maligned by false and fatuous assessments by “medical board experts”. Whoever did this evaluation is IMHO ..... [Left Blank]
NOTE: Daniel Horowitz has no interest or connection to this case. He reviews dozens of Accusations and once in a while will publish on an Accusation that seems particularly egregious and abusive.
A major problem is that there is an administrative process that kicks in regarding prescribing privileges. A huge government monster makes findings which are then published nationally. The burden then shifts to the doctor to prove his innocence. Here is what was published in the Federal Register on February 10, 2025 about Dr. Bockoff.
On October 25, 2022, the United States Department of Justice (Agency) issued an Order to Show Cause and Immediate Suspension of Registration (collectively, OSC) to David Bockoff, M.D., (Respondent) of Beverly Hills, California. OSC, at 1, 8. The OSC immediately suspended, and proposes the revocation of, Respondent's Drug Enforcement Administration (DEA) registration, No. BB4591839, “because . . . [Respondent's] continued registration constitutes ‘an imminent danger to the public health or safety,’ ” and “because . . . [Respondent's] continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823[(g)(1)].” [1] Id. at 1 (citing 21 U.S.C. 824(d) and (a)(4)).
Respondent timely requested a hearing. Request for Hearing (November 4, 2022), at 1; Prehearing Ruling (November 30, 2022), at 1. DEA Administrative Law Judge (ALJ) Teresa A. Wallbaum conducted a four-day hearing at the DEA Hearing Facility, attended by Respondent and his Counsel by video teleconference, on January 19, 20, 23, and 24, 2023. Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (RD), at 2. On May 2, 2023, the ALJ issued her RD recommending revocation of Respondent's registration.[2] Id. at 43.
Having thoroughly analyzed the record and applicable law, the Agency summarizes its findings and conclusions: (1) DEA (the Government) presented a prima facie case, (2) Respondent attempted, but failed, to rebut the Government's prima facie case, and (3) substantial and uncontroverted record evidence, including the testimony of the Government's expert witness, shows Respondent's violations of applicable law go to the core of the Controlled Substances Act (CSA). Accordingly, the Agency will revoke Respondent's registration. Infra Order.
II. California Physicians' and Surgeons' Standard of Care
According to the CSA, “[e]xcept as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally . . . to . . . distribute, . . . dispense, or possess with intent to . . . distribute[ ] or dispense, a controlled substance.” 21 U.S.C. 841(a)(1). The CSA's implementing regulations state that a lawful controlled substance order or prescription is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a).
The OSC is addressed to Respondent at his registered address in California. Therefore, the Agency also evaluates Respondent's actions according to California law, including the applicable California standard of care.[3] Authorities in the “Legal Requirements” and “Standard of Care” sections of the OSC give Respondent notice of the bases for the OSC's allegations and, accordingly, are the authorities that the Agency is using to adjudicate those allegations. OSC, at 2-3; infra.
The first California authority listed in the OSC's “Legal Requirements” section is California Health and Safety Code § 11153(a). During the time period alleged in the OSC, that California provision, similar to the CSA, required that a “prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.” Cal. Health & Safety Code § 11153(a) (West 2023-24); OSC, at 2. The provision explicitly includes two examples of prescriptions that are not legal. First, in salient part, “an order purporting to be a prescription which is issued not in the usual course of professional treatment” and, second, “an order for an addict or habitual user of controlled substances, which is issued not in the course of professional treatment or as part of an authorized narcotic treatment program, for the purpose of providing the user with controlled substances, sufficient to keep him or her comfortable by maintaining customary use.” Cal. Health & Safety Code § 11153(a). A violation of this provision is punishable by imprisonment, fine, or both. Id. § 11153(b).
Further, California authorities cited in the OSC define unprofessional conduct relevant to the OSC's allegations. OSC, at 2. According to the California Business and Professions Code, it is unprofessional conduct to prescribe a dangerous drug “without an appropriate prior examination and a medical indication.” [4] Cal. Bus. & Prof. Code § 2242(a) (West 2023-24); OSC, at 2; Tr. 261-63 (Government's expert witness, Dr. Munzing, testifying). The California Business and Professions Code also states that “[r]epeated acts of clearly excessive prescribing . . . of drugs or treatment . . . is unprofessional conduct for a physician.” [5] Cal. Bus. & Prof. Code § 725(a) (West 2023-24); OSC, at 2. The same California Code states that unprofessional conduct includes a physician's “failure . . . to maintain adequate and accurate records relating to the provision of services.” Cal. Bus. & Prof. Code § 2266 (West 2023-24); OSC, at 2.
After researching and analyzing the California standard of care, and reviewing the testimony of Dr. Munzing, the Agency credits Dr. Munzing's standard of care testimony in this matter as an accurate reflection of California law. Accordingly, the Agency agrees with the RD's assessment of Dr. Munzing's testimony, and affords Dr. Munzing's testimony full and controlling weight. See also RD, at 9-14; infra section III.A.
III. Findings of Fact [6]
A. The Government's Case
The Government presented three witnesses—two Diversion Investigators and its expert, Dr. Timothy Munzing. After Respondent stated that he had no objection, the ALJ accepted Dr. Munzing “as an expert in the practice of medicine in California, including, but not limited to, the applicable standards of care in California for the prescribing of controlled substances within the usual course of the professional practice of medicine, which is what he was proffered as an expert in the government's prehearing statement and his witness summary.” [7] Tr. 224. Having thoroughly analyzed the record and applicable law, the Agency agrees with the RD that Dr. Munzing “presented as a knowledgeable and reliable expert witness” whose testimony about the applicable standard of care and its application to specific individuals and circumstances was “detailed” and “consistent.” RD, at 9; supra section II. The Agency agrees with the RD's assessment that Dr. Munzing is a “reliable and credible witness” whose testimony deserves “full and controlling weight” and, accordingly, also affords Dr. Munzing's testimony full and controlling weight. RD, at 10; supra section II.
B. Respondent's Case
Although his filed submissions and statements indicate an intention to present an affirmative case, Respondent, in the end, chose not to testify or to call any witness.[8] Tr. 615 (Respondent's Counsel stating that “[t]here's an independent criminal investigation. And, I'm assuming you figured that out, given this case. And so, we are choosing not to” put on a case). Respondent successfully accomplished the admission of three documents, RX 8, RX 12, and RX 13. Supra section II, infra section III.C.2.a. His counsel cross-examined all of the Government's witnesses and presented an opening statement and a closing argument.[9] Tr. 17-26 (opening statement), Tr. 657-84 (closing argument). Although he indicated that he would, Respondent did not submit a brief or other written, final argument after the hearing.[10] The Agency carefully reviewed and analyzed Respondent's position in this adjudication, evidenced through items such as his filings, his cross-examinations of the Government's witnesses, the documents he successfully moved into evidence, and his opening statement and closing argument at the hearing. In sum, the Agency concludes that Respondent's arguments are not based on admitted record evidence, are not persuasive, and/or do not successfully rebut the record evidence sponsored by the Government or the Government's prima facie case. Infra sections III.C.2. and IV.B. Accordingly, and as discussed further throughout, the Agency does not credit Respondent's arguments.
C. Allegation That Respondent Issued Prescriptions for Controlled Substances Beneath the Applicable Standard of Care and Outside the Usual Course of Professional Practice
Having read and analyzed the transmitted record, the Agency finds substantial and uncontroverted record evidence that Respondent, between January 2020 and June 2022, repeatedly issued controlled substance prescriptions in California beneath the applicable standard of care and outside the usual course of professional practice.[11] See also RD, at 14-33. The record includes evidence of many such controlled substance prescriptions documented in the thousands of pages of the voluminous, transmitted record.[12] Examples of Respondent's illegal prescribing are set out below.
1. Examples of Respondent's Unlawful Controlled Substance Prescribing From January 2020 Through June 2022
The Agency finds substantial, uncontroverted record evidence of multiple controlled substance prescriptions that Respondent issued for multiple individuals from January 2020 through June 2022 beneath the applicable standard of care and outside the usual course of professional practice.
a. Examples of Unlawful Prescribing to Individual 1
The Agency finds substantial, uncontroverted record evidence that on January 24, 2020, Respondent issued two oxycodone (Schedule II) prescriptions to Individual 1: (1) oxycodone HCl ER 80 mg, #240 (thirty-day supply), with the instructions to “take one tablet by mouth every three to four hours for severe pain”; and (2) oxycodone HCl 30 mg, #240 (thirty-day supply), with instructions to “take one tablet by mouth every three to four hours as needed for severe breakthrough pain.” GX 2c, at 3-4. These prescriptions were issued without a single substantive medical data point, note, or comment in Individual 1's medical record associated with the date of this office visit. GX 2a, at 137.[13] The office visit records state only that Individual 1 will “. . . bring old records `again' that `office lost.' ” Id.
Dr. Munzing testified that Respondent's January 24, 2020 controlled substance prescribing for Individual 1 was beneath the applicable standard of care. Tr. 296-305, 306-12. Regarding the January 24, 2020 progress notes for Individual 1, Dr. Munzing testified that, “there's no information. . . . [I]t says it's an office visit but there's no history, there's no vital signs, there's no exam. . . . [T]here's no listing of diagnoses and no listing of medication. . . . There's nothing else. . . . It is missing more details in regards to the updated condition. It is lacking anything regarding are there any adverse or side effects. It has a minimal examination, but very minimal. There is no assessment listed. There is no management plan listed. . . . It also does not list even what the medications the patients were taking at any of these specific dates and visits.” Tr. 299-310. Based on this substantial, uncontroverted record evidence, including the expert testimony of Dr. Munzing, the Agency finds that Respondent issued these two Schedule II controlled substance prescriptions to Individual 1 beneath the applicable standard of care and outside the usual course of professional practice.[14]
Dr. Munzing went on to testify about the standard of care for a follow-up visit and concluded that Respondent prescribed subsequent controlled substances beneath that standard of care as well. Tr. 264-65. Dr. Munzing testified that during follow-up visits, physicians “use something called the five A's as a mnemonic. You know, analgesics: so, how's your pain doing? Activity, functional level. How are you functioning with, with the treatment, not just the medication treatment but the treatment that we have you doing. Are you having any adverse or side effects from the medications? How is the affect of the patient, you know, standing, sitting before you? Do they look high, or do they look like they're falling asleep, or are they actively engaged appropriately in the conversation? And any potential aberrant behaviors, whether it be either the patient saying, well, I got this medicine from someone else, or aberrant behaviors identified by whether it be the CURES reports or urine drug tests, et cetera.” Tr. 480-83.[15]
On February 24, 2020, Respondent re-issued to Individual 1 the same two oxycodone prescriptions from January 24, 2020. GX 2b, at 59. Again, Dr. Munzing testified that he did not “see any assessment at all,” that “[t]here is no plan . . . as best that . . . [he] can see,” that the minimal-to-no documentation means that there is no medication list, no impression documented, and no drug-testing/monitoring addressed until after June 22, 2020. Tr. 316; see also Tr. 313-24. Accordingly, the Agency finds substantial, uncontroverted record evidence that Respondent's issuance of the two oxycodone prescriptions on February 24, 2020,[16] was also beneath the applicable standard of care. Tr. 313-24. Notably, this illegal controlled substance prescribing by Respondent gave Individual 1 access to 480 Schedule II tablets in a thirty-day period. Supra.
b. Examples of Unlawful Prescribing to Individual 2
The Agency finds substantial, uncontroverted record evidence of illegal controlled substance prescribing regarding Individual 2. The Agency finds that there is substantial, uncontroverted record evidence that on March 18, 2020, Respondent added a new Schedule II controlled substance prescription, methadone HCl 5 mg, #70 (thirty-day supply), to two other controlled substance prescriptions that he had already prescribed to Individual 2 six days before on March 12, 2020, namely, morphine sulfate ER 100 mg, #90 (thirty-day supply) and oxycodone HCl 30 mg, #120 (thirty-day supply). GX 3c, at 7, 9, 10. Dr. Munzing testified that the medical record form that Respondent created for the associated encounter with Individual 2 contained information for encounters on January 16, 2020, March 12, 2020, May 7, 2020, June 29, 2020, August 28, 2020, and October 22, 2020. Tr. 374-80; see also GX 3b, at 63. However, Respondent's medical records do not include any entry for March 18, 2020, the date the methadone 5 mg prescription was issued. Tr. 374-76.
Regarding Respondent's addition of methadone 5 mg to the controlled substance prescriptions that he was issuing Individual 2, Dr. Munzing testified that Respondent's medical records for Individual 2, “just under” the March 12, 2020 date say “not getting much help from clonidine.” [17] Tr. 374; see also Tr. 375.[18] Dr. Munzing testified, “[c]lonidine is not a pain medication[, so] it [does not] explain why methadone is started.” Tr. 376. Dr. Munzing's testimony lists multiple other items missing from Respondent's medical record for Individual 2 associated with the addition of methadone 5 mg, including: an appropriate history, vital signs, a physical examination, an assessment, a specific plan, and documentation of Respondent's discussion with Individual 2 about the increased risk to Individual 2 of increasing the morphine milligram equivalent by adding methadone 5 mg.[19] Tr. 376-77.
The further substantial, undisputed record evidence is that on April 10, 2020, Respondent increased the dosage of the methadone HCl he had prescribed for Individual 2 from 5 mg to 10 mg, with instructions that increased Individual 2's daily methadone dose to 30 mg. GX 3c, at 17; Tr. 379. The Agency notes that Respondent's medical records for Individual 2 during this time period do not show an entry for any day in April 2020, let alone an entry for April 10, 2020, specifically. GX 3b, at 63; GX 3c, at 23 (CURES Consolidated Report showing that the methadone 10 mg prescription for Individual 2 was filled on April 14, 2020).
The Agency credits Dr. Munzing's testimony and finds substantial, uncontroverted record evidence that Respondent issued the March 18, 2020 and April 14, 2020 methadone prescriptions to Individual 2 beneath the applicable standard of care and outside the usual course of professional practice. Tr. 376-80. Moreover, Respondent's illegal morphine sulphate, oxycodone, and methadone controlled substance prescribing to Individual 2 gave Individual 2 access to 280 Schedule II controlled substance tablets in a thirty-day period. Supra.
c. Examples of Unlawful Prescribing to Individual 3
The Agency finds substantial, uncontroverted record evidence of illegal controlled substance prescribing regarding Individual 3. Substantial record evidence shows that on March 13, 2020, Respondent prescribed methadone HCl 5 mg, #70 (thirty-day supply) to Individual 3. GX 4d, at 30, 42. Dr. Munzing credibly testified that there is nothing on the January 13, 2020 through April 9, 2020 page of Respondent's medical record notes for Individual 3 documenting why Respondent issued the methadone HCl 5 mg prescription to Individual 3 on March 13, 2020. Tr. 420-23. The Agency, therefore, finds substantial, uncontroverted record evidence that Respondent's medical records for Individual 3, dated January 13, 2020, and March 13, 2020, do not include, as the applicable standard of care requires, Respondent's medical analyses, impressions, justifications, or rationales for prescribing methadone to Individual 3 on March 13, 2020.[20] Tr. 420-23; see also GX 4b, at 675; RD, at 20-21.
Similarly, the Agency finds substantial, uncontroverted record evidence that the following month, on April 9, 2020, Respondent increased the dosage of the methadone HCl prescribed to Individual 3 to 10 mg and the frequency from once a day to three times a day. GX 4d, at 51, 54; GX 4b, at 674. Again, Dr. Munzing testified that Respondent issued the April 9, 2020 prescription to Individual 3 without any explanation for the increased dosage in Respondent's corresponding medical record notes. Tr. 423-27. The Agency, therefore, finds that based on the substantial, uncontroverted record evidence, Respondent's April 9, 2020 medical record note does not include, as the applicable standard of care requires, Respondent's medical analyses, impressions, justifications, or rationales for increasing the methadone dosage for Individual 3 on that date. Tr. 423-27; see also RD, at 21.
Accordingly, based on the documentary record evidence and crediting the record testimony of Dr. Munzing, the Agency finds substantial, uncontroverted record evidence that in March and April of 2020, Respondent prescribed methadone for Individual 3 beneath the applicable standard of care and outside the usual course of professional practice. Tr. 422-27. Further, Respondent's illegal controlled substance prescribing to Individual 3 gave Individual 3 access to 70 Schedule II tablets for a thirty-day period.
d. Examples of Unlawful Prescribing to Individual 4
The Agency finds substantial, uncontroverted record evidence of illegal controlled substance prescribing regarding Individual 4. Substantial record evidence shows that on January 17, 2020, Respondent issued three controlled substance prescriptions to Individual 4: (1) alprazolam 2 mg, a benzodiazepine, #60 (thirty-day supply); (2) oxycodone 30 mg, #60 (fifteen-day supply); and (3) methadone 10 mg, #90 (fifteen-day supply). GX 6e, at 3-5; Tr. 489-90. The Agency finds that Respondent's medical record for Individual 4 associated with these three controlled substance prescriptions is dated January 10, 2020. Tr. 490-91; GX 6c, at 63. The Agency further finds substantial, uncontroverted record evidence that Respondent's medical record notes associated with the issuance of these three controlled substance prescriptions “lack[s] . . . a lot of information that would be expected and would be required.” Tr. 490-91 (Dr. Munzing testifying); see also RD, at 24-25. Accordingly, the Agency finds that, based on the documentary record evidence and the record testimony of Dr. Munzing, the substantial, uncontroverted record evidence shows that Respondent issued these three controlled substance prescriptions to Individual 4 beneath the applicable standard of care and outside the usual course of professional practice. Tr. 490-91. Further, Respondent's illegal controlled substance prescribing to Individual 4 gave Individual 4 access to 390 controlled substance tablets for a thirty-day period, of which 300 tablets were Schedule II and 90 tablets were Schedule IV.
e. Examples of Unlawful Prescribing to Individual 5
The Agency finds substantial, uncontroverted record evidence of illegal controlled substance prescribing regarding Individual 5. Substantial, uncontroverted record evidence shows that on January 7, 2020, Respondent issued four controlled substance prescriptions to Individual 5: (1) oxymorphone HCl ER 20 mg, #240 (thirty-day supply); (2) oxymorphone HCl 10 mg, #180 (thirty-day supply); (3) carisoprodol 350 mg, #90 (thirty-day supply); and 4) buprenorphine HCl 8 mg, #60 (thirty-day supply). GX 5c, at 1-8; Tr. 473-75. The Agency finds that the office visit associated with Respondent's issuance of these four controlled substance prescriptions was on January 7, 2020. GX 5b, at 82; Tr. 475-76. Although Respondent recorded that Individual 5 visited his office on January 7, 2020, he wrote nothing after the date of the office visit in Individual 5's medical records. GX 5b, at 82; RD, at 26. Dr. Munzing testified that Respondent's controlled substance prescribing to Individual 5 on January 7, 2020, was beneath the applicable standard of care because Respondent failed to document Individual 5's medical history, vital signs, and medications; an appropriate physical examination of Individual 5; an updated assessment of Individual 5; and a treatment plan for Individual 5. Tr. 476.
The Agency, therefore, finds that based on the substantial, uncontroverted record evidence and the testimony of Dr. Munzing, Respondent issued the four controlled substance prescriptions on January 7, 2020, beneath the applicable standard of care and outside the usual course of professional practice. Tr. 476; see also RD, at 26. Further, Respondent's illegal controlled substance prescribing for Individual 5 gave Individual 5 access to 570 controlled substance tablets for a thirty-day period, of which 420 tablets were Schedule II, 60 tablets were Schedule III, and 90 tablets were Schedule IV.
In sum, the Agency finds substantial, uncontroverted record evidence of multiple controlled substance prescriptions that Respondent issued for multiple individuals from January 2020 through June 2022 beneath the applicable standard of care and outside the usual course of professional practice.
2. Respondent's Arguments Against the Government's Evidence
Respondent sought to impugn the Government's evidence, including Dr. Munzing's credibility and testimony, in multiple ways.[21] Regarding Dr. Munzing's testimony about Respondent's medical records of his controlled substance prescribing, Respondent argues that Dr. Munzing is not in a position to formulate an expert opinion on the matter because he was not present during Respondent's interactions with any of the five individuals discussed in the OSC. Tr. 310-11 (Respondent arguing that “Dr. Munzing continues to conflate what is in the records and what happened at the actual exam. He acts as though, and testifies as such, that he knows what happened at this examination and that just simply is not true unless he has interviewed someone or is looking at other notes. He is perfectly capable, and it is proper for him to talk about the sufficiency of the medical records. And there is no indication in the records that these things occur. But that is not what he is saying. He is saying that these things never happened. And I do not believe there is a basis for that in the record nor do I believe he has a basis to make such a statement.”), id. at 319-20 (Respondent arguing that Dr. Munzing “continues to act as though the fact that something doesn't appear in the record means it didn't happen when in fact the evidence is to the contrary.”), id. at 344 (Respondent arguing that Dr. Munzing “clearly specifically is conflating the standard of care for informed consent with the standard of care for documentation”). The Agency does not credit this category of Respondent's objections.
Section 2266 of the California Business and Professions Code is clear: it is unprofessional conduct for a physician to fail “to maintain adequate and accurate records relating to the provision of services.” Supra section II. The ALJ handled Respondent's arguments correctly. Tr. 311 (ALJ stating that “there is agency case law that says if it is not in a document, then it did not happen”); RD, at 4, n.5 (citing prior Agency decisions, stating that they “make clear” that a controlled substance prescription is issued beneath the applicable standard of care and outside the usual course of professional practice when a registrant fails to create adequate documentation of his controlled substance prescribing, including of all of the steps that led to his issuing each controlled substance prescription), see also RD, at 38 (citing prior Agency decisions); Tr. 360-61 (ALJ ruling that Dr. Munzing “is reviewing documentation. He can make conclusions based on that documentation regarding the standard of care and I just didn't want to leave anybody with a misunderstanding of how I was approaching it. I'm not viewing it as just a recordkeeping violation and I will allow respondent to address on cross examination his point that Dr. Munzing is relying on documentation and was obviously not present during the examinations.”).
Respondent further argues that he is allowed to write “follow-up prescriptions” without “these intense examinations” that Dr. Munzing “has previously described.” Id. at 324-25. The Agency thoroughly reviewed California's standard of care and finds no support in it for Respondent's argument. Supra sections II and III.C.1.a.
Regarding the Government's allegation that Respondent's monitoring through UDS was beneath the applicable standard of care and outside the usual course of professional practice, Respondent argues that the “Government's theory has now shifted from the OSC. Now they say that . . . [Respondent] did not adequately address aberrant results.” Tr. 679. Based on the multiple references to UDS and UDS-related allegations in the OSC, the Agency does not credit Respondent's argument that the Government's theory about UDS “shifted from the OSC.” [22]
Respondent's argument about the OSC's UDS allegations then states that “the logical inference from looking at the patient files is that . . . [Respondent] addressed the issue with his patients to his satisfaction, sufficient to make him comfortable to continue prescribing. The notion that he ignored aberrant results is absurd. Why would . . . [Respondent] be doing regular urine drug screening to just ignore the results. It does not make any sense.” [23] Id. at 679. The Agency has not credited this argument in the past, and it does not credit Respondent's iteration of it now. E.g., Benton D. Wynn, M.D.,87 FR 24,228, 24,234-35 (2022); Craig S. Rosenblum, M.D.,87 FR 21,181, 21,203 (2022); John X. Qian, M.D.,87 FR 8039, 8051-52 (2022).
Regarding Respondent's continued controlled substance prescribing as his medical records improved, Dr. Munzing acknowledges that the “medical records improved a lot.” Tr. 537. When Respondent's Counsel retorted that Respondent “did nothing wrong” after his medical records improved and “had come into compliance,” Dr. Munzing answered that “[i]f the prescribing continued as it was, . . . I still don't agree that the prescribing was . . . okay.” Id. at 537-38. Respondent's argument that improved medical records also mean that the underlying controlled substance prescribings then become legitimate is a non sequitur. The Agency does not credit Respondent's argument that his improved medical records mean that his controlled substance prescribing then fell within the applicable standard of care and the usual course of professional practice.
The Agency addresses Respondent's other arguments below, starting with the arguments based on Respondent's three exhibits, and then categorizing Respondent's remaining arguments into those concerning Dr. Munzing and those concerning DEA's investigation. In sum, the Agency does not credit any of Respondent's arguments. See also, e.g., RD, at 4, 7-10, 26, 38-40.
a. Respondent's Arguments Based on His Three Exhibits
As already discussed, Respondent successfully offered three documents into evidence. First, RX 8 is titled “How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency” (Pandemic Prescribing).[24] This one-page document states that DEA “adopted policies to allow DEA-registered practitioners to prescribe controlled substances without having to interact in-person with their patients.” RX 8, at 1. It is a “guidance document” that is “not binding and lack[s] the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement.” Id. Pandemic Prescribing states that its “policies are effective beginning March 31, 2020, and will remain in effect for the duration of the public health emergency, unless DEA specifies an earlier date.” Id. Pandemic Prescribing states that, “[u]nder federal law, all controlled substance prescriptions must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice. 21 CFR 1306.04(a).” Id. It continues that, “[i]n all circumstances when prescribing a controlled substance, including those summarized below, the practitioner must use his/her sound judgment to determine that s/he has sufficient information to conclude that the issuance of the prescription is for a bona fide medical purpose.” Id. Its prefatory content concludes by stating that “[p]ractitioners must also comply with applicable state law.” Id. Finally, Pandemic Prescribing cites to the DEA Diversion internet address and “relevant law and regulations” for “[f]ull details.” Id.
According to RX 8, how a practitioner evaluates a patient, from March 31, 2020 through the duration of the public health emergency, depends on whether the practitioner previously examined the patient in person. Id. If so, then the “[p]ractitioner may conduct any needed follow-up evaluation by any method in person, telemedicine, telephone, email, etc.” Id. If not, then a Practitioner who is prescribing “buprenorphine for maintenance or detoxification treatment of an opioid use disorder . . . [e]valuate[s the] patient . . . in person, or via telemedicine using a real-time, two-way, audio-visual communications device.” Id. If the practitioner has not previously examined the patient in person and is not prescribing buprenorphine for maintenance or detoxification treatment of an opioid use disorder, then the practitioner “[e]valuates [the] patient . . . in person or via telemedicine using a real-time, two-way, audio-visual communications device.” Id. In short, the DEA document about prescribing controlled substances during the COVID-19 public health emergency does not dispense with the legal standards of the required evaluation; it expands the options available to practitioners for conducting the required evaluation. Id.
The Agency finds substantial record evidence that Dr. Munzing's testimony accurately describes the content of Pandemic Prescribing. See, e.g., Tr. 610-11. The Agency further finds substantial record evidence that Dr. Munzing's testimony accurately identifies which of Respondent's medical records concern in-person visits and which of Respondent's medical records describe telehealth interactions. See, e.g., id. at 609 (Dr. Munzing's testimony explaining that Respondent's medical records identify whether the note concerns an in-person visit or a telehealth interaction, and how they do so). Respondent, nevertheless, during his closing argument criticizing Dr. Munzing, argues that he “talked a lot about in[-]person examinations and the need for the practitioner to lay hands on a patient if you're seeing them in person. But he ignored the DEA's own guidelines for the COVID pandemic that said in person visits were not required during the pandemic.” Tr. 680. The Agency carefully considered this argument of Respondent and concludes that it is not a valid criticism of Dr. Munzing. On the one hand, Respondent's argument, cited in full above, accurately states that Dr. Munzing testified about the patient examination required by the applicable standard of care. This is to Dr. Munzing's credit.
On the other hand, Respondent's argument asserts, without support or citation to the record, that Dr. Munzing “ignored” Pandemic Prescribing. As already discussed, the record evidence shows the opposite and, therefore, the Agency does not credit this Respondent criticism of Dr. Munzing. Further, the Decision's findings that the Government established a prima facie case and that Respondent did not successfully rebut it are based solely on Respondent's in-person interactions. The Agency concludes that those in-person interactions and associated controlled substance prescribings do not comply with the applicable standard of care. Supra sections II and III, infra sections IV and V.
The second item that Respondent successfully moved into evidence is RX 12, a copy of section 124961 of the California Health and Safety Code. According to this provision, titled the “Pain Patient's Bill of Rights,” a “patient who suffers from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her pain,” and “has the option to choose opiate medications to relieve that pain without first having to submit to an invasive medical procedure,” among other things. Cal. Health & Safety Code § 124961(a) and (b). The provision also includes clauses addressing practitioners, such as ones explicitly stating that a “patient's physician may refuse to prescribe opiate medication,” and that a “physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve the patient's pain, as long as that prescribing is in conformance with Section 2241.5 of the Business and Professions Code.” Id. § 124961 (c) and (d).
Indeed, Respondent successfully moved into evidence, as RX 13, section 2241.5 of the California Business and Professions Code, a provision mentioned in section 124961 multiple times. Infra. Section 124961 references section 2241.5 when it states that, “[n]othing in this section shall be construed to alter any of the provisions set forth in Section 2241.5 of the Business and Professions Code.” Id. § 124961 (preface). Section 124961 further states, explicitly, that it shall not “[l]imit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act,” and that it shall not “[l]imit the applicability of any federal statute or federal regulation or any of the other statutes or regulations of this state that regulate dangerous drugs or controlled substances.” Id. § 124961 (preface) and (f)(2).
The Agency finds that the provisions of section 124961, while called the “Pain Patient's Bill of Rights,” do not alter the standard of care applicable to physicians treating those “Pain Patients.” For example, the provisions afford a patient “who suffers from severe chronic intractable pain . . . the option to request or reject the use of any or all modalities in order to relieve his or her pain.” Id. § 124961(a). At the same time, though, the section explicitly states that practitioners may refuse to prescribe opioids, and that practitioners who do prescribe opioids must continue to comply with all associated state and federal legal requirements when doing so. Id. § 124961(c) and (f)(2). In other words, the Agency finds that the provision does not alter a practitioner's responsibility to comply with the applicable standard of care.
In addition, the provisions of RX 13, section 2241.5, include permission for a “physician and surgeon . . . [to] prescribe for . . . a person under his or her treatment for a medical condition dangerous drugs or prescription controlled substances for the treatment of pain or a condition causing pain . . . including, but not limited to, intractable pain.” Cal. Bus. & Prof. Code § 2241.5(a). It also includes protections from disciplinary action for a physician who prescribes dangerous drugs or controlled substances “in accordance with this section,” and caveats that the section does not impact medical board action against a physician who, among other things, engages in unprofessional conduct including gross negligence, repeated negligent acts, or incompetence, violates the requirement to perform an appropriate prior examination before prescribing a dangerous drug, prescribes in violation of California law, or fails to comply with all state controlled substance recordkeeping requirements. Id. § 2241.5(b) and (c).
Regarding RX 12 and RX 13, Respondent, during his cross-examination of Dr. Munzing and his closing oral argument, primarily focuses on the prohibition of disciplinary action “for prescribing or administering a controlled substance in the course of treatment of a person for intractable pain” and how the “clear” California “public policy in favor of making sure patients have access to adequate treatment for their pain . . . would be severely undermin[ed]” if Respondent's registration were revoked. E.g., Tr. 554, 683. Respondent places much less, if any, emphasis on the fact that neither of these California statutes, or Pandemic Prescribing, authorizes a registrant to violate the applicable standard of care when prescribing a controlled substance. Supra. This fact is of the utmost importance for the appropriate adjudication of the OSC and leads to the inescapable conclusion that neither RX 8, RX 12, nor RX 13 justifies or excuses Respondent's violations of the applicable standard of care while prescribing controlled substances.
b. Respondent's Additional Arguments Concerning Dr. Munzing
Respondent levels multiple, additional criticisms against Dr. Munzing.[25] After carefully considering each of them, the Agency credits none of them. See also RD, at 7-8.
Respondent argues that Dr. Munzing does not have the expertise, as a career employee of Kaiser who is not board certified in pain, to testify about Respondent's controlled substance prescribing for individuals with intractable pain. E.g., Tr. 546-47. When given the opportunity during the hearing to address the Government's proffering of Dr. Munzing as an expert, however, Respondent twice stated that he had no objection to the acceptance of Dr. Munzing as an expert. Id. at 205, 224. Upon Respondent's final “no objection” response to the ALJ regarding qualifying Dr. Munzing as an expert, the ALJ accepted Dr. Munzing as an expert “in the practice of medicine in California, including, but not limited to, the applicable standards of care in California for the prescribing of controlled substances within the usual course of the professional practice of medicine, which is what he was proffered as an expert in the [G]overnment's prehearing statement and his witness summary [emphasis added].” Id. at 224.
Respondent had more than two months' notice of the Government's proposed parameters for Dr. Munzing's testimony. Id.; see also Government Prehearing Statement (November 16, 2022), at 5-6. Accordingly, this notice and Respondent's “no objection” responses to the ALJ about the Government's proffering Dr. Munzing as its expert foreclose Respondent's subsequent, closing argument challenges to Dr. Munzing's expert qualifications. They further foreclose Respondent's closing argument assertions that, “Dr. Munzing's opinion about the California standard of care is unreliable,” including that Dr. Munzing “rambled” and testified to best practices, not necessarily to the applicable standard of care.[26] Id. at 667. The Agency, as already discussed, finds that the testimony of Dr. Munzing, on which this Decision is based, is fully consistent with the applicable standard of care; it is not “rambling” and it does not confuse the Agency as to the difference between the applicable standard of care and matters that are not incumbent on registrants, like Respondent, to follow. Supra sections II and III.C.1, infra section IV.B; see also RD, at n.10. Accordingly, the Agency does not credit the “rambling” and “best practices” criticisms that Respondent levels against Dr. Munzing's expert testimony.
The Agency does not credit Respondent's closing argument and statements during Dr. Munzing's testimony criticizing Dr. Munzing because he never examined, interviewed, or otherwise interacted with any of the individuals who saw Respondent and whose medical records are referenced in the OSC. E.g., Tr. 312-13 (Dr. Munzing testifying that he did not speak to anybody whose medical records by Respondent he reviewed), id. at 592-93 (Dr. Munzing testifying that he reviewed the materials about the five individuals referenced in the OSC), id. at 311 (Respondent's Counsel stating that Dr. Munzing “acts as though, and testifies as such, that he knows what happened at this examination and that just simply is not true unless he has interviewed someone or is looking at other notes” and that Dr. Munzing “is saying that these things never happened. And I do not believe there is a basis for that in the record nor do I believe he has a basis to make such a statement.”), id. at 666-67 (Respondent's Counsel arguing that Dr. Munzing's testimony “lacks foundation” because he does not know how Respondent “actually examined his patients,” “[h]e has never examined these patients nor has he or anyone else from the DEA ever attempted to speak to them”), id. at 678 (Respondent's Counsel arguing that “notably, Dr. Munzing never testified that the course of treatment for these patients was inappropriate in any way. He merely testified that it was not adequately documented.”); id. at 311-12 (ALJ overruling Respondent's objection, stating that, “[t]he point is well taken . . . I would like precision here. I will note that there is agency case law that says if it is not in a document, then it did not happen. . . . [W]hat he [Dr. Munzing] is saying is his reading of the . . . records, that is not documented anywhere in these notes and that should be documented in these notes,” but interrupted by Respondent's Counsel stating that, “I fully accept that, Your Honor”).
As already discussed in the standard of care section, the Agency finds that Dr. Munzing's testimony accurately conveys and applies the applicable standard of care to the record evidence he was asked to address. Supra section II. Accordingly, Dr. Munzing's credible testimony informs this Decision's finding that the Government established a prima facie case and that Respondent did not successfully rebut it.[27] Supra sections II., III.A., and III.C.1; see also RD, at 7-14.
Respondent criticizes Dr. Munzing's consulting work, including his work for United States law enforcement, stating that it compromises the independence Dr. Munzing needs to be a credible witness in this adjudication. See, e.g., Tr. 514-17, 563-74. Further, Respondent, based on Dr. Munzing's curriculum vitae, GX 7, criticizes Dr. Munzing for lecturing about “collaborating” with law enforcement, suggesting that it shows “inappropriate collaboration” with law enforcement. GX 7, at 13; e.g., Tr. 514-17. The Agency considered these criticisms of Dr. Munzing's independence and does not credit them for multiple reasons, namely because the Agency finds that Dr. Munzing's standard-of-care testimony conforms to the applicable standard of care and Dr. Munzing credibly and consistently applied the standard of care to the facts in this case. Supra section II; see also RD, at 7-9.
Similarly, Respondent asked Dr. Munzing about whether he had foreknowledge of the search warrant, including whether he had a role in drafting the search warrant for Respondent's medical records, about whether he was involved in the Government's deployment of undercover officers during its investigation of Respondent, and about financial aspects of his service as a medical consultant to law enforcement, including insinuating financial irregularities by Dr. Munzing.[28] E.g., Tr. 575-92, 611-14. Although Respondent was given the opportunity and tried, the Agency finds that he did not successfully articulate the relevance of these questions. Even if he had been successful, Dr. Munzing's credible and consistent testimony is that he played no role in the search warrant drafting, that he did not see the search warrant affidavit before the September 2021 search took place, that he would not typically discuss whether to send undercover officers into a registrant's office, and that he “does not believe” that he discussed sending undercover officers into Respondent's office before the investigators took that action.[29] Id. at 521-22, 517.
Further, as already discussed, the Agency finds that Dr. Munzing's testimony accurately states the applicable standard of care, and accurately applies that standard of care to the record evidence that he was asked to address and that forms the bases of this Decision's findings of fact and conclusions of law. See also RD, at 8-10.
c. Respondent's Arguments Concerning DEA's Investigation
Respondent also challenges the process used during the Government's investigation of him and the ensuing issuance of the OSC. E.g., Tr. 525-30. For example, Respondent argues that DEA issued the OSC before it possessed all of Respondent's medical records and, therefore, Respondent posits, before it had a basis to allege that Respondent's controlled substance prescribing violates the applicable standard of care. E.g., id. at 620-25 (Respondent arguing that DEA's search warrant affidavit falsely states that the search warrant is necessary because Respondent's medical practice is “illegitimate” when DEA did not possess all of the records needed to reach such a conclusion). The Agency finds that the questions Respondent raises about DEA's investigation of his practice are not creditable. The Agency certainly understands that Respondent would have preferred for DEA to have possessed all of Respondent's medical records at once, for DEA to have assessed that Respondent's medical recordkeeping improved after he became aware of DEA's investigation of his practice, and for the Agency not to have suspended Respondent's registration due to Respondent's improved recordkeeping.[30] The Agency disagrees, though, as it recently reasserted. Morris & Dickson Co., LLC,88 FR 34,523, 34,539-40 (2023) (“[T]he Agency has also made it abundantly clear that remediation alone is not adequate to avoid a sanction and that limited-to-no-weight is given to remedial measures when the effort is not made until after enforcement begins. See Mireille Lalanne, M.D.,78 FR 47,750, 47,777 (2013) (quoting Liddy's Pharmacy, L.L.C.,76 FR 48,887, 48,897 (2011) (“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.”)); see also Southwood Pharm. Inc., 72 FR at 36,503 (giving no weight to respondent's `stroke-of-midnight decision' to cease supplying suspect pharmacies with controlled substances and to employ a compliance officer”); infra section V.[31]
After carefully reviewing the record, the Agency concludes that Respondent's arguments and defenses are not creditable, and do not successfully rebut the Government's case.
IV. Discussion
A. The Controlled Substances Act
Pursuant to the CSA, “[a] registration . . . to . . . distribute[ ] or 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 . . . [21 U.S.C. 823] inconsistent with the public interest as determined by such section.” 21 U.S.C. 824(a)(4). In the case of a “practitioner,” Congress directed the Attorney General to consider five factors in making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).[32] The five factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (“It is well established that these factors are to be considered in the disjunctive,” citing In re Arora,60 FR 4447, 4448 (1995)); Robert A. Leslie, M.D.,68 FR 15,227, 15,230 (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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D.,58 FR 37,507, 37,508 (1993).
According to DEA regulations, “[a]t any hearing for the revocation . . . of a registration, the . . . [Government] shall have the burden of proving that the requirements for such revocation . . . pursuant to . . . 21 U.S.C. [§ ] 824(a) . . . are satisfied.” 21 CFR 1301.44(e); see also Morall, 412 F.3d. at 174.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have been considered, the Agency finds that the Government's evidence in support of its prima facie public interest revocation case is confined to factors B and D.[33] Government's Proposed Findings of Fact and Conclusions of Law, at 19-28; see also RD, at 35-40.
B. Unlawful Prescribing and Public Interest Analysis
Factors B and/or D—Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances
According to the CSA's implementing regulations, a lawful prescription for controlled substances is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a); see Gonzales v. Oregon, supra, 546 U.S. at 274, United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444 U.S. 866 (1979). Applicable California law, similar to applicable federal law, provides that “prescriptions for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. Cal. Health & Safety Code § 11153(a); OSC, at 2; supra section II. Applicable California law also provides that it is unprofessional conduct to prescribe a controlled substance, or other “dangerous drug,” “without an appropriate prior examination and a medical indication.” Cal. Bus. & Prof. Code § 2242(a); OSC, at 2; supra section II. Further, California law states that “unprofessional conduct” by a physician includes the physician's “failure . . . to maintain adequate and accurate records relating to the provision of services.” Cal. Bus. & Prof. Code § 2266; OSC, at 2; supra section II.
As already noted, there is substantial, uncontroverted record evidence of violations of applicable law. Supra sections II and III.C.1. Those violations go to the heart of this Agency's law enforcement mission.
Having thoroughly analyzed the record evidence and applicable law, the Agency finds substantial, uncontroverted record evidence that Respondent issued multiple controlled substance prescriptions without, for example, having conducted an appropriate prior examination and establishing a medical indication, and that Respondent did not maintain adequate and accurate records, or maintained no records at all, relating to his controlled substance prescribing. Supra sections II and III.C.1; e.g. Tr. 296-324, 355-58, 374-80, 420-27, 490-91, 473-75.[34] In addition, as already discussed, the Agency finds that Respondent's case, including his arguments, three admitted exhibits, and challenges to the Government's evidence, does not rebut this substantial record evidence. Supra sections III.B. and III.C.2. Accordingly, the Agency concludes that Respondent issued multiple controlled substance prescriptions other than for a legitimate medical purpose while acting in the usual course of professional practice, prescribed controlled substances without an appropriate prior examination and a medical indication, and failed to maintain adequate and accurate records relating to the provision of services, thus committing multiple violations of California law and, therefore, of federal law. Cal. Health & Safety Code § 11153(a), Cal. Bus. & Prof. Code § 2242(a), Cal. Bus. & Prof. Code § 2266, 21 CFR 1306.04(a); supra sections II and III.C.1; see also RD, at 7-10, 14-15, 20-21, 24-26, 28-29. Substantial record evidence of any one of the founded violations is sufficient for the Agency to revoke Respondent's registration.
In sum, the Agency finds substantial record evidence that the Government established a prima facie case that Respondent violated federal and state law. Accordingly, the Agency finds that the Government established a prima facie case, that Respondent did not successfully rebut that prima facie case, and that there is substantial record evidence supporting the revocation of Respondent's registration. 21 U.S.C. 824(a)(4) and 823(g)(1)(B) and (D).[35]
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