Fares Jeries Rabadi, M.D.; Decision and Order

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-14]

Fares Jeries Rabadi, M.D.; Decision and Order

On March 2, 2020, a former Acting Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (hereinafter collectively, OSC) to Fares Jeries Rabadi, M.D. (hereinafter, Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1 (OSC), at 1. The OSC immediately suspended Respondent's DEA Certificate of Registration Number BR6081018 (hereinafter, registration or COR) “because [Respondent's] continued registration constitutes an `imminent danger to the public health or safety.' ”

Id.

(citing 21 U.S.C. 824(d)). The OSC also proposed revocation of Respondent's registration, the denial of any pending applications for renewal or modification of such registration, and the denial of any pending applications for additional DEA registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because Respondent's “continued registration is inconsistent with the public interest.”

Id.

In response to the OSC, Respondent timely requested a hearing before an Administrative Law Judge. ALJ Ex. 2. The hearing in this matter was conducted on September 29-30, 2020, via video teleconference technology. On December 22, 2020, Administrative Law Judge Mark M. Dowd, (hereinafter, ALJ) issued his Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (hereinafter, Recommended Decision or RD) to which both parties filed Exceptions. I have addressed both the Respondent's and Government's Exceptions in footnotes added to the corresponding parts of the RD. While I have made some modifications to the RD based on the Exceptions, none of those changes and none of Respondent's arguments persuaded me to reach a different conclusion than the ALJ in this matter. I issue my final Order in this case following the Recommended Decision.

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I have made minor, nonsubstantive, and grammatical changes to the RD and nonsubstantive conforming edits. Where I have added to the ALJ's opinion to include additional information, I have noted the additions in brackets or in footnotes marked with an asterisk and a letter. Where I have made substantive changes, omitted language for brevity or relevance, or where I have modified the ALJ's opinion, I have noted the edits in brackets and have included specific descriptions of the modifications in brackets or in footnotes marked with an asterisk and a letter. Within those brackets and footnotes, the use of the personal pronoun “I” refers to myself—the Administrator.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge

*B

*B

I have omitted the RD's discussion of the procedural history to avoid repetition with my introduction.

The issue to be decided by the Administrator is whether the record as a whole establishes by a preponderance of the evidence that the DEA Certificate of Registration, No. BR6081018, issued to Respondent should be revoked, and any pending applications for modification or renewal of the existing registration should be denied, and any pending applications for additional registrations should be denied, because his continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4).

After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions of law below.

The Allegations

The Government alleges the Respondent violated federal and California law,

1

by issuing numerous prescriptions for Schedule II through IV controlled substances outside the usual course of professional practice and not for a legitimate medical purpose to seven individuals as recently as December 31, 2019. These prescriptions fell below minimal medical standards applicable to the practice of medicine in California. Therefore, these prescriptions violated federal and California state law.

1

[Omitted for brevity. Specifically, Respondent was charged with violating:]

a. Cal. Health & Safety Code § 11153(a), requiring 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”;

b. Cal. Health & Safety Code § 11154(a), directing that “no person shall knowingly prescribe, administer, dispense, or furnish a controlled substance to or for any person . . . not under his or her treatment for a pathology or condition . . .”;

c. Cal. Bus.& Prof. Code § 2242, prohibiting the “[p]rescribing, dispensing, or furnishing [of controlled substances] . . . without an appropriate prior examination and a medical indication,” the violation of which constitutes unprofessional conduct;

d. Cal. Bus. & Prof. Code § 2234, defining unprofessional conduct to include: “[g]ross negligence”; “[r]epeated negligent acts”; “[i]ncompetence”; or “[t]he commission of any act involving dishonesty or corruption that is substantially related to the qualifications, functions, or duties of a physician and surgeon”; and

e. Cal. Bus. & Prof. Code § 725, further defining unprofessional conduct to include “[r]epeated acts of clearly excessive prescribing, furnishing, dispensing, or administering of drugs. . . .”

Additionally, [Respondent was alleged to have issued prescriptions outside of] California's applicable standard of care as outlined in the “Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons,” Medical Board of California, 7th ed. 2013 (the “Guide”). [Omitted for brevity.]

See

ALJ Ex. 1. [The Government did not address (b) or (d) above in its Posthearing Brief, so I will not address those allegations herein.]

The Government alleges the Respondent regularly prescribed highly addictive and intoxicating combinations of controlled substances to his patients, and that he consistently failed to: (1) Perform adequate physical evaluations and obtain appropriate patient histories; (2) make appropriate diagnoses based on sufficient clinical evidence and document these diagnoses in his medical records; (3) document a legitimate medical purpose for the controlled substances that he prescribed; (4) monitor his patients' medication compliance; and (5) respond to red flags of drug abuse and diversion. These failures constitute extreme departures from the standard of care in California, and that his actions were dangerous and reckless. Because of these failures, he regularly put his patients at significant risk for harm, including overdose or death. He also continued to prescribe controlled substances to these patients despite the fact that he knew they were suffering from opioid dependencies. [The OSC went on to provide specific examples of Respondent's alleged failures related to seven individuals: S.B., M.B., B.C., J.C., D.D., J.M., and K.S. ALJX 1, at 14.] For each of the seven patients, he continued to prescribe opioids to them, even while noting that each patient suffered from an opioid dependency.

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*C

Omitted for brevity.

The Hearing

Government's Opening Statement

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2

The Respondent waived the opportunity to make an opening statement. Tr. 30.

DEA initiated an investigation into Dr. Rabadi, a California registered physician, upon receipt of a report from the Department of Health and Human Services Office of Inspector General. Tr. 23. The report characterized him as a “high-risk prescriber” due to his prescribing of a large number of highly diverted and highly abused drugs. Initially, DEA reviewed Dr. Rabadi's prescribing practices through the California PDMP. Tr. 23. Significant red flags were revealed, including dangerous combinations of controlled substances. Three drugs, hydrocodone acetaminophen, alprazolam and

carisoprodol constituted over 95% of the controlled substance prescriptions he issued between November 20, 2015, and November 21, 2018. Tr. 24. In combination, these three drugs make up a highly dangerous and diverted cocktail commonly known among drug seekers as the Holy Trinity.

On November 6, 2018, an undercover agent (hereinafter, UC) posing as a prospective patient with back pain, sought treatment from Dr. Rabadi. Dr. Rabadi declined to treat UC, explaining that he was an internist and did not treat back pain. Tr. 24.

In February of 2019, DEA executed federal search warrants on Dr. Rabadi's clinic, home, and three safety deposit boxes. DEA seized a number of prescriptions and patient files. Tr. 24. DEA also seized an unusually large amount of cash from Dr. Rabadi's home and clinic examination room suggestive of diversion and mis-prescribing. Tr. 25. Subpoenas to pharmacies produced prescriptions for a number of Dr. Rabadi's patients, including the seven patients at issue in this case. Tr. 25.

The Government's expert, Dr. Timothy Munzing, will testify that his review of the patient files and prescriptions revealed, in his opinion, that Dr. Rabadi prescribed controlled substances to each of the seven patients outside the usual course of professional practice in California. Tr. 25. Dr. Munzing will testify that Dr. Rabadi never established a legitimate medical purpose for the controlled substances he prescribed, and was not acting in the usual course of professional practice. Tr. 25. Dr. Munzing will testify that Dr. Rabadi consistently failed to meet fundamental elements of the California standard of care for prescribing controlled substances, including failure to obtain appropriate medical histories, failure to perform minimally appropriate physical exams, failure to make appropriate diagnoses based on sufficient medical evidence, failure to document appropriate treatment plans, failure to document a legitimate medical purpose for the controlled substances, failure to discuss the risks and benefits of the cocktails and controlled substances he prescribed, failure to conduct even a single urine drug screen, and failure to respond to red flags of abuse and diversion. Tr. 27. Dr. Rabadi prescribed controlled substances in dangerous and addictive combinations and outside the usual course of professional practice and without establishing a legitimate medical purpose. Dr. Rabadi diagnosed neck and back pain without sufficient medical evidence. Tr. 27. Dr. Rabadi frequently and plausibly diagnosed opioid dependency for patients on long term opioid use. Dr. Rabadi frequently issued Norco prescriptions to treat M.B., B.C., J.C., D.D., J.M., and K.S. for opioid dependency, which was a dangerous and illegal course that was outside the standard of care. Tr. 27-28. Dr. Rabadi prescribed Xanax in dangerously high dosages to Patients S.B., B.C., J.M., and K.S. of six to eight mgs per day, almost twice the recommended maximum dosage for anxiety disorder. Tr. 28. With early refills of Xanax, the Respondent exposed J.M. to more than 10 mgs per day for nearly two years. Tr. 29. He further exposed these patients to the risk of overdose and death by concurrently prescribing them opioids. Tr. 28.

Thus, the Respondent was not providing medical care to these patients, he was exposing them to risk of harm by handing out dangerous and addictive drugs without medical justification. Dr. Rabadi's controlled substance prescriptions to Patients S.B., M.B., B.C., J.C., D.D., J.M., and K.S. were not issued for a legitimate medical purpose, were not issued by a practitioner acting within the usual course of professional practice in California, and were issued in violation of the standard of care in California and in violation of the laws of the United States. Tr. 29. Accordingly, the Government then requested that the tribunal recommend revocation of Dr. Rabadi's DEA certificate of registration.

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Government allegations included a reference to statistics that 95% of the Respondent's prescriptions were for the “Holy Trinity” suggesting that evidence, in itself, demonstrated illegitimate prescribing by the Respondent. The Government confirmed that those statistics did not form an independent allegation. Tr. 32-33.

Government's Case-in-Chief

The Government presented its case-in-chief through the testimony of two witnesses. First, the Government presented the testimony of a DEA Diversion Investigator (DI). Secondly, the Government presented the testimony of Dr. Timothy Munzing, M.D.

Diversion Investigator

DI has served as a Diversion Investigator at DEA's Los Angeles Field Division for three years. Tr. 33-34. Previously, she served with United States Citizenship and Immigration Service for four years. Tr. 75. As a DI, she enforces compliance with the Controlled Substances Act (CSA), looking for signs of diversion within the registration system, including monitoring for regulatory compliance. Tr. 34-35. She has attended the basic diversion investigation training at the DEA Academy, which included training to spot signs of diversion, investigating diversion and enforcing compliance with the CSA, both in the criminal and administrative settings. Tr. 35. She has also received training regarding CURES—the California prescription drug monitoring program.

Regarding the Respondent, in April 2018, DEA received a report from the Department of Health and Human Service (HHS) that the Respondent was on a “high-risk model for overprescribing of controlled substances.” Tr. 37, 75. DEA ran two CURES reports, one in April of 2018, which revealed numerous red flags, including prescribing hydrocodone at the maximum strength and a large amount of polypharmaceutical cocktails or combinations of a benzodiazepine and an opioid. Additionally, the volume of opioid prescribing was high, at over 9,000 prescriptions over the course of three years from November 2015 to November 2018. Tr. 38-39, 42, 56-57, 82; GX 16-19. Fifty-percent of these were for hydrocodone. Tr. 42. According to DI, the combination of a benzodiazepine and an opioid are significant as they are highly sought after by the black market and are dangerous to the patient. Tr. 39. The Respondent also prescribed a large number of combinations of the highly sought after “Holy Trinity,” which includes a narcotic, a muscle relaxant and a benzodiazepine—96% of his prescriptions during that three-year period.

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Tr. 40, 42-43. These highly addictive and highly dangerous combinations were prescribed over a long period of time. Tr. 40-41.

*D

To be clear, the DI did not testify that 96% of the prescriptions that Respondent issued were issued in the “Holy Trinity” combination. Rather, DI testified that 96% of Respondent's issued controlled substance prescriptions were for either hydrocodone (a narcotic), alprazolam (a benzodiazepine), or carisoprodol (a muscle relaxant). Tr. 42.

Due to these red flags, on September 26, 2018, DEA sent an undercover agent (UC) to the Respondent's clinic—posing as a prospective patient. Tr. 43. The first attempt was foiled as the clinic was closed. The second attempt occurred on October 30, 2018. Tr. 44, 75-76. The clinic was again closed. The third attempt occurred on November 6, 2018. UC complained of back pain and shoulder pain and sought help from Dr. Rabadi. Dr. Rabadi declined to help the UC—explaining that he was not taking new patients and that he was an internist and not a pain specialist. Tr. 45, 75-76. Ultimately, DEA obtained five search warrants, four of which were

executed on February 21, 2019. Tr. 46, 76-77. The fifth was served on February 22, 2019. Tr. 74. They were served on his clinic, on his home and on two safety deposit boxes at two separate banks. Tr. 46. DEA seized 1.2 million dollars in cash at his home.

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Dr. Rabadi was home when the search warrant was served. Tr. 77. He agreed to be interviewed regarding his prescribing practices. Tr. 77. At his clinic, DEA seized patient files and some prescriptions for S.B., B.C., M.B., J.C., D.D., J.M. and K.S. Tr. 49-50. Additional prescriptions and fill stickers were obtained from pharmacies.

5

Tr. 50-55; GX 1-15. Thereafter, in January 2020, DEA issued an administrative subpoena to the Respondent for any and all updated medical records and prescriptions for the noted patients. Tr. 55-56.

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In all, DEA obtained twenty-seven files or updated files. Tr. 78.

4

The Respondent objected to the evidence of the cash seizure as irrelevant and immaterial. The objection was carried. Tr. 47-49. [I find that this evidence, while useful to understanding the course of DEA's investigation, is immaterial to the ultimate issue in this case, which is whether or not Respondent issued controlled substance prescriptions that were outside the usual course of professional practice and beneath the standard of care. Accordingly, I have not considered this information in making my decision.]

5

DI noted record-keeping deficiencies on the part of some of the pharmacies, Tr. 51-55, but clarified they were not a negative reflection on the Respondent. Tr. 79-80.

6

The Government authenticated Government Demonstrative Exhibits 1-8, which were summary charts for each of the seven subject patients containing the subject prescriptions and patient files consistent with the seized and stipulated to records. Tr. 57-73.

Dr. Timothy Munzing

Dr. Munzing is a physician licensed in California and holds a DEA Certificate of Registration there. Tr. 86-87; GX 23. Dr. Munzing graduated from UCLA Medical School in 1982. Tr. 89. He completed his internship and residency in family medicine at the Kaiser Permanente Medical Center in Los Angeles in 1985. Tr. 89. He then went to Kaiser Permanente Orange County, where he has been employed for the last 35 years in the family medicine department. He is also available as a consultant. Tr. 90.

In his family medicine practice, he takes care of his patients from “cradle to grave.” Tr. 90. Most of his present patients are adults. Tr. 90. Twenty-five percent of his work is spent treating his patients. Tr. 92. In his clinical practice, he has prescribed controlled substances, including opioids and benzodiazepines. Tr. 92. Thirty-two years ago Dr. Munzing founded a family medicine practice residency program, and continues to be the residency director for twenty-four residents. Tr. 90. He also sits on the National Accreditation Board for Family Medicine Residency. He is a member of the American Medical Association, the California Medical Association, and the American Academy of Family Physicians, to name a few. Tr. 91; GX 23. He also serves as a full clinical professor at the University of California Irvine, and at the Kaiser Permanente School of Medicine. Tr. 91. He has been called as an expert witness by the California Medical Board for the past ten years, and by federal law enforcement for the past six years. Tr. 623. Dr. Munzing has been qualified approximately thirty-five times to offer his expert opinion for the California Medical Board, DEA, FBI, and the Department of Justice, including his opinion on the standard of care for prescribing controlled substances, and whether a prescription was issued for a legitimate medical purpose in the usual course of professional practice. Tr. 92-94, 623. He has testified as an expert in five or six prior DEA Administrative hearings. Most of his opinions have related to illegal prescribing of opioids. Tr. 95. Internal rules of Kaiser Permanente prevent him from testifying on behalf of physicians. Tr. 624. Dr. Munzing estimated he had received approximately $20,000 for his time on the instant case at $400 per hour. Tr. 624.

He is familiar with the California standard of care for prescribing controlled substances. Tr. 94. The California standard of care is informed by publications by the California Medical Board. Tr. 95-97; GX 20 at 59-61, GX 21. In particular, “The Laws Governing the Practice of Medicine by Physicians and Surgeons,” sets out minimum requirements for care, including history and physical examination, assessment of pain, physical and psychological functioning, substance abuse history, treatment plan, and maintaining accurate and complete records. Tr. 374-80. In forming his opinions in this case, Dr. Munzing reviewed the medical records and prescriptions for the subject patients. Tr. 100-01. Dr. Munzing was qualified, without objection, as an expert in California medical practice, including the applicable standards of care in California for the prescribing of controlled substances within the usual course of the professional practice of medicine. Tr. 101-02.

Dr. Munzing explained that the standard of care is generally “what a responsible, knowledgeable physician can do” under similar circumstances. Tr. 102-03. In prescribing controlled substances this would include performing a physical examination, taking a history, including both a medical history and a psychological and substance abuse history, attempting to obtain prior medical records, formulating a diagnosis, evaluating risk factors for the controlled medications including the risk of abuse, discussing the risks with the patient to obtain informed consent, developing a customized treatment plan with goals and objectives, documenting all of the above in the medical record, and providing ongoing monitoring of the patient and of his treatment, including urine drug screens (UDS) and alternate therapies. Tr. 103-112, 114-25, 128-35. Ongoing and comprehensive documentation is critical for accurate evaluation of a patient's condition and treatment. Tr. 142-50. The goal is to maximize function, while minimizing risk. Tr. 139-40. Compliance with all relevant California statutes and regulations is also required by the standard of care. Tr. 104. It requires addressing, resolving and documenting red flags. Tr. 112. Dr. Munzing identified the FDA “black box” warning regarding combining opioids with benzodiazepines, titled New Safety Measures Announced for Opioid Analgesics, dated August 31, 2016. Tr. 151; GX 22 at 1-3, 4, 25, 40. The FDA specifically noted diazepam, Klonopin, and Xanax should not be combined with opioids unless absolutely necessary, and for no longer than absolutely necessary. Tr. 153-55.

Dr. Munzing testified that the higher the morphine milligram equivalent (MME) prescribed, the increased risk of addiction and overdose. Tr. 126-28. Prescribing controlled substances for psychological illness requires an even greater emphasis on history, and a more-focused physical exam [of the “heart, lung, vital signs . . . seeing if [there is] any evidence of some other medical diagnosis” in addition to the mental health disorder.] Tr. 136, 138-39, 141. The General Anxiety Disorder screening tool, GAD-7, is a useful tool in assessing a patient's level of anxiety. Tr. 136-37.

Dr. Munzing reviewed the patient files, prescriptions, and CURES data for Patients S.B., M.B., B.C., J.C., D.D., J.M., and K.S. [and concluded that the prescriptions at issue were “not consistent with the standard of care in the state of California.”] Tr. 156-57. Dr. Munzing noted that the history for these seven patients was deficient. Tr. 157. There was no indication prior medical records were obtained. Tr. 157. The physical exams, if present, were missing key elements. There were no documented CURES checks. Tr. 158.

Diagnoses appeared and disappeared. Opioids were prescribed at high dosages. There was no indication of the necessary patient monitoring and there was no documentation of informed consent. Tr. 159-60, 207. Dr. Munzing summarized that none of the controlled prescriptions issued for the charged patients were issued for a legitimate medical purpose by a practitioner acting within the usual course of professional practice. Tr. 620-21. According to Dr. Munzing, all of the relevant prescriptions were issued outside the standard of care. Tr. 621.

Patient S.B.

As per the parties' stipulations, between February 2, 2017, and January 30, 2019, S.B. was prescribed hydrocodone, carisoprodol, Adderall and alprazolam. Tr. 162-63; GDX 1. Dr. Munzing characterized the patient file as meager. He characterized the controlled substance prescriptions as being outside the standard of care. Tr. 163, 207, 241-44. For S.B.'s initial visit on August 3, 2016, she was diagnosed with Generalized Anxiety Disorder (GAD), Attention Deficit Disorder (ADD), and Fibromyalgia. Tr. 163-65; GX 1 at 62, 66. There were no supporting findings from a physical examination or history for the fibromyalgia diagnosis, which typically is reached after a certain number of tender points are determined. Tr. 166. Similarly, there were no supporting findings from a physical examination or history to support the GAD or ADD diagnoses. Tr. 166-71, 241-44. There was no physical functioning level documented nor mental functioning level documented. Tr. 171. Without sufficient evaluation and supporting documentation for the three diagnoses, Dr. Munzing deemed the diagnoses inappropriate. Tr. 241-44. Without an appropriate diagnosis, there was no legitimate medical purpose for the controlled substance prescriptions. Tr. 172, 207, 241-44. Similarly, there was no documented treatment plan. Tr. 241-44. On February 2, 2017, S.B. presented to the clinic suffering from fibromyalgia and ADD. Tr. 173; GX 1 at 59. The Respondent diagnosed her with fibromyalgia-opioid dependent, refusing detox, and ADD. He prescribed hydrocodone, carisoprodol, and Adderall. Tr. 173-74. Again, there was no medical history justifying the diagnosis. The physical exam conducted on February 2, 2017, consisted of blood pressure, cardiovascular, heart and lung, all of which were normal. Again, the physical exam was insufficient to justify the fibromyalgia and ADD diagnoses. Tr. 175. There was no documentation of the pain level, or functionality level, to justify continued controlled substance prescribing. Tr. 175-76. For the progress notes of June 28, 2017, the Respondent diagnosed her with fibromyalgia-opioid dependent, refusing detox, and ADD. He prescribed hydrocodone, carisoprodol, and Adderall. Tr. 177. Again, there was no medical history justifying the diagnoses. There was no documentation of the pain level, or functionality level, to justify continued controlled substance prescribing. Tr. 177-78; GX 1 at 57. Again, blood pressure and heart and lung exams were performed. Tr. 177. There was insufficient medical evidence to justify the three diagnoses. Tr. 177-78. For the progress note for December 21, 2018, S.B. presented with eczema and fibromyalgia. Tr. 179; GX 1 at 49. The Respondent diagnosed her with fibromyalgia-opioid dependent, refusing detox. She was prescribed hydrocodone. No history was recorded. Again, blood pressure and heart and lung exams were performed. Tr. 180. There was no documentation of the pain level or functionality level, to justify continued controlled substance prescribing. Tr. 180. There was insufficient medical evidence to justify the fibromyalgia diagnosis. Tr. 181. In the progress notes for January 30, 2019, S.B. reported to the clinic with ADD and rhinitis. Tr. 181; GX 1 at 47. She was prescribed Adderall for the ADD. No medical history was taken. ADD patient progress was reported as “stable.” There was insufficient medical evidence to justify the ADD diagnosis. Tr. 183. Dr. Munzing deemed the ADD diagnoses inappropriate. Without an appropriate diagnosis, there is no legitimate medical purpose for the controlled substance prescription. Tr. 185-86. During the subject period of the Respondent's treatment of S.B., he never obtained any prior medical records. Tr. 184. He never recorded a history, which would justify his diagnoses for Fibromyalgia, GAD, or ADD. Tr. 184-85. He never reported a sufficient physical or mental exam to justify the Fibromyalgia, GAD, or ADD diagnoses.

Id.

He never reported a sufficient evaluation to justify his diagnoses for Fibromyalgia, GAD, or ADD.

Id.

The relevant controlled substance prescriptions for S.B. were not issued within the California standard of care, nor were they issued within the usual course of professional practice. Tr. 186-87, 244.

Dr. Munzing observed that the diagnoses would come and go in the records and were inconsistently reported, which is atypical for chronic diagnoses. Tr. 188-97. A chronic disease, with symptoms that appear to come and go would raise the question of whether the patient had the disease at all. Tr. 192. Even a lessening of symptoms should cause evaluation as to whether tapering of medication would be appropriate. Tr. 196.

Dr. Munzing noted that the Respondent prescribed S.B. both hydrocodone and Soma to treat Fibromyalgia on numerous occasions. Tr. 197-98. On other occasions, he prescribed the hydrocodone only without documenting any explanation for changing the medication protocol, which was beneath the California standard of care for documentation. Tr. 198-201; GX 20 at 61. [Dr. Munzing testified that Respondent did not establish a legitimate medical purpose for issuing to S.B. any of the controlled substances at issue. Tr. 201.] Dr. Munzing noted that S.B. was prescribed a dangerous, highly addictive combination of medications that was popular for abuse and diversion; namely hydrocodone and Soma, which are respiratory depressants, and Adderall. Tr. 202.

Another dangerous combination, hydrocodone, Adderall and Xanax was prescribed March 1, 2017, April 2017, and June 2017. Tr. 203; GX 1. Dr. Munzing noted this combination is referred to by drug abusers as the “new Holy Trinity.” Tr. 204. It includes the depressants, hydrocodone and Soma, and is followed by the stimulant, Adderall, to counteract the effects of the depressants. Again, the combination of hydrocodone and Soma are the subject of the FDA “black box” warning. Tr. 205. The high dosage of Xanax, 6 mg per day, heightens the risk of this already dangerous combination. With Xanax and Adderall prescribed at their highest commercially available dosage units, the danger and risk of addiction are further increased. Tr. 205. Additionally, two mg tablets of Xanax are popular for abuse and diversion. Tr. 217-18. On September 29, 2017, and monthly from July 2018, to July 2019, S.B. was prescribed hydrocodone and Adderall. Besides the serious risk of addiction posed by these two Schedule II medications, the hydrocodone was prescribed at a daily dosage of 60 mg MME, which significantly increases the risk of overdose and death. This risk was increased by its combination with Adderall. Tr. 206-07. Dr. Munzing could not foresee any medical condition in which this combination would be appropriate. Tr. 211-12.

Dr. Munzing noted that the medical records failed to disclose any indication that the Respondent warned S.B. regarding the risks associated with these dangerous combinations of controlled

substances. This failure precludes any informed consent by S.B. Tr. 207. The Declaration of Pain Medication Use document in the file, dated August 3, 2016, which requires the patient to alert the Respondent if the patient takes additional medications [(other than those prescribed by Respondent)] because they could result in drug interactions, does not put the patient on notice of the dangerous combinations prescribed by the Respondent. Tr. 207-10; GX 1 at 67. Similarly, Dr. Munzing noted the repeated notation within the patient records of “SED,” which Dr. Munzing assumed meant, “side effects discussed,” was insufficient documentation within the standard of care to establish that Respondent discussed the various risks of these medication combinations. Tr. 210-11; GX 1 at 59.

In March, April and June of 2017, the Respondent prescribed S.B. Xanax at 6 mg per day, in excess of the FDA recommended daily limit of 4 mg per day. Tr. 212-15; GX 1 at 57, 58, 59. GX 22 at 40, 59-61. In May of 2017, the Xanax was abruptly stopped. Tr. 216-17; GDX 1. And abruptly restarted in June of 2017, and again stopped. Tr. 217. This is very dangerous as the abrupt stoppage of Xanax without titration, especially at this high dosage, can cause seizures, and restarting at this high dosage can trigger an overdose, especially in conjunction with the prescribed opioid. Tr. 212-18.

Dr. Munzing testified that regarding the monitoring of S.B., there were no urine drug screens evident in the records, which the standard of care would have required at least quarterly. Tr. 218-21; GX 1 at 44. In the progress notes for February, March, April 2017, all the way to January 30, 2019, the Respondent noted “refusal to detox.” Tr. 220-21, 227-29; GX 1 at 58, 59. This is a huge red flag for opioid use disorder and for diversion. However, the chart reflects the Respondent did not take any necessary action, such as CURES monitoring, random pill count, UDS, counseling, or titration. Rather, he simply prescribed the same levels of medications she was on, PRN. Tr. 222-23. The Respondent's course of action was outside the California standard of care. Tr. 223, 229. Respondent's medical file for S.B. contained a June 2017 report from Dr. F., an orthopedic surgeon who saw S.B. for reported neck and back pain. According to Dr. F's report, S.B. reported her past medical history as only “anxiety.” Tr. 229; GX 1 at 30, 32, 36-42, 56. She did not report Fibromyalgia or ADD. Tr. 229-30. S.B. further reported to Dr. F. that she was not then taking any medication for pain, which is contrary to the Respondent's medical records and prescription evidence. Tr. 231-32. Dr. F.'s report was part of S.B.'s disability application, claiming disability as of June 15, 2017. A report from Chiropractor B.H. is also included in the disability packet. Tr. 235. Dr. B.H. reports the disability was caused by “accident or trauma,” which is inconsistent with what the patient reported to Dr. F. and to the Respondent. Tr. 236. There is no indication within the Respondent's records for S.B. that he ever discussed, with S.B. or with Dr. F., the discrepancies revealed by Dr. F.'s report. Tr. 233-37.

Contemporaneous to the preparation of the disability claim, Dr. Rabadi ordered a series of radiologic tests on S.B., none of which were related to the Respondent's diagnosis of fibromyalgia. The progress notes from August 17, 2017, say that S.B. presented with “overactive thyroid, gait disturbance.” Tr. 237-40; GX 1 at 5, 7, 9, 11, 13, 16, 17, 56. Dr. Rabadi ordered an MRI of the brain to rule out MS, a thyroid ultrasound to rule out hyperthyroidism, an MRI of the lumbar spine, and an MRI of the thoracic spine. The MRI of the cervical spine was ordered by Dr. F. Tr. 241.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for S.B., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for S.B.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded S.B.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with S.B., never appropriately monitored S.B. and failed to appropriately respond to red flags of diversion. Tr. 241-44. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to S.B. were issued without a legitimate medical purpose, outside the usual course of professional practice and beneath the standard of care in California. Tr. 244.]

Patient M.B.

After a review of M.B.'s patient file, CURES report and related prescriptions, Dr. Munzing observed that between January 5, 2018, and November 20, 2019, the Respondent prescribed hydrocodone and Adderall. Tr. 245. As with patient S.B., Dr. Munzing characterized the patient file as containing “very little” information. Tr. 245-47. The Respondent never obtained prior medical records of M.B. Tr. 288. Dr. Munzing observed that none of the subject prescriptions were within the California standard of care. Tr. 248, 289.

On April 19, 2006, M.B. presented for his first visit. Tr. 248-49; GX 3, p. 88, 91. In his “Comprehensive History and Physical Examination,” the Respondent reported that M.B. presented with symptoms of “chronic back pain, left knee pain, dyslipidemia.” Tr. 249-50. However, there are no appropriate diagnoses relating to the back and knee pain and therefore no legitimate medical purpose for prescribing hydrocodone.

*E

Tr. 250-51, 258. To address the reported pain, the Respondent prescribed hydrocodone. Tr. 252. The file fails to evidence sufficient history to justify the pain prescriptions under the standard of care. Tr. 252-54. The file fails to evidence any physical exam to justify the pain prescriptions under the standard of care.

*F

Tr. 254-55, 258, 287. The file fails to evidence any treatment plan or goals, or past drug abuse to justify the pain prescriptions under the standard of care. Tr. 254-55, 258, 287.

*E

Dr. Munzing clarified that “knee pain and back pain are really symptoms, and chronic back pain is essentially, you have a symptom that's there ongoing.” Tr. 250. He further testified that these symptoms are not diagnoses, though Respondent treated them as such, and that the distinction is important because the way knee and back pain are treated differs “depending on the more specific diagnoses or diagnosis causing the symptoms.” Tr. 251.

The Government's attorney and Dr. Munzing agreed about the importance of this distinction and the Government's attorney apologized in advance that he might refer to certain symptoms as diagnoses as “shorthand,” even though they both understood what he meant.

Id.

*F

Dr. Munzing testified, “there was no back exam. There was no knee exam. Again, heart, lung, abdomen. There is a head, ear, eyes exam. . . . He, once again, did a testicular and a rectal exam. But there is no back and knee exam evident.” Tr. 256.

Although M.B. declared on a “Declaration of Pain Medication Use” form that he had no prior drug abuse in August 2009, which was three years after his first visit, such static declaration does not satisfy the physician's ongoing responsibility under the standard of care to monitor this issue [to determine whether the patient is “currently using drugs.”] Tr. 259-61; GX 3 at 93.

On July 9, 2013, M.B. presented with ADD and neck pain. Tr. 261-62; GX 3 at 46. He was prescribed Adderall for the ADD. Tr. 262. Again, the records reveal there was no history taken to support the diagnosis or justify the prescriptions for Adderall. Tr. 262. There was no evident evaluation done by the Respondent. Tr. 287. There was no treatment plan. Tr. 263. Although

there was a diagnosis related to the neck pain, there was no history or physical exam evident in the file. Tr. 263-64. The Respondent never established a legitimate medical purpose for hydrocodone. Tr. 264. On September 6, 2013, M.B. presented with ADD. Tr. 264-65; GX 3 at 46. He was prescribed Adderall for the ADD, but at double the dosage of the previous visit without any reported justification. Tr. 264-65.

Dr. Munzing testified that on January 5, 2018, M.B. presented to the clinic. Tr. 265-66; GX 3 at 37. He was prescribed hydrocodone and Adderall. There was no medical history, assessment of M.B.'s response to treatment, evaluation of pain or functioning, substance abuse history, diagnoses, rationale for establishing a legitimate medical purpose for prescribing or to justify continuing the medication regimen. Tr. 265-66. On March 6, 2018, M.B. presented to the clinic with “ADD and opioid dependency.” Tr. 266-67; GX 3 at 36. Absent was any report of pain. He was diagnosed with “Opioid dependency, refusing detox.” Tr. 267. Hydrocodone as treatment for opioid dependency is not a legitimate medical purpose and is outside the usual course of professional practice. Tr. 268. He was prescribed hydrocodone, which not only is outside the standard of care, but is illegal in California.

*G

Tr. 267-68. Dr. Munzing observed that the Respondent prescribed hydrocodone repeatedly to address his diagnosis of opioid dependency until November 20, 2019. Tr. 268-69. On November 20, 2019, M.B. presented with ADD and back pain. Tr. 269; GX 3 at 27. He was prescribed Adderall, and his hydrocodone was increased. Tr. 270. No medical history was taken or updated. No response to treatment or patient functionality was included. Although vital signs were taken, no physical or mental exam was performed. Tr. 270-71. There was no appropriate diagnosis for the back pain. Tr. 272. There was no evaluation for ADD, such as mental functioning. Tr. 271, 274, 287-88. The Respondent never obtained a sufficient history to support the diagnosis for ADD. Tr. 273. There was no appropriate diagnosis for ADD. Tr. 272.

*G

As written, this language suggests that there is a specific California law prohibiting hydrocodone prescriptions for individuals who are opioid dependent and refusing detox. The Government did not introduce specific evidence of any such law. However, the Government, through Dr. Munzing's testimony, has established that opioid dependency is not a legitimate medical purpose for prescribing hydrocodone and that such prescriptions are outside the usual course of professional practice. Furthermore, the Government has established that prescribing without a legitimate medical purpose and outside of the usual course of professional practice is a violation of Cal. Health & Safety Code § 11153(a). Accordingly, I agree that the conduct is illegal and have moved the sentence for clarity.

[Dr. Munzing, in summary, testified that Respondent never took a proper medical or mental health history and never conducted a sufficient physical or mental health examination for M.B.'s relevant diagnoses; therefore, he never made an appropriately supported diagnosis. Tr. 273-74. Accordingly,] the Respondent never established a legitimate medical purpose to prescribe either hydrocodone or Adderall to M.B. throughout the reported treatment. Tr. 274. Dr. Munzing opined that such prescriptions were not issued in the usual course of professional practice, were not for a legitimate medical purpose, and were outside the standard of care. Tr. 274-75.

Dr. Munzing noted the inconsistency of the various diagnoses. Diagnoses would come and go within the records. Tr. 275-278; GX 3 at 35, 37, 43, 67. Although the recorded diagnoses were always treated with hydrocodone, the diagnoses varied greatly; [in 2009, it was prescribed for shoulder pain, in 2013, it was prescribed for neck pain, in 2014, it was prescribed for back pain, in 2018, it was prescribed for opioid dependency, and sometimes there was no diagnosis whatsoever given for the hydrocodone prescribed. Tr. 275-78.] Yet no explanation for the changing diagnoses is included in the file, as required by the standard of care. Tr. 278-80.

Dr. Munzing noted the serious dangers occasioned by the combination of Adderall and hydrocodone by reference to his testimony regarding S.B.'s similar prescriptions.

7

Tr. 281. Dr. Munzing deemed this combination of medications for over ten years inappropriate and unsafe. Tr. 284. The only semblance of a warning to M.B. regarding these dangerous combinations appeared in a 2009 “Controlled Substance Therapy Agreement.” For the same reasons as Patient S.B., Dr. Munzing deemed the signed form wholly insufficient to satisfy the California standard of care in this regard. Tr. 281-82; GX 3 at 92. Similarly, the notation within the file, “SED” was insufficient to satisfy the standard of care. Tr. 283. Dr. Munzing also testified that there was never a UDS ordered for M.B., which was necessary under the standard of care for any patient receiving opioids, but especially for a patient who has refused opioid detox. Tr. 284-85. A patient diagnosed with opioid dependency and refusing detox is also a red flag of abuse and diversion. Such red flag was not appropriately addressed by the Respondent repeatedly as to M.B. Tr. 285-87; GX 3 at 36.

7

On September 29, 2017, and monthly from July 2018, to July, 2019, S.B. was prescribed hydrocodone and Adderall. Besides the serious risk of addiction posed by these two Schedule II medications, the hydrocodone was prescribed at a daily dosage of 60 mg MME, which significantly increases the risk of overdose and death. This risk was increased by its combination with Adderall. Tr. 206-07. Dr. Munzing could not foresee a medical condition in which this combination would be appropriate. Tr. 211-12.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for M.B., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for M.B.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded M.B.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with M.B., never appropriately monitored M.B. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 287-89. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to M.B. were issued without a legitimate medical purpose, outside the usual course of professional practice and beneath the standard of care in California. Tr. 289-90.]

Patient B.C.

Dr. Munzing reviewed the subject prescriptions, patient file and CURES report for Patient B.C., which he described as containing “very little.” Tr. 290-92; GDX 3. He opined that the subject controlled substance prescriptions issued for hydrocodone, Xanax and Adderall, from January 25, 2017, to December 19, 2019, were all issued outside the California standard of care. Tr. 290-92, 335-38. B.C. presented on March 27, 2014, with GAD and back pain. Tr. 293-94; GX 5 at 48, 55. B.C. was diagnosed with GAD and back pain, refusing detox. He was prescribed Xanax (6 mg per day) for the GAD, and hydrocodone for the back pain, refusing detox. Tr. 294. Dr. Munzing reiterated the risks involved in prescribing 6 mg of Xanax per day. Tr. 295.

The records failed to disclose the minimum history necessary under the standard of care to appropriately diagnose “back pain” and GAD [or to prescribe controlled substances to treat those conditions.] Tr. 295-96. Other than limited vital signs, the records failed to disclose the minimum physical examination necessary under the

standard of care to appropriately diagnose “back pain,” or to justify a hydrocodone prescription. Tr. 296-97. Dr. Munzing could not remember seeing any prior medical records in the Respondent's subject files. Tr. 297. There were no entries in B.C.'s file indicating physical or mental functioning. Tr. 298, 335-38. There was no treatment plan indicated. The Declaration of Pain Medication Use, signed by B.C. at his first visit, as discussed previously, is insufficient to evaluate B.C. and to establish informed consent for the controlled substances prescribed. Tr. 299-300. There was insufficient medical evidence to support either diagnosis. Tr. 298, 335-38. Accordingly, there was no legitimate medical purpose for either controlled substance prescription. Tr. 299, 335-38.

B.C. presented on May 20, 2014, with ADD and was prescribed Adderall. Tr. 301-02; GX 5 at 47. The ADD diagnosis was deficient, as no history was developed, no mental functioning was assessed, the medical evidence was deficient, and a treatment plan was lacking. The Respondent failed to establish a legitimate medical purpose for prescribing Adderall. Tr. 302. Additionally, starting B.C. on 30 mg of Adderall twice daily is a very high dosage, and extremely inappropriate to an Adderall naive patient, which is not developed within the patient file. Tr. 302-03.

According to Dr. Munzing, B.C. presented on January 25, 2017, with ADD, opioid dependency and GAD. Tr. 303; GX 5 at 33. He was diagnosed with ADD for which he was prescribed Adderall, and GAD for which he was prescribed Xanax (6 mg per day). Tr. 304. Pain levels were not reported at this visit. The diagnoses were unsupported by sufficient medical history, medical evaluation, response to treatment, patient functionality, and medical evidence. Tr. 304-06. He failed to establish a legitimate medical purpose for both Adderall and Xanax. Tr. 306, 335-38. The Respondent further diagnosed, “Opioid dependency, refusing detox” for which the Respondent again prescribed hydrocodone. Tr. 306. Hydrocodone as treatment for opioid dependency is not a legitimate medical purpose and is outside the usual course of professional practice. Tr. 307. Prescribing hydrocodone for opioid dependence is not only outside the standard of care, but it is illegal in California. Tr. 307. A patient diagnosed with opioid dependency and refusing detox is also a red flag of abuse and diversion. Such red flag was not addressed by the Respondent repeatedly as to B.C. Tr. 306-07; GX 5, at 33.

On July 31, 2018, B.C. presented with ADD, back pain and GAD. Tr. 308; GX 5 at 28. He was diagnosed with ADD for which he was prescribed Adderall (60 mg per day), “back pain, opiate dependent, refusing detox” for which he was prescribed hydrocodone, and GAD for which he was prescribed Xanax (6 mg per day). Tr. 308. There was no medical history supporting the prescriptions. There was no indication how the patient was responding to treatment and no indication that a physical exam was performed to support the diagnoses or justify the prescriptions. Tr. 308-09, 335-38. There was no reference to pain levels or physical functionality. Tr. 309-10. There was no reference to mental functioning with respect to the ADD and GAD diagnoses. Though three diagnoses were recorded, Dr. Munzing testified that none of them were appropriate. Tr. 309-10. Neither did Respondent establish a legitimate medical purpose for the three controlled substance prescriptions. Tr. 311.

B.C. presented on December 19, 2019, with ADD and back pain, which were also his diagnoses, and for which he was prescribed Adderall (60 mg per day) and hydrocodone. Tr. 311-12; GX 5 at 20. The record is lacking documentation of a medical history, any updated medical history, the patient's state of health, how he is responding to treatment, a physical exam, pain levels, mental or physical functioning, appropriate rationale for continued treatment, and information relating to drug abuse. Tr. 312-13, 335-38. As a result, the three diagnoses are without sufficient medical evidence. Tr. 313. Dr. Munzing testified that each of the controlled substance prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care. Tr. 313-16, 335-38.

Dr. Munzing noted the inconsistency of diagnoses throughout B.C.'s records and the dual prescribing of hydrocodone, sometimes for opioid abuse, sometimes for skeletal pain, and sometimes for both, without explanation in the record. Tr. 316-19; GX 5 at 31, 32, 33. [Dr. Munzing explained that it “would be important to document [what is] going on here.” Tr. 318.] Dr. Munzing noted the GAD and ADD diagnoses appear and disappear within the record, as do their treatment medications without explanation. Tr. 319-24; GX 5 at 27, 31, 32, 33. Dr. Munzing deemed it highly unlikely that ADD and GAD were appropriate diagnoses.

*H

Tr. 322, 324.

*H

Dr. Munzing's opinion regarding the credibility of any assigned diagnosis is not particularly relevant to my analysis. Here, the standard of care requires that a diagnosis be based on a patient's history and physical examination.

See infra,

The Standard of Care for Prescribing. Accordingly, where, as here, Dr. Munzing has testified that the diagnosis was not adequately supported by the patient's history and physical examination, then I find that, based on his expert testimony, the diagnosis is inadequate to serve as the basis for the prescribed prescriptions. This is true whether or not a practitioner acting in the usual course of professional practice could have properly reached the same diagnosis for that individual.

Dr. Munzing also testified that the Respondent prescribed B.C. a combination of hydrocodone, Adderall and Xanax. Tr. 327; GDX 3. Dr. Munzing could not conceive of a medical condition warranting this dosage, duration, and combination of medications, noting Adderall is counter-indicated for GAD, and combining Xanax with an opioid represents a dangerous combination that is contrary to an FDA black box warning and CDC guidance. Tr. 327-29, 332-33; GDX 3. A further concern, as detailed earlier in his testimony, is reflected by the repeated combination of hydrocodone and Adderall by the Respondent. Tr. 329-30; GDX 3. These dangerous combinations were prescribed without an established legitimate medical purpose, outside the usual course of professional practice, without sufficient warnings and informed consent, without sufficient patient monitoring, and without regard to obvious red flags. Tr. 330-35.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for B.C., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for B.C.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded B.C.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with B.C., never appropriately monitored B.C. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 335-37. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to B.C. were issued without a legitimate medical purpose, Tr. 330, outside the usual course of professional practice and beneath the standard of care in California. Tr. 330, 338.]

Patient J.C.

Dr. Munzing reviewed the subject prescriptions issued from January 16, 2018, to December 30, 2019, patient records and CURES data relating to Patient J.C. Tr. 381-82; GDX 4. Dr. Munzing opined that none of the subject prescriptions issued to J.C. were issued within the California standard of care. Tr. 382. J.C. presented to the Respondent's clinic on May 18, 2009, with a headache and GAD. Tr. 383-384; GX 7, at 216, 233. He was prescribed hydrocodone for migraine and Xanax for GAD and remained on this medication regimen for a long period. As to the migraine diagnosis, insufficient medical history was obtained, symptom evaluation was absent, no neurological exam was conducted, no evaluation of functioning level was made, no treatment plan was evident, and no evaluation of possible drug abuse was provided. Tr. 384-90. In short, there was insufficient medical evidence to support the diagnoses of migraines and GAD, nor was there a legitimate medical purpose to prescribe hydrocodone and Xanax. Tr. 386-88.

[On August 17, 2009, J.C. signed a “Declaration of Pain Medication Use” form indicating that he had no prior drug abuse, and Dr. Munzing testified that there is no record of J.C. ever being asked about illicit substance abuse again. Tr. 389-90. Dr. Munzing testified that the 2009 Declaration was an insufficient inquiry to cover Respondent's prescribing during the relevant period.

Id.

]

J.C. presented on July 21, 2016, with “GAD, chronic back pain, consented for H&P.” Tr. 390; GX 7 at 189. He was diagnosed with GAD and back pain—refusing detox for which he was prescribed Xanax and hydrocodone, respectively. Tr. 390-91. There was no updated history taken for either diagnosis, no physical exam, no treatment plan, no response to treatment, no pain or functioning level evaluations, no discussion regarding drug abuse, and no rationale for continued treatment, as required by the standard of care. Tr. 390-94. There was deficient medical evidence to support either diagnosis. The Respondent did not establish a legitimate medical purpose to prescribe the controlled substances. Tr. 393-94. J.C. presented on January 16, 2018, with GAD and back pain for which he was diagnosed with GAD and back pain, opiate dependent, refused detox. Tr. 394-95; GX 7 at 180. He was prescribed Valium for the GAD (Klonopin was discontinued), and hydrocodone for back pain, although no explanation was given for substituting the Valium for the Klonopin. Tr. 395. There was no medical history included in the records, no response to treatment, no physical exam, no pain or functioning evaluation, no drug abuse history, rendering each diagnosis inappropriate. Tr. 395-97. Without a legitimate medical purpose, there was no appropriate rationale for continued treatment with controlled substances. Tr. 396-98. J.C. presented on February 16, 2018, with “opioid dependency, GAD,” yet without the previously noted back pain. Tr. 398; GX 7, 9. There was no reference to pain. He was diagnosed with “Opioid dependency, refusing detox” for which he was prescribed hydrocodone, which again, is outside the usual course of professional practice and illegal in California. Tr. 398-400. The diagnosis for opioid dependency that was treated with hydrocodone appeared repeatedly in the records. Tr. 399. J.C. presented on May 6, 2019, however no treatment notes for this visit are evident in the file. Tr. 401; GX 4, GX 7 at 168.

On April 9, 2019, J.C. presented with GERD and back pain for which he was prescribed hydrocodone. Tr. 402. However, there was no medical history included in the records, no response to treatment, no adequate physical exam, no pain or functioning evaluation, no mental health history, and no drug abuse history, which rendered the back pain diagnosis inappropriate. Tr. 402-04. Without a legitimate medical purpose, there was no appropriate rationale for continued treatment with controlled substances. Tr. 402-04. On December 30, 2019, J.C. presented with GERD and GAD. Tr. 404; GX 7, p. 171. He was prescribed Valium for the GAD. However, there was no appropriate medical history included in the records, no response to treatment, no documented evaluation for GAD or functioning evaluation, no mental health history, and no drug abuse history, rendering the GAD diagnosis inappropriate from January 16, 2018, to December 30, 2019. Tr. 404-08, 425-28. Without a legitimate medical purpose, there was no appropriate rationale for continued treatment with controlled substances. Tr. 408, 425-28. Such prescriptions, from January 16, 2018, to December 30, 2019, were issued outside the standard of care, without legitimate medical purpose and outside the usual course of professional practice. Tr. 408, 425-28.

Dr. Munzing noted the inconsistency of diagnoses throughout J.C.'s records, and the dual prescribing of hydrocodone for opioid abuse, migraines, and for skeletal (sometimes neck, sometimes back) pain, without documenting an explanation for the changes in the record. Tr. 410-14; GX 7 at 188, 189, 205, 214, 215. [There was never any discussion regarding “where one condition was going and another was coming from” as Dr. Munzing agreed “would be important for a practitioner acting within the standard of care to understand” and to document. Tr. 414.] Dr. Munzing noted the skeletal pain diagnoses appears and disappears within the record. Tr. 414-15. Dr. Munzing suspected the skeletal pain complaints were not legitimate. Tr. 415; GX 7 at 188, 189, 205, 214, 215. Dr. Munzing noted the Respondent had prescribed a combination of hydrocodone and Valium monthly between January 2018 and January 2019 without a legitimate medical purpose. Tr. 416-17; GX 4. Combining Valium with an opioid represents a dangerous combination and is contrary to an FDA black box warning and to CDC guidance, especially with the Valium at its highest available strength. Tr. 417. Dr. Munzing could not envision a condition for which this medication regimen would be appropriate treatment. Tr. 418. These dangerous combinations were prescribed without an established legitimate medical purpose, outside the usual course of professional practice, without sufficient warnings and informed consent, without sufficient patient monitoring,

*I

and without addressing obvious red flags. Tr. 418-23; GX 7 at 19, 25, 27, 180, 225.

*I

Dr. Munzing testified that given the prescribed combination of medications and how “highly sought after [they are] in the drug abusing community,” it would have been “[v]itally important” to conduct appropriate ongoing monitoring, which was not done and was therefore outside the standard of care here. Tr. 421.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for J.C., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for J.C.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded J.C.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with J.C., never appropriately monitored J.C. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 424-27. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to J.C. were issued without a legitimate medical purpose, outside the usual course of professional

practice and beneath the standard of care in California. Tr. 428.]

Patient D.D.

Dr. Munzing reviewed the subject prescriptions issued from January 4, 2018, to February 12, 2019, patient records and CURES data relating to Patient D.D. Tr. 428-29; GDX 5. Dr. Munzing opined that none of the subject prescriptions issued to D.D., which were for hydrocodone, Soma, and Xanax, were within the California standard of care. Tr. 430. Again, the records contained “very little information.” Tr. 429. D.D. presented on July 9, 2008, with GAD and back pain. Tr. 430-31 GX 9 at 74. For the GAD, he was prescribed Valium. For back pain, he was prescribed hydrocodone and Soma. Tr. 431. The medical records reflect that D.D. refused an MRI and refused referral to orthopedist or a pain specialist. Tr. 431. According to Dr. Munzing, each refusal is a red flag, and suggestive of drug-seeking behavior. Tr. 432. [“Those are huge red flags. [For] someone who truly wants to be treated for back pain to be refusing kind of ways to try to improve that or to better diagnose it through an MRI or an evaluation from a subspecialist are just enormous red flags and certainly brings in the distinct possibility [he] is here seeking drugs rather than really trying to get his pain managed.” Tr. 432.] Instead of addressing the red flags, the Respondent prescribed opioids. Tr. 432. The Respondent's response was the same throughout the subject treatment of D.D., a total of nine and a half years. Tr. 433.

According to Dr. Munzing, there was no appropriate medical history included in the records, no response to treatment, no physical exam, insufficient patient monitoring, no evaluation for GAD, no functioning evaluation, no mental health history, no drug abuse history, no discussion of risk factors and informed consent, and no patient monitoring, rendering the GAD and back pain diagnoses inappropriate from July 9, 2008, to January 4, 2019. Tr. 433-38; GX 9 at 37, 39, 41, 43, 44. Without a legitimate medical purpose, there was no appropriate rationale for continued treatment with controlled substances. Tr. 434-48. Such prescriptions, from July 9, 2008, to January 4, 2019,

*J

were issued outside the standard of care, without legitimate medical purpose and outside the usual course of professional practice. Tr. 434-48.

*J

Only the prescriptions issued between January 4, 2018, and February 12, 2019, were alleged in the OSC and are relevant to my decision.

[On January 11, 2019, D.D. was diagnosed with GERD and “back pain—opiate dependent refusing detox.” Tr. 439. This is the last time Respondent prescribed D.D. both hydrocodone and Soma, but the medical records again reflected a lack of appropriate medical history, response to treatment, an appropriate physical examination, assessment of pain or physical functionality, an appropriate diagnosis, or an established legitimate medical purpose for the prescriptions. Tr. 439-40. On February 12, 2019, Respondent prescribed D.D. hydrocodone to treat opioid dependency—refusing detox without there being any mention of pain. Dr. Munzing testified that this was outside the standard of care for all of the reasons he had previously testified. Tr. 441-42. Dr. Munzing testified that at no point during the treatment period did Respondent ever obtain a sufficient history to establish a diagnosis for back pain or support prescribing of hydrocodone and that the prescriptions for hydrocodone and Soma were not issued within the usual course of professional practice and were outside the standard of care. Tr. 443-44.”]

Dr. Munzing noted a period of over a year when no diagnosis for GAD appeared in D.D.'s records, from May 10, 2017, to September 19, 2018, and the 30 mg daily dose of Valium was stopped. Tr. 447-48. Then on September 19, 2018, the Respondent was placed on 6 mg of Xanax, which is a very high dosage especially for the beginning dosage. [Dr. Munzing testified that Respondent failed to obtain sufficient medical evidence upon which to base a GAD diagnosis. Tr. 446.] Compounding this dangerous dosage of Xanax, D.D. was prescribed hydrocodone in combination, which heightened the risk of overdose [without any warning from Respondent regarding the dangers of the controlled substances being prescribed.] Tr. 446, 448-50, 458. [Dr. Munzing testified that there was no established legitimate medical purpose for prescribing Xanax to D.D. Tr. 446.]

Dr. Munzing noted the inconsistency of diagnoses throughout D.D.'s records and the dual prescribing of hydrocodone and Soma for fibromyalgia, opioid abuse, and skeletal pain (namely back pain or neck pain), without a documented explanation in the record. Tr. 450-56; GX 9 at 43, 51, 64, 70; GDX 5. Dr. Munzing noted the skeletal pain diagnoses appear and disappear within the record. Tr. 450-56. Dr. Munzing suspected the skeletal pain complaints were not legitimate. Tr. 456; GX 9 at 43, 51, 64, 70. Prescribing Soma with hydrocodone presents considerable risks to the patient. Each are respiratory depressants, which presents a significant risk of overdose, [and each is highly abused.] Tr. 458. [Dr. Munzing also reiterated the risks of prescribing both hydrocodone and Xanax together. Tr. 458. Dr. Munzing testified that in 2009, D.D. signed “the same controlled substance therapy agreement we've seen with the previous four patients,” and it was insufficient notice of the risks of using controlled substances for the reasons already discussed. Tr. 458-59. Dr. Munzing further testified that the record is lacking any documentation that Respondent adequately warned D.D. of the risks of the controlled substances he was taking, particularly in light of the various combinations and high dosages. Tr. 459-60.]

D.D. presented on March 23, 2019, with opioid dependency, refusing detox, which is a red flag. He was again prescribed hydrocodone and Soma. Tr. 463; GX 9 at 42, 43. [Dr. Munzing reiterated his testimony that hydrocodone is not an appropriate treatment for opioid dependency and added that neither is Soma. Tr. 454-55. Accordingly, Dr. Munzing testified, every relevant prescription for hydrocodone and/or Soma that was issued to treat opioid dependency was issued outside the standard of care. Tr. 455.] The Respondent failed to address this red flag repeatedly, instead prescribing Soma and hydrocodone. Tr. 465.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for D.D., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for D.D.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded D.D.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with D.D., never appropriately monitored D.D. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 465-68. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to D.D. were issued without a legitimate medical purpose, outside the usual course of professional practice and beneath the standard of care in California. Tr. 468.]

Patient J.M.

Dr. Munzing reviewed the subject prescriptions and fill stickers issued from January 10, 2017, to December 31,

2019, patient records and CURES data relating to Patient J.M. Tr. 469-70; GDX 6. [Again Dr. Munzing testified there was “very little information” in the patient's medical records. Tr. 470.] Dr. Munzing opined that none of the subject prescriptions issued to J.C., namely for hydrocodone, Xanax and Soma, were issued within the California standard of care. Tr. 470-71.

On May 13, 2007, J.M. presented with hypertension, back pain, GAD, dyslipidemia and insomnia. Tr. 470-72; GX 7 at 104, 111. He was diagnosed with hypertension, back pain, GAD, dyslipidemia and insomnia. He was prescribed hydrocodone for back pain and Xanax (6 mg per day) for GAD. Tr. 472. Xanax and hydrocodone were recurring prescriptions. As discussed, the high dosage of Xanax was a concern to Dr. Munzing, as well as its combination with an opioid. Tr. 473.

According to Dr. Munzing, there was no appropriate medical history included in the records, no response to treatment, no physical exam of the back or other areas of issue, insufficient patient monitoring, no evaluation for GAD, no treatment plan, no pain or functioning evaluation, no mental health history, no ongoing drug abuse history or monitoring, no discussion of risk factors and informed consent, and no patient monitoring, which rendered the GAD and back pain diagnoses inappropriate from May 13, 2007, to January 13, 2017. Tr. 473-76, 478, 481-83, 485-500. The MRI dated May 30, 2007, and its “mild” findings, did not independently satisfy the Respondent's obligations or justify the subject prescriptions. Tr. 479-80, 485-87; GX 11 at 14, 16, 17, 22, 26, 31, 37, 41, 42, 115. [Dr. Munzing testified that for the five visits between January 10, 2017, through March 27, 2017, there is so little documentation that Dr. Munzing cannot tell whether the records reflect “actual visits” or just “documentation of a refill of the medication.” Tr. 482-85. This is because, according to Dr. Munzing, the records lack examination or history notations, documentation of the dose or strength prescribed, diagnoses, nothing to meet the standard of care for prescribing hydrocodone and Xanax for that period. Tr. 482-85.

The first prescription for Soma during the relevant time period was on April 13, 2017, and according to Dr. Munzing, the medical note said “Xanax number 90, Soma number 50SED, and then a signature” with absolutely nothing else recorded and none of the elements of the standard of care met. Tr. 485-86. Dr. Munzing testified specifically about selected office visits. On April 25, 2018, Respondent's records for J.M. contain information suggesting an office visit occurred, but they continue to have the same deficiencies. That day, J.M. was not diagnosed with pain, but with GAD and opioid dependence—refusing detox, which was treated with hydrocodone. Tr. 487. Dr. Munzing reiterated his concern that hydrocodone is not appropriate treatment for opioid dependence and was inappropriate each time it was prescribed for that purpose. Tr. 488. Dr. Munzing testified about the November 19, 2018 visit during which J.M. was prescribed Xanax for GAD and Soma for back pain; the February 20, 2019 visit during which he was prescribed Xanax for GAD and hydrocodone for back pain; and the December 31, 2019 visit during which he was prescribed Xanax for GAD and was not diagnosed with back pain. Tr. 489, 492-93, 495. Dr. Munzing again testified, amongst other things, that for each of these visits, there was an insufficient medical history or physical examination to make the diagnoses, there was no information regarding the response to treatment, pain level, or functionality, and there was no legitimate medical purpose established for the prescriptions at issue. Tr. 489-91, 493-97.] Without a legitimate medical purpose, there was no appropriate rationale for the controlled substance prescriptions, or to continue treatment with controlled substances. Tr. 473-76, 478, 485-500, 505; GDX 7.

There were also red flags left unaddressed by the Respondent. J.M. refused to see a pain specialist, which gives rise to the suspicion that he is not concerned about getting better, but just getting medicated. Tr. 476-77.

*K

Dr. Munzing noted that there were gaps in prescribing hydrocodone and Soma without any required explanation for changes to the medication regimen. Tr. 500-04; GX 11 at 36, 37, 40, 41, 42, 76. He observed that the hydrocodone was prescribed either for back pain or for opioid dependence. Tr. 504. However, as with the other patients, the required evaluation for the diagnoses coming and going and explanation for treatment is lacking. This further diminishes any medical legitimacy for prescribing hydrocodone. Tr. 504.

*K

Omitted for relevance.

Additionally, on multiple occasions the Respondent prescribed a very addictive and dangerous combination of medications including an opioid and a benzodiazepine. Tr. 558-60. Even more concerning, he added a muscle relaxant, to this already dangerous combination to form the “Holy Trinity,” which is a favorite drug combination for abuse. Tr. 505-10. Dr. Munzing could not conceive of a medical condition in which the trinity combination would represent appropriate treatment. Tr. 512. This trinity of medications was prescribed to J.M. repeatedly. GDX 6. The file fails to reveal whether appropriate warnings were given to J.M. in connection with this dangerous combination. Tr. 511; GX 11 at 113. The CURES report reveals that 40 Xanax prescriptions (totaling 3600 dosage units and 7200 mgs) were issued to J.M. over a period of 22 months between January 2017 and November 2018. This means that Respondent was issuing a Xanax prescription to Respondent every 16 days on average for an average total of 10.5 mgs per day. Tr. 512-17, 527-28; GX 7, 17, 18. Ten and a half mgs per day is considerably greater than the maximum 4 mg per day recommended for treatment of anxiety. The CURES report lists two different dates of birth for J.M., as well as two different spellings of his first name. Tr. 517-18, 547-49; GX 18. A CURES search would be name and date of birth specific, so a search by one name and date of birth would not reveal prescriptions filed under the alternate name and date of birth. Tr. 526. The main sources of the CURES report information are two pharmacies, Reliable Rexall and Northridge Pharmacy. Tr. 518-19. Despite the fact that J.M. was using different names and dates of birth at different pharmacies, which was a considerable red flag suggesting abuse or diversion, the Respondent did not address these issues. Tr. 519-20, 525-26. Even if J.M. or the pharmacies were the source of the alternate dates of birth and alternate first names, with due diligence, the Respondent would have discovered that a search by a single name and date of birth would only include half of the Xanax prescriptions the Respondent issued to J.M. Tr. 521-26, 549-50. [Dr. Munzing testified that there is “nothing in the notes” addressing this red flag.” Tr. 550.] Additionally, two prescriptions, one written by the Respondent and one called in by the Respondent on the same day, contain two different dates of birth. Tr. 533-34.

The CURES report also reveals J.M. was alternating the filling of the Xanax prescriptions between the two pharmacies—which could indicate that he was trying to hide the bi-monthly frequency of the prescriptions. Tr. 520; GX 17, 18. Dr. Munzing noted this was a suspicious prescribing practice by the Respondent. Tr. 530; GX 17, # 425 & 575.

8

He would issue two prescriptions

on the same day to J.M., one for hydrocodone and one for Xanax. He would issue a written prescription for hydrocodone, which J.M. would invariably fill at Northridge Pharmacy, but would call in the Xanax prescription to Reliable pharmacy. Tr. 531-33, 535-45, 550-58; GX 11 at 32, 33, 35, 36, 38, 40, 41, GX 12 at 5, 6, 10, 11, 14, 22, 24, 27, 33, 34; GX 13, at 20, 25, 27, 32, 34; GX 17, 18 #473, #474, #994, #1120, #1228, #1386, #1472, #1553, #2102, #2229, #2341, #2342. Dr. Munzing testified that this could have been an attempt to avoid the suspicion generated by the opioid/benzodiazepine combination if filled at a single pharmacy. Tr. 532-33, 557-60. There was an additional suspicious circumstance related to a Xanax prescription. The Respondent wrote in his medical notes that the medication should be taken once every eight hours, but the call-in information to the pharmacy was once every six hours. Tr. 543-45, 554, 556-57. [Dr. Munzing testified “[there is] not consistency between what [Respondent is] telling the pharmacist and what [he is] documenting in the progress note.” Tr. 545.]

8

These are prescription numbers.

The red flag of refusing to detox was repeatedly evident within J.M.'s patient file. Tr. 562; GX 11 at 37. He was diagnosed with “Opioid dependency, refusing detox” for which he was prescribed hydrocodone, which again, is outside the usual course of professional practice and illegal in California. Tr. 563-64. The diagnosis for opioid dependency being treated with hydrocodone appeared repeatedly in the records. The Respondent never addressed this red flag. Tr. 564.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for J.M., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for J.M.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded J.M.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with J.M., never appropriately monitored J.M. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 564-67. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to J.M. were issued without a legitimate medical purpose, outside the usual course of professional practice and beneath the standard of care in California. Tr. 567-68.]

*L

*L

This text replaces the ALJ's summary paragraph for consistency.

Patient K.S.

Dr. Munzing reviewed the subject prescriptions and fill stickers issued from January 19, 2018, to January 31, 2019, patient records and CURES data relating to Patient K.S. Tr. 469-70; GDX 8. [Again Dr. Munzing testified there was “very little” information in the medical records. Tr. 569.] Dr. Munzing opined that none of the subject prescriptions issued to K.S., namely hydrocodone, Xanax and Adderall, were issued within the California standard of care. Tr. 568-70. K.S. presented on June 21, 2007, with “back pain” for which he was prescribed hydrocodone and Soma. Tr. 570; GX 13 at 117. Although the Respondent noted he would get an MRI for the lumbar spine, no such MRI appears in the records. Tr. 571. There was no medical history included in this record regarding back pain, no treatment plan, no response to treatment, no physical exam of the back or musculoskeletal area, no pain or functioning evaluation, no ongoing drug abuse history, rendering the back pain diagnosis inappropriate. Tr. 570-74. Without a legitimate medical purpose, there was no appropriate rationale for continued treatment with controlled substances for back pain. Tr. 571-74.

[On August 5, 2009, K.S. signed a “Declaration of Pain Medication Use” form indicating that he had no prior drug abuse, and Dr. Munzing testified that there is no record of K.S. ever being asked about illicit substance abuse again. Tr. 575. Dr. Munzing testified that the 2009 Declaration was an insufficient inquiry to cover prescribing at any point in time when Respondent was treating K.S. Tr. 576.]

On May 1, 2012, K.S. presented with GAD and neck pain. Tr. 576; GX 14 at 80. He was diagnosed with GAD and neck pain, and prescribed Xanax for GAD and hydrocodone for the neck pain, refusing detox. Tr. 577. K.S. was prescribed a combination of hydrocodone and Xanax frequently throughout his treatment. This combination of an opioid and a benzodiazepine is dangerous, beneath the standard of care and represents a red flag unresolved by the Respondent throughout the records. Tr. 578-79. There was no medical history supporting the prescriptions. There was no indication of how the patient was responding to treatment. There was no treatment plan and no indication a physical exam was performed to support the diagnoses or justify the prescriptions. Tr. 579-81. There was no reference to pain levels or physical functionality. There was no reference to mental functioning with respect to the GAD diagnosis. There was no appropriate diagnosis for the GAD and neck pain. Respondent did not establish a legitimate medical purpose for the controlled substance prescriptions. Tr. 580-81.

According to Dr. Munzing, K.S. presented on November 18, 2013, and was prescribed Adderall (60 mg per day) with no documented evaluation for or diagnosis of any condition that Adderall may treat. Tr. 581-82; GX 14 at 70. There is also no medical history, physical exam, or treatment plan, and accordingly, the subject prescription is without a legitimate medical purpose.

*M

Tr. 582.

*M

This sentence was modified for clarity.

On January 19, 2018, K.S. presented with GAD, back pain and ADD.

*N

Tr. 583, 599; GX 14 at 41. For GAD, the Respondent prescribed Xanax. For back pain—opioid dependent, refusing detox, the Respondent prescribed hydrocodone; and for ADD, Adderall. Tr. 584. The record is missing any medical history, any updated medical history, the patient's state of health, how he is responding to treatment, a physical exam, pain levels, mental or physical functioning assessment, appropriate rationale for continued treatment, and information relating to drug abuse. Tr. 583-86. As a result, the treatment is without sufficient medical evidence. Tr. 584-86. Accordingly, the subject charged prescriptions are without a legitimate medical purpose. Tr. 586.

*N

Dr. Munzing testified that Respondent did not obtain sufficient medical evidence to diagnose K.S. with ADD at any point between the November 2013 visit and the January 2018 visit. Tr. 583.

On February 27, 2018, K.S. presented with ADD, opioid dependency and GAD. Tr. 586-87, 599-600; GX 14 at 39, 40. He was diagnosed with ADD, opioid dependency-refusing detox, and GAD. Back pain was not reported, nor was any report of pain made. At the April 30, 2018 visit, again, back pain was not reported, nor was any report of pain made. Tr. 601. Throughout the records, the Respondent failed to explain the appearance and disappearance of back pain. Tr. 601-02. Again, beneath the standard of care and against the law in California, K.S. was prescribed hydrocodone for opioid dependency, which Dr. Munzing testified was neither appropriate nor legal. Tr. 587-88. On November 28, 2018, K.S. presented with opioid dependency and GAD for which

he was diagnosed with opioid dependency-refusing detox and GAD, and for which he was prescribed hydrocodone and Xanax respectively. Tr. 588-589; GX 14 at 33; GDX 8. Again, beneath the standard of care and contrary to the law in California, K.S. was prescribed hydrocodone for opioid dependency. Tr. 588-89. And again, the medication regimen included the dangerous combination of an opioid and benzodiazepine. The record is missing any medical history, any updated medical history, the patient's state of health, how he is responding to treatment, a physical exam, pain levels, mental or physical functioning, any evaluation for GAD, appropriate rationale for continued treatment, and information relating to drug abuse. As a result, the treatment is without sufficient medical evidence. Tr. 588-89. Accordingly, the subject charged prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care. Tr. 590.

On December 11, 2018, K.S. presented with ADD and eczema for which he was diagnosed with ADD and eczema. Tr. 591; GX 14 at 33. For ADD, he was prescribed Adderall. [Dr. Munzing testified that the Adderall prescription lacked a legitimate medical purpose for the same reasons as the prior prescriptions he had just discussed. Tr. 591-93.] On January 31, 2019, K.S. presented with and was diagnosed with back pain and stomatitis. Tr. 593-94; GX 14 at 31. For the back pain he was prescribed hydrocodone. [Again, Dr. Munzing testified that the hydrocodone prescription lacked a legitimate medical purpose for the same reasons as the prior prescriptions he had just discussed. Tr. 594-95.]

A review of the entirety of K.S.'s subject medical records reveals that the Respondent never obtained any prior medical records. Tr. 596, 619. The record is missing an adequate prior medical history, any updated medical history, the patient's state of health, how he is responding to treatment, a physical exam, pain levels, mental or physical functioning, any evaluation for GAD, appropriate rationale for continued treatment, and information relating to drug abuse. As a result, the treatment is without sufficient medical evidence. Tr. 598-99, 620. Accordingly, the subject charged prescriptions were issued without a legitimate medical purpose, outside the usual course of professional practice, and beneath the standard of care. Tr. 597-98, 619-20.

[Dr. Munzing testified that, similar to the other patients, Respondent prescribed hydrocodone to K.S. for back pain, then neck pain, then for opioid dependency, and sometimes for a combination of these reasons, without any documentation regarding these changes or the coming and going of the pain issues as would be required by the standard of care. Tr. 598-602.] Dr. Munzing also noted the inconsistency of the GAD diagnoses throughout the records. Tr. 602-05; GX 14 at 31, 42, 47, 48. With the GAD diagnoses appearing and disappearing within the records and without any explanation, Dr. Munzing observed there is no medical evidence it was a medically legitimate diagnosis. Tr. 605-09; GX 8. Similarly, ADD was inconsistently diagnosed with Adderall inconsistently prescribed. Tr. 605-06; GX 14 at 34, 35; GX 8. With the ADD diagnoses appearing and disappearing within the records and without any explanation, Dr. Munzing observed there is no medical evidence it was a medically legitimate diagnosis. Tr. 609.

Dr. Munzing noted the Respondent prescribed a dangerous combination of medications, including hydrocodone, Adderall and Xanax, which was prescribed from January 2018, through August 2018. Tr. 609-10. Dr. Munzing noted it is referred to by drug abusers as the “new Holy Trinity.” Tr. 610. Additionally, the combination of an opioid and a benzodiazepine is present in August, October and November 2018. Tr. 610-11. The records fail to reveal that the appropriate warnings were conveyed to K.S., or that informed consent was obtained. Tr. 611-13; GX 8. Dr. Munzing could not conceive of a medical condition warranting the dangerous combinations of medications prescribed. Tr. 614. [Dr. Munzing also noted that Respondent failed to properly monitor medication compliance, and conducted no urine drug screens, as was required by the standard of care in California. Tr. 614.]

Dr. Munzing noted the Respondent's failure to resolve red flags, including K.S.'s diagnosis of opiate dependency with refusal to detox, the dangerous combinations of medications, and high dosages of controlled medications. Tr. 615-18, 620; GX 14 at 39, 40, 41. The refusal to detox is a major red flag for opioid use disorder and for diversion. However, the Respondent did not take any necessary action, such as CURES monitoring, UDS, counseling, or titration. Rather, he simply prescribed the same levels of medications she was on, PRN. Tr. 615-17. The Respondent's course of action was outside the California standard of care.

[Dr. Munzing, summarizing his opinions based on his review of the entire file for K.S., testified that Respondent never took a proper medical or mental health history, never conducted a sufficient physical or mental health examination for K.S.'s relevant diagnoses, never made an appropriately supported diagnosis, never recorded K.S.'s pain and functionality level, never documented an appropriate treatment plan with goals or objectives, never appropriately documented discussion of the risks of the prescribed controlled substances with K.S., never appropriately monitored K.S. for medication compliance and failed to appropriately respond to red flags of diversion. Tr. 617-20. Accordingly, Dr. Munzing opined that each of the relevant prescriptions Respondent issued to K.S. were issued without a legitimate medical purpose, outside the usual course of professional practice and beneath the standard of care in California. Tr. 620.

In summarizing the entire body of evidence he reviewed in this matter, Dr. Munzing opined that each of the controlled substance prescriptions at issue in this matter were issued “outside the standard of care” and that Respondent's prescribing of high dosages of these controlled substances “absolutely” constituted clear excessive prescribing. Tr. 621.]

Respondent's Case-in-Chief

The Respondent presented his case-in-chief through the testimony of one witness, the Respondent, Fares Rabadi, M.D.

Fares Rabadi, M.D.

Dr. Rabadi attended medical school in the former Soviet Union. Tr. 626. He underwent a three-year residency training in internal medicine at State University of New York School of Medicine and Biomedical Science in Buffalo, New York. Tr. 627. According to Respondent, he is currently licensed to practice medicine in New York (inactive), California, and Indiana. Tr. 627. He has been licensed in California since September 25, 1998. His first two years practicing in California were spent working at another medical group. For the past twenty-years he has had his own practice. Tr. 628. He is a member of the American Medical Association (AMA), the American College of Physicians, a Master of the College of Physicians, the American Society of Internal Medicine, the Los Angeles Medical Association and Arab American Medical Association. Tr. 628. He is affiliated with the U.S.C. Keck School of Medicine, and is on the volunteer faculty with the UCLA's David Geffen School of Medicine. He teaches family

medicine residents at the Northridge Hospital. Tr. 628-29.

Dr. Rabadi was familiar with the federal regulations, the California Health and Safety Code, and the California Business and Professional Code cited in the Order to Show Cause. Tr. 630. Dr. Rabadi was familiar with the Government Exhibits 1-19 (records relating to the prescribing to the charged patients), and 20 (The [California] Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons). Tr. 630. He was specifically familiar with pages 59-60 relating to pain management. Tr. 630; GX 20. He was also familiar with the Guidelines for Prescribing Controlled Substances. Tr. 630; GX 21.

In his medical career Dr. Rabadi has treated thousands of patients, including hundreds of pain patients. At the time of the issuance of the Order to Show Cause, Dr. Rabadi had 300-400 patients of which 175-200 were pain management patients. Tr. 631, 792. In both 2017 and 2018, he estimated he treated 400 to 500 patients. Tr. 803. In 2019, he estimated he saw 400 patients, and less than 200 in 2020.

9

Tr. 804.

9

There was some confusion in the transcript as to the total number of patients in 2019. The Respondent estimated 400 total patients for 2019, but later agreed it was approximately 200 total patients in 2019. Tr. 804. [Respondent also testified at the hearing that “I have close to 550-600 patients” suggesting that was his total number of patients at the time of the hearing in September 2020. Tr. 792. He testified that he had 175-200 patients who were specifically pain patients up until the time of the OSC which was dated March 2020. I note that the exact number of patients that Respondent was treating at any given time has little relevance to my decision in this matter, other than as it relates to his ability to accurately recall the undocumented details of each medical visit to which he testified.]

Dr. Rabadi described his protocol upon a patient's first visit to his clinic prior to the issuance of a prescription. Tr. 631. The patient initially fills out paperwork. His office verifies insurance coverage. The patient is weighed and then sent to an examination room. Dr. Rabadi enters the room, greets the patient and sits on a stool “so [his] eyes are with the same level as the patient's eyes.”

*O

Tr. 632. Dr. Rabadi determines how the patient was referred to him. Dr. Rabadi then takes the patient's history, which begins with the patient's main complaint. Dr. Rabadi disagreed with Dr. Munzing's estimate that a diagnosis is 85% based on the patient's history. Dr. Rabadi believed it was upwards of 95% based on history. Tr. 635-36. The Respondent conceded history is critical to understanding the patient's condition and how to treat the patient. Tr. 804. He inquires about family history and their medical issues. Dr. Rabadi then inquires regarding social history, surgeries and present pain. He inquires into habits, such as smoking, and past and present use of illegal drugs. He then probes any allergies, including allergies to medications. If a patient has no allergies, he reports NKDA. Tr. 635. Following history, Dr. Rabadi testified he “starts going in depth about the main complaint,” with an eye toward isolating the ultimate medical source of the malady, and whether the symptoms are resolved with medication. Tr. 635-37. Regarding complaints of “back pain,” for example, Dr. Rabadi testified that he will review previous diagnoses, probe the source and triggers for the pain, explore any nerve restrictions, and discuss the success of different past treatment methods. Tr. 638-40. If pain medication management was the only treatment that alleviated the pain, Dr. Rabadi would explore the history of that treatment and its efficacy. [Respondent testified that “after [he] complete[s] the history in general, and organ-specific where the complaint is, then [he does the] physical examination.” Tr. 641.]

*O

Modified for clarity.

Dr. Rabadi testified that the physical exam he performs for all patients starts with the head. He examines the skull. He explores headaches, noted in the records as, “HEENT.” Tr. 641. He then checks the eyes, the ears, and the mouth. Tr. 642. He moves down to the neck, checking for issues with the veins of the neck. He then checks the efficiency of the heart's pumping and its rhythm. Next, he checks the lungs. Moving down to the abdominal cavity, he palpates the liver and spleen for abnormal size. Tr. 643. He then checks the remaining organs of the abdomen and the bowel for irregularities. Tr. 643. He then checks the extremities for circulation issues, often noting in the records, “No ECC” (edema, clubbing or cyanosis). He then checks for skin issues. Finally, he performs a neurological examination, including a mini mental-state exam and their orientation as to time and space. Tr. 643-45. He checks their reflexes, their cranial nerves. Tr. 645. He decides if further radiologic testing is necessary. Tr. 651-52. For men aged 17-35, he offers a testicular exam to check for cancer. For men over 50, he offers a rectal exam to determine indications of prostate and colorectal cancer. The complete exam takes from 30-40 minutes. Then, Dr. Rabadi formulates his diagnosis, [though he noted that “the patient many times comes with a diagnosis already.”]

*P

Tr. 647. He then establishes a treatment plan. Tr. 649. He discusses the treatment plan with the patient and obtains informed consent. Tr. 658. For patients experiencing pain, he explains the mechanism of pain, the modalities of pain and the type of pain; chronic pain, acute pain, malignant pain, post-traumatic pain, rheumatological pain, psychogenic pain, and neuropathic pain.

10

Tr. 668. For patients receiving pain medication prescriptions, Dr. Rabadi explains the medications, their side effects, including addiction, overdose and death, and cautions patients not to operate machinery or use heavy equipment. Tr. 668-70. [When asked whether he had ever prescribed a controlled substance for a patient without having this discussion about the dangers, he responded, “Absolutely not. Absolutely not. Absolutely not.” Tr. 669.] Dr. Rabadi assures his patients that if they take the medication as prescribed, they will not overdose. Tr. 670.

11

He typically sees his pain patients monthly. Tr. 672.

*P

At this point in his testimony, Respondent stated, “[T]he Government seized more than 223 charts . . . they returned more than 200. . . . And now, they are focusing and fixating on these seven charts. So, they're just looking at the charts and some notes and immediately demonizing an astute clinician who's been in the medical field for 41 years without a blemish to my reputation and career. And now, I'm just portrayed as I'm just feeding the addicts; I'm just distributing his medications.” Tr. 648-49. I note that for the purposes of this Decision, I presume that all prescriptions issued by Respondent that are not at issue in this cases were legitimate.

10

Dr. Rabadi contrasted these classifications with those he indicated were described by Dr. Munzing, mild, moderate and severe. Tr. 667-68.

11

As I understand Dr. Rabadi's testimony, Dr. Rabadi noted that an unnamed study found that dosages 5-6 times higher than that recommended by the FDA were safe. This highly specific evidence was not noticed prehearing, was not reasonably anticipated by the Government, and will not be considered.

For return visits, Dr. Rabadi is focused on the specific reason for their visit. Tr. 673. This explains why Dr. Munzing's noted diagnoses would appear and disappear from month to month. Tr. 673. Dr. Rabadi does not make note each month of long-term chronic conditions. Tr. 673. If a patient has new symptoms, Dr. Rabadi will focus on these new symptoms and tailor his examination to these symptoms, although at least two organ systems are always examined. Tr. 674. At least every three months blood pressure is checked. Tr. 675. Dr. Rabadi explained that much depends on the physician's judgment. Guidelines are essentially recommendations. Following the guidelines does not make the Respondent a good doctor. The most important thing is to perform with knowledge, with care and in good faith, placing the interest of the patient as the Respondent's top priority. Tr. 676.

If patients' symptoms subsided and they did not finish their medication, Dr. Rabadi would not prescribe more medication. He would wait until the medication was finished. This explains why prescriptions would sometimes stop and restart from month to month. Tr. 673.

For patients on pain medication and desiring to continue on pain medication, he discusses the options of detox and referral to a pain specialist. Tr. 650. All of his patients on pain medications are required to sign a “Controlled Substance Agreement.” Tr. 658. Dr. Rabadi also verbally tells patients that they cannot obtain pain medication from different physicians, and they cannot go to different pharmacies for refills. Tr. 660. If a patient overdoses, or is arrested selling medications, he is banned from further treatment. Tr. 660. Dr. Rabadi has little sympathy for reports of lost or stolen medication. Tr. 661.

In the United States, the patient “is in the driver's seat.” The patient's wishes are granted unless they are asking for something illegal or abnormal. Treatment cannot be forced on them. Tr. 650. When a patient reports that he has received extensive radiologic testing and has exhausted medical treatment and surgeries for his injury and wishes to remain on pain medications, the only option is to prescribe those medications or to drop the patient, which Dr. Rabadi did not view as an ethical option.*

Q

Tr. 651. No one deserves to be in pain. Tr. 664-65, 670. If chronic pain patients were dropped from the practice, they may turn to buying illegal drugs off the street. Tr. 663. Dr. Rabadi was realistic as to most of his pain patients. Some had been on pain medications for 10, 15 and 20 years and were chemically dependent on them. Tr. 662. The goal was not to make them pain free, which would be impossible. It was to minimize the pain, and maximize their functionality without making them a slave to the medications. Tr. 662, 664. For acute pain, Dr. Rabadi typically restricted pain medication to one week. Tr. 662.

*

Q

Respondent testified, “[i]f the patient tells me, `Look, I've already been with pain specialists; I've already seen a couple of specialists; I already had three-four MRIs; I already had surgery; I'm on this medication for years, and it's working for me,' then it comes down to one of two options. Either I tell him I will fill his prescription or I kick him out of my office. And I don't think it is ethical to do that latter approach.” Tr. 651.

Dr. Rabadi noted that almost all of his patients work full time in the motion picture industry doing hard labor and suffer serious and sometimes recurring injuries. Tr. 647, 663. They have had long term injuries with surgeries, and have been on pain medication for a long period of time prior to coming to see him, and are still able to function. Tr. 647-48, 663.

Regarding the use of pain scales in diagnosing, Dr. Rabadi noted their limitations—it is purely subjective to each patient. Tr. 658-59. Regarding the high doses of medications he prescribed, Dr. Rabadi agreed with Dr. Munzing that starting patients on such high doses was dangerous. Tr. 640. However, if the patients were acclimated to such high doses, prescribing lower doses would be ineffectual and potentially dangerous. Tr. 656-58. If Dr. Rabadi was just starting treatment for ADD, for example, he would start the patient on .25 mg of Xanax per day. Tr. 657.

Patient S.B.

Patient S.B. remained a patient of Dr. Rabadi's. Tr. 708-09. She was prescribed hydrocodone, Xanax and Adderall. Tr. 709. Dr. Rabadi believed his prescription practice concerning S.B. was within the California standard of care. Tr. 709. Dr. Rabadi began his treatment of S.B. on August 3, 2016. Tr. 718. She presented as a 29 year-old female to establish care for the treatment of ongoing conditions of GAD, fibromyalgia, and ADD. Tr. 719. As per Dr. Rabadi's policy, as detailed in his earlier testimony, he took a complete history.*

R

Tr. 719-20. He performed a complete physical examination [“head to toe including every organ and system,”] reviewed her existing diagnoses of GAD and ADD, and her medication history in general and specifically for those diagnoses. Tr. 720, 722-24. He obtained her pain level with and without medication. Without medication her subjective pain level was eight. With medication, it was one to two, which permitted her to function and perform daily activities. Tr. 721. The Respondent conceded that the detailed findings of the complete physical exam are not reflected in his chart, but noted he was a clinician with 41-years of experience, and not a medical student. Tr. 810. Tr. 810. [He testified that he inquired regarding any behavioral and psychological issued S.B. might have. Tr. 722.] Dr. Rabadi noted that patients with ADD are six times more likely to have other psychiatric conditions as people without ADD. Tr. 722. Ultimately, Dr. Rabadi concurred with the previous physician's diagnoses of ADD, GAD, and fibromyalgia. Tr. 724, 728. To obtain informed consent to prescribe controlled substances to S.B., the Respondent executed the “pain management contract.” Tr. 728-29. The patient reads it and signs it. The Respondent then goes over the contract in detail with the patient. The Respondent then explains that the medications are meant to help the patient, not to cause side effects or addiction, although they tend to cause chemical dependence. Tr. 729. The Respondent then goes over all the alternative treatments, but in the end, it is the patient's decision as to the treatment she will receive. Tr. 729. If the Respondent objected to every patient's choice of treatment, there would no medical care. If a patient says she is on medication and it permits her to function, the Respondent will continue that treatment. Tr. 729-30. S.B. indicated she had been through several alternate treatments, including, occupational therapy, physical therapy, hydrotherapy, yoga and meditation. Tr. 731, 805.

*

R

Respondent testified both generally and specifically to S.B. that he “take[s] personally a very lengthy history. [He] spend[s] close to 60 minutes in the first visit the patient comes.” Tr. 719, 721.

The Respondent conceded the list of prior therapies was not in his progress notes. Tr. 805-06, 808. The Respondent explained its absence as maybe he “did not feel it was crucial to be documented,” as he memorizes what the patient tells him.*

S

Tr. 806. Respondent testified that including references to prior, concluded treatment was irrelevant as the prior treatment was concluded and the patient had moved on to the new treatment. Tr. 807-08. The Respondent testified to S.B.'s prior treatment from memory. Tr. 808. The Respondent explained that, as he still maintained handwritten records and saw up to 20 patients a day, with new patients taking an hour and returning patients taking up to 20 minutes each, he did not have the luxury of documenting in detail. Tr. 807, 849. So, the basic information is reflected in his written notes, while the rest he remembers; “I rely on my photographic memory.” Tr. 808-09. The

Respondent conceded that “maybe” it was “inappropriate” of him not to more thoroughly detail this information in the charts. Tr. 809. But with handwritten charts he was only able to include the “main ideas.” His notes are simply to remind him of the matters. Tr. 810-11. He keeps his notes as brief as possible to remind him in the future. Tr. 815.

*

S

Respondent testified that, “the record is probably missing these things, because maybe at the time of the documentation I did not feel that was crucial to be documented. As soon as the patient disclosed that to me, I memorize it. I remember it. You've seen how several years later I still remember it. . . . I did not feel I have to clutter my charts with, you know, this information.” Tr. 806-07. Respondent further testified that he does not have electronic medical records, he is “still writing . . . And when I see 15, 20 patients a day . . . There [are] only 24 hours a day. I don't have the luxury to write ten pages on each patient. . . . [W]hat's pertinent, what's your diagnosis, what's your main exam, and what's your treatment is reflected there. The rest I remember. I don't need to write it.” Tr. 807-08.

Respondent testified that S.B. further reported that she had been on the same dosage of medications for several years to good effect. Tr. 731-32. [Respondent testified that “medically it is very inappropriate when a patient is stable at [a] certain dose, to start cutting the dose because [the] patient will regress” and either] suffer withdrawal symptoms or have severe pain.*

T

Tr. 732. Prior to each prescription, the Respondent discussed side effects, and changes in status. Tr. 733.

*

T

Modified for clarity.

The Government sought to test the Respondent's “photographic memory” by asking to confirm that, consistent with his direct testimony, he only treated S.B. with hydrocodone, Xanax and Adderall. Tr. 810-13. The Respondent confirmed his direct testimony. Tr. 812. The Government reminded the Respondent that he prescribed Soma as well, [but Respondent testified that he did not mention it on direct because it “was not [an] ongoing prescription. Maybe the patient got it once or twice over the course of the years.”] Tr. 813.

Although the Respondent testified he developed a treatment plan for each of his patients, the Government pointed out, and the Respondent agreed, that S.B.'s treatment plan and objectives were not documented in her chart. Tr. 813-14.

Although the Respondent testified he did not introduce any of his subject patients to controlled substances, the chart reflects he did prescribe Soma to S.B. for the first time. Tr. 816-17; GX 1 at 61, 62. The Respondent remembered during cross-examination that, although not in the chart, S.B. told him she had been on Soma previously. Tr. 817-19.

Patient J.M.

12

12

In transcript pages 734-43, Patient J.M. is discussed. However, due to some confusion with patient initials, the Respondent described his treatment of J.M. as M.B. within the transcript. Tr. 774. [All of the questions and responses for pages 734-43 referred to this patient as “M.B.”; however the factual information that was being discussed was actually applicable to “J.M.” The error was not discovered until Respondent was questioned about the patient whose initials were actually M.B. The parties entered “a stipulation that Dr. Rabadi's [prior] testimony as to M.B., the second patient discussed, is actually applied or attributed to Patient J.M.” Tr. 774-75. This exchange did not fill me with confidence that Respondent's testimony reflected his true recollection of the specific actions he took with regard to the specific patient being discussed. Rather, Respondent seemed to testify to the policies and procedures he followed in the regular course and assumed that those policies and procedures were followed with regard to all the named patients.]

J.M. has been a patient for thirteen years. Tr. 734. The Respondent has prescribed him Xanax, Soma and hydrocodone. The Respondent believed his treatment of J.M. was within the California standard of care. J.M. first presented on May 14, 2007, with chronic pain syndrome, which sometimes manifests as back pain, and neck pain, and GAD. Tr. 735; GX 11 at 104. The Respondent took a history. J.M. had been involved in a motor vehicle accident injuring his back, neck and lumbar spine. Additionally, he suffered from GAD and hypertension. Tr. 736. The motor vehicle accident as the source of the injury was not documented. Tr. 853. J.M. had seen an orthopedic surgeon, although it was not documented in the chart. Tr. 853. Without medication, J.M. reported severe pain of 10 or 11 of 10. With medication, he reported pain levels of three of ten, which permitted him to function and to work full time; the pain levels were not documented in the chart. Tr. 736, 854-55. J.M. reported prior treatments and medication. He had received physical therapy, occupational therapy, hypnosis and acupuncture to no avail prior to turning to chronic pain management, although these previous therapies were not documented in the chart. Tr. 737, 854. His present medication protocol delivered the best results with the least side effects. Tr. 737. The Respondent probed his psychological history, which included an all-consuming fear.

The Respondent performed a comprehensive physical exam “head to toe.” Tr. 739. To obtain informed consent to prescribe J.M. controlled substances, the Respondent went over the pain management contract, which J.M. also read and signed. The Respondent cautioned J.M. about diversion and red flags of doctor shopping and pharmacy hopping, which would result in discharge. Tr. 739-40. The Respondent noted that J.M. is a very well-respected man. He's very well-known in the community. Tr. 740.

13

The Respondent then discussed the beneficial aspects of the pain medication and potential negative effects if abused. Respondent testified that J.M. never gave any indication he represented a risk of diversion. Tr. 741. Prior to seeing the Respondent, J.M. was on a higher MME of opioids. He was able to reduce the dosages to the level he was on when he first saw the Respondent. He remains on that dosage. Again, he is able to function and work full-time on this dosage. Tr. 742. The Respondent noted that J.M. would sometimes try to avoid taking his medication, even if he suffered pain, as explanation for the breaks in prescribing. Tr. 743.

13

J.M.'s prestigious background will not be considered. It is an unnoticed matter that the government would have no way of checking or countering. [It is also completely irrelevant to my decision in this case.]

The Respondent denied ever using a different first name for J.M., or using a different birth date for him [and attributed any mistake to the pharmacy.] Tr. 778-82.

Patient B.C.

Patient B.C. has been a patient of the Respondent since March 27, 2014. Tr. 750-51. Patient B.C. has been prescribed hydrocodone, Xanax and Adderall. Tr. 749. The Respondent obtained a complete history, a complete physical exam and then probed the complaint that brought him to the Respondent, which was right shoulder and chronic back pain. Tr. 751. Without medication, B.C. reported pain at seven or eight, and with medication at one or two. Tr. 752. As far as his medication history, B.C. had been on pain medication for years following a neurosurgical procedure to treat a herniated disc with radiculopathy.

14

Tr. 752. To obtain informed consent, the Respondent discussed the pain management contract, which B.C. read and signed. Tr. 752-53. The Respondent then discussed side effects of the medication [including “addiction, overdose, and death.” Tr. 753.] B.C. is a married man with three children. He works full time. He gave the Respondent no indication he was a risk for diversion. Tr. 753.

14

The Government objected to B.C.'s prior treatment history, which was not noticed in the RPHS. I ruled it was reasonably anticipated. The Respondent cited to specific treatment from a prior physician. The contested evidence is reflected in GX 5 at 14, so the Government was certainly not surprised by the evidence.

Regarding prior alternate treatment, B.C. reported that he has tried surgery, physical therapy and acupuncture, but that only pain medication therapy alleviates his pain to the extent he can function. Tr. 754. At each visit, the Respondent reviewed B.C.'s progress and believed B.C.'s condition warranted the medication he was prescribed. Tr. 754, 757. Although the Respondent remembered discussing B.C.'s pain levels on March 27, 2014, and that it was one or two on medication, he conceded it was not documented in the

chart. Tr. 832-34; GX 5 at 48. Although the Respondent remembered B.C. reporting he had a herniated disc, this report was not documented in the chart. Tr. 836. Neither were B.C.'s reported prior surgery, physical therapy, acupuncture, or occupational therapy documented. Tr. 837.

Patient J.C.

Patient J.C. presented on May 18, 2009, with chronic back pain, ulcerative colitis and GAD. Tr. 759-60, 761-62. He was prescribed hydrocodone, and Xanax, sometimes substituted with Valium. Tr. 759. The Government pointed out to the Respondent that there were visits during which several other controlled substances were prescribed. Tr. 842-46; GX 7 at 181, 214, 215.

He had suffered multiple injuries, and had been immobile for some time. However, the Respondent did not document the injuries or the immobility in the chart, nor did the file contain any prior medical records.

15

Tr. 839, 842; GX 7 at 216. He had undergone physical therapy, occupational therapy, and finally pain management, which permitted him to resume working full-time. Tr. 760. These alternate treatments and therapies and prior surgeries were not documented within the chart. Tr. 840. The Respondent could not remember if J.C. mentioned his prior surgeries at the first or second visit.*

U

Tr. 840. The Respondent performed a full exam on J.C. Tr. 760-61. His GAD resulted from his ulcerative colitis. Tr. 762.

15

The Respondent again explained the difficulty in obtaining prior medical records. Tr. 842.

*

U

Respondent testified, “[w]hether he mentioned the surgery the very first visit, that I cannot tell you yes or no at this point because it's not in my notes. So I'm just second guessing myself.” Tr. 841.

The Respondent obtained informed consent to prescribe controlled substances by explaining the pain contract; afterwards, J.C. read it and signed it. Tr. 763. The Respondent explained the dangers of overdose. Tr. 764. The Respondent had no concerns about J.C. diverting his medication. Tr. 764-65. On the basis of J.C.'s considerable injuries and condition, the Respondent felt J.C.'s medication protocol was fully justified. Tr. 765. The Respondent denied ever intentionally misspelling J.C.'s first name.*

V

Tr. 765-66. Although the Respondent remembered J.C. reporting that he had seen two previous doctors, including a pain physician, that report was not reflected in the chart. Tr. 841-42. Although the Respondent remembered performing a complete mental health evaluation on J.C., it is not documented in the chart. Tr. 842.

*

V

There was no allegation that Respondent misspelled J.C.'s name, but the OSC did allege that Respondent “used a variant spelling of Patient J.M.'s first name.” OSC, at 13. Accordingly, Respondent's testimony that he never intentionally misspelled J.C.'s first name is not relevant to this hearing other than it caused me to again question whether Respondent's testimony reflected his true recollection of the specific actions he took with regard to the specific patient being discussed.

See supra

n.12.

Patient D.D.

Patient D.D. first presented on July 9, 2008, with GAD and severe back pain, although the source of the back injury was not documented. Tr. 767-68, 850; GX 9 at 74. Over the course of treatment, the Respondent prescribed hydrocodone, Xanax and Soma. Tr. 850. The Respondent added that he probably prescribed Valium, as well, explaining he was remembering from 13 years ago. Tr. 850. The Respondent remembered D.D. was prescribed Valium, hydrocodone and Soma the first visit. Tr. 851-52. The Respondent believes his treatment was within the standard of care in California. The Respondent took a complete medical history, family history, personal history and medication history. Tr. 768. The family history was not documented in the chart. Tr. 848. The Respondent explained that the family history was not documented because it was non-contributory to his assessment. Tr. 848. There were no heart conditions in his family, etc. Tr. 849. The Respondent did document that D.D. was married, which he deemed contributory. Tr. 849. D.D. had a dirt bike accident, which shattered his shoulder and fractured several ribs, although the accident as the source of the injury was not documented.*

W

Tr. 850. He underwent physical therapy and occupational therapy after treatment by an orthopedic surgeon, although neither was documented within the chart. Tr. 769, 771, 850-51. It was several years before he reached the medication regimen he was on when he first reported to the Respondent. The Respondent performed a full physical exam. He established informed consent with the pain contract and discussion of side effects and overdose, as with all his patients. Tr. 770. He verbally cautioned D.D. regarding diversion and other red flags. Again, D.D. gave no indication of diversion. Tr. 771. Respondent testified that alternative treatments were discussed. Tr. 771.

*

W

Respondent testified that, “whether it is specifically dirt bike as opposed to car accident, as opposed to falling off the second story, this has become, there is a good reason for the back pain. That's the whole thing, why I did not mention specifically dirt bike injury.” Tr. 850.

Patient M.B.

Patient M.B. presented on April 19, 2006, with severe back pain, left knee pain and history of dyslipidemia. Tr. 782. The Respondent obtained a full medical history, medication history, pain level, and performed a complete head to toe physical exam. Tr. 783. The Respondent discovered M.B. had chronic back pain related to an injury, a manageable knee injury, and dyslipidemia. Tr. 784. Although the Respondent maintains he obtained a complete medical history as to the back pain and chronic knee pain, he concedes it is not detailed in the chart. Tr. 820-23. [He testified, “[maybe . . . I should have documented more. I'm not going to say anything to that.” Tr. 821.] He was already on hydrocodone, previously prescribed, when M.B. first saw the Respondent.

The Respondent obtained informed consent in the same manner as described for his earlier patients. Tr. 784. He discussed alternative forms of treatment with M.B., however M.B. had exhausted those.*

X

M.B. had physical

therapy, and perhaps acupuncture, but the Respondent could not quite remember. Tr. 827. The Respondent conceded he did not document these therapies in the chart. Tr. 828. The Respondent monitored M.B. throughout his treatment. Tr. 785. The Respondent believed his prescribing was justified on the basis of M.B.'s medical conditions, level of chronic pain and present level of functioning, working in a welding factory lifting heavy things.*

Y

Tr. 786, 832. The Respondent conceded that he did not document M.B.'s degree of pain, but minimized the value of the subjective pain scale. Tr. 823-24. The Respondent conceded there were no imaging reports in M.B.'s chart, but explained that these patients were from the movie business. They were treated by a Health Maintenance Organization (HMO) from which it is almost impossible to obtain records. Tr. 829.

*

X

Specifically, when asked whether he considered alternative forms of treatment for M.B., Respondent testified: “I do. We do discuss that. However, patient's already been through those. Again, the common denominator in my practice is unique thing . . . because these patients [have] been there, done that. They had surgeries, they had imaging, they had already physical therapy, activation, acupuncture, medication. I told you some of them had hypnosis, water pool or water therapy. Everything was done. But still . . . for the sake of clarity I have to discuss everything. The patient will tell me, Doctor, I've done that, I've been there, and this is what works for me right now.” Tr. 785. On cross examination when asked specifically whether M.B. told Respondent that he had tried each of these forms of alternative treatment, Respondent replied “[n]ot necessarily all of this. I always ask questions, what alternative therapy did you discuss.” Tr. 825. When directed to identify specifically which forms of alternative treatment M.B. had tried, Respondent testified, “I don't want to misspeak. I'm not sure if he had . . . acupuncture or not. But I know for a fact he had physical therapy.” Tr. 827. I find this testimony illustrative of two concerns I have with Respondents testimony. First, it appears that Respondent's testimony does not always reflect an independent recollection of the undocumented events that occurred between him and the specific patients being discussed. Even where Respondent seems to be testifying about a specific patient, it morphs into testimony about his patients collectively rather than as individuals. This sort of collective focus that appears throughout Respondent's testimony causes me to question Respondent's credibility—specifically whether he remembers the events that occurred at each specific visit for each specific patient that he discussed in the absence of medical records documenting these events. Indeed, Respondent testified that “[o]ver [his] career, [he] worked [with] about 5,000 patients.” Tr. 792. And at the time of the hearing he had “close to 550-600 patients” and prior to the order to show cause he “had between 175-200 [pain] patients.”

Id.

Secondly, I am concerned that Respondent's “photographic memory” may not be as reliable as he portrays it, particularly where, as

here, there is no documentation in support of his memory.

*

Y

On cross-examination Respondent testified “the patient is in motion picture but he has also something that he does on the side that has to do [with] welding iron or something like that as well.” Tr. 832.

Patient K.S.

Patient K.S. presented on June 21, 2007, with chronic back pain. He was later diagnosed with ADD. He was prescribed hydrocodone, Soma and sometimes Adderall. Tr. 788-89, 861; GX 14 at 110. The Respondent added that he may have also prescribed Xanax, but it is difficult to be sure with hundreds of patients and treatment dating back fifteen years. Tr. 859. Even with a “good memory, sometimes you just miss something.” Tr. 859. Additionally, he noted that many times patients do not disclose all of their medications at the initial visit, if they have plenty and do not then need them to be refilled. So, he is not always aware of all of their medications at the initial visit. Tr. 860-62.

The Respondent believed his prescribing was within the standard of care for California. Tr. 788. The Respondent obtained a full medical history, medication history, pain level, and performed a complete head-to-toe physical exam. Tr. 789. The Respondent discovered K.S. had chronic back pain related to a bike accident for which he had been treated by several doctors for several years, although the bike accident as the source of the injury and treatment by other doctors was not documented. Tr. 789, 856-57, 859. Additionally, there were no records from prior treatment in the patient's records. Tr. 857. Although the Respondent explained that he requested the prior medical records, none were provided. The Respondent explained that his request for records is simply faxed to the previous physician's office. Tr. 857-58. Its absence from the file was probably because a staffer forgot to file it. Tr. 858. The Respondent did not contest the Government's observation that no requests for previous medical records were in any of the seven patient files. Tr. 859. K.S. was already on hydrocodone when K.S. first saw the Respondent. The Respondent obtained informed consent [and disclosed the potential side effects including the risk of death] in the same manner as described for his earlier patients.*

Z

Tr. 790. He discussed alternative forms of treatment with K.S. K.S. was obtaining physical therapy prior to seeing the Respondent and continued physical therapy after beginning treatment with the Respondent. Tr. 791. The Respondent monitored K.S. throughout his treatment. Tr. 791. K.S. presented no indications of diversion. The Respondent has treated K.S. for thirteen years during which time K.S. got married and had three children. Tr. 790-91.

*

Z

Specifically, when asked whether he had a conversation with this patient involving informed consent, Respondent testified: “Yes, I did. And, as usual, he read the entire contract, understood it. Indicated that [he] understood, both verbally and signed it. Then I . . . explain[ed] the potential side effects of these medications that include from my explaining with sedation and constipation, all the way to addiction, overdose, and possible death. And I indicate always to my patients on the last two, the overdose and the death, is on you, because you can cause it yourself, or you could use this medication indefinitely and never have any problem. . . .” Tr. 790;

see also

Tr. 670-71, 753, 770. Once again, Respondent begins his testimony purporting to have a specific recollection of his 2007 conversation with K.S., but then he turns to general language, which more supports a general assumption that he had the conversation.

See, e.g.,

Respondent's use of “as usual, he,” which is ambiguous because, while all of Respondent's patients purportedly receive the contract, K.S. is only purported to have received it once.

The Respondent noted that, to the best of his knowledge, none of his thousands of patients have suffered any harm from his medication treatment. Tr. 793. [Respondent testified that a combination of an opiate, muscle relaxant, and benzodiazepine, when “used in the right dosages for the right indications, and used as prescribed by a knowledgeable M.D., . . . are safe to use in combination therapy.” Tr. 797.] The Respondent disagreed with Dr. Munzing's assertion that he could perceive of no medical condition justifying the dangerous combinations of medications identified herein. Tr. 794-800. The Respondent conceded the potential danger of individual pain medications, and the potential increase in risk in combination with other medications. However, according to him, if patients are responsible and take the medications as prescribed for the indications intended, these combinations are fairly safe. Tr. 800.

16

16

Although the government objected to this opinion by the Respondent, I overruled its objection. A general disagreement by the Respondent of the government expert's opinion is certainly reasonably anticipated. The Respondent did not cite to any unnoticed medical practice guide, medical theories or other basis for his contrary opinion. The government was readily able to confront the Respondent's opinion. The Respondent's opinions were not considered expert opinions.

The Respondent recognized his obligations to follow all federal and state rules concerning the practice of medicine, including the directives of the California Board of Medicine. Tr. 862. California's Compliance with Controlled Substance Laws and Regulations includes a provision on records. Tr. 864; GX 20 at 61. According to Respondent, it mandates that, the physician and surgeon should keep accurate and complete records according to the items above between the medical history and physical examination, other evaluations and consultations, treatment plan objectives, informed consent, treatments, medications, rationale for changes in the treatment plan or medications, agreements with the patient, and periodic reviews of the treatment plan. Tr. 864-65. The provision further requires, “[a] medical history and physical examination must be accomplished . . . this includes an assessment of the pain, physical and psychological function.” Tr. 866; GX 20 at 59. The Respondent assured the tribunal that the necessary assessments were made, but not fully documented. Tr. 866-67. The Respondent, [while again conceding that there was no documentation,] made the same assurances for the requirements as to “Treatment Plan Objectives,” “Informed Consent,” and “Periodic Review,” noting these Guidelines were published in 2013.

17

Tr. 867-72. [As justification for not documenting a treatment plan, Respondent testified that he was “carrying the same treatment [plan] and no change and the patient is stable,” but that “[i]f [he] changed the treatment plan” it would be important to document. Tr. 874. Contrary to Respondent's testimony, the treatment plan did change when on February 2, 2017, the Respondent prescribed Soma to S.B. Tr. 875; GX 1 at 59. By March 1, 2017, Soma had been discontinued, yet the chart reflected no rationale for

that change in medication regimen. Tr. 876-77. As the Respondent varied his prescribing between Soma and Xanax, he conceded he did document the reason for the variation in medication. Tr. 878-83. The Respondent conceded he did not document the rationale for the change in medication for J.M. or K.S. as well. Tr. 885. Similarly, the Respondent conceded he did not document pain level, function level and quality of life for any of the seven charged patients. Tr. 885-87; GX 20 at 61. The Respondent reiterated that, to his knowledge, none of his patients exhibited red flags or violated the pain agreement. Tr. 888-89.

17

See

Tr. 950-52. Dr. Munzing testified credibly that the 2013 version was the 7th edition and the basic requirements have not changed over the years.

[Respondent testified somewhat extensively and flippantly regarding his thoughts on California law's documentation requirements. “I am not going to just say, okay, write in the chart I told the patient hello, they said hello, I said, okay, what did you have for breakfast? I am not going to document all that, there is no reason. It is just excessive wrecking [sic.] havoc on the documentation. . . . [E]verything was addressed, everything was talked about, and every exam, every consent, everything was done by the book. I am a perfectionist. I am a perfectionist.” Tr. 871.]

Rebuttal Testimony

Diversion Investigator

DI identified a CURES Audit Report for the Respondent's Registration number. Tr. 893-94; GX 24. The audit report shows each time the Respondent accessed CURES to run a query on patients. Tr. 894. This particular audit included data from January 1, 2016, through January 13, 2020. DI also identified GX 25, which was a CURES Audit Report run on the DEA Registration of Dr. B.S., which included the patient M.B., a patient common to the Respondent. Tr. 904. Between October 10, 2018, and September 11, 2020, Dr. B.S. prescribed Suboxone

18

to M.B. Tr. 909; GX 24, 25, 25B. On March 15, 2019, the Respondent accessed CURES and would have observed M.B. was receiving Suboxone from Dr. B.S. Tr. 910; GX 24. DI identified GX 26, an additional CURES Audit Report for Dr. B.S.2, which spanned from January 2017, to September 2020, and which shared a common patient with the Respondent, J.M. Tr. 911-13; GX 26, 26B. Dr. B.S.2 similarly prescribed Suboxone to J.M. from January 2017 to August 2020. Tr. 913. The CURES Audit of the Respondent demonstrated he accessed the CURES database during the period J.M. was prescribed Suboxone by Dr. B.S.2, which would have been evident by this review. Tr. 914.

18

Buprenorphine.

Dr. Munzing

Dr. Munzing repeatedly gave his opinion regarding the credibility of the Respondent's testimony. I find that Dr. Munzing's opinion as to the Respondent's credibility is beyond Dr. Munzing's qualified expertise. Accordingly, those opinions will not be considered herein.

19

19

[Omitted for brevity.]

Dr. Munzing opined on the importance of documentation within medical records, including medical history and pain levels. Tr. 917, 936-38. He noted that documentation was not just for the then treating physician. It was important for other physicians, perhaps years later, who may treat the patient in an emergency room setting. [Dr. Munzing testified that “[t]rue, and accurate, and thorough documentation is vitally important for patient safety. It's also part of the standard of care.” Tr. 917.] He reiterated that the elements identified in the Board of Medicine's Guidelines on documentation are part of the standard of care. Tr. 917-18; GX 20 at 59, 60, 61. He noted the lapse in documentation regarding the history, pain levels, mental health exams, and treatment plans the Respondent testified he performed or obtained for each patient. Tr. 916, 921-22. [Specifically, Dr. Munzing testified that “practically none of the information that Respondent mentioned [during his testimony] was documented.” Tr. 916.] Dr. Munzing observed that the examination described by the Respondent for fibromyalgia was medically deficient and inconsistent with the standard of care, as it did not include a musculoskeletal exam. Tr. 918-20. Dr. Munzing observed that the standard of care applies equally to electronic records as to written records. It does not matter whether the physician documents electronically or in writing, the standard remains the same. Tr. 922.

Regarding the Respondent's testimony that he would continue patients on medication prescribed by previous physicians if they reported they were doing well on the medication, Dr. Munzing opined that Respondent needed to conduct an “independent evaluation” and “verify what [the patient is] saying” *

AA

to comply with the standard of care. Tr. 923-27, 928-29. Dr. Munzing observed that the Respondent's warnings regarding the potential for overdose were not consistent with the standard of care. Tr. 927. Dr. Munzing believed the Respondent's undocumented verbal caution that overdose was a potential risk if the patients took the medication other than as directed was misleading, because there were risks even if the medication were taken as prescribed, and it was beneath the standard of care. Tr. 927, 929-31.

*

AA

For example, Dr. Munzing testified that Respondent could have checked CURES or urine drug tests to verify what the patients were saying or could have asked the patients to bring copies of their prior medical records in with them. Tr. 923-24. Dr. Munzing testified that it is outside the standard of care in California to simply take a patient at their word when they say that they are receiving certain controlled substances in certain doses. Tr. 928-29.

Regarding the Respondent's explanation that he only documented the condition of which the patient was complaining, and did not document all the medications the patients were already on when coming to his clinic, Dr. Munzing opined such practice was inconsistent with the standard of care. Tr. 932. Dr. Munzing testified that the documentation was not just to remind the treating physician, but to alert any physician who may treat the patient. Tr. 931-34. Dr. Munzing also criticized the Respondent's handling of situations in which patients reported they still had medication remaining from the previous month. Rather than simply refraining from prescribing additional medication, Dr. Munzing indicated that that situation should trigger a discussion with the patient and evaluation whether the existing level of medication is appropriate, or whether titration is warranted. Tr. 933-36. Dr. Munzing deemed the Respondent's prescribing 10 mg a day of Xanax to J.M. to treat GAD and undocumented panic attacks as excessive and beneath the standard of care. Tr. 938-39. Dr. Munzing deemed the Respondent's reluctance to reduce the opioid dosage lest the patient suffer pain or withdrawal symptoms misguided. Tr. 941. Titration of high opioid dosage of high risk patients or exploration of alternate treatment is consistent with the standard of care. Tr. 941. Dr. Munzing was critical of the Respondent's handling of J.M. and S.B. after discovering they were being prescribed Suboxone by other physicians. Tr. 941-48. Suboxone is typically prescribed for opioid use disorder or addiction. Tr. 943. It directly violates the Respondent's pain contract for these patients, yet the Respondent took no action and continued to prescribe opioids. Tr. 947.

The Facts

20

20

[The contents of the original footnote are omitted due to my omission of the Joint Stipulations. The parties agreed to Joint Stipulations numbered 1-38.

See

ALJX 3, Govt Prehearing, at 1-14 and ALJX 13, Resp Supp. Prehearing, at 1. The RD included many of the stipulated facts between the parties, but appears to have inadvertently left some out.

See

RD, at 54-67. I have omitted the joint stipulations from this decision in the interest of brevity, but I incorporate fully herein by reference Joint Stipulations 1-38. Where there is a reference to the Joint Stipulations herein, the numbering aligns with the numbering in the Government's Prehearing Statement, GX3, at 1-14.]

Findings of Fact

The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me.

During the hearing conducted, via video teleconference, from September 28, 2020, to September 30, 2020, the Government established the following facts through evidence, testimony, or stipulation (“Proposed Findings of Fact” or “PFF”):

I. Investigatory Background

1. DI has been employed by DEA as a Diversion Investigator for three years. Tr. 33.

2. DEA began investigating Respondent in April of 2018, after receiving a February 2018 report issued by the Department of Health and Human Services indicating that Respondent's prescribing habits presented a high-risk for overprescribing. Tr. 37-38.

3. DEA monitored California's prescription drug monitoring program, known as CURES, and identified several red flags regarding Respondent's prescribing. Tr. 35, 38. CURES reports obtained by DEA were admitted into evidence as GX 16, 17, 18, and 19. Tr. 16-18;

see also

Joint Stipulation Nos. 31-34. Among other things, DEA found that; (1) Respondent frequently prescribed opioids at their maximum strength, Tr. 38-39; (2) Respondent frequently prescribed patients a combination of an opioid and a benzodiazepine, Tr. 39; (3) Respondent issued prescriptions for a combination of an opioid, a benzodiazepine, and carisoprodol—a combination that is highly sought after on the illicit market, and is known as “the Holy Trinity,” Tr. 40; (4) Respondent prescribed high doses of controlled substances to patients for long periods of time, Tr. 40-41; (5) between November 20, 2015, and November 21, 2018, Respondent issued approximately 9,000 prescriptions for controlled substances, Tr. 39; GX 16; GX 17; GX 18; (6) Over half of those 9,000 prescriptions were for hydrocodone, and approximately 96 percent of these prescriptions were for either hydrocodone, alprazolam, or carisoprodol—which together make up the “Holy Trinity” cocktail. Tr. 39, 42-43; GX 16; GX 17; GX 18.

4. DEA obtained medical files from Respondent, pursuant to a federal search warrant executed at Respondent's medical clinic in February of 2019, and pursuant to an administrative subpoena issued to Respondent in January of 2020. Tr. 46, 49, 49, 55-56. These included medical files for Patients S.B., M.B., B.C., J.C., D.D., J.M., and K.S. (admitted as GXs 1, 3, 5, 7, 9, 11, and 14; Tr. 16-18).

5. DEA also obtained prescriptions for the above-mentioned patients (see PFF ¶ 4) from its search of Respondent's clinic, and from pharmacies at which these prescriptions were filled (admitted as GXs 2, 4, 6, 8, 10, 12, and 15; Tr. 16:15-18:3). DEA also obtained fill stickers for certain prescriptions issued to Patient J.M. from one of the pharmacies at which Patient J.M. filled prescriptions Respondent issued to Patient J.M. (admitted as GX 13; Tr. 16:15-18:3).

II. The Government Expert's Qualifications

6. Dr. Munzing's curriculum vitae was admitted into evidence as GX 23; Tr. 89. He is a licensed physician in the State of California, who has worked in the field of family medicine for nearly forty years. Tr. 89.

7. Dr. Munzing received his medical degree from the University of California, Los Angeles, in 1982, and did his residency at Kaiser Permanente Medical Center in Los Angeles. Tr. 89. He then began working in the family medicine department of Kaiser Permanente Orange County, where he has been for the last thirty-five years, twice serving as president of the medical staff at the hospital. Tr. 89, 94. He has a DEA COR and an active clinical practice, prescribing, inter alia, opioids, benzodiazepines, and other controlled substances when indicated. Tr. 91-92.

8. In addition to his clinical practice, Dr. Munzing teaches extensively to physicians, serving as the director of the Kaiser Permanente Orange County family medicine residency program. Tr. 90. Further, he is a full clinical professor at University of California, Irvine. Tr. 91. He also sits on the National Accreditation Board for Family Medicine Residency, which accredits all of the residency programs in the United States of America. Tr. 90-91.

9. Dr. Munzing has been called upon to provide opinions about the prescribing of other medical professionals, and he has been qualified as an expert witness in over 30 cases, including in DEA administrative hearings. Tr. 93-94.

10. As a licensed California physician who has been practicing in California for nearly 40 years, Dr. Munzing is familiar with the standard of care for prescribing controlled substances in California. He also has reviewed publications by the Medical Board of California that inform his understanding of the standard of care, including the “Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons (7th Edition)” (admitted as GX 20, Tr. 16-18), and the “Guidelines for Prescribing Controlled Substances for Pain,” (admitted as GX 21, Tr. 16). In addition, he is familiar with the FDA's black box warning regarding the risks of overdose and death posed by concurrently taking opioids and benzodiazepines, and the FDA labels for benzodiazepines including Klonopin, Valium, and Xanax (admitted as GX 22, Tr. 16-18). Further, Dr. Munzing reviewed several laws and regulations that informed his understanding of the standard of care. Tr. 99.

11. Dr. Munzing was qualified as an expert in California medical practice, including, but not limited to, applicable standards of care in California for the prescribing of controlled substances within the usual course of the professional practice of medicine. Tr. 102.

III. The Standard of Care for Prescribing Controlled Substances in California

12. Dr. Munzing testified that the standard of care in California first requires that, before prescribing controlled substances, a practitioner perform a sufficient evaluation of the patient, including, a medical history and appropriate physical examination. Tr. 103.

a. In the context of treating a patient with controlled substances for pain, the standard of care in the state of California requires the following:

i. Medical history: The practitioner must obtain detailed information about the pain, including where the pain is, how long a patient has had it, how severe the pain is, the impact of the pain on the patient's functionality and activities of daily living, and any previous diagnoses and treatments the patient has received for the pain. The practitioner must also seek to obtain any relevant prior medical records and imaging. Tr. 114-115.

ii. Physical examination: The practitioner must look at the area of pain unclothed for any swelling, redness, or mass. Tr. 116-17. The practitioner must palpate the affected area and identify areas of particular tenderness or pain. Tr. 117-18. The practitioner also is required to test a patient's range of motion, as well as the patient's neurological conditions via targeted tests for the area affected by pain (

e.g.,

tendon reflexes, and strength tests for the affected area). Tr. 118-19.

b. In the context of treating a patient with controlled substances for mental health conditions, the standard of care in the state of California requires the following:

i. Medical history: The practitioner must inquire into the patient's condition, including symptoms the patient is experiencing, when the patient experiences symptoms, how those symptoms impact the patient's functionality and activities of daily living, when the condition began, and if there is a family history of mental health issues. The practitioner must also seek to obtain any relevant prior medical records. Tr. 136-38.

ii. Physical examination: The practitioner must conduct a limited and focused general examination, including heart, lungs, and vital signs, [to rule out other possible medical diagnosis.] Tr. 138-39.

13. As part of the medical history, the practitioner must inquire into the patient's history of, and/or current use or abuse of, tobacco, drugs, or alcohol, as well as into any family history of use or abuse of tobacco, drugs, or alcohol. Tr. 120-21, 142.

14. Based on the history and physical examination, the standard of care requires the practitioner to assign a diagnosis to the patient. Tr. 103. An appropriate history and physical examination are crucial to arriving at an appropriate diagnosis. Tr. 121-22, 141. Without an appropriate diagnosis, a practitioner cannot establish a legitimate medical purpose to prescribe. Tr. 124, 141. [The standard of care requires the diagnosis to be documented in the record. Tr. 122.]

15. Next, the standard of care requires the practitioner to develop a customized and documented treatment plan for the patient with goals and objectives. Tr. 109-110. The practitioner must relay that plan to the patient, inform the patient of the risks *

BB

and benefits of treatment with controlled substances, as well as potential alternative treatments, and obtain the patient's informed consent for the treatment. Tr. 103-04, 124-25. When prescribing high dosages of controlled substances, this discussion of risks must include risks of addiction, overdose, and death. Tr. 126-27. “All of [this] needs to be documented” in the medical record. Tr. 135.

*

BB

The practitioner must determine the risk posed to a patient by controlled substances due to the patient's overall health history—as well as the potential for substance abuse or addiction. Tr. 103, 109. This text, which appeared in the RD originally, has been relocated for clarity.

a. In the context of treating a patient with controlled substances for pain, the standard of care in the state of California requires that a treatment plan contain goals and objectives for pain management, such as maximizing benefit to function and minimizing pain, while also minimizing the risk to the patient from the controlled substances prescribed. Tr. 131.

b. In the context of treating a patient with controlled substances for mental health conditions, the standard of care in the State of California still requires that the treatment plan contain goals and objectives for the patient. Tr. 143.

c. With respect to risks of medications, Dr. Munzing explained that practitioner should only co-prescribe opioids and benzodiazepines when “absolutely necessary,” and should do so for “[n]o longer than absolutely necessary and typically in as low doses as possible to . . . decrease the risk.” Tr. 154-55.

16. As treatment progresses, the standard of care requires a physician to monitor the patient. Tr. 104, 132. A practitioner must periodically update the patient's medical history, conduct further physical examinations, and obtain updated information regarding the etiology of a patient's state of health. Tr. 106-08. The practitioner must periodically review the course of treatment, ascertain how the patient is responding thereto, determine if continued treatment is appropriate or if the treatment plan needs to be modified, and document the rationale for any modifications. Tr. 108-09, 206; GX 20 at 61. The practitioner must also periodically re-inquire into the patient's use or abuse of tobacco, drugs, or alcohol. Tr. 259-60.

17. The practitioner must also periodically conduct updated physical examinations, both brief general examinations to ensure that the patient is healthy enough to continue receiving controlled substances, as well as focused examinations of the area for which pain is being treated to help in determining how the patient is responding to treatment. Tr. 111-12.

18. When prescribing controlled substances, the standard of care in California also requires a practitioner to monitor medication compliance, including thorough reviews of CURES, Tr. 132, periodic urine drug screening, Tr. 133, and/or pill counts.

Id.

The practitioner must address any red flags of abuse or diversion. Tr. 112.

19. In addition, the standard of care requires that a practitioner document all of these above steps in detail.

See, e.g.,

Tr. 104, 109, 110, 112, 122, 135, 144. Such documentation is critically important as it: (1) enables the practitioner to recall important facts about the patient's state of health and treatment, Tr. 145, 146; and (2) allows other practitioners who may also see the patient to see these facts. Tr. 145-146.

20. Appropriate documentation is a well-known, fundamental requirement in the medical community. Tr. 146. [According to Dr. Munzing, “[t]he general mantra in medicine [is] . . . if [it is] not documented, it [did not] happen.” Tr. 148. Thus, it is not credible that a practitioner who consistently failed to document these basic elements for a patient actually performed them. Tr. 148-50.

21. The practitioner must also comply with all relevant California laws.

IV. Respondent's Improper Prescribing of Controlled Substances

A. Patient S.B.

i. Patient S.B.'s Initial Visit

22. Between February 2, 2017, and January 30, 2019, Respondent issued Patient S.B. the controlled substance prescriptions listed in Joint Stipulation No. 10.

See

ALJ Ex. 3 at 2-3. During this time, Respondent diagnosed Patient S.B. with fibromyalgia, GAD, and ADD. GX 1 at 47-59.

23. Respondent's initial encounter with Patient S.B. took place on August 3, 2016. GX 1 at 62, 66; Tr. 164-65. At that visit, Respondent diagnosed Patient S.B. with fibromyalgia, GAD, and ADD. GX 1 at 62; Tr. 165. Respondent prescribed Patient S.B. hydrocodone for fibromyalgia, Xanax for GAD, and Adderall for ADD. GX 1 at 62; Tr. 165. At this initial visit, Respondent failed to:

a. Take an appropriate medical history, GX 1 at 62; Tr. 166-68;

b. address Patient S.B.'s pain or functionality levels, GX 1 at 62; Tr. 171;

c. conduct an appropriate physical examination, GX 1 at 62; Tr. 166, 168-71;

d. establish appropriate diagnoses, and therefore to establish legitimate medical purposes for hydrocodone, Xanax, or Adderall, Tr. 171-72; or

e. establish and document a treatment plan with goals and objectives, GX 1 at 62; Tr. 172-73.

ii. Continued Controlled Substance Prescribing Violations

24. Throughout the entire course of treatment, Respondent never obtained a proper medical history of Patient S.B., never recorded Patient S.B.'s pain or functionality levels, never obtained prior medical records for Patient S.B.—nor does Patient S.B.'s medical file reflect Respondent requested such records—failed to periodically update Patient S.B.'s medical history as treatment progressed, and never conducted a sufficient physical examination for fibromyalgia.

See generally

GX 1; Tr. 241-43.

25. None of Respondent's diagnoses of Patient S.B. for which he prescribed controlled substances were based on sufficient clinical evidence. Tr. 243.

26. Over the course of his treatment of Patient S.B., Respondent's diagnoses of Patient S.B. for ADD, GAD and fibromyalgia came and went without explanation or comment.

See generally

GX 1; Tr. 188, 193-95. Fibromyalgia and ADD are chronic diagnoses. Tr. 188, 193. These erratic diagnoses were outside of the standard of care, [especially since these diagnoses,] including those made between February 2, 2017, and January 30, 2019, [were not supported by an adequate medical history and physical examination].*

CC

Tr. 191-92; 195-97.

*

CC

I have made this change for S.B. and each of the subsequent patients for legal clarity pursuant to

supra

n. *HH.

27. Respondent sometimes prescribed Patient S.B. both hydrocodone and Soma, and sometimes only hydrocodone, for fibromyalgia. See GX 1 at 47-59; Tr. 197:3-17. Respondent never documented any rationale for changing Patient S.B.'s course of medication in violation of the California standard of care. See GX 1 at 47-59; PFF ¶ 16; Tr. 199-200.

28. Respondent never documented an appropriate treatment plan with goals and objectives for Patient S.B., never documented an appropriate rationale for continued treatment of Patient S.B. with controlled substances, and failed to properly discuss the risks and benefits of the controlled substances he prescribed to Patient S.B.

See generally

GX 1; Tr. 243.

29. Respondent also prescribed Patient S.B. the following dangerous combinations of controlled substances that put Patient S.B. at serious risk of adverse medical consequences, including addiction, overdose, and death. Tr. 203-05:

a. Hydrocodone, Adderall, and Soma on February 2, 2017, May 8, 2017, June 2, 2017, August 1, 2017, August 30, 2017, November 6, 2017, and January 23, 2018. ALJ Ex. 3 at 2-3.

b. Hydrocodone, Adderall, and Xanax on March 1, 2017, April 4, 2017, June 28, 2017. ALJ Ex. 3 at 2-3.

c. Hydrocodone and Adderall on September 29, 2017, July 2018, and in August 2018, September 2018, October 2018, and November 2018. ALJ Ex. 3 at 3.

30. Respondent's prescriptions to Patient S.B. for Xanax between February 2, 2017, and January 30, 2019, were all for 6 mg of Xanax per day. GX 1 at 57-59; Tr. 212-13. The maximum recommended dosage for Xanax for treatment of GAD is 4 mg per day, according to the FDA label for Xanax. GX 22 at 59; Tr. 213. Prescribing such high dosages of Xanax placed Patient S.B. at risk of potentially lethal withdrawal, and presented risks of diversion. Tr. 217, 218-19. The fact that Respondent prescribed Xanax to Patient S.B. concurrently with opioids, see ALJ Ex. 3 at 2-3, dramatically increased her risk of overdose and death. Tr. 217-18.

31. Respondent noted, on fifteen occasions between February 2, 2017, and December 21, 2018, that Patient S.B. was opioid dependent and refusing detoxification. GX 1 at 49-59. Refusal to detoxify is a significant red flag of abuse or diversion, indicating the prescriber feels the patient needs to detoxify, but the patient refuses. Tr. 221-22. Respondent never addressed this red flag, but simply continued to prescribe the patient opioids on an as-needed basis. GX 1 at 49-59; Tr. 222. Prescribing opioids to the patient on an as-needed basis when a patient is refusing detoxification is particularly inappropriate, because any prescribed opioids must be carefully controlled. Tr. 223.

32. Patient S.B. provided inconsistent information to other providers; she told an orthopedic surgeon during a June 28, 2017 visit that she had only a past medical history of anxiety (with no mention of fibromyalgia or ADD), and she did not disclose taking any medications when she was receiving hydrocodone, Soma, Adderall, and Xanax from Respondent. See GX 1 at 30, 57. Patient S.B. also informed the orthopedic surgeon that she had no history of trauma,

see

GX 1 at 30, but reported to the California Employment Development Department that she was disabled as a result of accident or trauma that had occurred on June 15, 2017, see GX 1 at 40. These inconsistent reports were significant red flags of abuse or diversion. Tr. 230, 231-32. Respondent, however, never addressed these red flags. Tr. 233, 235-37.

This text is long and has been trimmed here. Open the source document for the complete record.